Leaflet: information for the user

Pantoprazol Teva-ratio 20 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before starting to take Pantoprazol Teva-ratio

3. How to take Pantoprazol Teva-ratio

4. Possible side effects

5. Storage of Pantoprazol Teva-ratio

6. Contents of the pack and additional information

Pantoprazol Teva-ratio 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 and intestinal acid.

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

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

Pantoprazol is used in adults to treat:

• Prevention of gastroduodenal ulcers induced by nonsteroidal anti-inflammatory drugs (NSAIDs, for example, ibuprofen) in patients at risk who require continued treatment with this type of medication.

Do not take Pantoprazol Teva-ratio:

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

Warnings and precautions

Consult 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 when you are on long-term treatment with pantoprazole.

In case of an increase in liver enzymes, treatment should be interrupted.

• If you need to take nonsteroidal anti-inflammatory drugs (NSAIDs) continuously and take pantoprazole, as there is a higher risk of developing complications in the stomach and intestine. Any increased risk will be evaluated according to your personal risk factors such as age (65 years or older), history of stomach or duodenal ulcers or gastrointestinal bleeding.
• If you have decreased vitamin B12 reserves or risk factors for it and receive pantoprazole treatment for a long period of time. As all acid-reducing medicines, 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 (e.g., if you are taking corticosteroids).
• If you have ever had a reaction to a similar medicine to Pantoprazol Teva-ratio for reducing 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 interrupt treatment with Pantoprazol Teva-ratio. Remember to mention any other symptoms you may notice, such as joint pain.

-You will be scheduled to have a specific blood test (Cromogranin A).

• If you take pantoprazole for more than three months, you may experience a decrease in magnesium levels in the blood. Symptoms of low magnesium levels may include fatigue, involuntary muscle contractions, disorientation, dizziness, or increased heart rate. If you have any of these symptoms, inform your doctor immediately. Additionally, low magnesium levels may cause a decrease in potassium and calcium levels in the blood. Your doctor will decide to perform periodic blood tests 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 the vomit
• pale appearance and feeling of weakness (anemia)
• blood in your stools
• severe or persistent diarrhea, as pantoprazole 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, as Pantoprazol Teva-ratio may alleviate cancer symptoms and potentially delay its diagnosis. If your symptoms persist despite treatment, further investigations will be performed.

If you take pantoprazole 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

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

Taking Pantoprazol Teva-ratio with other medicines

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

Pantoprazol Teva-ratio may affect the efficacy of other medicines, so 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 pantoprazole may make these and other medicines less effective.
• Warfarin and phenprocoumon, which affect blood clotting. You may need 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 will need to temporarily stop pantoprazole treatment.

-Fluvoxamine (used to treat depression and other psychiatric disorders) if youaretaking 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 insufficient data on the use of pantoprazole in pregnant women. Pantoprazole has been excreted in human breast milk.

If you are pregnant, or in the breastfeeding period, think you may be pregnant, or intend 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 operating machinery

Pantoprazole has no influence or insignificant influence on the ability to drive or operate machinery.

You should not drive or operate machinery if you experience side 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; it is essentially "sodium-free".

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

Administration Form

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

The recommended dose is:

Adults and adolescents 12 years and older

For treating symptoms associated with gastroesophageal reflux disease (stomach burning, acid regurgitation, difficulty swallowing):

The recommended dose is 1 tablet per day.

This dose usually provides relief within 2-4 weeks, and if not, within a maximum of 4 weeks. Your doctor will tell you how long you should continue taking the medication. Subsequently, any recurring symptom can be controlled as needed by taking 1 tablet per day.

For long-term treatment and prevention of esophagitis relapses:

The recommended dose is 1 tablet per day. If the disease recurs, your doctor may double the dose, in which case you can take pantoprazol 40 mg once a day. After healing, you can reduce the dose again to 1 tablet of 20 mg per day.

Adults

For the prevention of duodenal and stomach ulcers in patients requiring continuous treatment with NSAIDs

The recommended dose is 1 tablet per day.

Patients with liver problems

If you have moderate or severe liver problems, do not take more than 1 tablet of 20 mg per day.

Use in children and adolescents

These tablets are not recommended for use in children under 12 years old.

If you take more Pantoprazol Teva-ratio than you should

Inform your doctor or pharmacist or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken. No symptoms of overdose are known.

If you forget to take Pantoprazol Teva-ratio

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

If you interrupt treatment with Pantoprazol Teva-ratio

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

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

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

The frequency of the possible side 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 side effects, stop taking these tablets and inform your doctor immediately, or contact the emergency department of the nearest hospital:

• Severe allergic reactions (rare frequency):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 not known):Blisters on the skin and rapid deterioration of overall condition, erosion (including mild bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme), and light sensitivity.

You may also experience joint pain or flu-like symptoms, 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, drug reaction with eosinophilia and systemic symptoms (DRESS), photosensitivity).

• Other serious conditions (frequency not known):Yellow discoloration of the skin and white of the eyes (severe liver cell damage, jaundice), or fever, hives, increased kidney size with occasional pain while urinating and lower back pain (severe kidney inflammation), which may lead to kidney failure.

Other side effects are:

• Common

Benign polyps in the stomach.

• Uncommon

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

• Rare

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

• Very rare

Disorientation.

• Frequency not known

Illusion, confusion (especially in patients with a history of these symptoms), skin rash, possibly with joint pain, sensation of tingling, pinching, numbness, burning, or numbness, inflammation of the large intestine causing persistent watery diarrhea.

Side effects identified through blood tests:

• Uncommon

Increased liver enzymes.

• Rare

Increased bilirubin; increased levels of fats in the blood, sudden drop in granular white blood cells.

• Very rare

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; coexistence of an abnormal reduction in red blood cell, white blood cell, and platelet counts.

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

If you consider that any of the side effects you are experiencing are severe or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a 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: http://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.

Container:

No special storage conditions are required.

Blister:

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 point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Pantoprazol Teva-ratio

• The active ingredient is pantoprazol. Each gastro-resistant tablet contains 20 mg of pantoprazol (in the form of sodium sesquihydrate).
• The other components (excipients) are: anhydrous disodium phosphate (E339b), mannitol (E421), microcrystalline cellulose, sodium croscarmellose, magnesium stearate, hypromellose, triethyl citrate, sodium carboxymethylcellulose type A (from potato), copolymer of methacrylic acid-ethyl acrylate (1:1), 30% dispersion, and yellow iron oxide (E172).

Appearance of the product and content of the packaging

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

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

Each package contains 7, 14, 28, or 56 gastro-resistant tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva Pharma, S.L.U.

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

Alcobendas, 28108 Madrid (Spain)

Responsible for manufacturing

TEVA PHARMA, S.L.U.

Malpica Industrial Estate c/ C, 4.

50016 Zaragoza (Spain)

Last review date of this leaflet: May 2023

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

You can access detailed and updated information on this medicine by scanning the QR code included in the carton with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/72299/P_72299.html