Package Leaflet: Information for the User

rabeprazol cinfa 10 mg gastro-resistant tabletsEFG

Rabeprazol 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

rabeprazol cinfa contains the active ingredient rabeprazol sodium. Rabeprazol belongs to a class of medications known as “Proton Pump Inhibitors” (PPIs), which act by reducing the amount of acid produced by the stomach.

rabeprazol is used for the treatment of:

• “Gastroesophageal reflux disease” (GERD), which may include the appearance of acid reflux. The cause of GERD is the passage of acid and food from the stomach into the esophagus.

• Stomach ulcers or ulcers of the upper part of the small intestine (duodenal ulcers). If these ulcers are infected with a bacteria called “Helycobacter pylori” (H.pylori), you will need to take antibiotics. Taking rabeprazol and antibiotics together will eliminate the infection and the ulcer will heal. It will also prevent the infection and the recurrence of the ulcer.

• Zollinger-Ellison syndrome, a disease characterized by the production of very high amounts of acid in the stomach.

Do not take rabeprazol cinfa

-If you are allergic to rabeprazol sodium or to any of the other ingredients of this medicine (listed in section 6).

• If you are pregnant or think you may be pregnant.
• If you are breastfeeding.

Do not take rabeprazol if you are in any of the above situations. If you are unsure, consult your doctor or pharmacist before taking rabeprazol.

Warnings and precautions

Consult your doctor or pharmacist before starting to take rabeprazol cinfa

• If you are allergic to proton pump inhibitors or to “substituted benzimidazoles”.

• If you have seen liver and blood problems in some patients but often improve when the treatment with rabeprazol is interrupted.
• If you have a stomach tumor.
• If you have ever had liver problems.
• If you are taking atazanavir, a medicine for HIV infection.
• If you have reduced body reserves or have risk factors associated with a reduced amount of B12 and are receiving long-term treatment with rabeprazol sodium. Like all acid-reducing agents, rabeprazol sodium can lead to reduced B12 absorption.

• If you have ever had a skin reaction after treatment with a similar medicine to rabeprazol for reducing stomach acid.
• If you suffer from a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to interrupt treatment with rabeprazol. 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).

If you have doubts about whether the above affects you, consult your doctor or pharmacist before taking rabeprazol.

During treatment with rabeprazol, inflammation in your kidneys may occur. Among the signs and symptoms are: decreased urine volume or blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. You must notify these signs to your doctor.

Children

Rabeprazol should not be administered to children.

If you experience severe diarrhea (watery or bloody) with symptoms such as fever, abdominal pain, or sensitivity, stop taking rabeprazol and see your doctor immediately.

Taking a proton pump inhibitor like rabeprazol, especially for a period of more than a year, may slightly increase the risk of fractures in the hip, wrist, or spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

Taking rabeprazol cinfa with other medicines

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

Particularly, inform your doctor or pharmacist if you are taking any of the following medicines:

• Ketoconazole or itraconazole, medicines for fungal infections. Rabeprazol may reduce the amount of these medicines in the blood. Your doctor may need to adjust your dose.

• Atazanavir, a medicine used to treat HIV infection. Rabeprazol may reduce the amount of this type of medicine in the blood, so they should not be used together.
• Methotrexate (a chemotherapy medicine used at high doses to treat cancer) – if you are taking a high dose of methotrexate, your doctor may temporarily stop your treatment with rabeprazol.

If you have doubts about whether the above affects you, consult your doctor or pharmacist before taking rabeprazol.

Taking rabeprazol cinfa with food and drinks

The tablets should be swallowed with a little water. If a daily treatment is required, the tablets should be taken preferably before breakfast.

Pregnancy, breastfeeding, and fertility

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.

• Do not take rabeprazol if you are pregnant or think you may be pregnant.
• Do not take rabeprazol during breastfeeding or if you plan to start breastfeeding.

Driving and operating machines

It is unlikely that rabeprazol will affect your ability to drive or operate machinery.However, if you feel drowsy, avoid driving oroperatingmachinery.

Rabeprazol cinfa contains sodium.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially “sodium-free”.

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

Medication intake

• Only take one tablet out of the blister pack when it's time to take your medication.
• Swallow the tablet whole with a little water. Do not crush or chew the tablet.
• Your doctor will tell you how many tablets to take and the duration of your treatment, which will depend on your indication.
• If you are taking this medication for a long time, your doctor will want to monitor you.

Adults and elderly patients

Gastroesophageal reflux disease (GERD)

Symptomatic treatment of moderate to severe symptoms (GERD symptomatic)

The usual recommended dose is one

tablet of rabeprazole 10 mg once a day for up to 4 weeks

• Take the tablet in the morning before eating
• If your symptoms reappear after 4 weeks of treatment, your doctor will tell you to take a tablet of rabeprazole 10 mg as needed ("on demand")

Treatment of more severe symptoms (GERD erosive or ulcerative)

• The recommended dose is one tablet of rabeprazole 20 mg once a day for 4 to 8 weeks
• Take the tablet in the morning before eating

Maintenance treatment of symptoms (GERD maintenance)

• The recommended dose is one tablet of rabeprazole 10 mg or 20 mg once a day for as long as your doctor has indicated
• Take the tablet in the morning before eating
• Your doctor will want to see you at regular intervals to check your symptoms and the dose

For stomach ulcers (peptic ulcers)

• The recommended dose is one tablet of rabeprazole 20 mg once a day for 6 weeks
• Take the tablet in the morning before eating
• Your doctor may tell you to take rabeprazole for another 6 weeks if your symptoms do not improve.

For duodenal ulcers

• The recommended dose is one tablet of rabeprazole 20 mg once a day for 4 weeks
• Take the tablet in the morning before eating
• Your doctor may tell you to take rabeprazole for another 4 weeks if your symptoms do not improve

For ulcers caused by H. pylori infection and to prevent recurrences

• The recommended dose is one tablet of rabeprazole 20 mg twice a day for 7 days
• Your doctor will also tell you to take antibiotics called amoxicillin and clarithromycin

For more information on other medications used to treat H. pylori, read the prospectus for each one.

Zollinger-Ellison syndrome whereexcessive acid is produced in the stomach

• The recommended dose is three tablets of rabeprazole 20 mg once a day initially
• The dose may be adjusted by your doctor depending on how you respond to treatment. If you are on long-term treatment, you will need to see your doctor at regular intervals for dose review and symptom check

Patients with liver problems.Consult your doctor who will have special care in the start and during treatment with rabeprazole.

If you take more rabeprazole cinfa than you should

If you take more rabeprazole than you should, talk to your doctor or go to the hospital immediately. Bring the medication with you.

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.

If you forget to take rabeprazole cinfa

• If you forget to take a tablet, as soon as you remember take one and then continue as usual.
• However, if it is almost time to take the next tablet, simply skip the missed tablet and continue as usual.
• If you forget to take your medication for more than 5 days, consult your doctor before taking more medication

• Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with rabeprazole cinfa

The relief of symptoms usually occurs before the ulcer has healed completely.It is important not to interrupt treatment until your doctor tells you to.

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.

Side effects are usually mild and improve without you stopping treatment.

Stop taking rabeprazol and see your doctor immediately if you notice any of the following side effects – you may need urgent medical treatment:

• Allergic reactions – symptoms may include: sudden swelling of your face, difficulty breathing or low blood pressure that can cause dizziness or collapse
• Frequent infections, such as sore throat or high temperature (fever), or ulcers in your mouth or throat
• Cardenals or easy bleeding.

These side effects are rare (they may affect up to 1 in 1,000 patients)

• Severe blisters on your skin, or sores or ulcers in your mouth and throat.

These side effects are very rare (they may affect up to 1 in 10,000 patients)

Other possible side effects:

Frequent (they may affect up to 1 in 10 patients)

• Infections
• Difficulty sleeping
• Headache or dizziness
• Cough, runny nose or sore throat (pharyngitis)
• Effects on your stomach or intestines such as stomach pain, diarrhea, gas (flatulence), feeling sick (nauseas), being sick (vomiting) or constipation
• Pain or back pain
• Weakness or flu-like symptoms (pseudogripal)
• Benign polyps in the stomach.

Not very frequent (they may affect up to 1 in 100 patients)

• Feeling nervous or drowsy
• Chest infection (bronchitis)
• Blocked and painful sinuses (sinusitis)
• Dry mouth
• Indigestion or belching
• Rash on the skin or redness
• Muscle pain, leg pain or joint pain
• Fractures in the hip, wrist and spine
• Urinary tract infection
• Chest pain
• Chills or fever
• Changes in liver function (shown in blood tests)

Rare (they may affect up to 1 in 1,000 patients)

• Loss of appetite (anorexia)
• Depression
• Hypersensitivity (including allergic reactions)
• Visual disturbances
• Inflamed mouth (stomatitis) or taste disorders
• Stomach problems or stomach pain
• Liver problems that include yellowing of the skin and the white of the eyes (jaundice)
• Eruption with itching or blisters
• Sweating
• Renal problems
• Weight gain
• Changes in white blood cells in the blood (shown in blood tests) that may cause frequent infections
• Decreased platelets in the blood that may cause bleeding or the appearance of bruises with increased ease

Unknown frequency (cannot be estimated from available data)

• Swelling of the breasts in men
• Fluid retention
• Inflammation of the intestine (which leads to diarrhea)
• Low sodium levels in the blood that may cause fatigue and confusion, muscle spasms, convulsions and coma.
• Patients who have previously had liver problems, may develop very rarely a encephalopathy (brain disease)
• Skin rash, possibly with joint pain.

If you take rabeprazol for more than three months, it is possible that your magnesium levels in the blood will decrease. Low magnesium levels may manifest as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you experience any of these symptoms, please inform your doctor immediately. Low magnesium levels may also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.

Do not worry about the list of side effects. You may not experience any of them.

Reporting 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 prospectus. You can also report them directly through the Spanish System for 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 store at a temperature above 25°C.

Store in the original packaging.

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.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at 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.

Rabeprazole cinfa composition

• The active ingredient is rabeprazole sodium.
• The other components are:

Tablet core: Mannitol, magnesium oxide (E-530), hydroxypropylcellulose (E-463), magnesium stearate (E-470b).

Intermediate coating: Ethylcellulose, magnesium oxide (E-530).

Enteric coating: Hypromellose phthalate, dibutyl sebacate, talc, titanium dioxide (E-171), iron oxide red (E-172).

Product appearance and packaging contents

Rabeprazole cinfais presented in the form of pink, biconvex coated tablets with a 1 on one of the tablet faces. Each package contains 14, 28 or 120 (clinical package) tablets.

Only some package sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Cinfa Laboratories, S.A.

Olaz-Chipi Road, 10. Areta Industrial Estate

31620 Huarte (Navarra)- Spain

Responsible manufacturer

Cinfa Laboratories, S.A.

Olaz-Chipi Road, 10. Areta Industrial Estate

31620 Huarte (Navarra)- Spain

LICONSA, S.A.

Miralcampo Avenue, Nº 7,

Miralcampo Industrial Estate

(Azuqueca de Henares (Guadalajara))

- 19200 –

Spain

Last review date of this leaflet:September 2022

Detailed information about 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 the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet addresshttps://cima.aemps.es/cima/dochtml/p/72745/P_72745.html

QR code to:https://cima.aemps.es/cima/dochtml/p/72745/P_72745.html