Rabeprazole Alter 10 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Rabeprazol Alter 10 mg gastro-resistant tablets EFG

Sodium rabeprazole

Read the entire 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 and you should not give it to other people, even if

they have the same symptoms as you, because it may harm them.

• If you think any of the side effects you experience is serious, or if you notice any side effects

not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What Rabeprazol Alter is and what it is used for
2. Before you take Rabeprazol Alter
3. How to take Rabeprazol Alter
4. Possible side effects
5. How to store Rabeprazol Alter
6. Further information

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

Rabeprazol Alter contains the active ingredient sodium rabeprazole. Rabeprazole belongs to a class of medicines known as "Proton Pump Inhibitors" (PPIs), which work by reducing the amount of acid produced by the stomach.

Rabeprazol is used for the treatment of:

• Gastroesophageal reflux disease (GERD), which may include heartburn. The cause of GERD is the backflow of acid and food from the stomach into the esophagus.

• Stomach ulcers or ulcers in the upper part of the intestine (duodenal ulcers). If these ulcers are infected with a bacterium called Helicobacter pylori (H. pylori), you will need to take antibiotics. Taking Rabeprazol Alter together with antibiotics will eliminate the infection and allow the ulcer to heal. It will also help prevent recurrence of the infection and the ulcer.

• Zollinger-Ellison syndrome, a condition characterized by the production of very high levels of acid in the stomach.

2. Before taking Rabeprazol Alter

Do not take Rabeprazol Alter

• If you are allergic (hypersensitive) to sodium rabeprazole 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 section on Pregnancy and breastfeeding.

Children

Rabeprazol Alter must 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 benzimidazole compounds".

• If liver or blood problems have occurred in some patients, although these often improve when treatment with Rabeprazol Alter is stopped.

• 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 used to reduce stomach acid.

• If you develop a skin rash, especially in areas exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to discontinue 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 rabeprazole, inflammation of the kidney may occur. 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 must report these signs to your doctor.

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

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

Use of other medicines

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

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

• Ketoconazole or itraconazole, medicines used to treat fungal infections. Rabeprazole may reduce the amount of these medicines in the blood. Your doctor may need to adjust your dose.
• Atazanavir, a medicine used to treat AIDS. Rabeprazole may reduce the amount of this medicine in the blood and therefore they should not be used together.

If you are unsure whether the above applies to you, 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 while breastfeeding or if you plan to start breastfeeding.

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

Driving and using machines

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

3. How to take Rabeprazol Alter

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

How to take this medicine

• Only remove one tablet from the blister pack when it is time to take your medicine.
• Swallow the tablet whole with some water. Do not crush or chew the tablet.
• Your doctor will tell you how many tablets you should take and the duration of your treatment, which will depend on your condition.
• 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 daily 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 instruct 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 daily for 4 to 8 weeks.
• Take the tablet in the morning before eating.

Long-term treatment of symptoms (maintenance of GERD)

• The usual dose is one Rabeprazol Alter 10 mg or 20 mg tablet once daily 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 daily for 6 weeks.
• Take the tablet in the morning before eating.
• Your doctor may instruct you to continue Rabeprazol Alter for another 6 weeks if your symptoms have not improved.

For intestinal ulcers (duodenal ulcers)

• The usual dose is one Rabeprazol Alter 20 mg tablet once daily for 4 weeks.
• Take the tablet in the morning before eating.
• Your doctor may instruct you to continue Rabeprazol Alter for another 4 weeks if your symptoms have not improved.

For ulcers caused by H. pylori infection and to prevent relapses

• The usual dose is one Rabeprazol Alter 20 mg tablet twice daily for 7 days.
• Your doctor will also instruct you to take antibiotics called amoxicillin and clarithromycin.

For more information about the other medicines used to treat H. pylori, please read the package leaflets for each of them.

Zollinger-Ellison syndrome, where excess stomach acid is produced

• The usual starting dose is three Rabeprazol Alter 20 mg tablets once daily.
• Your doctor may adjust the dose depending on your response to treatment.

If you are on long-term treatment, you will need to see your doctor at regular intervals to review your dose and symptoms.

Children. This medicine must not be given to children.

Patients with liver problems. Consult your doctor, who will exercise special caution at the beginning and during treatment with Rabeprazol Alter.

If you take more Rabeprazol Alter than you should

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

In case of overdose or accidental ingestion, contact 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, then continue as usual. However, if it is almost time for your next dose, simply skip the missed dose and continue as usual.
• If you have forgotten to take your medicine for more than 5 days, consult your doctor before taking any more medicine.
• Do not take a double dose (two doses at the same time) to make up for a missed dose.

If you stop taking Rabeprazol Alter

Symptom relief usually occurs before the ulcer has completely healed.

It is important not to stop treatment until your doctor tells you to do so.

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

4. Possible adverse effects

Like all medicines, Rabeprazol Alter may cause adverse effects, although not everyone experiences them.

The adverse effects are usually mild and improve without you needing to stop treatment.

Stop taking Rabeprazol Alter and see your doctor immediately if you notice any of the following adverse effects – you may need urgent medical treatment:

• Allergic reactions – signs may include: sudden swelling of the face, difficulty breathing, or low blood pressure that may cause fainting or collapse.
• Frequent infections, such as sore throat or high temperature (fever), or ulcers in your mouth or throat.
• Bruising or easy bleeding.

These adverse effects are rare (affect fewer than 1 in 1,000 people).

• Severe blistering of the skin, or sores or ulcers in your mouth and throat.

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

Other possible adverse effects:

Frequent (affect fewer 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, diarrhoea, gas (flatulence), feeling sick (nausea), being sick (vomiting), or constipation.
• Aches or back pain.
• Weakness or flu-like symptoms (flu-like symptoms).
• Benign polyps in the stomach.

Uncommon (affect fewer than 1 in 100 people)

• Feeling nervous or drowsy.
• Chest infection (bronchitis).
• Painful and blocked sinuses (sinusitis).
• Dry mouth.
• Indigestion or burping.
• 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 fewer than 1 in 1,000 people)

• Loss of appetite (anorexia).
• Depression.
• Hypersensitivity (including allergic reactions).
• Visual disturbances.
• Inflamed mouth (stomatitis) or taste disturbances.
• Stomach disorder or stomach pain.
• Liver problems including yellowing of the skin and whites of the eyes (jaundice).
• Itchy rash or blistering.
• Sweating.
• Kidney problems.
• Weight gain.
• Changes in white blood cells (shown in blood tests) which may lead to frequent infections.
• Decreased blood platelets which may cause bleeding or bruising more easily than normal.

Other possible adverse effects (frequency not known)

• Breast swelling in men.
• Fluid retention.
• Low levels of sodium in the blood which may cause tiredness and confusion, muscle spasms, seizures and coma.
• Patients who have previously had liver problems may very rarely develop encephalopathy (a brain disorder).
• If you are taking Rabeprazol Alter for more than three months, magnesium levels in the blood may decrease. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, contact your doctor immediately. Low magnesium levels may also lead to decreased levels of potassium and calcium 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 diarrhoea).

If you are taking proton pump inhibitors such as Rabeprazol Alter, especially for over a year, there may be a slight increase in the risk of fractures of the hip, wrist, and spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

Do not be alarmed by this list of adverse effects. You may not experience any of them.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse 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 expiry date stated on the packaging and blister. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or in household waste. Dispose of unused medicines and their packaging at a SIGRE collection point (or any other medicine waste collection system) at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Additional Information

Composition of Rabeprazol Alter

-The active substance is sodium rabeprazole. Each Rabeprazol Alter tablet contains 10 milligrams of sodium rabeprazole as the active substance.

-The other components are: mannitol, trisodium phosphate, magnesium oxide, hypromellose, low-substituted hydroxypropylcellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, ethylcellulose, Eudragit, triethyl citrate, talc, titanium dioxide (E171), red iron oxide (E 172).

Appearance of the medicinal product and content of the pack

Rabeprazol Alter 10 mg gastro-resistant tablets are presented as pink, round, biconvex tablets, not scored, in packs of 28 or 56 tablets.

Other pack sizes:

Rabeprazol Alter 20 mg gastro-resistant tablets: packs of 14, 28 or 56 tablets.

Marketing Authorization Holder and Manufacturer:

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

Date of the most recent revision of this leaflet:

October 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/