NUMARK EXCESS ACID RELIEF TABLETS

(Ranitidine 75 mg)

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

This medicine is available without prescription for you to treat a mild illness without a doctor’s help. Nevertheless, you still need to use Numark Excess Acid Relief Tablets carefully to get the best results from them.

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

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

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

In this leaflet:

1.    What are Numark Excess Acid Relief Tablets and what are they used for

2.    Before you take Numark Excess Acid Relief Tablets

3.    How to take Numark Excess Acid Relief Tablets

4.    Possible side effects

5.    Storing Numark Excess Acid Relief Tablets

Your medicine is called Numark Excess Acid Relief Tablets.

Each film-coated tablet contains 83.75mg of ranitidine hydrochloride, equivalent to 75mg of ranitidine, as the active ingredient. 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 (El71) and red ferric oxide (El72).

The Printing ink contains Opacode-S-I-8152HV Black which contains Shellac, black ferric oxide (El72), n-butyl alcohol, Soya lecithin MC thin and Antifoam DC 1510.

Marketing Authorisation Holden Ranbaxy (UK) Ltd., 95 Park Lane, Mayfair, London WIY 3TA. Manufacturer: Ranbaxy Ireland Limited, Spafield, Cork Road, Cashel, Co. Tipperary, Republic of Ireland.

I. What are Numark Excess Acid Relief Tablets and what are they used for

These tablets contain ranitidine, one of a group of medicines called Histamine H2 antagonists. These work by reducing the amount of acid in your stomach, which can help in the short-term to relieve the symptoms of acid-related indigestion and heartburn.

Numark Excess Acid Relief Tablets are light pink, round, biconvex tablets printed with ‘75’ black ink on one side.

Numark Excess Acid Relief Tablets come in the following packs: Blister sheets of 6 or 10 film-coated tablets each, in boxes of 6, 10 or 12 tablets. Not all pack sizes may be marketed.

2. Before you take Numark Excess Acid Relief Tablets

Do not take this medicine if any of the following apply to you.

•    you have ever had an allergic reaction (this may include rash, itching, swollen face or lips, or breathing difficulties) to ranitidine hydrochloride or to any of the ingredients listed above.

•    you are under 16 years of age.

Before taking this medicine tell your doctor or pharmacist if:

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

•    you are middle aged or older and have new or recently changed indigestion symptoms

•    you have lost weight unintentionally and have associated indigestion

•    you have liver or kidney problems

•    you are receiving regular medical attention for any reason

•    you are suffering from any other illness or taking any other medicines either prescribed by your doctor, bought from the pharmacist or self-prescribed

•    you are regularly taking medicines known as non-steroidal anti-inflammatory drugs (NSAIDS) such as aspirin or ibuprofen, especially if you are elderly

•    you suffer or have suffered on occasion with an excess of protein in the urine (porphyria)

Pregnancy and breast-feeding

Do not take this medicine if you are pregnant, breast-feeding or trying to become pregnant.

Important information about some of the ingredients of this medicine

This medicinal product contains 0.31 mg of sodium per dose. To be taken into consideration by patients on a controlled sodium diet. The tablets also contain castor oil. This may cause stomach upset or diarrhoea. Driving and operating machinery

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

Taking other medicines

Please inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, even those not prescribed but bought/obtained without a prescription._

Care is needed if you are taking any of the following medicines:

•    NSAIDS (e.g. aspirin or ibuprofen)

•    antacids (help neutralize stomach acid)

•    sucralfate (an ulcer healing drug)

•    procainamide (a medicine used in treating abnormal heartbeat)

•    theophylline (used in the treatment of asthma)

•    ketoconazole (an anti-fungal medicine)

•    glipizide (a medicine used to treat diabetes).

If you are taking antacids or sucralfate having discussed this with your doctor, please ensure that Numark Excess Acid Relief Tablets are taken at least two hours before such medicines.

Since the effects of alcohol may be enhanced by these tablets, talk to your doctor about how much alcohol you may consume whilst taking this medicine.

3. Howto take Numark Excess Acid Relief Tablets

Check the medicine 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 are as follows:

Adults, the elderly and children over the age of I 6 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 6 days continuously. If the symptoms deteriorate or persist after 6 days, consult your doctor or pharmacist. 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 medicines) without first checking with your doctor. If you take more Numark Excess Acid Relief Tablets than you should, consult your doctor or go to the nearest hospital casualty department immediately. Take this leaflet or some tablets with you so your doctor will know what you have taken.

4. Possible side effects

As with all medicines, as well as benefits, these tablets may cause unwanted effects.

Rare side effects (i.e. between I in 1,000 and I in I 0,000 patients are affected) include:

•    slow, rapid or irregular heart beat

•    skin rash which may be severe, hair loss, itching

•    muscle and joint pain, blurred vision, severe stomach pain (caused by inflamed pancreas)

•    allergic reactions including: difficulty breathing, speaking or swallowing, tightness or pain in the chest, lumpy skin rash, swelling of the eyelids, face, lips, tongue or throat, unexplained fever, fainting, anaphylactic shock (i.e. severe allergic reactions).

Some people may be allergic to these tablets. If you experience any allergic reaction soon after taking these tablets, tell your doctor at once and stop taking the tablets immediately.

Other side effects include:

•    feeling sick, constipation, diarrhoea, headache, dizziness, fatigue

•    upset blood counts resulting in a tendency to bruise easily, unusual tiredness, shortness of breath or frequent infections

•    confusion, restlessness, depression and hallucinations, mainly reported in the severely ill and elderly

•    results of laboratory tests on your liver may have altered

•    inflammation of the liver which may be associated with yellowing of the skin or whites of eyes (jaundice)

•    isolated cases of swollen or tender breasts in men.

If you suffer any of the above side-effects, stop taking the tablets and consult your doctor.

If you notice any other side effects which are not mentioned in this leaflet please speak with your doctor or pharmacist.