PATIENT INFORMATION LEAFLET

Rabeprazol Almus 20 mg gastro-resistant tablets EFG

Rabeprazol sodium

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

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

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

2. What you need to know before you start taking Rabeprazol Almus

3. How to take Rabeprazol Almus

4. Possible side effects

5. Storage of Rabeprazol Almus

6. Contents of the pack and additional information

Rabeprazol Almus belongs to the class of medications known as “Proton Pump Inhibitors” (PPIs), which act by reducing the amount of acid produced by the stomach. This preventsirritation of the stomach mucosa, allowing the healing of gastric ulcers andrelieving the pain and discomfort caused by ulcers.

Rabeprazol Almus is used for the treatment of:

• “Gastroesophageal reflux disease” (GERD), which may include the appearance 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. If these ulcers are infected with a bacteria called “Helicobacter pylori” (H. pylori), you will need to take antibiotics. Taking Rabeprazol Almus and antibiotics together will eliminate the infection and the ulcer will heal. It will also prevent 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.

Do not take Rabeprazol Almus:

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

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rabeprazol Almus:

• 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 Rabeprazol Almus is interrupted
• if you have a stomach tumor
• if you have had any liver problems
• if you are taking atazanavir, a medication for HIV infection
• if you have reduced body reserves or have risk factors associated with a reduced amount of B12 and are receiving long-term treatment with rabeprazol sodium. Like all acid-reducing agents, rabeprazol sodium may lead to reduced B12 absorption
• if you have ever had a skin reaction after treatment with a similar medication to Rabeprazol Almus for reducing stomach acid
• if you suffer from a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to interrupt treatment with Rabeprazol Almus. Remember to mention any other symptoms you may notice, such as joint pain
• if you are scheduled to have a specific blood test (Cromogranin A)
• during treatment with rabeprazol, inflammation in your kidney 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.

If you are unsure about whether the above affects you, consult your doctor or pharmacist before taking Rabeprazol Almus.

Children

Rabeprazol Almus should not be administered to children.

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

If you are taking proton pump inhibitors such as Rabeprazol Almus, especially for a period of over one year, it 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).

Taking Rabeprazol Almus with other medications

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 Almus 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 infection. Rabeprazol Almus may decrease the amount of this type of medication in the blood, so they should not be used together.
• Methodrexate (a chemotherapy medication used at high doses to treat cancer) – if you are taking a high dose of methotrexate, your doctor may temporarily stop your treatment with Rabeprazol Almus.

If you are unsure about whether the above affects you, consult your doctor or pharmacist before taking Rabeprazol Almus.

Pregnancy, breastfeeding, and fertility

Do not take Rabeprazol Almus if you are pregnant or plan to become pregnant.

Do not take Rabeprazol Almus if you are breastfeeding.

If you are pregnant, 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 Almus. If this occurs, do not drive or operate tools or machinery.

Rabeprazol Almus contains sodium

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

Follow exactly the administration instructions of Rabeprazol Almus indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Medication intake

• 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)

Symptomatic treatment of moderate to severe symptoms (GERD symptomatic)

• The usual dose is one Rabeprazol Almus 10 mg tablet once a day for up to 4 weeks.
• Take the tablet in the morning before eating.
• If your symptoms recur after 4 weeks of treatment, your doctor will tell you to take one Rabeprazol Almus 10 mg tablet as needed ("on demand").

Treatment of more severe symptoms (GERD erosive or ulcerative)

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

Maintenance treatment of symptoms (GERD maintenance)

• The usual dose is one Rabeprazol Almus 10 mg or 20 mg 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 dosage.

Stomach ulcers (peptic ulcers)

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

Duodenal ulcers

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

Ulcers caused by H. Pylori infection and to prevent recurrences

• The usual dose is one Rabeprazol Almus 20 mg tablet twice a day for 7 days.
• Your doctor will also tell you to take antibiotics called amoxicillin and clarithromycin.

For more information on other medications used to treat H. pylori, read the prospectus for each one.

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

• The usual dose is three Rabeprazol Almus 20 mg 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 a review of the dose and your symptoms.

Patients with liver problems.Consult your doctor, who will have special care in the initiation and during treatment with Rabeprazol Almus.

If you take more Rabeprazol Almus than you should

If you take more Rabeprazol Almus 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: 91 562 04 20 (indicating the medication and the amount ingested).

If you forget to take Rabeprazol Almus

If you forget to take a tablet, as soon as you remember take one and then continue normally. However, if it is almost time to take the next dose, 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 (two doses at the same time) to compensate for the missed doses.

If you interrupt treatment with Rabeprazol Almus

Relief of symptoms usually occurs before the ulcer has completely healed.It is therefore important not to interrupt treatment with Rabeprazol Almus 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 Almus and see your doctor immediately if you notice any of the following side effects – you may need urgent medical treatment:

• Allergic reactions – signs 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 ease of bleeding.

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

• Severe blisters on the 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
• Fractures in the hip, wrist and spine
• Urinary tract infection
• Chest pain
• Chills or fever
• Changes in liver function (shown in blood tests)

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 disorders
• Stomach upset or stomach pain
• Liver problems that include yellowing of the skin and the white of the eyes (jaundice)
• Eruption with itching or blisters
• Sweating
• Renal 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 takingRabeprazol Almusfor more than three months, it is possible that the levels of magnesium in the blood may decrease. Low levels of magnesium may cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness and increased heart rate. If you have any of these symptoms,please inform your doctor immediately. Low levels of magnesium may also produce a decrease in potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

Do not worry about the list of side effects. You may not experience any of them.

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 of Pharmacovigilance 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 this medication out of the sight and reach of children.

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

Do not store at a temperature above 25 °C. Store in the original packaging to protect from moisture.

Do not use Rabeprazol Almus if you observe the packaging damaged or with signs of manipulation.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and unused medications at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

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Composition of Rabeprazol Almus

The active ingredient is Rabeprazol sodium.

Each Rabeprazol Almus 20 mg tablet contains 20 mg of rabeprazol sodium.

The other components are:

Tablet core : mannitol, magnesium oxide, hydroxypropylcellulose, magnesium stearate.

Subcoat : ethylcellulose, magnesium oxide.

Enteric coating : hypromellose phthalate, dibutyl sebacate, yellow iron oxide (E172), titanium dioxide (E171), talc.

Appearance of the product and content of the packaging

Yellow, biconvex, enteric-coated tablets.

The packaging contains aluminum blister strips of 1, 5, 7, 14, 15, 25, 28, 30, 50, 56, 75, 98, and 120 tablets.

Not all presentations may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder :

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: [email protected]

Responsible manufacturer:

Laboratorios LICONSA, S.A.

Avda. Miralcampo, Nº7, Industrial Estate Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

Last review date of this leaflet : November 2023

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