Rabeprazole Sandoz 20 mg gastro-resistant tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Rabeprazol Sandoz 20 mg gastro-resistant tablets EFG

rabeprazole sodium

Read the entire leaflet carefully before you start taking this medicine, as 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, and you should not give it to others, 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 these effects are not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Rabeprazol Sandoz belongs to a group of medicines known as "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 known as benign gastric ulcer),
• relief of heartburn symptoms caused by erosive or ulcerative gastroesophageal reflux disease (GERD), also known as reflux esophagitis,
• long-term treatment of GERD to prevent recurrence,
• relief of moderate to very severe symptoms of GERD (symptomatic GERD), such as heartburn and acid regurgitation,
• severe increased acid secretion in the stomach (Zollinger-Ellison syndrome),
• treatment of infections caused by a bacterium called Helicobacter pylori (H. pylori), when administered in combination with antibiotic therapy.

2. What you need to know before taking Rabeprazol Sandoz

Do not take Rabeprazol Sandoz

• if you are allergic to rabeprazole 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 breastfeeding.

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

Warnings and precautions

Consult your doctor or pharmacist before starting rabeprazole:

• if you are allergic to proton pump inhibitors or to "substituted benzimidazoles",
• if you have a stomach tumour,
• if you are undergoing long-term treatment (more than one year), you will need periodic check-ups with your doctor,
• if you have or have had liver problems, you must inform your doctor. Your doctor may monitor your liver function more frequently,
• if you are taking atazanavir (a medicine used to treat HIV), as rabeprazole is not recommended when taking this medicine (see section 2),
• if you have reduced body stores or risk factors associated with low levels of B12 and are receiving long-term treatment with sodium rabeprazole. Like all agents that reduce acidity, sodium rabeprazole may lead to reduced absorption of vitamin B12,
• if you are scheduled to have a specific blood test (Chromogranin A),
• if you have ever had a skin reaction after treatment with a medicine similar to rabeprazole for reducing stomach acid,
• 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,
• during treatment with rabeprazole, inflammation of the kidney may occur. Signs and symptoms include: decreased urine volume or blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. You must report these signs to your doctor.

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

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

Children

Rabeprazole must not be given to children.

Taking Rabeprazol Sandoz with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

• ketoconazole or itraconazole (medicines for fungal infections); your dose may need adjustment,
• atazanavir (a medicine used to treat HIV), rabeprazole may reduce blood levels of this medicine and therefore they should not be used together,
• methotrexate (a chemotherapeutic agent used at high doses to treat cancer); if you are receiving high-dose methotrexate, your doctor may temporarily interrupt treatment with rabeprazole.

If you are unsure whether the above applies to you, consult your doctor or pharmacist before taking rabeprazole.

Pregnancy and breastfeeding

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

Do not take Rabeprazol Sandoz if you are pregnant or breastfeeding.

Driving and using machines

Rabeprazole normally does not affect your ability to drive or operate machinery. However, this medicine may cause drowsiness in some patients. If you experience drowsiness, avoid driving or operating machinery.

Rabeprazol Sandoz contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; therefore, it is essentially "sodium-free".

3. How to take Rabeprazol Sandoz

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

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

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

Duodenal ulcers

The usual dose is 20 mg once daily in the morning, usually for 4 weeks. Your doctor will decide whether to continue treatment for another 4 weeks.

Gastric ulcers

The usual dose is 20 mg once daily in the morning, usually for 6 weeks. Your doctor will decide whether to continue treatment for another 6 weeks.

Ulcerative or erosive gastroesophageal reflux disease (GERD)

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

Long-term treatment of gastroesophageal reflux disease (GERD)

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

Treatment to relieve symptoms of moderate to severe gastroesophageal reflux disease (GERD)

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

If symptoms do not resolve within 4 weeks, consult your doctor. After the initial 4-week treatment, if symptoms recur, your doctor may instruct you to take one 10 mg tablet as needed to control your symptoms.

Severe increase in stomach acid secretion (Zollinger-Ellison syndrome)

The usual initial dose is 60 mg once daily. Your doctor may adjust the dose depending on your response to treatment. You may be given up to 60 mg twice daily. Your doctor will tell you how many tablets to take, when to take them, and for how long.

Treatment of infections caused by H. pylori when used in combination with antibiotic therapy

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.

Patients with hepatic or renal impairment

Dose adjustment is not 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, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

Take this leaflet and the medicine or its packaging to the doctor or hospital so they can see how many tablets you have taken.

If you forget to take Rabeprazol Sandoz

It is important to take your medicine every day, as this makes the treatment more effective. However, if you forget to take one or more doses, take the next dose as soon as you remember, and then continue as prescribed by your doctor. Do not take a double dose to make up for a missed dose.

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

If you stop treatment with Rabeprazol Sandoz

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.

4. Possible adverse effects

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

Serious adverse effects

You should contact your doctor immediately if you notice any of the following serious adverse effects (these may be signs of an allergic reaction).

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

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

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

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

Other possible adverse effects

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

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

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

• nervousness, drowsiness,
• cough with phlegm, chest pain, and fever,
• sensation of pressure or pain in the cheeks and forehead,
• indigestion, dry mouth, burping,
• rash, redness of the skin,
• muscle pain, leg cramps, joint pain,
• urinary tract infection,
• chest pain, chills, fever,
• increased liver enzymes,
• hip, wrist, or vertebral fractures.

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

• blood disorders that may lead to frequent infections, increased tendency to bleed or bruise, or fatigue,
• loss of appetite (anorexia),
• vision disorders,
• gastritis, which may cause stomach pain and nausea,
• mouth pain,
• taste disturbances,
• liver disease (hepatitis), causing yellowing of the skin or whites of the eyes (jaundice),
• liver failure leading to brain damage in patients with prior liver disease,
• itching and skin blisters: usually resolve upon discontinuation of treatment,
• sweating,
• kidney problems, which may cause increased or decreased urine production,
• weight gain,
• depression,
• hypersensitivity (including allergic reactions).

Adverse effects of unknown frequency (frequency cannot be estimated from available data)

• low levels of sodium in the blood,
• low levels of magnesium in 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 rabeprazole for more than three months, your blood magnesium levels may decrease. Low magnesium levels may cause fatigue, 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 and 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: https://www.notificaram.es. By reporting adverse 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 stated on the blister and packaging following EXP. The expiry date is the last day of the month indicated.

Do not store above 25°C. Keep in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rabeprazol Sandoz

• The active substance is sodium rabeprazole.

Each 20 mg gastro-resistant tablet contains 20 mg of sodium rabeprazole.

• The other components are:

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

Intermediate coating: hypromellose and talc.

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

Nature of the product and pack contents

Rabeprazol Sandoz 20 mg are yellow, round, biconvex gastro-resistant tablets.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Parque Norte Business Park

Building 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 medicinal product is authorized in the European Economic Area member states under the following names:

Date of the last review of this leaflet:

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