PACKAGE LEAFLET:

INFORMATION LEAFLET FOR THE USER

GAVILAST 75 MG TABLETS

(Ranitidine]

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 Gavilast 75 mg

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 Gavilast 75 mg Tablets is and what it is used for

2.    Before you take Gavilast 75 mg Tablets

3.    How to take Gavilast 75 mg Tablets

4.    Possible side effects

5.    How to store Gavilast 75 mg Tablets

6.    Further Information

Taking other medicines:

Please tell your doctor or pharmadst if you are taking or have recently taken any other medidnes including medicines obtained witiiout 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). This advice is even more important if you are elderly

-    Ketoconazde (an antifungal agent)

-    Glipizide (a drug used to treat diabetes)

-    Theophylline (used in the treatment of asthma)

-    Sucralfate (an ulcer healing drug)

-    Antacids (for your stomach)

-    Procainamide (used to treat an irregular heart beat)

-    Tolazdine (used to treat spasm of blood vessels that supply blood to the hands and feet)

If you are faking antacids or Sucralfate (having discussed this with your doctor) ensure that Gavilast 75mg Tablets are taken at least two hours before you fake them.

□ WHAT GAVILAST 75 MG TABLETS IS AND WHAT FT IS USED FOR

Gavilast 75 mg Tablets belongs to a group of medicines called H2 antagonists which works by redudng the amount of add In your stomach which helps in the short term relief of acid related indigestion and heartburn.

□ BEFORE YOU TAKE GAVILAST 75 MG TABLETS

Do not take Gavilast 75 mg 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 indude 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 Gavilast 75 mg Tablets:

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

• you are middle aged or older with new or recently changed symptoms of indigestion • you are suffering from any other illness or taking medicines either prescribed by your doctor or have been taking on your own • you have unexplained weight loss or have associated indigestion

• you are receiving medical attention for any reason • you have kidney and or liver problems.

• you suffer from porphyria (excess protein in the urine)

If any of the above applies to you, please talk to your doctor or pharmadst for advice if you have not already done so before taking Gavilast 75 mg Tablets.

Taking Gavilast 75 mg Tablets with food and drink:

Gavilast 75 mg Tablets should be swallowed whole with a glass of water. You should not drink alcohol when taking this medicine. The effects of alcohol may be increased by taking Gavilast 75 mg Tablets.

Pregnancy and breast-feeding

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

Gavilast 75 mg Tablets should not be taken during pregnancy. If you become pregnant while taking Gavilast 75 mg Tablets you should talk to your doctor immediately,

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

Driving or using machines:

There have been no reported effects on the ability to drive or operate machinery. However, side effects like severe dizziness, blurred vision and fatigue have been reported in patients whilst on Gavilast 75 mg Tablets. It is advisable to exercise caution when driving or operating machinery. If you get these side effects, do not drive or use machines or do anything else where you need to be alert and concentrate,

Important Information about some of the Ingredients of Gavilast 75 mg 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 diarrhea.

□

HOW TO TAKE GAVILAST 75 MG 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 Gavilast 75 mg Tablets are: Adults, the elderly and children over the age of 16 years

Take one tablet whenever the symptoms of add-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 6 days continuously. You should not purchase a second pack of tablets without the advice of a pharmacist or doctor.

If you 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-prescription medidnes) without first checking with your doctor.

If you take more Gavilast 75 mg Tablets than you should:

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

If you forget to take Gavilast 75 mg 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.

Q POSSIBLE SIDE EFFECTS

Like all medidnes, Gavilast 75 mg 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 on 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 you doctor Immediately.

•    Severe stomach pain, nausea, loss of appetite, diarrhoea or constipation

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

•    Slow or irregular heart beat

•    Skin rash, itching or, jaundice (yellow skin or whites of eyes)

•    Depression, hallucinations, confusion or feeling agitated

•    Headache, dizziness, blurred vision

•    Pain in musdes 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 Gavilast 75 mg Tablets.

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.

0HOW TO STORE GAVILAST 75 MG TABLETS

Do not store above 25°C. Store in the original container to protect them from light.

Keep out of the reach and sight of children.

Do not use Gavilast 75 mg 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 howto dispose of medicines no longer required. These measures will help to protect the environment.

fl FURTHER INFORMATION What Gavilast 75 mg Tablets contain The active Ingredient Is: Ranitidine

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 contain: 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 Gavilast 75 mg Tablets look like and contents of the pack Gavilast 75 mg Tablets are light pink round, biconvex, film coated tablets printed with “75” in black edible ink on one side.    g

Gavilast 75 mg Tablets are available in packs a containing 6,10,12,20,24 or 28 tablets. g Not all pack sizes may be marketed.    ¹⁰

Marketing Authorisation Holder and Manufechrer Marketing Authorisation Holder: Ranbaxy (UK) Limited, Building 4, Chiswick Park, 566 Chiswick High Road, London, W4 5YE, United Kingdom. Manufacturer: Ranbaxy Ireland Limited, Spafield, Cork Road, Cashel, Co, Tipperary, Ireland,

This leaflet was last revised in April 2012.    8018891