Pantoprazole teva

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet. The information on the immediate packaging is in a foreign language!
Pantoprazol Teva (Pantoprazole-Teva)
20 mg, enteric-coated tablets
Pantoprazolum
Pantoprazol Teva and Pantoprazole-Teva are different brand names for the same medicine.
Please read this leaflet carefully before taking the medicine, as it contains important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by the physician or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If any of the side effects worsens or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement after 2 weeks, or if you feel worse, you should contact your doctor. Do not take Pantoprazol Teva for longer than 4 weeks without consulting your doctor.

Contents of the leaflet

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

1. What Pantoprazol Teva is and what it is used for

Pantoprazol Teva belongs to a group of medicines called proton pump inhibitors. The active substance is pantoprazol, which blocks the “proton pump” responsible for producing stomach acid. This way, the medicine reduces the amount of acid in the stomach.
Pantoprazol Teva is used for short-term treatment of symptoms of gastroesophageal reflux disease (GERD) (for example, heartburn, acid regurgitation) in adults.
Reflux refers to the backward flow of stomach acid into the oesophagus, which may lead to inflammation of the oesophagus and cause pain. Other symptoms may include a burning sensation in the chest rising up to the throat (heartburn) and a sour taste in the mouth (acid regurgitation).
Pantoprazol Teva may relieve symptoms associated with reflux disease and heartburn as early as on the first day of treatment, but it is not intended to provide immediate relief. For complete symptom relief, it may be necessary to take the tablets for 2 to 3 consecutive days.
If there is no improvement after 2 weeks, or if you feel worse, you should contact your doctor.

2. Important information before using Pantoprazol Teva

When not to use Pantoprazol Teva

• If the patient is allergic (hypersensitive) to pantoprazole or any of the other ingredients of Pantoprazol Teva (listed in section 6).
• If the patient is taking HIV protease inhibitors, such as atazanavir, nelfinavir (used in the treatment of HIV infection). See "Pantoprazol Teva with other medicines".
• If the patient is taking a medicine containing atazanavir (used in the treatment of HIV infection). See section "Pantoprazol Teva with other medicines";
• If the patient is scheduled for a specific blood test (chromogranin A level).

Warnings and precautions
Before starting to take Pantoprazol Teva, consult a doctor or pharmacist if the patient:

• has been treated for heartburn or indigestion continuously for 4 weeks or longer;
• is over 55 years old and takes over-the-counter medicines for indigestion daily;
• is over 55 years old and has noticed any new symptoms or a change in the nature of existing reflux symptoms;
• has had a stomach ulcer disease or undergone stomach surgery;
• has liver problems or jaundice (yellowing of the skin and eyes);
• is under continuous medical supervision due to other serious conditions or diseases; is scheduled for endoscopic or biopsy testing;
• has ever experienced a skin reaction while taking a medicine similar to Pantoprazol Teva that reduces gastric acid secretion, before a planned specific blood test (chromogranin A level);
• is taking HIV protease inhibitors such as atazanavir or nelfinavir (used in the treatment of HIV infection) concomitantly with pantoprazole, should consult the doctor for detailed advice.

Do not take this medicine for longer than 4 weeks without consulting a doctor. If symptoms of reflux disease (heartburn or acid regurgitation) persist for more than 2 weeks, consult a doctor, who will decide whether long-term treatment is necessary.
Long-term use of Pantoprazol Teva may be associated with additional risks, such as:

• reduced absorption of vitamin B({12}) and vitamin B({12}) deficiency in case of low vitamin B(_{12}) levels in the body;
• fractures of the hip, wrist, or spine, especially if the patient already suffers from osteoporosis (reduced bone density) or if the doctor has informed the patient that they are at risk of developing osteoporosis (for example, if the patient is taking steroid medicines);
• decreased magnesium levels in the blood (possible symptoms: fatigue, involuntary muscle contractions, confusion, seizures, dizziness, rapid heartbeat). Low magnesium levels may also lead to decreased potassium and calcium levels in the blood. If the medicine is taken for longer than 4 weeks, consult a doctor. The doctor may recommend regular blood tests to monitor magnesium levels.

Immediately inform the doctor before or after taking this medicine if the patient experiences any of the following symptoms, which may indicate other serious diseases:

• unintentional weight loss (not related to diet or exercise);
• vomiting, especially recurrent;
• vomiting blood, which may look like dark coffee grounds;
• blood in stool, black or tarry stools;
• difficulty swallowing or pain during swallowing;
• pallor and weakness (anaemia);
• chest pain;
• abdominal pain;
• severe and/or persistent diarrhoea, as use of this medicine is associated with a slightly increased risk of infectious diarrhoea;
• if the patient develops a skin rash, especially in areas exposed to sunlight, they should inform the doctor as soon as possible, as discontinuation of Pantoprazol Teva may be necessary. Also report any other adverse reactions such as joint pain.

The doctor may decide that additional tests are necessary.
If the patient is scheduled for a blood test, they should inform the doctor about taking this medicine.
The patient may notice improvement in reflux symptoms and heartburn as early as one day after starting pantoprazole tablets. However, this is not a medicine intended for immediate symptom relief. It should not be used preventively.
If the patient has had recurrent heartburn or indigestion symptoms for some time, they should remain under regular medical supervision.
Children and adolescents
Pantoprazol Teva should not be used in children and adolescents under 18 years of age due to lack of safety data in this younger patient group.
Pantoprazol Teva with other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Pantoprazol Teva may reduce the effectiveness of other medicines, especially those containing any of the following active substances:

• HIV protease inhibitors, such as atazanavir, nelfinavir (used in the treatment of HIV infection). Pantoprazol Teva must not be used concomitantly with HIV protease inhibitors. See "When not to use Pantoprazol Teva";
• ketoconazole (used for fungal infections);
• warfarin and phenprocoumon (affect blood clotting and prevent thrombosis). Additional blood testing may be required;
• methotrexate (used in rheumatoid arthritis, psoriasis, and cancer conditions) – if the patient is taking methotrexate, the doctor may temporarily discontinue treatment with Pantoprazol Teva, as pantoprazole increases methotrexate levels in the blood.

Do not take Pantoprazol Teva with medicines that reduce stomach acid production, such as other proton pump inhibitors (omeprazole, lansoprazole, or rabeprazole) or H(_{2})-antagonists (e.g. ranitidine, famotidine).
Pantoprazol Teva may be taken if necessary with antacids (e.g. magaldrate, alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate, or their combinations).
Pregnancy and breastfeeding
Do not use Pantoprazol Teva in pregnant or breastfeeding women.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Driving and using machines
If the patient experiences adverse effects such as dizziness or visual disturbances, they should not drive or operate machinery.
Pantoprazol Teva contains sodium
The medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. is essentially "sodium-free".

3. How to take Pantoprazol Teva

Pantoprazol Teva must always be taken according to the information provided in this leaflet or
as directed by your doctor or pharmacist. If in doubt, consult your
doctor or pharmacist.
The recommended dose is one tablet daily. Do not exceed the recommended dose of 20 mg
of pantoprazole per day.
The medicine should be taken for at least 2 to 3 consecutive days. Treatment with Pantoprazol Teva
should be discontinued once symptoms have completely resolved. Relief of reflux and heartburn
symptoms may occur as early as one day after starting Pantoprazol Teva. However, it should be
remembered that this medicine is not intended to provide immediate relief.
Consult your doctor if symptoms persist after taking this medicine for a full 2 weeks.
Do not take Pantoprazol Teva for longer than 4 weeks without consulting your doctor.
Take the tablets before a meal, at the same time each day. Swallow the tablets whole, with plenty of water. Do not chew, crush, or split the tablets.
Taking more Pantoprazol Teva than recommended
If you take more Pantoprazol Teva than recommended, contact your doctor or pharmacist immediately. If possible, bring the medicine and this leaflet with you.
If you miss a dose of Pantoprazol Teva
Do not take a double dose to make up for a missed dose. Take the next scheduled dose at the usual time the following day.
If you have any further doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although they do not occur in everyone.

Seek immediate medical advice from a doctor or the emergency department of the nearest hospital if any of the following serious adverse reactions occur. You must immediately stop taking this medicine and bring the package leaflet and/or the tablets with you.

• Severe allergic reactions (rare: affects no more than 1 in 1,000 people): hypersensitivity reactions, so-called anaphylactic reactions, anaphylactic shock, and angioedema. Typical symptoms include swelling of the face, lips, mouth, tongue, and/or throat, which may cause difficulty in swallowing or breathing; urticaria (hives); severe dizziness with rapid heartbeat and excessive sweating.

• Severe skin reactions (frequency unknown: frequency cannot be estimated based on available data): the patient may notice one or more of the following symptoms – skin rash with swelling, blistering, or peeling of the skin; extensive peeling of the skin; bleeding around the eyes, nose, mouth, or genital areas; rapid deterioration in general condition; rash particularly affecting skin areas exposed to sunlight. Joint pain or flu-like symptoms, fever, swollen glands (e.g., under the arms), and blood tests showing changes in certain white blood cells or liver enzymes may also occur.

• Other severe reactions (frequency unknown: frequency cannot be estimated based on available data): yellowing of the skin and eyes (due to severe liver damage), or fever, rash, and kidney enlargement sometimes accompanied by painful urination and lower back pain (severe kidney inflammation), which may lead to kidney failure.

Other adverse reactions include:

• Common (affects no more than 1 in 10 people): benign gastric polyps
• Uncommon (affects no more than 1 in 100 people): headache; dizziness; diarrhoea; nausea; vomiting; flatulence and bloating with gas release; constipation; dry mouth; abdominal pain and discomfort; skin rash or urticaria; itching; weakness; fatigue or malaise; sleep disturbances; increased liver enzyme activity (detected in blood tests); fracture of the hip, wrist, or spine.
• Rare (affects no more than 1 in 1,000 people): distortion or complete loss of taste; visual disturbances such as blurred vision; joint pain; muscle pain; changes in body weight; elevated body temperature; swelling of the extremities (hands and feet); depression; increased levels of bilirubin (bile pigment) and blood lipids (detected in blood tests); breast enlargement in men; high fever; and sudden drop in circulating granulocytes (white blood cells) (detected in blood tests).
• Very rare (affects no more than 1 in 10,000 people): disorientation; reduced platelet count, which may lead to increased tendency to bleed and development of purpura (bruising) on the skin (thrombocytopenia); reduced white blood cell count, which may increase susceptibility to infections; concurrent reduction in red blood cells, white blood cells, and platelets (detected in blood tests).
• Frequency unknown (frequency cannot be estimated based on available data): hallucinations; confusion (particularly in patients who have previously experienced such symptoms); decreased blood concentrations of sodium, magnesium, calcium, or potassium (see section 2); rash associated with joint pain; sensations of tingling, itching, pricking, burning, or numbness; inflammation of the large intestine causing persistent, watery diarrhoea.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions to Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw,
tel.: +48 22 49 21 301, fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Pantoprazol Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Shelf-life after first opening: 0 days.
Blisters OPA/Al/PVC/Al in a cardboard box.
Do not store above 30°C.
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 Pantoprazol Teva contains

• The active substance is pantoprazole. Each enteric-coated tablet contains 20 mg of pantoprazole (as sodium pantoprazole sesquihydrate).
• Other components are:
  Core: Disodium phosphate, mannitol, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, hypromellose (type 6 cP), sodium carboxymethyl starch (type A);
  Coating: Copolymer of methacrylic acid and ethyl acrylate (1:1), 30% dispersion, triethyl citrate, iron oxide yellow (E 172).

What Pantoprazol Teva looks like and contents of the pack
Pantoprazol Teva is an oval, yellow tablet available in OPA/Al/PVC/Al blisters containing
14 tablets.

For more detailed information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Hungary, country of export:
Teva Gyógyszergyár Zrt.
4042 Debrecen, Pallagi út 13.
Hungary

Manufacturers:
Teva Pharma, S.L.U
Poligono Industrial Malpica calle C, Numero 4, 50016 Zaragoza
Spain
Teva Gyógyszergyár Zrt.
4042 Debrecen, Pallagi út 13.
Hungary
Pharmachemie B.V.
Swensweg 5, 2031 GA Haarlem
The Netherlands

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged by:
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Poland
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Poland
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
Poland
IVA Pharm Sp. z o.o.
ul. Drawska 14/1
02-202 Warsaw
Poland
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Poland
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Hungary Marketing Authorisation Number (country of export): OGYI-T-21497/01
Parallel Import Licence Number: 166/21

The following lifestyle recommendations and dietary changes may also help relieve heartburn or other acid-related symptoms:

• Avoid large meals
• Eat slowly
• Stop smoking
• Limit alcohol and caffeine intake
• Reduce body weight (if overweight)
• Avoid wearing tight clothing or belts
• Avoid eating meals less than three hours before going to bed
• Sleep with your head elevated (in case of nocturnal symptoms)
• Limit consumption of foods that commonly trigger heartburn, such as: chocolate, peppermint, spearmint, fatty and fried foods, spicy foods, citrus fruits, fruit juices, and tomatoes.