RANITIDINE 150MG EFFERVESCENT TABLETS

Active substance: RANITIDINE HYDROCHLORIDE

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GB 726-9947-APIL

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: The usual dosage is 150 mg twice daily, taken in the morning and
evening or 300 mg at bedtime.
Children: 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
• Skin rash;
• Increase of creatinine in the blood (kidne
Very rare (affects less than 1 in 10,000 pe
• Reductions in your blood counts (rare co
thrombocytopenia, pancytopenia, leucop
occurred in patients taking ranitidine). If
unexpected bruising or bleeding, or more
sore throats) than usual please tell your
to conduct tests on your blood periodical
symptoms;
• Confusion;
• Feeling of depression;
• Hallucinations;
• Headache (sometimes severe);
• Dizziness;
• Uncontrolled movements. This effect is u
get better once you stop taking this med
• Blurred vision;
• Combined symptoms of unexplained feve
which could indicate inflammation of blo
• Unexplained hair loss (alopecia);
• Pink/red marks on your skin that look lik
• Pain in muscles or joints;
• Breast tenderness, breast enlargement a
• Interference with sexual function in men
reversible once the medication is stoppe

If any of the side effects becomes severe, or
not listed in this leaflet, please tell your doc
immediately.

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, α-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: January 2013

1074950

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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