Rabeprazole Krka 20 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rabeprazol Krka 20 mg gastro-resistant tablets EFG

Rabeprazole sodium

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only; do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Rabeprazol Krka contains the active ingredient sodium rabeprazole. Rabeprazole belongs to a group of medicines called "proton pump inhibitors" (PPIs), which work by reducing the amount of acid produced by the stomach.

Rabeprazole is used to treat the following conditions:

• "Gastroesophageal reflux disease" (GERD), which may include heartburn. GERD is caused by stomach acid and food flowing back from the stomach into the oesophagus.
• 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), antibiotic treatment will be required. Taking rabeprazole together with antibiotics will eliminate the infection and heal the ulcer. It will also prevent recurrence of the infection and ulcer.
• Zollinger-Ellison syndrome, a condition in which the stomach produces excessive amounts of acid.

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

Do not take Rabeprazol Krka

• If you are allergic to sodium rabeprazole or to 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 breastfeeding.

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, breastfeeding, and fertility.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take rabeprazole.

• If you are allergic to other proton pump inhibitors or to "substituted benzimidazole compounds".
• Blood and liver problems have been observed in some patients, but these often improve when 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.
• If you have low body stores or risk factors for low vitamin B12 levels and are receiving long-term treatment with rabeprazole. Like all agents that reduce acidity, rabeprazole may reduce the absorption of vitamin B12.
• If you have ever had a skin reaction after treatment with a medicine to reduce stomach acid similar to rabeprazole.
• If you develop a skin rash, especially in areas of skin exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to stop treatment with rabeprazole. Remember to mention any other symptoms you may notice, such as joint pain.
• If you are scheduled to have a specific blood test (chromogranin A).
  • During treatment with rabeprazole, kidney inflammation may occur. Signs and symptoms may 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 whether any of the above applies to you, 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 contact your doctor immediately.

If you are taking a proton pump inhibitor such as rabeprazole, especially for more than one year, there may be a slight increase in the risk of fractures of the hip, wrist, or spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

Children

Rabeprazole must not be used in children.

Taking Rabeprazol Krka with other medicines

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

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

• Ketoconazole or itraconazole – used to treat fungal infections. Rabeprazole may reduce the blood levels of these medicines. Your doctor may need to adjust your dose.
• Atazanavir – used to treat HIV infection. Rabeprazole may reduce blood levels of this type of medicine and must 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 unsure whether any of the above applies to you, consult your doctor or pharmacist before taking rabeprazole.

Pregnancy, breastfeeding, and fertility

• Do not take rabeprazole if you are pregnant or think you may be pregnant.
• Do not take rabeprazole while breastfeeding or if you plan to start breastfeeding.

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

Driving and using machines

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

3. How to take Rabeprazol Krka

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

How to take this medicine

• Remove one tablet from the blister pack only when it is time to take your dose.
• Swallow the tablets whole with some water. Do not crush or chew the tablets.
• 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 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 tablet once daily for up to 4 weeks.
• Take the tablet in the morning before eating.
• If your symptoms return after 4 weeks of treatment, your doctor will tell you to take one 10 mg rabeprazole tablet as needed.

Treatment of more severe symptoms (erosive or ulcerative GERD)

• The usual dose is one 20 mg rabeprazole tablet once daily for 4 to 8 weeks.
• Take the tablet in the morning before eating.

Long-term treatment of symptoms (maintenance of GERD)

• The usual dose is one 10 mg or 20 mg rabeprazole tablet once daily for as long as your doctor has instructed.
• Take the tablet in the morning before eating.
• Your doctor will want to see you regularly to monitor your symptoms and dosage.

For stomach ulcers (peptic ulcers)

• The usual dose is one 20 mg rabeprazole tablet once daily for 6 weeks.
• Take the tablet in the morning before eating.
• Your doctor may tell you to continue rabeprazole for another 6 weeks if your symptoms have not improved.

For intestinal ulcers (duodenal ulcers)

• The usual dose is one 20 mg rabeprazole tablet once daily for 4 weeks.
• Take the tablet in the morning before eating.
• Your doctor may tell you to continue rabeprazole for another 4 weeks if your symptoms have not improved.

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

• The usual dose is one 20 mg rabeprazole tablet twice daily for seven days.
• Your doctor will also instruct you to take antibiotics called amoxicillin and clarithromycin.

For more information about the other medicines used to treat H. pylori, please read the package leaflets for each of them.

Zollinger-Ellison syndrome, where excess stomach acid is produced

• The usual starting dose is three 20 mg rabeprazole tablets once daily.
• Your doctor may adjust the dose depending on your response to treatment.

If you are on long-term treatment, you will need regular check-ups with your doctor to review your dose and symptoms.

Children: This medicine should not be used in children.

Patients with liver problems: You should consult your doctor, who will exercise special caution when starting and during treatment with rabeprazole.

If you take more Rabeprazol Krka than you should

If you take more rabeprazole than prescribed, speak to your doctor or go to a hospital immediately. Take the medicine with you.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine 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 for your next dose, skip the missed dose and continue with your regular schedule.
• If you have missed taking 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 Krka

Symptom relief usually occurs before the ulcer has completely healed. It is important not to stop treatment until your doctor tells you to do so.

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

4. Possible adverse effects

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

Stop taking rabeprazole and contact your doctor immediately if you notice any of the following adverse effects – you may need urgent medical treatment:

• Allergic reactions – signs may include: sudden swelling of the face, difficulty breathing, or low blood pressure that may cause fainting or collapse.
• Frequent infections, such as sore throat or high temperature (fever), or mouth or throat ulcers.
• Bruising or easy bleeding.

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

• Severe blistering of the skin, or sores or ulcers in the mouth or throat.

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

Other possible adverse 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 intestinal effects such as stomach pain, diarrhoea, gas (flatulence), nausea, vomiting, or constipation.
• Aches or back pain.
• Weakness or flu-like symptoms (pseudoinfluenza symptoms).
• Benign polyps in the stomach.

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

• Feeling nervous or drowsy.
• Chest infection (bronchitis).
• Painful and blocked sinuses (sinusitis).
• Dry mouth.
• Indigestion or burping.
• Skin rash or redness.
• Muscle, leg, or joint pain.
• Fractures of the hip, wrist, or spine.
• Bladder infection (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):

• Loss of appetite (anorexia).
• Depression.
• Hypersensitivity (including allergic reactions).
• Visual disturbances.
• Inflamed mouth (stomatitis) or taste disturbances.
• Stomach disorder or stomach pain.
• Liver problems, including yellowing of the skin and whites of the eyes (jaundice).
• Itchy rash or blistering.
• Sweating.
• Kidney problems.
• Weight gain.
• Changes in white blood cells (seen in blood tests) that may lead to frequent infections.
• Decrease in blood platelets that may cause bleeding or bruising more easily than normal.

Other possible adverse effects (frequency not known – cannot be estimated from available data):

• Breast swelling in men.
• Fluid retention.
• Inflammation of the intestine (leading to diarrhoea).
• Low levels of sodium in the blood that may cause tiredness and confusion, muscle spasms, seizures, 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 for more than three months, it is possible that magnesium levels in the blood may decrease. Low magnesium levels may cause tiredness, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, contact your doctor immediately. Low magnesium levels may also lead to decreased levels of potassium or calcium in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rabeprazol Krka

Keep this medicine out of sight and reach of children.

Do not use rabeprazol after the expiry date stated on the packaging and on the blister after EXP. The expiry date refers to the last day of the month indicated.

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

Do not store above 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. Ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rabeprazol Krka

• The active substance is sodium rabeprazole. Each gastro-resistant tablet contains 20 mg of sodium rabeprazole, equivalent to 18.85 mg of rabeprazole.
• The other components 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; ethylcellulose (E-462), light magnesium oxide (E-530), hypromellose phthalate, diacetylated monoglycerides (E-472a), talc (E-553b), titanium dioxide (E-171), and yellow iron oxide (E-172) in the coating.

Appearance of the product and contents of the pack

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

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

KRKA, d.d. Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia

For further information about this medicine, contact the Marketing Authorization Holder's Local Representative:

Krka Farmacéutica, S.L.
C/ Anabel Segura 10
28108 Alcobendas, Madrid
Spain

Date of the most recent review of this leaflet:

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