Pantoprazol Teva

Patient Information Leaflet: User Information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Pantoprazol Teva (Pantoprazole-Teva 20 mg)

20 mg, gastro-resistant tablets

Pantoprazolum(in the form of pantoprazole sodium sesquihydrate)
Pantoprazol Teva and Pantoprazole-Teva 20 mg are different trade names for the same medicine.

The leaflet should be read carefully before taking the medicine, as it contains important information for the patient.

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

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If any of the side effects worsen or any side effects not mentioned in the leaflet occur, the doctor, pharmacist, or nurse should be informed. See section 4.
• If after 2 weeks there is no improvement or the patient feels worse, the doctor should be contacted. The medicine Pantoprazol Teva should not be taken for longer than 4 weeks without consulting a 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. 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. Symptoms such as burning pain in the chest that can reach the throat (heartburn), sour taste in the mouth (acid regurgitation) may also occur.
Pantoprazol Teva can relieve symptoms of reflux disease and heartburn from 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, the doctor should be contacted.

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 doctor or pharmacist should be consulted if the patient:

• has been treated for heartburn or indigestion continuously for 4 or more weeks;
• is over 55 years old and takes over-the-counter indigestion medicines every day;
• is over 55 years old and has noticed any new symptoms or a change in the character of existing reflux symptoms;
• has had stomach ulcers or stomach surgery;
• has liver problems or jaundice (yellowing of the skin and eyes);
• is under regular medical supervision for other serious conditions or diseases; will undergo endoscopy or stress test
• if the patient has ever had a skin reaction after taking a medicine similar to Pantoprazol Teva, which reduces stomach acid production, scheduled specific blood test (chromogranin A levels);
• if the patient is taking HIV protease inhibitors, such as atazanavir or nelfinavir (used to treat HIV infection) at the same time as pantoprazole, the doctor should be asked for detailed instructions.

The medicine should not be taken without consulting a doctor for a period longer than 4 weeks. If the symptoms of reflux disease (heartburn or acid regurgitation) persist for more than 2 weeks, a doctor should be consulted, who will decide on the need for long-term use of 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;
• hip fracture, wrist fracture, or spine fracture, especially if the patient already has osteoporosis (reduced bone density) or if the doctor has informed the patient that they are at risk of osteoporosis (e.g., if the patient is taking steroid medicines);
• reduced magnesium levels in the blood (possible symptoms: fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, rapid heartbeat). Low magnesium levels can also lead to reduced potassium and calcium levels in the blood. If the medicine is used for more than 4 weeks, a doctor should be consulted. The doctor may order regular blood tests to monitor magnesium levels.

The doctor should be informed immediatelybefore or after taking this medicine if the patient notices the occurrence of the following symptoms, which may be a sign of 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 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 a skin rash occurs, especially in areas of the skin exposed to sunlight, the doctor should be informed as soon as possible, as it may be necessary to discontinue the use of Pantoprazol Teva. Any other adverse reactions, such as joint pain, should also be reported.

The doctor may decide on the need for additional tests.
If the patient is to undergo a blood test, the doctor should be informed about the use of this medicine.
It is possible that the patient will notice relief from reflux symptoms and heartburn after just one day of taking pantoprazole in tablet form. However, this is not a medicine intended for immediate relief. It should not be used as a preventive measure.
If the patient has been experiencing recurring heartburn or indigestion 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 patient group.

Pantoprazol Teva and other medicines

The doctor or pharmacist should be told about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take.
Pantoprazol Teva may affect the effectiveness of other medicines, especially those containing one of the following active substances:

• HIV protease inhibitors, such as atazanavir, nelfinavir (used to treat HIV infection). Pantoprazol Teva should not be taken 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 discontinue treatment with Pantoprazol Teva, as pantoprazole increases methotrexate levels in the blood.

Pantoprazol Teva should not be taken with medicines that reduce the amount of acid produced in the stomach, such as other proton pump inhibitors (omeprazole, lansoprazole, rabeprazole) or H2 antagonists (e.g., ranitidine, famotidine).
Pantoprazol Teva can be used if necessary with antacids (e.g., magaldrate, alginic acid, sodium bicarbonate, aluminum hydroxide, magnesium carbonate, or their combinations).

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 a doctor or pharmacist before taking this medicine.

Driving and operating machinery

If the patient experiences side effects such as dizziness or vision 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, 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 doctor or pharmacist should be consulted.
The recommended dose is one tablet per day. The recommended dose of 20 mg of pantoprazole per day should not be exceeded.
The medicine should be taken for at least 2 to 3 consecutive days. The use of Pantoprazol Teva should be stopped after complete relief of symptoms. It is possible to notice relief from reflux symptoms and heartburn after just one day of taking Pantoprazol Teva. However, it should be remembered that the medicine is not intended for immediate relief.
A doctor should be consulted if after 2 weeks of taking the medicine the symptoms do not improve.
Pantoprazol Teva should not be taken for longer than 4 weeks without consulting a doctor.
Tablets should be taken before a meal, at the same time every day. The tablets should be swallowed whole, with plenty of water. The tablets should not be chewed, crushed, or divided.

Overdose of Pantoprazol Teva

A doctor or pharmacist should be contacted immediately in case of taking too much of the medicine. If possible, the medicine and leaflet should be taken along.

Missed dose of Pantoprazol Teva

A double dose should not be taken to make up for a missed dose. The next planned dose should be taken the next day at the usual time.
In case of further doubts about the use of the medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

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

The doctor or the emergency department of the nearest hospital should be contacted immediately in case of occurrence of any of the following serious side effects. The use of this medicine should be stopped, and the leaflet and/or tablets should be taken along.

• Severe allergic reactions (rare: affects no more than 1 in 1000 people):Allergic reactions, so-called anaphylactic reactions, anaphylactic shock, and angioedema. Typical symptoms are: swelling of the face, lips, tongue, and/or throat, which can cause difficulty swallowing or breathing, hives, severe dizziness with rapid heartbeat and excessive sweating.
• Severe skin reactions (frequency not known: frequency cannot be estimated from the available data):The patient may notice one or more of the following symptoms - rash

with blistering, or peeling of the skin, blistering of the skin, bleeding from the eyes, nose, mouth, or genitals, and rapid worsening of the general condition, rash, especially on areas of the skin exposed to sunlight. Joint pain or flu-like symptoms, fever, swelling of the lymph nodes (e.g., under the arms), and changes in blood test results may also occur. Other serious reactions (frequency not known: frequency cannot be estimated from the available data):yellowing of the skin and eyes (due to severe liver damage) or kidney problems, manifested by painful urination, lower back pain with fever.
Other side effects include:

• -Common (affects no more than 1 in 10 people)mild polyps in the stomach.
• 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 activity of liver enzymes (found in blood tests); hip fracture, wrist fracture, or spine fracture.
• Rare (affects no more than 1 in 1000 people)distortion or complete loss of taste, vision disturbances, such as blurred vision, joint pain, muscle pain, changes in body weight, elevated body temperature, swelling of the limbs (hands and feet), depression, elevated bilirubin (bile pigment) and lipid levels in the blood (found in blood tests), breast enlargement in men, high fever, and sudden drop in circulating granulocytes (in blood tests).
• Very rare (affects no more than 1 in 10,000 people)disorientation, decreased platelet count, which can cause increased tendency to bleeding and bruising on the skin (thrombocytopenia); 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 (found in blood tests).
• Frequency not known (frequency cannot be estimated from the available data)hallucinations, confusion (especially in patients who have had such 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.

Reporting side effects

If any side effects occur, including those not mentioned in the leaflet, the doctor, pharmacist, or nurse should be informed. 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, 2-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Pantoprazol Teva

The medicine should be stored out of sight and reach of children.
Do not store above 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 month.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked 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 (in the form of pantoprazole sodium sesquihydrate).
• The medicine also contains: disodium phosphate, mannitol (E 421), microcrystalline cellulose, hypromellose 6cP, sodium carboxymethyl cellulose (type A), croscarmellose sodium, magnesium stearate; coating: 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 oval, yellow, gastro-resistant tablets available in blisters of OPA/Al/PVC/Al foil, containing 7, 14, or 28 gastro-resistant tablets.
For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization 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, Netherlands

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number, in Hungary, country of export: OGYI-T-21497/01
OGYI-T-21497/03

Parallel import authorization number: 280/20 Date of approval of the leaflet: 10.06.2022

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 (in case of overweight)
• Avoid wearing tight clothing or belts;
• Avoid eating meals later than 3 hours before bedtime;
• Sleep with the head elevated (in case of nighttime symptoms);
• Limits the consumption of foods that usually cause heartburn, such as chocolate, peppermint, spearmint, fatty and fried foods, acidic, spicy, citrus fruits, fruit juices, and tomatoes.

[Information about the trademark]