PATIENT INFORMATION LEAFLET

Rabeprazol Alter 20 mg gastro-resistant tablets EFG

Rabeprazol sodium

Read this leaflet carefully before you start taking this medicine.

-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. Do not pass it on to others even if their symptoms are the same.

It may harm them.

-If you think you have suffered a side effect you can report it directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Alternatively you can report it on the MHRA's website (www.mhra.gov.uk/yellowcard).

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

2.Before taking Rabeprazol Alter

3.How to take Rabeprazol Alter

4.Possible side effects

5.Storage of Rabeprazol Alter

6.Further information

Rabeprazol Alter 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 appearance of

acid reflux. The cause of GERDis 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 Alter and the antibiotics

together will eliminate the infection and the ulcer will heal. It will also prevent the infection and the reoccurrence 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 Alter

•If you are allergic (hypersensitive) to rabeprazol sodium, or to any of the

other components of Rabeprazol Alter (see list 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 Alter.

See also the Pregnancy and breastfeeding section.

Children

It should not be administered to children.

Warnings and precautionsConsult your doctor or pharmacist before taking Rabeprazol:

• If you are allergic to proton pump inhibitors or to “substituted benzimidazoles”.

Inform your doctor or pharmacist if you have any of the following:

• Problems with the liver and blood in some patients, but often improve when treatment with Rabeprazol Alter is stopped.
• You have a stomach tumor.
• You have ever had liver problems.
• You are taking atazanavir, a medication for HIV/AIDS.

If you have ever had a skin reaction after treatment with a similar medication to Rabeprazol Alter for reducing stomach acid. If you suffer from a skin rash, especially in exposed areas, consult your doctor as soon as possible, as it may be necessary to stop treatment with Rabeprazol Alter. Remember to mention any other symptoms you may notice,such as joint pain.

• You are scheduled to have a specific blood test (Cromogranina A).
• During treatment with rabeprazol, inflammation in your kidney 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 your doctor of these signs.

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

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

Use of other medications

Inform your doctor or pharmacist if you are taking or have recently taken other medications, including over-the-counter medications and herbal supplements.

In particular, 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 your blood. Your doctor may need to adjust your dose.
• Atazanavir, a medication used to treat HIV/AIDS. Rabeprazol may decrease the amount of this type of medication in your blood, so they should not be used together.

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

Pregnancy and breastfeeding

• 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.

Consult your doctor or pharmacist before using any medication during pregnancy or breastfeeding.

Driving and operating machinery

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

Follow exactly the administration instructions of Rabeprazol Alter indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Medication intake

• Only take one tablet out of the blister pack when it's 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 Rabeprazol Alter 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 Rabeprazol Alter 10 mg tablet as needed.

Treatment of more severe symptoms (GERD erosive or ulcerative)

• The usual dose is one Rabeprazol Alter 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 Rabeprazol Alter 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 Rabeprazol Alter 20 mg tablet once a day for 6 weeks.
• Take the tablet in the morning before eating.
• Your doctor may tell you to take Rabeprazol Alter for another 6 weeks if your symptoms do not improve.

For duodenal ulcers

• The usual dose is one Rabeprazol Alter 20 mg tablet once a day for 4 weeks.
• Take the tablet in the morning before eating.
• Your doctor may tell you to take Rabeprazol Alter for another 4 weeks if your symptoms do not improve.

For ulcers caused by H. Pylori infection and to prevent recurrences

• The usual dose is one Rabeprazol Alter 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 H. pylori, read the prospectus for each one.

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

• The usual dose is three Rabeprazol Alter 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.

Children.This medication should not be administered to children.

Patients with liver problems.Consult your doctor, who will have special care in the initiation and during treatment with Rabeprazol Alter.

If you take more Rabeprazol Alter than you should

If you take more Rabeprazol Alter 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 Alter

• 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 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 Alter

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 doubts about the use of this product, ask your doctor or pharmacist.

Like all medicines, Rabeprazol Alter may cause side effects, although not everyone will experience them.

Side effects are usually mild and improve without you stopping treatment.

Stop taking Rabeprazol Alter 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.
• Cardinal or easy bleeding.

These side effects are rare (affect less than 1 in 1,000 people).

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

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

Other possible side effects:

Frequent (affect less than 1 in 10 people)

• 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 (nausea), being sick (vomiting) or constipation.
• Pain or back pain.
• Weakness or flu-like symptoms.
• Benign polyps in the stomach.

Occasional (affect less than 1 in 100 people)

• Feeling nervous or drowsy.
• Chest infection (bronchitis).
• Blocked and painful sinuses.
• Dry mouth.
• Indigestion or belching.
• Rash on the skin or redness.
• Muscle pain, leg pain or joint pain.
• Urinary tract infection.
• Chest pain.
• Chills or fever.
• Changes in liver function (shown in blood tests).

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

• Loss of appetite (anorexia).
• Depression.
• Hypersensitivity (including allergic reactions).
• Visual disturbances.
• Inflamed mouth (stomatitis) or taste disturbances.
• Stomach problems or stomach pain.
• Liver problems that include yellowing of the skin and the white of the eyes (jaundice).
• Rash 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.

Other possible side effects (frequency unknown)

• Swelling of the breasts in men.
• Fluid retention.
• Low sodium levels in the blood that may cause fatigue and confusion, muscle spasms, convulsions and coma.
• Patients who have previously had liver problems may develop a very rare encephalopathy (brain disease).
• If you are taking Rabeprazol Alter 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, convulsions, dizziness, increased heart rate. If you have any of these symptoms, see your doctor immediately. Low magnesium levels may also cause a decrease in potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.
• Skin rash, possibly with joint pain.
• Inflammation of the intestine (leading to diarrhea).

If you are taking proton pump inhibitors such as Rabeprazol Alter, especially for more than a year, you may slightly increase the risk of hip, wrist and spinal fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (they may increase the risk of osteoporosis).

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 theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine

Keep out of reach and sight of children.

Do not store above 86°F (30°C).

Do not refrigerate.

Do not use Rabeprazol Alter after the expiration date that appears on the packaging and in the blister pack. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point (or any other medication waste collection system) at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Rabeprazol Alter Composition

-The active ingredient is rabeprazol sodium. Each Rabeprazol Alter tablet contains 20 milligrams of rabeprazol sodium as the active ingredient.

-The other components are: mannitol, trisodium phosphate, magnesium oxide, hydroxypropylmethylcellulose, low-substituted hydroxypropylcellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, ethylcellulose, Eudragit, triethyl citrate, talc, titanium dioxide (E171), yellow iron oxide (E172).

Product Appearance and Packaging Contents

Rabeprazol Alter 20 mg gastro-resistant tablets are presented as round, biconvex, yellow ochre-colored tablets without scoring in packs of 14, 28, or 56 tablets.

Other presentations:

Rabeprazol Alter 10 mg gastro-resistant tablets: pack of 28 or 56 tablets.

Marketing Authorization Holder and Responsible Manufacturer:

Alter Laboratories, S.A.

Mateo Inurria,30

28036 Madrid

Last Review Date of this Leaflet:

October 2022

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