PACKAGE LEAFLET:

INFORMATION LEAFLET FOR THE USER

RANITIDINE 75MG 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 Ranitidine 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 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 Ranitidine is and what it is used for

2.    Before you take Ranitidine

3.    How to take Ranitidine

4.    Possible side effects

5.    How to store Ranitidine

6.    Further information

WU WHAT RANITIDINE IS AND WHAT IT IS U USED FOR

iRanitidine 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.

FI BEFORE YOU TAKE RANITIDINE

Do not take Ranitidine:

•    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

I 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 Ranitidine:

•    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

I* if you are receiving medical attention for any reason

•    if you have kidney problems

I* if you suffer from porphyria (excess protein in your urine)

•    if you have difficulty with swallowing

•    if you have persistent stomach pain.

f 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 Ranitidine. Taking other medicines:

Please tell your doctor or pharmacist if you 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 nonsteroidal 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 Ranitidine 75mg Tablets are taken at least two hours before you take them.

Taking Ranitidine with food and drink: Ranitidine 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.

Ranitidine should not be taken during pregnancy.

If you become pregnant while taking Ranitidine you should talk to your doctor immediately.

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

El HOW TO TAKE RANITIDINE

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 Ranitidine 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.

Do not take more than two tablets in 24 hours.

You should not take the tablets for more than 2 weeks continuously. If the symptoms worsen or persist after 2 weeks, consult your doctor or pharmacist.

You should not purchase a second pack of tablets without the advice of a pharmacist or doctor.

_Further information overleaf

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

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

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

If you take more Ranitidine than you should:

Ilf you have taken too much Ranitidine, 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. Jf you forget to take Ranitidine:

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 Iproduct, ask your doctor.

n POSSIBLE SIDE EFFECTS

Like ail medicines, Ranitidine can have side effects, although not everybody gets them.

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

!• sudden wheeziness or tightness in the chest or throat, difficulty in breathing, speaking and I swallowing

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

•    feeling faint.

[These are ail 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

I mouth, mouth ulceration, flatulence, diarrhoea or constipation

•    unusual tiredness , shortness of breath, tendency

i 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 I agitated

•    headache, dizziness, migraine, tremor, loss of co-ordination, loss of consciousness, feeling lethargic or sleepy

!• blurred vision, double vision or 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 H 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 Ranitidine.

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/vellowcard.

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

FI HOW TO STORE RANITIDINE

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 Ranitidine 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.

n FURTHER INFORMATION

What Ranitidine 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). The Printing ink contains Opacode S-1 -17823 Black (containing shellac, Isopropyl alcohol, Iron oxide black, N-Butyl alcohol, Propylene glycol and Ammonium Hydroxide 28%). What Ranitidine 75mg Tablets look like and contents of the pack:

Ranitidine 75mg Tablets are light pink, round, biconvex, film coated tablets printed with “75” in black edible ink on one side.

Ranitidine 75mg Tablets are available in packs containing 6, 10, 12, 20, 24 or 28 tablets.

Not all pack sizes may be marketed. Pack sizes of 20 and above are only available from your pharmacist. Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

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

Manufacturer:

Ranbaxy Ireland Limited, Spafield, Cork Road, Cashel, Co. Tipperary, Ireland.

Text revised: April 2014._ _ _4004535|