RABEPRAZOL NORMON 10 mg GASTRO-RESISTANT TABLETS

1. What Rabeprazol Normon 10 mg Gastro-Resistant Tablets are and what they are used for

Rabeprazol Normon contains the active substance rabeprazol sodium. Rabeprazol 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 is used for the treatment of:

• “Gastro-Oesophageal Reflux Disease” (GORD), which may include symptoms such as acid reflux. 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 bacterium called Helicobacter pylori (H. pylori), you will also need to take antibiotics. Taking rabeprazol and antibiotics together will get rid of the infection and the ulcer will heal.

This will also stop the infection and the ulcer from coming back.

• Zollinger-Ellison Syndrome, a disease characterised by the production of very large amounts of acid in the stomach.

2. What you need to know before you take Rabeprazol Normon 10 mg Gastro-Resistant Tablets

Do not take Rabeprazol Normon

• If you are allergic (hypersensitive) to rabeprazol sodium or any of the other ingredients of this medicine (see section 6).
• If you are pregnant or think you may be pregnant.
• If you are breast-feeding.

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

Warnings and Precautions

Consult your doctor, pharmacist or nurse before starting treatment with rabeprazol:

• If you are allergic to proton pump inhibitors or “substituted benzimidazoles”.
• If liver or blood problems have been seen in some patients but often improve when treatment with rabeprazol is stopped.
• If you have a stomach tumour.
• If you have ever had liver problems.
• If you are taking atazanavir, a medicine used to treat HIV infection.
• If you have reduced body stores or risk factors for reduced vitamin B12 and are taking long-term treatment with rabeprazol sodium. Like all acid-reducing agents, rabeprazol sodium may lead to a reduced absorption of vitamin B12.
• If you have ever had a skin reaction with a medicine that reduces stomach acid.
• If you get a rash on your skin, especially in areas exposed to the sun, you should contact your doctor as soon as possible, as you may need to stop your treatment with rabeprazol. Also remember to mention any other symptoms you might notice, such as joint pain.
• If you are due to have a specific blood test (Chromogranin A).
• During treatment with rabeprazol, 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 inform your doctor of these signs.

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

Children

Rabeprazol Normon should not be used in children.

If you experience severe diarrhoea with blood and mucous, fever, abdominal pain or tenderness, stop taking rabeprazol and consult your doctor immediately.

Taking a proton pump inhibitor like rabeprazol, especially over a period of more than one year, may slightly increase the risk of fracture of the hip, wrist or spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

Other medicines and Rabeprazol Normon

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 used to treat fungal infections. Rabeprazol 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 infection. Rabeprazol may decrease the amount of this type of medicine in your blood, so they 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 treatment with rabeprazol.

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

Pregnancy, Breast-feeding and Fertility

• Do not take rabeprazol if you are pregnant or if you think you may be pregnant.
• Do not take rabeprazol during breast-feeding or if you plan to breast-feed.

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. If this happens, do not drive or use tools or machines.

3. How to take Rabeprazol Normon 10 mg Gastro-Resistant Tablets

Take Rabeprazol exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Taking this medicine

• Only remove a tablet from the blister strip 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.
• 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 (symptomatic GORD)

• The usual dose is one 10 mg tablet of rabeprazol 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 10 mg tablet of rabeprazol when you need it (“on demand”).

Treatment of more severe symptoms (erosive or ulcerative GORD)

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

For Duodenal Ulcers

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

For Ulcers Caused by H. Pylori Infection and to Prevent Them Coming Back

• The usual dose is one 20 mg tablet of rabeprazol 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 20 mg tablets of rabeprazol 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 your dose and symptoms to be checked.

Patients with Liver Problems

Consult your doctor, who will take special care when starting and during treatment with rabeprazol.

If you take more Rabeprazol than you should

If you take more rabeprazol than you should, talk to a doctor, pharmacist or nurse immediately. Take the medicine pack with you.

In case of overdose or accidental ingestion, contact the Toxicology Information Service (Telephone 91 562 04 20).

If you forget to take Rabeprazol

• If you forget to take a tablet, take one as soon as you remember and then continue as normal. However, if it is almost time for your next tablet, skip the missed tablet and continue as normal.
• 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

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 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 and see a 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 mouth or throat ulcers.
• bruising or bleeding easily.

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

• Severe skin blisters or rash, 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:

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, wind (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).
• Sinusitis (blocked or painful sinuses).
• Dry mouth.
• Indigestion or belching.
• Rash or redness of the skin.
• Muscle pain, leg pain or joint pain.
• Fractures of the hip, wrist or spine.
• Urinary tract infection (infection of the urine system).
• Chest pain.
• Chills or fever.
• Changes in liver function (shown in blood tests).

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 disorders or stomach pain.
• Liver problems including yellowing of the skin and whites of the eyes (jaundice).
• Itchy rash or blistering.
• Sweating.
• Kidney problems.
• Weight increase.
• 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 easily.

Other possible side effects (frequency not known)

• Breast swelling in men.
• Fluid retention.
• Inflammation of the intestine (leading to diarrhoea).
• 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).
• Skin rash possibly with joint pain.

If you take Rabeprazol Normon for more than three months, it is possible that your magnesium levels in the blood may decrease. Low magnesium levels can manifest as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness and a rapid heart rate. If you experience any of these symptoms, please inform your doctor immediately. Low magnesium levels can also lead to a decrease in potassium or calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.

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 and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Rabeprazol Normon 10 mg Gastro-Resistant Tablets

Keep out of the sight and reach of children.

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

Do not store above 30°C. Store in the original package to protect from moisture.

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 Normon:

The active substance is rabeprazol sodium.

Each tablet contains 10 mg of rabeprazol sodium.

The other ingredients (excipients) are: mannitol, heavy magnesium oxide, hydroxypropylcellulose, magnesium stearate, ethylcellulose, hypromellose phthalate, dibutyl sebacate, red iron oxide, titanium dioxide and talc.

Appearance of the product and pack contents:

Tablets are pink, biconvex, film-coated.

The tablets come in packs of 28 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760

Tres Cantos – Madrid, Spain

Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos – Madrid,

Spain

or

Laboratorios Liconsa, S.A.

Avda. Miralcampo, Nº7. Polígono Industrial Miralcampo- 19200

Azuqueca de Henares- Guadalajara,

Spain

Date of last revision of this leaflet:February 2025

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