Package Insert: Information for the User

Rabeprazol Combix 20 mg gastro-resistant tablets EFG

Rabeprazol sodium

Read this package insert carefully before starting to take this medicine, as it contains important information for you

• Keep this package insert, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms of illness as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist or nurse, even if they are not listed in this package insert.See section 4.

Rabeprazol Combix 20 mg contains the active ingredient rabeprazol sodium. Rabeprazol Combix belongs to a class of medicines known as “Proton Pump Inhibitors” (PPIs), which act 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 the appearance of heartburn. The cause of GERD is the passage of acid and food from the stomach into the esophagus.
• Stomach ulcers or ulcers of the upper part of the small intestine (duodenal ulcers).If these ulcers are infected with a bacteria called “Helicobacter pylori” (H. pylori), you will need to take antibiotics. Taking Rabeprazol Combix and the antibiotics together will clear the infection and the ulcer will heal. It will also prevent the infection and the recurrence of the ulcer.
• Zollinger-Ellison syndrome, a disease characterized by the production of very high amounts of acid in the stomach.

Do not take Rabeprazol Combix 20 mg

• if you are allergic (hypersensitive) to rabeprazol sodium, or to any of the excipients of 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 you are in any of the above situations. If you are unsure, consult your doctor or pharmacist before taking Rabeprazol Combix.

See also the Pregnancy and breastfeeding section.

Warnings and precautions

Consult your doctor or pharmacist before taking Rabeprazol Combix:

• if you have ever had a skin reaction after treatment with a similar medication to Rabeprazol Combix for reducing stomach acid.

If you suffer from a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to interrupt 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 benzimidazoles".
• liver and blood problems have been seen in some patients, but often improve when treatment with Rabeprazol Combix 10mg is stopped.
• if you have a stomach tumor.
• if you have ever had liver problems.
• if you are taking atazanavir, a medication for HIV/AIDS.
• if you are due to have a specific blood test (Cromogranin A).
• during treatment with rabeprazol, inflammation in your kidneys may occur. Among the signs and symptoms are: decreased urine volume or blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. You must notify these signs to your doctor.

If you are unsure about 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 sensitivity, stop taking Rabeprazol Combix and see your doctor immediately.

Children

Should not be administered to children.

Rabeprazol Combix interaction with other medications

Inform your doctor or pharmacist if you are taking or have recently taken other medications, including over-the-counter medications and herbal supplements.

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

• ketoconazole or itraconazole, medications for fungal infections. Rabeprazol Combix may decrease the amount of these medications in the blood. Your doctor may need to adjust your dose.
• atazanavir, a medication used to treat HIV/AIDS. Rabeprazol Combix may decrease the amount of this type of medication in the blood, so they should not be used together.

If you are unsure about the above, 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 during breastfeeding or if you plan to start breastfeeding.

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machines

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor again.

Taking this medication

• Only remove one tablet from the blister pack when it is time to take your medication.
• 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 the duration of your treatment, which will depend on your indication.
• If you aretaking thismedication for a long time, your doctor will want to monitor you.

Adults and elderly patients

For gastroesophageal reflux disease (GERD)

Moderate to severe symptom treatment (GERD symptomatic)

• 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 recur after 4 weeks of treatment, your doctor will tell you to take one Rabeprazol Combix 10 mg tablet as needed.

Severe symptom treatment (GERD erosive or ulcerative)

• 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.

Maintenance treatment of symptoms (GERD maintenance)

• The usual dose is one Rabeprazol Combix 10 mg or 20 mg tablet once a day 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 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 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 recurrences

• 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 on other medications used to treatH. pylori, read the prospectus for each one.

Zollinger-Ellison syndrome, where excess acid is produced in the stomach

• The usual dose is three Rabeprazol Combix 20 mg 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 dosage and symptom review.

Use in children

This medication should not be given to children.

Patients with liver problems

Consult your doctor, who will have special care in the initiation 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 the hospital immediately. Bring the medication with you.

In case of overdose or accidental ingestion, consult the Toxicological Information Service (Telephone: 91 5620420)

If you forget to take Rabeprazol Combix

• If you forget to takeonetablet, as soon as you remember take one and then continue as usual. However, if it is almost time to take the next tablet, simply skip the missed tablet and continue as usual.
• If you forget to take your medication for more than 5 days, consult your doctor before taking more medication.
• Do not take a double dose (two doses at the same time) to compensate for the missed dose.

If you interrupt treatment with Rabeprazol Combix

Relief of symptoms usually occurs before the ulcer has completely healed.

It is essential not to interrupt treatment until your doctor tells you to.

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

Like all medicines, Rabeprazol Combix may cause side effects, although
not everyone will experience them.
Side effects are usually mild and improve without you stopping treatment.

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

• Allergic reactions – symptoms may include: sudden swelling of your face, difficulty breathing or low blood pressure that can cause dizziness or collapse.
• Frequent infections, such as sore throat or high temperature (fever), or ulcers in your mouth or throat.
• Cardenals or easy bleeding.
  These side effects are rare (affect less than 1 in 1,000 people).
• Severe blisters on your skin, or sores or ulcers in your mouth and throat.

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

Other possible side effects;

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

Rare (affect less than 1 in 100 people)

• Feeling nervous or drowsy.
• Chest infection (bronchitis).
• Blocked and painful sinuses (sinusitis).
• Dry mouth.
• Indigestion or belching.
• Rash on the skin or redness.
• Muscle pain, leg pain or joint pain.
• 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)

• Loss of appetite (anorexia)
• Depression.
• Hypersensitivity (including allergic reactions).
• Visual disturbances.
• Inflamed mouth (stomatitis) or taste disturbances.
• Stomach problems or stomach pain.
• Liver problems that include yellow skin and white eyes (jaundice).
• Rash with itching or blisters.
• Sweating.
• Kidney problems.
• Weight gain.
• Changes in white blood cells (shown in blood tests) that may cause frequent infections.
• Decreased platelets in the blood that may cause bleeding or the appearance of bruises more easily than normal.

Other possible side effects (frequency unknown)

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

Do not worry about the list of side effects. You may not experience any of them.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Rabeprazol Combix 20 mg

The active ingredient is rabeprazole sodium. Each tablet contains 20 mg of rabeprazole sodium (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;enteric coating: ethyl acrylate-methacrylic acid copolymer, polysorbate 80, sodium lauryl sulfate, propylene glycol, talc, iron oxide red (E172), iron oxide yellow (E172), titanium dioxide (E171).

Appearance of the product and content of the container

Rabeprazol Combix 20 mg is presented as yellow-colored enteric-coated tablets in containers that contain aluminum blisters with the tablets housed in individual unit cells.

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

Only some container sizes may be commercially marketed.

Marketing authorization holder

Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing

Balkanpharma Dupnitsa Ad

3 Samokovsko Shosse Str.

Dupnitsa

Bulgaria

Last review date of this leaflet: October 2022

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es.