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Pariet Pharmacy 10mg Gastro-Resistant Tablets

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PACKAGE LEAFLET: INFORMATION FOR THE USER


Pariet®Pharmacy    10 mg

Rabeprazole sodium    gastro-resistant tablets


Read all of this leaflet carefully before you

start taking this medicine.

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

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

•    You must contact a doctor if your symptoms worsen or do not improve after 2 weeks.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.


In this leaflet:

1.    What Pariet Pharmacy is and what it is used for

2.    Before you take Pariet Pharmacy

3.    How to take Pariet Pharmacy

4.    Possible side effects

5.    How to store Pariet Pharmacy

6.    Further information


1. What Pariet Pharmacy is and what it is used for

Pariet Pharmacy 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.


Pariet Pharmacy tablets give relief of heartburn and acid reflux (when acid and food from your stomach escapes into your food pipe).


2. Before you take Pariet Pharmacy

Do not take Pariet Pharmacy if:

•    You are allergic (hypersensitive) to rabeprazole sodium, or any of the other ingredients of Pariet Pharmacy (listed in Section 6 below).

•    You are pregnant or think that you are pregnant.

•    You are breast-feeding.

Pariet Pharmacy should not be taken to prevent stomach problems.

Do not use Pariet Pharmacy if any of the above applies to you.

If you are not sure, talk to your pharmacist before using Pariet.

Ask your doctor before you take this medicine if:

•    You have unintentionally lost weight, anaemia, bleeding of the stomach, difficulty or pain on swallowing, persistent vomiting or vomiting blood, a lump in your stomach area, jaundice or have previously had a gastric ulcer or stomach surgery.

•    You are 55 years or older with symptoms that are new or recently changed or if you need to take treatment for your symptoms on a daily basis.

Children

Pariet Pharmacy should not be used in children or teenagers under the age of 18 years.

Tate special care with Pariet Pharmacy

Check with your pharmacist before taking Pariet Pharmacy if:

•    You are allergic to other proton pump inhibitor medicines.

•    You have a stomach tumour.

•    You have ever had liver problems.

•    If you are taking atazanavir - for HIV infection.

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

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

Using other medicines

Please tell your pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a rescription, including herbal medicines.

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

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


•    Atazanavir - for HIV infection. Pariet Pharmacy may lower this type of medication in your blood and they should not be used together.

You should not take other medicines to control stomach acid (e.g. other PPIs or tablets called H2 blockers) at the same time as this medicine.

Tell your doctor about any treatments you are taking for heartburn or indigestion if you are going to have a test called an endoscopy (a test that looks inside the foodpipe).

Avoid using Pariet Pharmacy if you are going to have a urea breath test.

Pregnancy and breast-feeding

•    Do not use if you are pregnant or think you may be pregnant

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

Ask your pharmacist for advice before taking any medicine during pregnancy or while breast-feeding.

Taking Pariet Pharmacy with food and drink

Having your tablets with or after food does not affect how Pariet Pharmacy works.

Driving and using machines

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

Special advice for people taking medicines for indigestion or heartburn without a prescription

You should talk to your pharmacist or doctor if:

•    You need to take medicines for heartburn or indigestion for 4 weeks or more to control your symptoms.

•    You have lost weight without trying to; you have been told you are are anaemic or you have had bleeding from your stomach or have black stools.

•    You have difficulty swallowing or it is painful to swallow.

•    You are being sick a lot or there is blood in your sick.

•    You have noticed a lump in your stomach.

•    You have had stomach ulcers in the past or surgery for ulcers.

•    You have yellowing of the skin (jaundice) or any other serious illness.


3. How to take Pariet Pharmacy

Always take Pariet Pharmacy exactly as this

leaflet tells you.

You should 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.

•    Take one Pariet Pharmacy 10 mg tablet once a day for up to 2 weeks until your symptoms are completely gone. If you still have symptoms after taking Pariet Pharmacy every day for 4 weeks you should talk to your doctor.

•    You may not get relief of your symptoms with the first dose of Pariet Pharmacy.


If you take more Pariet Pharmacy than you should

If you take more Pariet Pharmacy 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 Pariet Pharmacy

•    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.

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

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


4. Possible side effects

Like all medicines, Pariet Pharmacy may sometimes 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 Pariet Pharmacy 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 (affect less than 1 in 1,000 people).

Other possible side effects:

Common (affect less than 1 in 10 people)

•    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.

•    Non-specific pain or back pain.

•    Weakness or flu-like symptoms.

Uncommon (affect less than 1 in 100 people)

•    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).

Rare (affect less than 1 in 1,000 people)

•    Anorexia.

•    Depression.

•    Hypersensitivity.

•    Visual disturbance.

•    Sore mouth (stomatitis) or taste disturbance.

•    Upset stomach.

•    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).

•    Reduction in platelets.

Very rare (affect less than 1 in 10,000 people)

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

Other possible side effects (unknown frequency)

•    Breast swelling.

•    Fluid retention.

•    Changes in sodium levels (measured in blood tests).

•    Confusion.

Do not be concerned by this list of side effects. You may not get any of them. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.


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5. How to store Pariet Pharmacy

Keep out of the reach and sight of children. Do not store this medicine above 250C.

Do not refrigerate.

Do not use Pariet Pharmacy after the expiry date which is stated on the carton and blister foil. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.

6. Further Information

What Pariet Pharmacy contains

Each Pariet Pharmacy 10 mg tablet contains 10 mg of the active substance rabeprazole sodium.

The other ingredients it contains are: mannitol, magnesium oxide, low-substituted hyprolose, hyprolose, magnesium stearate, ethylcellulose, hypromellose phthalate, diacetylated monoglycerides, talc, titanium dioxide (E171), red iron oxide (E172), Carnauba wax and ink (white shellac, black iron oxide (E172)), dehydrated ethyl alcohol, 1-butanol.

What Pariet Pharmacy looks like and contents of the pack

Pariet Pharmacy 10 mg gastro-resistant tablet is a pink, film coated biconvex tablet with 'E241' printed on one side.

The tablets are packed in blister strips and come in pack sizes that contain: 14 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Eisai Ltd., European Knowledge Centre Mosquito Way,

Hatfield,

Herts,

AL10 9SN UK

Manufacturer:

Eisai Manufacturing Ltd, European Knowledge, Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN United Kingdom.

Pariet Pharmacy bulk tablets are manufactured for Eisai Ltd. by: Eisai Co. Ltd., (Misato Plant), 950 Oaza Hiroki, Misato-cho, Kodama-gun, Saitama Prefecture 367-0198, Japan.

This leaflet was last approved in 01/2012


Eisai Ltd.

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