PANTOPRAZOL 20 mg Tablets

Contents of the leaflet

1. What is Pantoprazol Teva and what is it used for
2. Important information before taking Pantoprazol Teva
   1. When not to take Pantoprazol Teva
   2. Warnings and precautions
   3. Children and adolescents
   4. Pantoprazol Teva and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Pantoprazol Teva contains sodium
3. How to take Pantoprazol Teva
   1. Taking a higher dose of Pantoprazol Teva than recommended
   2. Missing a dose of Pantoprazol Teva
4. Possible side effects
   1. You should immediately contact your doctor or the emergency department of your nearest hospital if you experience any of the following serious side effects. You should stop taking this medicine and take the leaflet and/or the tablets with you.
   2. Reporting side effects
5. How to store Pantoprazol Teva
6. Contents of the pack and other information
   1. What Pantoprazol Teva contains
   2. What Pantoprazol Teva looks like and contents of the pack
   3. Marketing authorization holder and manufacturer

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

Pantoprazol Teva belongs to a group of medicines called proton pump inhibitors. The active substance of the medicine is pantoprazole, which blocks the "pump" that produces stomach acid. This reduces the amount of acid in the stomach.
Pantoprazol Teva is used for the short-term treatment of symptoms of gastroesophageal reflux disease (e.g., heartburn, acid regurgitation) in adults.
Reflux occurs when stomach acid flows back into the esophagus, which can cause inflammation of the esophagus and pain. Symptoms may also include painful burning in the chest that can extend to the throat (heartburn), sour taste in the mouth (acid regurgitation).
Pantoprazol Teva can relieve symptoms of reflux disease and heartburn within the first day of treatment, but it is not intended for immediate relief. To achieve full relief of symptoms, it may be necessary to take the tablets for 2 to 3 consecutive days.
If after 2 weeks there is no improvement, or if you feel worse, you should consult a doctor.

2. Important information before taking Pantoprazol Teva

When not to take Pantoprazol Teva

• If you are allergic (hypersensitive) to pantoprazole or any of the other ingredients of Pantoprazol Teva (listed in section 6).

Internal Use Only

• if you are taking HIV protease inhibitors such as atazanavir, nelfinavir (used to treat HIV infection). See "Pantoprazol Teva and other medicines".
• If you are taking a medicine containing atazanavir (for HIV infection treatment). See section "Pantoprazol Teva and other medicines";
• If you are scheduled for a specific blood test (chromogranin A levels).

Warnings and precautions

Before taking Pantoprazol Teva, you should discuss it with your doctor or pharmacist if you:

• have been treated for heartburn or indigestion continuously for 4 or more weeks;
• are over 55 years old and have been taking over-the-counter indigestion medicines every day for more than 3 years;
• are over 55 years old and have noticed any new symptoms or a change in the nature of your reflux symptoms;
• have had stomach ulcers or stomach surgery;
• have liver problems or jaundice (yellowing of the skin and eyes);
• are under regular medical supervision due to other serious conditions or diseases;
• are scheduled for an endoscopy or an ulcer test;
• have ever had a skin reaction after taking a medicine that reduces stomach acid, such as a proton pump inhibitor;
• are scheduled for a specific blood test (chromogranin A levels);
• are taking HIV protease inhibitors such as atazanavir or nelfinavir (used to treat HIV infection) at the same time as pantoprazole, you should ask your doctor for specific advice.

You should tell your doctor immediatelybefore or after taking this medicine if you notice the appearance of any of the following symptoms, which may be signs of other serious diseases:

• unintentional weight loss (not related to diet or exercise);
• vomiting, especially if it is repeated;

Internal Use Only

• vomiting blood, which may look like dark coffee grounds;
• blood in the stool, black or tarry stools;
• difficulty swallowing or pain when swallowing;
• pallor 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.
• 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. You should stop taking pantoprazole and seek medical advice immediately if you notice any symptoms related to these severe skin reactions described in section 4.

Your doctor may decide that you need additional tests.
If you are going to have a blood test, you should tell your doctor that you are taking this medicine.
It is possible that you may notice relief from reflux symptoms and heartburn within the first day of taking pantoprazole tablets. However, this is not a medicine intended for immediate relief. Do not take it to prevent symptoms.
If you have had heartburn or indigestion for some time, you 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 a lack of data on safety in this younger patient population.

Pantoprazol Teva and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take.
Pantoprazol Teva may affect the action of other medicines, especially those containing the following active substances:

• HIV protease inhibitors such as atazanavir, nelfinavir (used to treat HIV infection). Do not take Pantoprazol Teva at the same time as HIV protease inhibitors. See "When not to take Pantoprazol Teva";
• ketokonazole (used to treat fungal infections);
• warfarin and phenprocoumon (which affect blood clotting and prevent thrombosis). Additional blood tests may be necessary.
• methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) - if you are taking methotrexate, your doctor may temporarily stop treatment with Pantoprazol Teva, as pantoprazole increases methotrexate levels in the blood.

Do not take Pantoprazol Teva with medicines that reduce the amount of acid produced in the stomach, such as other proton pump inhibitors (omeprazole, lansoprazole, or rabeprazole) or H2 antagonists (e.g., ranitidine, famotidine).
Internal Use Only
Pantoprazol Teva can be taken with antacids (e.g., magaldrate, aluminum hydroxide, magnesium carbonate, or their combinations) if necessary.
Before taking Pantoprazol Teva, you should discuss it with your doctor if you are going to have a specific urine test (for the presence of tetrahydrocannabinol (THC)).

Pregnancy and breastfeeding

Pantoprazol Teva should not be used during pregnancy and breastfeeding.
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.

Driving and using machines

If you experience side effects such as dizziness or blurred vision, do not drive or operate machinery.

Pantoprazol Teva contains sodium

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

3. How to take Pantoprazol Teva

Pantoprazol Teva should always be taken exactly as described in this leaflet or as directed by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist for advice.
The recommended dose is one tablet per day. 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. You should stop taking Pantoprazol Teva after complete relief of symptoms. It is possible that you may notice relief from reflux symptoms and heartburn within the first day of taking Pantoprazol Teva. However, remember that this medicine is not intended for immediate relief.
Consult your doctor if after 2 weeks of treatment your symptoms have not improved.
Do not take Pantoprazol Teva for more than 4 weeks without consulting a doctor.
Take the tablets before a meal, once a day, at the same time. Swallow the tablets whole with plenty of water. Do not chew, crush, or split the tablets.

Taking a higher dose of Pantoprazol Teva than recommended

Immediately contact your doctor or pharmacist if you have taken too much of Pantoprazol Teva. If possible, take the medicine and the leaflet with you.

Missing a dose of Pantoprazol Teva

Do not take a double dose to make up for a missed dose. Take the next scheduled dose the next day at the usual time.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Pantoprazol Teva can cause side effects, although not everybody gets them.
Internal Use Only

You should immediately contact your doctor or the emergency department of your nearest hospital if you experience any of the following serious side effects. You should stop taking this medicine and take the leaflet and/or the tablets with you.

• Severe allergic reactions (rare: may affect up to 1 in 1,000 people):hypersensitivity reactions, including anaphylactic reactions, anaphylactic shock, and angioedema. Typical symptoms include: swelling of the face, lips, tongue, and/or throat, which may cause difficulty in swallowing or breathing, hives, severe dizziness with rapid heartbeat and excessive sweating.
• Severe skin reactions (frequency not known: cannot be estimated from the available data):you may notice one or more of the following symptoms
• a rash with swelling, blisters, or peeling of the skin, exfoliative dermatitis, purpura, and blistering of the skin, mucous membranes, and eyes, and rapid deterioration of the general condition, rash, especially on areas of skin exposed to sunlight. Joint pain or flu-like symptoms, fever, swelling of lymph nodes (e.g., in the armpits), and changes in blood tests, including some white blood cells or liver enzymes.
• red, non-raised, target-like, or circular patches on the trunk, often with blisters in the center, peeling of the skin, oral, throat, nose, genital, and eye mucosa. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• widespread rash, high fever, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).
• Other severe reactions (frequency not known: cannot be estimated from the available data):yellowing of the skin and eyes (due to severe liver damage) or fever, rash, and kidney enlargement, sometimes with painful urination, and lower back pain (severe kidney inflammation), which can lead to kidney failure.

Other side effects include:

• Common (affects no more than 1 in 10 people)mild gastric polyps
• Uncommon (affects no more than 1 in 100 people)headache; dizziness; diarrhea; nausea; vomiting; bloating and gas; constipation; dry mouth; abdominal pain and discomfort; skin rash or hives; itching; weakness; fatigue or malaise; sleep disturbances; increased liver enzymes (detected in blood tests); hip, wrist, or spine fractures.
• 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; increased body temperature; swelling of limbs (hands and feet); depression; increased bilirubin (bile pigment) and lipid levels in the blood (detected in blood tests); gynecomastia (breast enlargement in men); high fever and sudden drop in circulating granulocytes (a type of white blood cell) (detected in blood tests).

Internal Use Only
krwi (stwierdzane w badaniu krwi); powiększenie piersi u mężczyzn; wysoka gorączka oraz nagły
spadek krążących ziarnistych krwinek białych (w badaniach krwi).

• Bardzo rzadko (dotyczą nie więcej niż 1 na 10 000 osób)dezorientacja, zmniejszenie liczby płytek krwi, co może powodować zwiększoną tendencję do krwawień i tworzenia się wybroczyn („siniaków”) na skórze (trombocytopenia); zmniejszenie liczby białych krwinek, co może sprzyjać częstszym zakażeniom, współistniejące obniżenie liczby czerwonych i białych krwinek, jak również płytek krwi (stwierdzane w badaniu krwi).
• Częstość nieznana (częstość nie może być określona na podstawie dostępnych danych)omamy, splątanie (szczególnie u pacjentów, u których wcześniej występowały takie objawy), zmniejszenie stężenia sodu, magnezu, wapnia lub potasu we krwi (patrz punkt 2); wysypka mogąca przebiegać z bólem stawów; uczucie mrowienia, swędzenia, kłucie, uczucie pieczenia lub drętwienia, zapalenie jelita grubego, powodujące uporczywą, wodnistą biegunkę.

Reporting side effects

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

5. How to store Pantoprazol Teva

Keep the medicine out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the label, blister, and carton after EXP. The expiry date refers to the last day of that month.
Aluminum/Aluminum blisters.
Store in a temperature below 30°C.
HDPE bottle.
This medicine does not require any special storage conditions.
After the first opening of the HDPE bottle, the shelf life of the medicine is 28 days.
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 Pantoprazol Teva contains

• The active substance of the medicine is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole (as sodium sesquihydrate).
• The medicine also contains: disodium phosphate, mannitol, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, hypromellose (type 6cP), triethyl citrate, sodium carboxymethylcellulose (type A), methacrylic acid, and ethyl acrylate copolymer (1:1) dispersion 30%, yellow iron oxide (E 172).

Internal Use Only

What Pantoprazol Teva looks like and contents of the pack

Pantoprazol Teva is oval, yellow tablets available in aluminum blisters containing 7 and 14 tablets * or HDPE bottles with a child-resistant closure, containing 28 tablets *.
* Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Teva Pharmaceuticals Polska Sp. z o.o.,
ul. Emilii Plater 53,
00-113 Warszawa,
tel.: (22) 345 93 00.
Manufacturer:
Teva Pharma S.L.U.,
Poligono Industrial Malpica, c/C, No. 4,
50016 ZARAGOZA, Spain
Date of last revision of the leaflet:November 2023.
The following lifestyle and dietary recommendations may also help alleviate heartburn or other acid-related symptoms:

• Avoid large meals
• Eat slowly
• Quit smoking
• Limit alcohol and caffeine consumption
• Lose weight (if overweight)
• Avoid tight clothing or belts;
• Avoid eating meals later than 3 hours before bedtime;
• Sleep with your head elevated (if you experience nighttime symptoms);
• Limit foods that usually trigger heartburn, such as: chocolate, peppermint, spearmint, fatty and fried foods, acidic, spicy, citrus fruits, fruit juices, and tomatoes.