RABEPRAZOL CINFA 20 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for theuser

rabeprazole cinfa 20 mg gastro-resistant tabletsEFG

Rabeprazole sodium

Read all of this leaflet carefully before you start taking this medicine, 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 signs of illness 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 thepackage leaflet

1. What is rabeprazole cinfa and what is it used for
2. What you need to know before you take rabeprazole cinfa
3. How to take rabeprazole cinfa
4. Possible side effects
5. Storing rabeprazole cinfa
6. Package contents and further information

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

Rabeprazole cinfa contains the active ingredient rabeprazole sodium. Rabeprazole belongs to a class of medicines known as “Proton Pump Inhibitors” (PPIs), which work by reducing the amount of acid produced by the stomach.

Rabeprazole is used to treat:

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

• Stomach ulcers or ulcers in the upper part of the intestine (duodenal). If these ulcers are infected with a bacterium called “Helicobacter pylori” (H. pylori), you will need to take antibiotics. Taking rabeprazole and antibiotics together will get rid of the infection and the ulcer will heal. It will also stop the infection and the ulcer from coming back.

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

2. What you need to know before you take rabeprazole cinfa

Do not take rabeprazole cinfa

• If you are allergic to rabeprazole sodium or 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 breast-feeding.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take rabeprazole cinfa

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

• If liver and blood problems have been seen in some patients but often improve when treatment with rabeprazole is stopped.
• 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 stores or have risk factors associated with a reduced amount of B12 and are receiving long-term treatment with rabeprazole sodium. As with all acid-reducing agents, rabeprazole sodium may lead to reduced absorption of vitamin B12.

• If you have ever had a skin reaction after treatment with a medicine similar to rabeprazole to reduce stomach acid.
• If you get a skin rash, especially in areas of skin exposed to the sun, consult your doctor as soon as possible, as you may need to stop treatment with rabeprazole. Remember to mention any other symptoms that you notice, such as joint pain.
• If you are scheduled to have a specific blood test (Chromogranin A).

If you are unsure about any of the above, consult your doctor or pharmacist before taking rabeprazole.

During treatment with rabeprazole, kidney inflammation can occur. The signs and symptoms include: decreased urine volume or blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. You should report these signs to your doctor.

Children

Rabeprazole should not be given to children.

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

Taking a proton pump inhibitor like rabeprazole, especially for more than one year, may slightly increase the risk of fracture 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 rabeprazole cinfa with othermedicines

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

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

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

• Atazanavir, a medicine used to treat HIV infection. Rabeprazole may decrease the amount of this type of medicine in your 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 stop your treatment with rabeprazole temporarily.

If you are unsure about any of the above, consult your doctor or pharmacist before taking rabeprazole.

Taking rabeprazole cinfa with food anddrinks

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

Pregnancy,breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

• Do not take rabeprazole if you are pregnant or if you think you may be pregnant.
• Do not take rabeprazole during breast-feeding or if you plan to start breast-feeding.

Driving and usingmachines

Rabeprazole is unlikely to affect your ability to drive or use machines. However, if you feel drowsy, avoid driving or using machines.

Rabeprazole cinfa contains sodium

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

3. How to take rabeprazole cinfa

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Taking this medicine

• Only remove a tablet from the blister when it is time to take your medicine.
• 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 for how long, depending on your condition.
• If you are taking this medicine for a long time, your doctor will want to monitor you.

Adults and elderly patients

For “gastroesophageal reflux disease” (GORD)

Treatment of moderate to severe symptoms (symptomatic GORD)

The recommended dose is one 10 mg rabeprazole tablet once a day for up to 4 weeks

• Take the tablet in the morning before eating
• If your symptoms come back after 4 weeks of treatment, your doctor will tell you to take one 10 mg rabeprazole tablet when you need it (“on demand”)

Treatment of more severe symptoms (erosive or ulcerative GORD)

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

Long-term treatment of symptoms (GORD maintenance)

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

For stomach ulcers (peptic ulcers)

• The recommended dose is one 20 mg rabeprazole tablet 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 20 mg rabeprazole tablet 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 recurrence

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

For more information on the other medicines used to treat H. pylori, read the package leaflets for each of them.

Zollinger-Ellison syndrome wherethere is excess acid in the stomach

• The recommended dose is three 20 mg rabeprazole tablets 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 and symptom review

Patients with liver problems.Your doctor will be particularly careful when starting 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 a hospital immediately. Take the medicine with you.

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 taken.

If you forget to take rabeprazole cinfa

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

• Do not take a double dose to make up for missed doses.

If you stop taking rabeprazole cinfa

Relief of symptoms usually occurs before the ulcer is completely healed. It is important that you do not stop treatment until your doctor tells you to.

If you have any further questions about 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.

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

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

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

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

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

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

Other possible side effects:

Common (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 (nausea), being sick (vomiting), or constipation
• Pain or back pain
• Weakness or flu-like symptoms
• Benign polyps in the stomach.

Uncommon (may affect up to 1 in 100 patients)

• Feeling nervous or drowsy
• Chest infection (bronchitis)
• Sinusitis (painful sinuses)
• Dry mouth
• Indigestion or belching
• Skin rash or redness
• Muscle, leg, or joint pain
• Fractures in the hip, wrist, and spine
• Urinary tract infection (infection of the bladder)
• Chest pain
• Chills or fever
• Changes in liver function (shown in blood tests)

Rare (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 disorder or stomach pain
• Liver problems, including yellowing of the skin and whites of the eyes (jaundice)
• Itchy rash or blisters
• Sweating
• Kidney problems
• Weight gain
• Changes in white blood cells (shown in blood tests) that can cause frequent infections
• Decreased platelet count that can cause bleeding or bruising more easily than normal

Frequency not known (cannot be estimated from the available data)

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

If you take rabeprazole for more than three months, it is possible that your magnesium levels in the blood may decrease. Low magnesium levels can cause tiredness, muscle contractions, disorientation, convulsions, dizziness, and increased heart rate. If you have any of these symptoms, please inform your doctor immediately. Low magnesium levels can also lead to a decrease 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 of side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them 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. Storing rabeprazole cinfa

Keep this medicine out of the sight and reach of children.

Do not store above 25°C.

Store in the original package.

Do not use this medicine after the expiry date which is stated on the packaging after “EXP”. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicine to a pharmacy for disposal. If you are unsure, ask your pharmacist how to dispose of the containers and any unused medicine. This will help protect the environment.

6. Packaging Content and Additional Information

Composition of Rabeprazole Cinfa

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

Core of the tablet: 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), yellow iron oxide (E-172).

Appearance of the Product and Packaging Content

Rabeprazole Cinfa is presented in the form of yellow, biconvex, film-coated tablets with a 2 on one of the tablet faces. Each package contains 14, 28, 56, or 120 (clinical package) tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing authorization holder

Cinfa Laboratories, S.A.

Olaz-Chipi Road, 10 – Areta Industrial Estate

31620 Huarte (Navarra) - Spain

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

Date of the Last Revision of this Prospectus:September 2022

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/72744/P_72744.html

QR code at: https://cima.aemps.es/cima/dochtml/p/72744/P_72744.html