Package Insert: Information for the User

Rabeprazol Qualigen 20 mg Gastrorresistant Tablets EFG

Rabeprazol sodium

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.

• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert.See section 4.

1. What is Rabeprazol Qualigen and how is it used

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

3. How to take Rabeprazol Qualigen

4. Possible adverse effects

5. Storage of Rabeprazol Qualigen

6. Contents of the package and additional information

Rabeprazol Qualigen contains the active ingredient rabeprazol sodium. Rabeprazol belongs to a class of medications known as “Proton Pump Inhibitors” (PPIs), which act by reducing the amount of acid produced by the stomach.

Rabeprazol is used to treat:

• “Gastroesophageal Reflux Disease” (GERD), which may include the occurrence of acid reflux. The cause of GERD is the passage of acid and food from the stomach into the esophagus.
• Stomach ulcers or duodenal ulcers.
• Zollinger-Ellison syndrome, a disease characterized by the production of very high amounts of acid in the stomach.

Do not take Rabeprazol Qualigen

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

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

See also the Pregnancy and breastfeeding section.

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 you have seen liver and blood problems in some patients but often improve when the treatment with this medication is interrupted.
• if you have a stomach tumor.
• if you have ever had liver problems.
• if you are taking atazanavir, a medication for HIV/AIDS.
• if you have ever had a skin reaction after treatment with a similar medication to rabeprazol for reducing stomach acid.
• You are scheduled to have a specific blood test (Chromogranin A)

If you have doubts about whether the above affects you, consult your doctor or pharmacist before taking this medication.

If you suffer from a skin rash, especially in areas of skin exposed to the sun, consult your doctor as soon as possible, as it may be necessary to interrupt 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 medication and see your doctor immediately.

During treatment with rabeprazol, inflammation in your kidneys may occur. Among the signs and symptoms are: decreased urine volume or blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. You must notify these signs to your doctor.

Children

This medication should not be administered to children.

Other medications and Rabeprazol Qualigen

Inform your doctor or pharmacist if you are taking or have recently taken other medications, including over-the-counter medications and herbal supplements.

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

• Ketoconazole or itraconazole, medications for fungal infections. Rabeprazol may decrease the amount of these medications in the blood. Your doctor may need to adjust your dose.
• Atazanavir, a medication used to treat HIV/AIDS. Rabeprazol may decrease the amount of this type of medication in the blood, so they should not be used together.

If you have doubts about whether the above affects you, consult your doctor or pharmacist before taking rabeprazol.

Pregnancy and breastfeeding

• Do not take this medication if you are pregnant or think you may be pregnant.
• Do not take this medication during 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 medication.

Driving and operating machinery

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

Rabeprazol Qualigen contains sodium

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

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

Administration of this medication

• Only remove one tablet from the blister pack when it is time to take your medication.
• Swallow the tablet whole with a little water. Do not crush or chew the tablet.
• Your doctor will tell you how many tablets to take and the duration of your treatment, which will depend on your indication.
• If you are taking this medication for a long time, your doctor will want to monitor you.

Adults and elderly patients

Gastroesophageal reflux disease (GERD)

Treatment of severe symptoms (erosive or ulcerative GERD)

• The recommended dose is one tablet of rabeprazole 20 mg 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 tablet of rabeprazole 10 mg or 20 mg 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 the dose.

For stomach ulcers (peptic ulcers)

• The recommended dose is one tablet of rabeprazole 20 mg 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 duodenal ulcers

• The recommended dose is one tablet of rabeprazole 20 mg 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.

Zollinger-Ellison syndrome, where excess acid is produced in the stomach

• The recommended dose is three tablets of rabeprazole 20 mg 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 review and symptom check.

Use in children

This medication should not be given to children.

Patients with liver problems

Consult your doctor, who will have special care in the initiation and during treatment with Rabeprazole Qualigen.

If you take more Rabeprazole Qualigen than you should

If you take more Rabeprazole Qualigen than you should, talk to your doctor or go to the hospital immediately. Bring the medication with you.

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

If you forget to take Rabeprazole Qualigen

• If you forget to take a tablet, as soon as you remember take one and then continue as usual. However, if it is almost time to take the next tablet, simply skip the missed tablet and continue as usual.
• If you forget to take your medication for more than 5 days, consult your doctor before taking more medication.

Do not take a double dose to compensate for missed doses.

If you interrupt treatment with Rabeprazole Qualigen

Relief of symptoms usually occurs before the ulcer is completely healed.It is essential not to interrupt treatment until your doctor tells you to.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience 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 – symptoms may include; sudden swelling of your face, difficulty breathing or low blood pressure that can cause dizziness or collapse.
• Frequent infections, such as sore throat or high temperature (fever), or ulcers in your mouth or throat.
• Cardenals or easy bleeding.

These side effects are rare (affect less than 1 in 1,000 people).

• Severe blisters on your skin, 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 intestines such as stomach pain, diarrhea, gas (flatulence), feeling sick (nauseas), being sick (vomiting) or constipation.
• Pain or back pain.
• Weakness or flu-like symptoms (pseudogripal).
• Benign polyps in the stomach.

Rare (affect less than 1 in 100 people)

• Feeling nervous or drowsy.
• Chest infection (bronchitis).
• Blocked and painful sinuses (sinusitis).
• Dry mouth.
• Indigestion or belching.
• Rash on the skin or redness.
• Muscle pain, leg pain or joint pain.Infection of the bladder (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 rabeprazol, especially for a period of more than one year, you may slightly increase the risk of hip, wrist and spinal fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (they may increase the risk of osteoporosis).

Rare (affect less than 1 in 1,000 people)

• Loss of appetite (anorexia)
• Depression.
• Hypersensitivity (including allergic reactions).
• Visual disturbances.
• Inflamed mouth (stomatitis) or taste disturbances.
• Stomach problems or stomach pain.
• Liver problems that include yellowing of the skin and white of the eyes (jaundice).
• Itching or blistering rash.
• Sweating.
• Kidney problems.
• Weight gain.
• Changes in white blood cells in the blood (shown in blood tests) that may cause frequent infections.
• Decreased platelets in the blood that may cause bleeding or the appearance of bruises with increased ease.

Other possible side effects (frequency unknown)

• Swelling of the breasts in men.
• Fluid retention.
• Inflammation of the intestine (leading to diarrhea)
• Low sodium levels in the blood that may cause fatigue and confusion, muscle spasms, convulsions and coma.
• Patients who have previously had liver problems, may develop very rarely a encephalopathy (brain disease).
• Skin rash, possibly with joint pain.
• If you are taking rabeprazol for more than three months, it is possible that the levels of magnesium in the blood may decrease. Low magnesium levels may 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 may 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 side effects

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

Keep out of sight and reach of children.

Do not store at a temperature above 25°C.

Storein the outer packaging to protect it from moisture.

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medicines at the SIGRE collection pointat the pharmacy. Askyour pharmacist how to dispose of the packaging and medicines that you no longer need. By doing so, you will help protect the environment.

Composition of Rabeprazol Qualigen 20 mg

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

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

Rabeprazol Qualigen is presented as yellow-colored enteric-coated (gastric-resistant) tablets in packaging containing aluminum blister strips with the tablets housed in individual alveoli.

Rabeprazol Qualigen tablets are available in blister packs containing 14, 28 tablets.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

Responsible manufacturer:

Balkanpharma Dupnitsa AD

3 Samokovsko Shosse Str.,

Dupnitsa- Bulgaria

Last review date of this leaflet:May 2023

The detailed information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es