Pantoprazole teva

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
Pantoprazol Teva (Pantoprazole-Teva)
20 mg, enteric-coated tablets
Pantoprazolum
Pantoprazol Teva and Pantoprazole-Teva are different trade names for the same medicinal product.
Please read the leaflet carefully before using the 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
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, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 2 weeks or if the patient feels worse, consult a doctor. Do not take Pantoprazol Teva for longer than 4 weeks without consulting a doctor.

Contents of the leaflet:

1. What Pantoprazol Teva is and what it is used for
2. What you need to know 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 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) (for example, heartburn, acid regurgitation) in adults.
Reflux refers to the backflow of stomach acid into the oesophagus, which may lead to inflammation
of the oesophagus and cause pain. Other symptoms may include a painful burning sensation in the
chest rising up to the throat (heartburn), or 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 the medicine 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 the patient feels worse, consult a 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 or 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 weeks or longer;
• is over 55 years old and takes over-the-counter antacids daily;
• is over 55 years old and has noticed any new symptoms or a change in the nature of existing reflux symptoms;
• has a history of peptic ulcer disease or has undergone 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 an endoscopic examination or a biopsy;
• has ever experienced a skin reaction while taking a medicine similar to Pantoprazol Teva that reduces gastric 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) concomitantly with pantoprazole; in such case, please 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 B12 and vitamin B12 deficiency in patients with low vitamin B12 levels. Contact a doctor if any of the following symptoms occur, which may indicate low vitamin B12 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 of an increased 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 may also lead to reduced potassium and calcium levels in the blood. If this 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 conditions:

• unintentional weight loss (not related to diet or exercise);
• vomiting, especially recurrent;
• vomiting blood, which may appear as dark coffee-ground-like material;
• blood in the stool, black or tarry stools;
• difficulty swallowing or pain during swallowing;
• paleness and weakness (anemia);
• chest pain;
• abdominal pain;
• severe and/or persistent diarrhea, as use of this medicine is associated with a slightly increased risk of infectious diarrhea;
• if the patient develops a skin rash, especially in areas exposed to sunlight, the patient 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 pantoprazole use. Discontinue pantoprazole and seek immediate medical advice if any symptoms suggestive of these serious skin reactions occur, as described in section 4.

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 and heartburn symptoms 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 and 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, particularly those containing any of the following active substances:

• HIV protease inhibitors such as atazanavir or nelfinavir (used in the treatment of HIV infection). Concomitant use of Pantoprazol Teva with HIV protease inhibitors is not recommended. 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 Pantoprazol Teva treatment, as pantoprazole may increase methotrexate blood levels.

Do not take Pantoprazol Teva with other medicines that reduce stomach acid production, such as other proton pump inhibitors (e.g. omeprazole, lansoprazole, rabeprazole) or H2-receptor 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).
Before starting Pantoprazol Teva, discuss with the doctor if the patient is scheduled for a specific urine test (for tetrahydrocannabinol (THC) detection).

Pregnancy and breastfeeding
Do not use Pantoprazol Teva in pregnant or breastfeeding women.
If the patient is pregnant, 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 operating machinery
If the patient experiences adverse effects such as dizziness or visual disturbances, do not drive or operate machinery.

Pantoprazol Teva contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet and is therefore 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 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.

Take the medicine 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, keep in mind that this medicine is not intended to provide immediate relief.

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

Do not take Pantoprazol Teva for longer than 4 weeks without consulting a 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 too much Pantoprazol Teva, 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 the missed dose. Take the next scheduled dose at the usual time 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 your 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) 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; severe dizziness with rapid heartbeat and profuse sweating.
• Severe skin reactions (frequency unknown: frequency cannot be determined from available data): the patient may notice one or more of the following symptoms:
  • rash with swelling, blisters, or peeling skin; sheet-like peeling of the skin; bleeding from the eyes, nose, mouth, or genital areas; rapid deterioration in general condition; rash particularly affecting areas of skin exposed to sunlight. Joint pain or flu-like symptoms may also occur, along with fever, swollen glands (e.g., under the arms), and blood tests may show changes in certain white blood cells or liver enzymes.
  • red, flat, disc-shaped or round spots on the trunk, often with blisters in the center, skin peeling, and 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 body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Other severe reactions (frequency unknown: frequency cannot be determined from 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 up to 1 in 10 people): benign gastric polyps
• Uncommon (affects up to 1 in 100 people): headache; dizziness; diarrhoea; nausea; vomiting; flatulence and bloating; constipation; dryness of the 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 up to 1 in 1,000 people): distortion or complete loss of taste sensation; 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 bilirubin levels (bile pigment) and increased lipid levels in the blood (detected in blood tests); breast enlargement in males; high fever and sudden drop in circulating granulocytes (white blood cells) (detected in blood tests).
• Very rare (affects up to 1 in 10,000 people): disorientation; reduced platelet count, which may lead to increased tendency to bleed and development of petechiae (‘bruises’) on the skin (thrombocytopenia); reduced white blood cell count, which may predispose to more frequent infections; concurrent reduction in red blood cells, white blood cells, and platelets (detected in blood tests).
• Frequency unknown (frequency cannot be determined from available data): hallucinations, confusion (particularly in patients who previously experienced such symptoms); decreased levels of sodium, magnesium, calcium, or potassium in the blood (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 Drug Reactions 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 using 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.
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 in use. Such measures help protect the environment.

6. Contents of the package 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, sodium croscarmellose, magnesium stearate, hypromellose, sodium carboxymethyl starch (type A).
• Tablet coating: triethyl citrate, copolymer of methacrylic acid and ethyl acrylate (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 OPA/Al/PVC//Al blisters containing 7 and 14 enteric-coated tablets, packed in a cardboard box.
For further 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
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 Authorisation Numbers in Hungary, country of export: OGYI-T-21497/01
OGYI-T-21497/03
Parallel Import Authorisation Number: 294/19

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