PANTOPRAZOL TARBIS FARMA 40 mg GASTRO-RESISTANT TABLETS
How to use PANTOPRAZOL TARBIS FARMA 40 mg GASTRO-RESISTANT TABLETS
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
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Introduction
Package Leaflet: Information for the User
Pantoprazole Tarbis Farma 40 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, you may need to read it again. If you have any further questions, ask your doctor, pharmacist, or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
Contents of the Package Leaflet
- What is Pantoprazole Tarbis Farma and what is it used for
- What you need to know before you take Pantoprazole Tarbis Farma
- How to take Pantoprazole Tarbis Farma
- Possible side effects
- Storage of Pantoprazole Tarbis Farma
- Contents of the pack and other information
1. What is Pantoprazole Tarbis Farma and what is it used for
Pantoprazole Tarbis Farma contains the active substance pantoprazole.
- Pantoprazole is a selective inhibitor of the "proton pump", a medicine that reduces the amount of acid produced in your stomach. It is used for the treatment of diseases related to stomach and intestine acid.
Pantoprazole is used in adults and adolescents aged 12 years and older 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 the stomach.
Pantoprazole is used in adults to treat:
- Infection with 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 bacteria and thus reduce the likelihood of ulcers recurring.
- Stomach and duodenal ulcers,
- Zollinger-Ellison syndrome and other conditions in which too much acid is produced in the stomach.
2. What you need to know before you take Pantoprazole Tarbis Farma
Do not take Pantoprazole Tarbis Farma
- If you are allergic to pantoprazole or any of the other ingredients of this medicine (listed in section 6).
- If you are allergic to medicines that contain other proton pump inhibitors.
Warnings and precautions
Consult your doctor, pharmacist, or nurse before starting to take this medicine.
- If you have severe liver problems. Tell your doctor if you have ever had liver problems. Your doctor will monitor you more frequently for liver enzymes, especially when you are on long-term treatment with this medicine. In case of an increase in liver enzymes, treatment should be discontinued.
- If you have decreased body stores of vitamin B12 or risk factors for it and receive long-term treatment with pantoprazol. Like all medicines that reduce acid, pantoprazol may reduce the absorption of vitamin B12.
- Consult your doctor if you are taking HIV protease inhibitors such as atazanavir (for HIV infection treatment) at the same time as pantoprazol.
- Taking a proton pump inhibitor like pantoprazol, especially for more than a year, may increase the risk of hip, wrist, or spine fractures. 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, it is possible that your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you experience any of these symptoms, see your doctor immediately. Low magnesium levels can also produce a decrease in blood potassium and calcium levels. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.
- If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazol Tarbis Farma to reduce stomach acid.
- If you get a skin rash, especially in areas of skin exposed to the sun, 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.
- If you are scheduled to have a specific blood test (Chromogranin A).
Tell your doctor immediatelybefore or after taking this medicine if you notice any of the following symptoms, which may be signs of more serious diseases:
- unintentional weight loss
- vomiting, particularly if it is repeated
- blood in the vomit: it may appear as a dark coffee grounds-like substance 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 pantoprazol 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 because pantoprazol can alleviate the symptoms of cancer and may delay its diagnosis. If, despite treatment, your symptoms persist, complementary tests will be performed.
If you take this medicine for a prolonged period (more than a year), your doctor will probably monitor you regularly. You should inform your doctor of any symptoms and/or new or unexpected events each time you visit your doctor.
Children and adolescents
The use of this medicine is not recommended in children as it has not been tested 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 take any other medicines, including those obtained without a prescription.
Pantoprazol may affect the efficacy 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 to treat certain types of cancer), as pantoprazol may make these and other medicines not work properly.
- Warfarin and phenprocoumon, which affect blood coagulation. You may need additional checks.
- 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 stop treatment with this medicine because pantoprazol can increase methotrexate levels in the blood.
- Fluvoxamine (used to treat depression and other psychiatric diseases). 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, breastfeeding, and fertility
There is not enough data on the use of pantoprazol in pregnant women. It has been reported that in humans, pantoprazol is excreted in 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 for you is greater than the potential risk to the fetus or baby.
Driving and using machines
Pantoprazol has no significant influence on the ability to drive or use machines.
You should not drive or use machines if you experience side effects such as dizziness or blurred vision.
Pantoprazol Tarbis Farma contains lactose
If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.
Pantoprazol Tarbis Farma contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".
3. How to take Pantoprazol Tarbis Farma
Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.
Method of administration:
Take the tablets 1 hour before meals without chewing or breaking them and swallow 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 indicate an increase to 2 tablets per day. The treatment time for reflux esophagitis is usually between 4 and 8 weeks. Your doctor will indicate how long you should take this medicine.
Adults:
For the treatment of an infection with a bacterium called Helicobacter pylori in patients with stomach and/or duodenal ulcers 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 to be taken twice a day with your pantoprazol tablet. Take the first pantoprazol tablet one hour before breakfast and the second one hour before dinner. Follow your doctor's instructions and make sure to read the leaflets of the antibiotics.
The duration of treatment is usually one to two 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 indicate how long you should take this medicine. The duration of treatment for stomach ulcers is usually between 4 and 8 weeks. The duration of treatment 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 secretion:
The initial recommended dose is two tablets per day. Take the two tablets one hour before a meal. Later, your doctor may adjust your dose, depending on the amount of acid secretion you produce. If you are prescribed more than two tablets per day, you should take the tablets divided into two doses per day. If you are prescribed more than four tablets per day, you will be told exactly when to finish the 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 pantoprazol tablet per day (for this case, 20 mg pantoprazol tablets are available).
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
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 Toxicology Information Service, phone: 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 forgotten 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 on the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets 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, rash (urticaria), difficulty breathing, swelling of the face of allergic origin (Quincke's edema/angioedema), intense dizziness with very rapid heartbeats and profuse 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 rapid deterioration of general conditions, erosion (including slight bleeding) of eyes, nose, mouth/lips, or genitals, or sensitivity/skin rash, particularly in areas of skin exposed to light/sun. You may also have joint pain or symptoms similar to those of the flu, fever, swollen glands (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, subacute cutaneous lupus erythematosus, drug reaction with eosinophilia and systemic symptoms (DRESS), photosensitivity).
- Other serious conditions (frequency not known; cannot be estimated from available data): yellowing of the skin and whites of the eyes (severe liver cell damage, jaundice), or fever, rash, increased kidney size sometimes with pain when urinating, and pain in the lower back (severe kidney inflammation), which may lead to kidney failure.
Other side effects are:
- Frequent (may affect up to 1 in 10 patients): Benign polyps in the stomach.
- Uncommon (may affect up to 1 in 100 patients)
Headache; dizziness; diarrhea; feeling of dizziness, vomiting; swelling and flatulence (gas); constipation; dry mouth; abdominal pain and discomfort; skin rash, exanthema, eruption; tingling; feeling of weakness, fatigue, or general malaise; sleep disturbances; hip, wrist, and spine fractures.
- Rare (may affect up to 1 in 1,000 patients)
Alteration or complete loss of taste; vision disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; high fever; swelling in the limbs (peripheral edema); 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)
Hallucinations, confusion (especially in patients with a history of these symptoms), tingling, pinching, numbness, burning sensation, or numbness, skin rash, possibly with joint pain, inflammation of the large intestine that causes persistent watery diarrhea.
Side 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 white blood cells, associated with high fever.
- Very rare (may affect up to 1 in 10,000 patients)
Reduced platelet count, which may cause bleeding or more bruising than usual; reduced white blood cell count, which may lead to more frequent infections; abnormal reduction in the balance between red and white blood cell counts, as well as platelets.
- Frequency not known(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 side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects that are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es
By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of Pantoprazol Tarbis Farma
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.
Store below 30°C.
Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. Container Content and Additional Information
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 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 Container Content of Pantoprazol Tarbis Farma
The tablets are yellow to pale yellow, oval, approx. 11.6 mm long and 5.90 mm wide, biconvex and with the imprint “H126” on one side with black ink and smooth on the other side.
Pantoprazol Tarbis Farma is available in PVC/AL/OPA-AL blister packs of 14, 28, 30, 56, 60, 90, 98 or 100 tablets and in high-density polyethylene bottles with a screw cap made of low-density polyethylene 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
Netherlands
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Germany: Pantoprazol Amarox 40 mg magensaftresistente Tabletten
Spain: Pantoprazol Tarbis Farma 40 mg gastro-resistant tablets EFG
Italy: Pantoprazol Amarox
Netherlands: Pantoprazol ARX 40 mg maagsapresistente tabletten
Sweden: Pantoprazol Amarox 40 mg Enterotablett
Date of the Last Revision of this Leaflet:
April 2023
Detailed 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/)
- Country of registration
- Average pharmacy price8.74 EUR
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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