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Rabeprazole Sodium 10mg Gastro-Resistant Tablets

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Rabeprazole - UK - Leaflet


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PHARMACEUTICALS

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

Rabeprazole sodium

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-    Keep this leaflet. You may need to read it again.

-    If you have any further questions, ask your doctor or pharmacist.

-    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

What is in this leaflet:

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

2.    What you need to know before you take Rabeprazole sodium

3.    How to take Rabeprazole sodium

4.    Possible side effects

5.    How to store Rabeprazole sodium

6.    Contents of the pack and other information

1. WHAT RABEPRAZOLE SODIUM IS AND WHAT IT IS USED FOR

Rabeprazole sodium tablets contain the active ingredient rabeprazole sodium. This belongs to a group of medicines called ‘Proton Pump Inhibitors' (PPIs). They work by lowering the amount of acid that your stomach produces.

Rabeprazole sodium tablets are used to treat the following conditions:

-    ‘Gastro-oesophageal reflux disease' (GORD), which can include heartburn. GORD is caused when acid and food from your stomach escapes into your food pipe (oesophagus)

-    Ulcers in your stomach or the upper part of your gut (intestine). If these ulcers are infected with bacteria called ‘Helicobacter pylori' (H. Pylori), you will also be given antibiotics. Using Rabeprazole sodium tablets and antibiotics together gets rid of the infection and makes the ulcer heal. It also stops the infection and ulcer from coming back

-    Zollinger-Ellison Syndrome where your stomach produces too much acid.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RABEPRAZOLE SODIUM

Do not take Rabeprazole sodium if:

-    You are allergic to rabeprazole sodium, or any of the other ingredients of this medicine (listed in Section 6 below)

-    You are pregnant or think that you are pregnant

-    You are breast-feeding.

Do not use Rabeprazole sodium if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before using Rabeprazole sodium.

Also see Pregnancy and breast-feeding section.

Children

Rabeprazole sodium should not be used in children.

Warnings and precautions

Check with your doctor or pharmacist before taking Rabeprazole sodium if:

-    You are allergic to other proton pump inhibitor medicines or ‘substituted benzimidazoles'.

-    You have a stomach tumour.

-    You have ever had liver problems.

-    If you are taking atazanavir- for HIV infection.

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

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Rabeprazole sodium.

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.

Other medicines and Rabeprazole sodium

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

-    Ketoconazole or itraconazole - used to treat infections caused by a fungus. Rabeprazole sodium may lower the amount of this type of medicine in your blood. Your doctor may need to adjust your dose.

-    Atazanavir- used to treat HIV-infection. Rabeprazole sodium may lower the amount of this type of medicine in your blood and they should not be used together.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using Rabeprazole sodium.

Pregnancy and breast-feeding

-    Do not use Rabeprazole sodium if you are pregnant or think you may be pregnant

-    Do not use Rabeprazole sodium if you are breast-feeding or planning to breast-feed

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

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

3. HOW TO TAKE RABEPRAZOLE SODIUM

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Taking this medicine

-    Only remove a tablet from the blister strip when it is time to take your medicine.

-    Swallow your tablets whole with a drink of water. Do not chew or crush the tablets.

-    Your doctor will tell you how many tablets to take and how long to take them for. This will depend on your condition.

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

Adults and the Elderly

For ‘gastro-oesophageal reflux disease’ (GORD)

Treatment of moderate to severe symptoms (symptomatic GORD)

-    The usual dose is one Rabeprazole sodium 10 mg tablet once a day for up to 4 weeks.

-    Take the tablet in the morning before eating.

-    If your condition returns after 4 weeks treatment, your doctor may tell you to take one Rabeprazole sodium 10 mg tablet as and when you require it.

Treatment of more severe symptoms (erosive or ulcerative GORD)

-    The usual dose is one Rabeprazole sodium 20 mg tablet once a day for 4 to 8 weeks.

-    Take the tablet in the morning before eating.

Long-term treatment of symptoms (GORD maintenance)

-    The usual dose is one Rabeprazole sodium 10 mg or 20 mg tablet once a day for as long as your doctor has told you.

-    Take the tablet in the morning before eating.

-    Your doctor will want to see you at regular intervals to check your symptoms and dosage.

For ulcers of the stomach (peptic ulcers)

-    The usual dose is one Rabeprazole sodium 20 mg tablet once a day for 6 weeks.

-    Take the tablet in the morning before eating.

-    Your doctor may tell you to take Rabeprazole sodium for another 6 weeks if your condition does not improve.

For ulcers of the intestine (duodenal ulcers)

-    The usual dose is one Rabeprazole sodium 20 mg tablet once a day for 4 weeks.

-    Take the tablet in the morning before eating.

-    Your doctor may tell you to take Rabeprazole sodium for another 4 weeks if your condition does not improve.

For ulcers caused by H. Pylori infection and to stop them coming back

-    The usual dose is one Rabeprazole sodium 20 mg tablet twice a day for seven days.

-    Your doctor will also tell you to take antibiotics called amoxicillin and clarithromycin.

For further information on the other medicines used for the H. Pylori treatment, see the individual product information leaflets.

Zollinger-Ellison Syndrome where excess acid is produced in the stomach

-    The usual 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.

If you are on long-term treatment you will need to see your doctor at regular intervals for review of your tablets and symptoms.

Children. The product should not to be used in children.

Patients with liver problems. You should consult your doctor who will take special care when beginning treatment with Rabeprazole sodium and while you continue to be treated with Rabeprazole sodium.

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If you take more Rabeprazole sodium than you should

If you take more Rabeprazole sodium than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you.

If you forget to take Rabeprazole sodium

-    If you forget to take a dose, take it as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose and continue as usual.

-    If you forget to take your medicine for more than 5 days, talk to your doctor before taking any more medicine.

-    Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If you stop taking Rabeprazole sodium

Relief of symptoms will normally occur before the ulcer has completely healed. It is important that you do not stop taking the tablets until told to do so by your doctor.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects are usually mild and improve without you having to stop taking this medicine.

Stop taking Rabeprazole sodium and see a doctor straight away if you notice any of the following side effects - you may need urgent medical treatment:

-    Allergic reactions - the signs may include: sudden swelling of your face, difficulty breathing or low blood pressure which may cause fainting or collapse

-    Frequent infections, such as a sore throat or high temperature (fever), or ulcers in your mouth or throat

-    Bruising or bleeding easily.

These side effects are rare (affects 1 to 10 users in 10,000).

-    Severe skin blistering, or soreness or ulcers in your mouth and throat.

These side effects are very rare (affects less than 1 user in 10,000). Other possible side effects:

Common (affects 1 to 10 users in 100)

-    Infections

-    Difficulty sleeping

-    Headache or feeling dizzy

-    Cough, runny nose or sore throat (pharyngitis)

-    Effects on your stomach or gut such as stomach pain, diarrhoea, wind (flatulence), feeling sick (nausea), being sick (vomiting) or constipation

-    Aches or back pain

-    Weakness or flu-like symptoms.

Uncommon (affects 1 to 10 users in 1,000)

-    Feeling nervous or drowsy

-    Chest infection (bronchitis)

-    Painful and blocked sinuses (sinusitis)

-    Dry mouth

-    Indigestion or belching

-    Skin rash or redness

-    Muscle, leg or joint pain

-    Bladder infection (urinary tract infection)

-    Chest pain

-    Chills or fever

-    Changes in how your liver is working (shown in blood tests)

-    Taking a proton pump inhibitor like rabeprazole sodium, especially over a period of more than one year, may slightly increase your risk of fracture in the hip, wrist or spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

Rare (affects 1 to 10 users in 10,000)

-    Loss of appetite (Anorexia)

-    Depression

-    Hypersensitivity (includes allergic reactions)

-    Visual disturbance

-    Sore mouth (stomatitis) or taste disturbance

-    Upset stomach or stomach pain

-    Liver problems including yellowing of your skin and whites of your eyes (jaundice)

-    Itchy rash or blistering skin

-    Sweating

-    Kidney problems

-    Weight gain

-    Changes in white blood cells (shown in blood tests) which may result in frequent infection.

-    Reduction in blood platelets resulting in bleeding or bruising more easily than normal.

Other possible side effects (Not known - frequency cannot be estimated from the available data)

-    Breast swelling in men

-    Fluid retention

-    Low blood levels of sodium which can cause tiredness and confusion, muscle twitching, fits and coma.

-    Patients who have previously had liver problems may very rarely get encephalopathy (a brain disease).

-    If you are on rabeprazole sodium for more than three months it is possible that the levels of magnesium in your blood may fall. Low levels of magnesium can be seen as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you get any of these symptoms, please tell your doctor promptly. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium.

Do not be concerned by this list of side effects. You may not get any of them. If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

5. HOW TO STORE RABEPRAZOLE SODIUM

Keep this medicine out of the sight and reach of children.

Store below 25°C.

Store in the original package in order to protect from moisture.

Do not use this medicine 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 throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Rabeprazole sodium contains

- The active substance is rabeprazole sodium.

Each gastro-resistant tablet contains 10 mg rabeprazole sodium, equivalent to 9.42 mg rabeprazole.

Each gastro-resistant tablet contains 20 mg rabeprazole sodium, equivalent to 18.85 mg rabeprazole.

The other ingredients are:

Tablet core: Mannitol, Magnesium oxide, hydroxy propylcellulose, crospovidone, low-substituted hydroxy propylcellulose, Magnesium stearate.

Under coating: Ethyl cellulose, magnesium oxide.

Enteric coating:    Hypromellose phthalate, diacetylated

monoglycerides, talc, titanium dioxide (E171), yellow iron oxide (E172) - 20mg only.

What Rabeprazole sodium looks like and contents of the pack

Gastro-resistant tablet

Rabeprazole sodium 10 mg gastro-resistant tablet is round (diameter 5.72 mm), white, biconvex, enteric coated tablets.

Rabeprazole sodium 20 mg gastro-resistant tablet is round (diameter 7.17 mm), yellow, biconvex, enteric coated tablets.

Rabeprazole sodium gastro-resistant tablets are available in Polyamide/Aluminium/ PVC/Aluminium foil blister pack.

Blister pack: 14, 28, 30, 56 and 98 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Amneal Pharma Europe Limited 70 Sir John Rogerson’s Quay Dublin 2 Ireland

Manufacturer:

APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate,

Hal Far, Birzebbugia, BBG 3000 Malta

This leaflet was last revised in 06/2014

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