Pantoprazol Teva

Patient Information Leaflet: User Information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Pantoprazol Teva(Pantoprazole-Teva)

20 mg, gastro-resistant tablets

Pantoprazolum
Pantoprazol Teva and Pantoprazole-Teva are different trade names for the same medicine.

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for you.

for the patient.
This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again later.
• If you need advice or further information, you should speak to your pharmacist.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. See section 4.
• If after 2 weeks you do not feel better or if you feel worse, you should contact your doctor. You should not take Pantoprazol Teva for more than 4 weeks without consulting your doctor.

Table of Contents of the Leaflet:

• 1. What is Pantoprazol Teva and what is it 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 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. In 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 (e.g., heartburn, acid regurgitation) in adults.
Reflux occurs when acid from the stomach flows back into the esophagus, which can lead to inflammation of the esophagus and cause pain. Other symptoms may also occur, such as: painful burning in the chest that can extend to the throat (heartburn), sour taste in the mouth (acid regurgitation).
Pantoprazol Teva can eliminate symptoms associated with reflux disease and heartburn as early as the first day of use, but the medicine 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 the patient does not improve or feels worse, they should contact their doctor.

2. Important information before taking Pantoprazol Teva

When not to take 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 to treat HIV infection). See "Pantoprazol Teva and other medicines";
• If the patient is taking a medicine containing atazanavir (for HIV infection treatment). See section "Pantoprazol Teva and other medicines";
• If the patient is scheduled for a specific blood test (chromogranin A levels).

Warnings and precautions

Before starting to take Pantoprazol Teva, the patient should discuss it with their doctor or pharmacist if they:

• 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 unusual symptoms or a change in their reflux symptoms;
• have had stomach ulcers or stomach surgery;
• have liver or jaundice (yellowing of the skin and eyes) problems;
• are under regular medical supervision for other serious conditions or diseases;
• are going to have an endoscopy or an ulcer healing test;
• have ever had a skin reaction with a medicine that reduces stomach acid, such as a proton pump inhibitor;
• are going to have 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, they should ask their doctor for specific advice.

The patient should not take this medicine for more than 4 weeks without consulting their doctor. If symptoms of gastroesophageal reflux disease (heartburn or acid regurgitation) persist for more than 2 weeks, the patient should consult their doctor, who will decide whether they need to continue taking the medicine.
Long-term use of Pantoprazol Teva may be associated with additional risks, such as:

• reduced absorption of vitamin B and vitamin B deficiency in case of low vitamin B levels in the body. The patient should contact their doctor if they notice any of the following symptoms that may indicate low vitamin B levels:
• 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
• hip, wrist, or spine fractures, especially if the patient already has osteoporosis (reduced bone density) or if the doctor has told the patient that they are at risk of osteoporosis (e.g., if the patient is taking steroid medicines);
• low magnesium levels in the blood (possible symptoms: fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, rapid heartbeat). Low magnesium levels can also lead to low potassium and calcium levels in the blood. If the patient is taking the medicine for more than 4 weeks, they should consult their doctor. The doctor may order regular blood tests to monitor magnesium levels.

The patient should immediately inform their doctorbefore or after taking this medicine if they notice the occurrence 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 recurring;
• 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;
• if the patient experiences a skin rash, especially in areas exposed to sunlight, they should tell their doctor as soon as possible, as it may be necessary to stop taking Pantoprazol Teva. The patient should also tell their 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. The patient should stop taking pantoprazole and seek medical advice immediately if they notice any symptoms related to these severe skin reactions described in section 4.

The doctor may decide to perform additional tests.
If the patient is going to have a blood test, they should inform their doctor that they are taking this medicine.
It is possible that the patient may notice relief from reflux symptoms and heartburn as early as the first day of taking pantoprazole in tablet form. However, this is not a medicine intended for immediate relief. The patient should not take it as a preventive measure.
If the patient has been experiencing recurring 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 the lack of information on safety in this younger group of patients.

Pantoprazol Teva and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Pantoprazol Teva may affect the efficacy of other medicines, especially those containing the following active substances:

• HIV protease inhibitors, such as atazanavir, nelfinavir (used to treat HIV infection). The patient should 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 (affecting blood density and preventing blood clots). Additional blood tests may be necessary.
• methotrexate (used to treat rheumatoid arthritis, psoriasis, cancer) - if the patient is taking methotrexate, the doctor may temporarily stop treatment with Pantoprazol Teva, as pantoprazole increases methotrexate levels in the blood.

The patient should 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).
Pantoprazol Teva can be taken with antacids (e.g., magaldrate, alginic acid, sodium bicarbonate, aluminum hydroxide, magnesium carbonate, or their combinations) if necessary.
Before starting to take Pantoprazol Teva, the patient should discuss it with their doctor if they are going to have a specific urine test (for tetrahydrocannabinol (THC)).

Pregnancy and breastfeeding

Pantoprazol Teva should not be used in pregnant or breastfeeding women.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

If the patient experiences side effects such as dizziness or vision problems, they should not drive or operate machinery.

Pantoprazol Teva contains sodium

The 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 the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The recommended dose is one tablet per day. The patient should 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. The patient should stop taking Pantoprazol Teva after complete relief of symptoms. It is possible to notice relief from reflux symptoms and heartburn as early as the first day of taking Pantoprazol Teva. However, the patient should remember that the medicine is not intended for immediate relief.
The patient should consult their doctor if, after taking the medicine for 2 weeks, the symptoms do not improve.
The patient should not take Pantoprazol Teva for more than 4 weeks without consulting their doctor.
Tablets should be taken before a meal, once a day, at the same time. The tablets should be swallowed whole, with plenty of water. The tablets should not be chewed, crushed, or divided.

Taking a higher dose of Pantoprazol Teva than recommended

The patient should immediately contact their doctor or pharmacist if they have taken too much of the medicine. If possible, they should bring the medicine and the leaflet with them.

Missing a dose of Pantoprazol Teva

The patient should not take a double dose to make up for a missed dose. They should take the next scheduled dose the next day at the usual time.
If the patient has any further doubts about taking the medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

The patient should immediately contact their doctor or the emergency department of the nearest hospital if they experience any of the following serious side effects.

• Severe allergic reactions (rare: affects up to 1 in 1000 people):hypersensitivity reactions, such as anaphylactic reactions, anaphylactic shock, and angioedema. Typical symptoms are: 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):the patient may notice one or more of the following symptoms
• rash with swelling, blisters, or peeling of the skin, flaking of the skin, bleeding from the eyes, nose, mouth, or genitals, and rapid deterioration of general condition, rash, especially on areas of skin exposed to sunlight. Joint pain or flu-like symptoms, fever, swelling of the lymph nodes (e.g., in the armpits), and changes in blood test results may also occur.
• red, non-raised, target-like, or circular patches on the trunk, often with blisters in the center, peeling of the skin, mouth ulcers, throat, nose, genitals, and eye inflammation. These severe skin rashes may 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: cannot be estimated from the available data):yellowing of the skin and eyes (due to severe liver damage) or fever, rash, and swollen kidneys, sometimes with painful urination, and lower back pain (severe kidney inflammation), which can lead to kidney failure.

Other side effects include:

• Common (affects up to 1 in 10 people)mild gastric polyps
• Uncommon (affects up to 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 disorders; increased liver enzyme activity (detected in blood tests); hip, wrist, or spine fractures.
• Rare (affects up to 1 in 1000 people)distorted or complete loss of taste; vision problems, such as blurred vision; joint pain; muscle pain; changes in body weight; elevated body temperature; swelling of the limbs (hands and feet)

of the limbs (hands and feet); depression; increased bilirubin (bile pigment) and lipid levels in the blood (detected in blood tests); breast enlargement in men; high fever and sudden drop in circulating granulocytes (in blood tests).

• Very rare (affects up to 1 in 10,000 people)disorientation, decreased platelet count, which can lead to increased tendency to bleeding and bruising, decreased white blood cell count, which can lead to more frequent infections, concurrent decrease in red and white blood cell count, as well as platelet count (detected in blood tests).
• Frequency not known (frequency cannot be estimated from the available data)hallucinations, confusion (especially in patients who have had these symptoms before), decreased sodium, magnesium, calcium, or potassium levels in the blood (see section 2); rash that may be accompanied by joint pain; tingling, itching, prickling, burning, or numbness, colitis, causing persistent, watery diarrhea.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their 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, more information can be collected on the safety of the medicine.

5. How to store Pantoprazol Teva

The medicine should be stored out of sight and reach of children.
The patient should not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
The medicine should not be stored at temperatures above 30°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 pantoprazole sodium sesquihydrate).
• The medicine also contains: disodium phosphate, mannitol (E 421), microcrystalline cellulose, sodium croscarmellose, magnesium stearate, hypromellose, sodium carboxymethylcellulose (type A).
• Coating of the tablet:triethyl citrate, methacrylic acid, and ethyl acrylate copolymer (1:1), dispersion 30%, yellow iron oxide (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 7 and 14 gastro-resistant tablets, in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Hungary, the country of export:

Teva Gyógyszergyár Zrt.
4042 Debrecen, Pallagi út 13.
Hungary

Manufacturer:

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

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Hungary, the country of export:OGYI-T-21497/01
OGYI-T-21497/03
Parallel import authorization number:294/19

Date of leaflet approval: 04.07.2024

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

• Avoid large meals.
• Eat slowly.
• Stop 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.