Rabeprazole Aurovitas Spain 20 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Rabeprazol Aurovitas Spain 20mg gastro-resistant tablets EFG

Rabeprazole sodium

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Rabeprazol Aurovitas Spain is and what it is used for
2. What you need to know before taking Rabeprazol Aurovitas Spain
3. How to take Rabeprazol Aurovitas Spain
4. Possible side effects
5. How to store Rabeprazol Aurovitas Spain
6. Contents of the pack and other information

1. What Rabeprazol Aurovitas Spain is and what it is used for

Rabeprazol Aurovitas Spain contains the active substance 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.

Rabeprazole is used for the treatment of:

• Gastroesophageal reflux disease (GERD), which may include heartburn. GERD is caused by stomach acid and food flowing back 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), antibiotic treatment will be required. Taking rabeprazole together with antibiotics eradicates the infection and allows the ulcer to heal. This also prevents recurrence of the infection and ulcer.
• Zollinger-Ellison syndrome, a condition characterized by excessive production of stomach acid.

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

Do not take Rabeprazol Aurovitas Spain

• if you are allergic to sodium rabeprazole or to any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant or think you may be pregnant.
• if you are breastfeeding.

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to take Rabeprazol Aurovitas Spain.

• If you are allergic to other proton pump inhibitors or to "substituted benzimidazole compounds".
• Liver and blood problems have been observed in some patients, but these often improve when treatment with rabeprazole is stopped.
• If you have a stomach tumour.
• If you have previously had liver problems.
• If you are taking atazanavir, a medicine used to treat HIV infection.
• If you have low body reserves or risk factors for low vitamin B12 levels and are receiving long-term treatment with rabeprazole. Like all agents that reduce acidity, rabeprazole may reduce the absorption of vitamin B12.
• If you have ever had a skin reaction after treatment with a medicine similar to rabeprazole for reducing stomach acid.
• If you develop a skin rash, especially in areas of skin exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to stop treatment with rabeprazole. 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).

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

During treatment with rabeprazole, kidney inflammation 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 should report these signs to your doctor.

Children

Rabeprazole must not be given to children.

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

Taking a proton pump inhibitor such as rabeprazole, especially for more than one year, may slightly increase the risk of fracture of the hip, wrist, or spine. Inform your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).

Other medicines and Rabeprazol Aurovitas Spain

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other 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 blood levels of these medicines. Your doctor may need to adjust your dose.
• Atazanavir, a medicine used to treat HIV infection. Rabeprazole may reduce blood levels of this medicine and therefore must not be used together.
• Methotrexate (a chemotherapy medicine used at high doses to treat cancer) – if you are taking a high dose of methotrexate, your doctor may temporarily stop your rabeprazole treatment.

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

Pregnancy, breastfeeding, and fertility

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

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and use of machines

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

Rabeprazol Aurovitas Spain contains sodium

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

3. How to take Rabeprazole Aurovitas Spain

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

How to take this medicine

• Only remove a 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 tablets.
• Your doctor will tell you how many tablets you should take and how long your treatment should last, depending 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 10 mg rabeprazole 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 10 mg rabeprazole tablet as needed.

Treatment of more severe symptoms (erosive or ulcerative GERD)

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

For stomach ulcers (peptic ulcers)

• The usual dose is one 20 mg rabeprazole tablet once daily for 6 weeks.
• Take the tablet in the morning before eating.
• Your doctor may instruct you to continue rabeprazole for another 6 weeks if your symptoms do not improve.

For intestinal ulcers (duodenal ulcers)

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

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

• The usual dose is one 20 mg rabeprazole tablet twice daily for seven 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 20 mg rabeprazole 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.

Patients with liver problems. You should consult your doctor, who will exercise special caution at the start and during treatment with rabeprazole.

If you take more Rabeprazole Aurovitas Spain than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Rabeprazole Aurovitas Spain

• If you forget to take a tablet, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue as usual.
• If you have missed taking 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 forgotten dose.

If you stop taking Rabeprazole Aurovitas Spain

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 medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

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

• 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 mouth or throat ulcers.
• Bruising or increased tendency to bleed.

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

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

• Other possible adverse effects:

Frequent (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, diarrhoea, gas (flatulence), nausea, vomiting, or constipation.

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

Uncommon (may affect up to 1 in 100 people):

• Feeling restless or drowsy.
• Chest infection (bronchitis).
• Painful and blocked sinuses (sinusitis).
• Dry mouth.
• Indigestion or burping.
• Skin rash or redness.
• Muscle, leg, or joint pain.
• Fractures of the hip, wrist, or spine.
• Bladder infection (urinary tract infection).
• Chest pain.
• Chills or fever.
• Changes in liver function (seen in blood tests).

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

• Loss of appetite (anorexia).
• Depression.
• Hypersensitivity (including allergic reactions).
• Visual disturbances.
• Inflamed mouth (stomatitis) or taste disturbances.
• Stomach discomfort 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 (seen in blood tests) that may lead to frequent infections.
• Decreased platelet count in the blood, which may lead to bleeding or bruising more easily than normal.

Frequency not known (cannot be estimated from available data):

• Breast enlargement in men.
• Fluid retention.
• Low sodium levels 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 (brain disease).
• Skin rash, possibly with joint pain.
• Inflammation of the intestine (leading to diarrhoea).
• If you are taking rabeprazole for more than three months, magnesium levels in your 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 potassium or calcium levels in your blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.

Reporting of adverse effects:

If you experience any adverse effect, talk to 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 Aurovitas Spain

Keep this medicine out of sight and reach of children.

Blister packs: Do not store above 25°C. Store in the outer packaging to protect from moisture.

Bottles: Do not store above 25°C. Keep the container tightly closed to protect from moisture.

Do not use this medicine after the expiry date stated on the carton, blister, and label after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rabeprazol Aurovitas Spain

• The active substance is rabeprazol sodium. Each tablet contains 20 mg of rabeprazol sodium.
• The other components are: core: povidone, mannitol (E421), light magnesium oxide, low-substituted hydroxypropyl cellulose, magnesium stearate; coating: ethylcellulose, light magnesium oxide; gastro-resistant coating: methacrylic acid-ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate, propylene glycol, talc, yellow iron oxide (E172), titanium dioxide (E171).

Appearance of the product and contents of the pack

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

Pack 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 integrated desiccant: 30, 100 and 250 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

Coripharma ehf.

Reykjavikurvegur 78

IS-220 Hafnarfjörður

Iceland

or

Puren Pharma GmbH & Co. KG,

Willy-Brandt-Allee 2,

81829 Munich,

Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: October 2022

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