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Ranitidine 75mg Tablets

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Document: leaflet WILKO_PL 16028-0122 change

PACKAGE LEAFLET: INFORMATION LEAFLET FOR THE USER


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Wilko Heartburn & Indigestion Relief 75 mg Tablets

(Ranitidine Hydrochloride)


Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to take Wilko Heartburn & Indigestion Relief 75mg Tablets carefully to get the best results from it.

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

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

•    You must contact a doctor if your symptoms worsen or do not improve after 6 days.

•    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 Wilko Heartburn & Indigestion Relief 75mg Tablets are and what they are used for

2.    Before you take Wilko Heartburn & Indigestion Relief 75mg Tablets

3.    How to take Wilko Heartburn & Indigestion Relief 75mg Tablets

4.    Possible side effects

5.    How to store Wilko Heartburn & Indigestion Relief 75mg Tablets

6.    Further information

WHAT WILKO HEARTBURN &

INDIGESTION RELIEF 75MG TABLETS ARE AND WHAT THEY ARE USED FOR

Wilko Heartburn & Indigestion Relief 75mg Tablets belongs to a group of medicines called H2 antagonists which works by reducing the amount of acid in your stomach which helps in the short term relief of acid related indigestion and heartburn.


Taking other medicines:

Please tell your doctor or pharmacist if youi are taking or have recently taken any other medicines obtained without a prescription. This particularly applies to the following:

-    If you are taking medicines known as non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin or Ibuprofen (a pain relieving medicine)

-    Warfarin (an anti-coagulant)

-    Ketoconazole (an antifungal agent)

-    Triazolam and Midazolam (drugs used for sedation e.g. to treat insomnia)

-    Glipizide (a drug used to treat diabetes)

-    Atazanavir and Delavirdine (drugs used to treat HIV)

-    Gefitinib (a drug used to treat some cancers)

-    Theophylline (used in the treatment of asthma)

-    Sucralfate (an ulcer healing drug)

-    Antacids (for your stomach)

-    Procainamide (used to treat an irregular heartbeat)

If you are taking antacids or Sucralfate (having discussed this with your doctor) ensure that Wilko Heartburn &

Indigestion Relief 75mg Tablets are taken! at least two hours before you take them.

Taking Wilko Heartburn & Indigestion Relief 75mg Tablets with food and drink:

Wilko Heartburn & Indigestion Relief 75mg Tablets should be swallowed whole with a glass of water. You should not drink alcohol when taking this medicine.

Pregnancy and breast-feeding:

Ask your doctor or pharmacist for advice before taking any medicine.

Wilko Heartburn & Indigestion Relief 75mg Tablets should not be taken during pregnancy. If you become pregnant whilei taking Wilko Heartburn & Indigestion Relief 75mg Tablets you should talk to your doctor immediately.


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BEFORE YOU TAKE WILKO HEARTBURN & INDIGESTION RELIEF 75MG TABLETS


It is also not advised to take this medicine while breast-feeding as Ranitidine passes into breast milk.


Do not take Wilko Heartburn & Indigestion Relief 75mg Tablets:

•    If you are, or have ever been told you are allergic to Ranitidine or to any of the other ingredients in these tablets (an allergic reaction may include rash, itching, swollen face or lips, or breathing difficulties). See section 6 for a list of ingredients.

•    If you are under 16 years of age.

Take special care with Wilko Heartburn & Indigestion Relief 75mg Tablets:

•    If you have been diagnosed with or told you are at risk from a duodenal (part of the small intestine) ulcer.

•    If you have unexplained weight loss or have associated indigestion.

•    If you are receiving medical attention for any reason.

•    If you have kidney problems.

•    If you suffer from porphyria (excess protein in your urine).

•    If you have difficulty with swallowing.

•    If you have persistent stomach pain.

If any of the above applies to you, please talk to your doctor or pharmacist for advice, if you have not already done so before taking Wilko Heartburn & Indigestion Relief 75mg Tablets.


Driving or using machines:

There have been no reported effects on the ability to drive or operate machinery.

Important information about some of the ingredients of Wilko Heartburn & Indigestion Relief 75mg Tablets

This medicinal product contains 0.31 mg of sodium (salt) per dose. This should be taken into consideration by patients on a controlled sodium (salt) diet. The tablets also contain castor oil. This may cause stomach upset and diarrhoea.

HOW TO TAKE WILKO

HEARTBURN & INDIGESTION RELIEF 75MG TABLETS

Check the label to see how many tablets to take and how often to take them. The tablets should be swallowed whole with a glass of water.

The usual doses of Wilko Heartburn & Indigestion Relief 75mg Tablets are:

Adults, the elderly and children over the age of 16 years:

Take one tablet whenever the symptoms of acid-related indigestion and heartburn appear, day or night.

Further information overleaf


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Do not take more than two tablets in 24 hours.

I'ou should not take the tablets for more than 6 days continuously. If the Symptoms worsen or persist after 6 days, consult your doctor or pharmacist.

kou should not purchase a second pack of tablets without the advice of a pharmacist Jor doctor.

If you are unsure about how many tablets to take or when to take them, ask your doctor or pharmacist.


'• Blurred vision, double vision of conjunctivitis.

•    Pain in muscles and joints.

•    In men swollen or tender breasts, difficulty in achieving or maintaining an erection.

There have been a few isolated reports of blood abnormalities. This would only usually be seen after you have had a blood test. Your doctor may perform blood tests to check for abnormalities while you are taking Wilko Heartburn & Indigestion Relief 75mg Tablets.


Do not give these tablets to children under 16 years of age.

Do not take any other medicine (including non-prescription medicines) without first checking with your doctor.

If you take more Wilko Heartburn & Indigestion Relief 75mg Tablets than you should:

If you have taken too much Wilko Heartburn & Indigestion Relief 75mg Tablets, or if someone else has taken your medicine, you / they should contact your doctor or your nearest hospital casualty department immediately. Please take any remaining medicine with you in the carton in which it came so that staff will know what has been taken.

If you forget to take Wilko Heartburn & Indigestion Relief 75mg Tablets:

Take it as soon as you remember then continue as before. If it is nearly time for your next tablet, leave the missed dose and continue as before. Do not take more than two tablets in 24 hours.

Do not take a double dose to make up for a missed dose.

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

POSSIBLE SIDE EFFECTS

Like all medicines, Wilko Heartburn & Indigestion Relief 75mg Tablets can have side effects, although not everybody gets them.

Stop taking the tablets and tell your doctor immediately if you experience any of the following rare effects:

•    Sudden wheeziness or tightness in the chest or throat, difficulty in breathing, speaking and swallowing.

•    Itchy skin rash (hives) or swelling of the eyelids, face, neck or lips

•    Feeling faint.

These are all possible signs of a severe allergic reaction.

If you notice any of the following side effects, tell your doctor immediately.

•    Severe stomach pain, being sick (vomiting) or feeling sick (nausea), loss of appetite, dry mouth, mouth ulceration, flatulence, diarrhoea or constipation.

•    Unusual tiredness, shortness of breath, tendency to bruising, unexplained fever or frequent infections.

•    Fast, slow or irregular heartbeat, high blood pressure or flushing (redness of the face, hands or body).

•    Skin rash, itching, hair loss or excessive sweating.

•    Changes in liver function which may cause jaundice (yellowing of the skin or the whites of the eyes).

•    Inflammation of the kidneys.

•    Depression, hallucinations, difficulty sleeping (insomnia), nightmares, confusion or feeling agitated.

•    Headache, dizziness, migraine, tremor, loss of co-ordination, loss of

_consciousness, feeling lethargic or sleepy.


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.aov.ukA/ellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

0HOW TO STORE WILKO

HEARTBURN & INDIGESTION RELIEF 75MG TABLETS

Do not store above 25°C.

Store in the original container to protect them from light.

Keep out of the sight and reach of children.

Do not use Wilko Heartburn &

Indigestion Relief 75mg Tablets after the expiry date which is stated on the blister and outer carton after EXP. 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 no longer required. These measures will help to protect the environment.

HI FURTHER INFORMATION

What Wilko Heartburn & Indigestion Relief 75mg Tablets contain

The active ingredient is: Ranitidine Hydrochloride

Each film-coated tablet contains 83.75mg of ranitidine hydrochloride, equivalent to 75mg of ranitidine, as the active ingredient.

The other ingredients are: The tablets also contain some inactive ingredients: microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate and talc. Film-coating on the tablets contains: castor oil & Opadry OY-S-54902 Pink which contains hypromellose, talc, titanium dioxide (E171) and red ferric oxide (E172).

What Wilko Heartburn & Indigestion Relief 75mg Tablets look like and contents of the pack:

Wilko Heartburn & Indigestion Relief 75mg Tablets are light pink, round, biconvex, film coated tablets with '75' on one side.

Wilko Heartburn & Indigestion Relief 75mg Tablets' are available in packs containing 6, 10 or 12 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Galpharm Healthcare Ltd., Wrafton, Braunton, Devon, EX33 2DL,

United Kingdom.

Manufacturer:

Galpharm International Ltd., Elmhirst Park, Middle Field Road, Barnsley South Yorkshire, S75 4LS, United Kingdom.

Text revised: August 2016.

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