Leaflet: information for the user

Pantoprazol Teva-ratio 40 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 doubts, 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:

• Reflux esophagitis. It is an inflammation of your esophagus (the tube that connects your throat to your stomach) accompanied by regurgitation of acid from your stomach.

Pantoprazol is used in adults to treat:

• Infection caused by a bacteria called Helicobacter pylori in patients with stomach and/or duodenal ulcers in combination with two antibiotics (eradication treatment). The goal is to eliminate 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.

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 have decreased vitamin B12 reserves or risk factors for it and receive treatment with pantoprazole for a long period of time. As all medicines that reduce the amount of acid, 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 skin reaction after treatment with 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 undergo 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 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 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, additional 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 Pantoprazol Teva-ratio 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 those purchased without a prescription.

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 not work correctly.
• Warfarin and phenprocoumon, which affect blood clotting. You may need additional monitoring.
• Medicines used to treat HIV infection, such asatazanavir
• 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 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 insufficient data on the use of pantoprazole in pregnant women. Pantoprazole has been excreted in human 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 operating machines

Pantoprazolehas no influence or this is insignificant on the ability to drive or operate machines.

You should not drive or operate machines 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; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication 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 the treatment of esophagitis by reflux:

The recommended dose is 1 tablet per day. Your doctor may indicate an increase to 2 tablets per day. The treatment time for esophagitis by reflux usually lasts between 4 and 8 weeks. Your doctor will indicate for how long you should take this medication.

Adults

For the treatment of an infection with a bacteria called Helicobacter pylori in patients with stomach and/or duodenal ulcer in combination with two antibiotics (eradication treatment):

1 tablet twice a day plus the two antibiotic tablets, either amoxicillin, clarithromycin and metronidazole (or tinidazole), each must be taken twice a day 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 antibiotic prospectuses. The treatment duration is usually 1 to 2 weeks.

For the treatment of stomach and duodenal ulcers:

The recommended dose is 1 tablet per day. The dose may be doubled by your doctor. Your doctor will indicate for how long you should take this medication. The treatment duration for stomach ulcers is usually between 4 and 8 weeks. The treatment duration for duodenal ulcers is normally between 2 and 4 weeks.

For the long-term treatment of Zollinger-Ellison syndrome and other conditions in which there is an increase in stomach acid production:

The initial recommended dose is 2 tablets per day.

Take the two tablets 1 hour before a meal. Your doctor may then adjust your dose, depending on the amount of stomach acid you produce. If you are prescribed more than 2 tablets per day, you should take the tablets twice a day. If you are prescribed more than 4 tablets per day, you will be told exactly when to stop treatment.

Patients with kidney problems

If you have kidney problems, you should not take pantoprazole for the elimination of Helicobacter pylori.

Patients with liver problems

If you have severe liver problems, you should not take more than 1 tablet of 20 mg of pantoprazole per day (for this case, tablets of 20 mg of pantoprazole are available).

If you have moderate or severe liver problems, you should not take pantoprazole for the elimination of Helicobacter pylori.

Use in children and adolescents

This medication is not recommended for use in children under 12 years.

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 ingested. There are no known symptoms of overdose.

If you forgot to take Pantoprazol Teva-ratio

Do not take a double dose to compensate for the missed doses. 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 doubts 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 nearest hospital emergency service:

• 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 general 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 symptoms similar to the flu, 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 subacute cutaneous lupus erythematosus, drug reaction with eosinophilia and systemic symptoms (DRESS), photosensitivity).

• Other serious conditions (frequency not known):Yellow discoloration of the skin and the 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), possibly leading 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 the number of platelets that could cause bleeding or more frequent bruising; 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: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 not mentioned in this leaflet. You can also report them directly through the Spanish System for the 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. Deposit the 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 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 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 container

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

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

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

They may not be marketed in all container sizes.

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 packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/72298/P_72298.html