©SOVEREIGN

MEDICAL

Ranitidine 150 mg and 300 mg Effervescent Tablets

Read all of this leaflet carefully before you start taking this medicine.

•    Please keep this leaflet. You may need to read it again.

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

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects becomes severe, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Ranitidine 150 mg and 300 mg Effervescent Tablets are and what they are used for

2.    Before you take Ranitidine 150 mg and 300 mg Effervescent Tablets

3.    How to take Ranitidine 150 mg and 300 mg Effervescent Tablets

4.    Possible side effects

5.    How to store Ranitidine 150 mg and 300 mg Effervescent Tablets

6.    Further information

1.    WHAT RANITIDINE 150 MG AND 300 MG EFFERVESCENT TABLETS ARE AND WHAT THEY ARE USED FOR

Ranitidine is one of a group of medicines called H₂-antagonists. They

reduce the amount of acid in your stomach and are therefore used:

•    to heal and prevent ulcers in the duodenum (the part of the body that the stomach empties into);

•    to treat ulcers caused by a type of bacteria known as Helicobacter pylori;

•    to prevent ulcers from bleeding (in those patients that have stress-related ulcers);

•    to heal and prevent problems caused by acid in the gullet (oesophagus) or too much acid in the stomach which can cause pain or discomfort sometimes known as “indigestion”, “dyspepsia” or “heartburn”;

•    to prevent ulcers, which can be a side effect of some medicines (non-steroidal anti-inflammatory drugs) used to treat arthritis;

•    before surgical operations, to prevent acid coming up from the stomach during the anaesthetic (particularly in patients who have a condition known as Mendelson's Syndrome).

If you are not sure why you are taking these tablets ask your doctor.

2.    BEFORE YOU TAKE RANITIDINE 150 MG AND 300 MG EFFERVESCENT TABLETS

Do not take this medicine if:

•    you have ever had an allergic reaction to any of the ingredients of Ranitidine 150 mg and 300 mg Effervescent Tablets or any other medicines that you may have taken to treat stomach ulcers (allergic reactions include mild symptoms such as itching and/or rash. More severe symptoms include swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing).

Take special care with this medicine and tell your doctor or

pharmacist if:

•    you have kidney problems;

•    you are on a low sodium diet;

•    you have a long-term lung disease;

•    you have diabetes;

•    you have stomach cancer;

•    you have been told you have a rare condition called porphyria (a blood disease);

•    you have had stomach ulcers before and you are taking non-steroidal anti-inflammatory (NSAID) medicines;

•    your immune system is weakened, e.g. you have HIV, are undergoing cancer treatment or are receiving steroids.

Taking other medicines

Tell your doctor if you are taking, or have recently taken any other

medications, including those obtained without a prescription.

This is especially important if you are taking:

•    medicines that thin the blood, e.g. warfarin;

•    medicines for HIV, e.g. atazanavir or delavirdine;

•    procainamide or N-acetylprocainamide (for heart arrhythmias);

•    midazolam or triazolam (sedative/relaxant medicines);

•    glipizide (for diabetes);

•    ketoconazole (an antifungal medicine);

•    gefitinib (for breast cancer);

•    non-steroidal anti-inflammatory (NSAID) medicines, for pain and inflammation;

•    sucralfate (for duodenal ulcers).

Pregnancy and breast-feeding

Tell your doctor before you take this medicine if you are pregnant, planning to become pregnant or if you are breast-feeding.

Driving and using machines

Ranitidine 150 mg and 300 mg Effervescent Tablets do not cause side effects which impair the ability to drive or use machines.

Important information about some of the ingredients of Ranitidine 150 mg and 300 mg Effervescent Tablets

Tell your doctor before taking this medicine if you have been told that you have an intolerance to some sugars as these tablets contain lactose, a type of sugar.

3.    HOW TO TAKE RANITIDINE 150 MG AND 300 MG EFFERVESCENT TABLETS

Always take your medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. He or she will tell you how many to take and how often to take them.

Adults and children 12 years and over: The usual dosage is 150 mg twice daily, taken in the morning and evening or 300 mg at bedtime.

Children over 30 kg in weight and from 3 to 11 years: If the tablets are for a child, your doctor will work out the dose depending on the child's weight. The recommended daily dose for children is 2 - 4 milligrams per kilogram body weight to be taken twice daily to a maximum of 300 mg ranitidine per day.

Dissolve the tablets completely in half a glass of water (minimum 75 ml) before swallowing.

If you take more tablets than you should

If you accidentally take too much of your medicine, tell your doctor at once or contact your nearest hospital casualty department immediately. Take your medicine with you.

If you forget to take your medicine

If you forget to take a dose, just take the next dose at the usual time. DO NOT take a double dose.

4.    POSSIBLE SIDE EFFECTS

Like all medicines Ranitidine 150 mg and 300 mg Effervescent Tablets can cause unwanted side effects, although not everybody gets them. You are unlikely to get any of the following, but if you do, tell your doctor immediately:

•    Sudden wheeziness or tightness in the chest;

•    Swelling of eyelids, face or lips, with or without a lumpy skin rash (hives) anywhere on the body;

•    Unexplained fever;

•    Feeling faint, especially on standing up.

•    Slow or irregular heartbeat;

•    Severe stomach pain caused by an inflamed pancreas (pancreatitis);

•    Inflammation of the liver (hepatitis) with or without jaundice (yellowing of the skin and whites of eyes);

•    A change in the amount of urine you produce or blood in your urine.

Also, check with your doctor or pharmacist as soon as possible if any

of the side effects listed below are noticed:

Uncommon (affects less than 1 in 100 people):

•    Stomach pain;

•    Diarrhoea;

•    Constipation;

•    Nausea (feeling sick).

Rare (affects up to 1 in 1,000 people):

•    Changes to liver function (shown in blood tests);

•    Skin rash;

•    Increase of creatinine in the blood (kidney function test).

Very rare (affects less than 1 in 10,000 people):

•    Reductions in your blood counts (rare conditions known as thrombocytopenia, pancytopenia, leucopenia and agranulocytosis have occurred in patients taking ranitidine). If you feel very tired, experience unexpected bruising or bleeding, or more infections (e.g. colds and sore throats) than usual please tell your doctor. Your doctor may decide to conduct tests on your blood periodically as a result of these symptoms;

•    Confusion;

•    Feeling of depression;

•    Hallucinations;

•    Headache (sometimes severe);

•    Dizziness;

•    Uncontrolled movements. This effect is usually reversible and should get better once you stop taking this medicine;

•    Blurred vision;

•    Combined symptoms of unexplained fever, feeling unwell and rash which could indicate inflammation of blood vessels (vasculitis);

•    Unexplained hair loss (alopecia);

•    Pink/red marks on your skin that look like targets;

•    Pain in muscles or joints;

•    Breast tenderness, breast enlargement and/or breast discharge;

•    Interference with sexual function in men (impotence) that is usually reversible once the medication is stopped.

If any of the side effects becomes severe, or if you notice any side effects

not listed in this leaflet, please tell your doctor or pharmacist

immediately.

5.    HOW TO STORE RANITIDINE 150 MG AND 300 MG EFFERVESCENT TABLETS

Do not store above 25°C. Keep the container tightly closed and store in the original container. Do not use after the expiry date that is stated on the carton.

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN

Return any unused medicine to your pharmacist.

6.    FURTHER INFORMATION

What Ranitidine 150 mg and 300 mg Effervescent Tablets contain:

Each tablet contains 150 mg or 300 mg of ranitidine (as hydrochloride). Other ingredients are: tartaric acid, a-lactose monohydrate, povidone K25, riboflavin 5'-phosphate sodium, sodium cyclamate, saccharin sodium, lemon flavour (citral, citronella oil, coriander oil, gum arabic, lime oil), macrogol 6000, sodium bicarbonate, simethicone emulsion (methylcellulose and sorbic acid) and magnesium stearate.

What Ranitidine 150 mg and 300 mg Effervescent Tablets look like and the contents of the pack:

Ranitidine 150 mg and 300 mg Effervescent Tablets are off white to light yellow cylindrical tablets with bevel edges on both sides.

Ranitidine 150 mg and 300 mg Effervescent Tablets are packed in polypropylene tubes. Each pack contains 4 x 15 Tablets (60 tablets per pack) for Ranitidine 150 mg and 2 x 15 Tablets (30 tablets per pack) for Ranitidine 300 mg.

Marketing Authorisation Holder and Manufacturer:

Waymade Plc trading as Sovereign Medical, Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR.

This leaflet does not contain all the available information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

Date of preparation of the leaflet: October 2013

©SOVEREIGN

MEDICAL