Pantoprazole teva

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

• Keep this leaflet for future reference.
• If you need advice or further information, consult your pharmacist.
• If any of the side effects worsens or if you experience any side effects not listed in the leaflet, inform your doctor, pharmacist, or nurse. 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.

Leaflet contents:

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 pantoprazole (in the form of sodium pantoprazole sesquihydrate), which blocks the "proton pump" responsible for gastric acid production. 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) (e.g., heartburn, acid regurgitation) in adults.
Reflux refers to the backward flow of acid from the stomach 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), 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; however, this medicine is not intended to provide immediate relief. To achieve full 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 to 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 levels).

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 or more weeks;
• is over 55 years old and regularly takes over-the-counter antacids;
• is over 55 years old and has noticed any new symptoms or a change in the nature of existing reflux symptoms;
• has had a peptic ulcer disease or previous stomach surgery;
• has liver problems or jaundice (yellowing of the skin and eyes);
• is under ongoing medical care for other serious conditions or diseases; is scheduled for endoscopic examination or biopsy;
• has ever experienced a skin reaction while taking a medicine similar to Pantoprazol Teva that reduces stomach acid secretion;
• is scheduled for a specific blood test (chromogranin A levels);
• is taking HIV protease inhibitors such as atazanavir or nelfinavir (used in the treatment of HIV infection) together with pantoprazole, the patient should consult the doctor for specific 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. Contact a doctor if any of the following symptoms occur, which may indicate low vitamin B({12}) levels:
• extreme fatigue or lack of energy,
• numbness and tingling sensations,
• pain or redness of the tongue, mouth ulcers,
• muscle weakness,
• vision disturbances,
• memory problems, disorientation, depression;
• fractures of the hip, wrist, or spine, especially if the patient already has osteoporosis (reduced bone density) or if the doctor has informed the patient that they are at risk of developing 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 may also lead to reduced potassium and calcium levels in the blood. If the medicine is taken for longer than 4 weeks, consult a doctor. The doctor may order regular blood tests to monitor magnesium levels.

Contact a doctor immediately before or after taking this medicine if the patient notices the appearance of any of the following symptoms, which may indicate other serious conditions:

• 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;
• paleness and weakness (anaemia);
• chest pain;
• abdominal pain;
• severe and/or persistent diarrhoea, as use of this medicine is associated with a small 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.
• severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme, have been reported with the use of pantoprazole. The patient should stop taking pantoprazole and seek immediate medical advice if any symptoms related to these severe skin reactions described in section 4 occur.

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.
Symptom relief from reflux and heartburn may be noticed 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 recurrent heartburn or indigestion symptoms over time, regular medical monitoring is recommended.

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 currently or recently taken, as well as any medicines the patient plans to take.
Pantoprazol Teva may reduce the effectiveness of other medicines, especially medicines 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 together 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 necessary;
• 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 together with medicines that reduce stomach acid production, such as other proton pump inhibitors (e.g. omeprazole, lansoprazole, or rabeprazole) or H2 antagonists (e.g. ranitidine, famotidine).
Pantoprazol Teva may be taken, if necessary, together with antacids (e.g. magaldrate, alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate, or their combinations).

Before starting Pantoprazol Teva, discuss with the doctor if the patient is scheduled for a specific urine test (for detection of tetrahydrocannabinol (THC)).

Pregnancy and breastfeeding
Pantoprazol Teva should not be used in pregnant or breastfeeding women.
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
If the patient experiences adverse effects such as dizziness or visual disturbances, they should not drive or operate machinery.

Pantoprazol Teva contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. it is essentially "sodium-free".

3. How to use Pantoprazol Teva

Pantoprazol Teva must always be taken exactly as described 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 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. Treatment with Pantoprazol Teva should be discontinued once symptoms have completely resolved. Symptoms of reflux and heartburn may improve already after one day of treatment with Pantoprazol Teva. However, keep in mind that this medicine is not intended to provide immediate relief.

Consult your doctor if symptoms have not improved after taking this medicine for a full 2 weeks.

Do not take Pantoprazol Teva for longer than 4 weeks without consulting your doctor.

Take 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 too much Pantoprazol Teva, contact your doctor or pharmacist immediately. If possible, bring the medicine and this leaflet with you.

If you forget to take Pantoprazol Teva

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

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Immediately contact a doctor or the emergency department of the nearest hospital if any of the following severe adverse reactions occur. You must immediately stop taking this medicine and bring the package leaflet and (or) 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, severe dizziness with rapid heartbeat and profuse 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:
• rash with swelling, blisters or peeling of the skin, sheet-like peeling of the skin, bleeding from the eyes, nose, mouth or genital areas, rapid deterioration of general condition, rash particularly in areas of skin exposed to sunlight. Joint pain or flu-like symptoms, fever, swollen glands (e.g. under the arms) may also occur, and blood tests may show changes in certain white blood cells or liver enzymes.
• red, non-elevated, target-shaped or circular spots on the trunk, often with blisters in the center, skin peeling, ulceration of the mouth, throat, nose, genital organs and eyes. 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 syndrome or drug hypersensitivity syndrome).
• 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 enlarged kidneys sometimes with 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 fundic gland polyps.
• Uncommon (affects no more than 1 in 100 people): headache, dizziness, diarrhoea, nausea, vomiting, flatulence and bloating, constipation, dry mouth, abdominal pain and discomfort, skin rash or urticaria, itching, fatigue, exhaustion or malaise, sleep disturbances, increased liver enzyme activity (detected in blood tests); fractures 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 lipid levels (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, decreased platelet count, which may lead to increased tendency to bleeding and formation of petechiae (bruises) on the skin (thrombocytopenia); decreased white blood cell count, which may predispose to more frequent infections, concurrent decrease in red and white blood cells as well as platelets (detected in blood tests).
• Frequency unknown (frequency cannot be estimated based on available data): hallucinations, confusion (particularly in patients who previously experienced such symptoms), decreased blood levels of sodium, magnesium, calcium or potassium (see section 2); rash possibly 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 adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 2-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Pantoprazol Teva

Keep this medicine out of the sight and reach of children.
Store below 30°C.
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.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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 ingredients are: disodium phosphate, mannitol (E 421), microcrystalline cellulose, hypromellose 6 cP, sodium starch glycolate (type A), sodium croscarmellose, magnesium stearate; coating: triethyl citrate, methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion, yellow iron oxide (E 172).

What Pantoprazol Teva looks like and contents of the pack
Pantoprazol Teva is an oval, yellow tablet available in blisters made of OPA/Al/PVC//Al foil,
containing 7, 14 or 28 enteric-coated tablets, packed in a cardboard box.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Hungary, 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 Zaragoza, Spain
Teva Gyógyszergyár Zrt., 4042 Debrecen, Pallagi út 13., Hungary
Pharmachemie B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands
Parallel Importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Hungarian Marketing Authorisation Numbers (country of export): OGYI-T-21497/01
OGYI-T-21497/03
Parallel Import Licence Number: 280/20
The following lifestyle recommendations and dietary changes may also help relieve heartburn
or other symptoms related to gastric acid:

• 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 usually trigger heartburn, such as: chocolate, peppermint, spearmint, fatty and fried foods, spicy foods, citrus fruits, fruit juices and tomatoes.