RABEPRAZOL SANDOZ 10 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the User

Rabeprazol Sandoz 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 and other information

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

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

Rabeprazol Sandoz belongs to a group of medicines called “Proton Pump Inhibitors”. These medicines reduce the amount of acid produced by the stomach.

Rabeprazol Sandoz is used in adults to treat the following conditions:

• ulcers in the intestine (also called duodenal ulcer),
• ulcers in the stomach (also called benign gastric ulcer),
• to relieve symptoms of heartburn caused by gastro-oesophageal reflux disease (GORD), which is also known as reflux oesophagitis,
• long-term treatment of GORD to prevent symptoms from coming back,
• to relieve symptoms of moderate to very severe GORD (symptomatic GORD) such as heartburn and acid regurgitation,
• severe increase of acid production in the stomach (Zollinger-Ellison syndrome),
• treatment of infections caused by a bacterium called Helicobacter pylori (H. pylori) when given in combination with antibiotic treatment.

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

Do not take Rabeprazol Sandoz

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

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with rabeprazol:

• if you are allergic to proton pump inhibitors or “substituted benzimidazoles”,
• if you have a stomach tumour,
• if you have been treated with rabeprazol for a long period of time (more than one year), you will need to visit your doctor regularly,

• if you have or have had liver problems, you should inform your doctor. Your doctor may need to check your liver function more frequently,
• if you are taking atazanavir (a medicine used to treat HIV), as this medicine should not be taken with rabeprazol (see section 2),
• if you have reduced body stores or risk factors for reduced vitamin B12 and are taking long-term treatment with rabeprazol sodium. As with all acid-reducing agents, rabeprazol sodium may lead to a reduced absorption of vitamin B12,
• if a specific blood test (Chromogranin A) is scheduled,
• if you have ever had a skin reaction with a medicine used to reduce stomach acid,

similar to rabeprazol.

• if you get a rash, especially in areas of skin exposed to the sun, you should contact your doctor as soon as possible, as you may need to stop treatment with rabeprazol. Also, remember to mention any other symptoms you notice, such as joint pain,
• kidney inflammation can occur during treatment with rabeprazol. 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 experience severe diarrhoea (watery or bloody) with symptoms such as fever, abdominal pain or tenderness, stop taking rabeprazol and see your doctor immediately.

If you take a proton pump inhibitor like rabeprazol, especially over a period of more than one year, you may slightly increase your risk of fracturing your 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

Rabeprazol should not be given to children.

Using Rabeprazol Sandoz with other medicines

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Tell your doctor before taking this medicine if you are taking:

• ketoconazole or itraconazole (medicines for fungal infections), the dose may need to be adjusted,
• atazanavir (a medicine used to treat HIV), rabeprazol can decrease the blood levels of this medicine, so they should not be used at the same time,
  • methotrexate (a chemotherapy medicine used at high doses to treat cancer), if you are being treated with methotrexate at high doses, your doctor may temporarily stop your treatment with rabeprazol.

If you are in doubt, consult your doctor or pharmacist before taking rabeprazol.

Pregnancy and 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.

Do not take Rabeprazol Sandoz if you are pregnant or breast-feeding.

Driving and using machines

Rabeprazol usually does not affect your ability to drive or use machines. However, this medicine may cause drowsiness in some patients. If you are affected, do not drive or use machines.

Rabeprazol Sandoz contains sodium

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

3. How to take Rabeprazol Sandoz

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

If you are taking rabeprazol once a day, the tablets should be taken preferably before breakfast.

Swallow the tablet whole. Do not chew or crush the tablet.

Duodenal ulcers

The usual dose is 20 mg once daily, usually for 4 weeks. Your doctor will decide if you need to continue treatment for another 4 weeks.

Gastric ulcers

The usual dose is 20 mg once daily, usually for 6 weeks. Your doctor will decide if you need to continue treatment for another 6 weeks.

Gastro-oesophageal reflux disease (GORD)

The usual dose is 20 mg once daily for 4-8 weeks.

Long-term treatment of GORD

The usual maintenance dose is 10 mg or 20 mg once daily. If you are on long-term treatment, you should see your doctor for regular check-ups of your dose and symptoms.

Treatment for the relief of symptoms of moderate to very severe GORD

The usual dose is 10 mg once daily for 4 weeks.

If symptoms do not disappear after 4 weeks, consult your doctor. After the first 4-week treatment, if symptoms come back, your doctor may tell you to take one 10 mg tablet when needed to control your symptoms.

Severe increase of acid production in the stomach (Zollinger-Ellison syndrome)

The usual starting dose is 60 mg once daily. The dose may be adjusted by your doctor depending on how you respond to treatment. You may be given up to 60 mg twice a day. Your doctor will tell you how many tablets to take, when to take them and for how long you should take them.

Treatment of infections caused by H. pyloriwhen given in combination with antibiotic treatment

The usual dose is 20 mg twice daily in combination with two antibiotics. The recommended combination is:

Rabeprazol 20 mg + clarithromycin 500 mg + amoxicillin 1 g, taken together twice daily for 7 days.

Patient with liver and kidney impairment

No dose adjustment is necessary.

Use in children

Do not give these tablets to children.

If you take more Rabeprazol Sandoz than you should

If you have taken more rabeprazol than you should, consult your doctor, pharmacist or call the national Poison Centre (telephone 91 562 04 20), stating the medicine and the amount taken.

Take this leaflet and the medicine or the box with you to the doctor or hospital, so they know how many tablets you have taken.

If you forget to take Rabeprazol Sandoz

It is important that you take your medicine every day, as this will help your treatment to be more effective. However, if you forget to take one or more doses, take another as soon as you remember and then continue as your doctor has told you. Do not take a double dose to make up for forgotten doses.

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

If you stop taking Rabeprazol Sandoz

Normally, relief of symptoms occurs before the ulcer is completely healed. It is important that you do not stop treatment until your doctor tells you to.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

You should immediatelycontact your doctor if you notice any of the following serious side effects(can be any allergic reaction).

Rare side effects (may affect up to 1 in 1,000 patients)

• swelling of the face, lips, tongue and/or throat that may cause difficulty in breathing, speaking or swallowing, sudden drop in blood pressure, pallor, feeling of fainting or collapse.

Very rare side effects (may affect up to 1 in 10,000 patients)

• blisters on the skin and/or in the mouth, eyes, lips, nose and/or genitals (Stevens-Johnson syndrome) or skin peeling (toxic epidermal necrolysis).

Other possible side effects

Common side effects(may affect more than 1 in 10 patients)

• headache, dizziness,
• insomnia,
• cough, sore throat, runny nose and nasal congestion,
• diarrhoea, vomiting, nausea, stomach pain, constipation, gas (flatulence),
• general pain, back pain,
• infection,
• weakness, flu-like symptoms,
• benign polyps in the stomach.

Uncommon side effects(may affect up to 1 in 100 patients)

• nervousness, somnolence,
• cough with phlegm, chest pain and fever,
• feeling of pressure or pain in the cheeks and forehead,
• indigestion, dry mouth, belching,
• rash, redness of the skin,
• muscle pain, leg cramps, joint pain,
• urinary tract infection,
• chest pain, chills, fever,
• increase in liver enzymes,
• fracture of the hip, wrist and spine.

Rare side effects(may affect up to 1 in 1,000 patients)

• blood disorders that may cause frequent infections, easy bruising or bleeding, or anaemia,
• loss of appetite (anorexia),
• vision disorders,
• gastritis, which may cause stomach pain and nausea,
• mouth pain,
• taste disorders,
• liver disease (hepatitis), which may cause yellowing of the skin or the whites of the eyes (jaundice),
• liver failure that can lead to brain damage in patients who have previously had liver disease,
• itching and blistering skin: usually gets better when treatment is stopped,
• sweating,
• kidney problems, which can cause a high or low urine output,
• weight increase,
• depression,
• hypersensitivity (including allergic reaction).

Side effects with unknown frequency(frequency cannot be estimated from the available data)

• low levels of sodium in the blood,
• low levels of magnesium in the blood*,
• confusion,
• breast enlargement in men,
• swelling of the ankles, feet or fingers,
• skin rash, possibly with joint pain,
• inflammation of the intestine (leading to diarrhoea).

*If you are taking rabeprazol for more than three months, it is possible that your blood magnesium levels may fall. Low magnesium levels can cause fatigue, muscle spasms, convulsions, dizziness and a rapid heartbeat. If you get any of these symptoms, please tell your doctor immediately. Low magnesium levels can also lead to a reduction in blood potassium and calcium levels. 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 Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Rabeprazol Sandoz

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

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of the month shown.

Do not store above 25°C. Store in the original package to protect from moisture.

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 further information

Composition of Rabeprazol Sandoz

• The active substance is rabeprazol sodium.

Each gastro-resistant tablet of 10 mg contains 10 mg of rabeprazol sodium.

• The other ingredients are:

Core: calcium hydroxide, mannitol, low-substituted hydroxypropylcellulose and sodium stearyl fumarate.

Intermediate coating: hypromellose and talc.

Gastro-resistant coating: hypromellose phthalate, dibutyl sebacate, yellow iron oxide (E172), red iron oxide (E172) and titanium dioxide (E171).

Appearance of the product and packaging

Rabeprazol Sandoz 10 mg are pink, round, biconvex gastro-resistant tablets.

Al/Al blister pack with desiccant: 5, 7, 10, 14, 15, 20, 25, 28, 30, 37, 50, 56, 60, 75, 90, 98, 100 and 120 gastro-resistant tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals d.d.

Verovskova 57

1526 Ljubljana

Slovenia

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

or

Lek S.A.

ul. Domaniewska 50 C

02-672 Warszawa

Poland

or

Lek Pharmaceuticals d.d.

Trimlini 2D

9220 Lendava

Slovenia

This medicine is authorised in the Member States of the European Economic Area under the following names:

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/