Rabeprazole Sandoz

PACKAGE LEAFLET: INFORMATION FOR THE USER

Rabeprazole Sandoz 10 mg gastro-resistant tablets, 20 mg gastro-resistant tablets

Read this leaflet carefully before 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Rabeprazole belongs to a group of medicines called "proton pump inhibitors".
These medicines reduce the production of acid in the stomach.
Rabeprazolo Sandoz is used in adults for:

• the treatment of intestinal ulcers (a condition also known as duodenal ulcer)
• the treatment of stomach ulcers (a condition also known as benign gastric ulcer)
• relieving heartburn symptoms caused by erosive or ulcerative gastro-oesophageal reflux disease (GORD), also called reflux oesophagitis
• long-term treatment of GORD, to prevent its recurrence
• relieving symptoms of moderate to very severe GORD (symptomatic GORD), such as heartburn and acid regurgitation
• the treatment of markedly increased gastric acid secretion (Zollinger-Ellison syndrome)
• the treatment of infections caused by bacteria called Helicobacter pylori (H. pylori), when administered in combination with antibiotic therapy.

2. What you need to know before taking Rabeprazole Sandoz

Do not take Rabeprazole Sandoz if

• you are allergic to rabeprazole or to any of the other ingredients of this medicine (listed in section 6)
• you are pregnant or think you might be pregnant
• you are breastfeeding

Do not take Rabeprazole Sandoz if any of the conditions above apply to you. If you have any doubts, consult your doctor or pharmacist before taking Rabeprazole Sandoz.

Warnings and precautions
Inform your doctor or pharmacist before taking Rabeprazole Sandoz:

• if you are allergic to other proton pump inhibitors or "imidazole substitutes"
• if you have a stomach tumour
• if you are undergoing long-term treatment (over one year), you must consult your doctor at regular intervals
• if you have or have previously had liver problems, you must inform your doctor. Your doctor may check your liver function more frequently
• taking these tablets is not recommended if you are concurrently taking atazanavir (a medicine used to treat HIV) (see section 2)
• if you have low body stores or risk factors that reduce vitamin B12 absorption and you are receiving long-term treatment with sodium rabeprazole. Like all other agents that reduce acid, sodium rabeprazole may lead to reduced absorption of vitamin B12
• if you are due to undergo a specific blood test (Chromogranin A)
• if you have ever had a skin reaction after treatment with a medicine similar to Rabeprazole Sandoz that reduces gastric acidity
• if you develop a skin rash, especially in areas exposed to sunlight, contact your doctor as soon as possible, as it may be necessary to discontinue treatment with Rabeprazole Sandoz. Remember to report any other adverse effects such as joint pain. If you experience severe diarrhoea (watery or with blood) with symptoms such as fever, abdominal pain or tenderness, stop taking Rabeprazole Sandoz and contact your doctor.

If you take a proton pump inhibitor such as Rabeprazole Sandoz, especially for more than one year, there may be a slight increase in the risk of fractures of the hip, wrist or spine. If you suffer from osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis), consult your doctor.

Children
Rabeprazole Sandoz must not be used in children.

Other medicines and Rabeprazole Sandoz
Inform your doctor if you are taking, have recently taken or might take any other medicine.

Consult your doctor before taking these tablets if you are already taking:

• ketoconazole or itraconazole (medicines used to treat fungal infections): a dose adjustment may be necessary
• atazanavir (a medicine used to treat HIV). Rabeprazole Sandoz may reduce the amount of this medicine in the blood and the two must not be used together
• methotrexate (a chemotherapeutic medicine used at high doses for cancer treatment)
• if you are taking high doses of methotrexate, your doctor may temporarily suspend your treatment with Rabeprazole Sandoz

If you are unsure whether any of the conditions listed above apply to you, consult your doctor or pharmacist before taking Rabeprazole Sandoz.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Do not take these tablets if you are pregnant or breastfeeding.

Driving and using machines
Generally, Rabeprazole Sandoz does not impair the ability to drive or operate machinery. However, in some patients this medicine may cause drowsiness. If you experience this adverse effect, you must not drive or operate machinery.

Rabeprazole Sandoz contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per gastro-resistant tablet, i.e. essentially "sodium-free".

3. How to take Rabeprazole Sandoz

Take this medicine exactly as instructed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
If you are taking Rabeprazole Sandoz once daily, take the tablet before breakfast in the morning.
Swallow the tablets whole. Do not crush or chew the tablets.

Duodenal ulcers (ulcers in the intestine)
The usual dose is 20 mg once daily in the morning for 4 weeks. Your doctor may decide to extend the treatment for another 4 weeks.

Gastric ulcers (ulcers in the stomach)
The usual dose is 20 mg once daily in the morning for 6 weeks. Your doctor may decide to extend the treatment for another 6 weeks.

Erosive or ulcerative 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 must consult your doctor regularly to review your dosage and symptoms.

Relief of moderate to very severe gastroesophageal reflux disease (GERD) symptoms
The usual dose is 10 mg once daily for 4 weeks.
If symptoms do not resolve within 4 weeks, consult your doctor. After this initial four-week treatment period, if symptoms recur, your doctor may prescribe one 10 mg tablet as needed to control these symptoms.

Severe increase in stomach acid secretion (Zollinger-Ellison syndrome)
The usual initial dose is 60 mg once daily. The dose may then be adjusted by your doctor depending on your response to treatment. You may be prescribed doses 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 given in combination with antibiotic therapy
The usual dose is 20 mg twice daily, in combination with two antibiotics. The recommended combination is:
Rabeprazole Sandoz 20 mg + clarithromycin 500 mg + amoxicillin 1 g, taken together twice daily for 7 days.

Hepatic and renal impairment
No dose adjustment is necessary.

Use in children
These tablets must not be given to children.

If you take more Rabeprazole Sandoz than you should
If you accidentally take more medicine than prescribed, contact your doctor or go to the nearest hospital emergency department. Bring this leaflet, any remaining tablets, and the outer packaging with you so that the doctor or healthcare staff know which medicine you have taken.

If you forget to take Rabeprazole Sandoz
It is important to take the medicine every day, as regular treatment is more effective. If, however, you forget to take one or more doses, take it as soon as you remember, then continue as prescribed. Do not take a double dose to make up for a forgotten dose.

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

If you stop taking Rabeprazole Sandoz
Symptom relief usually occurs before the ulcer is completely healed. It is important not to stop taking the tablets unless your doctor tells you to do so.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
If you notice any of the following serious side effects, you must contact your doctor immediately
(it could be an allergic reaction).
Rare serious side effects (may affect up to 1 in 1,000 people)

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

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

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

Other possible side effects
Common side effects (may affect up to 1 in 10 people) are:

• headache, dizziness
• inability to sleep
• cough, sore throat, runny or stuffy nose
• diarrhoea, vomiting, nausea, stomach ache, constipation, flatulence
• non-specific pain, back pain
• infection
• weakness, flu-like illness
• benign polyps in the stomach

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

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

Rare side effects (may affect up to 1 in 1,000 people) are:

• blood disorders, which may cause frequent infections or increased tendency to bleeding and bruising or fatigue
• loss of appetite (anorexia)
• vision disorders
• gastritis, which may cause stomach pain and nausea
• mouth cavity pain
• taste disturbances
• liver disease (hepatitis), which may cause yellowing of the skin or whites of the eyes (jaundice)
• liver failure, causing brain damage in patients who previously suffered from liver disorders
• itching and blistering of the skin: these usually disappear when treatment is stopped
• sweating
• kidney problems, which may cause increased or decreased urine output
• weight gain
• depression
• hypersensitivity (including allergic reactions)

Frequency not known (frequency cannot be estimated from the available data)
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• low levels of sodium in the blood
• low levels of magnesium in the blood
• confusion
• breast enlargement in men
• swelling of ankles, feet or fingers
• erythema, possible joint pain
• inflammation of the intestine (causing diarrhoea)
  If you take Rabeprazole Sandoz for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as tiredness, involuntary muscle contractions, disorientation, seizures, dizziness, increased heart rate. If you experience any of these symptoms, contact your doctor immediately. Low magnesium levels may also lead to reduced blood levels of potassium or calcium. Your doctor should decide whether to monitor your blood magnesium levels periodically.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Rabeprazolo 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 tablet blister and on the outer packaging after the word "Exp". The expiry date refers to the last day of that month.
Do not store above 25°C. Keep in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Rabeprazolo Sandoz contains
The active substance is sodium rabeprazole.
Each 10 mg gastro-resistant tablet contains 10 mg of 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 sodium stearate fumarate.
Coating 1: hypromellose, talc.
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Gastro-resistant coating 2 (10 mg): hypromellose phthalate, dibutyl sebacate, yellow iron oxide (E172), red iron oxide (E172) and titanium dioxide (E171).
Gastro-resistant coating 2 (20 mg): hypromellose phthalate, dibutyl sebacate, yellow iron oxide (E172) and titanium dioxide (E171).

Description of the appearance of Rabeprazolo Sandoz and package contents
Rabeprazolo Sandoz 10 mg is presented as pink, round, biconvex, film-coated gastro-resistant tablets.
Rabeprazolo Sandoz 20 mg is presented as yellow, round, biconvex, film-coated gastro-resistant tablets.
Al/Al blister packs with desiccant: 7, 10, 14, 20, 28, 30, 56, 60 and 98 gastro-resistant tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A., L.go U. Boccioni 1, 21040 Origgio (VA)

Manufacturers
Salutas Pharma GmbH, Otto-von Guericke-Allee 1, 39179 Barleben, Germany
LEK S.A., Ul. Domaniewska 50 C, 02-672 Warszawa, Poland
Lek Pharmaceuticals d.d., Verovskova 57, SI-1526, Ljubljana, Slovenia
Lek Pharmaceuticals d.d., Trimlini 2 D, 9220 Lendava, Slovenia

This medicinal product is authorized in the European Economic Area countries under the
following names:
Austria Rabeprazol Hexal 10 mg - magensaftresistente Tabletten
Rabeprazol Hexal 20 mg - magensaftresistente Tabletten
Ireland Rabeprazole 10 mg gastro-resistant tablets
Rabeprazole 20 mg gastro-resistant tablets
Italy RABEPRAZOLO Sandoz 10 mg gastro-resistant tablets
RABEPRAZOLO Sandoz 20 mg gastro-resistant tablets
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