RABEPRAZOL VIATRIS 20 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the User

Rabeprazol Viatris 20 mg Gastro-Resistant Tablets EFG

rabeprazol sodium

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Rabeprazol Viatris and what is it used for
2. What you need to know before you take Rabeprazol Viatris
3. How to take Rabeprazol Viatris
4. Possible side effects
5. Storage of Rabeprazol Viatris

1. Contents of the pack and further 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 acts by reducing the amount of acid produced by the stomach. This prevents irritation of the stomach mucosa, allowing the healing of gastric ulcers and relieving the pain and discomfort caused by ulcers.

Rabeprazol is used for the treatment of:

• “Gastroesophageal Reflux Disease” (GERD), which may include the appearance of acidity. The cause of GERD is the passage of acid and food from the stomach into the esophagus.

The cause of GERD is the passage of acid and food from the stomach into the esophagus.

• Stomach ulcers or ulcers in the upper part of the intestine (duodenal). If these ulcers are infected with a bacterium called “Helicobacter pylori” (H. pylori), you will need to take antibiotics. By taking rabeprazol and antibiotics together, the infection will disappear and the ulcer will heal. It will also stop 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.

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

Do not take Rabeprazol Viatris:

• If you are allergic to rabeprazol sodium 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 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 this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rabeprazol Viatris.

• If you are allergic to proton pump inhibitors or to “substituted benzimidazoles”.
• If liver and blood problems have been seen in some patients, but often improve when treatment with this medicine is interrupted.

• If you have a stomach tumor.
• If you have ever had liver problems.
• If you are taking atazanavir, a medicine for HIV infection.
• If you have reduced body stores or have risk factors associated with reduced vitamin B12 and receive long-term treatment with rabeprazol sodium. Like all agents that reduce acidity, rabeprazol sodium may lead to reduced absorption of vitamin B12.
• If you have ever had a skin reaction after treatment with a medicine similar to rabeprazol to reduce stomach acidity.

• If you get a skin rash, especially in areas of the skin exposed to the sun, consult your doctor as soon as possible, as it may be necessary to interrupt treatment with rabeprazol. Remember to mention any other symptoms you may notice, such as joint pain.

• If you are undergoing long-term treatment (particularly if you have been treated for more than a year) with this medicine, you should be regularly reviewed.
• If you are scheduled to have a specific blood test (Chromogranin A).
• During treatment with rabeprazol, kidney inflammation may occur. The signs and symptoms include: decreased urine volume or blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. You should report these signs to your doctor.

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

Children and adolescents

Rabeprazol should not be given 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 a period of more than a year, may slightly increase the risk of fracture in the hip, wrist, or spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

Other medicines and Rabeprazol Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

• Ketoconazole or itraconazole, medicines for 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

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

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

Driving and using machines

You may feel drowsy while taking rabeprazol. If this happens, do not drive or use tools or machines.

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 administration of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Taking this medicine

• Only remove a tablet from the blister 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 the number of tablets you should take and the duration of your treatment, which will depend on your indication.
• 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 rabeprazol tablet 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 rabeprazol tablet when needed (“on demand”).

Treatment of more severe symptoms (Erosive or Ulcerative GERD)

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

Long-term treatment of symptoms (Maintenance GERD)

• The usual dose is one 10 mg or 20 mg rabeprazol 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 dose.

For stomach ulcers (peptic ulcers)

• The usual dose is one 20 mg rabeprazol 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.

For duodenal ulcers

• The usual dose is one 20 mg rabeprazol 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.

For ulcers caused by Helicobacter Pylori infection and to prevent relapse

• The usual dose is one 20 mg rabeprazol tablet 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 Helicobacter pylori, read the package leaflets for each of them.

Zollinger-Ellison Syndrome where there is an excess of acid in the stomach

• The usual dose is three 20 mg rabeprazol tablets once a day at the start.
• 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 review of your dose and symptoms.

Patients with liver problems.Consult your doctor, who will be particularly careful when starting and during treatment with rabeprazol.

If you take more Rabeprazol Viatris than you should

If you take more rabeprazol than you should, talk to your doctor or go to a hospital immediately. Take the medicine with you.

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

If you forget to take Rabeprazol Viatris

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 dose and continue as usual.

If you forget to take your medicine for more than 5 days, consult your doctor before taking more medicine.

Do not take a double dose (two doses at the same time) to make up for the missed dose.

If you stop taking Rabeprazol Viatris

Relief of symptoms usually 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 other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects are usually mild and improve without interrupting 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, the signs can include: sudden swelling of your face, difficulty breathing, or low blood pressure that can cause fainting or collapse.
• Frequent infections, such as sore throat or high temperature (fever), or ulcers in your mouth or throat.
• Bruises or easy bleeding.

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

• Severe skin blistering or rashes or ulcers in your mouth and throat.

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

Other possible side 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.
• Pains or back pain.
• Weakness or flu-like symptoms.
• Benign polyps in the stomach.

Uncommon(may affect up to 1 in 100 patients)

• Feeling nervous or drowsy.
• Chest infection (bronchitis).
• Painful sinuses and blocked sinuses (sinusitis).
• Dry mouth.
• Indigestion or belching.
• Skin rash or redness.
• Muscle pain, leg pain, or joint pain.
• Fractures in the hip, wrist, and spine.
• Urinary tract 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)

• Lack of appetite (anorexia).
• Depression.
• Hypersensitivity (including allergic reactions).
• Vision disorders.
• Inflamed mouth (stomatitis) or taste disorders.
• Stomach disorder or stomach pain.
• Liver problems, including yellowing of the skin and the whites of the eyes (jaundice).
• Itchy rash or blisters.
• Sweating.
• Kidney problems.
• Weight gain.
• Changes in white blood cells (shown in blood tests) that can cause frequent infections.
• Decrease in blood platelets that can cause bleeding or bruising more easily than normal.

Frequency not known (cannot be estimated from the available data)

• Swelling of the breasts in men.
• Fluid retention.
• Inflammation of the intestine (leading to diarrhea).
• Low sodium levels in the blood, which can cause fatigue and confusion, muscle spasms, convulsions, 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 for more than three months, it is possible that your blood magnesium levels may decrease. Low magnesium levels can manifest as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you have any of these symptoms, please inform your doctor immediately. Low magnesium levels can also lead to a reduction in blood potassium or calcium levels. 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 of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es/. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Rabeprazol Viatris

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

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

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

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

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If you are in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Rabeprazol Viatris Composition

• The active ingredient 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.

Product Appearance and Package Contents

Enteric-coated (gastro-resistant) yellow, biconvex tablets

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

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

ManufacturerLaboratorios Liconsa, S.A.

Avda. Miralcampo, 7, Polígono Industrial Miralcampo

19200 - Azuqueca de Henares (Guadalajara)

Spain

Date of the Last Revision of this Prospectus:October 2022

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