Package Leaflet: Information for the User

Rabeprazol Krka 20 mg gastro-resistant tablets EFG

Rabeprazol sodium

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

-Keep this leaflet, as you may need to read it again.

-If you have any questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do 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. See section 4.

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

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

3.How to take Rabeprazol Krka

4.Possible side effects

5.Storage of Rabeprazol Krka

6.Contents of the pack and additional information

Rabeprazol Krka contains the active ingredient rabeprazol sodium. Rabeprazol belongs to a group of medications called “Proton Pump Inhibitors” (PPIs), which act by reducing the amount of acid produced by the stomach.

Rabeprazol is used to treat the following diseases:

•Gastroesophageal reflux disease (GERD), which may include the appearance of heartburn. 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 small intestine (duodenal ulcers). If these ulcers are infected with a bacteria called “Helicobacter pylori” (H.pylori), you will need to take antibiotics. Taking rabeprazol 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, in which the stomach produces too much acid.

Do not takeRabeprazol Krka

•If you are allergic to rabeprazol sodium or any of the other components of this medication (listed in section 6).

•If you are pregnant or think you may be pregnant.

•If you are breastfeeding.

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

See also the section on pregnancy, breastfeeding, and fertility.

Warnings and precautions

Consult your doctor or pharmacist before starting to takerabeprazol.

•If you are allergic to other proton pump inhibitors or to “substituted benzimidazole compounds”.

•In some patients, problems with the blood and liver have been observed, but often improve when treatment with rabeprazol is stopped.

•If you have a stomach tumor.

•If you have ever had liver problems.

•If you are taking atazanavir - for HIV infection.

•If you have reduced body reserves or risk factors for having low vitamin B12 levels and are receiving long-term treatment with rabeprazol. Like all acid-reducing agents, rabeprazol may reduce vitamin B12 absorption

•If you have ever had a skin reaction after treatment with a similar stomach acid-reducing medication to rabeprazol.

•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 stop treatment with rabeprazol. 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 your doctor of these signs.

If you are unsure about whether this affects you, consult your doctor or pharmacist before taking rabeprazol.

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

If you are taking a proton pump inhibitor such asrabeprazol, especially for a period of more than one year, you may slightly increase the risk of hip, wrist, or spinal column fractures. Inform your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).

Children

Rabeprazol should not be used in children.

Taking Rabeprazol Krka with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.This includes medications purchased without a prescription and herbal remedies.

Particularly, inform your doctor or pharmacist if you are taking any of the following medications:

•Ketoconazole or itraconazole - used to treat fungal infections. Rabeprazol may reduce the amount of these medications in the blood. Your doctor may need to adjust your dose.

•Atazanavir - used to treat HIV infection. Rabeprazol may reduce the amount of this type of medication in the blood and should not be used together.

•Methotrexate (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.

If you are unsure about whether this affects you, consult your doctor or pharmacist before taking rabeprazol.

Pregnancy, breastfeeding, and fertility

•Do not take rabeprazol if you are pregnant or think you may be pregnant.

•Do not take rabeprazol during breastfeeding or if you plan to start breastfeeding.

If you are pregnant, breastfeeding, think you may be pregnant, or plan to start breastfeeding, consult your doctor or pharmacist before using this medication.

Driving and operating machines

You may feel drowsy while taking rabeprazol. If this occurs, do not drive or operate tools or machines.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Administration of this medication

•Only remove one tablet from the blister pack when it is time to take your medication.

•Swallow the tablets whole with a little water. Do not crush or chew the tablets.

•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

For gastroesophageal reflux disease (GERD)

Symptomatic treatment of moderate to severe symptoms (GERD symptomatic)

•The usual dose is one 10 mg rabeprazole 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 a 10 mg rabeprazole tablet when needed.

Treatment of more severe symptoms (GERD erosive or ulcerative)

•The usual dose is one 20 mg rabeprazole 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 10 or 20 mg rabeprazole 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 monitor your symptoms and dose.

For stomach ulcers (peptic ulcers)

•The usual dose is one 20 mg rabeprazole tablet 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 rabeprazole tablet 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 rabeprazole 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 package inserts for each one.

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

•The usual dose is three 20 mg rabeprazole tablets once a day initially.

•Your doctor may adjust the 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 dose and symptom review.

Children:This medication should not be used in children.

Patients with liver problems. You should consult your doctor, who will have special care in the initiation and during treatment with rabeprazole.

If you take more Rabeprazol Krka than you should

If you take more rabeprazole 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 Krka

•If you forget to take a tablet, take it as soon as you remember. However, if it is almost time to take the next tablet, 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 dose.

If you interrupt treatment with Rabeprazol Krka

The relief of symptoms usually occurs before the ulcer is completely healed. It is essential not to interrupt treatment until your doctor tells you to.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking rabeprazol and see your doctor immediately if you notice any of the following side effects – you may need urgent medical treatment:

•Allergic reactions – symptoms may include: sudden swelling of the 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 the mouth or throat.

•Cardenales or ease of bleeding.

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

Other possible side effects:

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

•Infections.

•Difficulty sleeping.

•Headache or dizziness.

•Cough, runny nose or sore throat (pharyngitis).

•Effects on the stomach or intestines such as stomach pain, diarrhea, gas (flatulence), nausea, vomiting or constipation.

•Pain or back pain.

•Weakness or flu-like symptoms (pseudogripal).

•Benign polyps in the stomach.

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

•Feeling of nervousness or drowsiness.

•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 (observed in blood tests).

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

•Loss of appetite (anorexia).

•Depression.

•Hypersensitivity (including allergic reactions).

•Visual disturbances.

•Inflamed mouth (stomatitis) or taste disturbances.

•Stomach upset or stomach pain.

•Liver problems that include yellowing of the skin and the white of the eyes (jaundice).

•Itching or blistering rash.

•Sweating.

•Renal problems.

•Weight gain.

•Changes in white blood cells in the blood (observed in blood tests) that may cause frequent infections.

•Decreased platelets in the blood that may cause bleeding or the appearance of bruises with greater ease than normal.

Other possible side effects (frequency unknown – cannot be estimated from available data):

•Swelling of the breasts in men.

•Fluid retention.

•Inflammation of the intestine (which leads 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).

•Rash on the skin, possibly with joint pain.

If you are taking rabeprazol for more than three months, it is possible that the levels of magnesium in the blood will decrease. Low levels of magnesium may cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you experience any of these symptoms, see your doctor immediately. Low levels of magnesium may also lead to a decrease in potassium or calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist or nurse, 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 for the Vigilance of Medicines for Human Use: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 userabeprazolafter the expiration date that appears on the packaging and in the blister pack after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture and light.

Do not store at a temperature above30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment

Composition of Rabeprazol Krka

• The active ingredient is rabeprazol sodium. Each gastro-resistant tablet contains 20 mg of rabeprazol sodium, equivalent to 18.85 mg of rabeprazol.
• The other components are mannitol (E-421), light magnesium oxide (E-530), hydroxypropylcellulose (E-463), hydroxypropylcellulose of low substitution degree (E-463), and magnesium stearate (E-572) in the core, and ethylcellulose (E-462), light magnesium oxide (E-530), hypromellose phthalate, monoglycerides diacetates (E-472a), talc (E-553b), titanium dioxide (E-171), and yellow iron oxide (E-172) in the coating.

Appearance of the product and content of the packaging

Gastro-resistant tablets of 20 mg are yellow, biconvex, and round.

They are available in blisters in packaging of 14, 28, and 56 gastro-resistant tablets.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and Responsible for manufacturing

KRKA, d.d. Novo mesto

Šmarješka cesta 6

85 01 Novo mesto

Slovenia

For more information about this medication, please contact the Local Representative of the Marketing Authorization Holder:

Krka Farmacéutica, S.L.

C/ Anabel Segura 10

28108 Alcobendas, Madrid

Spain

Last review date of this leaflet:

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