RABEPRAZOL COMBIX 20 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the User

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

1. What Rabeprazol Combix 20 mg gastro-resistant tablets are and what they are used for

Rabeprazol Combix 20 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 acid reflux. The cause of GORD is acid and food flowing back into the oesophagus from the stomach.
• 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 20 mg gastro-resistant tablets

Do not take Rabeprazol Combix 20 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. Remember to also 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 treatment is stopped.
• if you have a stomach tumour.
• 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 may occur. 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 report these signs to your doctor.

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

If you experience severe diarrhoea with blood and mucous, 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 unsure 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 20 mg gastro-resistant tablets

Follow the instructions for administration of this medicine exactly as your doctor has told you. If you are unsure, 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 chew or crush the tablet.
• Your doctor will tell you how many tablets to take and for how long. This will depend on your condition.
• If you are taking this medicine for a long time, your doctor will want to check you regularly.

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 you need it (“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 to start with.
• 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.

Patient with liver problems

Consult 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, take one as soon as you remember and then continue as usual. However, if it is almost time for your next tablet, 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 a forgotten 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 having to stop taking the medicine.

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 blistering or peeling or mouth ulcers.

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, diarrhoea, gas (flatulence), feeling sick (nausea), being sick (vomiting) or constipation.
• Pains 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.
• Urinary tract infection.
• Chest pain.
• Chills or fever.
• Changes in how your liver is working (shown in blood tests).
• Fracture of the hip, wrist, or spine

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

• Lack of appetite (anorexia)
• Depression.
• Hypersensitivity (including allergic reactions).
• Visual disturbances.
• Inflamed mouth (stomatitis) or taste disturbances.
• Stomach disorders or stomach pain.
• Liver problems including jaundice (shown by yellowing of the skin and whites of the eyes).
• Itchy rash or blistering.
• Sweating.
• Kidney problems.
• Weight increase.
• Changes in your white blood cells (shown in blood tests) which may lead to frequent infections.
• Decrease in the number of blood platelets which may lead to easy bruising or bleeding.

Other possible side effects (frequency not known)

• Enlargement of the breasts in men.
• Fluid retention.
• Low levels of sodium in the blood which may 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 the levels of magnesium in your blood may fall. Low levels of magnesium can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, rapid heart rate. If you experience any of these symptoms, contact your doctor immediately. Low levels of magnesium can also lead to a decrease in the 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 like Rabeprazol Combix, especially over a period of more than one year, you may have a slightly increased risk of fractures of 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).
• skin rash, possibly with joint pain.
• Inflammation of the intestine (leading to diarrhoea).

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

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. 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 20 mg gastro-resistant tablets

Keep out of the reach and sight of children. Do not store above 25°C. Store in the original package 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 to protect the environment.

6. Contents of the pack and other information

Composition of Rabeprazol Combix 20 mg

The active substance is rabeprazole sodium. Each tablet contains 20 mg of rabeprazole sodium (equivalent to 18.85 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: ethyl acrylate/methacrylic acid 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 gastro-resistant tablets in aluminium blister packs with the tablets housed in unitary cavities.

Rabeprazol Combix tablets are available in blister packs containing 14, 28 tablets.

Not all pack sizes may be marketed.

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.