Rabeprazole Normon 20 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rabeprazol Normon 20 mg gastro-resistant tablets EFG

sodium rabeprazole

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

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

Contents of the leaflet

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

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

Rabeprazol Normon contains the active substance rabeprazole sodium. Rabeprazole belongs to a class of medicines known as "Proton Pump Inhibitors" (PPIs), which work by reducing the amount of acid produced by the stomach.

Rabeprazole is used for the treatment of:

• Gastroesophageal reflux disease (GERD), which may include symptoms such as heartburn. GERD is caused by the backflow of acid and food from the stomach into the esophagus.
• Stomach ulcers or ulcers in the upper part of the intestine (duodenal ulcers). If these ulcers are infected with a bacterium called Helicobacter pylori (H. pylori), antibiotic treatment will be required. Taking rabeprazole together with antibiotics eradicates the infection and allows the ulcer to heal.

It also prevents recurrence of the infection and the ulcer.

• Zollinger-Ellison syndrome, a condition characterized by the production of very high levels of acid in the stomach.

2. What you need to know before starting to take Rabeprazol Normon 20 mg gastro-resistant tablets

Do not take Rabeprazol Normon

• If you are allergic (hypersensitive) to sodium rabeprazole or to any of the excipients of this medicine (see list in section 6).
• If you are pregnant or think you may be pregnant.
• If you are breastfeeding.

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

Warnings and precautions

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

• If you are allergic to proton pump inhibitors or to "substituted benzimidazole compounds".

• If liver and blood problems have been observed in some patients, but these often improve when rabeprazol treatment is discontinued.

• If you have a stomach tumor.

• 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 associated with low levels of B12 and are receiving long-term treatment with sodium rabeprazol. As with all agents that reduce acidity, sodium rabeprazol may lead to reduced absorption of vitamin B12.

• If you have ever had a skin reaction after treatment with a medicine similar to Rabeprazol used to reduce stomach acid.

• If you develop a skin rash, especially in areas of skin exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with Rabeprazol. Remember to mention any other symptoms you may notice, such as joint pain.

• If you are scheduled to have a specific blood test (Chromogranin A).

• During treatment with rabeprazol, inflammation of the kidney may occur. Signs and symptoms include: decreased volume of urine or blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. You must report these signs to your doctor.

If you have any doubts about whether the above affects you, consult your doctor or pharmacist before taking rabeprazole.

Children

Must not be given to children.

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

Taking a proton pump inhibitor such as rabeprazole, especially for a period longer than one year, may slightly increase the risk of fracture of 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 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, as well as herbal medicines.

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

• Ketoconazole or itraconazole, medicines used to treat fungal infections. Rabeprazole may reduce the amount of these medicines in the blood. Your doctor may need to adjust your dose.
• Atazanavir, a medicine used to treat HIV infection. Rabeprazole may reduce the amount of this medicine in the blood; therefore, they should not be used together.
• Methotrexate (a chemotherapy medicine used in high doses to treat cancer) – if you are taking a high dose of methotrexate, your doctor may temporarily stop your treatment with rabeprazole.

If you have any doubts about whether the above applies to you, consult your doctor or pharmacist before taking rabeprazole.

Pregnancy, breastfeeding, and fertility

• Do not take rabeprazole if you are pregnant or think you might be pregnant.
• Do not take rabeprazole while breastfeeding or if you plan to start breastfeeding.

If you are pregnant or breastfeeding, think you might be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and operating machinery

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

3. How to take Rabeprazol Normon 20 mg gastro-resistant tablets

Follow exactly the rabeprazole dosing instructions provided by your doctor. If in doubt, consult your doctor or pharmacist again.

How to take this medicine

• Remove a tablet from the blister pack only 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 how many tablets you should take and for how long, depending on your condition.
• If you are taking this medicine for a long time, your doctor will want to monitor you regularly.

Adults and elderly patients

For gastroesophageal reflux disease (GERD)

Treatment of moderate to severe symptoms (symptomatic GERD)

• The usual dose is one 10 mg rabeprazole tablet once daily for up to 4 weeks.
• Take the tablet in the morning before eating.
• If your symptoms return after 4 weeks of treatment, your doctor may instruct you to take one 10 mg rabeprazole tablet as needed (“on-demand”).

Treatment of more severe symptoms (erosive or ulcerative GERD)

• The usual dose is one 20 mg rabeprazole tablet once daily for 4 to 8 weeks.
• Take the tablet in the morning before eating.

Long-term treatment of symptoms (maintenance of GERD)

• The usual dose is one 10 mg or 20 mg rabeprazole tablet once daily for as long as your doctor has instructed.
• Take the tablet in the morning before eating.
• Your doctor will want to see you at regular intervals to monitor your symptoms and dosage.

For stomach ulcers (peptic ulcers)

• The usual dose is one 20 mg rabeprazole tablet once daily for 6 weeks.
• Take the tablet in the morning before eating.
• Your doctor may instruct you to continue rabeprazole for another 6 weeks if your symptoms do not improve.

For intestinal ulcers (duodenal ulcers)

• The usual dose is one 20 mg rabeprazole tablet once daily for 4 weeks.
• Take the tablet in the morning before eating.
• Your doctor may instruct you to continue rabeprazole for another 4 weeks if your symptoms do not improve.

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

• The usual dose is one 20 mg rabeprazole tablet twice daily for seven days.
• Your doctor will also prescribe antibiotics called amoxicillin and clarithromycin.

For more information about the other medicines used to treat H. pylori, please read the package leaflets for each of them.

Zollinger-Ellison syndrome, in which excess stomach acid is produced

• The usual starting dose is three 20 mg rabeprazole tablets once daily.
• Your doctor may adjust the dose depending on your response to treatment.

If you are on long-term treatment, you will need regular medical check-ups to review your dose and symptoms.

Patients with liver problems

Consult your doctor, who will exercise special caution when starting and during treatment with rabeprazole.

If you take more rabeprazole than you should

If you take more rabeprazole than prescribed, contact your doctor or pharmacist immediately, or go to a hospital. Bring the medicine with you.

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

If you forget to take Rabeprazol Normon

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

If you stop treatment with rabeprazole

Symptom relief usually occurs before the ulcer has completely healed.

It is important not to stop treatment until your doctor tells you to do so.

If you have any further questions about using this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Rabeprazol Normon may produce adverse effects, although not everyone experiences them.

The adverse effects are usually mild and improve without you needing to stop treatment.

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

• Allergic reactions, signs may include: sudden swelling of the face, difficulty breathing, or low blood pressure that may cause fainting or collapse.
• Frequent infections, such as sore throat or high temperature (fever), or ulcers in your mouth or throat.
• Bruising or easy bleeding.

These adverse effects are rare (affect fewer than 1 in 1,000 people).

• Severe blisters on the skin, sores or ulcers in your mouth and throat.

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

Other possible adverse effects:

Frequent (affect fewer than 1 in 10 people)

• Infections.
• Difficulty sleeping.
• Headache or dizziness.
• Cough, runny nose, or sore throat (pharyngitis).
• Effects on your stomach or intestine such as stomach pain, diarrhea, gas (flatulence), feeling sick (nausea), being sick (vomiting), or constipation.
• Aches or back pain.
• Weakness or flu-like symptoms (pseudoinfluenza symptoms).
• Benign polyps in the stomach.

Uncommon (affect fewer than 1 in 100 people)

• Feeling nervous or drowsy.
• Chest infection (bronchitis).
• Painful and blocked sinuses (sinusitis).
• Dry mouth.
• Indigestion or burping.
• Skin rash or redness.
• Muscle, leg, or joint pain.
• Fractures in the hip, wrist, and spine.
• Bladder infection (urinary tract infection).
• Chest pain.
• Chills or fever.
• Changes in liver function (shown in blood tests).

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

• Loss of appetite (anorexia).
• Depression.
• Hypersensitivity (including allergic reactions).
• Visual disturbances.
• Inflamed mouth (stomatitis) or taste disturbances.
• Stomach disorder or stomach pain.
• Liver problems including yellowing of the skin and 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.
• Decreased blood platelets which may cause bleeding or bruising more easily than normal.

Other possible adverse effects (frequency not known)

• Breast swelling in men.
• Fluid retention.
• Inflammation of the intestine (leading to diarrhea).
• Low levels of sodium in the blood which may cause tiredness and confusion, muscle spasms, seizures, and coma.
• Patients who have previously had liver problems may very rarely develop encephalopathy (brain disease).
• Skin rash, possibly with joint pain.

If you take Rabeprazol Normon for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as tiredness, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, please inform your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.

Do not be alarmed by this list of adverse effects. You may not experience any of them.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rabeprazole Normon 20 mg gastro-resistant tablets

Keep out of sight and reach of children.

Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of RabeprazolNormon

The active substance is sodium rabeprazole.

Each tablet contains 20 mg of sodium rabeprazole.

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 pack:

Yellow, biconvex coated tablets.

The tablets are available in packs of 14, 28 or 56 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 the most recent review of this leaflet: June 2024

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You may also access this information at the following web address: https://cima.aemps.es/cima/dochtml/p/72265/P_72265.html