RABEPRAZOL AUROVITAS SPAIN 20 mg GASTRO-RESISTANT TABLETS

Introduction

Patient Information: Summary of Product Characteristics

Rabeprazol Aurovitas Spain 20mg gastro-resistant EFG tablets

Rabeprazole sodium

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

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

Rabeprazol Aurovitas Spain contains the active ingredient rabeprazole sodium. 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 the occurrence of acidity. 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 intestine (duodenal ulcers). If these ulcers are infected with a bacterium called “Helicobacter pylori” (H. pylori), you will need to take antibiotics. Taking rabeprazole and antibiotics together will eliminate the infection and the ulcer will heal. It will also stop 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.

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

Do not takeRabeprazol Aurovitas Spain

• if you are allergic to rabeprazole sodium or 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 breast-feeding.

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Rabeprazol 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 they often improve when treatment with rabeprazole is stopped.
• If you have a stomach tumor.
• If you have ever had liver problems.
• If you are taking atazanavir, a medicine for HIV infection.
• If you have low body stores or risk factors for low vitamin B12 levels and are receiving long-term treatment with rabeprazole. Like all acid-reducing agents, rabeprazole may reduce the absorption of vitamin B12.
• If you have ever had a skin reaction after treatment with a medicine similar to rabeprazole to reduce stomach acid.
• If you get a skin rash, especially in areas of the skin exposed to the sun, 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 about any of the above, consult your doctor or pharmacist before taking rabeprazole.

During treatment with rabeprazole, kidney inflammation may occur. The 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

Rabeprazol should not be given to children.

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

Taking a proton pump inhibitor like rabeprazole, especially for more than one year, may slightly increase the risk of fracture in the hip, wrist, or spine. Inform your doctor if you have osteoporosis or are taking corticosteroids (which can 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 take any other medicines.

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

• Ketoconazole or itraconazole, medicines for fungal infections. Rabeprazole may decrease the amount of these medicines in your blood. Your doctor may need to adjust your dose.
• Atazanavir, a medicine used to treat HIV infection. Rabeprazole may decrease the amount of this type of medicine in your blood, so they should 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 treatment with rabeprazole.

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

Pregnancy, breast-feeding, and fertility

• Do not take rabeprazole if you are pregnant or think you may be pregnant.
• Do not take rabeprazole during breast-feeding or if you plan to start breast-feeding.

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

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

Rabeprazol Aurovitas Spain contains sodium

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

3. How to take Rabeprazol Aurovitas Spain

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

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 tablets.
• Your doctor will tell you how many tablets to take and how long to take them, depending on your illness.
• If you are taking this medicine for a long time, your doctor will want to monitor you.

Adults and elderly

For “gastroesophageal reflux disease” (GERD)

Treatment of moderate to severe symptoms (symptomatic GERD)

• The usual dose is one 10 mg tablet of rabeprazole once a day for up to 4 weeks.
• Take the tablet in the morning before eating.
• If your symptoms come back after 4 weeks of treatment, your doctor will tell you to take one 10 mg tablet of rabeprazole when you need it.

Treatment of more severe symptoms (erosive or ulcerative GERD)

• The usual dose is one 20 mg tablet of rabeprazole 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 10 mg or 20 mg tablet of rabeprazole 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 20 mg tablet of rabeprazole 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 intestinal ulcers (duodenal ulcers)

• The usual dose is one 20 mg tablet of rabeprazole 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 tablet of rabeprazole 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 leaflet for each of them.

Zollinger-Ellison syndrome where there is an excess of acid in the stomach

• The usual dose is three 20 mg tablets of rabeprazole once a day at the start.
• 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 a review of your dose and symptoms.

Patients with liver problems. You should consult your doctor, who will be particularly careful when starting 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 a doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine 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 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 the missed dose.

If you stop taking Rabeprazol Aurovitas Spain

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 further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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

• Allergic reactions – the signs may include: sudden swelling of the 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 the mouth or throat.
• Bruising or easy bleeding.

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

• Severe skin blistering or ulcers or ulcers in your mouth and throat.

• Other possible side effects:

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

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

• Effects on the stomach or intestine such as stomach pain, diarrhea, gas (flatulence), nausea, vomiting, or constipation.
  • Back pain or pain.
  • Weakness or flu-like symptoms.
  • Benign polyps in the stomach.

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

• Nervousness or drowsiness.
• Chest infection (bronchitis).
• Painful or blocked sinuses (sinusitis).
• Dry mouth.
• Indigestion or belching.
• Redness of the skin or rash.
• Muscle pain, leg pain, or joint pain.
• Fractures in the hip, wrist, and spine.
• Urinary tract infection (urinary tract infection).
• Chest pain.
• Chills or fever.
• Changes in liver function (observed in blood tests).

Rare (may affect up to 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 (observed in blood tests) that can cause frequent infections.
• Decrease in blood platelets that can cause bleeding or bruising more easily than normal.

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

• Swelling of the breasts 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).
• Skin rash, possibly with joint pain.
• Inflammation of the intestine (leading to diarrhea).
• If you are taking rabeprazole 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, and increased heart rate. If you have any of these symptoms, see your doctor immediately. Low magnesium levels can also lead to a decrease in potassium or calcium levels in your blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.

Reporting of side effects:

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Rabeprazol Aurovitas Spain

Keep this medicine out of the 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 which is stated on the carton, blister, and label after EXP. The expiry 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 at your pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container Content and Additional Information

Composition of Rabeprazol Aurovitas Spain

• The active ingredient is sodium rabeprazole. Each tablet contains 20 mg of sodium rabeprazole.
• The other components are: core: povidone, mannitol (E421), light magnesium oxide, low-substitution 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 Container Content

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

Container 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 an integrated desiccant: 30, 100, and 250 tablets.

Only some container 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 Last Revision of this Leaflet: October 2022

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