Pantoprazole Tarbis Farma 40 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pantoprazole Tarbis Farma 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, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Pantoprazol Tarbis Farma contains the active substance pantoprazol.

• Pantoprazol 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 acid-related diseases of the stomach and intestine.

Pantoprazol is used in adults and adolescents from 12 years of age to treat:

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

Pantoprazol is used in adults to treat:

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

2. What you need to know before taking Pantoprazol Tarbis Farma

Do not take Pantoprazol Tarbis Farma

• If you are allergic to pantoprazole or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to medicines containing other proton pump inhibitors.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting this medicine

• 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 this medicine. If liver enzymes increase, treatment should be discontinued.

• If you have reduced body stores of vitamin B12 or risk factors for this, and are receiving long-term treatment with pantoprazole. Like all medicines that reduce acid levels, pantoprazole may reduce the absorption of vitamin B12. Please contact your doctor if you experience any of the following symptoms, which could indicate low vitamin B12 levels:

  • Extreme tiredness or lack of energy
  • Tingling
  • Painful or red tongue, mouth sores
  • Muscle weakness
  • Vision disturbances
  • Memory problems, confusion, depression

• Consult your doctor if you are taking HIV protease inhibitors such as atazanavir (for treatment of HIV infection) at the same time as pantoprazole.

• Taking a proton pump inhibitor such as pantoprazole, especially for more than one year, may increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if you have osteoporosis (reduced bone density) or if you have been told you are at risk of osteoporosis (for example, if you are taking corticosteroids).

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

• If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazol Tarbis Farma used to reduce stomach acidity.

• 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 this medicine.

Remember to mention any other symptoms you may notice, such as joint pain.

• Serious skin reactions have been reported, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme, associated with pantoprazole treatment. Stop using pantoprazole and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.
• If you are scheduled to have a specific blood test (chromogranin A).

Contact your doctor immediately, before or after taking this medicine, if you notice any of the following symptoms, which may be signs of more serious conditions:

• Unintentional weight loss
• Vomiting, particularly if repeated
• Blood in the vomit: it may appear as dark coffee-ground material in your vomit
• Blood in your stools, which may appear black or dark
• Difficulty swallowing, or pain when swallowing
• Pale appearance and feeling weak (anemia)
• Chest pain
• Stomach pain
• 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 this medicine 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 and/or events at each visit.

Children and adolescents

The use of this medicine is not recommended in children, as it has not been studied in children under 12 years of age.

Other medicines and Pantoprazol Tarbis Farma

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Pantoprazole may affect the effectiveness of other medicines. 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 may cause these and other medicines to not work properly.

• Warfarin and phenprocoumon, which affect blood clotting. You may need additional monitoring.

• Medicines used to treat HIV infection, such as atazanavir.

• Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer). If you are taking methotrexate, your doctor may temporarily discontinue treatment with this medicine, as pantoprazole may increase methotrexate levels in the blood.

• Fluvoxamine (used to treat depression and other psychiatric conditions). If you are taking fluvoxamine, your doctor may reduce your dose.

• Rifampicin (used to treat infections)

• St. John’s wort (Hypericum perforatum) (used to treat mild depression)

Consult your doctor before taking pantoprazole if you are scheduled to undergo a specific urine test (for THC; tetrahydrocannabinol).

Pregnancy and breastfeeding and fertility

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.

You should only use this medicine if your doctor considers that the benefit to you outweighs the potential risk to the fetus or baby.

Driving and using machines

Pantoprazole has no effect or an effect that is negligible on the ability to drive or operate machinery.

You should not drive or operate machinery if you experience adverse effects such as dizziness or blurred vision.

Pantoprazol Tarbis Farma contains lactose

If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

Pantoprazol Tarbis Farma contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, it is essentially “sodium-free”.

3. How to take Pantoprazol Tarbis Farma

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Method of administration:

Take the tablets 1 hour before meals, without chewing or breaking them, swallowing them whole with water.

The recommended 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 the dose to 2 tablets per day. The treatment duration for reflux esophagitis is usually between 4 and 8 weeks. Your doctor will advise you on 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 one hour before breakfast and the second one hour before dinner. Follow your doctor's instructions and make sure to read the package leaflets of the antibiotics.

The duration of treatment 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 advise you on how long to 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 increased gastric acid secretion occurs:

The recommended initial dose is two tablets per day. Take both tablets one hour before a meal. Subsequently, your doctor may adjust your dose depending on the amount of gastric acid secreted. If you are prescribed more than two tablets per day, you should take them in two divided doses daily. If you are prescribed more than four tablets per day, you will be informed exactly when to stop treatment.

Patients with kidney problems:

If you have kidney problems, you should not take this medicine for the eradication of Helicobacter pylori.

Patients with liver problems:

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).

If you have moderate or severe liver problems, you should not take this medicine for the eradication of Helicobacter pylori.

Use in children and adolescents:

The use of these tablets is not recommended in children under 12 years of age.

If you take more Pantoprazol Tarbis Farma than you should:

Inform your doctor or pharmacist. There are no known symptoms of overdose.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take this medicine:

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

If you stop taking Pantoprazol Tarbis Farma:

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, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If you experience any of the following adverse effects, stop taking these tablets immediately and contact your doctor or the emergency department of your nearest hospital without delay.

• Severe allergic reactions (uncommon; may affect up to 1 in 1,000 people): 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; cannot be estimated from available data): you may notice one or more of the following – blisters on the skin and a rapid worsening of general condition, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals, or skin sensitivity/rash, particularly in areas of skin exposed to light/sun. You may also experience joint pain or flu-like symptoms, fever, swollen glands (e.g. in the armpit), and blood tests may show changes in certain white blood cells or liver enzymes.

  • Red, non-elevated, target-shaped or circular spots on the trunk, often with blisters in the center, peeling of the skin, mouth, throat, nose, genital or eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
  • Widespread skin rash, high fever, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

• 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 on urination and lower back pain (severe kidney inflammation), which may possibly lead to kidney failure.

Other adverse effects are:

• Common (may affect up to 1 in 10 patients): Benign polyps in the stomach.

• Uncommon (may affect up to 1 in 100 patients):
  Headache; dizziness; diarrhoea; feeling of dizziness, vomiting; bloating and flatulence (gas); constipation; dry mouth; abdominal pain and discomfort; skin rash, exanthema, eruption; tingling; feeling of weakness, tiredness or general malaise; sleep disturbances; hip, wrist or spinal fractures.

• Rare (may affect up to 1 in 1,000 patients):
  Impaired or complete loss of taste sensation; vision disorders such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; high fever; swelling of the limbs (peripheral oedema); allergic reactions; depression; breast enlargement in men.

• Very rare (may affect up to 1 in 10,000 patients):
  Disorientation.

• Frequency not known (cannot be estimated from available data):
  Hallucination, confusion (especially in patients with a history of these symptoms), sensation of tingling, pricking, numbness, burning or stinging, skin rash, possibly with joint pain, inflammation of the large intestine causing persistent watery diarrhoea.

Adverse effects identified through blood tests:

• Uncommon (may affect up to 1 in 100 patients):
  Increased liver enzymes.

• Rare (may affect up to 1 in 1,000 patients):
  Increased bilirubin; increased blood fat levels; sudden drop in granular white blood cells in circulation, associated with high fever.

• Very rare (may affect up to 1 in 10,000 patients):
  Reduced platelet count which may cause bleeding or increased bruising; reduced white blood cell count which may lead to more frequent infections; abnormal reduction in the balance between red blood cells, white blood cells, and platelets.

• Frequency not known (cannot be estimated from available data): decreased levels of sodium, magnesium, calcium or potassium in the blood (see section 2).

Reporting of adverse effects

If you experience any type of 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: www.notificaRAM.es

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pantoprazole Tarbis Farma

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Store below 30°C.

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

6. Contents of the pack and other information

Composition of Pantoprazol Tarbis Farma

The active substance is pantoprazole. Each gastro-resistant tablet contains 40 mg of pantoprazole (as sodium sesquihydrate).

The other components are:

Core: lactose monohydrate, hydroxypropylcellulose, calcium stearate, sodium carbonate, sodium lauryl sulfate

Coating: hypromellose, yellow iron oxide (E172), propylene glycol, titanium dioxide (E171), methacrylic acid-ethyl acrylate copolymer (1:1), triethyl citrate, polysorbate 80, carnauba wax

Printing ink: shellac, black iron oxide (E172), propylene glycol

Appearance of the product and contents of the container of Pantoprazol Tarbis Farma

The tablets are yellow to pale yellow, oval-shaped, approximately 11.6 mm long and 5.90 mm wide, biconvex, with the imprint “H126” on one side in black ink and smooth on the other side.

Pantoprazol Tarbis Farma is available in PVC/AL/OPA-AL blisters of 14, 28, 30, 56, 60, 90, 98 or 100 tablets and in high-density polyethylene bottles with low-density polyethylene screw-cap closure containing 90 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

Amarox Pharma B.V.

Rouboslaan 32

2252 TR Voorschoten

The Netherlands

This medicinal product is authorized in the European Economic Area member states under the following names:

Germany: Pantoprazol Amarox 40 mg magensaftresistente Tabletten

Spain: Pantoprazol Tarbis Farma 40 mg gastro-resistant tablets EFG

Italy: Pantoprazol Amarox

The Netherlands: Pantoprazol ARX 40 mg maagsapresistente tabletten

Sweden: Pantoprazol Amarox 40 mg Enterotablett

Date of the most recent revision of this leaflet: August 2025

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