Controloc 20

CHARACTERISTICS OF THE MEDICINAL PRODUCT

1. NAME OF THE MEDICINAL PRODUCT

Controloc 20, 20 mg, gastro-resistant tablets

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each gastro-resistant tablet contains 20 mg of pantoprazole (as pantoprazole sodium sesquihydrate).
A full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Gastro-resistant tablet.
Yellow, oval, biconvex coated tablet with brown imprint "P20" on one side.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Controloc 20 is indicated for use in adults and adolescents 12 years of age and above for:
Symptomatic gastroesophageal reflux disease.
Long-term management and prevention of relapse in reflux oesophagitis.

• Symptomatic treatment of gastroesophageal reflux disease.
• Long-term management and prevention of relapse in reflux oesophagitis.

Controloc 20 is indicated for use in adults for:
Prevention of gastroduodenal ulcers induced by non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in patients at risk, who require continuous NSAID treatment (see section 4.4).

• Prevention of gastroduodenal ulcers induced by non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in patients at risk, who require continuous NSAID treatment.

4.2 Posology and method of administration

Dosage
Adults and adolescents 12 years of age and above
Symptomatic gastroesophageal reflux disease
The recommended oral dose is 20 mg once daily. Symptoms are usually relieved promptly, most patients will get relief within 2-4 weeks. If symptom control has not been achieved after 4 weeks of treatment, the patient should be further investigated.

After symptom relief, the dose can be reduced to 1 tablet Controloc 20 per day if needed (on demand). In case of insufficient symptom control, the dose can be increased to continuous treatment.

Long-term management and prevention of relapse in reflux oesophagitis
For long-term management, a maintenance dose of 1 tablet Controloc 20 per day is recommended, increasing to 40 mg pantoprazole per day if a relapse occurs. In this case, it is recommended to switch to Controloc 40.

Adults
Prevention of gastroduodenal ulcers induced by non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in patients at risk, who require continuous NSAID treatment.

The recommended dose is 1 tablet Controloc 20 per day.

Special patient populations
Patient with hepatic impairment
In patients with severe hepatic impairment, the dose should not exceed 20 mg pantoprazole per day (see section 4.4).

Patient with renal impairment
No dose adjustment is necessary in patients with impaired renal function (see section 5.2).

Elderly patients
No dose adjustment is necessary in elderly patients (see section 5.2).

Paediatric population
Controloc 20 is not recommended for use in children below 12 years of age because of limited data on safety and efficacy in this age group (see section 5.2).

Method of administration
Oral use.
The tablets should not be chewed or crushed, and should be swallowed whole 1 hour before a meal with a sufficient amount of 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

Hepatic impairment
In patients with severe hepatic impairment, particularly when long-term treatment is contemplated, liver enzyme monitoring should be performed regularly, especially during the first year of treatment. If the liver enzymes increase, the treatment should be discontinued (see section 4.2).

Concomitant use with NSAIDs
The use of Controloc 20 for the prevention of gastroduodenal ulcers induced by non-selective non-steroidal anti-inflammatory drugs (NSAIDs) should be restricted to patients who are at risk and require continuous NSAID treatment.

Gastric malignancy
As with other proton pump inhibitors, symptomatic response to pantoprazole may mask the symptoms of gastric malignancy. Therefore, if a patient presents with symptoms such as significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melaena, and if these symptoms persist despite pantoprazole treatment, further investigation should be performed to rule out a gastric malignancy.

Concomitant use with HIV protease inhibitors
Pantoprazole should not be used concomitantly with HIV protease inhibitors that depend on a specific pH for their absorption, such as atazanavir, because it may significantly decrease their bioavailability (see section 4.5).

Effect on vitamin B12 absorption
Pantoprazole, like other proton pump inhibitors, may reduce the absorption of vitamin B12 (cyanocobalamin) due to the decreased secretion of gastric acid and the resulting decrease in the formation of intrinsic factor.

Long-term treatment
During long-term treatment, especially when exceeding one year of use, patients should be kept under regular surveillance.

Gastrointestinal infections caused by bacteria
Treatment with Controloc 20 may lead to a slightly increased risk of gastrointestinal infections caused by bacteria such as Salmonella and Campylobacter or Clostridium difficile.

Hypomagnesaemia
Rarely, severe hypomagnesaemia has been reported in patients treated with proton pump inhibitors (PPIs) like pantoprazole for at least three months, and in most cases for more than one year. Serious consequences of hypomagnesaemia, such as fatigue, tetany, delirium, convulsions, and ventricular arrhythmia, may occur. Hypomagnesaemia may also lead to hypocalcaemia and (or) hypokalaemia.

Fractures of the hip, wrist, and spine have been reported in patients treated with PPIs for long periods of time. The mechanism is not entirely clear, but it may be related to other factors.

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 (see section 4.8).

Photosensitivity

Subacute cutaneous lupus erythematosus (SCLE) has been reported in association with PPIs, including pantoprazole (see section 4.8).

Effects on laboratory tests

Increased chromogranin A (CgA) levels may interfere with investigations for neuroendocrine tumours. To avoid this interference, pantoprazole treatment should be stopped for at least 5 days before CgA measurements (see section 5.1). If CgA and gastrin levels are not normal after initial measurement, measurements should be repeated 14 days after cessation of proton pump inhibitor treatment.

Controloc 20 contains sodium.

This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.

4.5 Interaction with other medicinal products and other forms of interaction

Medicinal products whose absorption is dependent on pH

Due to the profound and long-lasting decrease in gastric acidity, pantoprazole may interfere with the absorption of other medicinal products where gastric pH is an important determinant of their bioavailability.

HIV protease inhibitors

Pantoprazole should not be used concomitantly with HIV protease inhibitors that depend on a specific pH for their absorption, such as atazanavir, because it may significantly decrease their bioavailability (see section 4.4).

Other interaction studies

Pantoprazole is extensively metabolized in the liver by the cytochrome P450 system. The main metabolic pathway is demethylation by CYP2C19, followed by sulphate conjugation, while other metabolic pathways include oxidation by CYP3A4.

Interaction studies have been performed with the following medicinal products: carbamazepine, diazepam, diclofenac, digoxin, ethanol, glibenclamide, ketoconazole, metoprolol, nifedipine, phenytoin, theophylline, and warfarin.

No clinically significant interactions were found.

Pantoprazole is not likely to produce clinically significant interactions with other medicinal products that are metabolized by CYP1A2, CYP2C9, CYP2D6, or CYP2E1.

Medicinal products that inhibit or induce CYP2C19

Inhibitors of CYP2C19, such as fluvoxamine, may increase the plasma concentrations of pantoprazole.

4.6 Fertility, pregnancy and lactation

Pregnancy

A moderate amount of data on pregnant women (between 300-1000 pregnancy outcomes) indicates no malformative or foetal/neonatal toxicity of pantoprazole.

Animal studies have shown reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of Controloc 20 during pregnancy.

Breast-feeding

Animal studies have shown excretion of pantoprazole in breast milk. It is unknown whether this could harm the infant. Therefore, a decision should be made whether to suspend breast-feeding or to suspend/omit therapy with Controloc 20, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Fertility

Animal studies did not reveal any effects on fertility (see section 5.3).

4.7 Effects on ability to drive and use machines

Pantoprazole has no or negligible influence on the ability to drive and use machines.

However, dizziness and visual disturbances may occur (see section 4.8). In this case, patients should not drive or operate machines.

4.8 Undesirable effects

Adverse drug reactions such as headache, dizziness, and diarrhoea may occur (see section 4.8).

Uncommon adverse reactions include pruritus, rash, and urticaria.

Rare adverse reactions include anaphylactic reactions and angioedema.

Very rare adverse reactions include Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms (DRESS syndrome).

4.9 Overdose

There is no known overdose toxicity.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Proton pump inhibitors, ATC code: A02BC02

Mechanism of action

Pantoprazole is a substituted benzimidazole that inhibits the secretion of hydrochloric acid in the stomach by irreversibly blocking the enzyme system of H+, K+-ATPase (proton pump) at the secretory surface of gastric parietal cells.

Pharmacodynamic effects

The effect of food on the bioavailability of pantoprazole has not been studied.

During long-term treatment, especially when exceeding one year of use, patients should be kept under regular surveillance.

5.2 Pharmacokinetic properties

Absorption

Pantoprazole is rapidly absorbed after oral administration, with peak plasma concentrations reached after a single oral dose of 20 mg.

Distribution

Pantoprazole is extensively distributed in the body, with a volume of distribution of approximately 0.15 l/kg.

Metabolism

Pantoprazole is extensively metabolized in the liver by the cytochrome P450 system, primarily by CYP2C19 and to a lesser extent by CYP3A4.

Elimination

The terminal half-life of pantoprazole is approximately 1 hour, and the total clearance is approximately 0.1 l/h/kg.

5.3 Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, and carcinogenic potential.

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 - 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)

Ammonium hydroxide concentrated

6.2 Incompatibilities

None.

6.3 Shelf life

Blisters

3 years

Bottles

Unopened: 3 years

Shelf life after first opening: 120 days.

6.4 Special precautions for storage

No special precautions for storage.

6.5 Nature and contents of container

HDPE bottle with LDPE cap.

7 gastro-resistant tablets

10 gastro-resistant tablets

14 gastro-resistant tablets

15 gastro-resistant tablets

24 gastro-resistant tablets

28 gastro-resistant tablets

30 gastro-resistant tablets

48 gastro-resistant tablets

49 gastro-resistant tablets

56 gastro-resistant tablets

60 gastro-resistant tablets

84 gastro-resistant tablets

90 gastro-resistant tablets

98 gastro-resistant tablets

98 (2x49) gastro-resistant tablets

100 gastro-resistant tablets

112 gastro-resistant tablets

Hospital packs

50 gastro-resistant tablets

56 gastro-resistant tablets

84 gastro-resistant tablets

90 gastro-resistant tablets

112 gastro-resistant tablets

140 gastro-resistant tablets

140 (10x14), (5x28) gastro-resistant tablets

150 (10x15) gastro-resistant tablets

280 (20x14), (10x28) gastro-resistant tablets

500 gastro-resistant tablets

700 (5x140) gastro-resistant tablets

Aluminium/Aluminium blisters.

Aluminium/Aluminium blisters with paper backing (wallet).

7 gastro-resistant tablets

10 gastro-resistant tablets

14 gastro-resistant tablets

15 gastro-resistant tablets

24 gastro-resistant tablets

28 gastro-resistant tablets

30 gastro-resistant tablets

48 gastro-resistant tablets

49 gastro-resistant tablets

56 gastro-resistant tablets

60 gastro-resistant tablets

84 gastro-resistant tablets

90 gastro-resistant tablets

98 gastro-resistant tablets

98 (2x49) gastro-resistant tablets

100 gastro-resistant tablets

112 gastro-resistant tablets

168 gastro-resistant tablets

Hospital packs

50 gastro-resistant tablets

56 gastro-resistant tablets

84 gastro-resistant tablets

90 gastro-resistant tablets

112 gastro-resistant tablets

140 gastro-resistant tablets

50 (50x1) gastro-resistant tablets

140 (10x14), (5x28) gastro-resistant tablets

150 (10x15) gastro-resistant tablets

280 (20x14), (10x28) gastro-resistant tablets

500 gastro-resistant tablets

700 (5x140) gastro-resistant tablets

In Poland, the following pack sizes are registered: 14, 28, and 60 tablets in Aluminium/Aluminium blisters; 14 and 28 tablets in Aluminium/Aluminium blisters with paper backing, and 14, 28, and 100 tablets in HDPE bottles with LDPE caps.

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 requirements.

7. MARKETING AUTHORISATION HOLDER

RESPONSIBLE FOR BATCH RELEASE

Takeda Pharma Sp. z o.o.

ul. Prosta 68

00-838 Warszawa

[email protected]

8. MARKETING AUTHORISATION NUMBER

4787

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

DATE OF REVISION OF THE TEXT

Date of first authorisation: 29 February 2000

Date of last renewal: 16 March 2010

10. DATE OF REVISION OF THE TEXT

26 April 2023

LABELLING OF OUTER PACKAGING

INFORMATION TO BE INCLUDED ON THE OUTER PACKAGING

BOX FOR BLISTERS (1 X 14 TAB)

BOX FOR BLISTERS (2 X 14 TAB)

BOX FOR BLISTERS (4 X 15 TAB)

1. NAME OF THE MEDICINAL PRODUCT

Controloc 20, 20 mg, gastro-resistant tablets

2. CONTENTS OF ACTIVE SUBSTANCE

Each gastro-resistant tablet contains 20 mg of pantoprazole (as pantoprazole sodium sesquihydrate).

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS OF THE PACKAGING

14 gastro-resistant tablets code 5909990478767

28 gastro-resistant tablets code 5909990478774

60 gastro-resistant tablets code 5909990820351

5. METHOD AND ROUTE OF ADMINISTRATION

Oral use.

Read the package leaflet before use.

Swallow whole, do not chew or crush.

6. SPECIAL WARNING ABOUT STORAGE OF THE MEDICINAL PRODUCT

OUT OF SIGHT AND REACH OF CHILDREN

Keep out of sight and reach of children.

7. OTHER SPECIAL WARNINGS, IF NECESSARY

8. EXPIRY DATE

Expiry date (EXP):

9. SPECIAL PRECAUTIONS FOR STORAGE

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCT OR WASTE MATERIALS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Takeda Pharma Sp. z o.o.

ul. Prosta 68

00-838 Warszawa

12. MARKETING AUTHORISATION NUMBER

Authorisation number: 4787

13. BATCH NUMBER

Batch number (Lot):

14. GENERAL CATEGORY OF DISPENSING

Rp - Prescription-only medicine.

15. INSTRUCTIONS FOR USE

16. INFORMATION PROVIDED IN BRAILLE

controloc 20

17. UNIQUE IDENTIFIER - 2D BAR CODE

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

18. UNIQUE IDENTIFIER - HUMAN-READABLE DATA

PC:

SN:

NN:

LABELLING OF OUTER PACKAGING

BOX FOR BLISTERS IN PAPER BACKING (2 X 7 TAB)

1. NAME OF THE MEDICINAL PRODUCT

Controloc 20, 20 mg, gastro-resistant tablets
pantoprazole

2. ACTIVE SUBSTANCE CONTENT

Each gastro-resistant tablet contains 20 mg of pantoprazole (in the form of pantoprazole sodium sesquihydrate).

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND PACKAGING CONTENT

14 gastro-resistant tablets code 5909990614967
28 gastro-resistant tablets code 5909990614974

5. METHOD AND ROUTE OF ADMINISTRATION

Oral administration.
Read the package leaflet before taking the medicine.
Swallow whole, do not chew or crush.

6. WARNING ABOUT STORAGE OF THE MEDICINAL PRODUCT

IN A PLACE INVISIBLE AND INACCESSIBLE TO CHILDREN

Store the medicine 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 AUTHORISATION HOLDER

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

12. MARKETING AUTHORISATION NUMBER

Marketing authorisation number 4787

13. BATCH NUMBER

Batch number (Lot):

14. GENERAL AVAILABILITY CATEGORY

Rp - Prescription-only medicine.

15. INSTRUCTIONS FOR USE

16. INFORMATION PROVIDED IN BRAILLE

controloc 20

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 20, 20 mg, gastro-resistant tablets
pantoprazole

2. ACTIVE SUBSTANCE CONTENT

Each gastro-resistant tablet contains 20 mg of pantoprazole (in the form of pantoprazole sodium sesquihydrate).

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND PACKAGING CONTENT

14 gastro-resistant tablets code 5909990478729
28 gastro-resistant tablets code 5909990478736
100 gastro-resistant tablets code 5909990478743

5. METHOD AND ROUTE OF ADMINISTRATION

Oral administration.
Read the package leaflet before taking the medicine.
Swallow whole, do not chew or crush.

6. WARNING ABOUT STORAGE OF THE MEDICINAL PRODUCT

IN A PLACE INVISIBLE AND INACCESSIBLE TO CHILDREN

Store the medicine 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 120 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 AUTHORISATION HOLDER

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

12. MARKETING AUTHORISATION NUMBER

Marketing authorisation number 4787

13. BATCH NUMBER

Batch number (Lot):

14. GENERAL AVAILABILITY CATEGORY

Rp - Prescription-only medicine.

15. INSTRUCTIONS FOR USE

16. INFORMATION PROVIDED IN BRAILLE

controloc 20

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 20, 20 mg, gastro-resistant tablets
pantoprazole

2. ACTIVE SUBSTANCE CONTENT

Each gastro-resistant tablet contains 20 mg of pantoprazole (in the form of pantoprazole sodium sesquihydrate).

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND PACKAGING CONTENT

7 gastro-resistant tablets

5. METHOD AND ROUTE OF ADMINISTRATION

Oral administration.
Read the package leaflet before taking the medicine.
Swallow whole, do not chew or crush.

6. WARNING ABOUT STORAGE OF THE MEDICINAL PRODUCT

IN A PLACE INVISIBLE AND INACCESSIBLE TO CHILDREN

Store the medicine 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 AUTHORISATION HOLDER

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

12. MARKETING AUTHORISATION NUMBER

Marketing authorisation number 4787

13. BATCH NUMBER

Batch number (Lot):

14. GENERAL AVAILABILITY CATEGORY

Rp - Prescription-only medicine.

15. INSTRUCTIONS FOR USE

16. INFORMATION PROVIDED IN BRAILLE

MINIMUM INFORMATION TO BE INCLUDED ON BLISTERS OR FOIL PACKAGING

BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Controloc 20, 20 mg, tablets
pantoprazole

2. NAME OF THE MARKETING AUTHORISATION HOLDER

((marketing authorisation holder's logo))

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Batch number (Lot):

5. OTHER

INFORMATION TO BE INCLUDED ON DIRECT PACKAGING

Label on bottle

1. NAME OF THE MEDICINAL PRODUCT

Controloc 20, 20 mg, gastro-resistant tablets
pantoprazole

2. ACTIVE SUBSTANCE CONTENT

Each gastro-resistant tablet contains 20 mg of pantoprazole (in the form of pantoprazole sodium sesquihydrate).

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND PACKAGING CONTENT

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

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral administration.
Read the package leaflet before taking the medicine.
Swallow whole, do not chew or crush.

6. WARNING ABOUT STORAGE OF THE MEDICINAL PRODUCT

IN A PLACE INVISIBLE AND INACCESSIBLE TO CHILDREN

Store the medicine in a place invisible and inaccessible to children.

7. OTHER SPECIAL WARNINGS, IF NECESSARY

8. EXPIRY DATE

EXP:
Do not use the medicine after 120 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 AUTHORISATION HOLDER

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

12. MARKETING AUTHORISATION NUMBER

Marketing authorisation number 4787

13. BATCH NUMBER

Batch number (Lot):

14. GENERAL AVAILABILITY CATEGORY

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 with the packaging: information for the patient

Controloc 20, 20 mg, gastro-resistant tablets

pantoprazole

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 20 and what is it used for
• 2. Important information before taking Controloc 20
• 3. How to take Controloc 20
• 4. Possible side effects
• 5. How to store Controloc 20
• 6. Contents of the pack and other information

1. What is Controloc 20 and what is it used for

Controloc 20 contains the active substance pantoprazole. Controloc 20 is a selective "proton pump inhibitor", a medicine that reduces the amount of acid produced in the stomach. It is used to treat stomach and gut conditions related to acid production.
Controloc 20 is used in adults and adolescents aged 12 years and above for:

• Treating symptoms (such as heartburn, acid reflux, pain when swallowing) related to acid reflux disease.
• Long-term treatment of reflux oesophagitis (inflammation of the oesophagus caused by acid reflux) and prevention of its recurrence.

Controloc 20 is used in adults for:

• Preventing stomach and duodenal ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen) in patients at risk who need to take NSAIDs continuously.

2. Important information before taking Controloc 20

When not to take Controloc 20

• 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 20, tell your doctor, pharmacist or nurse:

• If you have severe liver problems. Tell your doctor if you have ever had liver problems in the past. Your doctor may need to monitor your liver function more closely, especially if you are taking Controloc 20 for a long time. If your liver function increases, your doctor may need to stop the treatment.
• If you need to take NSAIDs continuously and also take Controloc 20, as this may increase the risk of stomach or gut problems. Your doctor will assess the increased risk based on your individual risk factors, such as age (65 years or older), stomach or duodenal ulcers in the past, or bleeding from the stomach or gut.
• If you have a deficiency of vitamin B12 or risk factors for a decrease in vitamin B12 levels, and you are taking pantoprazole long-term. Like all medicines that reduce stomach acid, pantoprazole may lead to decreased absorption of vitamin B12. Tell your doctor if you notice any of the following symptoms, which may indicate low vitamin B12 levels:
• extreme tiredness or lack of energy,
• tingling or numbness,
• 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), with pantoprazole, 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 hip, wrist or spine fractures. 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 take Controloc 20 for more than 3 months, you may experience 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 cause low potassium and calcium levels in the blood. Your doctor may decide to monitor your magnesium levels periodically.
• If you have ever had a skin reaction after taking a medicine that reduces stomach acid.
• If you have ever had a rash, especially in areas exposed to the sun, tell your doctor immediately, as you may need to stop taking Controloc 20. 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 of these severe skin reactions described in section 4.

of these severe skin reactions.

• About a planned specific urine test (chromogranin A levels).

Tell your doctor immediatelybefore or during treatment with Controloc 20 if you:

• have unintentional weight loss;
• have vomiting, especially if it is repeated;
• have bloody vomiting, which may look like coffee grounds;
• have blood in your stools or black, tarry stools;
• have difficulty swallowing or pain when swallowing;
• have pale skin or feel weak;
• have chest pain;
• have stomach pain;
• have severe and/or persistent diarrhoea, as taking this medicine may be associated with a small increased risk of infectious diarrhoea.

Your doctor may decide to perform tests to rule out an underlying tumour, as treatment with pantoprazole may alleviate the symptoms of the tumour and delay its diagnosis. If symptoms persist despite treatment, further tests should be considered.
In the event of long-term treatment with Controloc 20 (more than 1 year), you will likely be under regular medical supervision. In this case, during each visit to your doctor, report any new or unexpected symptoms and the circumstances in which they occurred.

Children and adolescents

Controloc 20 is not recommended for use in children, as its efficacy has not been established in children under 12 years of age.

Controloc 20 and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken or might take, including those obtained without a prescription.
Since Controloc 20 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 20 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 20, as pantoprazole may increase methotrexate levels 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 to undergo a specific urine test [for tetrahydrocannabinol (THC)].

Pregnancy and breastfeeding and fertility

Experience with the use of Controloc 20 in pregnant women is limited. The active substance of the medicine passes into breast milk.
If you are pregnant or breastfeeding, 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 are breastfeeding or may become pregnant or are planning to become pregnant only if the doctor considers that the benefits of the treatment outweigh the potential risks to the unborn child or baby.

Driving and using machines

Controloc 20 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 blurred vision.

Controloc 20 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 20

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 above:

• -In the treatment of symptoms (e.g. heartburn, acid reflux, pain when swallowing) related to acid reflux diseaseThe usual dose is one tablet per day. This dose usually provides relief within 2-4 weeks of treatment - at the latest within a further 4 weeks. Your doctor will decide how long you should take the medicine. Recurring symptoms can be controlled by taking one tablet per dayas needed.
• -In the long-term treatment and prevention of recurrence of reflux oesophagitisThe usual dose is one tablet per day. If symptoms of the disease return, your doctor may recommend doubling the dose. In this case, one tablet per day of Controloc 40 can be used. After the symptoms have subsided, the dose can be reduced again to one tablet (20 mg) per day.

Adults:

• -In the prevention of stomach and duodenal ulcers in patients who need to take NSAIDs continuouslyThe usual dose is one tablet per day.

Patient with liver impairment

In case of severe liver disease, do not take more than one 20 mg tablet per day.

Use in children and adolescents

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

Taking a higher dose of Controloc 20 than recommended

Ask your doctor or pharmacist. The symptoms of overdose are not known.

Missing a dose of Controloc 20

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

Stopping treatment with Controloc 20

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

4. Possible side effects

Like all medicines, Controloc 20 can cause side effects, although not everybody gets them.

In case of any of the following side effects, stop taking the tablets and contact your doctor or the nearest hospital emergency department immediately:

• Severe allergic reactions (rare: less than 1 in 1000 people):swelling of the tongue and/or throat, difficulty swallowing, hives (nettle rash), difficulty breathing, allergic swelling of the face (Quincke's oedema / angioedema), severe dizziness with rapid heartbeat and excessive sweating.
• Severe skin reactions (frequency not known: frequency 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, erosion (with slight bleeding) of the eyes, nose, mouth/ lips or genital areas or rash, especially in areas of the skin exposed to the sun. Joint pain or flu-like symptoms, fever, swelling of the lymph nodes (e.g. in the armpits), and changes in white blood cells or liver enzymes may also occur.
• red spots or patches on the trunk, often with blisters in the centre, peeling of the skin, mouth ulcers, genital ulcers, and eye inflammation. The appearance of such a severe rash can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• widespread rash, high fever and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).
• Other severe reactions (frequency not known: frequency cannot be estimated from the available data):yellowing of the skin and eyes (severe liver damage, jaundice) or fever, rash and kidney problems, which may lead to kidney failure.

Other side effects that may occur:

• Common(less than 1 in 10 people) Mild stomach polyps.
• Uncommon(less than 1 in 100 people) Headache; dizziness; diarrhoea; nausea, vomiting; feeling of fullness in the abdominal cavity and bloating with gas; constipation; dry mouth; abdominal pain and discomfort; skin rash, redness, eruptions; itching; weakness, fatigue or general malaise; sleep disorders, fractures of the hip, wrist or spine.

fatigue, weakness or general malaise; sleep disorders, fractures of the hip, wrist or spine.

• Rare(less than 1 in 1000 people) Disturbances or complete loss of taste; visual disturbances, such as blurred vision; hives; joint pain; muscle pain; changes in body weight; increased body temperature; high fever; swelling of the limbs (peripheral oedema); allergic reactions; depression; breast enlargement in men.
• Very rare(less than 1 in 10,000 people) Disorientation.
• Frequency not known(frequency cannot be estimated from the available data) Hallucinations, confusion (especially in patients who have experienced such symptoms before); tingling, prickling, tingling, burning or numbness; rash that may be accompanied by joint pain, colitis (inflammable bowel disease) causing persistent watery diarrhoea.

Side effects detected by blood tests:

• Uncommon(less than 1 in 100 people) Increased liver enzyme activity.
• Rare(less than 1 in 1000 people) Increased bilirubin levels; increased fat levels in the blood; associated with high fever, sudden decrease in the number of circulating granulocytes - white blood cells.
• Very rare(less than 1 in 10,000 people) Decreased platelet count, which can cause 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(frequency 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 experience 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 directly to the Department for Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: + 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 authorisation holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Controloc 20

Store the medicine in a place invisible and inaccessible to children.
Do not use this medicine after the expiry date stated on the carton and blister or bottle, which is the last day of that month.
Bottle: do not use the medicine after 120 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 that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Controloc 20 contains

• The active substance of the medicine is pantoprazole. Each gastro-resistant tablet contains 20 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.

What Controloc 20 looks like and contents of the pack

Controloc 20 is a yellow, oval, biconvex gastro-resistant tablet with the inscription "P20" on one side.
Packaging: HDPE bottles with LDPE caps or aluminium/aluminium blisters or aluminium/aluminium blisters in paper packaging (wallet for blister).
Controloc 20 is available in the following packaging sizes containing:
14, 28, 60 and 100 gastro-resistant tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Takeda Pharma Sp. z o.o.
ul. Prosta 68
00-838 Warsaw
[email protected]

Manufacturer

Takeda GmbH
Manufacturing site Oranienburg
Lehnitzstrasse 70-98
16515 Oranienburg
Germany

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

Date of last revision of the package leaflet 04/2023