Package Insert: Information for the User

Rabeprazol Viatris 10 mg Gastrorresistant Tablets EFG

Rabeprazole 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 questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• Ifyou experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

6. Contents of the pack and additional information

Rabeprazol belongs to a class of medications known as “Proton Pump Inhibitors” (PPIs). Rabeprazol acts by reducing the amount of acid produced by the stomach. This preventsirritation of the stomach mucosa, allowing the healing of gastric ulcers andrelieving the pain and discomfort caused by ulcers.

Rabeprazol is used to treat:

• “Gastroesophageal Reflux Disease” (GERD), which may include the occurrence of acid reflux. 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 small intestine (duodenal ulcers). If these ulcers are infected with a bacteria called “Helicobacter pylori” (H. pylori), you will need to take antibiotics. Taking rabeprazol and antibiotics together will eliminate the infection and the ulcer will heal. It will also prevent 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.

Do not take Rabeprazol Viatris:

• If you are allergic to rabeprazol sodium or any of the other components of this medication (listed in section 6).
• If you are pregnant or think you may be pregnant.
• If you are breastfeeding.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Viatris.

• If you are allergic to proton pump inhibitors or to "substituted benzimidazole compounds".
• If you have experienced liver and blood problems in some patients, but often improve when the treatment with this medication is interrupted.

-If you have a stomach tumor.

-If you have ever had liver problems.

-If you are taking atazanavir, a medication for HIV infection.

-If you have reduced body reserves or have risk factors associated with a reduced amount of B12 and are receiving long-term treatment with rabeprazol sodium. Like all acid-reducing agents, rabeprazol sodium may lead to reduced B12 absorption.

-If you have ever had a skin reaction after treatment with a similar medication to rabeprazol for reducing stomach acid.

• If you suffer from a skin rash, especially in sun-exposed areas, 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 medication, you should be reviewed regularly.
• If you are scheduled to have a specific blood test (Cromogranin A).
• During treatment with rabeprazol, inflammation in your kidneys may occur. Among the signs and symptoms are: decreased urine volume or blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. You must notify these signs to your doctor.

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

Children and adolescents

Rabeprazol should not be administered 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 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 Viatris

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

Pregnancy, breastfeeding, and fertility

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

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

Driving and operating machines

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

Rabeprazol Viatris contains sodium

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

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

Administration of this medication

-Only remove one tablet from the blister pack when it is 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

For gastroesophageal reflux disease (GERD)

Symptomatic treatment of moderate to severe symptoms (GERD symptomatic)

-The usual dose is one rabeprazole 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 rabeprazole 10 mg tablet as needed.

Treatment of more severe symptoms (GERD erosive or ulcerative)

-The usual dose is one rabeprazole 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 rabeprazole 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.

For stomach ulcers (peptic ulcers)

-The usual dose is one rabeprazole 20 mg tablet once a day for 6 weeks.

-Take the tablet in the morning before eating.

-Your doctor may tell you to take rabeprazole for another 6 weeks if your symptoms do not improve.

For duodenal ulcers

-The usual dose is one rabeprazole 20 mg tablet once a day for 4 weeks.

-Take the tablet in the morning before eating.

-Your doctor may tell you to take rabeprazole for another 4 weeks if your symptoms do not improve.

For ulcers caused by Helicobacter Pylori infection and to prevent recurrence

-The usual dose is one rabeprazole 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 Helicobacter pylori, read the package inserts for each one.

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

-The usual dose is three rabeprazole 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 problemsConsult your doctor, who will have special care in the initiation and during treatment with rabeprazole.

If you take more Rabeprazol Viatris than you should

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

In case of overdose or accidental ingestion, consult the Toxicological 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 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 treatment with Rabeprazol Viatris

Relief of symptoms usually occurs before the ulcer is completely healed.It is essential not to interrupt treatment until your doctor tells you to.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience 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, 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.
• Cardenales or easy bleeding.

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

• Severe blisters on the skin, or sores 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:

Frequent(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 intestines, such as stomach pain, diarrhea, gas (flatulence), feeling sick (nauseas), vomiting or constipation.

-Pain or back pain.

-Weakness or flu-like symptoms (pseudogripal).

-Benign polyps in the stomach.

Occasional(may affect up to 1 in 100 patients)

-Feeling nervous or drowsy.

-Chest infection (bronchitis).

-Sinuses painful and blocked (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(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 upset or stomach pain.

-Liver problems that include yellowing of the skin and the white of the eyes (jaundice).

-Eruption with itching or blisters.

-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.

Unknown frequency (cannot be estimated from available data)

-Swelling of the breasts in men.

-Fluid retention.

-Intestinal inflammation (leading to diarrhea).

-Low sodium levels in the blood, which may cause fatigue and confusion, muscle spasms, convulsions and coma.

-Patients who have previously had liver problems, may develop very rarely a encephalopathy (brain disease).

-Skin rash, possibly with joint pain.

If you take rabeprazol for more than three months, it is possible that your magnesium levels in the blood will decrease. Low levels of magnesium may manifest as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, 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 a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es/. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

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

Do not use this medication if you observe the packaging damaged or with signs of manipulation.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Rabeprazol Viatris

• The active ingredient is rabeprazol sodium. Each tablet contains 10 mg of rabeprazol sodium.

• The other components are:

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

Subcoat:ethylcellulose, heavy magnesium oxide.

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

Appearance of the product and contents of the packaging

Pink, biconvex, enteric-coated tablets.

The packaging contains aluminum blisters of 1, 5, 7, 14, 15, 25, 28, 30, 50, 56, 75, 98, and 120 tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Responsible manufacturer

Laboratorios Liconsa, S.A.

Avda. Miralcampo, 7, Industrial Estate Miralcampo

19200 - Azuqueca de Henares (Guadalajara)

Spain

Last review date of this leaflet:October 2022

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