Pantoprazole Tarbis 40 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Pantoprazole Tarbis 40 mg gastro-resistant tablets EFG

Read the entire 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 it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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 adverse 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 disorders related to acid.

Pantoprazol Tarbis is used for:

Adults and adolescents aged 12 years and older:

• Reflux esophagitis. This is inflammation of your esophagus (the tube connecting your throat to your stomach), accompanied by regurgitation of acid from the stomach.

Adults:

• Infection with a bacterium called Helicobacter pylori in patients with gastric and/or duodenal ulcer, in combination with two antibiotics (eradication treatment). The aim is to eliminate the bacterium and thereby reduce the likelihood of ulcer recurrence.
  • Gastric and duodenal ulcers, and
  • Zollinger-Ellison syndrome and other conditions in which excessive acid is produced in the stomach.

2. What you need to know before starting to take 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

Consult 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 have reduced body stores of vitamin B12 or risk factors for this, and you are receiving pantoprazole treatment for a long period of time. Like all medicines that reduce acid levels, pantoprazole may reduce the absorption of vitamin B12.
• if you are taking a medicine containing atazanavir (used to treat 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, disorientation, 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 may decide to perform periodic blood tests 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.

Immediately inform your doctor 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 diarrhea, as pantoprazole has been associated with a small increased risk of infectious diarrhea.

Your doctor will decide whether you need additional tests to rule out malignancy, as pantoprazole may relieve cancer symptoms 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 must inform your doctor of any new or unexpected symptoms or events at each visit.

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

Use of 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 or phenprocoumon, which affect blood clotting. You may require additional monitoring.

• Atazanavir (used to treat HIV infection).

Inform your doctor or pharmacist about any other medicines you are currently taking, have recently taken, or might need to take.

Pregnancy and breastfeeding

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

Driving and use of machines

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

3. How to take Pantoprazol 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 Pantoprazol Tarbis?

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

Unless otherwise directed by your doctor, the usual dose is:

Adults and adolescents aged 12 years and older:

For the treatment of reflux esophagitis:

The usual dose is one tablet per day. Your doctor may instruct you to increase this to two tablets per day. The treatment duration for reflux esophagitis is usually between 4 and 8 weeks. Your doctor will tell you how long to take this medicine.

Adults:

For the treatment of infection with a bacterium called Helicobacter pylori in patients with gastric and/or duodenal ulcer, in combination with two antibiotics (eradication therapy):

One tablet twice daily, plus two antibiotic tablets—either amoxicillin, clarithromycin, and metronidazole (or tinidazole)—each to be taken twice daily along with your pantoprazole tablet. Take the first pantoprazole tablet 1 hour before breakfast and the second 1 hour before dinner. Follow your doctor's instructions and make sure to read the package leaflets of the antibiotics.

The treatment duration is normally one to two weeks.

For the treatment of gastric and duodenal ulcers:

The usual dose is one tablet per day. Your doctor may double the dose. Your doctor will tell you how long you should take this medicine. The treatment duration for gastric ulcers is usually between 4 and 8 weeks. The treatment duration for duodenal ulcers is normally between 2 and 4 weeks.

For long-term treatment of Zollinger-Ellison syndrome and other conditions in which there is increased gastric acid secretion:

The recommended initial dose is two tablets per day.

Take both tablets 1 hour before a meal. Afterwards, your doctor may adjust your dose depending on the amount of gastric acid secreted. If more than two tablets per day are prescribed, you should take the tablets in two divided doses per day. If more than four tablets per day are prescribed, you will be given specific instructions on when to stop treatment.

Special patient groups:

• If you have kidney problems, or moderate to severe liver problems, you should not take pantoprazole for Helicobacter pylori eradication.

• If you have severe liver problems, you should not take more than one 20 mg pantoprazole tablet per day (20 mg pantoprazole tablets are available for this purpose).

• Children (under 12 years): the use of these tablets is not recommended in children under 12 years of age.

If you take more Pantoprazol Tarbis than you should

Inform your doctor or pharmacist, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested. There are no known symptoms of overdose.

If you forget to take Pantoprazol Tarbis: Do not take a double dose to make up for missed doses. Take your next dose as usual.

If you stop taking Pantoprazol 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 experiences 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 consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist or contact the nearest hospital emergency department.

- Severe allergic reactions (rare frequency): swelling of the tongue and/or throat, difficulty swallowing, rash (urticaria), breathing difficulties, 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 of 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 sometimes with pain during urination and lower back pain (severe kidney inflammation).

Other adverse effects include:

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

benign stomach polyps.

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

headache; dizziness; diarrhoea; feeling of drowsiness, vomiting; bloating and flatulence; constipation; dry mouth; abdominal pain and discomfort; 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)

hallucinations, confusion (especially in patients with a history of these symptoms), decreased sodium levels in the blood, tingling sensation, prickling, paraesthesia (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)

increase in liver enzymes.

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

increase in bilirubin; increase in blood fat levels.

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

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

Frequency unknown

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 more 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 are taking corticosteroids (which may increase the risk of osteoporosis).

Reporting of adverse effects

If you experience any adverse effect, consult 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 aluminium/aluminium blisters: store below 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. 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 40 mg of pantoprazole (as sodium sesquihydrate).

• Other components (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 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 pack

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

Packaging:

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

Packs containing 14, 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 most recent review of this leaflet: August 2019

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/