RABEPRAZOL COMBIX 10 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the User

Rabeprazol Combix 10 mg Gastro-Resistant Tablets EFG

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, pharmacist, or nurse.
• 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Rabeprazol Combix 10 mg gastro-resistant tablets are and what they are used for
2. What you need to know before you take Rabeprazol Combix 10 mg gastro-resistant tablets
3. How to take Rabeprazol Combix 10 mg gastro-resistant tablets
4. Possible side effects
5. Storage of Rabeprazol Combix 10 mg gastro-resistant tablets
6. Contents of the pack and other information

1. What Rabeprazol Combix 10 mg gastro-resistant tablets are and what they are used for

Rabeprazol Combix 10 mg contains the active ingredient rabeprazole sodium. 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:

• “Gastro-oesophageal reflux disease” (GORD), which may include symptoms of acidity. The cause of GORD is acid and food flowing back up from the stomach into the oesophagus.
• Stomach ulcers or ulcers of the upper part of the intestine (duodenal ulcers). If these ulcers are infected with a bacteria called “Helicobacter pylori” (H. pylori), you will also need to take antibiotics. Taking Rabeprazol Combix 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 where very high amounts of acid are produced in the stomach.

2. What you need to know before you take Rabeprazol Combix 10 mg gastro-resistant tablets

Do not take Rabeprazol Combix 10 mg

• if you are allergic (hypersensitive) to rabeprazole sodium or any of the other ingredients of Rabeprazol Combix (see section 6).
• if you are pregnant or think you may be pregnant.
• if you are breast-feeding.

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

See also the section on Pregnancy and breast-feeding.

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 to reduce stomach acid.

If you get a rash, especially in areas of skin exposed to the sun, tell your doctor as soon as possible, as you may need to stop taking Rabeprazol Combix. Also, remember to mention any other symptoms you notice, such as joint pain.

• if you are allergic to proton pump inhibitors or “substituted benzimidazoles”.
• liver and blood problems have been seen in some patients but often get better when Rabeprazol Combix 10mg is stopped.
• if you have a stomach tumor.
• if you have ever had liver problems.
• if you are taking atazanavir, a medicine for HIV.
• if you are due to have a specific blood test (Chromogranin A).
• during treatment with rabeprazole, kidney inflammation can occur. The signs and symptoms include: decreased urine output or blood in the urine and/or hypersensitivity reactions such as fever, rash, and joint stiffness. You should inform your doctor of these signs.

If you are in doubt about any of the above, consult your doctor or pharmacist before taking Rabeprazol Combix.

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

Children

Should not be given to children.

Interaction of Rabeprazol Combix with other medicines

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

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

• Ketoconazole or itraconazole, medicines for fungal infections. Rabeprazol Combix 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. Rabeprazol Combix may decrease the amount of this type of medicine in your blood, so they should not be used together.

If you are in doubt about any of the above, consult your doctor or pharmacist before taking Rabeprazol Combix.

Pregnancy and breast-feeding

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

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

Driving and using machines

You may feel drowsy while taking Rabeprazol Combix. If this happens, do not drive or use tools or machines.

3. How to take Rabeprazol Combix 10 mg gastro-resistant tablets

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are not sure, ask your doctor 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 the number of tablets to take and the length of your treatment, which will depend on your condition.
• If you are taking this medicine for a long time, your doctor will want to check you.

Adults and elderly patients

For “gastro-oesophageal reflux disease” (GORD)

Treatment of moderate to severe symptoms

• The usual dose is one Rabeprazol Combix 10 mg 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 Rabeprazol Combix 10 mg tablet when needed (“on demand”).

Treatment of more severe symptoms (erosive or ulcerative GORD)

• The usual dose is one Rabeprazol Combix 20 mg 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 usual dose is one Rabeprazol Combix 10 mg or 20 mg 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 usual dose is one Rabeprazol Combix 20 mg tablet once a day for 6 weeks.
• Take the tablet in the morning before eating.
• Your doctor may tell you to take Rabeprazol Combix for another 6 weeks if your symptoms do not improve.

For ulcers of the intestine (duodenal ulcers)

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

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

• The usual dose is one Rabeprazol Combix 20 mg tablet twice a day 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, read the package leaflets for each of them.

Zollinger-Ellison syndrome where there is too much acid in the stomach

• The usual dose is three Rabeprazol Combix 20 mg tablets once a day at the start.
• 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 a review of your dose and symptoms.

Use in children

Should not be given to children.

Patients with liver problems

Ask your doctor who will take special care 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, talk 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, as soon as you remember, take one and then continue as usual. However, if it is almost time for your next tablet, just skip the missed tablet 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 (two doses at the same time) to make up for the missed dose.

If you stop taking Rabeprazol Combix

Relief of symptoms normally 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 on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rabeprazol Combix can cause side effects, although not everybody gets them. Side effects are usually mild and improve without you stopping the treatment.

Stop taking Rabeprazol Combix and see your doctor immediately if you notice any of the following serious 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 which may cause dizziness or fainting.
• Frequent infections, such as sore throat or high temperature (fever), or ulcers in your mouth or throat.
• Bruising or bleeding easily. These side effects are rare (affect less than 1 in 1,000 people).
• Severe skin blisters or rash, or sores in your mouth and throat.

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

Other possible side effects:

Common (affect less than 1 in 10 people)

• 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 (affect less than 1 in 100 people)

• Feeling nervous or sleepy.
• Chest infection (bronchitis).
• Painful sinuses (sinusitis).
• Dry mouth.
• Indigestion or belching.
• Rash or redness of the skin.
• Muscle pain, leg pain, or joint pain.
• Bladder infection (urinary tract infection).
• Chest pain.
• Chills or fever.
• Changes in liver function (shown in blood tests).
• Fracture of the hip, wrist, and spine

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

• Lack of appetite (anorexia)
• Depression.
• Hypersensitivity (including allergic reactions).
• Vision problems.
• Inflamed mouth (stomatitis) or taste problems.
• Stomach problems or stomach pain.
• Liver problems including yellowing of the skin and the 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 lead to bleeding or bruising more easily than usual.

Other possible side effects (frequency not known)

• Enlargement of the breasts in men.
• Fluid retention.
• Low levels of sodium in the blood which can cause tiredness and confusion, muscle cramps, convulsions, and coma.
• Patients who have previously had liver problems may very rarely develop a brain disease (encephalopathy).
• if you are taking Rabeprazol Combix for more than three months, it is possible that your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you have any of these symptoms, go to your doctor immediately. Low magnesium levels can also lead to a decrease in blood potassium and calcium levels. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.
• If you are taking proton pump inhibitors like Rabeprazol Combix, especially for a period of more than one year, you may slightly increase the risk of fracture of the hip, wrist, and spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).
• Skin rash, possibly with joint pain.
• Inflammation of the intestine (leading to diarrhea).

Do not worry about this list of side effects. You may not get any of them.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Rabeprazol Combix 10 mg gastro-resistant tablets

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

Do not use this medicine after the expiry date which is stated on the carton. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rabeprazol Combix 10 mg

The active substance is rabeprazole sodium. Each tablet contains 10 mg of rabeprazole sodium (equivalent to 9.42 mg of rabeprazole).

The other ingredients 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 pack contents

Rabeprazol Combix 10 mg is presented as pink gastro-resistant tablets in aluminum blister packs containing unit dose blisters.

Rabeprazol Combix tablets are available in blister packs containing 28 tablets.

Marketing Authorisation 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 last revision of this leaflet: October 2022

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