Pantoprazole Teva-Ratio 20 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Pantoprazole Teva-ratio 20 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the 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 Pantoprazol Teva-ratio is and what it is 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 aged 12 years and older to treat:

• Symptoms associated with gastroesophageal reflux disease (heartburn, acid regurgitation, painful swallowing) caused by acid reflux from the stomach.
• Long-term treatment of reflux esophagitis (inflammation of the oesophagus accompanied by acid regurgitation from the stomach) and prevention of relapses.

Pantoprazole is used in adults to treat:

• Prevention of gastroduodenal ulcers induced by non-steroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen) in at-risk patients who require ongoing treatment with these medicines.

2. What you need to know before taking Pantoprazole Teva-ratio

Do not take Pantoprazole 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 taking Pantoprazole 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, 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 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 Pantoprazole Teva-ratio 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 Pantoprazole Teva-ratio. Remember to mention any other symptoms you may notice, such as joint pain.

• You are scheduled to have a specific blood test (chromogranin A).

  • If you take pantoprazole for more than three months, you may experience a decrease in blood magnesium levels. 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. In addition, low magnesium levels may lead to decreased levels of potassium and calcium in the blood. Your doctor will decide whether periodic blood tests are needed to monitor magnesium levels.

Inform your doctor immediately 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 diarrhea, as pantoprazole has been associated with a small increased risk of infectious diarrhea.

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

If you take pantoprazole 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 or events at each visit.

Children and adolescents

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

Taking Pantoprazole 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 over-the-counter medicines.

Pantoprazole 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 cause these and other medicines to be less effective.

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

• Medicines used to treat HIV infection (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 your pantoprazole treatment.

• 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 plan 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 infant.

Driving and using machines

Pantoprazole has no effect or an insignificant 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.

Pantoprazole Teva-ratio contains sodium

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

3. How to take Pantoprazol Teva-ratio

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 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

To treat symptoms associated with gastroesophageal reflux disease (heartburn, acid regurgitation, pain when swallowing):

The recommended dose is one tablet daily.

This dose generally provides relief within 2–4 weeks, and if not, within a maximum of 4 additional weeks. Your doctor will advise you on how long you should continue taking the medicine. Afterwards, any recurring symptoms can be managed as needed by taking one tablet daily.

For long-term treatment and prevention of relapse of reflux esophagitis:

The recommended dose is one tablet daily. If the condition recurs, your doctor may double your dose, in which case you may take pantoprazole 40 mg once daily. After healing, the dose may be reduced again to one 20 mg tablet daily.

Adults

For prevention of duodenal and gastric ulcers in patients requiring ongoing treatment with NSAIDs:

The recommended dose is one tablet daily.

Patients with liver problems

If you have moderate or severe liver problems, you must not take more than one 20 mg tablet daily.

Use in children and adolescents

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. Symptoms of overdose are not known.

If you forget to take Pantoprazol Teva-ratio

Do not take a double dose to make up for forgotten 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 the 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 and rapid deterioration in general condition, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals, 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, peeling, mouth, throat, nose, genital or eye ulcers. These serious rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

• Widespread 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 include:

• Common: benign gastric polyps.

• Uncommon: headache; dizziness; diarrhoea; feeling of dizziness, nausea, vomiting; bloating and flatulence (gas); constipation; dry mouth; pain and discomfort in the abdomen; skin rash, exanthema, eruption; tingling; feeling of weakness, tiredness or general malaise; sleep disturbances; hip, wrist and spinal 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 in the extremities (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 with joint pain, tingling, pricking, numbness, burning or stinging sensations, 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 granulocyte white blood cells.

• 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; coexistence of an 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, consult your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet. You may 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 are required.

Blister pack:

Store below 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE point located at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pantoprazole Teva-ratio

• The active substance is pantoprazole. Each gastro-resistant tablet contains 20 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) dispersion 30%, and yellow iron oxide (E172).

Appearance of the 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 7, 14, 28 or 56 gastro-resistant tablets.

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 the most recent review of this leaflet: February 2026

Detailed information on 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/72299/P_72299.html