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PACKAGE LEAFLET: INFORMATION FOR THE USER

Rabeprazole sodium 10 mg Gastro-resistant Tablets Rabeprazole sodium 20 mg gastro-resistant tablets

Rabeprazole sodium

In this leaflet:

1.    What Rabeprazole sodium is and what it is used for

2.    Before you take Rabeprazole sodium

3.    How to take Rabeprazole sodium

4.    Possible side effects

5.    How to store Rabeprazole    sodium

6.    Further information

Rabeprazole sodium tablets contain rabeprazole. It belongs to a class of medicines called proton pump

inhibitors. They act by reducing the amount of acid made by the stomach.

Rabeprazole sodium tablets are used for:

-    Active duodenal ulcer or active benign gastric/stomach ulcer (peptic ulcers).

-    Symptomatic erosive or ulcerative gastro-oesophageal reflux disease (GORD) commonly referred to as inflammation of the gullet caused by acid and associated with heartburn, or for long-term treatment of GORD (GORD maintenance).

-    The symptomatic treatment of moderate to very severe gastro-oesophageal reflux disease (symptomatic GORD) also associated with heartburn.

-    Zollinger-Ellison Syndrome, a rare condition in patients whose stomachs make extremely high amounts of acid.

-    In combination with two antibiotics (clarithromycin and amoxycillin) Rabeprazole sodium tablets are used for the eradication of H. pylori infection in patients with peptic ulcer disease.

Do not take Rabeprazole sodium

-    If you are allergic (hypersensitive) to rabeprazole sodium, other proton pump inhibitors or any of the other ingredients of Rabeprazole sodium (see section 6)

-    If you are pregnant, you think you might be pregnant or if you are breast-feeding (please see “Pregnancy and breast-feeding”).

Take special care with Rabeprazole sodium

Tell your doctor or pharmacist:

-    If you are allergic to other proton pump inhibitors.

-    If you have been told you have a stomach tumour.

-    If you have a history of liver disease.

-    If you are taking atazanavir (a drug used to treat HIV).

If you are taking this medicine for a long time, your doctor will want to monitor you.

Blood and liver problems have been seen in some patients but often get better when rabeprazole treatment is stopped.

Rabeprazole sodium should not be used in children.

If you experience severe (watery or bloody) diarrhoea with symptoms such as fever, abdominal pain or tenderness, stop taking Rabeprazole sodium and see a doctor straight away.

Taking other medicines

Tell your doctor or pharmacist:

-    If you are taking ketoconazole or itraconazole (drugs used to treat fungal infections).

-    If you are taking atazanavir (a drug used to treat HIV).

Pregnancy and breast-feeding

Do not take Rabeprazole sodium tablets if you are pregnant or think you may be pregnant. Do not take Rabeprazole sodium tablets if you are breast-feeding or planning to breast-feed.

Driving and using machines

You may feel sleepy while taking Rabeprazole sodium. If this happens, do not drive or use any tools or machines.

YOU MUST SWALLOW THE RABEPRAZOLE SODIUM TABLET WHOLE.

DO NOT CRUSH OR CHEW IT.

The dosages below are those usually recommended for adults and the elderly. Do not change the dose or length of the treatment yourself. Rabeprazole sodium should not be used in children.

Active duodenal ulcer and active benign gastric ulcer

The usual dose is one Rabeprazole sodium 20 mg tablet once a day.

If you have an active duodenal ulcer, your treatment is expected to continue for four weeks; but after that time your doctor may decide to continue your treatment for a further four weeks.

If you have an active benign gastric ulcer, your treatment is expected to continue for six weeks; but after that time your doctor may decide to continue your treatment for a further six weeks.

Erosive or ulcerative gastro-oesophageal reflux disease

The usual dose is one Rabeprazole sodium 20 mg tablet once a day. Your treatment is expected to continue for four weeks; but after that time your doctor may decide to continue your treatment for a further four weeks.

GORD maintenance

The usual dose is one Rabeprazole sodium 10 mg or 20 mg tablet once a day. Your doctor will advise you on how long to take your tablets. You need to see your doctor at regular intervals for review of your tablets and symptoms.

Symptomatic GORD

The usual dose is one Rabeprazole sodium 10 mg tablet once a day. Your once daily treatment is expected to continue for up to four weeks. If your symptoms do not resolve within four weeks consult your doctor. Following this initial four week treatment, if your symptoms return, your doctor may then tell you to take one Rabeprazole sodium 10 mg tablet as and when you require it in order to control your symptoms.

Zollinger-Ellison Syndrome:

The usual recommended dose is three Rabeprazole sodium 20 mg tablets once a day to start with. The dose may then be adjusted by your doctor depending on how you respond to the treatment. Your doctor will tell you how many tablets to take and when to take them. You need to see your doctor at regular intervals for review of your tablets and symptoms.

Eradication of H. pylori

The usual recommended dose is Rabeprazole sodium 20 mg to be taken (in combination with two antibiotics - clarithromycin 500 mg and amoxycillin 1 g) twice each day and normally for 7 days. Relief of symptoms will normally occur before the ulcer has completely healed. Therefore it is important that you do not stop taking the tablets until told to do so by your doctor. For further information on the other components of the H. pylori eradication therapy see the individual product information leaflets.

If you take more Rabeprazole sodium than you should

Do not take more tablets each day than you are prescribed. If you accidentally take more tablets than the prescribed dose, please consult your doctor or go to the hospital straight away. Always take the tablets and the carton with you to the hospital so that the doctor knows what has been taken.

If you forget to take Rabeprazole sodium

If you forget to take a dose, just take it immediately when you remember, and then continue as usual. If you forget to take your medicine for more than 5 days, call your doctor before taking any more medicine.

Do not take a double dose to make up for a forgotten gastro-resistant tablet.

If you stop taking Rabeprazole sodium

Do not change the dosage or stop the medication without discussing it with your doctor first.

Like all medicines, Rabeprazole sodium can cause side effects, although not everybody gets them.

Very common:	Affects more than 1 user in 10
Common:	Affects 1 to 10 users in 100
Uncommon:	Affects 1 to 10 users in 1,000
Rare:	Affects 1 to 10 users in 10,000
Very rare:	Affects less than 1 user in 10,000
Not known:	Frequency cannot be estimated from available data

Stop taking Rabeprazole sodium and see a doctor straight away if you notice reddening of the skin with blisters or peeling. There may also be severe blisters and bleeding in the lips, eyes, mouth, nose and genitals. This could be ‘Stevens-Johnson syndrome’ or ‘toxic epidermal necrolysis’.

Other possible side effects:

Common:

-    Infection

-    Insomnia (difficult sleeping)

-    Headaches, dizziness

-    Cough, pharyngitis (sore throat), rhinitis (runny nose)

-    Diarrhoea, vomiting, nausea, abdominal pain, constipation (costiveness), flatulence (wind)

-    Pain without any known cause, back pain

-    Asthenia (weakness), flu like syndrome

Uncommon:

-    Nervousness or drowsiness

-    Bronchitis, sinusitis

-    Dyspepsia (indigestion), dry mouth, eructation (belching)

-    Skin rash, redness of the skin

-    Muscle or joint pain, leg cramps

-    Urinary tract infection

-    Chest pain

-    Chills, fever

-    Changes in liver function test values Rare:

-    Anorexia (loss of appetite)

-    Depression

-    Hypersensitivity - a severe immediate allergic reaction for example facial swelling, low blood pressure and shortness of breath which resolve after stopping the treatment.

-    Vision disturbances

-    Gastritis (upset stomach or stomach pain), stomatitis (sore mouth), taste disturbances

-    Liver problems such as hepatitis (inflammation of the liver) and jaundice (yellowing of your skin and whites of your eyes), hepatic encephalopathy (brain damage due to liver disease)

-    Itching, sweating, skin blisters (these reactions have usually resolved after discontinuation of therapy)

-    Kidney problems such as interstitial nephritis (disorders of the connective tissue within the kidney)

-    Weight gain

-    Changes in white blood cells:

-    Neutropenia (decrease of neutrophils, a type of white blood cell) or leucopenia (decrease of white blood cells) - reductions in white blood cells resulting in frequent infections, such as sore throath or high temperature (fever), or ulcers in your mouth or throat.

-    Leucocytosis (increase in white blood cells)

Thrombocytopenia (decrease of blood platelets) - reduction in blood platelets resulting in bleeding or bruising more easily than normal.

Very rare:

-    Severe skin reactions such are:

-    Erythema multiforme (reddening of the skin with blisters)

-    Toxic epidermal necrolysis (severe skin damage with the detachment of the top layer of skin the lower layers of the skin over the body)

-    Steven-Johnson syndrome (severe blisters, peeling and bleeding in the skin and also in the lips, mouth and nose)

Frequency not known:

-    Confusion

-    Swelling of the feet or ankles

-    Breast swelling in men

-    Hyponatremia (low levels of sodium in the blood) - the symptoms are feeling sick and unwell with weak muscles or confused.

Keep out of the reach and sight of children.

Do not use Rabeprazole sodium after the expiry date which is stated on the carton and blister after {EXP} .The expiry date refers to the last day of that month.

Do not store above 30 °C. Store in the original package in order to protect from moisture.

Do not use any Rabeprazole sodium pack that is damaged or shows signs of tampering.

Medicine should not be disposed of in waste-water or with household garbage. Ask your pharmacist what you should do with medications you no longer need. These measures will help to protect the environment.

What Rabeprazole sodium contains

The active substance is: rabeprazole sodium.

One gastro-resistant tablet contains 10 mg rabeprazole sodium, equivalent to 9.42 mg rabeprazole. One gastro-resistant tablet contains 20 mg rabeprazole sodium, equivalent to 18.85 mg rabeprazole.

The other ingredients are:

Tablet Core: Magnesium oxide, mannitol, sodium starch glycollate (Type A), povidone (K-30), magnesium stearate

Intermediate layer: Ethyl cellulose, magnesium oxide, diethyl phthalate,

Coating: Hypromellose phthalate, titanium dioxide (E 171), talc, diethyl phthalate, iron oxide red (E 172)

Rabeprazole sodium 20 mg gastro-resistant tablets:

Tablet Core: Magnesium oxide, mannitol, sodium starch glycollate (Type A), povidone (K-30), magnesium stearate

Intermediate layer: Ethyl cellulose, magnesium oxide, diethyl phthalate

Coating: Hypromellose phthalate, titanium dioxide (E 171), talc, diethyl phthalate,iron oxide yellow (E 172)

What Rabeprazole sodium looks like and contents of the pack

Rabeprazole sodium 10 mg gastro-resistant tablets are pink, round biconvex, coated tablets, plain on both sides.

Rabeprazole sodium 20 mg gastro-resistant tablets are yellow, round biconvex, coated tablets, plain on both sides.

Pack sizes:

7, 14, 15, 25, 28, 30, 50, 56, 75, 98, 112, 120 gastro-resistant tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Torrent Pharma GmbH Sudwestpark 50 90449 Nurnberg Germany

This medicinal product is authorised in the Member States of the EEA under the following names:

DK: Rabetan 10 mg enterotabletter

AT: Rabetorr 10 mg magensaftresistente Tabletten

DE: Rabeprazol Torrent 10 mg magensaftresistente Tabletten

ES: Rabeprazol ratiopharm 10 mg comprimidos gastroresistentes EFG

FR: Rabeprazole Torrent Pharma 10 mg, comprime gastro-resistant

HU: Rabeprazol Torrent 10 mg gyomornedv-ellenallo tabletta

IT: Rabeprazolo ratiopharm, 10 mg compresse gastroresistenti

LU: Rabeprazol Torr 10 mg magensaftresistente Tabletten

NL: Rabeprazolnatrium Torrent 10 mg, maagsapresistente tabletten

PT: Rabeprazol Torrent, 10 mg, Comprimido gastrorresistente

UK: Rabeprazole sodium 10 mg Gastro-resistant Tablets

This leaflet was last approved in 03/2013.

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