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Ranitidine 75mg Film-Coated Tablets

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•    Headache, dizziness or blurred vision

•    Your small blood vessels can become swollen (known as Vasculitis'). Signs of this can include a rash, swollen joints or kidney problems

•    Diarrhoea

•    Flushing or marks on your skin that look like targets

•    Unexplained hair loss

•    Painful or swollen joints or muscles

•    Difficulty controlling muscles

•    Impotence

•    Breast tenderness, enlargement or discharge.

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.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.    HOW TO STORE INDIGESTION AND HEARTBURN RELIEF FILM-COATED TABLETS

Do not store above 25°C.

Keep out of sight and reach of children

Do not use after the expiry date stated on the carton and blister foil. Medicines should not be disposed of via wastewater or household waste, Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6.    CONTENTS OF THE PACK AND OTHER INFORMATION

What Indigestion and Heartburn Relief film-coated tablets contain

The active substance is ranitidine hydrochloride (75mg).

The other ingredients are microcrystalline cellulose, magnesium stearate, hypromellose and titanium dioxide (El71).

What Indigestion and Heartburn Relief film-coated tablets look like and contents of the pack

Indigestion and Heartburn Relief film-coated tablets are white, round and film coated with a "K" logo on one side and 75 on the other. They come in blisters of 6 and 12 tablets

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation holder, manufacturer and distributor is

Medreich PLC, Warwick House, Plane Tree Crescent, Feltham, TW1 3 7HF, UK Email : info@medreich.co.uk

PL 21880/0022

This package leaflet was last revised in March 2015.

GSL


002 2/G/ PI L/0 01 /1 / (wa it ros e)



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PACKAGE LEAFLET: INFORMATION FOR THE USER

Waitrose Indigestion and Heartburn Relief 75mg film-coated tablets

(Raniditine Hydrochloride)

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

Always take this medicine exactly as described in this leaflet or as your doctor has told you.

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

•    Ask your pharmacist if you need more information or advice.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

•    You must talk to a doctor if you do not feel better, or if you feel worse, after 6 days.

What is in this leaflet:

1.    What Indigestion and Heartburn Relief film-coated tablets are and what they are used for

2.    What you need to know before you take Indigestion and Heartburn Relief film-coated tablets

3.    Howto take Indigestion and Heartburn Relief film-coated tablets

4.    Possible side effects

5.    Howto store Indigestion and Heartburn Relief film-coated tablets

6.    Contents of the pack and other information

1. WHAT INDIGESTION AND HEARTBURN RELIEF FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR

This medicine contains Ranitidine. This is known as a histamine H2 antagonist. It works by reducing the natural production of acid in the stomach. Indigestion and Heartburn Relief film-coated tablets are used for the symptomatic relief of heartburn, indigestion, acid indigestion and too much acid in the stomach.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE INDIGESTION AND HEARTBURN RELIEF FILM-COATED TABLETS Do not take Indigestion and Heartburn Relief film-coated tablets if:

•    you are hypersensitive (allergic) to ranitidine or any of the other ingredients of Indigestion and Heartburn Relief film-coated tablets. See section 6 for ingredients.

Warnings and precautions

Talk to your doctor or pharmacist before taking these tablets if you:

•    have a liver or kidney problems

•    have had a stomach ulcer or a duodenal ulcer in the past

•    have a rare illness called porphyria

•    have breathing problems

•    have weak immune system

•    suffer from diabetes

•    you are under regular medical supervision for other reasons

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•    are taking non-steroidal anti-inflammatories (NSAIDs) e.g. Indometa-cin, aspirin. This is particularly important in the elderly or those with a history of ulcers.

•    you are taking other medicines either prescribed by your doctor or self-prescribed

•    you have difficulty swallowing, persistent stomach pain or unintended weight loss in association with symptoms of indigestion

•    you are of middle age or older with new or recently changed symptoms of indigestion

If any of these points apply to you, do not take this medicine until you have talked to your doctor. You may need to be given a different medicine or the dose may need to be changed.

Other medicines and Indigestion and Heartburn Relief film-coated tablets:

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal medicines. This is because Indigestion and Heartburn Relief film-coated tablets can affect the way some other medicines work. Also some other medicines can affect the way Indigestion and Heartburn Relief film-coated tablets work.

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

•    Blood thinning medicines e.g warfarin

Taking Indigestion and Heartburn Relief film-coated tablets with food and drink

Indigestion and Heartburn Relief film-coated tablets may be taken before or after meals, as soon as you have symptoms.

Pregnancy and breast-feeding:

Ask your doctor or pharmacist for advice before taking any medicine. Indigestion and Heartburn Relief film-coated tablets should only be used during pregnancy and breast-feeding if considered essential.

Driving and using machines:

Indigestion and Heartburn Relief film-coated tablets have no known effects on the ability to drive or operate machinery.

3. HOWTO INDIGESTION AND HEARTBURN RELIEF FILM-COATED TABLETS

Adults (including the elderly) and children 16 years of age and over:

Swallow one tablet whole with a glass of water as soon as you have symptoms. If symptoms persist for more than one hour or return, take another tablet. Do not take more than two tablets in 24 hours

Do not take the tablets for more than 6 days is a row unless told to by your doctor. Talk to your doctor if your symptoms get worse or persist after 6 days treatment.

Do not buy a second pack of Indigestion and Heartburn Relief film-coated tablets without the advice of a pharmacist or doctor.

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Not recommended for children under 1 6 years of age

If you take more Indigestion and Heartburn Relief film-coated tablets than you should:

If you have taken too much tell your doctor or hospital casualty department straight away. Take your tablet pack with you.

If you forget to take Indigestion and Heartburn Relief film-coated tablets:

Do not take a double dose to make up for forgotten individual doses. Take your next dose at the normal time.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Indigestion and Heartburn Relief film-coated tablets can cause side effects.

Serious Allergic Reactions

If you experience any of these reactions, stop taking the medicine and seek medical help immediately:

•    Rash, itching or hives on the skin

•    Swelling of your face, lips, tongue or other parts of the body

•    Chest pain, shortness of breath, wheezing or having trouble breathing.

•    Unexplained fever and feeling faint, especially when standing up.

Other Serious Side Effects

•    Kidney problems, which can lead to back pain, fever, pain when passing urine, blood in the urine and changes in blood tests.

•    Hepatitis (swollen liver). This can lead to feeling sick or being sick, loss of appetite or generally feeling unwell, itching, fever, yellowing of the skin and eyes or dark coloured urine.

•    Pancreatitis, which can lead to severe abdominal pain, nausea, and fever.

•    Slow or irregular heartbeat

If you experience any of the above side effects tell your doctor IMMEDIATELY or go to a casualty department at your nearest hospital.

Other Possible side effects:

Uncommon side effects (experienced by between 1 in 1 00 and 1 in 1000 patients)

•    Abdominal pain, constipation, nausea

Rare side effects (experienced by between 1 in 1000 and 1 in 10000 patients)

•    Liver enzyme increases which may have an effect on some medical tests

•    Rise in plasma creatinine which may show up in kidney function tests

•    Skin rash

Very rare side effects (experienced by less than 1 in 10,000 patients)

•    Blood count changes, which could cause you to have an increased risk of infection, or have a tendency to bruise or bleed more easily

•    Feeling confused, seeing or hearing unexplained things (hallucinations)

•    Depression

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