PANTOPRAZOL CINFA 20 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the User

pantoprazol cinfa 20 mg gastro-resistant tablets EFG

Pantoprazole sodium

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 signs of illness 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 the pack

1. What is pantoprazol cinfa and what is it used for
2. What you need to know before you take pantoprazol cinfa
3. How to take pantoprazol cinfa
4. Possible side effects
5. Storing pantoprazol cinfa
6. Contents of the pack and other information

1. What is pantoprazol cinfa and what is it used for

pantoprazol cinfa contains the active substance pantoprazole. Pantoprazole is a selective inhibitor of the "proton pump", a medicine that reduces the amount of acid produced in your stomach. It is used for the treatment of diseases related to stomach and intestine acid.

pantoprazol cinfa is used for:

Adults and adolescents from 12 years:

• Treatment of symptoms associated with gastroesophageal reflux disease (e.g. heartburn, acid regurgitation, pain when swallowing) caused by acid reflux from the stomach.

• Long-term treatment and prevention of relapses of reflux esophagitis (inflammation of the esophagus accompanied by acid regurgitation from the stomach).

Adults:

Prevention of gastroduodenal ulcers induced by non-steroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen) in patients at risk who require continued treatment with this type of medicine.

2. What you need to know before you take pantoprazol cinfa

Do not take pantoprazol cinfa

• 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.

Warnings and precautions

Consult your doctor or pharmacist before starting to take pantoprazol cinfa.

• 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 pantoprazol. If your liver enzymes increase, treatment should be discontinued.
• If you need to take medicines called NSAIDs continuously and take pantoprazol, as there is a greater risk of developing complications in the stomach and intestine. 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 reduced body stores of vitamin B12 or risk factors for this and receive treatment with pantoprazol for a long period. Like all acid-reducing medicines, 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. Inform 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 take pantoprazol for more than three months, you may suffer from a decrease in magnesium levels in your 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, inform your doctor immediately. Additionally, low magnesium levels can lead to a decrease in potassium and calcium levels in your blood. Your doctor will decide whether to perform periodic blood tests to monitor magnesium levels.
• If you have ever had a skin reaction after treatment with a medicine similar to pantoprazol 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 interrupt treatment with pantoprazol. Remember to mention any other symptoms you may notice, such as joint pain.
• If you are scheduled to have a specific blood test (Chromogranin A).

Tell your doctor immediatelybefore or after taking this medicine if you notice any of the following symptoms, which may be signs of more serious diseases:

• unintentional weight loss
• vomiting, particularly if it is repeated
• blood in the vomit: it may appear as a dark brown powder in your vomit
• if you notice blood in your stools, which may appear black or dark
• difficulty swallowing or pain when swallowing
• pale appearance and feeling of weakness (anemia)
• chest pain
• stomach pain
• 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 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 inform your doctor of any new or unexpected symptoms or events each time you visit your doctor.

Children and adolescents

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

Other medicines and pantoprazol cinfa

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pantoprazol may affect the efficacy of other medicines. 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 pantoprazol may make these and other medicines not work properly.
• Warfarin and phenprocoumon, which affect blood coagulation. You may need additional monitoring.
• Medicines used to treat HIV infection, such as atazanavir.
• Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer). If you are taking methotrexate, your doctor may temporarily stop treatment with pantoprazol, as pantoprazol may increase methotrexate levels in your blood.
• 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 and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

There is not enough data on the use of pantoprazol in pregnant women. It has been reported that pantoprazol is excreted in human breast milk.

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 using machines

Pantoprazol has no 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 cinfa contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

pantoprazol cinfa 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 cinfa

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Method of administration:

Swallow the tablets whole with a little water, 1 hour before meals.

The recommended dose is:

Adults and adolescents from 12 years:

For treating symptoms associated with gastroesophageal reflux disease (heartburn, acid regurgitation, pain when swallowing)

The recommended dose is 1 tablet per day.

This dose usually provides relief within 2-4 weeks, and if not, at most, within the following 4 weeks. Your doctor will tell you how long you should continue to take the medicine. After that, any recurring symptoms can be controlled by taking 1 tablet per day as needed.

For long-term treatment and prevention of relapses of reflux esophagitis

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 back to 1 tablet of 20 mg per day.

Adults

For the prevention of duodenal and stomach ulcers in patients who require continued treatment with NSAIDs

The usual dose is 1 tablet per day.

Patients with liver problems

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

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 cinfa than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

No symptoms of overdose are known.

If you forget to take pantoprazol cinfa

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

If you stop taking pantoprazol cinfa

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.

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; may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, hives (urticaria), difficulty breathing, swelling of the face of allergic origin (Quincke's edema/angioedema), intense dizziness with very rapid heartbeat and profuse sweating.

• Severe skin disorders(frequency not known: cannot be estimated from the available data): you may notice one or more of the following effects: blisters on the skin and rapid deterioration of general conditions, erosion (including slight bleeding) of eyes, nose, mouth/lips, or genitals, or sensitivity/ skin rash, particularly in areas of skin exposed to light/sun. You may also have joint pain or symptoms similar to those of the flu, 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: cannot be estimated from the available data): 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 possibly cause kidney failure.

Other side effects are:

• Frequent:may affect up to 1 in 10 people.

Benign polyps in the stomach.

• Uncommon:may affect up to 1 in 100 people.

Headache; dizziness; diarrhea; feeling of dizziness, vomiting; swelling 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:may affect up to 1 in 1,000 people.

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

• Very rare:may affect up to 1 in 10,000 people.

Disorientation.

• Frequency not known(cannot be estimated from the available data):

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

Side effects identified through blood tests:

• Uncommon: may affect up to 1 in 100 people.

Increased liver enzymes.

• Rare: may affect up to 1 in 1,000 people.

Increased bilirubin; increased levels of fat in the blood, sudden drop in white blood cells with high fever.

• Very rare: may affect up to 1 in 10,000 people.

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; abnormal reduction in the balance between the number of red and white blood cells, as well as platelets.

• Frequency not known(cannot be estimated from the available data): decrease in sodium, magnesium, calcium, or potassium levels in the blood (see section 2).

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: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing pantoprazol cinfa

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: This medicine does not require any special storage conditions.

Blister: Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container Content and Additional Information

Pantoprazol Cinfa Composition

• The active ingredient is pantoprazol. Each gastro-resistant tablet contains 20 mg of pantoprazol (in the form of pantoprazol sodium sesquihydrate).
• The other components (excipients) are: microcrystalline cellulose (E-460i), lactose monohydrate, sodium croscarmellose, anhydrous colloidal silica, vegetable magnesium stearate, Opadry II 85F32081 yellow (partially hydrolyzed poly(vinyl alcohol), macrogol/PEG 3350, titanium dioxide (E-171), talc (E-553b), yellow iron oxide (E-172), aluminum lake of quinoline yellow (E-104)), methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30% (sodium lauryl sulfate, polysorbate 80, methacrylic acid-ethyl acrylate copolymer), triethyl citrate (E-1505), talc (E-553b).

Product Appearance and Container Content

Yellow to ochre-colored, prolonged-release tablets.

Pantoprazol Cinfa 20 mg is available in packs of 14, 28, 56 or 504 (clinical pack) tablets in Al/Al blisters or in HDPE bottles of 14, 28 or 56 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain.

Date of Last Revision of this Prospectus:October 2021

Detailed information on this medicinal product 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 medicinal product by scanning the QR code included in the prospectus and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/71118/P_71118.html

QR code at: https://cima.aemps.es/cima/dochtml/p/71118/P_71118.html