RABEPRAZOL LICONSA 10 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the User

Rabeprazol Liconsa 10 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.
• 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. See section 4.

Contents of the pack

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

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

Rabeprazol Liconsa contains the active ingredient rabeprazol sodium. Rabeprazol Liconsa 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 Liconsa is used for the treatment of:

• “Gastro-Oesophageal Reflux Disease” (GORD), which may include symptoms of acidity. The cause of GORD is acid and food flowing back up from the stomach into the oesophagus.
• Stomach ulcers or ulcers of the upper part of the intestine (duodenal ulcers). If these ulcers are infected with a bacterium called “Helicobacter pylori” (H. pylori), you will also need to take antibiotics. Taking Rabeprazol Liconsa 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 large amounts of acid in the stomach.

2. What you need to know before you take Rabeprazol Liconsa

Do not take Rabeprazol Liconsa:

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

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Rabeprazol Liconsa:

• if you are allergic to proton pump inhibitors or “substituted benzimidazoles”.
• if liver or blood problems have been seen in some patients, but they usually improve when treatment with Rabeprazol Liconsa 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 risk factors for reduced vitamin B12 and are receiving long-term treatment with rabeprazol sodium. Like all acid-reducing agents, rabeprazol 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 Rabeprazol Liconsa to reduce stomach acid
• if you get a 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 Rabeprazol Liconsa. Also, remember to mention any other symptoms you notice, such as joint pain.
• if you are due to have a specific blood test (Chromogranin A).
• During treatment with rabeprazol, kidney inflammation may occur. Signs and symptoms include: decreased urine output or blood in the urine and/or hypersensitivity reactions such as fever, rash, and joint stiffness. You should report these signs to your doctor.

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

ChildrenRabeprazol Liconsa should not be given to children.

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

Taking a proton pump inhibitor like Rabeprazol Liconsa, especially over a period of more than one year, may slightly increase the risk of fracture in the hip, wrist, or spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

Other medicines and Rabeprazol Liconsa

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 Liconsa may reduce the amount of these medicines in your blood. Your doctor may need to adjust your dose.
• Atazanavir, a medicine used to treat HIV infection. Rabeprazol Liconsa may reduce 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 Rabeprazol Liconsa temporarily.

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

Pregnancy, breast-feeding, and fertility

• Do not take Rabeprazol Liconsa if you are pregnant or think you may be pregnant.
• Do not take Rabeprazol Liconsa during breast-feeding or if you plan to start 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 Rabeprazol Liconsa. If this happens, do not drive or use tools or machines.

Rabeprazol Liconsa 10 mg contains sodium

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

3. How to take Rabeprazol Liconsa

Follow the instructions for administration of this medicine exactly as indicated by your doctor. In case of doubt, 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, depending on your condition.
• If you are taking this medicine for a long time, your doctor will want to check you.

Adults and elderly patients

For “Gastro-Oesophageal Reflux Disease” (GORD)

Treatment of moderate to severe symptoms (symptomatic GORD)

• The usual dose is one Rabeprazol Liconsa 10 mg 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 Rabeprazol Liconsa 10 mg tablet when needed (“on demand”)

Treatment of more severe symptoms (erosive or ulcerative GORD)

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

Long-term treatment of symptoms (maintenance therapy for GORD)

• The usual dose is one Rabeprazol Liconsa 10 mg or 20 mg 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 Rabeprazol Liconsa 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 Liconsa for another 6 weeks if your symptoms do not improve

For ulcers of the intestine (duodenal ulcers)

• The usual dose is one Rabeprazol Liconsa 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 Liconsa 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 Rabeprazol Liconsa 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 about 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 Rabeprazol Liconsa 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 dose and symptom review

Patients with liver problems.Consult your doctor who will be particularly careful when starting and during treatment with Rabeprazol Liconsa.

If you take more Rabeprazol Liconsa than you should

If you take more Rabeprazol Liconsa 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 the Toxicology Information Service (Telephone: 91 562 04 20).

If you forget to take Rabeprazol Liconsa

• 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 tablet, simply 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 a missed dose.

If you stop taking Rabeprazol Liconsa

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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rabeprazol Liconsa can cause side effects, although not everybody gets them.

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

Stop taking Rabeprazol Liconsa 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 which may cause fainting or collapse.
• Frequent infections, such as sore throat or high temperature (fever) or ulcers in your mouth or throat.
• Bruising or tendency to bleed.

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

• Severe skin blistering or rashes or sores 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 intestines 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 sleepy
• Chest infection (bronchitis)
• Sinusitis (sinus infection)
• Dry mouth
• Indigestion or belching
• Rash or redness of the skin
• Muscle pain, leg pain, 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)

• Lack of appetite (anorexia)
• Depression
• Hypersensitivity (including allergic reactions)
• Visual disturbances
• Inflamed mouth (stomatitis) or taste disorders
• Stomach upset 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) which may lead to frequent infections
• Decrease in blood platelets which may lead to bleeding or bruising more easily than usual

Other possible side effects (frequency not known)

• Swelling of the breasts in men
• Fluid retention
• Inflammation of the intestine (leading to diarrhea)
• Low levels of sodium in the blood which can cause tiredness and confusion, muscle cramps, convulsions, and coma
• Patients who have previously had liver problems may very rarely develop a brain disease (encephalopathy)
• Skin rash, possibly with joint pain

If you take Rabeprazol Liconsa 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, 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, even if it is possible that they are 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 Rabeprazol Liconsa

Keep out of the sight and reach of children.

Do not store above 25°C.

Do not refrigerate.

Do not use Rabeprazol Liconsa after the expiry date which is stated on the carton and blister. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Rabeprazol Liconsa

The active substance is rabeprazol sodium.

Each Rabeprazol Liconsa 10 mg gastro-resistant tablet contains 10 mg of rabeprazol sodium as the active substance.

The other ingredients are:

Core of the tablet:mannitol, magnesium oxide, hydroxypropylcellulose, magnesium stearate

Subcoating:ethylcellulose, magnesium oxide

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

Appearance of the product and pack contents

Rabeprazol Liconsa 10mg gastro-resistant tablet is a pink, round tablet.

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

Not all packs are marketed.

Marketing authorization holder and manufacturer

LABORATORIOS LICONSA, S.A.

Calle Dulcinea s/n, 28805 Alcalá de Henares, Madrid, Spain.

Date of last revision of this leaflet: December 2023

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