Pantoprazol Teva

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE USER

Warning! Keep the leaflet, the information on the immediate packaging is 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 the leaflet before taking 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 your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, you should ask your pharmacist.
• If any of the side effects get worse, or if you notice any side effects not listed in the leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 2 weeks there is no improvement, 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 reflux) in adults.
Reflux occurs when stomach acid flows back into the esophagus, which can lead to inflammation of the esophagus and cause pain. Symptoms such as painful burning in the chest that can reach the throat (heartburn), sour taste in the mouth (acid reflux), and others may also occur.
Pantoprazol Teva can eliminate symptoms associated with reflux disease and heartburn as early as the first day of treatment; however, the medicine is not intended for immediate relief. To achieve complete 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 show improvement 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 taking 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 take over-the-counter indigestion medicines every day;
• are over 55 years old and have noticed any new symptoms or a change in the character of existing 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 for other serious conditions or diseases; will undergo endoscopy or stress test;
• have ever had a skin reaction after taking a medicine that reduces stomach acid production before 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.

You should not take this medicine for more than 4 weeks without consulting your doctor. If the symptoms of gastroesophageal reflux disease (heartburn or acid reflux) persist for more than 2 weeks, you should consult your doctor, who will decide whether you 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;
• 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 taken for more than 4 weeks, the patient 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;

The doctor may decide to perform additional tests.
If the patient is scheduled for 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. 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 group of patients.

Pantoprazol Teva and other medicines

The patient should tell their doctor or pharmacist about all the 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). 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 stop the 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, 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.

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 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 means it 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 doubts, the patient should consult their doctor or pharmacist.
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 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 this 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 meals, 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.
In case of further doubts about taking the medicine, the patient 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. They should stop taking the medicine and bring the leaflet and/or tablets with them.

• Severe allergic reactions (rare: affects no more than 1 in 1000 people):hypersensitivity reactions, so-called anaphylactic reactions, anaphylactic shock, and angioedema

vascular disorders. 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: frequency 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, patchy skin peeling, 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 glands (e.g., under the arms), and changes in white blood cell counts or liver enzymes may also occur.

Other severe reactions (frequency not known: frequency cannot be estimated from the available data):

jaundice (yellowing of the skin and eyes due to severe liver damage) orfever, 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 enzyme activity (detected in blood tests); hip fracture, wrist fracture, or spine fracture.

Rare (affects no more than 1 in 1000 people)

distorted or complete loss of sense of taste; vision disturbances, such as blurred vision; joint pain; muscle pain; changes in body weight; elevated body temperature; swelling of limbs (hands and feet); depression; increased bilirubin levels (bile pigment) and lipid levels in the blood (detected in blood tests); breast enlargement in men; high fever and sudden drop in circulating white blood cell count (in blood tests).

Very rare (affects no more than 1 in 10,000 people)

disorientation, decreased platelet count, which may cause increased tendency to bleeding and bruising (thrombocytopenia); decreased white blood cell count, which may lead to more frequent infections, concurrent decrease in red and white blood cell counts, 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 experienced 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 the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +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

Store the medicine out of 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 month stated.
Shelf life after first opening: 100 days.
Blisters OPA/Al/PVC/Al in a cardboard box.
Do not store 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 they no longer use. 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: Core: disodium phosphate, mannitol, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, hypromellose (type 6cP), sodium carboxymethylcellulose (type A); Coating: methacrylic acid and ethyl acrylate copolymer (1:1), dispersion 30%, triethyl citrate, 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 14 tablets.
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:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
IVA Pharm Sp. z o.o.
ul. Drawska 14/1
02-202 Warszawa
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Hungary, the country of export: OGYI-T-21497/01
Parallel import authorization number: 166/21
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 three hours before bedtime;
• Sleep with your head elevated (if you experience nighttime symptoms);
• Limits foods that usually cause heartburn, such as: chocolate, peppermint, spearmint, fatty and fried foods, acidic, spicy, citrus fruits, fruit juices, and tomatoes.

Date of leaflet approval: 05.05.2023
[Information about the trademark]