Product Information for the Patient

Pantoprazol Tarbis 40 mg gastro-resistant tablets EFG

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before starting to take Pantoprazol Tarbis

3. How to take Pantoprazol Tarbis

4. Possible side effects

5. Storage of Pantoprazol Tarbis

6. Contents of the pack and additional information

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

Pantoprazol Tarbis is used for:

Adults and adolescents 12 years and older:

• Gastroesophageal reflux esophagitis. It is an inflammation of your esophagus (the tube that connects your throat to your stomach) accompanied by regurgitation of acid from your stomach.

Adults:

-Infection caused by a bacteria calledHelicobacter pyloriin patients with stomach and/or duodenal ulcers in combination with two antibiotics (eradication treatment). The goal is to get rid of the bacteria and thus reduce the likelihood of ulcers reappearing

• Stomach and duodenal ulcers, and
• Zollinger-Ellison syndrome and other conditions in which too much acid is produced in the stomach.

Do not takePantoprazol Tarbis

• If you are allergic (hypersensitive) to pantoprazole or to any of the other components 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 have severe liver problems. Inform your doctor if you have ever had liver problems. Your doctor will monitor your liver enzymes more frequently, especially when you are on long-term treatment with pantoprazole. If liver enzyme levels increase, treatment should be interrupted.
• if you have reduced vitamin B12 reserves or risk factors for this and are receiving long-term treatment with pantoprazole. Like all acid-reducing medicines, pantoprazole may reduce vitamin B12 absorption.
• if you are taking any medicine that contains atazanavir (for HIV treatment) at the same time as pantoprazole.
• if you have ever had a skin reaction after treatment with a similar medicine to Pantoprazol Tarbis for reducing stomach acid.
• if you are due to have a specific blood test (Cromogranin 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. Low magnesium levels may also cause a decrease in potassium and calcium levels in the blood. Your doctor will decide to perform regular blood tests to control magnesium levels.

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

Inform 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 weak (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 cancer symptoms and delay its diagnosis. If your symptoms persist despite treatment, further investigations will be performed.

If you take pantoprazole for a prolonged period (more than one year), your doctor may regularly monitor you. You should inform your doctor of any new or unexpected symptoms and/or events each time you attend your consultation.

Consult your doctor or pharmacist before starting to takePantoprazol Tarbis.

Use ofPantoprazol Tarbiswith other medicines

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

• Medicines such as ketoconazole, itraconazole, and posaconazole (used for fungal infections) or erlotinib (used for certain types of cancer), asPantoprazol Tarbismay make these and other medicines not work correctly.
• Warfarin or phenprocoumon, which affect blood clotting. You may need additional monitoring.

-Atazanavir (used for HIV treatment).

Inform your doctor or pharmacist about any other medicines you are using, have used recently, or may need to use.

Pregnancy and breastfeeding

There is insufficient data on the use of pantoprazole in pregnant women. Pantoprazole has been found to be excreted in human breast milk.

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

Driving and operating machinery

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor again.

When and how should you take Pantoprazol Tarbis?

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

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

Adults and adolescents 12 years and older:

For the treatment of esophagitis by reflux:

The usual dose is one tablet per day. Your doctor may indicate an increase to 2 tablets per day. The treatment time for esophagitis by reflux usually lasts between 4 and 8 weeks. Your doctor will tell you for how long you should take this medication.

Adults:

For the treatment of an infection with a bacteria called Helicobacter pylori in patients with stomach and/or duodenal ulcer in combination with two antibiotics (eradication treatment)

One tablet twice a day, plus the two antibiotic tablets, either amoxicillin, clarithromycin, and metronidazole (or tinidazole), each taken twice a day, 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 antibiotic prospectuses.

The treatment duration is usually 1 to 2 weeks.

For the treatment of stomach and duodenal ulcers:

The usual dose is one tablet per day. The dose may be doubled by your doctor. Your doctor will tell you for how long you should take this medication. The treatment duration for stomach ulcers is usually between 4 and 8 weeks. The treatment duration for duodenal ulcers is usually between 2 and 4 weeks.

For long-term treatment of Zollinger-Ellison Syndrome and other conditions in which there is an increase in stomach acid production

The recommended initial dose is two tablets per day.

Take the two tablets 1 hour before a meal. Your doctor may then adjust your dose, depending on the amount of stomach acid you produce. If you are prescribed more than two tablets per day, you should take the tablets twice a day. If you are prescribed more than four tablets per day, you will be told exactly when to stop treatment.

Special patient groups:

-If you have kidney problems, or moderate or severe liver problems, you should not take pantoprazole for the elimination of Helicobacter pylori.

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

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

If you take more Pantoprazol Tarbis than you should

Inform your doctor or pharmacist or call the Toxicological Information Service phone number 91 562 04 20, indicating the medication and the amount ingested. There are no known symptoms of overdose.

If you forget to take Pantoprazol TarbisDo not take a double dose to compensate for the missed doses.Take your next dose as usual.

If you interrupt treatment with Pantoprazol TarbisDo not stop taking these tablets without consulting your doctor or pharmacist first.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications,Pantoprazol Tarbismay cause side effects, although not everyone will experience them.

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

Very common (affects more than one patient in every 10)

Common (affects between 1 and 10 patients in every 100)

Uncommon (affects between 1 and 10 patients in every 1,000)

Rare (affects between 1 and 10 patients in every 10,000)

Very rare (affects fewer than one patient in every 10,000)

Frequency unknown (cannot be estimated from available data).

If you consider that any of the side effects you are experiencing is severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist 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, allergic swelling of the face (Quincke's edema/angioedema), intense dizziness with very rapid heartbeats and excessive sweating.

-Severe skin alterations(frequency unknown):blistering of the skin and a 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 severe conditions (frequency unknown):yellowing of the skin and the white of the eyes (severe liver cell damage, jaundice), or fever, hives, increased size of the kidneys sometimes with painful urination and lower back pain (severe kidney inflammation)

Other side effects are:

• Common(affects between 1 and 10 patients in every 100)

benign polyps in the stomach.

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

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

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

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

• Very rare(affects fewer than one patient in every 10,000)

disorientation

• Frequency unknown(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, numbness, paresthesia (tingling), burning or numbness,inflammatory bowel disease that causes persistent watery diarrhea.

Side effects identified through blood tests:

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

increased liver enzymes

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

Increased bilirubin; increased levels of fat in the blood

• Very rare(affects fewer than one patient in every 10,000)

reduction in the number of platelets, which could cause bleeding or more frequent bruising; reduction in the number of white blood cells, which could lead to more frequent infections.

Unknown frequency

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

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

Reporting side effects

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

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

Do not usethis medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

PantoprazolTarbis in a Polyethylene bottle, does not require special storage conditions.

PantoprazolTarbis in Aluminum/Aluminum blister:store below30°C.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medicines that you no longer need at the SIGRE collection pointof the pharmacy. In case of doubtask your pharmacist how to dispose of the packaging and medicines that you no longer need. By doing so, you will help protect the environment.

Composition ofPantoprazol Tarbis

The active ingredient is pantoprazole. Each gastro-resistant tablet contains 40 mg of pantoprazole (in the form of sodium sesquihydrate).

- The other components (excipients) are:

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

Coating:Hydroxypropyl methylcellulose, Triethyl citrate, Sodium carboxymethyl starch from potato, Copolymer of methacrylic acid-ethyl acrylate (1:1), 30% dispersion

Printing ink:Yellow iron oxide (E-172)

Appearance of the product and contents of the packaging

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

Packaging:

Bottles (high-density polyethylene packaging with a polyethylene cap with a polyethylene thread) and blisters (Alu/Alu blisters).

Packaging with 14, 28, or 56 gastro-resistant tablets

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Responsible manufacturer

Teva Pharma S.L.U.

Malpica Industrial Estate, c/ C, 4.

50016 Zaragoza

Spain

Last review date of this leaflet: August 2019

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/