Package Leaflet: Information for the User

pantoprazol cinfa 20 mg gastro-resistant tablets EFG

Pantoprazole sodium

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 questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do 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.

pantoprazol cinfa contains the active ingredient pantoprazol. Pantoprazol is a selective proton pump inhibitor, a medication that reduces the amount of acid produced in the stomach. It is used for the treatment of diseases related to stomach and intestinal acid.

pantoprazol cinfa is used for:

Adults and adolescents aged 12 years and above:

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

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

Adults:

Prevention of nonsteroidal anti-inflammatory drug (NSAID)-induced gastroduodenal ulcers in patients at risk who require continued treatment with this type of medication.

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.

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 need to take NSAIDs continuously and take pantoprazol, as there is a higher risk of developing complications in the stomach and intestines. Any increased risk will be evaluated based on individual risk factors such as age (65 years or older), history of stomach or duodenal ulcers, or gastrointestinal bleeding.
• If you have reduced vitamin B12 reserves or risk factors for it and receive pantoprazol treatment for a long period. Like all medications that reduce acid production, pantoprazol 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 pantoprazol.
• Taking a proton pump inhibitor like pantoprazol, 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 (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 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 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 pantoprazol treatment. Remember to mention any other symptoms you notice, such as joint pain.
• If you are scheduled to have a specific blood test (Cromogranin A).

Inform your doctor immediatelybefore 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 vomit: may appear as a dark brown powder in your vomit
• Blood in 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 cancer, as pantoprazol may alleviate cancer symptoms and potentially delay diagnosis. If your symptoms persist despite treatment, further investigations 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 doctor of 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 to treat fungal infections) or erlotinib (used to treat certain types of cancer), as pantoprazol may make these and other medications less effective.
• Warfarin and phenprocoumon, which affect blood clotting. You may need additional monitoring.
• Medications 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 pantoprazol treatment, as pantoprazol may increase methotrexate levels in the 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, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

There is insufficient data on the use of pantoprazol in pregnant women. Pantoprazol has been reported to be excreted in human breast milk.

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 machinery

Pantoprazol has no influence or insignificant influence on the ability to drive or operate machinery.

You should not drive or operate machinery 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 certain sugars, consult with them before taking this medication.

pantoprazol cinfa contains sodium

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

Follow exactly the administration instructions of this medication as 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 breaking them and swallow them with a little water, 1 hour before meals.

The recommended dose is:

Adults and adolescents 12 years and older

For treating symptoms associated with gastroesophageal reflux disease (stomach burning, acid regurgitation, difficulty swallowing)

The recommended dose is 1 tablet per day.

This dose usually provides relief within 2-4 weeks and if not, at most, within 4 weeks thereafter. Your doctor will tell you how long you should continue taking the medication. Subsequently, any recurring symptom can be controlled as needed, by taking 1 tablet per day.

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

The recommended dose is 1 tablet per day. If the disease reappears, your doctor may double the dose, in which case you can take pantoprazole 40 mg, once a day. After healing, you can reduce the dose again to 1 tablet of 20 mg per day.

Adults

For preventing duodenal and stomach ulcers in patients requiring continued treatment with NSAIDs

The usual dose is 1 tablet per day.

Patients with liver problems

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

Use in children and adolescents

These tablets are not recommended for use in children under 12 years old.

If you take more pantoprazole cinfa than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

No symptoms of overdose are known.

If you forgot to take pantoprazole cinfa

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

If you interrupt the treatment with pantoprazole cinfa

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.

If you experience any of the following side effects, stop taking these tablets and inform your doctor immediately, or contact the hospital's emergency service nearest to you:

• Severe allergic reactions(rare; may affect up to 1 in 1,000 patients)): 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 unknown: cannot be estimated from available data)):You may notice one or more of the following effects: blisters on the skin and rapid deterioration of overall condition, erosion (including mild bleeding) of the eyes, nose, mouth/lips, or genitals, or skin sensitivity/eruption, particularly in areas of exposed skin to light/sun. 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 cutaneous lupus erythematosus, pharmacological reaction with eosinophilia and systemic symptoms (DRESS), photosensitivity).

• Other serious conditions(frequency unknown: cannot be estimated from available data)):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), which may lead to kidney failure.

Other side effects are:

• Frequent:mayaffect up to 1 in 10 patients.

Benign polyps in the stomach.

• Infrequent:mayaffect 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, rash; tingling; feeling of weakness, fatigue, or general discomfort; sleep disturbances, hip fracture, wrist fracture, and spinal column fracture.

• Rare:mayaffect up to 1 in 1,000 patients.

Alteration or complete loss 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:mayaffect 1 in 10,000 patients.

Disorientation.

• Frequency unknown:cannot be estimated from available data.

Illusion, confusion (especially in patients with a history of these symptoms), sensation of tingling, prickling, paresthesia (tingling), burning, numbness, pinching, numbness, skin rash, possibly with joint pain, inflammatory bowel disease causing persistent watery diarrhea.

Side effects identified through blood tests:

• Infrequent:mayaffect up to 1 in 100 patients.

Increased liver enzymes.

• Rare::mayaffect up to 1 in 1,000 patients.

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

• Very rare:mayaffect 1 in 10,000 patients.

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

• Frequencyunknown(cannot be estimated from available data): reduction in the level of sodium, magnesium, calcium, or potassium in the 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 Medicines 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 after CAD. The expiration date is the last day of the month indicated.

Container: This medication does not require special storage conditions.

Blister: Do not store above 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 pantoprazole cinfa

-The active ingredient is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole (in the form of pantoprazole sesquihydrate sodium).

-The other components (excipients) are: microcrystalline cellulose (E-460i), lactose monohydrate, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate (vegetal), Opadry II 85F32081 yellow (poly (vinyl alcohol) partially hydrolyzed, macrogol/PEG 3350, titanium dioxide (E-171), talc (E-553b), yellow iron oxide (E-172), yellow quinoline aluminum lake (E-104)), acid methacrylic copolymer-acrylic acid ethyl ester (1:1) dispersion 30% (sodium lauryl sulfate, polisorbate 80, acid methacrylic copolymer-acrylic acid ethyl ester), triethyl citrate (E-1505), talc (E-553b).

Appearance of the product and content of the packaging

Yellow to ochre-colored elongated coated tablets.

pantoprazole cinfa 20 mg is presented in packaging of 14, 28, 56 or 504 (clinical packaging) tablets in Al/Al blister or in HDPE bottles of 14, 28 or 56 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 Park Areta

31620 Huarte (Navarra)- Spain.

Date of the last review of this leaflet:October 2021

The detailed information of 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 about this medicine 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/71118/P_71118.html

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