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Document: leaflet ASDA_PL 21880-0133 change

• leaflet ASDA_PL 21880-0133
• leaflet MAH BRAND_PL 21880-0133
• leaflet MAH GENERIC_PL 21880-0133
• leaflet MORRISON_PL 21880-0133
• leaflet TESCO_PL 21880-0133

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•    Headache, dizziness or blurred vision

•    Your small blood vessels can become swollen (known as 'vasculitis⁷). 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.

If you get any side effects, talk to your doctor or pharmacist. 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 RANITIDINE TABLETS

Do not store above 25°C.

Keep out of the 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 Ranitidine tablets contain

The active substance is ranitidine hydrochloride (75mg).

The other ingredients are microcrystalline cellulose, magnesium stearate, hypromellose and titanium dioxide (El 71).

What Ranitidine tablets look like and contents of the pack

Ranitidine 75mg 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, 1 2 and 24 tablets

PL 21880/0133

This package leaflet was last revised in October 201 6.

0

Marketing Authorisation Holder and Manufacturer: I MEDREICH PLC,

| Warwick House, Plane Tree Crescent,

Feltham, TW1 3 7HF, UK E-mail: info@medreich.co.uk

®

Ranitidine 75mg film-coated tablets

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.

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

•    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 Ranitidine tablets are and what they are used for

2.    What you need to know before you take Ranitidine tablets

3.    How to take Ranitidine tablets

4.    Possible side effects

5.    How to store Ranitidine tablets

6.    Contents of the pack and other information

1. WHAT RANITIDINE 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.

Ranitidine 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 RANITIDINE TABLETS Do not take Ranitidine tablets if:

•    you are hypersensitive (allergic) to ranitidine or any of the other ingredients of Ranitidine 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

•    are taking non-steroidal anti-inflammatories (NSAIDs) e.g. Indometacin, 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 Ranitidine 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 Ranitidine tablets can affect the way some other medicines work. Also some other medicines can affect the way Ranitidine 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 Ranitidine Tablets with food and drink

Ranitidine 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. Ranitidine should only be used during pregnancy and breast-feeding if considered essential.

Driving and using machines:

Ranitidine tablets have no known effects on the ability to drive or operate machinery.

3. HOW TO TAKE RANITIDINE 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 in 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 Ranitidine tablets without the advice of a pharmacist or doctor.

Not recommended for children under 1 6 years of age

121XXXX-V1

If you take more Ranitidine 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 Ranitidine 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, Ranitidine tablets can cause side effects, although not everybody gets them.

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 100 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