Pantoprazole Tarbis 20 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Pantoprazole 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, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

Pantoprazol Tarbis is used for:

Adults and adolescents aged 12 years and older:

• Treatment of symptoms associated with gastroesophageal reflux disease (heartburn, acid regurgitation, painful 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 only:

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

2. What you need to know before taking Pantoprazole Tarbis

Do not take Pantoprazole Tarbis

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

Warnings and precautions

Talk to your doctor before starting to take Pantoprazole Tarbis:

• if you have severe liver problems. Inform your doctor if you have ever had liver problems. Your doctor will monitor your liver enzymes more frequently, especially if you are on long-term treatment with pantoprazole. If liver enzymes increase, treatment should be discontinued.
• if you need to take non-steroidal anti-inflammatory drugs (NSAIDs) continuously while taking pantoprazole, as there is an increased risk of developing stomach and intestinal complications. Any increase in risk will be assessed according to personal risk factors such as age (65 years or older), history of stomach or duodenal ulcer, or gastrointestinal bleeding.
• if you have reduced body stores of vitamin B12 or risk factors for this, and are receiving pantoprazole treatment for a long period of time. As with all medicines that reduce acid levels, pantoprazole may reduce the absorption of vitamin B12.
• if you are taking a medicine containing atazanavir (for the treatment of HIV infection) at the same time as pantoprazole.
• if you have ever had a skin reaction after treatment with a medicine similar to Pantoprazole Tarbis used to reduce stomach acidity.
  • if you are scheduled to have a specific blood test (chromogranin A).
  • if you take pantoprazole for more than three months, you may experience a decrease in magnesium levels in the blood. Symptoms of low magnesium levels may include fatigue, involuntary muscle contractions, confusion, dizziness, or increased heart rate. If you experience any of these symptoms, inform your doctor immediately. In addition, low magnesium levels may lead to decreased levels of potassium and calcium in the blood. Your doctor will decide whether periodic blood tests are needed to monitor magnesium levels.

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

Contact your doctor immediately if you notice any of the following symptoms:

• unintentional weight loss
• repeated vomiting
• difficulty swallowing
• blood in vomit
• pale appearance and feeling weak (anemia)
• blood in your stools
• severe or persistent diarrhoea, as pantoprazole has been associated with a small increased risk of infectious diarrhoea.

Your doctor will decide whether you need additional tests to rule out malignancy, as pantoprazole may relieve symptoms of cancer and could delay diagnosis. If your symptoms persist despite treatment, further investigations will be carried out.

If you take pantoprazole for a prolonged period (more than one year), your doctor will likely monitor you regularly. You should inform your doctor of any new or unexpected symptoms or events at each visit.

Talk to your doctor or pharmacist before taking Pantoprazole Tarbis.

Taking Pantoprazole Tarbis with other medicines

Pantoprazole Tarbis may affect the effectiveness of other medicines. Therefore, inform your doctor if you are taking:

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer), as Pantoprazole Tarbis may reduce the effectiveness of these and other medicines.
• Warfarin and fenprocoumon, which affect blood clotting. You may require additional monitoring.
• Atazanavir (used for the treatment of HIV infection).

Tell your doctor or pharmacist which medicines you are currently taking, have recently taken, or might need to take.

Pregnancy and breast-feeding

There are insufficient data on the use of pantoprazole in pregnant women. It has been reported that pantoprazole is excreted in human breast milk.

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

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

3. How to take Pantoprazole Tarbis

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor again.

When and how should you take Pantoprazole Tarbis?

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

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

Adults and adolescents aged 12 years and older:

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

The usual dose is one tablet per day.

This dose generally provides relief within 2–4 weeks, and if not, within a maximum of the following 4 weeks. Your doctor will advise you on how long you should continue taking the medicine. Subsequently, any recurring symptoms can be managed as needed by 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 your dose, in which case you may take Pantoprazole 40 mg once daily. After healing, the dose may be reduced again to one 20 mg tablet per day.

Adults:

For prevention of duodenal and gastric ulcers in patients requiring ongoing treatment with NSAIDs

The usual dose is one tablet per day.

Special patient groups:

• If you have severe liver problems, you must 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 of age.

If you take more Pantoprazole Tarbis than you should

Inform your doctor or pharmacist, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested. Symptoms of overdose are not known.

If you forget to take Pantoprazole Tarbis

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

If you stop taking Pantoprazole Tarbis

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

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

4. Possible adverse effects

Like all medicines, Pantoprazol Tarbis may cause adverse effects, although not everyone will experience them.

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

very common (affects more than 1 in 10 people)
common (affects between 1 and 10 in 100 people)
uncommon (affects between 1 and 10 in 1,000 people)
rare (affects between 1 and 10 in 10,000 people)
very rare (affects fewer than 1 in 10,000 people)
frequency not known (cannot be estimated from available data).

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

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

• Severe skin disorders (frequency not known): skin blisters and rapid deterioration in general condition, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme), and photosensitivity, skin rash, possibly accompanied by joint pain.

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

Other adverse effects are:

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

benign gastric polyps.

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

headache; dizziness; diarrhoea; feeling of dizziness, vomiting; bloating and flatulence; constipation; dry mouth; pain and discomfort in the abdomen; skin rash, exanthema, eruption; feeling of weakness, tiredness or general malaise; sleep disturbances.

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

vision disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; swelling in the extremities (peripheral oedema); allergic reactions; depression; enlargement of the breasts in men.

• Very rare (affects fewer than 1 in 10,000 people)

disorientation.

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

Hallucination, confusion (especially in patients with a history of these symptoms), decreased sodium levels in the blood, sensation of tingling, pricking, paresthesia (tingling), burning or numbness, inflammation of the large intestine causing persistent watery diarrhoea.

Adverse effects identified through blood tests:

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

Increased liver enzymes.

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

Increased bilirubin; increased levels of blood fats.

• Very rare (affects fewer than 1 in 10,000 people)

reduction in platelet count which could lead to bleeding or unusual bruising; reduction in white blood cell count which could lead to more frequent infections.

Unknown frequency

If you are taking Pantoprazol Tarbis for more than three months, your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels may also lead to decreased levels of potassium and calcium in the blood. Your doctor may perform periodic blood tests to monitor your magnesium levels.

If you are taking proton pump inhibitors such as Pantoprazol Tarbis, especially for longer than one year, there may be a slight increase in the risk of fractures of the hip, wrist, and spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Pantoprazol Tarbis in polyethylene bottles does not require special storage conditions.

Pantoprazol Tarbis in aluminum/aluminum blisters: store below 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of PANTOPRAZOLE TARBIS

The active substance is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole (as sodium sesquihydrate).

• The other components (excipients) are:

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

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

Printing ink: Yellow iron oxide (E-172)

Appearance of the product and contents of the container

Yellow, oval-shaped, concave, smooth gastro-resistant tablet.

Packaging:

Bottles (high-density polyethylene container with polyethylene screw cap) and blisters (Alu/Alu blisters)

Packs containing 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.

Malpica Industrial Estate, Street C, 4

50016 Zaragoza

Spain

Date of the most recent review of this leaflet: August 2019

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/