Rabeprazole Combix 20 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Rabeprazol Combix 20 mg gastro-resistant tablets EFG

Rabeprazole sodium

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, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it 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, pharmacist, or nurse, even if these effects are not listed in this leaflet. See section 4.

Leaflet contents

1. What Rabeprazol Combix 20 mg gastro-resistant tablets are and what they are used for
2. What you need to know before taking Rabeprazol Combix 20 mg gastro-resistant tablets
3. How to take Rabeprazol Combix 20 mg gastro-resistant tablets
4. Possible side effects
5. How to store Rabeprazol Combix 20 mg gastro-resistant tablets
6. Contents of the pack and other information

1. What Rabeprazol Combix 20 mg enteric-coated tablets are and what they are used for

Rabeprazol Combix 20 mg contains the active ingredient sodium rabeprazole. Rabeprazol Combix belongs to a class of medicines known as "Proton Pump Inhibitors" (PPIs), which work by reducing the amount of acid produced by the stomach.

Rabeprazol Combix tablets are used for the treatment of:

• Gastroesophageal reflux disease (GERD), which may include heartburn. GERD is caused by stomach acid and food flowing back 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 Rabeprazol Combix together with antibiotics will eliminate the infection and allow the ulcer to heal. It will also prevent recurrence of the infection and ulcer.
• Zollinger-Ellison syndrome, a condition characterized by excessive production of stomach acid.

2. What you need to know before starting to take Rabeprazol Combix 20 mg gastro-resistant tablets

Do not take Rabeprazol Combix 20 mg

• if you are allergic (hypersensitive) to sodium rabeprazole or to any of the excipients in Rabeprazol Combix (see list in section 6).
• if you are pregnant or think you may be pregnant.
• if you are breastfeeding.

Do not take Rabeprazol Combix if any of the above apply to you. If you are unsure, consult your doctor or pharmacist before taking Rabeprazol Combix.

See also the section on Pregnancy and breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before taking Rabeprazol Combix:

• if you have ever had a skin reaction after treatment with a medicine similar to Rabeprazol Combix used to reduce 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 Rabeprazol Combix. Remember to mention any other symptoms you may notice, such as joint pain.

• if you are allergic to proton pump inhibitors or to "substituted benzimidazole compounds".
• liver and blood-related problems have been observed in some patients, but these often improve when treatment with Rabeprazol Combix 10 mg is discontinued.
• if you have a stomach tumor.
• if you have ever had liver problems.
• if you are taking atazanavir, a medicine for HIV/AIDS.
• if you are scheduled to have a specific blood test (chromogranin A).
• during treatment with rabeprazole, inflammation of the kidney may occur. Signs and symptoms include: reduced urine volume or blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. You must report these signs to your doctor.

If you are unsure whether any of the above apply to you, consult your doctor or pharmacist before taking Rabeprazol Combix.

If you experience severe diarrhoea (watery or bloody) with symptoms such as fever, abdominal pain or tenderness, stop taking Rabeprazol Combix and see your doctor immediately.

Children

Rabeprazol Combix should not be given to children.

Interaction of Rabeprazol Combix with other medicines

Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription, as well as herbal remedies.

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

• Ketoconazole or itraconazole, medicines used to treat fungal infections. Rabeprazol Combix may reduce the blood levels of these medicines. Your doctor may need to adjust your dose.
• Atazanavir, a medicine used to treat HIV/AIDS. Rabeprazol Combix may reduce blood levels of this medicine and therefore should not be used together.

If you are unsure whether any of the above apply to you, consult your doctor or pharmacist before taking Rabeprazol Combix.

Pregnancy and breastfeeding

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

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.

Driving and use of machines

You may feel drowsy while taking Rabeprazol Combix. If this occurs, do not drive or operate tools or machinery.

3. How to take Rabeprazol Combix 20 mg gastro-resistant tablets

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor again.

Taking this medicine

• Only remove a tablet from the blister pack 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 you should take and the duration of your treatment, which will depend 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 dose is one Rabeprazol Combix 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 Rabeprazol Combix 10 mg tablet as needed ("on-demand").

Treatment of more severe symptoms (erosive or ulcerative GERD)

• The usual dose is one Rabeprazol Combix 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 usual dose is one Rabeprazol Combix 10 mg or 20 mg tablet once daily 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 dosage.

For stomach ulcers (peptic ulcers)

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

For intestinal ulcers (duodenal ulcers)

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

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

• The usual dose is one Rabeprazol Combix 20 mg tablet twice daily for 7 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 usual starting dose is three Rabeprazol Combix 20 mg tablets once daily.
• Your doctor may adjust the dose depending on your response to treatment. If you are on long-term treatment, you will need to see your doctor at regular intervals to review your dose and symptoms.

Use in children

This medicine must not be given to children.

Patients with liver problems

Consult your doctor, who will exercise special caution when starting and during treatment with Rabeprazol Combix.

If you take more Rabeprazol Combix than you should

If you take more Rabeprazol Combix 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 the Toxicology Information Service (Telephone: 91 5620420).

If you forget to take Rabeprazol Combix

• 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 with your regular schedule.
• If you have missed taking your medicine for more than 5 days, consult your doctor before taking any more medicine.
• Do not take a double dose (two doses at the same time) to make up for a missed dose.

If you stop taking Rabeprazol Combix

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 product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Rabeprazol Combix may cause adverse effects, although not everyone experiences them. Adverse effects are usually mild and improve without you needing to stop treatment.

Stop taking Rabeprazol Combix 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 that may cause fainting or collapse.
• Frequent infections, such as sore throat or high temperature (fever), or ulcers in your mouth or throat.
• Bruising or bleeding easily. These adverse effects are rare (affect fewer than 1 in 1,000 people).
• Severe blisters on the skin, or sores or ulcers in your mouth and throat.

These adverse effects are very rare (affect fewer than 1 in 10,000 people).

Other possible adverse effects:

Frequent (affect fewer than 1 in 10 people)

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

Uncommon (affect fewer than 1 in 100 people)

• 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.
• Bladder infection (urinary tract infection).
• Chest pain.
• Chills or fever.
• Changes in liver function (shown in blood tests).
• Fractures of the hip, wrist, and spine.

Rare (affect fewer than 1 in 1,000 people)

• 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 blisters.
• Sweating.
• Kidney problems.
• Weight gain.
• Changes in white blood cells (shown in blood tests) which may lead to frequent infections.
• Decrease in blood platelets which may cause bleeding or bruising more easily than normal.

Other possible adverse effects (frequency not known)

• Breast swelling in men.
• Fluid retention.
• 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 (a brain disorder).
• If you are taking Rabeprazol Combix for more than three months, your blood magnesium levels may decrease. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels may also lead to decreased levels of potassium and calcium in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.
• If you are taking proton pump inhibitors such as Rabeprazol Combix, especially for more than one year, there may be a slight increase in the risk of fractures of the hip, wrist, and spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).
• Skin rash, possibly with joint pain.
• Inflammation of the intestine (leading to diarrhoea).

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 Rabeprazol Combix 20 mg gastro-resistant tablets

Keep out of the reach and sight of children. Do not store above 25°C. Keep in the outer packaging to protect from moisture.

Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of Rabeprazol Combix 20 mg

The active substance is sodium rabeprazole. Each tablet contains 20 mg of sodium rabeprazole (equivalent to 18.85 mg of rabeprazole).

The other components are: core: povidone, mannitol (E421), light magnesium oxide, low-substituted hydroxypropyl cellulose, magnesium stearate; coating: ethyl cellulose, light magnesium oxide; gastro-resistant coating: methacrylic acid-ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate, propylene glycol, talc, red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171).

Appearance of the product and contents of the pack

Rabeprazol Combix 20 mg is presented as yellow enteric-coated (gastro-resistant) tablets in packs containing aluminum blisters with tablets housed in individual alveoli.

Rabeprazol Combix tablets are available in blisters containing 14 or 28 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Balkanpharma Dupnitsa Ad

3 Samokovsko Shosse Str.

Dupnitsa

Bulgaria

Date of the most recent revision of this leaflet: October 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es.