RABEPRAZOL KRKA 20 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the User

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

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

Rabeprazol Krka contains the active substance rabeprazole sodium. Rabeprazole belongs to a group of medicines called “Proton Pump Inhibitors” (PPIs), which reduce the amount of acid produced by the stomach.

Rabeprazole is used to treat the following conditions:

• “Gastro-Oesophageal Reflux Disease” (GORD), which may include symptoms of acid reflux. The cause of GORD is acid and food flowing back into the oesophagus from the stomach.
• Stomach ulcers or ulcers of the upper 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 and antibiotics together will get rid of the infection and the ulcer will heal. It will also stop the infection and the ulcer coming back.
• Zollinger-Ellison Syndrome, where the stomach produces too much acid.

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

Do not takeRabeprazol Krka

• If you are allergic to rabeprazole sodium or any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant or think you may be pregnant.
• If you are breast-feeding.

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

See also the section on pregnancy, breast-feeding and fertility.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with rabeprazole.

• If you are allergic to other proton pump inhibitors or to “substituted benzimidazoles”.
• In some patients, blood and liver problems have been observed, but these usually get better when the treatment with rabeprazole is stopped.
• If you have a stomach tumour.
• If you have ever had liver problems.
• If you are taking atazanavir - for HIV infection. Rabeprazole may lower the amount of this type of medicine in your blood and they should not be used together.
• If you have reduced body stores or risk factors for low vitamin B12 and are taking long-term treatment with rabeprazole. Like all acid-reducing agents, rabeprazole may reduce the absorption of vitamin B12.
• If you have ever had a skin reaction with a medicine for reducing stomach acid similar to rabeprazole.
• If you get a rash, especially in areas of skin exposed to the sun, tell your doctor as soon as possible, as you may need to stop your treatment with rabeprazole. 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 can 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 inform your doctor of these signs.

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

If you experience severe diarrhoea (watery or bloody) with symptoms such as fever, abdominal pain or tenderness, stop taking rabeprazole and consult your doctor immediately.

If you are taking a proton pump inhibitor like rabeprazole, especially over a period of more than one year, you may have a slightly increased risk of fractures of 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).

Children

Rabeprazole should not be used in children.

Taking Rabeprazol Krka with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines.

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

• Ketoconazole or itraconazole - used to treat fungal infections. Rabeprazole may lower the amount of these medicines in your blood. Your doctor may need to adjust your dose.
• Atazanavir - used for HIV infection. Rabeprazole may lower the amount of this type of medicine in your blood and 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.

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

Pregnancy, breast-feeding and fertility

• Do not take rabeprazole if you are pregnant or if you think you may be pregnant.
• Do not take rabeprazole 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. If this happens, do not drive or use any tools or machines.

3. How to take Rabeprazol Krka

Take this medicine exactly as your doctor has told you. If you are not sure, check with 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 tablets whole with a little water. Do not chew or crush the tablets.
• 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 10 mg tablet of rabeprazole 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 tablet of rabeprazole when you need it.

Treatment of more severe symptoms (erosive or ulcerative GORD)

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

For ulcers caused by H. pylori infection and to prevent recurrence

• The usual dose is one 20 mg tablet of rabeprazole 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 the stomach produces too much acid

• The usual dose is three 20 mg tablets of rabeprazole once a day to start with.
• Your doctor may adjust your dose 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 your dose and symptoms to be checked.

Children:this medicine should not be used in children.

Patients with liver problems. You should consult your doctor, who will be cautious when starting and during treatment with rabeprazole.

If you take more Rabeprazol Krka than you should

If you take more rabeprazole 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Rabeprazol Krka

• If you forget to take a tablet, take it as soon as you remember. 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 Rabeprazol Krka

Relief of symptoms normally 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 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 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 the 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 the mouth or throat.
• bruising or bleeding easily.

These side effects are rare (may affect up to 1 in 1,000 people).

• Severe skin blisters or rash or sores in your mouth and throat.

These side effects are very rare (may affect up to 1 in 10,000 people).

Other possible side effects:

Common (may affect up to 1 in 10 people):

• Infections.
• Difficulty sleeping.
• Headache or dizziness.
• Cough, runny nose or sore throat (pharyngitis).
• Stomach or bowel problems such as stomach pain, diarrhoea, wind (flatulence), feeling sick (nausea), vomiting or constipation.
• Pain or back pain.
• Weakness or flu-like symptoms.
• Benign polyps in the stomach.

Uncommon (may affect up to 1 in 100 people):

• Feeling nervous or sleepy.
• Chest infection (bronchitis).
• Sinusitis (blocked or painful sinuses).
• 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.
• Chest pain.
• Chills or fever.
• Changes in liver function (seen in blood tests).

Rare (may affect up to 1 in 1,000 people):

• Lack of appetite (anorexia).
• Depression.
• Hypersensitivity (including allergic reactions).
• Vision problems.
• Inflamed mouth (stomatitis) or taste problems.
• Stomach problems or stomach pain.
• Liver problems including jaundice (yellowing of the skin and whites of the eyes).
• Itchy rash or blistering.
• Sweating.
• Kidney problems.
• Weight increase.
• Changes in white blood cells (seen in blood tests) which may lead to frequent infections.
• Decrease in blood platelets which may lead to bleeding or bruising easily.

Other possible side effects (frequency not known - cannot be estimated from the available data):

• Enlargement 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.
• Patient who have previously had liver problems may very rarely develop encephalopathy (a brain disease).
• Rash, possibly with joint pain.

If you are taking rabeprazole for more than three months, it is possible that the levels of magnesium in your blood may fall. Low levels of magnesium can cause tiredness, muscle cramps, convulsions and dizziness. If you get any of these symptoms, tell your doctor immediately. Low levels of magnesium can also lead to a decrease in the levels of potassium or calcium in the blood. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System for Human Use: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Rabeprazol Krka

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

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

Store in the original package to protect from moisture and light.

Do not store above 30°C.

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

What is in Rabeprazol Krka

• The active substance is rabeprazole sodium. Each gastro-resistant tablet contains 20 mg of rabeprazole sodium, equivalent to 18.85 mg of rabeprazole.
• The other ingredients are mannitol (E-421), light magnesium oxide (E-530), hydroxypropylcellulose (E-463), low-substituted hydroxypropylcellulose (E-463) and magnesium stearate (E-572) in the core and ethylcellulose (E-462), light magnesium oxide (E-530), hypromellose phthalate, mono- and di-glycerides (E-472a), talc (E-553b), titanium dioxide (E-171) and yellow iron oxide (E-172) in the coating.

Appearance and packaging

The 20 mg gastro-resistant tablets are yellow, biconvex and round.

They are available in blister packs in cartons of 14, 28 and 56 gastro-resistant tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

KRKA, d.d. Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

You can obtain further information on this medicine from the Local Representative of the Marketing Authorisation Holder:

Krka Farmacéutica, S.L.

C/ Anabel Segura 10

28108 Alcobendas, Madrid

Spain

Date of last revision of this leaflet:

“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/”