RABEPRAZOL QUALIGEN 20 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the User

Rabeprazol Qualigen 20 mg Gastro-Resistant Tablets EFG

rabeprazol 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 or 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 or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Rabeprazol Qualigen contains the active substance rabeprazol sodium. Rabeprazol 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 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).
• 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 Qualigen

Do not take Rabeprazol Qualigen

• if you are allergic (hypersensitive) to rabeprazol 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 this medicine if you are in any of the above situations. If you are not sure, consult your doctor or pharmacist before taking this medicine.

See also the section on Pregnancy and breast-feeding.

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 this medicine is stopped.
• if you have a stomach tumor.
• if you have ever had liver problems.
• if you are taking atazanavir, a medicine for HIV.
• if you have ever had a skin reaction after treatment with a medicine similar to rabeprazol to reduce stomach acidity.
• A specific blood test (Chromogranin A) is planned

If you are in doubt about any of the above, consult your doctor or pharmacist before taking this medicine.

If you get a 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 rabeprazol. Remember to mention any other symptoms you may notice, such as joint pain.

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

During treatment with rabeprazol, 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

It should not be given to children.

Other medicines and Rabeprazol Qualigen

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

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

If you are in doubt about any of the above, consult your doctor or pharmacist before taking rabeprazol.

Pregnancy and breast-feeding

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

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

Driving and using machines

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

Rabeprazol Qualigen contains sodium

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

3. How to take Rabeprazol Qualigen

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor again.

Taking this medicine

• Only remove a tablet from the blister 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 the number of tablets you should 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 more severe symptoms (erosive or ulcerative GERD)

• The recommended dose is one 20 mg rabeprazol tablet once a day for 4 to 8 weeks.
• Take the tablet in the morning before eating.

Long-term treatment of symptoms (GERD maintenance)

• The recommended dose is one 10 mg or 20 mg rabeprazol 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 recommended dose is one 20 mg rabeprazol tablet once a day for 6 weeks.
• Take the tablet in the morning before eating.
• Your doctor may tell you to take rabeprazol for another 6 weeks if your symptoms do not improve.

For duodenal ulcers

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

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

• The recommended dose is three 20 mg rabeprazol 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 dose and symptom review.

Use in children

It should not be given to children.

Patient with liver problems

Consult your doctor, who will take special care when starting and during treatment with Rabeprazol Qualigen.

If you take more Rabeprazol Qualigen than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 5620420, indicating the medicine and the amount ingested.

If you forget to take Rabeprazol Qualigen

• 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 for your next dose, simply skip the missed dose 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 to make up for missed doses.

If you stop taking Rabeprazol Qualigen

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 about 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.

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

Stop taking Rabeprazol Qualigen 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 easy bleeding.

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 or blocked sinuses (sinusitis).
• Dry mouth.
• Indigestion or belching.
• Skin rash or redness.
• Muscle pain, leg pain, or joint pain. Urinary tract infection (urinary tract infection).
• Chest pain.
• Chills or fever.
• Changes in liver function (shown in blood tests).
• If you are taking proton pump inhibitors like rabeprazol, especially for a period of more than one 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).

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 the 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)

• Swelling of the breasts in men.
• Fluid retention.
• Inflammation of the intestine (leading to diarrhea)
• 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.
• if you are taking rabeprazol 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.

Reporting of side effects

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

5. Storing Rabeprazol Qualigen

Keep out of the sight and reach of children.

Do not store above 25°C.

Keep in the outer packaging to protect from moisture.

Do not use this medicine after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rabeprazol Qualigen 20 mg

The active substance is rabeprazol sodium. Each tablet contains 20 mg of rabeprazol sodium (equivalent to 18.85 mg of rabeprazol).

The other ingredients are: core: povidone, mannitol (E-421), magnesium oxide, hydroxypropyl cellulose, magnesium stearate; coating: ethyl cellulose, magnesium oxide; gastro-resistant coating: methacrylic acid-acrylic acid ethyl ester copolymer, polysorbate 80, sodium lauryl sulfate, propylene glycol (E-1520), talc, iron oxide red (E-172), iron oxide yellow (E-172), titanium dioxide (E-171).

Appearance of the product and contents of the pack

Rabeprazol Qualigen is presented as yellow-colored tablets with an enteric coating (gastro-resistant) in aluminum blister packs containing unitary alveoli.

Rabeprazol Qualigen tablets are available in blisters containing 14, 28 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

Manufacturer:

Balkanpharma Dupnitsa AD

3 Samokovsko Shosse Str.,

Dupnitsa- Bulgaria

Date of the last revision of this leaflet:May 2023

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