Rabeprazole Qualigen 20 mg gastro-resistant tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Rabeprazol Qualigen 20 mg 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 must not pass it on 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 these effects are not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Rabeprazol Qualigen 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 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).
• Zollinger-Ellison syndrome, a condition characterized by the production of very high amounts of acid in the stomach.

2. What you need to know before starting to take Rabeprazol Qualigen

Do not take Rabeprazol Qualigen

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

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

See also the section on Pregnancy and breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before taking rabeprazole:

• if you are allergic to proton pump inhibitors or to "substituted benzimidazoles".
• if liver or blood problems have occurred in some patients, but these 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/AIDS.
• if you have ever had a skin reaction after treatment with a medicine similar to rabeprazole used to reduce stomach acid.
• 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 this medicine.

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 discontinue treatment with rabeprazole. 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 tenderness, stop taking this medicine and see your doctor immediately.

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.

Children

This medicine must 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, 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 blood levels of these medicines. Your doctor may need to adjust your dose.
• Atazanavir, a medicine used in the treatment of HIV/AIDS. Rabeprazole may reduce blood levels of this type of medicine and therefore they should not be used together.

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

Pregnancy and breastfeeding

• Do not take this medicine if you are pregnant or think you may be pregnant.
• Do not take this medicine 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 Qualigen contains sodium

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

3. How to take Rabeprazol Qualigen

Follow exactly the administration instructions for this medicine as indicated by your doctor. If in doubt, consult your doctor 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 a little 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 more severe symptoms (erosive or ulcerative GERD)

• The recommended 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 recommended dose is one 10 mg or 20 mg rabeprazole tablet once daily for as long as your doctor has instructed.
• 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 recommended 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 take rabeprazole for another 6 weeks if your symptoms do not improve.

For intestinal ulcers (duodenal ulcers)

• The recommended 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 take rabeprazole for another 4 weeks if your symptoms do not improve.

Zollinger-Ellison syndrome, in which excess stomach acid is produced

• The recommended 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 undergoing long-term treatment, you will need regular check-ups with your doctor to review your dose and symptoms.

Use in 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 Qualigen.

If you take more Rabeprazol Qualigen than you should

If you take more Rabeprazol Qualigen 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 your doctor or pharmacist immediately or call the Toxicology Information Service at 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, then continue as usual. However, if it is almost time for your next dose, simply skip the missed dose and continue your regular dosing schedule.
• 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 to make up for a missed dose.

If you stop taking Rabeprazol Qualigen

Relief of symptoms 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, this medicine can cause adverse effects, although not everyone experiences them.

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

Stop taking Rabeprazol Qualigen and see your doctor immediately if you experience 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.
• Pains or back pain.
• Weakness or flu-like symptoms (pseudoinfluenza 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).
• If you are taking proton pump inhibitors such as rabeprazole, especially for a period longer than one 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 are taking corticosteroids (which may increase the risk of osteoporosis).

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.
• Decrease in 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.
• Inflammation of the intestine (leading to diarrhoea).
• 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).
• Skin rash, possibly with joint pain.
• If you are taking rabeprazole for more than three months, your blood magnesium levels 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 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 Medicinal Products: http://www.notificaram.es/. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rabeprazol Qualigen

Keep out of the sight and reach of children.

Do not store above 25°C.

Store in the original outer packaging to protect from moisture.

Do not use this medicine after the expiry date stated on the container. The expiry date is the last day of the month indicated.

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

6. Package contents and additional information

Composition of Rabeprazol Qualigen 20 mg

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

The other components are: core: povidone, mannitol (E-421), magnesium oxide, hydroxypropyl cellulose, magnesium stearate; coating: ethyl cellulose, magnesium oxide; enteric (gastric-resistant) coating: methacrylic acid-ethyl acrylate 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 container

Rabeprazol Qualigen is presented as yellow enteric-coated (gastric-resistant) tablets, in packaging containing aluminum blisters with tablets housed in individual alveoli.

Rabeprazol Qualigen tablets are available in blisters containing 14 or 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 most recent revision of this leaflet: May 2023

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