PANTOPRAZOL TARBIS 20 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the Patient

Pantoprazol Tarbis 20 mg Gastro-Resistant Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Pantoprazol Tarbis and what is it used for
2. What you need to know before you take Pantoprazol Tarbis
3. How to take Pantoprazol Tarbis
4. Possible side effects
5. Storage of Pantoprazol Tarbis
6. Contents of the pack and other information

1. What is Pantoprazol Tarbis and what is it used for

Pantoprazol Tarbis is a selective inhibitor of the "proton pump", a medicine that reduces the amount of acid produced in your stomach. It is used for the treatment of diseases related to stomach and intestine acid.

Pantoprazol Tarbisis used for:

Adults and adolescents from 12 years:

• Treatment of symptoms associated with gastroesophageal reflux disease (heartburn, acid regurgitation, pain when swallowing) caused by acid reflux from the stomach.

• Long-term treatment and prevention of relapses of reflux esophagitis (inflammation of the esophagus accompanied by acid regurgitation from the stomach).

Adults:

• Prevention of gastroduodenal ulcers induced by non-steroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen) in patients at risk who require continued treatment with these types of drugs.

2. What you need to know before taking Pantoprazol Tarbis

Do not takePantoprazol Tarbis

• If you are allergic (hypersensitive) to pantoprazole or any of the other ingredients of Pantoprazol Tarbis (see section 6).
• If you are allergic to medicines that contain other proton pump inhibitors (e.g. omeprazole, lansoprazole, rabeprazole, esomeprazole)

Warnings and precautions

Consult your doctor before starting to take Pantoprazol Tarbis:

If you experience a skin rash, especially in areas of the skin exposed to the sun, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with Pantoprazol Tarbis. Remember to mention any other symptoms you may notice, such as joint pain.

Tell your doctor immediatelyif you notice any of the following symptoms:

• unintentional weight loss
• repeated vomiting
• difficulty swallowing
• blood in the vomit
• pale appearance and feeling of weakness (anemia)
• blood in your stools

• severe or persistent diarrhea, as pantoprazole has been associated with a small increase in infectious diarrhea.

Your doctor will decide if you need any additional tests to rule out a malignant disease, as pantoprazole may alleviate the symptoms of cancer and could delay its diagnosis. If, despite treatment, your symptoms persist, complementary tests will be performed.

If you take pantoprazole for a prolonged period (more than one year), your doctor may perform regular follow-up. You should inform your doctor of any symptoms and/or new or unexpected events each time you visit your doctor.

Consult your doctor or pharmacist before starting to take Pantoprazol Tarbis.

Use ofPantoprazol Tarbiswith other medicines

Pantoprazol Tarbis may affect the efficacy of other medicines, so inform your doctor if you are taking:

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used to treat certain types of cancer), as Pantoprazol Tarbis may cause these and other medicines to not work properly.

• Warfarin and fenprocoumon, which affect blood coagulation. You may need additional controls.

• Atazanavir (used to treat HIV infection).

Tell your doctor or pharmacist what you are using, have recently used, or may need to use any other medicine.

Pregnancy and breastfeeding

There is not enough data on the use of pantoprazole in pregnant women. It has been reported that in humans, pantoprazole is excreted in breast milk.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Pantoprazol Tarbis is unlikely to affect your ability to drive or use tools or machines. Side effects such as dizziness and visual disturbances (see section 4) may occur. If they do, you should not drive or use machines.

3. How to take Pantoprazol Tarbis

Follow the instructions for administration of this medicine indicated by your doctor. If in doubt, consult your doctor again.

When and how should you take Pantoprazol Tarbis?

Take the tablets whole, without chewing or crushing, with a little water, 1 hour before a meal.

Unless your doctor has indicated otherwise, the usual dose is:

Adults and adolescents from 12 years:

To treat symptoms associated with gastroesophageal reflux disease (heartburn, acid regurgitation, pain when swallowing)

The usual dose is one tablet per day.

This dose usually provides relief within 2-4 weeks, and if not, within a maximum of 4 weeks. Your doctor will indicate how long you should continue taking the medicine. Subsequently, any recurring symptoms can be controlled as needed, taking one tablet per day.

For long-term treatment and prevention of relapses of reflux esophagitis

The usual dose is one tablet per day. If the disease recurs, your doctor may double the dose, in which case you can take Pantoprazol 40 mg once a day. After healing, you can reduce the dose back to one 20 mg tablet per day.

Adults:

To prevent duodenal and stomach ulcers in patients who require continuous treatment with NSAIDs

The usual dose is one tablet per day.

Special patient groups:

• If you have serious liver problems, you should not take more than one 20 mg tablet per day.
• Children under 12 years: The use of these tablets is not recommended in children under 12 years.

If you take morePantoprazol Tarbisthan you should

Inform your doctor or pharmacist or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken. No symptoms of overdose are known.

If you forget to takePantoprazol Tarbis

Do not take a double dose to make up for forgotten doses. Take your next dose as usual.

If you stop takingPantoprazol Tarbis

Do not stop taking these tablets without consulting your doctor or pharmacist first.

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

4. Possible side effects

Like all medicines, Pantoprazol Tarbis can cause side effects, although not everybody gets them.

The frequency of the possible side effects described below is classified as follows:

very common (affects more than 1 in 10 people)

common (affects between 1 and 10 people in 100)

uncommon (affects between 1 and 10 people in 1,000)

rare (affects between 1 and 10 people in 10,000)

very rare (affects less than 1 in 10,000 people)

frequency not known (cannot be estimated from the available data).

If you experience any of the following side effects, stop taking these tablets and inform your doctor immediately, or contact the emergency department of the nearest hospital:

• Severe allergic reactions (rare frequency): swelling of the tongue and/or throat, difficulty swallowing, hives (urticaria), difficulty breathing, swelling of the face of allergic origin (angioedema/Quincke's edema), severe dizziness with very rapid heartbeat and profuse sweating.

• Severe skin reactions (frequency not known):blisters on the skin and rapid deterioration of general conditions, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme), and sensitivity to light, skin rash, possibly with joint pain.

• Other serious conditions (frequency not known):yellowing of the skin and the whites of the eyes (severe liver cell damage, jaundice), or fever, rash, increased kidney size with occasional pain when urinating and pain in the lower back (severe kidney inflammation)

Other side effects are:

• Common(affects between 1 and 10 people in 100)

benign polyps in the stomach.

• Uncommon(affects between 1 and 10 people in 1,000)

headache; dizziness; diarrhea; feeling of dizziness, vomiting; bloating and flatulence (gas); constipation; dry mouth; abdominal pain and discomfort; skin rash, exanthema, eruption; feeling of weakness, fatigue or general malaise; sleep disturbances.

• Rare(affects between 1 and 10 people in 10,000)

visual disturbances such as blurred vision; hives; joint pain; muscle pain; weight changes; increased body temperature; swelling in the extremities (peripheral edema); allergic reactions; depression; increased breast size in men.

• Muy raros (afecta a menos de 1 paciente de cada 10.000)

disorientation

• Frequency not known(cannot be estimated from the available data)

hallucination, confusion (especially in patients with a history of these symptoms), decreased sodium levels in the blood, sensation of tingling, numbness, paresthesia (tingling), burning or numbness, inflammation of the large intestine that causes persistent watery diarrhea.

Side effects identified through blood tests:

• Uncommon (affects between 1 and 10 people in 1,000)

increased liver enzymes

• Rare(affects between 1 and 10 people in 10,000)

increased bilirubin; increased levels of fats in the blood

• Muy raros (afecta a menos de 1 paciente de cada 10.000)

reduction of platelet count that could lead to bleeding or more bruising than usual; reduction of white blood cell count that could lead to more frequent infections.

Unknown frequency

If you are taking Pantoprazol Tarbis for more than three months, it is possible that your magnesium levels in the blood may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, or increased heart rate. If you have any of these symptoms, go to the doctor immediately. Low magnesium levels can also cause a decrease in potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

If you are taking proton pump inhibitors like Pantoprazol Tarbis, especially for a period of more than one year, you may have a slightly increased risk of hip, wrist, and spine fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pantoprazol Tarbis

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Pantoprazol Tarbis in a polyethylene bottle does not require special storage conditions.

Pantoprazol Tarbis in an aluminum/aluminum blister: store below 30°C

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition ofPANTOPRAZOL TARBIS

The active ingredient is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole (in the form of sodium sesquihydrate).

• The other ingredients (excipients) are:

Core: Anhydrous disodium phosphate (E-339), Mannitol (E-421), Microcrystalline cellulose (E-460), Sodium croscarmellose, Magnesium stearate (E-470)

Coating: Hypromellose, Triethyl citrate, Sodium carboxymethyl potato starch, Methacrylic acid-ethyl acrylate copolymer (1:1), 30% dispersion

Printing ink: Yellow iron oxide (E-172)

Appearance of the product and contents of the pack

Gastro-resistant tablet, yellow, oval, concave, and smooth.

Packaging:

Bottles (high-density polyethylene packaging with a screw cap made of polyethylene) and blisters (aluminum/aluminum blisters)

Packaging with 28 or 56 gastro-resistant tablets

Marketing authorization holder and manufacturer

Marketing authorization holder

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona, Spain

Manufacturer

Teva Pharma S.L.U.

Polígono Malpica c/ C, 4.

50016 Zaragoza

Spain

Date of the last revision of this leaflet:August 2019

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/