Package Leaflet: Information for the User

Rabeprazol Sandoz 10 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 Sandoz is and what it is used for

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

3.How to take Rabeprazol Sandoz

4.Possible side effects

5.Storage of Rabeprazol Sandoz

6.Contents of the pack and additional information

Rabeprazol Sandoz belongs to a group of medications known as “Proton Pump Inhibitors”. These medications 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 known as duodenal ulcer),

-ulcers in the stomach (also known as benign gastric ulcer),

-relieve the symptoms of stomach burning caused by erosive or ulcerative gastroesophageal reflux disease (GERD), also known as esophagitis due to reflux,

-long-term treatment of GERD to prevent its recurrence,

-relieve the symptoms of moderate to severe GERD (symptomatic GERD) such as stomach burning and acid regurgitation,

-severe acid secretion in the stomach (Zollinger-Ellison syndrome),

-treatment of infections caused by a bacteria calledHelicobacter pylori (H. pylori)when administered in combination with antibiotic treatment.

Do not take Rabeprazol Sandoz

-if you are allergic to rabeprazol 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 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 rabeprazol:

• if you are allergic to proton pump inhibitors or to “substituted benzimidazole compounds”,
• if you have a stomach tumor,
• if you have been taking this medication for a long period of time (more than one year), you will need to visit your doctor periodically,

• if you have or have had liver problems, inform your doctor. Your doctor may check your liver function more frequently,
• if you are taking atazanavir (a medication used to treat HIV) as rabeprazol is not recommended with this medication (see section 2),
• if you have reduced body reserves or have risk factors associated with a reduced amount of B12 and are receiving long-term treatment with rabeprazol sodium. Like all acid-reducing agents, rabeprazol sodium may lead to reduced B12 absorption,
• if you are scheduled to have a specific blood test (Cromogranin A),
• if you have ever had a skin reaction after treatment with a similar medication to rabeprazol for reducing stomach acid,

such as a skin eruption, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to interrupt treatment with rabeprazol. Remember to mention any other symptoms you may notice, such as joint pain,

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

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

Children

Rabeprazol should not be administered to children.

Use of Rabeprazol Sandoz with other medications

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medication.

Inform your doctor before taking this medication if you are taking:

-ketoconazole or itraconazole (medications for fungal infections), your dose may need to be adjusted,

-atazanavir (a medication used to treat HIV), rabeprazol may decrease the blood content of this medication, so they should not be used together,

• metotrexate (a chemotherapy medication used at high doses to treat cancer), if you are taking metotrexate at high doses, your doctor may temporarily interrupt treatment with rabeprazol.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using any medication.

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

Driving and operating machinery

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

Rabeprazol Sandoz contains sodium

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

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

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

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

Ulcers of the intestine (duodenal ulcer)

The usual dose is 20 mg per day in the morning, usually for 4 weeks. Your doctor will decide if you continue treatment for another 4 weeks.

Stomach ulcers

The usual dose is 20 mg per day in the morning, usually for 6 weeks. Your doctor will decide if you continue treatment for another 6 weeks.

Chronic erosive or ulcerative gastroesophageal reflux disease (GERD)

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

Long-term treatment of gastroesophageal reflux disease (GERD)

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

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

The usual dose is 10 mg once a day for 4 weeks.

If symptoms do not disappear in 4 weeks, consult your doctor. After the first 4-week treatment, if symptoms recur, your doctor may instruct you to take a 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 a day. 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 to take them.

Treatment of infections caused byH. pyloriwhen administered in combination with antibiotic treatment

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

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

Patients with liver and kidney insufficiency

No dose adjustment is necessary.

Use in children

Do not administer 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

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

If you forget to take Rabeprazol Sandoz

It is essential to take your medication every day, as this makes treatment more effective. However, if you forget to take one or more doses, take another as soon as you remember and continue as your doctor prescribed. Do not take a double dose to compensate for the missed doses.

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

If you interrupt treatment with Rabeprazol Sandoz

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

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

Severe side effects

You should contact your doctorimmediatelyif you notice any of the followingsevere side effects(it may be anyallergic reaction).

Rare side 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 of fainting or collapse.

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

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

Other possible side effects

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

• Headache, dizziness,
• Difficulty sleeping,
• Cough, sore throat, runny nose, and nasal congestion,
• Diarrhea, vomiting, nausea, stomach pain, constipation, gas (flatulence),
• Unspecified 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, drowsiness,
• Cough with mucus, chest pain, and fever,
• Sensation 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,
• Increased 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 lead to frequent infections, appearance of bleeding or bruising more easily than normal, or fatigue,
• Loss of appetite (anorexia),
• Vision problems,
• Gastritis, which may cause stomach pain and nausea,
• Pain in the mouth,
• Changes in taste,
• Liver disease (hepatitis), which makes your skin or the white of your eyes turn yellow (jaundice),
• Liver insufficiency that leads to brain damage in patients who have previously had liver disease,
• Itching and blisters on the skin: usually disappear when treatment is stopped,
• Sweating,
• Kidney problems, which may cause high or low urine production,
• Weight gain,
• Depression,
• Hypersensitivity (includes allergic reaction).

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

• Low sodium levels in the blood,
• Low magnesium levels in blood*,
• Confusion,
• Enlargement of the breasts in men,
• Swelling of the ankles, feet, or toes,
• Rash, possibly with joint pain,
• Inflammation of the intestine (leading to diarrhea).

*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 fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, and increased heart rate. If you experience any of these symptoms, see your doctor immediately. Low magnesium levels may also cause a decrease in potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

Reporting 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 theSpanish System for Pharmacovigilance of Medicines for Human Use:https://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 use this medication after the expiration date that appears on the blister and packaging after CAD. The expiration date is the last day of the month indicated.

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

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 point of the pharmacy. If in doubt, 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 Sandoz

• The active ingredient is rabeprazol sodium.

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

• The other components are:

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

Intermediate coating: hypromellose and talc.

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

Appearance of the product and contents of the package

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

Aluminum/Aluminum 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 package sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer:

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible 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. Domaniewska50 C

02-672 Warszawa

Poland

or

Lek Pharmaceuticals d.d.

Trimlini 2D

9220 Lendava

Slovenia

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/