Package Insert: Information for the User

Rabeprazol Normon 20 mg Gastrorresistant Tablets EFG

rabeprazol sodium

Read this package insert carefully before starting to take this medication, 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 or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

Rabeprazol Normon contains the active ingredient rabeprazol sodium. Rabeprazol 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 is used to treat:

It will also stop the infection and the recurrence of the ulcer.

Do not take RabeprazolNormon

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

Warnings and precautions

Consultyour doctor, pharmacist, or nurse before starting to take Rabeprazol Normon:

If you are unsure about the above, consult your doctor or pharmacist before taking rabeprazol.

Children

Do not administer to children.

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

Taking a proton pump inhibitor like rabeprazol, especially for more than a year, may slightly increase the risk of fractures in the hip, wrist, or spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

Other medications and Rabeprazol Normon

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

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

• Ketoconazole or itraconazole, medications for fungal infections. Rabeprazol 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 infection. Rabeprazol may decrease the amount of this type of medication in the blood, so they should not be used together.
• Methotrexate (a chemotherapy medication 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 unsure about the above, consult your doctor or pharmacist before taking rabeprazol.

Pregnancy, breastfeeding, and fertility

• Do not take rabeprazol if you are pregnant or think you may be pregnant.
• Do not take rabeprazol during breastfeeding or if you plan to start breastfeeding.

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

Driving and operating machinery

You may feel drowsiness while taking rabeprazol. If this occurs, do not drive or operate tools or machinery.

Follow exactly the administration instructions of rabeprazol indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Medication intake

• Only remove one tablet from the blister when it's 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 are taking this medication for a long time, your doctor will want to monitor you.

Adults and elderly patients

Gastroesophageal reflux disease (GERD)

Symptomatic treatment of moderate to severe symptoms (GERD symptomatic)

• The usual dose is one rabeprazol 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 10 mg tablet as needed ("on demand").

Treatment of more severe symptoms (GERD erosive or ulcerative)

• The usual dose is one rabeprazol 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 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.

Stomach ulcers (peptic ulcers)

• The usual dose is one rabeprazol 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 for another 6 weeks if your symptoms do not improve.

Duodenal ulcers

• The usual dose is one rabeprazol 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 for another 4 weeks if your symptoms do not improve.

Ulcers caused by H. Pylori infection and to prevent recurrences

• The usual dose is one rabeprazol 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 treat H. pylori, read the prospectus of each one.

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

• The usual dose is three rabeprazol 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 a review of the dose and your symptoms.

Patients with liver problems

Consult your doctor, who will have special care in the initiation and during treatment with rabeprazol.

If you take more rabeprazol than you should

If you take more rabeprazol than you should, talk to your doctor or pharmacist, or go to the hospital immediately. Bring the medication with you.

In case of overdose or accidental ingestion, consult the Toxicological Information Service (Telephone: 91562 04 20).

If you forget to take Rabeprazol Normon

• 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 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 the treatment with rabeprazol

The relief of symptoms usually occurs before the ulcer has healed completely.

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

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

Like all medicines, Rabeprazol Normon can cause side effects, although not everyone will experience them.

Side effects are usually mild and improve without you stopping treatment.

Stop taking rabeprazol 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 ease of bleeding.

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

• Severe skin blisters, 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.

Rarely (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.
• Fractures in the hip, wrist and spine.
• Urinary tract infection.
• 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 problems or stomach pain.
• Liver problems that include yellow skin and white eyes (jaundice).
• Itching or blistering rash.
• Sweating.
• Renal problems.
• Weight gain.
• Changes in white blood cells in the blood (shown in blood tests) that may cause frequent infections.
• Decreased platelets in the blood that may cause bleeding or the appearance of bruises with increased ease.

Other possible side effects (frequency unknown)

• Swelling of the breasts in men.
• Fluid retention.
• Inflammation of the intestine (leading to diarrhea).
• 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 rare encephalopathy (brain disease).
• 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 will decrease. Low magnesium levels may manifest as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness and increased heart rate. If you experience any of these symptoms, please inform your doctor immediately. Low magnesium levels may also lead to a reduction 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 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 side effects that do not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for human use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Do not store above25ºC. Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Rabeprazol Normon

The active ingredient is rabeprazol sodium.

Each tablet contains 20 mg of rabeprazol sodium.

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

Appearance of the product and contents of the packaging:

Yellow-coated, biconvex tablets.

The tablets are presented in packaging of 14, 28, or 56 tablets.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos – Madrid,

Spain

Responsible for manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos – Madrid,

Spain

or

Laboratorios Liconsa, S.A.

Avda. Miralcampo, Nº7. Industrial Park Miralcampo-

19200 Azuqueca de Henares- Guadalajara,

Spain

Last review date of this leaflet : June 2024

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