Controloc 40

CHARACTERISTICS OF THE MEDICINAL PRODUCT

1. NAME OF THE MEDICINAL PRODUCT

Controloc 40, 40 mg, enteric-coated tablets

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each enteric-coated tablet contains 40 mg of pantoprazole (in the form of pantoprazole sodium sesquihydrate).
A full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Enteric-coated tablet (tablet).
Yellow, oval, biconvex, enteric-coated tablet with brown imprint "P40" on one side.

4. CLINICAL PARTICULARS

4.1 Therapeutic Indications

Controloc 40 is indicated for use in adults and adolescents aged 12 years and above for:

• Reflux esophagitis.

Controloc 40 is indicated for use in adults for:

• Eradication of Helicobacter pylori (H. pylori) in combination with appropriate antibiotics in patients with H. pylori-associated peptic ulcer disease.
• Peptic ulcer disease and (or) duodenal ulcer.
• Zollinger-Ellison syndrome and other conditions associated with excessive acid secretion.

4.2 Posology and Method of Administration

Dosage
Adults and adolescents aged 12 years and above
Reflux esophagitis
1 tablet of Controloc 40 per day. In individual cases, the dose may be doubled (increased to 2 tablets of Controloc 40 per day) especially when there is no response to other treatments. For the treatment of reflux esophagitis, the product is usually administered for 4 weeks. If this period is not sufficient to achieve healing, the product is usually administered for another 4 weeks.
Adults
Eradication of H. pylori in combination with two appropriate antibiotics
In patients with gastric and duodenal ulcers and confirmed presence of H. pylori, eradication of the bacteria should be performed using combination therapy. Official local guidelines (e.g., national recommendations) regarding bacterial resistance and proper use and prescription of antibacterial agents should be taken into account.
Depending on the type of resistance, the following combination therapy regimens are recommended for H. pylori eradication:
a)
twice daily 1 tablet of Controloc 40
+ twice daily 1000 mg of amoxicillin
+ twice daily 500 mg of clarithromycin
b)
twice daily 1 tablet of Controloc 40
+ twice daily 400-500 mg of metronidazole (or 500 mg of tinidazole)
+ twice daily 250-500 mg of clarithromycin
c)
twice daily 1 tablet of Controloc 40
+ twice daily 1000 mg of amoxicillin
+ twice daily 400-500 mg of metronidazole (or 500 mg of tinidazole)
In the case of combination therapy for H. pylori eradication, the second tablet of Controloc 40 should be taken 1 hour before dinner. Combination therapy is usually administered for 7 days and may be extended for another 7 days, up to a total treatment duration of 2 weeks. If further treatment with pantoprazole is indicated to ensure complete healing of ulcers, the recommended dosage for the treatment of peptic ulcer disease should be considered.
If combination therapy is not necessary, e.g., when the H. pylori test result is negative, the recommended dosage of Controloc 40 in monotherapy is:
Treatment of gastric ulcer
One tablet of Controloc 40 per day. In individual cases, the dose may be doubled (increased to 2 tablets of Controloc 40 per day) especially when there is no response to other treatments. Usually, within 4 weeks, gastric ulcers heal. If this period is insufficient, in most cases, to achieve complete healing, it should be extended by another 4 weeks.
Treatment of duodenal ulcer
One tablet of Controloc 40 per day. In individual cases, the dose may be doubled (increased to 2 tablets of Controloc 40 per day) especially when there is no response to other treatments. Usually, within 2 weeks, duodenal ulcers heal. If the 2-week period is insufficient, in most cases, to achieve complete healing, it should be extended by another 2 weeks.
Zollinger-Ellison syndrome and other conditions associated with excessive acid secretion
Long-term treatment of Zollinger-Ellison syndrome and other conditions associated with excessive acid secretion should be started with a daily dose of 80 mg (2 tablets of Controloc 40). Then, the dose may be increased or decreased depending on the needs, based on the results of gastric acid secretion tests. Daily doses greater than 80 mg should be divided and administered twice daily. It is possible to periodically increase the dose of pantoprazole above 160 mg per day, but it should not be used for longer than necessary to achieve adequate acid suppression.
The duration of treatment of Zollinger-Ellison syndrome and other conditions associated with excessive acid secretion is not limited and should be adjusted according to clinical symptoms.
Special patient populations
Patients with impaired liver function
A daily dose of more than 20 mg of pantoprazole should not be used in patients with severe liver impairment. Controloc 40 should not be used in combination therapy for H. pylori eradication in patients with moderate and severe liver impairment, as there is currently a lack of data on the efficacy and safety of Controloc 40 in combination therapy in this patient population (see section 4.4).
Patients with impaired renal function
In patients with impaired renal function, there is no need to modify the dosage. Controloc 40 should not be used in combination therapy for H. pylori eradication in patients with impaired renal function, as there is currently a lack of data on the efficacy and safety of Controloc 40 in combination therapy in this patient population (see section 5.2).
Elderly patients
In elderly patients, there is no need to modify the dosage (see section 5.2).
Children and adolescents
Controloc 40 is not recommended for use in children under 12 years of age due to limited data on safety and efficacy in this age group (see section 5.2).
Method of administration
Oral administration.
The tablets should not be chewed or crushed, they should be taken 1 hour before a meal, swallowed whole, and washed down with water.

4.3 Contraindications

Hypersensitivity to the active substance, substituted benzimidazoles, or to any of the excipients listed in section 6.1.

4.4 Special Warnings and Precautions for Use

Impaired liver function
In patients with severe liver impairment, during pantoprazole treatment, especially in the case of long-term use, liver enzyme activity should be regularly monitored. In the case of increased liver enzyme activity, treatment should be discontinued (see section 4.2).
Combination therapy
In the case of combination therapy, the information contained in the Summary of Product Characteristics of the concomitantly used medicinal products should also be taken into account.
Gastric cancer
The symptomatic response to pantoprazole may mask the symptoms of gastric cancer and may delay its diagnosis. In the case of alarm symptoms (such as significant unintentional weight loss, recurrent vomiting, dysphagia, hematemesis, anemia, melena) and suspected or confirmed gastric ulcers, their malignant background should be excluded.
Further investigations should be considered in patients whose symptoms persist despite adequate treatment.
Concomitant use with HIV protease inhibitors
Concomitant use of pantoprazole with HIV protease inhibitors, whose absorption depends on acidic gastric pH, such as atazanavir, is not recommended, as it may significantly decrease their bioavailability (see section 4.5).
Effect on vitamin B12 absorption
In patients with Zollinger-Ellison syndrome and other conditions associated with excessive acid secretion requiring long-term treatment, pantoprazole, like other acid-suppressing drugs, may reduce vitamin B12 (cyanocobalamin) absorption. This is due to the lack of gastric acid or achlorhydria in gastric juice. This should be taken into account during long-term treatment of patients with vitamin B12 deficiency and those at risk of impaired vitamin B12 absorption or if clinical symptoms occur.
Long-term therapy
During long-term therapy, especially when treatment lasts more than a year, patients should be regularly monitored by a doctor.
Gastrointestinal infections caused by bacteria
Treatment with Controloc 40 may cause a slight increase in the risk of gastrointestinal infections caused by bacteria of the Salmonella and Campylobacter or Clostridium difficile families.
Hypomagnesemia
In patients treated with proton pump inhibitors (PPIs), such as pantoprazole, for a period of at least three months and in most cases, for a period of one year, rare cases of severe hypomagnesemia have been reported. Symptoms of severe hypomagnesemia, such as fatigue, tetany, confusion, convulsions, dizziness, and cardiac arrhythmias, may develop insidiously and may not be recognized. Hypomagnesemia may lead to hypocalcemia and (or) hypokalemia (see section 4.8). In patients with the most severe hypomagnesemia (and hypomagnesemia-related hypocalcemia and (or) hypokalemia), discontinuation of proton pump inhibitors and initiation of magnesium supplementation led to improvement.
In patients who are to receive proton pump inhibitors for a long time and in patients taking proton pump inhibitors with drugs such as digoxin or other medicinal products that may cause hypomagnesemia (e.g., diuretics), healthcare professionals should consider measuring magnesium levels before starting proton pump inhibitor therapy and periodically during its course.
Fractures
The use of proton pump inhibitors, especially when taken in high doses and in long-term therapy (over 1 year), may slightly increase the risk of fractures of the hip, wrist, or spine, especially in elderly patients or patients with other risk factors. Observational studies suggest that proton pump inhibitors may increase the overall risk of fractures by 10-40%. The increase in risk may also be caused by other factors. Patients at risk of osteoporosis should be treated in accordance with applicable clinical guidelines to ensure adequate intake of vitamin D and calcium.
Severe cutaneous adverse reactions (SCARs)
Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported with the use of pantoprazole (frequency not known). In addition, drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported (frequency not known). These reactions are potentially life-threatening or fatal (see section 4.8). When prescribing the medicinal product, patients should be informed about the signs and symptoms and closely monitored for skin reactions.
In the event of signs and symptoms indicating these reactions, pantoprazole should be discontinued immediately and alternative treatment considered.
Subacute cutaneous lupus erythematosus (SCLE)
The use of proton pump inhibitors is associated with the rare occurrence of SCLE. If skin lesions occur, especially in areas exposed to sunlight, with joint pain, the patient should seek medical attention immediately, and the doctor should consider discontinuing Controloc 40.
The occurrence of SCLE due to previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.
Effect on laboratory tests
An increase in chromogranin A (CgA) levels may interfere with investigations for neuroendocrine tumors. To avoid this, treatment with Controloc 40 should be discontinued at least 5 days before measuring CgA levels (see section 5.1). If after initial measurement, CgA and gastrin levels still exceed the reference range, measurements should be repeated after 14 days of discontinuation of proton pump inhibitor treatment.
Controloc 40 contains sodium.
This medicinal product contains less than 1 mmol (23 mg) of sodium per tablet, i.e., the medicinal product is essentially "sodium-free".

4.5 Interaction with Other Medicinal Products and Other Forms of Interaction

Medicinal products whose pharmacokinetics of absorption depends on pH
Due to the strong and long-lasting inhibition of gastric acid secretion, pantoprazole may interfere with the absorption of other medicinal products for which gastric pH is an important factor influencing bioavailability, such as certain antifungal azoles, e.g., ketoconazole, itraconazole, posaconazole, and other drugs such as erlotinib.
HIV protease inhibitors
Concomitant use of pantoprazole with HIV protease inhibitors, whose absorption depends on acidic gastric pH, such as atazanavir, is not recommended, as it may significantly decrease their bioavailability (see section 4.4).
If concomitant use of HIV protease inhibitors with a proton pump inhibitor is necessary, close monitoring of the patient's clinical condition (e.g., viral load) is recommended. A dose of more than 20 mg of pantoprazole per day should not be used. It may be necessary to adjust the dose of the HIV protease inhibitor.
Anticoagulants of the coumarin type (phenprocoumon or warfarin)
Concomitant use of pantoprazole with warfarin or phenprocoumon did not affect the pharmacokinetics of warfarin, phenprocoumon, or the change in INR (International Normalized Ratio) values. However, increased INR values and prothrombin time have been reported in patients taking proton pump inhibitors and warfarin or phenprocoumon concomitantly. The increase in INR values and prothrombin time may lead to abnormal bleeding, even death. In patients treated concomitantly with pantoprazole and warfarin or phenprocoumon, it may be necessary to monitor the increase in INR values and prothrombin time.
Methotrexate
In some patients, concomitant use of high-dose methotrexate (e.g., 300 mg) with proton pump inhibitors has led to increased methotrexate levels. Therefore, in patients taking high-dose methotrexate, e.g., for cancer or psoriasis, it is recommended to temporarily discontinue pantoprazole use.
Other interaction studies
Pantoprazole is extensively metabolized in the liver, mainly by the cytochrome P450 enzyme system. The main metabolic pathway is demethylation by CYP2C19, while other metabolic pathways include oxidation by CYP3A4.
Interaction studies with other medicinal products metabolized by the same enzyme system, such as carbamazepine, diazepam, glibenclamide, nifedipine, and oral contraceptives containing levonorgestrel and ethinylestradiol, did not reveal clinically significant interactions.
It cannot be excluded that pantoprazole interacts with other medicinal products or compounds metabolized by the same enzyme system.
The results of interaction studies indicate that pantoprazole does not affect the metabolism of substances metabolized by CYP1A2 (e.g., caffeine, theophylline), CYP2C9 (e.g., piroxicam, diclofenac, naproxen), CYP2D6 (e.g., metoprolol), CYP2E1 (e.g., ethanol), and does not interfere with the P-glycoprotein-dependent absorption of digoxin.
No interactions have been reported with concomitantly used antacids.
Interaction studies have also been conducted in which pantoprazole was administered concomitantly with appropriate antibiotics (clarithromycin, metronidazole, amoxicillin). No clinically significant interactions have been reported.
Medicinal products that inhibit or induce CYP2C19
CYP2C19 inhibitors, such as fluvoxamine, may increase the systemic exposure to pantoprazole. It is recommended to consider a dose reduction in patients treated long-term with high doses of pantoprazole or in patients with impaired liver function.
CYP2C19 and CYP3A4 enzyme inducers, such as rifampicin or St. John's wort (Hypericum perforatum), may decrease the plasma levels of proton pump inhibitors metabolized by these enzyme systems.
Effect on laboratory tests
In some urine screening tests for tetrahydrocannabinol (THC), false-positive results have been reported in patients taking pantoprazole. It is recommended to consider using an alternative testing method to verify positive results.

4.6 Fertility, Pregnancy, and Lactation

Pregnancy
A moderate amount of data in pregnant women (between 300-1000 pregnant women) does not indicate that pantoprazole causes developmental toxicity or fetal harm. In animal studies, adverse effects on reproduction have been observed (see section 5.3). For safety reasons, it is recommended to avoid using Controloc 40 during pregnancy.
Breastfeeding
In animal studies, pantoprazole has been detected in breast milk. There is insufficient data on the passage of pantoprazole into human milk; however, there are reports of such passage. It cannot be excluded that adverse reactions may occur in the breastfed infant. Therefore, a decision should be made to either discontinue breastfeeding or discontinue/avoid the use of Controloc 40, taking into account the benefits of breastfeeding for the child and the benefits of treatment for the mother.
Fertility
In animal studies, no impairment of fertility has been observed after administration of pantoprazole (see section 5.3).

4.7 Effects on Ability to Drive and Use Machines

Pantoprazole has no influence or negligible influence on the ability to drive and use machines.
Adverse reactions, such as dizziness and visual disturbances (see section 4.8), may occur. In such cases, patients should not drive vehicles or operate machinery.

4.8 Undesirable Effects

About 5% of patients may experience undesirable effects (ADRs).
In the table below, undesirable effects are classified according to the following frequency:
Very common (≥1/10); common (≥1/100 to <1>For all undesirable effects reported after the medicinal product was placed on the market, it is not possible to apply a frequency classification, so their frequency is marked as "not known".
Within each frequency group, undesirable effects are listed in order of severity, from most severe to least severe.
Table 1. Undesirable effects related to the use of pantoprazole reported in clinical trials and after marketing authorization

Hypocalcemia and (or) hypokalemia may be associated with hypomagnesemia (see section 4.4)
Muscle spasms due to electrolyte disturbances
Reporting suspected adverse reactions
After the medicinal product has been placed on the market, it is important to report any suspected adverse reactions. This allows for the continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Department of Adverse Reaction Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl .
Adverse reactions can also be reported to the marketing authorization holder.

4.9 Overdose

There are no known symptoms of overdose in humans.
Doses of up to 240 mg administered intravenously over 2 minutes were well tolerated.
Since pantoprazole is extensively bound to plasma proteins, it is not easily dialyzable. In the case of overdose with clinical symptoms of poisoning, apart from symptomatic and supportive treatment, there are no specific therapeutic recommendations.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic Properties

Therapeutic group: Proton pump inhibitors, ATC code: A02BC02
Mechanism of action
Pantoprazole is a substituted benzimidazole that inhibits gastric acid secretion by specifically blocking the proton pump in parietal cells.
In the acidic environment of parietal cells, pantoprazole is converted to its active form and inhibits the activity of H+,K+-ATPase, the final step in gastric acid production. The degree of inhibition is dose-dependent and affects both basal and stimulated acid secretion. In most patients, symptom relief is achieved within 2 weeks. As with other acid-suppressing drugs, treatment with pantoprazole leads to a decrease in gastric acidity and a secondary increase in gastrin secretion in proportion to the decrease in acidity.
The increase in gastrin secretion is reversible. Since pantoprazole binds to the enzyme at the receptor level of the parietal cell, it can affect acid secretion independently of the stimulation by other substances (acetylcholine, histamine, gastrin). The effect is the same regardless of whether the product is administered orally or intravenously.
Pharmacodynamic effects
Gastrin levels on an empty stomach increase under the influence of pantoprazole. During short-term use, these values usually do not exceed the upper limit of normal. During long-term treatment, gastrin levels in most cases double. However, excessive increases in gastrin levels occur only in rare cases. As a result, in rare cases of long-term treatment, mild to moderate increases in the number of specific ECL cells in the stomach (simple to nodular hyperplasia) have been observed. However, according to the studies conducted so far, the development of precancerous changes (atypical hyperplasia) or gastric carcinomas, which have been observed in animal studies (see section 5.3), has not been observed in humans.
During long-term therapy, when pantoprazole treatment lasts more than a year, based on animal studies, it cannot be entirely excluded that pantoprazole may affect the parameters of thyroid hormone secretion.
During treatment with acid-suppressing medicinal products, gastrin levels in serum increase in response to the decrease in gastric acid secretion. CgA levels also increase due to the decrease in intragastric acidity. The increase in CgA levels may interfere with investigations for neuroendocrine tumors.
Available published evidence suggests that treatment with proton pump inhibitors should be discontinued for a period of 5 to 14 days before measuring CgA levels. This is to allow the CgA levels, which may be falsely elevated due to proton pump inhibitor treatment, to return to the reference range.

5.2 Pharmacokinetic Properties

Absorption
Pantoprazole is rapidly absorbed from the gastrointestinal tract, reaching maximum plasma concentrations after a single oral dose of 40 mg, even after multiple doses. The maximum plasma concentration is reached on average 2.5 hours after administration and is approximately 2-3 μg/ml. These values do not change after multiple doses.
There are no differences in pharmacokinetics after single and multiple doses. Within the dose range of 10 to 80 mg, the pharmacokinetics of pantoprazole are linear, both after oral and intravenous administration.
The absolute bioavailability of pantoprazole in the form of a tablet is approximately 77%. Concomitant intake of food does not affect the area under the plasma concentration-time curve (AUC), maximum plasma concentration, and thus the bioavailability. Concomitant intake of food may affect the delay in the onset of action of the medicinal product.
Distribution
Pantoprazole is bound to plasma proteins at approximately 98%. The volume of distribution is approximately 0.15 l/kg.
Metabolism
The substance is metabolized almost exclusively in the liver. The main metabolic pathway is demethylation by CYP2C19, while other metabolic pathways include oxidation by CYP3A4.
Elimination
The terminal half-life is approximately 1 hour, and the clearance is approximately 0.1 l/h/kg.
A few cases have been reported where the elimination half-life was prolonged. Since pantoprazole specifically binds to the proton pump in parietal cells, the elimination half-life does not correlate with the longer duration of action (inhibition of acid secretion).
Pantoprazole metabolites are excreted mainly by the kidneys (approximately 80%), and the rest is excreted in the feces. The main metabolite, both in plasma and urine, is demethylpantoprazole, which is conjugated with sulfate. The half-life of the main metabolite (approximately 1.5 hours) does not differ significantly from the half-life of pantoprazole.
Special patient populations
Poor metabolizers
In approximately 3% of the European population, defined as poor metabolizers, there is no functional CYP2C19 enzyme. In these individuals, the metabolism of pantoprazole is probably catalyzed mainly by CYP3A4. After a single dose of 40 mg of pantoprazole, the mean area under the plasma concentration-time curve was 6 times higher in poor metabolizers compared to individuals with a functional CYP2C19 enzyme (extensive metabolizers). The mean maximum plasma concentrations increased by approximately 60%. These data do not affect the dosage of pantoprazole.
Patients with impaired renal function
There is no need to reduce the dose of pantoprazole in patients with impaired renal function (including those undergoing dialysis). As in healthy individuals, the half-life of pantoprazole is short. Only small amounts of pantoprazole are removed during dialysis. Although the half-life of the main metabolite is moderately prolonged (2-3 hours), elimination is still rapid, and no accumulation of the product occurs.
Patients with impaired liver function
In patients with liver cirrhosis (Child A and B), the half-life is prolonged to 7-9 hours, and AUC values increase 5-7 times. However, the maximum plasma concentration increases only slightly, 1.5 times, compared to healthy individuals.
Elderly patients
A slight increase in AUC and maximum plasma concentration (C) values in elderly volunteers compared to younger volunteers has been observed, but this is not clinically significant.
Children and adolescents
After administration of a single oral dose of 20 or 40 mg of pantoprazole to children aged 5-16 years, AUC and C values were within the range of values for adults.
After a single intravenous dose of pantoprazole 0.8 or 1.6 mg/kg body weight to children aged 2-16 years, no significant relationship was found between the clearance of pantoprazole and age or body weight. The AUC and volume of distribution values were consistent with the data obtained in adults.

5.3 Preclinical Safety Data

Non-clinical data from conventional pharmacological studies on safety, repeated dose toxicity studies, and genotoxicity studies do not indicate any special hazard for humans.
In two-year carcinogenicity studies conducted in rats, the occurrence of neuroendocrine tumors has been observed. Additionally, in rats, the occurrence of squamous cell papillomas in the forestomach has been observed. The mechanism leading to the development of gastric carcinomas by substituted benzimidazoles has been extensively studied and allows us to conclude that it is a secondary reaction to significantly increased gastrin levels in the blood, which occur in rats during long-term treatment with high doses. In two-year studies, an increased number of cases of liver tumors has been observed in rats and female mice, which is thought to be a phenomenon dependent on the high rate of pantoprazole metabolism in the liver.
In the case of rats receiving the highest doses of pantoprazole (200 mg/kg body weight), a slight increase in the frequency of thyroid tumors has been observed. The occurrence of these tumors is associated with changes in the distribution of thyroxine in the liver of rats caused by pantoprazole. Since therapeutic doses in humans are low, no adverse effects on the thyroid gland are expected.
In a study on the effect on reproduction in rats during the perinatal period, aimed at assessing the development of bones, signs of toxicity in the offspring (mortality, lower average body weight, lower average body weight gain, and reduced bone growth) were observed at exposure (C) corresponding to approximately 2 times the clinical exposure in humans. At the end of the recovery phase, bone parameters were similar in all groups, and body weights also showed a tendency to reverse after the recovery phase without drug administration. Increased mortality was observed only in young rats before weaning (up to 21 days of age), which approximately corresponds to infants up to 2 years of age. The significance of this observation for the population of children and adolescents is unknown. An earlier study in rats during the perinatal period, with slightly lower doses, did not show any adverse effects at a dose of 3 mg/kg body weight compared to a low dose of 5 mg/kg body weight used in this study.
Studies have not shown any effect on fertility or teratogenic effects of the product.
Studies in rats have shown that the product crosses the placental barrier, resulting in increased exposure of the fetus to pantoprazole shortly before birth.

6. PHARMACEUTICAL PARTICULARS

6.1 List of Excipients

Core
Sodium carbonate anhydrous
Mannitol (E421)
Crospovidone
Povidone K90
Calcium stearate
Coating
Hypromellose
Povidone K25
Titanium dioxide (E171)
Yellow iron oxide (E172)
Propylene glycol (E1520)
Methacrylic acid and ethyl acrylate copolymer (1:1)
Polysorbate 80
Sodium lauryl sulfate
Triethyl citrate
Ink
Shellac
Red iron oxide (E172)
Black iron oxide (E172)
Yellow iron oxide (E172)
Concentrated ammonia solution

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

Blister packs
3 years
Bottles
Unopened: 3 years
Shelf life after first opening: 100 days.

6.4 Special Precautions for Storage

No special storage precautions for the medicinal product.

6.5 Nature and Contents of Container

HDPE bottle with LDPE cap.
7
enteric-coated tablets
10
enteric-coated tablets
14
enteric-coated tablets
15
enteric-coated tablets
24
enteric-coated tablets
28
enteric-coated tablets
30
enteric-coated tablets
48
enteric-coated tablets
49
enteric-coated tablets
56
enteric-coated tablets
60
enteric-coated tablets
84
enteric-coated tablets
90
enteric-coated tablets
98
enteric-coated tablets
98 (2x49) enteric-coated tablets
100
enteric-coated tablets
Hospital packs
50
enteric-coated tablets
90
enteric-coated tablets
100
enteric-coated tablets
140
enteric-coated tablets
140 (10x14) enteric-coated tablets
150 (10x15) enteric-coated tablets
700 (5x140) enteric-coated tablets
Aluminum/Aluminum blisters.
Aluminum/Aluminum blisters with paper backing (wallet for blister).
7
enteric-coated tablets
10
enteric-coated tablets
14
enteric-coated tablets
15
enteric-coated tablets
24
enteric-coated tablets
28
enteric-coated tablets
30
enteric-coated tablets
48
enteric-coated tablets
49
enteric-coated tablets
56
enteric-coated tablets
60
enteric-coated tablets
84
enteric-coated tablets
90
enteric-coated tablets
98
enteric-coated tablets
98 (2x49) enteric-coated tablets
100
enteric-coated tablets
112
enteric-coated tablets
168
enteric-coated tablets
Hospital packs
50
enteric-coated tablets
90
enteric-coated tablets
100
enteric-coated tablets
140
enteric-coated tablets
50 (50x1) enteric-coated tablets
140 (10x14) enteric-coated tablets
150 (10x15) enteric-coated tablets
500
enteric-coated tablets
700 (5x140) enteric-coated tablets
In Poland, packaging with 14, 28, and 60 tablets in Aluminum/Aluminum blisters and with 14 and 28 tablets in Aluminum/Aluminum blisters with paper backing, as well as with 14, 28, and 100 tablets in an HDPE bottle with an LDPE cap, are registered.
Not all pack sizes may be marketed.

6.6 Special Precautions for Disposal

No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local regulations.

7. MARKETING AUTHORIZATION HOLDER

RESPONSIBLE FOR BATCH RELEASE

Takeda Pharma Sp. z o.o.
ul. Prosta 68
00-838 Warsaw
medinfoEMEA@takeda.com

8. MARKETING AUTHORIZATION NUMBER

R/6898

9. DATE OF FIRST AUTHORIZATION

10. DATE OF APPROVAL OR PARTIAL REVISION OF THE TEXT

CHARACTERISTICS OF THE MEDICINAL PRODUCT

April 26, 2023

LABELING OF PACKAGING

INFORMATION TO BE INCLUDED ON OUTER PACKAGING

Box for blisters (1 x 14 tabs)

Box for blisters (2 x 14 tabs)

Box for blisters (4 x 15 tabs)

1. NAME OF THE MEDICINAL PRODUCT

Controloc 40, 40 mg, gastro-resistant tablets
pantoprazolum

2. ACTIVE SUBSTANCE CONTENT

Each gastro-resistant tablet contains 40 mg of pantoprazole (in the form of pantoprazole sodium sesquihydrate).

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENT OF THE PACKAGING

14 gastro-resistant tablets, code 5909990689842
28 gastro-resistant tablets, code 5909990689859
60 gastro-resistant tablets, code 5909990820344

5. METHOD AND ROUTE OF ADMINISTRATION

Oral administration.
Before taking the medicine, the patient should read the package leaflet.
The tablet should be swallowed whole, without chewing or crushing.

6. WARNING ABOUT STORAGE OF THE MEDICINAL PRODUCT

IN A PLACE INVISIBLE AND INACCESSIBLE TO CHILDREN

The medicine should be stored in a place invisible and inaccessible to children.

7. OTHER SPECIAL WARNINGS, IF NECESSARY

8. EXPIRY DATE

Expiry date (EXP):

9. STORAGE CONDITIONS

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCT OR WASTE DERIVED FROM IT, IF APPROPRIATE

PRODUCT OR WASTE DERIVED FROM IT, IF APPROPRIATE

APPLICABLE

11. NAME AND ADDRESS OF THE MARKETING AUTHORIZATION HOLDER

Takeda Pharma Sp. z o.o.
ul. Prosta 68
00-838 Warsaw
((marketing authorization holder's logo))

12. MARKETING AUTHORIZATION NUMBER

Marketing authorization number R/6898

13. BATCH NUMBER

Batch number (Lot):

14. GENERAL CATEGORY OF AVAILABILITY

Rp - Prescription-only medicine.

15. INSTRUCTIONS FOR USE

16. INFORMATION PROVIDED IN BRAILLE

controloc 40

17. UNIQUE IDENTIFIER – 2D CODE

Includes a 2D code that is a carrier of a unique identifier.

18. UNIQUE IDENTIFIER – HUMAN-READABLE DATA

PC:
SN:
NN:

INFORMATION TO BE INCLUDED ON OUTER PACKAGING

Box for blisters in paper wrapper (2 x 7 tabs)

Box for blisters in paper wrapper (4 x 7 tabs)

1. NAME OF THE MEDICINAL PRODUCT

Controloc 40, 40 mg, gastro-resistant tablets
pantoprazolum

2. ACTIVE SUBSTANCE CONTENT

Each gastro-resistant tablet contains 40 mg of pantoprazole (in the form of pantoprazole sodium sesquihydrate).

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENT OF THE PACKAGING

14 gastro-resistant tablets, code 5909990614752
28 gastro-resistant tablets, code 5909990614769

5. METHOD AND ROUTE OF ADMINISTRATION

Oral administration.
Before taking the medicine, the patient should read the package leaflet.
The tablet should be swallowed whole, without chewing or crushing.

6. WARNING ABOUT STORAGE OF THE MEDICINAL PRODUCT

IN A PLACE INVISIBLE AND INACCESSIBLE TO CHILDREN

The medicine should be stored in a place invisible and inaccessible to children.

7. OTHER SPECIAL WARNINGS, IF NECESSARY

8. EXPIRY DATE

Expiry date (EXP):

9. STORAGE CONDITIONS

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCT OR WASTE DERIVED FROM IT, IF APPROPRIATE

PRODUCT OR WASTE DERIVED FROM IT, IF APPROPRIATE

APPLICABLE

11. NAME AND ADDRESS OF THE MARKETING AUTHORIZATION HOLDER

Takeda Pharma Sp. z o.o.
ul. Prosta 68
00-838 Warsaw
((marketing authorization holder's logo))

12. MARKETING AUTHORIZATION NUMBER

Marketing authorization number R/6898

13. BATCH NUMBER

Batch number (Lot):

14. GENERAL CATEGORY OF AVAILABILITY

Rp - Prescription-only medicine.

15. INSTRUCTIONS FOR USE

16. INFORMATION PROVIDED IN BRAILLE

controloc 40

17. UNIQUE IDENTIFIER – 2D CODE

Not applicable

18. UNIQUE IDENTIFIER – HUMAN-READABLE DATA

Not applicable

INFORMATION TO BE INCLUDED ON OUTER PACKAGING

Box for bottle (14 tabs)

Box for bottle (28 tabs)

Box for bottle (100 tabs)

1. NAME OF THE MEDICINAL PRODUCT

Controloc 40, 40 mg, gastro-resistant tablets
pantoprazolum

2. ACTIVE SUBSTANCE CONTENT

Each gastro-resistant tablet contains 40 mg of pantoprazole (in the form of pantoprazole sodium sesquihydrate).

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENT OF THE PACKAGING

14 gastro-resistant tablets, code 5909990689811
28 gastro-resistant tablets, code 5909990689828
100 gastro-resistant tablets, code 5909990689835

5. METHOD AND ROUTE OF ADMINISTRATION

Oral administration.
Before taking the medicine, the patient should read the package leaflet.
The tablet should be swallowed whole, without chewing or crushing.

6. WARNING ABOUT STORAGE OF THE MEDICINAL PRODUCT

IN A PLACE INVISIBLE AND INACCESSIBLE TO CHILDREN

The medicine should be stored in a place invisible and inaccessible to children.

7. OTHER SPECIAL WARNINGS, IF NECESSARY

8. EXPIRY DATE

Expiry date (EXP):
Do not use the medicine after 100 days from the first opening of the bottle.

9. STORAGE CONDITIONS

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCT OR WASTE DERIVED FROM IT, IF APPROPRIATE

PRODUCT OR WASTE DERIVED FROM IT, IF APPROPRIATE

APPLICABLE

11. NAME AND ADDRESS OF THE MARKETING AUTHORIZATION HOLDER

Takeda Pharma Sp. z o.o.
ul. Prosta 68
00-838 Warsaw
((marketing authorization holder's logo))

12. MARKETING AUTHORIZATION NUMBER

Marketing authorization number R/6898

13. BATCH NUMBER

Batch number (Lot):

14. GENERAL CATEGORY OF AVAILABILITY

Rp - Prescription-only medicine.

15. INSTRUCTIONS FOR USE

16. INFORMATION PROVIDED IN BRAILLE

controloc 40

17. UNIQUE IDENTIFIER – 2D CODE

Includes a 2D code that is a carrier of a unique identifier.

18. UNIQUE IDENTIFIER – HUMAN-READABLE DATA

PC:
SN:
NN:

INFORMATION TO BE INCLUDED ON DIRECT PACKAGING

Wallet for blister

1. NAME OF THE MEDICINAL PRODUCT

Controloc 40, 40 mg, gastro-resistant tablets
pantoprazolum

2. ACTIVE SUBSTANCE CONTENT

Each gastro-resistant tablet contains 40 mg of pantoprazole (in the form of pantoprazole sodium sesquihydrate).

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENT OF THE PACKAGING

7 gastro-resistant tablets

5. METHOD AND ROUTE OF ADMINISTRATION

Oral administration.
Before taking the medicine, the patient should read the package leaflet.
The tablet should be swallowed whole, without chewing or crushing.

6. WARNING ABOUT STORAGE OF THE MEDICINAL PRODUCT

IN A PLACE INVISIBLE AND INACCESSIBLE TO CHILDREN

The medicine should be stored in a place invisible and inaccessible to children.

7. OTHER SPECIAL WARNINGS, IF NECESSARY

8. EXPIRY DATE

EXP:

9. STORAGE CONDITIONS

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCT OR WASTE DERIVED FROM IT, IF APPROPRIATE

PRODUCT OR WASTE DERIVED FROM IT, IF APPROPRIATE

APPLICABLE

11. NAME AND ADDRESS OF THE MARKETING AUTHORIZATION HOLDER

Takeda Pharma Sp. z o.o.
ul. Prosta 68
00-838 Warsaw
((marketing authorization holder's logo))

12. MARKETING AUTHORIZATION NUMBER

Marketing authorization number R/6898

13. BATCH NUMBER

Lot:

14. GENERAL CATEGORY OF AVAILABILITY

Rp - Prescription-only medicine.

15. INSTRUCTIONS FOR USE

16. INFORMATION PROVIDED IN BRAILLE

17. UNIQUE IDENTIFIER – 2D CODE

Not applicable

18. UNIQUE IDENTIFIER – HUMAN-READABLE DATA

Not applicable

MINIMUM INFORMATION TO BE INCLUDED ON BLISTERS OR FOIL PACKAGING

BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Controloc 40, 40 mg, tablets
pantoprazolum

2. NAME OF THE MARKETING AUTHORIZATION HOLDER

((marketing authorization holder's logo))

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. OTHER

INFORMATION TO BE INCLUDED ON DIRECT PACKAGING

Label for bottle

1. NAME OF THE MEDICINAL PRODUCT

Controloc 40, 40 mg, gastro-resistant tablets
pantoprazolum

2. ACTIVE SUBSTANCE CONTENT

Each gastro-resistant tablet contains 40 mg of pantoprazole (in the form of pantoprazole sodium sesquihydrate).

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENT OF THE PACKAGING

14 gastro-resistant tablets
28 gastro-resistant tablets
100 gastro-resistant tablets

5. METHOD AND ROUTE OF ADMINISTRATION

Oral administration.
Before taking the medicine, the patient should read the package leaflet.
The tablet should be swallowed whole, without chewing or crushing.

6. WARNING ABOUT STORAGE OF THE MEDICINAL PRODUCT

IN A PLACE INVISIBLE AND INACCESSIBLE TO CHILDREN

The medicine should be stored in a place invisible and inaccessible to children.

7. OTHER SPECIAL WARNINGS, IF NECESSARY

8. EXPIRY DATE

EXP:
Do not use the medicine after 100 days from the first opening of the bottle.

9. STORAGE CONDITIONS

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCT OR WASTE DERIVED FROM IT, IF APPROPRIATE

PRODUCT OR WASTE DERIVED FROM IT, IF APPROPRIATE

APPLICABLE

11. NAME AND ADDRESS OF THE MARKETING AUTHORIZATION HOLDER

Takeda Pharma Sp. z o.o.
ul. Prosta 68
00-838 Warsaw
((marketing authorization holder's logo))

12. MARKETING AUTHORIZATION NUMBER

Marketing authorization number R/6898

13. BATCH NUMBER

Lot:

14. GENERAL CATEGORY OF AVAILABILITY

Rp - Prescription-only medicine.

15. INSTRUCTIONS FOR USE

16. INFORMATION PROVIDED IN BRAILLE

17. UNIQUE IDENTIFIER – 2D CODE

18. UNIQUE IDENTIFIER – HUMAN-READABLE DATA

PATIENT INFORMATION LEAFLET

Patient information leaflet included in the packaging: information for the patient

Controloc 40, 40 mg, gastro-resistant tablets

pantoprazolum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

• 1. What is Controloc 40 and what is it used for
• 2. Important information before taking Controloc 40
• 3. How to take Controloc 40
• 4. Possible side effects
• 5. How to store Controloc 40
• 6. Contents of the pack and other information

1. What is Controloc 40 and what is it used for

Controloc 40 contains the active substance pantoprazole. Controloc 40 is a selective "proton pump inhibitor", a medicine that reduces the amount of acid produced in the stomach. It is used to treat diseases of the stomach and intestines related to the production of hydrochloric acid.
Controloc 40 is used in adults and adolescents aged 12 years and older to treat:

• Reflux esophagitis. This is a condition in which the esophagus (the tube that connects the throat to the stomach) becomes inflamed due to the reflux of hydrochloric acid from the stomach.

Controloc 40 is used in adults to:

• Treat an infection with the bacterium Helicobacter pylori in patients with stomach ulcers and/or duodenal ulcers, in combination with two antibiotics (eradication therapy), to eliminate the bacteria and prevent recurrence of ulcers.
• Treat stomach ulcers and/or duodenal ulcers.
• Treat Zollinger-Ellison syndrome and other conditions associated with excessive production of hydrochloric acid in the stomach.

2. Important information before taking Controloc 40

When not to take Controloc 40

• If you are allergic to pantoprazole or any of the other ingredients of this medicine (listed in section 6).
• If you have been diagnosed with an allergy to other proton pump inhibitors.

Warnings and precautions

Before taking Controloc 40, tell your doctor, pharmacist, or nurse:

• If you have severe liver problems. If you have ever had liver problems, tell your doctor. Your doctor may decide to monitor your liver enzymes more frequently, especially if you are taking Controloc 40 for a long time. If your liver enzymes increase, your doctor may decide to stop the treatment.
• If you have a deficiency of vitamin B12 or factors that may lead to a decrease in vitamin B12 levels, and you are taking pantoprazole for a long time. Like all medicines that reduce the production of hydrochloric acid in the stomach, pantoprazole may lead to a decrease in the absorption of vitamin B12. Tell your doctor if you notice any of the following symptoms, which may indicate a low level of vitamin B12:
• extreme fatigue or lack of energy,
• numbness or tingling,
• pain or redness of the tongue, mouth ulcers,
• muscle weakness,
• vision problems,
• memory problems, disorientation, depression.
• If you are taking HIV protease inhibitors such as atazanavir (used to treat HIV infection), ask your doctor for specific advice.
• Taking a proton pump inhibitor like pantoprazole, especially for a period of more than 1 year, may slightly increase the risk of fractures of the hip, wrist, or spine. Tell your doctor if you have osteoporosis (reduced bone density) or if your doctor has told you that you are at risk of osteoporosis (e.g., if you are taking corticosteroids).
• If you have taken Controloc 40 for more than 3 months, it may lead to a decrease in magnesium levels in the blood, which can cause fatigue, tremors, disorientation, seizures, dizziness, and cardiac arrhythmias. If you experience any of these symptoms, tell your doctor. Low magnesium levels in the blood can also lead to low potassium and calcium levels in the blood. Your doctor may decide to periodically check your magnesium levels.
• If you have ever had a skin reaction after taking a medicine that reduces the production of hydrochloric acid in the stomach.
• If you have ever had a rash, especially in areas exposed to sunlight, tell your doctor immediately, as you may need to stop taking Controloc 40. Also, tell your doctor about any other side effects, such as joint pain.
• Severe skin reactions have been reported with pantoprazole, including Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme. Stop taking pantoprazole and seek immediate medical attention if you notice any of the following symptoms related to these severe skin reactions, described in section 4.

Tell your doctor immediatelybefore or during treatment with Controloc 40 if you notice any of the following symptoms, which may be signs of a more serious disease:

• unintentional weight loss;
• vomiting, especially if it is repeated;
• bloody vomiting, which may look like coffee grounds;
• blood in the stool, black or tarry stools;
• difficulty swallowing or pain when swallowing;
• pale skin and weakness (anemia);
• chest pain;
• abdominal pain;
• severe and/or persistent diarrhea, as the use of this medicine is associated with a small increased risk of infectious diarrhea.

Your doctor may decide to perform tests to rule out an underlying malignant disease, as treatment with pantoprazole may alleviate the symptoms of the disease and delay its diagnosis. If the symptoms persist despite treatment, further tests should be considered.
In the event of long-term use of Controloc 40 (more than 1 year), you will likely be under regular medical supervision. In this case, during each visit to your doctor, report any new and unexpected symptoms and the circumstances in which they occurred.

Children and adolescents

Controloc 40 is not recommended for use in children, as its efficacy has not been established in children under 12 years of age.

Controloc 40 and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take, including those obtained without a prescription.
Since Controloc 40 may affect the efficacy of other medicines, tell your doctor if you are taking:

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used to treat certain types of cancer), as Controloc 40 may inhibit the proper functioning of these and other medicines.
• Warfarin and phenprocoumon, which affect blood clotting and prevent thrombosis. Further tests may be necessary.
• Medicines used to treat HIV infection, such as atazanavir.
• Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) - if you are taking methotrexate, your doctor may temporarily stop the treatment with Controloc 40, as pantoprazole may increase the levels of methotrexate in the blood.
• Fluvoxamine (used to treat depression and other mental disorders) - if you are taking fluvoxamine, your doctor may reduce the dose.
• Rifampicin (used to treat infections).
• St. John's Wort (Hypericum perforatum) (used to treat mild depression).

Before taking pantoprazole, discuss with your doctor if you are going to have a specific urine test (for tetrahydrocannabinol (THC)).

Pregnancy and breastfeeding and fertility

Experience with the use of Controloc 40 in pregnant women is limited. It has been found that the active substance of the medicine passes into human milk.
If you are pregnant or breastfeeding, or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
The medicine may be used in pregnant women or women who may be pregnant or are breastfeeding only if the doctor considers that the benefits of the treatment outweigh the potential risks to the unborn child or infant.

Driving and using machines

Controloc 40 has no or negligible influence on the ability to drive and use machines.
Do not drive or operate machinery if you experience side effects such as dizziness or vision disturbances.

Controloc 40 contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that it is essentially "sodium-free".

3. How to take Controloc 40

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Method of administration

Take the medicine 1 hour before a meal, without chewing or breaking the tablet. Swallow the tablet whole with water.
Recommended dose

Adults and adolescents aged 12 years and older

In the treatment of reflux esophagitis
The usual dose is one tablet per day. Your doctor may increase the dose to 2 tablets per day. The treatment of reflux esophagitis usually lasts from 4 to 8 weeks.
Your doctor will decide how long you should take the medicine.

Adults

In the treatment of Helicobacter pylori infection, in patients with duodenal ulcers and/or stomach ulcers, in combination with two antibiotics (eradication therapy)
One tablet twice a day, plus two tablets of antibiotics: amoxicillin, clarithromycin, or metronidazole (or tinidazole) taken twice a day with a tablet of pantoprazole.
Take the first tablet of pantoprazole 1 hour before breakfast and the second tablet of pantoprazole 1 hour before dinner. Follow the instructions given by your doctor and read the patient information leaflet included in the packaging of the antibiotics. The treatment usually lasts for 1 to 2 weeks.
In the treatment of stomach ulcers and/or duodenal ulcers
The usual dose is one tablet per day. After consulting your doctor, the dose may be doubled. Your doctor will decide how long you should take the medicine. The treatment of stomach ulcers usually lasts from 4 to 8 weeks. The treatment of duodenal ulcers usually lasts from 2 to 4 weeks.
In long-term treatment of Zollinger-Ellison syndrome and other conditions associated with excessive production of hydrochloric acid in the stomach
The recommended initial dose is usually 2 tablets per day.
Take both tablets 1 hour before a meal. Later, the dosage may be adjusted by your doctor, depending on the amount of hydrochloric acid produced in the stomach. If your doctor prescribes more than 2 tablets per day, take them twice a day.
If your doctor prescribes a daily dose greater than 4 tablets per day, he will inform you exactly when to stop taking the medicine.

Patients with renal impairment

Do not take Controloc 40 for the eradication of Helicobacter pylori if you have kidney problems.

Patients with hepatic impairment

In severe liver disease, do not take more than one 20 mg tablet of pantoprazole per day (20 mg tablets are available for this purpose).
In moderate or severe liver disease, do not take Controloc 40 for the eradication of Helicobacter pylori.

Use in children and adolescents

Tablets are not recommended for use in children under 12 years of age.

Taking a higher dose of Controloc 40 than recommended

Ask your doctor or pharmacist. Symptoms of overdose are not known.

Missing a dose of Controloc 40

Do not take a double dose to make up for a forgotten dose. Take the next scheduled dose at the usual time.

Stopping treatment with Controloc 40

Do not stop taking the tablets without consulting your doctor or pharmacist first.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following side effects, stop taking the tablets and contact your doctor or go to the nearest hospital emergency department:

• Severe allergic reactions (rare: may affect up to 1 in 1,000 people):swelling of the tongue and/or throat, difficulty swallowing, hives (urticaria), difficulty breathing, allergic edema (angioedema), severe dizziness with rapid heartbeat and excessive sweating.
• Severe skin reactions (frequency not known: cannot be estimated from the available data):the patient may notice one or more of the following symptoms - blistering of the skin and rapid deterioration of the general condition, ulcers of the eyes, nose, mouth/ lips, or genitals, or rash, especially on sun-exposed areas. It may also be accompanied by joint pain or flu-like symptoms, fever, swelling of the lymph nodes (e.g., in the armpits), and changes in blood tests showing changes in some white blood cells or liver enzymes.

Other side effects:

• Frequent(may affect up to 1 in 10 people) Mild polyps in the stomach.
• Uncommon(may affect up to 1 in 100 people) Headache; dizziness; diarrhea; nausea, vomiting; feeling of fullness in the abdominal cavity and bloating with gas (gas); constipation; dry mouth; abdominal pain and discomfort; skin rash, redness, skin eruptions; itching; weakness, fatigue, or general malaise; sleep disturbances; fractures of the hip, wrist, or spine.
• Rare(may affect up to 1 in 1,000 people) Disturbances or complete loss of taste; visual disturbances, such as blurred vision; hives; joint pain; muscle pain; changes in body weight; elevated body temperature; high fever; swelling of the limbs (peripheral edema); allergic reactions; depression; gynecomastia (enlargement of breast tissue in men).
• Very rare(may affect up to 1 in 10,000 people) Disturbances of orientation.
• Frequency not known(cannot be estimated from the available data) Hallucinations, confusion (especially in patients who have had these symptoms before); tingling, prickling, tingling, burning, or numbness; rash that may be accompanied by joint pain, and flu-like symptoms.

Side effects detected by blood tests:

• Uncommon(may affect up to 1 in 100 people) Increased liver enzymes.
• Rare(may affect up to 1 in 1,000 people) Increased bilirubin; increased triglycerides; associated with high fever, sudden decrease in the number of circulating granulocytes - white blood cells.
• Very rare(may affect up to 1 in 10,000 people) Decreased platelet count, which can lead to more frequent bleeding and bruising; decreased white blood cell count, which can lead to more frequent infections; concurrent, abnormal decrease in the number of red and white blood cells, as well as platelets.
• Frequency not known(cannot be estimated from the available data) Decreased sodium, magnesium, calcium, or potassium levels in the blood (see section 2).

Reporting side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. Side effects can be reported to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Controloc 40

Store the medicine in a place invisible and inaccessible to children.
Do not use this medicine after the expiry date stated on the packaging and blister or bottle (EXP). The expiry date refers to the last day of the month.
Bottle: do not use the medicine after 100 days from the first opening of the bottle.
No special precautions for storage are necessary.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Controloc 40 contains

• The active substance is pantoprazole. Each gastro-resistant tablet contains 40 mg of pantoprazole (in the form of pantoprazole sodium sesquihydrate).
• The other ingredients are: Core: anhydrous sodium carbonate, mannitol (E421), crospovidone, povidone K90, calcium stearate. Coating: hypromellose, povidone K25, titanium dioxide (E171), yellow iron oxide (E172), propylene glycol (E1520), methacrylic acid and ethyl acrylate copolymer (1:1), polysorbate 80, sodium lauryl sulfate, triethyl citrate. Ink: shellac, red, black, and yellow iron oxide (E172), concentrated ammonia solution.

What Controloc 40 looks like and contents of the pack

Controloc 40 is a yellow, oval, biconvex gastro-resistant tablet with the inscription "P40" on one side.
Packaging: HDPE bottles with LDPE caps or blisters of aluminum/aluminum foil or blisters of aluminum/aluminum foil in a paper wrapper (wallet for blister).
Controloc 40 is available in the following packaging sizes containing:
14, 28, 60, and 100 gastro-resistant tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Takeda Pharma Sp. z o.o.
ul. Prosta 68
00-838 Warsaw
medinfoEMEA@takeda.com

Manufacturer

Takeda GmbH
Manufacturing site Oranienburg
Lehnitzstrasse 70-98
16515 Oranienburg
Germany
Delpharm Novara S.r.l.
Via Crosa 86
28065 Cerano (NO)
Italy

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet 04/2023