RABEPRAZOL LICONSA 20 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the User

Rabeprazole Liconsa 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. See section 4.

Contents of the pack

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

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

Rabeprazole Liconsa contains the active ingredient rabeprazole sodium. Rabeprazole 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.

Rabeprazole 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 into the oesophagus from the stomach.
• Stomach ulcers or ulcers of the upper part of the intestine (duodenal ulcers). If these ulcers are infected with a bacteria called “Helicobacter pylori” (H. pylori), you will also need to take antibiotics. Taking Rabeprazole 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 characterised by the production of very large amounts of acid in the stomach.

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

Do not take Rabeprazole Liconsa:

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

Warnings and precautions

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

• If you are allergic to proton pump inhibitors or “substituted benzimidazoles”.
• If liver or blood problems have been seen in some patients, but often improve when treatment with Rabeprazole Liconsa is stopped.
• If you have a stomach tumour.
• 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 low vitamin B12 and are taking long-term treatment with rabeprazole sodium. Like all acid-reducing agents, rabeprazole sodium may lead to a reduced absorption of vitamin B12.
• If you have ever had a skin reaction with a medicine that reduces stomach acid.
• If you get a rash on your skin, especially in areas exposed to the sun, tell your doctor as soon as possible, as you may need to stop your treatment with Rabeprazole Liconsa. Also remember to mention any other symptoms you might notice, such as joint pain.
• If you are due to have a specific blood test (Chromogranin A).
• During treatment with rabeprazole, kidney inflammation may occur. Signs and symptoms include: decrease in urine volume or blood in the urine and/or hypersensitivity reactions such as fever, rash and joint stiffness. You should inform your doctor of these signs.

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

ChildrenRabeprazole Liconsa should not be used in children.

If you experience severe diarrhoea with blood and mucous, fever, abdominal pain or tenderness, stop taking Rabeprazole Liconsa and see a doctor immediately.

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

Other medicines and Rabeprazole Liconsa

Tell your doctor or pharmacist if you are taking, have recently taken or might take 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 Liconsa 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 Liconsa 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 temporarily stop your treatment with Rabeprazole Liconsa.

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

Pregnancy, breast-feeding and fertility

• Do not take Rabeprazole Liconsa if you are pregnant or if you think you may be pregnant.
• Do not take Rabeprazole Liconsa during breast-feeding or if you plan to breast-feed.

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 Liconsa. If this happens, do not drive or use any tools or machines.

Rabeprazole Liconsa 20mg 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 Rabeprazole Liconsa

Take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.

Taking this medicine

• Only remove a tablet from the blister strip when it is time to take your medicine.
• Swallow the tablet whole with a little water. Do not chew or crush the tablet.
• Your doctor will tell you how many tablets to take and for how long.
• If you are taking this medicine for a long time, your doctor will want to check you regularly.

Adults and elderly patients

For “Gastro-Oesophageal Reflux Disease” (GORD)

Treatment of moderate to severe symptoms (symptomatic GORD)

• The usual dose is one Rabeprazole 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 Rabeprazole Liconsa 10 mg tablet when you need it (“on demand”)

Treatment of more severe symptoms (erosive or ulcerative GORD)

• The usual dose is one Rabeprazole 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 (GORD maintenance)

• The usual dose is one Rabeprazole 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 Rabeprazole 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 Rabeprazole Liconsa for another 6 weeks if your symptoms do not improve

For ulcers of the intestine (duodenal ulcers)

• The usual dose is one Rabeprazole 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 Rabeprazole 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 Rabeprazole 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 leaflets for each of them Zollinger-Ellison Syndrome where there is an excess of acid in the stomach

• The usual dose is three Rabeprazole Liconsa 20 mg tablets once a day to start with
• 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 have to be very careful when you start and during treatment with Rabeprazole Liconsa.

If you take more Rabeprazole Liconsa than you should

If you take more Rabeprazole Liconsa than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you.

In case of overdose or accidental ingestion, contact the Toxicology Information Service (Telephone: 91 562 04 20).

If you forget to take Rabeprazole Liconsa

• If you forget to take a tablet, take one as soon as you remember and then continue as normal. However, if it is almost time for your next tablet, skip the missed tablet and continue as normal.

• 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 forgotten dose.

If you stop taking Rabeprazole Liconsa

Relief of symptoms will occur 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 on 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.

Stop taking Rabeprazole Liconsa and see a doctor immediately if you notice any of the following serious 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 dizziness or fainting.
• Frequent infections, such as sore throat or high temperature (fever), or ulcers in your mouth or throat.
• bruising or bleeding more easily than normal.

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

• Severe skin blistering or peeling or mouth ulcers.

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, diarrhoea, wind (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 anxious or depressed
• Chest infection (bronchitis)
• Painful sinuses (sinusitis)
• Dry mouth
• Indigestion or belching
• Rash or redness of the skin
• Muscle or leg or joint pain
• Fractures of the hip, wrist or spine
• Urinary tract infection (infection of the urine system)
• 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 disturbances
• Stomach disorders or stomach pain
• Liver problems including yellowing of the skin and whites of the eyes (jaundice)
• Itchy rash or blistering
• Sweating
• Kidney problems
• Weight increase
• Changes in white blood cells (shown in blood tests) which may lead to frequent infections
• Decrease in the number of blood platelets which may lead to 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 diarrhoea)
• Low levels of sodium in the blood which may 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 Rabeprazole Liconsa for more than three months, it is possible that the levels of magnesium in your blood will fall. Low levels of magnesium can make you feel tired, dizzy, confused, have fits, a fast heart rate and muscle cramps. If you get any of these symptoms, please tell your doctor immediately. Low levels of magnesium can also lead to a reduction in the levels of potassium or calcium in your blood. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium.

Do not worry about this list of possible side effects. You may not get any of them.

Reporting of side effects

If you get 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 via 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. Storage of Rabeprazole Liconsa

Keep out of the sight and reach of children.

Do not store above 25°C.

Do not refrigerate.

Do not use Rabeprazole Liconsa after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month.

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 Rabeprazole Liconsa

The active substance is Rabeprazole Sodium.

Each Rabeprazole Liconsa 20 mg tablet contains 20 mg of rabeprazole sodium

The other ingredients are:

Core of the tablet: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 and packaging

Rabeprazole Liconsa 20mg gastro-resistant tablet is a yellow, round tablet.

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

Not all packs are marketed.

Marketing authorisation 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 up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.