Pantoprazole Genoptim

Leaflet attached to the packaging: patient information

Pantoprazole Genoptim, 20 mg, gastro-resistant tablets

Pantoprazolum

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

1. What is Pantoprazole Genoptim and what is it used for

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

• Treatment of symptoms (e.g., heartburn, acid reflux, pain when swallowing) associated with gastroesophageal reflux disease caused by the reflux of hydrochloric acid from the stomach.
• Long-term treatment of reflux esophagitis (inflammatory disease of the esophagus, accompanied by the reflux of stomach acid) and prevention of its recurrence.

Pantoprazole Genoptim is used in adults for:

• Prevention of duodenal and (or) gastric ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs, e.g., ibuprofen) in patients at risk who must constantly take NSAIDs.

2. Important information before taking Pantoprazole Genoptim

When not to take Pantoprazole Genoptim

• 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 medicines containing other proton pump inhibitors.

Warnings and precautions

Before taking Pantoprazole Genoptim, inform your doctor,
pharmacist, or nurse.

• If you have severe liver function disorders. Inform your doctor if you have ever had liver function disorders in the past. Your doctor may order more frequent monitoring of liver enzyme activity, especially if you are taking long-term treatment with Pantoprazole Genoptim. If liver enzyme activity increases, the use of the medicine should be discontinued.
• If you must constantly take NSAIDs and take Pantoprazole Genoptim at the same time, due to the increased risk of stomach or intestinal complications. The increased risk will be assessed according to the risk factors for the individual patient, such as age (65 years or older), stomach or duodenal ulcers in the medical history, or stomach or intestinal bleeding.
• If you have a vitamin B deficiency or risk factors indicating a possible decrease in vitamin B levels, and you are being treated with pantoprazole long-term. Like all medicines that reduce the production of hydrochloric acid in the stomach, pantoprazole may lead to reduced absorption of vitamin B.
• If you are taking HIV protease inhibitors, such as atazanavir (used to treat HIV infection), along with pantoprazole, you should ask your doctor for detailed advice.
• Taking a proton pump inhibitor, such as 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 informed you that you are at risk of osteoporosis (e.g., if you are taking corticosteroid medicines, which can increase the risk of osteoporosis).
• If you take Pantoprazole Genoptim for a period longer than three 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, inform your doctor. Low magnesium levels in the blood can also cause a decrease in potassium or calcium levels in the blood. Your doctor may decide to periodically check your magnesium levels in the blood.
• If you have ever had a skin reaction after taking a medicine similar to Pantoprazole Genoptim, which reduces the production of hydrochloric acid in the stomach.
• If you experience a skin rash, especially in areas exposed to sunlight, tell your doctor as soon as possible, as it may be necessary to discontinue the use of Pantoprazole Genoptim. Also, inform your doctor about any other side effects, such as joint pain.
• About a planned specific blood test (chromogranin A levels).

Tell your doctor immediatelybefore starting or during treatment with
the medicine, if you experience any of the following symptoms, which may be a sign of a more serious disease:

• unintentional weight loss
• vomiting, especially recurring
• bloody vomiting, which may look like dark 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 slight increase in the risk of infectious diarrhea.

Your doctor may decide to perform tests to rule out a 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.
Pantoprazole Genoptim may affect the absorption of vitamin B by the body,
especially if it needs to be taken for a long time. Contact your doctor if you notice any of the following symptoms, which may indicate a low level of vitamin B:

• extreme fatigue or lack of energy
• tingling
• painful or red tongue, oral ulcers
• muscle weakness
• vision problems
• memory problems, confusion, depression.

When taking Pantoprazole Genoptim for a longer period (more than 1 year), you will likely be under constant medical supervision. In this case, inform your doctor about any new and unexpected symptoms and circumstances during each visit.

Children and adolescents

Pantoprazole Genoptim is not recommended for use in children, as its effects in children under 12 years of age have not been studied.

Pantoprazole Genoptim and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take, including those available without a prescription.
Pantoprazole Genoptim may affect the effectiveness of other medicines; inform 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 Pantoprazole Genoptim may inhibit the proper functioning of these and other medicines.
• Warfarin and phenprocoumon, which affect blood density and prevent blood clots. 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 discontinue the use of Pantoprazole Genoptim, 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 order a dose reduction.
• Rifampicin (used to treat infections).
• St. John's Wort (Hypericum perforatum) (used to treat mild depression).

Pregnancy, breastfeeding, and fertility

Experience with the use of Pantoprazole Genoptim 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, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
The medicine may only be used if your doctor considers that the benefit of its use is greater than the potential risk to the unborn child or infant.

Driving and using machines

Pantoprazole Genoptim has no influence 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.

Pantoprazole Genoptim contains sodium

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

3. How to take Pantoprazole Genoptim

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

Method of administration

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

Adults and adolescents aged 12 years and older:

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

Adults:

• -In the prevention of duodenal and (or) gastric ulcers in patients who must constantly takeNSAIDsThe usual dose is one tablet per day.

Patients with liver function disorders

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

Use in children and adolescents

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

Taking a higher dose of Pantoprazole Genoptim than recommended

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

Missing a dose of Pantoprazole Genoptim

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

Stopping treatment with Pantoprazole Genoptim

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

4. Possible side effects

Like all medicines, Pantoprazole Genoptim can cause side effects, although not everybody gets them.

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

• Severe allergic reactions (rare: less than 1 in 1000 people):swelling of the tongue and (or) throat, difficulty swallowing, hives (rash like after a nettle burn), difficulty breathing, allergic swelling of the face (Quincke's edema/anaphylactic shock), severe dizziness with rapid heartbeat and profuse 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 severe deterioration of the general condition, erosion (with slight bleeding) of the eyes, nose, mouth/ lips, or genitals, or rash, especially on areas of the skin exposed to sunlight. Joint pain or flu-like symptoms, fever, swelling of the lymph nodes (e.g., under the arms), and changes in blood test results may also occur (Stevens-Johnson syndrome, Lyell's syndrome, polymorphic erythema, subacute cutaneous lupus erythematosus, drug rash with eosinophilia and systemic symptoms (DRESS), hypersensitivity to light).
• Other severe reactions (frequency not known: frequency cannot be estimated from the available data):yellowing of the skin and eyes (severe liver cell damage, jaundice) or fever, rash, and kidney problems manifested by their enlargement, sometimes with pain when urinating and pain in the lower back (severe kidney inflammation) that can lead to kidney failure

Other side effects that may occur:

• Common (less than 1 in 10 people):mild gastric polyps
• Uncommon (less than 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 (less than 1 in 1000 people):disturbances or complete loss of taste; vision 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 (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); feeling of tingling, prickling; tingling and prickling; burning or numbness;

a rash that may be accompanied by joint pain, colitis that causes persistent watery diarrhea.

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; sudden decrease in the number of circulating granulocytes - white blood cells, associated with high fever,
• 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 levels in the blood, decreased magnesium levels in the blood (see section 2).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to 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 authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pantoprazole Genoptim

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton (after the expiry date). The expiry date refers to the last day of the month.
Do not store above 30°C.
Medicines should not be disposed of via wastewater (e.g., toilet or sink) or household waste. Ask your pharmacist how to dispose of medicines you no longer need. This will help protect the environment.

6. Contents of the packaging and other information

What Pantoprazole Genoptim 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).
• Other ingredients of the medicine are: Core: mannitol (E 421), crospovidone (Type A), anhydrous sodium carbonate, calcium stearate. Coating: hypromellose 5 cP (E 464), povidone K25 (E 1201), propylene glycol (E 1520), titanium dioxide (E 171), yellow iron oxide (E 172), methacrylic acid, and ethyl acrylate copolymer (1:1) [polysorbate 80, sodium lauryl sulfate], triethyl citrate (E 1505).

What Pantoprazole Genoptim 20 mg gastro-resistant tablets look like and what the packaging contains

Yellow, oval, biconvex gastro-resistant tablets, smooth on both sides (approximately 8.45 mm x 4.20 mm).
Pantoprazole Genoptim 20 mg gastro-resistant tablets are available in the following packaging: 28, 56, 90, or 100 gastro-resistant tablets in blisters.
Not all pack sizes may be marketed.

Marketing authorization holder

Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw
tel. 22 32 16 240

Manufacturer / Importer

IDIFARMA DESARROLLO FARMACÉUTICO, S.L.
Polígono Mocholí
C/Noain, n 1 Noain, 31110 Navarra
Spain
Synoptis Industrial Sp. z o.o.
ul. Rabowicka 15
62-020 Swarzędz
Macleods Pharma UK Limited
Wynyard Park House
Wynyard Avenue
Wynyard, Billingham
TS22 5TB, United Kingdom
Netpharmalab Consulting Services
Carretera de Fuencarral 22,
Alcobendas, Madrid, 28108,
Spain

Date of the last revision of the leaflet: 03.2023