Package Leaflet: Information for the User

Pantoprazol Tarbis Farma 40 mg gastro-resistant tablets EFG

Read 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

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

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

3. How to take Pantoprazol Tarbis Farma

4. Possible side effects

5. Storage of Pantoprazol Tarbis Farma

6. Contents of the pack and additional information

Pantoprazol Tarbis Farma contains the active substance pantoprazol.

- Pantoprazol is a selective 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 is used in adults and adolescents aged 12 and above to treat:

- 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.

Pantoprazol is used in adults to treat:

- Infection of a bacterium called Helicobacter pylori in patients with stomach and/or duodenal ulcers in combination with two antibiotics (eradication treatment). The goal is to get rid of the bacterium and thus reduce the likelihood of ulcers reappearing

- Stomach and duodenal ulcers,

- Zollinger-Ellison syndrome and other conditions in which too much acid is produced in the stomach.

Do not take Pantoprazol Tarbis Farma

- If you are allergic to pantoprazole or any of the other ingredients of this medication (listed in section 6).

- If you are allergic to medications that contain other proton pump inhibitors.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take this medication

- If you have severe liver problems. Inform your doctor if you have ever had liver problems. Your doctor will monitor your liver enzyme levels more frequently, especially when you are on long-term treatment with this medication. If liver enzyme levels increase, treatment should be discontinued.

- If you have decreased vitamin B12 reserves or risk factors for it and receive long-term treatment with pantoprazole. Like all medications that reduce acid production, pantoprazole may reduce vitamin B12 absorption.

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

- Taking a proton pump inhibitor like pantoprazole, especially for more than a 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 developing osteoporosis (for example, if you are taking corticosteroids).

- If you are taking this medication for more than three months, it is possible that 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 can also cause decreased levels of potassium and calcium in the blood. Your doctor may decide to perform regular blood tests to monitor your magnesium levels.

- If you have ever had a skin reaction after treatment with a similar medication to Pantoprazol Tarbis Farma to reduce stomach acid.

- If you suffer from a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with this medication.

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

- If you are scheduled to have a specific blood test (Cromogranin A).

Inform your doctor immediately, before or after taking this medication, if you notice any of the following symptoms, which may be signs of more serious underlying diseases:

- Unintentional weight loss

- Vomiting, particularly if repeated

- Blood in vomit: may appear as a dark brown powder in your vomit

- If you notice blood in your stools, which may appear black or dark

- Difficulty swallowing, or pain when swallowing

- Pale appearance and feeling of weakness (anemia)

- Chest pain

- Stomach pain

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

Your doctor will decide if you need additional testing to rule out a malignant disease, as pantoprazole may alleviate cancer symptoms and potentially delay diagnosis. If your symptoms persist despite treatment, further investigations will be performed.

If you take this medication for a prolonged period (more than a 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.

Children and adolescents

This medication is not recommended for children, as it has not been tested in children under 12 years old.

Other medications and Pantoprazol Tarbis Farma

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication, including over-the-counter medications.

Pantoprazole may affect the efficacy of other medications. Inform your doctor if you are taking:

- Medications such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used to treat certain types of cancer), as pantoprazole may make these and other medications less effective.

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

- Medications 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 medication, as pantoprazole may increase methotrexate levels in the blood.

- Fluvoxamine (used to treat depression and other psychiatric disorders) 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)

Pregnancy and lactation and fertility

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

If you are pregnant, breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

You should only use this medication if your doctor considers the benefits for you to be greater than the potential risk to the fetus or baby.

Driving and operating machinery

Pantoprazole has no influence or has a negligible influence 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 told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Pantoprazol Tarbis Farma contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

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

Administration form:

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

Recommended dose:

Adults and adolescents 12 years and older:

For the treatment of esophagitis due to reflux:

The usual dose is 1 tablet per day. Your doctor may indicate an increase to 2 tablets per day. The treatment time for esophagitis due to reflux usually lasts between 4 and 8 weeks. Your doctor will tell you for how long to 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)

1 tablet twice a day plus the 2 antibiotic tablets, either amoxicillin, clarithromycin, and metronidazole (or tinidazole), each must be 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 1 tablet per day. The dose may be doubled by your doctor.

Your doctor will tell you for how long to 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 initial recommended dose is 2 tablets per day. Take the 2 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 2 tablets per day, you should take the tablets twice a day. If you are prescribed more than 4 tablets per day, you will be told exactly when to stop treatment.

Patients with kidney problems:

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

Patients with liver problems

If you have severe liver problems, you should not take more than 1 tablet of 20 mg of pantoprazole per day (for this case, tablets of 20 mg of pantoprazole are available).

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

Use in children and adolescents

This medication is not recommended for use in children under 12 years old.

If you take more Pantoprazol Tarbis Farma than you should

Tell 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take this medication

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

If you interrupt treatment with Pantoprazol Tarbis Farma

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

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

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

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; may affect up to 1 in 1,000 people): 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; cannot be estimated with available data): you may notice one or more of the following - blisters on the skin and rapid deterioration of general condition, erosion (including mild bleeding) of eyes, nose, mouth/lips or genitals or skin sensitivity/eruption, particularly in areas of exposed skin to light/sun. You may also have joint pain or symptoms similar to the flu, fever, swollen lymph nodes (e.g., in the armpit) and blood tests may show changes in certain white blood cells or liver enzymes (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme, acute cutaneous lupus erythematosus, pharmacological reaction with eosinophilia and systemic symptoms (DRESS), photosensitivity).

-Other serious conditions (frequency unknown; cannot be estimated with available data): yellow discoloration of the skin and 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), possibly leading to renal failure.

Other side effects are:

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

- Infrequent(may affect up to 1 in 100 patients)

Headache; dizziness; diarrhea; sensation of dizziness, vomiting; bloating and flatulence (gas); constipation; dry mouth; abdominal pain and discomfort; hives on the skin, exanthema, eruption; tingling; feeling of weakness, fatigue or general discomfort; sleep disturbances; hip, wrist, and spinal column fractures.

- Rare(may affect up to 1 in 1,000 patients)

Alteration or complete loss of taste; visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; high fever; swelling in the extremities (peripheral edema); allergic reactions; depression; gynecomastia in men.

- Very Rare(may affect up to 1 in 10,000 patients)

Disorientation

- Frequency unknown(cannot be estimated from available data)

Hallucination, confusion (especially in patients with a history of these symptoms), sensation of tingling, pinching, numbness, burning, or numbness, skin eruption, possibly with joint pain, inflammatory bowel disease causing persistent watery diarrhea.

Side effects identified through blood tests:

- Infrequent(may affect up to 1 in 100 patients)

Elevated liver enzymes

- Rare(may affect up to 1 in 1,000 patients)

Elevated bilirubin; elevated levels of fat in the blood; sudden drop in granular white blood cells in circulation, associated with high fever.

- Very rare(may affect up to 1 in 10,000 patients)

Reduction in platelet count that could cause bleeding or more frequent bruising; reduction in white blood cell count that could lead to more frequent infections; abnormal imbalance between the number of red and white blood cells, as well as platelets.

• Frequency unknown(cannot be estimated from available data) decrease in sodium, magnesium, calcium, or potassium levels in the blood (see section 2)

Reporting of side effects

If you experience any type of side effect, consult your doctor, 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 Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

Store below 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point of the pharmacy.Ask your pharmacist how to dispose of packaging and unused medications if you are unsure. By doing so, you will help protect the environment.

Composition of Pantoprazol Tarbis Farma

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

The other components are:

Core: lactose monohydrate, hydroxypropylcellulose, calcium stearate, sodium carbonate, sodium laurylsulfate

Coating: hypromellose, yellow iron oxide (E172), propylene glycol, titanium dioxide (E171), copolymer of methacrylic acid-ethyl acrylate (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 packaging of Pantoprazol Tarbis Farma

The tablets are yellow to pale yellow, oval, approximately 11.6 mm long and 5.90 mm wide, biconvex, and with the imprint “H126” on one face 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 a screw cap of low-density polyethylene of 90 tablets.

They may not be commercially available in all packaging sizes.

Marketing Authorization Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible for manufacturing

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

Amarox Pharma B.V.

Rouboslaan 32

2252 TR Voorschoten

Netherlands

This medicine is authorized in the member states of the European Economic Area with the following names:

Germany:Pantoprazol Amarox 40 mg gastro-resistant tablets

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

ItalyPantoprazol Amarox

Netherlands:Pantoprazol ARX 40 mg gastric-resistant tablets

Sweden:Pantoprazol Amarox 40 mg Enterotablet

Last review date of this leaflet:

April 2023

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