Rabeprazole Sandoz 10 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rabeprazol Sandoz 10 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 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 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 effects 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 side 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 relapse,
• relief of moderate to severe symptoms of GERD (symptomatic GERD) such as heartburn and acid regurgitation,
• severe increase in stomach acid secretion (Zollinger-Ellison syndrome),
• treatment of infections caused by a bacterium called Helicobacter pylori (H. pylori), when given 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 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 Rabeprazol Sandoz if you are in any of the above situations. If you are unsure, consult your doctor or pharmacist before taking Rabeprazol Sandoz.

Warnings and precautions

Consult your doctor or pharmacist before starting to take rabeprazole:

• if you are allergic to proton pump inhibitors or to "substituted benzimidazole compounds",
• if you have a stomach tumour,
• if you are on 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 used to reduce stomach acidity,
• 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 should 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 be slightly increased. Inform your doctor if you have osteoporosis or if you 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 medicine 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 are planning 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; essentially, it is "sodium-free".

3. How to take Rabeprazol Sandoz

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

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

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

Duodenal ulcers (intestinal 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 (stomach 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 to 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 very 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. The dose may be adjusted by your doctor 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 administered in combination with antibiotic therapy

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

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

Patients with hepatic and 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 rabeprazole than you should, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

Take this leaflet and the medicine or the package 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 makes the treatment more effective. However, if you forget to take one or more doses, take it as soon as you remember, and then continue as prescribed by your doctor. Do not take a double dose to make up for missed doses.

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

If you stop treatment with Rabeprazol Sandoz

Usually, symptom relief 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 (may include any allergic reaction).

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

• swelling of the face, lips, tongue, and throat which 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,
• diarrhea, vomiting, nausea, stomach pain, constipation, gas (flatulence),
• nonspecific 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, skin redness,
• muscle pain, leg cramps, joint pain,
• urinary tract infection,
• chest pain, chills, fever,
• increased liver enzymes,
• hip, wrist, and spinal 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 pre-existing 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 reaction).

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

• low sodium levels in the blood,
• low magnesium levels 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 diarrhea).

*If you are taking rabeprazole for more than three months, magnesium levels in the blood 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, consult your doctor immediately. Low magnesium levels may also lead to decreased potassium and calcium levels 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 type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through 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 which is stated on the blister pack and outer packaging after EXP. The expiry date refers to the last day of the month indicated.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. 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 10 mg gastro-resistant tablet contains 10 mg of sodium rabeprazole.

• The other components 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 pack contents

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

Al/Al blister 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 some pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Parque Norte Business Centre

Roble Building

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 revision of this leaflet:

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