Pantoprazole CINFA 20 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

pantoprazol cinfa 20 mg gastro-resistant tablets EFG

Pantoprazole sodium

Read the entire 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, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

pantoprazol cinfa contains the active substance pantoprazol. Pantoprazol is a selective proton pump inhibitor, a medicine that reduces the amount of acid produced in the stomach. It is used for the treatment of acid-related disorders of the stomach and intestine.

pantoprazol cinfa is used for:

Adults and adolescents aged 12 years and older:

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

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

Adults:

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 cinfa

Do not take pantoprazole cinfa

• 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.

Warnings and precautions

Talk to your doctor or pharmacist before taking pantoprazole 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 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 you 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 protease inhibitors for HIV, 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 if you have been told you are at risk of osteoporosis (for example, if you are taking corticosteroids).
• 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, confusion, 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.
• If you have ever had a skin reaction after treatment with a medicine similar to pantoprazole 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. 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).

Inform your doctor immediately, before or after taking this medicine, if you notice any of the following symptoms, which could be signs of more serious conditions:

• unintentional weight loss
• vomiting, particularly if repeated
• blood in vomit: this may appear as dark coffee-ground-like material in your vomit
• noticing blood in your stools, which may appear black or dark
• difficulty swallowing or pain when swallowing
• pale appearance and feeling weak (anaemia)
• chest pain
• stomach pain
• severe or persistent diarrhoea, as pantoprazole has been associated with a small increased risk of infectious diarrhoea.

Your doctor will decide whether additional tests are needed to rule out malignant disease, as pantoprazole may relieve cancer symptoms 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 report any new or unexpected symptoms or events to your doctor 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.

Other medicines and pantoprazole cinfa

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

Pantoprazole may affect the effectiveness 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 for certain types of cancer), as pantoprazole may reduce the effectiveness of these and other medicines.

• Warfarin and phenprocoumon, which affect blood clotting. You may require 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 discontinue pantoprazole treatment, as pantoprazole may increase methotrexate levels in the blood.

• Fluvoxamine (used to treat depression and other psychiatric conditions). 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

There are insufficient data on the use of pantoprazole in pregnant women. It has been reported that pantoprazole is excreted in human breast milk.

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 only a negligible effect on the ability to drive or operate machinery.

You should not drive or operate machinery if you experience adverse effects such as dizziness or blurred vision.

pantoprazole cinfa contains lactose

If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

pantoprazole cinfa contains sodium

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

3. How to take pantoprazole cinfa

Follow exactly the administration instructions for this medicine 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 breaking them, swallowing them with a little water, 1 hour before meals.

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 1 tablet per day.

This dose generally provides relief within 2–4 weeks, and if not, at most within the following 4 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 1 tablet per day.

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 your dose; in this case, you may take pantoprazole 40 mg once daily. After healing, the dose may be reduced again to 1 tablet of 20 mg per day.

Adults

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

The usual dose is 1 tablet per day.

Patients with liver problems

If you have severe liver problems, you must 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 pantoprazole cinfa than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately 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 pantoprazole cinfa

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

If you stop taking pantoprazole cinfa

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.

If you experience any of the following adverse effects, stop taking these tablets immediately and contact your doctor straight away, or contact the emergency department of your nearest hospital:

• Severe allergic reactions (rare frequency; may affect up to 1 in 1,000 patients): swelling of the tongue and/or throat, difficulty swallowing, rash (urticaria), difficulty breathing, allergic swelling of the face (angioedema/Quincke's oedema), severe dizziness with very rapid heartbeat and excessive sweating.

• Severe skin disorders (frequency not known: cannot be estimated from available data): you may notice one or more of the following effects: blisters on the skin and rapid deterioration in general condition, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals, or skin sensitivity/rash, particularly in areas of skin exposed to light/sun. 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. (Stevens-Johnson syndrome, Lyell's 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 available data): yellowing of the skin and whites of the eyes (severe liver cell damage, jaundice), or fever, rash, kidney enlargement with occasional pain when urinating and lower back pain (severe kidney inflammation), which could possibly lead to kidney failure.

Other adverse effects are:

• Common: may affect up to 1 in 10 patients.

Benign gastric polyps.

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

Headache; dizziness; diarrhoea; feeling of dizziness, vomiting; bloating and flatulence (gas); constipation; dry mouth; pain and discomfort in the abdomen; skin rash, exanthema, eruption; tingling; feeling of weakness, fatigue or general malaise; sleep disturbances, hip, wrist and spinal fractures.

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

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

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

Disorientation.

• Frequency not known: cannot be estimated from available data.

Hallucination, confusion (especially in patients with a history of these symptoms), sensation of tingling, prickling, paraesthesia (tingling), burning, numbness, stinging, deadness, skin rash, possibly with joint pain, inflammation of the large intestine causing persistent watery diarrhoea.

Adverse effects identified through blood tests:

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

Increased liver enzymes.

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

Increased bilirubin; increased blood fat levels, sudden drop in granular white blood cells in circulation, associated with high fever.

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

Reduction in the number of platelets, which could cause bleeding or more bruising than usual; reduction in the number of white blood cells, which could lead to more frequent infections; abnormal reduction in the balance between red blood cells, white blood cells and platelets.

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of pantoprazole cinfa

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date which appears on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Vial: This medicine does not require any special storage conditions.

Blister pack: Do not store above 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of pantoprazol cinfa

• The active substance is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole (as sodium pantoprazole sesquihydrate).
• The other components (excipients) are: microcrystalline cellulose (E-460i), lactose monohydrate, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate (vegetable), Opadry II 85F32081 yellow (partially hydrolyzed poly(vinyl) alcohol, macrogol/PEG 3350, titanium dioxide (E-171), talc (E-553b), yellow iron oxide (E-172), quinoline yellow aluminium lake (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).

Appearance of the product and contents of the pack

Yellow to ochre, elongated coated tablets.

pantoprazol cinfa 20 mg is available in packs of 14, 28, 56 or 504 (hospital pack) tablets in Al/Al blisters or in HDPE bottles containing 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 the most recent revision of this leaflet: October 2021

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (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 package leaflet and packaging. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/71118/P_71118.html

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