RABEPRAZOL ALTER 20 mg GASTRO-RESISTANT TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Rabeprazol Alter 20 mg gastro-resistant tablets EFG

Rabeprazol sodium

Read all of this leaflet carefully before you start taking this medicine.

• 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, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

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 Rabeprazol Alter.

See also the section on Pregnancy and breast-feeding.

Children

It should not be given to children.

Warnings and precautions

Consult your doctor or pharmacist before taking Rabeprazol:

• 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 Rabeprazol Alter is interrupted.
• If you have a stomach tumor.
• If you have ever had liver problems.
• If you are taking atazanavir, a medicine for AIDS.

If you have ever had a skin reaction after treatment with a medicine similar to Rabeprazol Alter to reduce stomach acid. If you get a rash, especially in areas exposed to the sun, consult your doctor as soon as possible, as it may be necessary to interrupt treatment with Rabeprazol Alter. Remember to mention any other symptoms you may notice, such as joint pain.

• If you are scheduled to have a specific blood test (Chromogranin A).
• During treatment with rabeprazol, kidney inflammation can occur. The signs and symptoms include: decreased urine volume or blood in the urine and/or hypersensitivity reactions such as fever, rash, and joint stiffness. You should report these signs to your doctor.

If you are in doubt about whether the above applies to you, 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 medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription, including herbal remedies.

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 AIDS. Rabeprazol can decrease the amount of this type of medicine in your blood, so they should not be used together.

If you are in doubt about whether the above applies to you, consult your doctor or pharmacist before taking Rabeprazol.

Pregnancy and breast-feeding

• 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.

Consult your doctor or pharmacist before using any medicine during pregnancy or breast-feeding.

Driving and using machines

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

3. How to take Rabeprazol Alter

Follow the instructions for taking Rabeprazol Alter exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

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 to 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 Rabeprazol Alter 10 mg tablet once a day 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 tell you to take one Rabeprazol Alter 10 mg tablet as needed ("on demand").

Treatment of more severe symptoms (erosive or ulcerative GERD)

• 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.

Long-term treatment of symptoms (maintenance GERD)

• 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 dose.

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 relapse

• 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 the other medicines used to treat H. 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 Rabeprazol Alter 20 mg 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 dose and symptom review.

Children

It should not be given to children.

Patients with liver problems

Consult your doctor, who will take special care when starting 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 a hospital immediately. Bring 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 Alter

• 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 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 Alter

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 product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rabeprazol Alter can cause side effects, although not everyone gets 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 - the signs may 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.
• Bruising or bleeding easily.

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

• Severe skin blisters, 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 intestine 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 stomach polyps.

Uncommon (affect less than 1 in 100 people)

• Feeling nervous or drowsy.
• Chest infection (bronchitis).
• Painful and blocked sinuses (sinusitis).
• Dry mouth.
• Indigestion or belching.
• Skin rash or redness.
• Muscle, leg, or joint pain.
• Bladder infection (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)

• Lack of appetite (anorexia).
• Depression.
• Hypersensitivity (including allergic reactions).
• Visual disturbances.
• Inflamed mouth (stomatitis) or taste disorders.
• Stomach disorder or stomach pain.
• Liver problems including yellowing of the skin and 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.

Other possible side effects (frequency not known)

• Breast swelling in men.
• Fluid retention.
• Low sodium levels in the blood that can cause fatigue and confusion, muscle spasms, convulsions, and coma.
• Patients who have previously had liver problems may very rarely develop encephalopathy (brain disease).
• If you are taking Rabeprazol Alter for more than three months, it is possible that your blood magnesium levels may decrease. Low magnesium levels can 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 can 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 like Rabeprazol Alter, especially for more than a year, you may have a slightly increased risk of hip, wrist, and spine fractures. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

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, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Rabeprazol Alter

Keep out of the reach and sight of children.

Do not store above 30°C.

Do not refrigerate.

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

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE Collection Point (or any other medicine waste collection system) at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Additional information

Composition of Rabeprazol Alter

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

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

Appearance of the product and packaging contents

Rabeprazol Alter 20 mg gastro-resistant tablets are presented as yellow-ochre, biconvex, round 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 manufacturer:

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

Date of last revision of this leaflet:

October 2022

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