PANTOPRAZOL 40 mg Gastro-Resistant Tablets

Contents of the leaflet

1. Introduction
2. What is pantoprazol cinfa and what is it used for
3. What you need to know before you take pantoprazol cinfa
4. How to take pantoprazol cinfa
5. Possible side effects
6. Storage of pantoprazol cinfa
7. Container Content and Additional Information

Introduction

Package Leaflet: Information for the User

pantoprazol cinfa 40 mg gastro-resistant tabletsEFG

Sodium Pantoprazole

Read all of this leaflet carefully before you start taking thismedicine, 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 symptoms 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. Storage of 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 12years:

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

Adults:

• Infection with a bacterium called Helicobacter pyloriin patients with stomach and/or duodenal ulcers in combination with two antibiotics (eradication treatment). The goal is to get rid of 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.

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

Warnings and precautions

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

• If you have severe liver problems. Tell your doctor if you have ever had liver problems. Your doctor will perform more frequent monitoring of liver enzymes, especially when you are on long-term treatment with pantoprazole. In case of an increase in liver enzymes, treatment should be discontinued.
• If you have reduced body reserves of vitamin B12 or risk factors for it and receive long-term treatment with pantoprazole. Like all acid-reducing medicines, pantoprazole 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 pantoprazole.
• Taking a proton pump inhibitor like pantoprazole, 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 pantoprazole 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, inform your doctor immediately. Additionally, low magnesium levels can produce a decrease in potassium and calcium levels in the blood. Your doctor will decide to perform periodic blood tests to monitor magnesium levels.
• If you have ever had a skin reaction after treatment with a medicine similar to pantoprazole to reduce stomach acid.
• If you suffer from a skin rash, especially in areas of skin exposed to the sun, consult your doctor as soon as possible, as it may be necessary to interrupt 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).

Tell your doctor immediately,before 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 coffee grounds-like substance in your vomit
• difficulty swallowing, or pain when swallowing
• pale appearance and feeling of weakness (anemia)
• chest pain
• stomach pain
• 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 because pantoprazole can alleviate the symptoms of cancer and may delay its diagnosis. If, despite treatment, your symptoms persist, complementary tests will be performed.

If you take pantoprazole for a prolonged period (more than a year), your doctor will possibly monitor you regularly. You should inform your doctor of any new or unexpected symptoms and/or events each time you visit your doctor.

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.

Other medicines and pantoprazol cinfa

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

Pantoprazole may influence 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 to treat certain types of cancer), as pantoprazole 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 methotrexate, your doctor may temporarily interrupt treatment with pantoprazole because pantoprazole can increase methotrexate levels in the blood.
• Fluvoxamine (used to treat depression and other psychiatric diseases) 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 andbreast-feeding

There is not enough data on the use of pantoprazole in pregnant women. It has been reported that in humans, pantoprazole is excreted in breast milk. If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking 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 usingmachines

Pantoprazole 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 1mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take pantoprazol cinfa

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

Method of administration:

Take the tablets whole, without chewing or breaking them, and swallow them with a little water, 1 hour before meals.

The recommended dose is:

Adults and adolescents from 12years:

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 calledHelicobacter pyloriin patients with stomach and/or duodenal ulcers in combination with twoantibiotics(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 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 leaflets of the antibiotics.

The treatment duration 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 duration for stomach ulcers is usually between 4 and 8 weeks. The treatment duration for duodenal ulcers is usually between 2 and 4 weeks.

For long-term treatment of Zollinger-Ellison syndrome and other conditionsin which there is an increase in gastric 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 you should finish the treatment.

Patients with kidney problems:

If you have kidney problems, you should not take pantoprazole for Helicobacter pylorieradication.

Patients with liver problems:

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

If you have moderate or severe liver problems, you should not take pantoprazole for Helicobacter pylorieradication.

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 ingested. There are no known symptoms of overdose.

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 medicine, 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 immediatelyor contactthe emergency department of the nearest hospital.

• Severe allergic reactions (frequency rare: may affect up to 1 in 1,000 patients): swelling of the tongue and/or throat, difficulty swallowing, hives (urticaria), difficulty breathing, swelling of the face of allergic origin (angioedema/Quincke's edema), severe dizziness with very rapid heartbeats 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, increase in kidney size, sometimes with pain when urinating, and pain in the lower back (severe kidney inflammation), which may possibly cause kidney failure.

Other side effectsare:

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

Benign polyps in the stomach.

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

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 patients.

Alteration or complete loss of taste, vision 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 patients.

Disorientation.

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

Hallucinations, confusion (especially in patients with a history of these symptoms), tingling, pinching, numbness, burning sensation, 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 patients.

Increased liver enzymes.

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

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

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

Reduced platelet count, which could lead to bleeding or more bruising than usual; reduced white blood cell count, which could lead to more frequent infections; abnormal reduction in the balance between red and white blood cell count, 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. Storage of 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.

Blister: Do not store above 30°C.

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

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 40 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, magnesium stearate (vegetal), Opadry II 85F32029 yellow (partially hydrolyzed poly(vinyl alcohol), macrogol/PEG 3350, titanium dioxide (E-171), talc (E-553b), yellow iron oxide (E-172)), 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 40 mg gastro-resistant tablets EFG are available in HDPE bottles or Al/Al blisters of 14, 28, 56 or 500 (clinical packaging) tablets.

Only some package 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 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 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/68076/P_68076.html

QR code at: https://cima.aemps.es/cima/dochtml/p/68076/P_68076.html