Rabeprazole Viatris 20 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rabeprazol Viatris 20 mg gastro-resistant tablets EFG

rabeprazole sodium

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

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

Leaflet contents

1. What Rabeprazol Viatris is and what it is used for

2. What you need to know before taking Rabeprazol Viatris

3. How to take Rabeprazol Viatris

4. Possible side effects

5. How to store Rabeprazol Viatris

6. Contents of the pack and other information

1. What is Rabeprazol Viatris and what is it used for

Rabeprazol belongs to a class of medicines known as “Proton Pump Inhibitors” (PPIs). Rabeprazol works by reducing the amount of acid produced by the stomach. This helps prevent irritation of the stomach lining, allowing gastric ulcers to heal and relieving the pain and discomfort caused by ulcers.

Rabeprazol is used for the treatment of:

• “Gastroesophageal reflux disease” (GERD), which may include symptoms such as heartburn. GERD is caused by the backflow of stomach 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 rabeprazol together with antibiotics eliminates 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 amounts of acid in the stomach.

2. What you need to know before starting to take Rabeprazol Viatris

Do not take Rabeprazol Viatris:

• If you are allergic to sodium rabeprazole or any of the other ingredients of this medicine (listed 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 this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Rabeprazol Viatris if:

• You are allergic to proton pump inhibitors or to "substituted benzimidazoles".

• Liver or blood problems have been observed in some patients, although these often improve when treatment with this medicine is stopped.

• You have a stomach tumor.

• You have ever had liver problems.

• You are taking atazanavir, a medicine used to treat HIV infection.

• You have reduced body stores or risk factors associated with low levels of vitamin B12 and are receiving long-term treatment with sodium rabeprazole. Like all agents that reduce acidity, sodium rabeprazole may reduce the absorption of vitamin B12.

• You have ever had a skin reaction after treatment with a medicine similar to rabeprazole 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 treatment with rabeprazole may need to be stopped. Remember to mention any other symptoms you may notice, such as joint pain.

• You are undergoing long-term treatment (particularly if you have been treated for more than one year) with this medicine and should therefore be monitored regularly.

• You are scheduled to have a specific blood test (chromogranin A).

• During treatment with rabeprazole, 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 applies to you, consult your doctor or pharmacist before taking rabeprazole.

Children and adolescents

Rabeprazole 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 more than one year, may slightly increase the risk of fracture of the hip, wrist, or spine. Inform your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).

Other medicines and Rabeprazol Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other 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 decrease the blood levels of these medicines. Your doctor may need to adjust your dose.

• Atazanavir, a medicine used to treat HIV infection. Rabeprazole may reduce blood levels of this type of medicine and therefore 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 rabeprazole treatment.

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

Pregnancy, breastfeeding, and fertility

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

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

Driving and using machines

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

Rabeprazol Viatris contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

3. How to take Rabeprazol Viatris

Follow exactly the instructions for administering this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Taking this medicine

• Only remove a tablet from the blister pack 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 how long your treatment should last, depending on your condition.
• If you are taking this medicine for a long time, your doctor will want to monitor you.

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 will 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 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 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 have not improved.

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 have not improved.

For ulcers caused by Helicobacter pylori infection and to prevent relapses

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

For more information about the other medicines used to treat Helicobacter 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 to see your doctor at regular intervals 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 Rabeprazol Viatris than you should

If you take more rabeprazole than you should, speak 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 Viatris

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 as usual.

If you have forgotten 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 missed dose.

If you stop taking Rabeprazol Viatris

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 the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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 which 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 (may affect up to 1 in 1,000 patients).

• Severe blistering of the skin, or sores or ulcers in your mouth and throat.

These adverse effects are very rare (may affect up to 1 in 10,000 patients).

Other possible adverse effects:

Common (may affect up to 1 in 10 patients)

• 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 (may affect up to 1 in 100 patients)

• 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, or spine.
• Bladder infection (urinary tract infection).
• Chest pain.
• Chills or fever.
• Changes in liver function (shown in blood tests).

Rare (may affect up to 1 in 1,000 patients)

• 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 blistering.
• Sweating.
• Kidney problems.
• Weight gain.
• Changes in white blood cells (shown in blood tests) which may lead to frequent infections.
• Decrease in blood platelets which may cause bleeding or bruising more easily than normal.

Frequency not known (cannot be estimated from available data)

• 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 rabeprazole for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as tiredness, involuntary muscle contractions, disorientation, seizures, dizziness, or 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 adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es/. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rabeprazole Viatris

Keep this medicine out of the sight and reach of children.

Do not store above 25°C. Keep in the original packaging to protect from light.

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

Do not use this medicine if the packaging is damaged or shows signs of tampering.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rabeprazol Viatris

• The active substance is rabeprazol sodium. Each tablet contains 20 mg of rabeprazol sodium.

• The other components are:

Tablet core: mannitol, heavy magnesium oxide, hydroxypropylcellulose, magnesium stearate.

Subcoating: ethylcellulose, heavy magnesium oxide.

Enteric coating: hypromellose phthalate, dibutyl sebacate, yellow iron oxide (E-172), titanium dioxide (E-171), talc.

Appearance of the product and contents of the pack

Yellow, biconvex, coated (gastro-resistant) tablets.

The packs contain aluminum blister strips containing 1, 5, 7, 14, 15, 25, 28, 30, 50, 56, 75, 98 and 120 tablets.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Manufacturer

Laboratorios Liconsa, S.A.

Avda. Miralcampo, 7, Polígono Industrial Miralcampo

19200 - Azuqueca de Henares (Guadalajara)

Spain

Date of the most recent revision of this leaflet: October 2022

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