Package Insert: Information for the Patient

Rabeprazol Aurovitas Spain 20mg gastro-resistant EFG tablets

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 refer to it again.

-If you have any questions, consult your doctor, pharmacist, or nurse.

-This medication has been prescribed only for you, and you should not give it to others who may 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.

1.What is Rabeprazol Aurovitas Spain and how is it used

2.What you need to know before starting to take Rabeprazol Aurovitas Spain

3.How to take Rabeprazol Aurovitas Spain

4.Possible adverse effects

5.Storage of Rabeprazol Aurovitas Spain

6.Contents of the package and additional information

Rabeprazol Aurovitas Spain contains the active ingredient rabeprazol sodium. Rabeprazol belongs to a class of medications known as “Proton Pump Inhibitors” (PPIs), which act by reducing the amount of acid produced by the stomach.

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 takeRabeprazol Aurovitas Spain

-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 rabeprazol.

Warnings and precautions

Consult your doctor,pharmacist or nurse before starting to takeRabeprazol Aurovitas Spain.

-if you are allergic to other proton pump inhibitors or to “substituted benzimidazoles”.

-liver and blood problems have been seen in some patients, but often improve when treatment with rabeprazol is stopped.

-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 risk factors for low vitamin B12levels and receive long-term treatment with rabeprazol. Like all acid-reducing agents, rabeprazol may reduce vitamin B12absorption.

-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 stop 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 (Cromogranina A).

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

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

Children

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

Other medications and Rabeprazol Aurovitas Spain

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 reduce 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 reduce 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, breastfeeding, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

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

Rabeprazol Aurovitas Spain contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as 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 tablets.

-Your doctor will tell you how many tablets to take and the duration of your treatment, which will depend on your condition.

-If you are taking this medication for a long time, your doctor will want to monitor you.

Adults and elderly people

For gastroesophageal reflux disease (GERD)

Symptomatic treatment of moderate to severe symptoms (GERD symptomatic)

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

Treatment of more severe symptoms (GERD erosive or ulcerative)

-The usual dose is one 20 mg rabeprazole 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 10 mg or 20 mg rabeprazole 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 monitor your symptoms and dose.

For stomach ulcers (peptic ulcers)

-The usual dose is one 20 mg rabeprazole 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 20 mg rabeprazole 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 H. Pylori infection and to prevent recurrence

-The usual dose is one 20 mg rabeprazole 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 package inserts for each one.

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

-The usual dose is three 20 mg rabeprazole tablets once a day initially.

-Your doctor may adjust the dose 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 dose review and symptom monitoring.

Patients with liver problems. You should consult your doctor, who will have special care in the initiation and during treatment with rabeprazole.

If you take more Rabeprazol Aurovitas Spain than you should

If you take more rabeprazole than your doctor has prescribed, consult your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Rabeprazol Aurovitas Spain

-If you forget to take a tablet, take it as soon as you remember. However, if it is almost time to take the next tablet, 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 Aurovitas Spain

The relief of symptoms usually occurs before the ulcer has 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.

Stop taking rabeprazol and seek medical attention immediately if you notice any of the following side effects – you may need urgent medical treatment:

These side effects are rare (they may affect up to 1 in 1,000 people):

-Allergic reactions – symptoms may include: sudden swelling of the face, difficulty breathing, or low blood pressure that can cause dizziness or fainting.

-Frequent infections, such as sore throat or high temperature (fever), or ulcers in the mouth or throat.

-Cardinal or easy bleeding.

These side effects are very rare (they may affect up to 1 in 10,000 people):

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

• Other possible side effects:

Frequent (they may affect up to 1 in 10 people):

• Infections.
• Difficulty sleeping.
• Headache or dizziness.
• Cough, runny nose, or sore throat (pharyngitis).

-Stomach or intestinal effects such as stomach pain, diarrhea, gas (flatulence), nausea, vomiting, or constipation.

• Pain or back pain.
• Weakness or flu-like symptoms.
• Benign polyps in the stomach.

Not very frequent (they may affect up to 1 in 100 people):

• Nervousness or drowsiness.
• 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 (observed in blood tests).

Rare (they may affect up to 1 in 1,000 people):

Frequency unknown (cannot be estimated from available data):

• Swelling of the breasts in men.
• Fluid retention.
• Low sodium levels in the blood that may cause fatigue and confusion, muscle spasms, seizures, and coma.
• Patients who have previously had liver problems, may develop a very rare encephalopathy (brain disease).
• Rash, possibly with joint pain.
• Intestinal inflammation (leading to diarrhea).
• If you are taking rabeprazol for more than three months, it is possible that magnesium levels in the blood may decrease. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, increased heart rate. If you experience any of these symptoms, seek medical attention immediately. Low magnesium levels may also lead to a decrease in potassium or calcium levels in your blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

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 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 this medication out of the sight and reach of children.

Blister packaging: Do not store at a temperature above 25?°C. Storein the outer packaging to protect it from humidity.

Bottles: Do not store at a temperature above 25?°C. Keep the container perfectly closed to protect it from humidity.

Do not use this medication after the expiration date that appears on the carton, blister, and label after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines you no longer need at the SIGREpoint of the pharmacy. Ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Rabeprazol Aurovitas Spain

-The active ingredient is rabeprazol sodium. Each tablet contains 20 mg of rabeprazol sodium.

-The other components are:nucleus: povidone, mannitol (E421), magnesium oxide, low-substituted hydroxypropyl cellulose, magnesium stearate;coating: ethylcellulose, magnesium oxide;gastro-resistant coating: methacrylic acid-ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate, propylene glycol, talc, iron oxide yellow (E172), titanium dioxide (E171).

Appearance of the product and contents of the package

Rabeprazol Aurovitas Spain 20mg gastro-resistant tablets EFG: Yellow-coated, biconvex, and elliptical tablets.

Package sizes:

Blister packs: 7, 14, 20, 28, 30, 56, 60, 98, 100, and 120 tablets.

Plastic bottles with a desiccant: 30, 100, and 250 tablets.

Plastic bottles with incorporated desiccant: 30, 100, and 250 tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer

Coripharma ehf.

Reykjavikurvegur 78

IS-220 Hafnarfjörður

Iceland

or

Puren Pharma GmbH & Co. KG,

Willy-Brandt-Allee 2,

81829 Munich,

Germany

This medication is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: October 2022

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