Leaflet: information for the user

pantoprazol cinfa 40 mg gastro-resistant tabletsEFG

Pantoprazole sodium

Read this leaflet carefully before you start taking thismedicine, 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 orpharmacist.

• This medicine has been prescribed for you only and should not be given to others, even if they have thesamesymptoms as you, as it mayharm them.
• If you experience any side effects, consult your doctor orpharmacist, even if they are not listed in this leaflet. See section 4.

pantoprazol cinfa contains the active ingredient pantoprazol. Pantoprazol is a selective proton pump inhibitor, a medicationthatreduces the amount of acid produced in your stomach. It is used for the treatmentofconditions related to stomach acid andintestine.

pantoprazol cinfa is usedfor:

Adults and adolescents aged 12years and above:

• Gastroesophageal reflux esophagitis. It is an inflammation of your esophagus (the tube that connects your throatwithyour stomach) accompanied by regurgitation of acid from thestomach.

Adults:

• Infection caused by a bacteria calledHelicobacter pyloriin patients with stomach and/or duodenal ulcers in combination with two antibiotics (eradication treatment). The goalisto get rid of the bacteria and thus reduce the likelihood of ulcers reappearing.
• Stomach and duodenal ulcers.
• Zollinger-Ellison syndrome and other conditions in which too much acidisproducedinthestomach.

Do not take pantoprazol cinfa

• If you are allergic to pantoprazol or any of the other components of this medication (listed in section 6).
• If you are allergic to medications 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. 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 liver enzyme levels increase, treatment should be interrupted.
• If you have decreased vitamin B12 reserves or risk factors for itandare receiving pantoprazol treatment for a long period of time. Like allmedications that reduce the amount of acid, pantoprazol may reduce the absorptionofvitaminB12.
• 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 fractures of the hips, wrists, 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 (for example, if you are taking corticosteroids).
• If you take pantoprazol for more than three months, you may experience a decrease in magnesium levels in your blood. Symptoms of low magnesium levels may include fatigue, involuntary muscle contractions, disorientation, dizziness, or increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Additionally, low magnesium levels may cause a decrease in potassium and calcium levels in your 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 similar medication to pantoprazol for reducing stomach acid.
• If you experience 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. Remember to mention any other symptoms you may notice, such as joint pain.
• If you are scheduled to have a specific blood test (Cromogranin A).

Inform your doctor immediately, before or after taking this medication, if you notice any of the following symptoms, which may be signs of more serious underlying diseases:

• Unintentional weight loss
• Vomiting, particularly if repeated
• Blood in the vomit: it may appear as a dark brown powder in your vomit
• Noticeable 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 additional testing to rule out a malignant disease, as pantoprazol may alleviate cancer symptoms and potentially delay diagnosis.Ifyour symptoms persist despite treatment, additional explorations will be performed.

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

Children and adolescents

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

Other medications and pantoprazol cinfa

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Pantoprazol may affect the efficacy of other medications, inform your doctor if you are taking:

-Medications such as ketoconazole, itraconazole, and posaconazole (used for fungal infections) or erlotinib (used for certain types of cancer), as pantoprazol may make these and other medications not work correctly.

-Warfarin and phenprocoumon, which affect blood coagulation. You may need additional controls.

-Medications used for HIV infection treatment, such as atazanavir.

-Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer). If you are taking methotrexate, your doctor may temporarily interrupt 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 for treating infections).

-St. John's Wort(Hypericum perforatum)(used to treat mild depression).

Pregnancy and lactation

There is insufficient data on the use of pantoprazol in pregnant women. It has been noted that in humans, pantoprazol is excreted in breast milk. If you are pregnant, breastfeeding, or suspect you may be pregnant, consult your doctor or pharmacist before using this medication.

You should only use this medication if your doctor considers the benefits for you to be greater than the potential risk to the fetus or baby.

Driving and operating machines

Pantoprazol has no influence or insignificant influence 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 cinfa contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking thismedication.

pantoprazol cinfa contains sodium

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

See exactly the administration instructions for this medication indicated by yourdoctoror pharmacist. In case of doubt, consult your doctor or pharmacistagain.

Administration form:

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

The recommended doseis:

Adults and adolescents 12years and older:

For the treatment of esophagitis due toreflux:

The recommended dose is one tablet per day. Your doctor may indicate an increase to2tablets per day. The treatment time for esophagitis due to reflux usually lasts between 4 and 8weeks.Your doctor will indicate for how long you should take thismedicine.

Adults:

For the treatment of an infection with a bacteria calledHelicobacter pyloriinpatients 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 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 leaflets.

The treatment duration is usually 1 to 2weeks.

For the treatment of stomach and duodenal ulcers:

The recommended dose is one tablet per day. The dose may be doubled by yourdoctor.

Your doctor will indicate for 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 normally between 2 and 4weeks.

For long-term treatment of Zollinger-Ellison syndrome and other conditionsinwhich there is an increase in stomach acidsecretion:

The initial recommended dose is two tablets perday.

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 two tablets per day, you should take the tablets divided intotwotimes perday.

If you are prescribed more than four tablets per day, you will be told exactly when tofinishthetreatment.

Patients with kidney problems:

If you have kidney problems, you should nottakepantoprazole for the elimination ofHelicobacterpylori.

Patients with liver problems:

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

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

Use in children and adolescents

This medication is not recommended for use inchildrenunder 12years old.

If you take more pantoprazole cinfa thanyou

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Servicetelephone91 562 04 20, indicating the medication and the amount ingested. No known symptoms of overdose.

If you forgot to take pantoprazolecinfa

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

If you interrupt the treatment with pantoprazolecinfa

Do not stop taking these tablets without consulting your doctor orpharmacist.

If you have any other questions about the use of this medication, ask your doctor orpharmacist.

Like all medicines, this medicine may cause side effects, althoughnotall people willsuffer them.

If you experience any of the following side effects, stop taking these tablets and inform your doctorimmediatelyor contactthe nearest hospital's emergency service.

-Severe allergic reactions(rare frequency:may affect up to 1 in 1,000 patients): swelling of the tongue and/or throat,difficultyswallowing, hives (urticaria), difficulty breathing, swelling of the face ofallergicorigin (Quincke's edema/angioedema), intense dizziness with veryrapidheartbeats and excessive sweating.

-Severe skin alterations(unknown frequency:cannot be estimated from available data): you may notice one or more of the following effects: blisters on the skin and a rapid deterioration of overall conditions, erosion (including mild bleeding) of eyes, nose, mouth/lips or genitals or skin sensitivity/eruption, particularly in areas of skin exposed to light/sun. You may also have 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, Multiform erythema, Acute cutaneous lupus erythematosus, Pharmacological reaction with eosinophilia and systemic symptoms (DRESS), Photosensitivity).

-Other severe conditions(unknown frequency: cannot be estimated from available data):yellowing of the skin andthewhite of the eyes (severe liver cell damage, jaundice), or fever,hives,swollen kidneys sometimes with painful urination and lower back pain (severe kidney inflammation), possibly causing renal failure.

Other side effectsare:

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

Benign polyps in the stomach.

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

Headache; dizziness; diarrhea; sensation of dizziness, vomiting; bloating and flatulence(gas);constipation; dry mouth; abdominal pain and discomfort; hives on the skin,exanthema,eruption; tingling; feeling of weakness, fatigue or general discomfort; sleep disturbances,fracture of the hip, wrist and spine.

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

Alteration or complete absence of taste, visual disturbances such as blurred vision; urticaria; joint pain;muscle pain; weight changes; increased body temperature; high fever; swelling in the extremities(peripheral edema); allergic reactions; depression; gynecomastia in men.

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

Disorientation.

• Unknown frequency:cannot be estimated from available data.

Illusion, confusion (especially in patients with a history of these symptoms), sensation of tingling, pinching, numbness, burning sensation or numbness, skin eruption, possibly with joint pain, intestinal inflammation causing persistent watery diarrhea.

Side effects identified through blood tests:

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

Increased liver enzymes.

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

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

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

Reduced platelet count, which could cause bleeding or more frequent bruising than usual;reduced white blood cell count, which could lead to more frequent infections;abnormal imbalance between the number of red and white blood cells, as well as platelets.

• Unknown frequency(cannot be estimated from available data): reduction of sodium, magnesium, calcium or potassium levels in blood (see section 2).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use: https://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 afterCAD. The expiration date is the last day of the month indicated.

Blister: Do not store at a temperature above 30°C.

Bottle: This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging andmedicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask yourpharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of pantoprazol cinfa

• The active ingredient is pantoprazol. Each gastro-resistant tablet contains 40 mg of pantoprazol (in the form of pantoprazol sódico sesquihidrato).
• The other components (excipients) are: microcrystalline cellulose (E-460i), lactose monohydrate, croscarmelosa sódica, anhydrous colloidal silica, magnesium stearate (vegetal), Opadry II 85F32029 yellow (poly (alcohol) vinílico parcialmente hidrolizado, macrogol/PEG 3350, dióxido de titanio (E-171), talco (E-553b), óxido de hierro amarillo (E-172)), copolímero ácido metacrílico-acrilato de etilo (1:1) dispersión 30% (laurilsulfato de sodio, polisorbato 80, copolímero ácido metacrílico-acrilato de etilo), triethyl citrate (E-1505), talco (E-553b).

Appearance of the product and contents of the packaging

Yellow to ocre-colored elongated coated tablets.

pantoprazol cinfa 40 mg gastro-resistant tablets EFG are presented in HDPE bottles or Al/Al blisters of 14, 28, 56 or 500 (clinical packaging) tablets.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Date of the last review of this leaflet:October 2021

Detailed information about this medication 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 about this medication by scanning with your smartphone the QR code included in the leaflet and packaging. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/68076/P_68076.html

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