RABEPRAZOL ALMUS 20 mg GASTRO-RESISTANT TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Rabeprazole Almus 20 mg gastro-resistant tablets EFG

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 or pharmacist.
• 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. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

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

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

Rabeprazole Almus belongs to a class of medicines known as “Proton Pump Inhibitors” (PPIs), which work by reducing the amount of acid produced by the stomach. This prevents irritation of the stomach lining, allowing the stomach ulcer to heal and relieving the pain and discomfort caused by ulcers.

Rabeprazole Almus is used for the treatment of:

• “Gastroesophageal reflux disease” (GERD), which may include symptoms 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 Almus and antibiotics together will get rid of the infection and the ulcer will heal. It will also stop the infection and the ulcer from coming back.
• 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 Rabeprazole Almus

Do not take Rabeprazole Almus:

• if you are allergic (hypersensitive) to rabeprazole sodium or any of the other ingredients of this medicine (see section 6)
• if you are pregnant or think you may be pregnant
• if you are breast-feeding

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

Warnings and precautions

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

• 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 Rabeprazole Almus 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 reduced body stores or have risk factors for reduced vitamin B12 and are receiving long-term treatment with rabeprazole sodium. As with all acid-reducing agents, rabeprazole sodium may lead to a reduced absorption of vitamin B12
• if you have ever had a skin reaction after treatment with a medicine similar to Rabeprazole Almus to reduce stomach acid
• if you get a skin rash, especially in areas of skin exposed to the sun, consult your doctor as soon as possible, as you may need to stop treatment with Rabeprazole Almus. Remember to mention any other symptoms that you notice, such as joint pain
• if you are due to have a specific blood test (Chromogranin A)
• during treatment with rabeprazole, kidney inflammation can 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.

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

Children

Rabeprazole Almus should not be given to children.

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

If you are taking proton pump inhibitors like Rabeprazole Almus, especially for more than one year, you may slightly increase the risk of hip, wrist, and spine fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

Taking Rabeprazole Almus with other medicines

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. Rabeprazole Almus 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 Almus 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 stop your treatment with Rabeprazole Almus temporarily.

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

Pregnancy, breast-feeding, and fertility

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

Do not take Rabeprazole Almus if you are 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 Almus. If this happens, do not drive or use tools or machines.

Rabeprazole Almus contains sodium

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

3. How to take Rabeprazole Almus

Follow the instructions for administration of Rabeprazole Almus exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist 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 how many tablets to take and for how long. This 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 moderate to severe symptoms (symptomatic GERD)

• The usual dose is one 10 mg Rabeprazole Almus tablet 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 Rabeprazole Almus tablet as needed.

Treatment of more severe symptoms (erosive or ulcerative GERD)

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

For duodenal ulcers

• The usual dose is one 20 mg Rabeprazole Almus tablet once a day for 4 weeks.
• Take the tablet in the morning before eating.
• Your doctor may tell you to take Rabeprazole Almus 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 Rabeprazole Almus tablet 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 Rabeprazole Almus tablets once a day at the start.
• 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 your dose and symptoms.

Patients with liver problems.Your doctor will be very careful when starting and during treatment with Rabeprazole Almus.

If you take more Rabeprazole Almus than you should

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

If you forget to take Rabeprazole Almus

If you forget to take a tablet, take one as soon as you remember. Then continue as normal. However, if it is almost time for your next dose, 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 missed doses.

If you stop taking Rabeprazole Almus

Relief of symptoms usually occurs before the ulcer has completely healed. It is therefore important not to stop treatment with Rabeprazole Almus until your doctor tells you to.

If you have any other 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 Rabeprazole Almus 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:

Common (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 polyps in the stomach

Uncommon (affect less than 1 in 100 people)

• Feeling nervous or drowsy
• Chest infection (bronchitis)
• Sinusitis (painful sinuses)
• Dry mouth
• Indigestion or belching
• Skin rash or redness
• Muscle, leg, or joint pain
• Fractures in the hip, wrist, and spine
• Urinary tract infection (infection of the bladder)
• 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 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 tiredness 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 Rabeprazole Almus for more than three months, it is possible that your blood magnesium levels may decrease. Low magnesium levels can cause tiredness, muscle contractions, disorientation, convulsions, dizziness, and increased heart rate. If you have any of these symptoms, please inform your doctor immediately. Low magnesium levels can also lead to a decrease in blood potassium and calcium levels. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects 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 Rabeprazole Almus

Keep this medicine out of the sight and reach of children.

Do not use Rabeprazole Almus after the expiry date stated on the pack. The expiry date is the last day of the month stated.

Do not store above 25°C. Store in the original package to protect from moisture.

Do not use Rabeprazole Almus if you notice the pack is damaged or shows signs of tampering.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Packaging Content and Additional Information

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.

Subcoating: ethylcellulose, magnesium oxide.

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

Appearance of the Product and Packaging Content

Enteric-coated (gastro-resistant) yellow, biconvex tablets.

The packages contain 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 Manufacturer

Marketing Authorization Holder:

Almus Pharmaceutical, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: farmacovigilancia@almusfarmaceutica.es

Manufacturer:

LICONSA Laboratories, S.A.

Miralcampo Avenue, No. 7, Miralcampo Industrial Estate

19200 Azuqueca de Henares (Guadalajara)

Spain

Date of the Last Revision of this Leaflet:November 2023

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