Pantoprazole Teva-Ratio 40 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pantoprazole Teva-ratio 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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What is Pantoprazol Teva-ratio and what is it used for?

Pantoprazol Teva-ratio 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 disorders of the stomach and intestine.

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

• Reflux esophagitis. This is inflammation of your esophagus (the tube connecting 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 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 starting to take Pantoprazol Teva-ratio

Do not take Pantoprazol Teva-ratio:

• 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 (e.g., omeprazole, lansoprazole, rabeprazole, esomeprazole).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Pantoprazol Teva-ratio.

• 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 need to take non-steroidal anti-inflammatory drugs (NSAIDs) continuously while taking pantoprazole, as there is an increased risk of developing stomach and intestinal complications. Any increase in risk will be assessed according to personal risk factors such as age (65 years or older), history of stomach or duodenal ulcer, or gastrointestinal bleeding.

• If you have reduced body stores of vitamin B12 or risk factors for this and 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.

• 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, particularly 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 have ever had a skin reaction after treatment with a medicine similar to Pantoprazol Teva-ratio used to reduce stomach acidity.

• If you develop a skin rash, especially on areas of skin exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with Pantoprazol Teva-ratio. Remember to mention any other symptoms you may experience, such as joint pain.

• If you are scheduled to have a specific blood test (Chromogranin A):

  • If you take pantoprazole for more than three months, you may develop low levels of magnesium in the blood. Symptoms of low magnesium levels may include fatigue, involuntary muscle contractions, confusion, 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.

Inform your doctor immediately before or after taking this medicine if you notice any of the following symptoms:

• unintentional weight loss
• repeated vomiting
• difficulty swallowing or pain when swallowing
• blood in vomit
• pale appearance and feeling weak (anemia)
• blood in stools
• severe or persistent diarrhoea, as pantoprazole has been associated with a small increased risk of infectious diarrhoea.

Your doctor will decide whether you need further tests to rule out malignancy, as Pantoprazol Teva-ratio may relieve cancer symptoms and could delay diagnosis. If your symptoms persist despite treatment, additional investigations will be carried out.

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

Children and adolescents

The use of Pantoprazol Teva-ratio is not recommended in children, as it has not been studied in children under 12 years of age.

Taking Pantoprazol Teva-ratio with other medicines

Inform 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.

Pantoprazol Teva-ratio 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 may reduce the effectiveness of these and other medicines.
• Warfarin and phenprocoumon, which affect blood clotting. You may require additional monitoring.
• Medicines used to treat HIV infection, such as atazanavir.
• Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer). If you are taking a high dose of methotrexate, your doctor may need to temporarily stop treatment with pantoprazole.
• 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, 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, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

This medicine should only be used 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 a negligible effect on the ability to drive or use machines.

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

Pantoprazol Teva-ratio contains sodium

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

3. How to take Pantoprazol Teva-ratio

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

Method of administration

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

The recommended dose is:

Adults and adolescents aged 12 years and older

For the treatment of reflux esophagitis:

The recommended 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 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, together with 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 duration of treatment is normally one to two weeks.

For the treatment of gastric and duodenal ulcers:

The recommended 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 there is increased gastric acid secretion:

The recommended initial dose is two tablets per day.

Take both tablets 1 hour before a meal. Subsequently, 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 divided into two daily doses. If more than four tablets per day are prescribed, you will be informed exactly when to stop treatment.

Patients with kidney problems

If you have kidney problems, you should not take pantoprazole 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 case).

If you have moderate or severe liver problems, you should not take pantoprazole 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 Teva-ratio than you should

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

If you forget to take Pantoprazol Teva-ratio

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

If you stop taking Pantoprazol Teva-ratio

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

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

very common (may affect more than 1 in 10 people)
common (may affect up to 1 in 10 people)
uncommon (may affect up to 1 in 100 people)
rare (may affect up to 1 in 1,000 people)
very rare (may affect up to 1 in 10,000 people)
frequency not known (cannot be estimated from available data).

If you experience any of the following adverse effects, stop taking these tablets immediately and contact your doctor or go to the nearest hospital emergency department:

• Severe allergic reactions (rare frequency): swelling of the tongue and/or throat, difficulty swallowing, rash (urticaria), difficulty breathing, allergic swelling of the face (Quincke's oedema/angioedema), severe dizziness with very rapid heartbeat and excessive sweating.

• Severe skin disorders (frequency not known):

You may notice one or more of the following reactions:

• Skin rash with swelling, blistering or peeling of the skin, rapid deterioration in general condition, erosion, and sensitivity to light.

• 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.

• Circular or target-shaped slightly reddish spots on the trunk, often with blisters in the centre, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These serious rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

• Generalised rash, high body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity).

• 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 with occasional pain when urinating and lower back pain (severe kidney inflammation), which could possibly lead to kidney failure.

Other adverse effects are:

• Common: benign gastric polyps.

• Uncommon: headache; dizziness; diarrhoea; feeling of dizziness, nausea, vomiting; bloating 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 vertebral fractures.

• Rare: distortion or complete loss of taste sensation, visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; swelling of the limbs (peripheral oedema); allergic reactions; depression; breast enlargement in men.

• Very rare: disorientation.

• Frequency not known: hallucination, confusion (especially in patients with a history of these symptoms), skin rash, possibly accompanied by joint pain, tingling sensation, pricking, numbness, burning or tingling, inflammation of the large intestine causing persistent watery diarrhoea.

Adverse effects identified through blood tests:

• Uncommon: increased liver enzymes.

• Rare: increased bilirubin; increased blood fat levels, sudden drop in circulating granulocytes.

• Very rare: reduced platelet count, which could lead to bleeding or more bruising than usual; reduced white blood cell count, which could lead to more frequent infections; concurrent abnormal reduction in red blood cells, white blood cells, and platelets.

• Frequency not known: decreased levels of sodium, magnesium, calcium, or potassium in the blood (see section 2).

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects:

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pantoprazole Teva-ratio

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 refers to the last day of the month indicated.

Vial:

No special storage conditions required.

Blister pack:

Store below 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of Pantoprazol Teva-ratio

• The active substance is pantoprazole. Each gastro-resistant tablet contains 40 mg of pantoprazole (as sodium sesquihydrate).
• The other components (excipients) are: anhydrous disodium phosphate (E339b), mannitol (E421), microcrystalline cellulose, sodium croscarmellose, magnesium stearate, hypromellose, triethyl citrate, sodium carboxymethyl starch type A (derived from potato), methacrylic acid-ethyl acrylate copolymer (1:1), 30% dispersion, and yellow iron oxide (E172).

Appearance of the medicinal product and contents of the pack

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

Packaging: bottles (high-density polyethylene bottle with low-density polyethylene screw cap) and blisters (Alu/Alu blisters).

Each pack contains 14, 28 or 56 gastro-resistant tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/Anabel Segura 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108 Madrid (Spain)

Manufacturer

TEVA PHARMA, S.L.U.

Polígono Malpica c/ C, 4.

50016 Zaragoza (Spain)

Date of latest revision of this leaflet: February 2025

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/72298/P_72298.html