PANTOPRAZOL TEVA-RATIO 40 mg GASTRO-RESISTANT TABLETS

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

Do not take Pantoprazol Teva-ratio:

• if you are allergic to pantoprazol 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. 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 pantoprazol.

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

• If you need to take medicines called NSAIDs continuously and take pantoprazol, as there is a greater risk of developing stomach and intestine complications. Any increased risk will be assessed according to your personal risk factors such as age (65 years or older), history of stomach or duodenal ulcers or stomach or intestinal bleeding.

• If you have decreased body reserves 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. Tell your doctor if you have osteoporosis (reduced bone density) or if you have been told you are at risk of osteoporosis (e.g. if you are taking corticosteroids).
• If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazol Teva-ratio to reduce stomach acid.
• If you get a skin rash, especially in areas of the skin exposed to the sun, consult your doctor as soon as possible, as it may be necessary to stop treatment with Pantoprazol Teva-ratio. Remember to mention any other symptoms you may notice, such as joint pain.

• It is planned that you will have a specific blood test (Chromogranin A).
  • If you take pantoprazol for more than three months, you may suffer from a decrease in magnesium levels in the blood. Symptoms of low magnesium levels can include fatigue, involuntary muscle contractions, disorientation, dizziness, or increased heart rate. If you have any of these symptoms, tell your doctor immediately. Additionally, low magnesium levels can cause a decrease in potassium and calcium levels in the blood. Your doctor will decide whether to perform periodic blood tests to monitor magnesium levels.

Tell your doctor immediatelybefore 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 the vomit
• pale appearance and feeling of weakness (anemia)
• blood in your stools
• 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 Teva-ratio may alleviate the symptoms of cancer and could delay its diagnosis. If, despite treatment, your symptoms persist, complementary tests will be performed.

If you take pantoprazol for a prolonged period (more than a year), your doctor may monitor you regularly. You should tell your doctor about any new symptoms and/or unexpected events each time you visit your doctor.

Children and adolescents

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

Taking Pantoprazol Teva-ratio with other medicines

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 Teva-ratio may affect the efficacy of other medicines, so tell 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 cause these and other medicines to 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 a high dose of methotrexate, your doctor may need to temporarily stop treatment with pantoprazol.
• Fluvoxamine (used to treat depression and other psychiatric disorders) if you are taking fluvoxamine, your doctor may reduce the 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 to you is greater than the potential risk to the fetus or baby.

Driving and using machines

Pantoprazol has no influence or negligible 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 Teva-ratio contains sodium

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

3. How to take Pantoprazol Teva-ratio

Follow the instructions for administration of this medicine exactly as indicated 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 from 12 years

For the treatment of reflux esophagitis:

The recommended 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 1 hour before breakfast and the second 1 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 recommended 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 treatment time for stomach ulcers is usually between 4 and 8 weeks. The treatment time 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 1 hour before a meal. Later, your doctor may adjust the 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 treatment.

Patients with kidney problems

If you have kidney problems, you should not take pantoprazol 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 pantoprazol for the eradication of Helicobacter pylori.

Use in children and adolescents

The use of these tablets is not recommended in children under 12 years.

If you take more Pantoprazol Teva-ratio than you should

Inform your doctor or pharmacist or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken. 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 forgotten doses. Take your next dose as usual.

If you stop taking Pantoprazol Teva-ratio

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

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The frequency of the possible side effects listed 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 get any of the following side effects, stop taking these tablets and tell your doctor immediately, or contact the emergency department of the nearest hospital:

• Severe allergic reactions (rare):swelling of the tongue and/or throat, difficulty swallowing, hives (urticaria), difficulty breathing, swelling of the face of allergic origin (Quincke's edema/angioedema), severe dizziness with very rapid heartbeats and profuse sweating.

• Severe skin reactions (frequency not known):blisters on the skin and rapid deterioration of general conditions, erosion (including slight bleeding) of eyes, nose, mouth/lips, or genitals (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme), and sensitivity to light.

You may also have 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 (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):yellowing of the skin and the whites of the eyes (severe liver cell damage, jaundice), or fever, rash, increased kidney size with occasional pain when 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; 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 spine fractures.

• Rare

distortion or complete loss of taste, vision changes such as blurred vision; hives; joint pain; muscle pain; weight changes; increased body temperature; swelling in the limbs (peripheral edema); allergic reactions; depression; breast enlargement in men.

• Very rare

disorientation.

• Frequency not known

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

Side effects identified through blood tests:

• Uncommon

Increased liver enzymes.

• Rare

Increased bilirubin; increased blood fat levels, sharp drop in circulating granulocytes.

• Very rare

Reduction in the number of platelets that could lead to bleeding or more bruising than usual; reduction in the number of white blood cells that could lead to more frequent infections; coexistence of an abnormal reduction in the number of red blood cells, white blood cells, and platelets.

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

If you think any of the side effects you are experiencing is serious, or if you notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pantoprazol Teva-ratio

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 stated.

Bottle:

No special storage conditions are required.

Blister:

Store below 30°C.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Packaging Contents and Additional Information

Composition of Pantoprazol Teva-ratio

• The active ingredient is pantoprazol. Each gastro-resistant tablet contains 40 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 carboxymethyl starch type A (derived from potato), methacrylic acid-ethyl acrylate copolymer (1:1), 30% dispersion, and yellow iron oxide (E172).

Appearance of the Product and Packaging Contents

Gastro-resistant tablet, yellow, oval, concave, smooth.

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

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

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

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 Last Revision of this Prospectus: May 2023

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

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