Rabeprazole Cinfa 20 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

rabeprazol cinfa 20 mg gastro-resistant tablets EFG

Sodium rabeprazole

Read the entire 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 pass it on to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What rabeprazol cinfa is and what it is used for
2. What you need to know before taking rabeprazol cinfa
3. How to take rabeprazol cinfa
4. Possible side effects
5. How to store rabeprazol cinfa
6. Contents of the pack and other information

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

rabeprazole cinfa contains the active ingredient sodium rabeprazole. 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 for the treatment of:

• Gastroesophageal reflux disease (GERD), which may include symptoms of heartburn. GERD is caused by the backflow of acid and food from the stomach into the esophagus.

• Stomach ulcers or ulcers in the upper part of the intestine (duodenal ulcers). If these ulcers are infected with a bacterium called "Helicobacter pylori" (H. pylori), antibiotic treatment will be required. Taking rabeprazole together with antibiotics eradicates the infection and allows the ulcer to heal. This also prevents recurrence of the infection and ulcer.

• Zollinger-Ellison syndrome, a condition characterized by excessive production of acid in the stomach.

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

Do not take rabeprazole cinfa

• If you are allergic to sodium rabeprazole 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 breastfeeding.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take rabeprazole cinfa

• If you are allergic to proton pump inhibitors or to "substituted benzimidazole compounds".

• If liver or blood disorders have been observed in some patients, although these often improve when rabeprazole treatment is discontinued.

• If you have a stomach tumour.

• If you have ever had liver problems.

• If you are taking atazanavir, a medicine for HIV infection.

• If you have reduced body stores or risk factors associated with low levels of vitamin B12 and are receiving long-term treatment with sodium rabeprazole. Like all agents that reduce acidity, sodium rabeprazole may lead to reduced absorption of vitamin B12.

• If you have ever had a skin reaction after treatment with a medicine similar to rabeprazole for reducing stomach acidity.

• If you develop a skin rash, especially in areas of skin exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with rabeprazole. 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).

If you have any doubts about whether the above applies to you, consult your doctor or pharmacist before taking rabeprazole.

During treatment with rabeprazole, kidney inflammation may occur. Signs and symptoms may 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 diarrhoea (watery or bloody) with symptoms such as fever, abdominal pain or tenderness, stop taking rabeprazole and see your doctor immediately.

Taking a proton pump inhibitor such as rabeprazole, especially for more than one year, may slightly increase the risk of fracture of the hip, wrist or spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

Taking rabeprazole cinfa with other medicines

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

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

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

• Atazanavir, a medicine used to treat HIV infection. Rabeprazole may reduce blood levels of this medicine and therefore 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 rabeprazole treatment.

If you have any doubts about whether the above applies to you, consult your doctor or pharmacist before taking rabeprazole.

Taking rabeprazole cinfa with food and drinks

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

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Driving and using machines

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

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 exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

How to take this medicine

• Only remove a tablet from the blister pack when it is time to take your medicine.
• Swallow the tablet whole with some water. Do not crush or chew the tablet.
• Your doctor will tell you how many tablets you should take and how long your treatment should last, 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" (GERD)

Treatment of moderate to severe symptoms (symptomatic GERD)

The usual recommended dose is one

rabeprazole 10 mg tablet once daily for up to 4 weeks.

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

Treatment of more severe symptoms (erosive or ulcerative GERD)

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

Long-term treatment of symptoms (maintenance of GERD)

• The recommended dose is one rabeprazole 10 mg or 20 mg tablet once daily for as long as your doctor has instructed.
• Take the tablet in the morning before eating.
• Your doctor will want to see you regularly to check your symptoms and dosage.

For stomach ulcers (peptic ulcers)

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

For intestinal ulcers (duodenal ulcers)

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

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

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

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

Zollinger-Ellison syndrome, in which excess stomach acid is produced

• The recommended dose is three rabeprazole 20 mg tablets once daily initially.
• The dose may be adjusted by your doctor depending on your response to treatment. If you are on long-term treatment, you will need regular check-ups with your doctor to review your dose and symptoms.

Patients with liver problems. Consult your doctor, who will exercise special caution when starting and during treatment with rabeprazole.

If you take more rabeprazole cinfa than you should

If you take more rabeprazole than you should, speak to your doctor or go to a hospital immediately. Take the medicine with you.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take rabeprazole cinfa

• If you forget to take a tablet, take one as soon as you remember, 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 have forgotten 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 a missed dose.

If you stop taking rabeprazole cinfa

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

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Adverse effects are usually mild and improve without you needing to stop treatment.

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

• Allergic reactions – signs may include: sudden swelling of the face, difficulty breathing, or low blood pressure which may 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 adverse effects are rare (may affect up to 1 in 1,000 patients):

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

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

Other possible adverse effects:

Common (may affect up to 1 in 10 patients)

• Infections
• Difficulty sleeping
• Headache or dizziness
• Cough, runny nose or sore throat (pharyngitis)
• Stomach or intestinal problems such as stomach pain, diarrhoea, gas (flatulence), feeling sick (nausea), being sick (vomiting), or constipation
• Aches or back pain
• Weakness or flu-like symptoms (pseudoinfluenza)
• Benign polyps in the stomach.

Uncommon (may affect up to 1 in 100 patients)

• Feeling nervous or drowsy
• Chest infection (bronchitis)
• Painful and blocked sinuses (sinusitis)
• Dry mouth
• Indigestion or burping
• Skin rash or redness
• Muscle, leg or joint pain
• Fractures in the hip, wrist or spine
• Bladder infection (urinary tract infection)
• 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 disturbances
• Stomach disorder or stomach pain
• Liver problems including yellowing of the skin and whites of the eyes (jaundice)
• Itchy rash or blistering
• Sweating
• Kidney problems
• Weight gain
• Changes in white blood cells (shown in blood tests) which may lead to frequent infections
• Decreased blood platelets which may cause bleeding or bruising more easily than normal

Frequency not known (cannot be estimated from available data)

• Breast enlargement in men
• Fluid retention
• Inflammation of the intestine (leading to diarrhoea)
• Low levels of sodium in the blood which may cause tiredness and confusion, muscle spasms, seizures 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, your blood magnesium levels may decrease. Low magnesium levels may present as tiredness, involuntary muscle contractions, disorientation, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, please inform your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor may decide to carry out periodic blood tests to monitor your magnesium levels.

Do not be alarmed by this list of adverse effects. You may not experience any of them.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of rabeprazole cinfa

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

Do not store above 25°C.

Store in the original packaging.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of rabeprazolcinfa

• The active substance is sodium rabeprazole.
• 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), yellow iron oxide (E-172).

Appearance of the product and contents of the pack

rabeprazol cinfa is presented as yellow, biconvex coated tablets, with the number "2" on one side of the tablet. Each pack contains 14, 28, 56, or 120 tablets (hospital pack).

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10 – Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer:

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10 – Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

LICONSA, S.A.

Avda. Miralcampo, Nº 7,

Pol. Ind. Miralcampo

(Azuqueca de Henares (Guadalajara))

19200 - Spain

Date of the most recent review of this summary: September 2022

Detailed information on this medicinal product 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 up-to-date information on this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/72744/P_72744.html

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