Read all of this leaflet carefully before you start using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What this medicine is and what it is used for
2. Before you take
3. How to take
4. Possible side effects
5. How to store
6. Further information
Tagamet Syrup contains cimetidine which is a histamine H2 antagonist. It helps to reduce the natural production of acid in the stomach.
It is used to treat and relieve:
• the symptoms of peptic ulcers which occur in the stomach or intestine (gut)
• oesophageal reflux disease which can be caused when food and acid from the stomach washes back into the food pipe (oesophagus). This can cause a burning feeling in the chest known as heartburn
• a rare condition called Zollinger-Ellison syndrome when the stomach produces very large amounts of acid.
This medicine may also be prescribed for a range of other medical conditions where a reduction of acid production in the stomach is needed, or to protect your stomach from other medicines (such as non-steroidal anti-inflammatories).
Do NOT take Tagamet Syrup if you:
• are allergic to cimetidine or to any of the other ingredients (see Section 6).
If this applies to you, speak to your doctor or pharmacist.
Take special care with Tagamet Syrup
Before taking the syrup, tell your doctor if you:
• have a kidney problem
• have a blood disease
• have had a peptic ulcer and are also taking a non-steroidal anti-inflammatory drug (NSAID), (e.g. ibuprofen)
• are pregnant or planning a pregnancy
• are breast-feeding.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, and herbal preparations.
Some medicines may be affected by Tagamet or they may affect how well Tagamet will work. Tell your doctor or pharmacist if you are taking medicines which:
• control epilepsy (e.g. phenytoin). Your doctor will monitor you
• thin the blood (e.g. warfarin). Your doctor will monitor you
• treat breathing problems (e.g. theophylline)
• may cause your blood cell count to change (e.g. antibiotics)
• treat fungal (yeast) infections (e.g. ketoconazole, itraconazole, posaconazole)
• treat diabetes (e.g. glipizide, metformin)
• treat anxiety (e.g.diazepam)
• treat depression, called tricyclic antidepressants (e.g. amitriptylline)
• lower blood pressure or treat heart conditions (e.g. metoprolol, propranolol, nifedipine, diltiazem, procainamide)
• numb the body such as anaesthetics used in hospital (e.g. lidocaine)
• are strong pain relievers (e.g. morphine)
• suppress the immune system (e.g. ciclosporin, tacrolimus)
• treat HIV/AIDS (e.g. atazanavir)
• treat tumours or cancer (e.g. carmustine, fluorouracil, epirubicin), or if you are having radiation therapy.
Pregnancy and breast-feeding
DO NOT take Tagamet if you are pregnant, planning to become pregnant or breast-feeding unless advised to by your doctor.
Ask your doctor for advice before taking any medicine.
Driving and using machines
Tagamet syrup is unlikely to affect your ability to use machinery or to drive.
Important information about some of the ingredients of Tagamet Syrup
Each 5 ml of Tagamet Syrup contains 12.8 mg of sodium.
This should be taken into consideration by patients on a controlled sodium diet.
• methyl hydroxybenzoate and propyl hydroxybenzoate
These may cause allergic reactions (possibly delayed).
• sucrose and sorbitol
If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.
• sunset yellow
This may cause allergic reactions.
• ethanol (alcohol)
This medicine contains small amounts of ethanol, less than 100 mg per 5 ml.
Always take Tagamet Syrup exactly as your doctor has told you and always read the label. Your doctor will decide on the appropriate dose to suit your condition. Ask your doctor or pharmacist if you are not sure.
• Take the syrup with meals or at bedtime as advised by your doctor. Doses
Adults and the elderly: the usual dose is 10 ml twice a day, with breakfast and at bedtime.
Your doctor will tell you the correct dose depending on your condition.
The maximum dose is 60 ml a day
Children: your doctor will decide on the dose according to your child's body weight.
The usual length of treatment is at least four weeks though this may be longer in some conditions. Your doctor will advise you.
If you take more than you should
1. Tell your doctor, pharmacist or nearest hospital casualty department immediately.
2. Take the bottle and any remaining solution with you so that people can see what you have taken.
3. Do this even if you feel well.
Continued over page
If you forget to take a dose take it as soon as you remember, but if it is almost time for your next dose, skip the missed dose and continue as usual.
Do not use a double dose to make up for a missed dose.
If you stop taking
If you stop your treatment too soon, your symptoms may come back. You may feel better after a few days, but you should keep taking your medicine until the prescribed course is finished.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
• Keep out of the reach and sight of children.
• Do not take after the expiry date which is stated on the bottle label and on the carton. The expiry date refers to the last day of that month.
• Store below 25°C.
• Do not throw it away with your household waste or in water. Return all the unwanted medicine to your pharmacist. This will help to protect the environment.
Like all medicines, Tagamet Syrup can cause side effects, although not everybody gets them. Do not be alarmed by this list of possible side effects. You may not experience any of them.
STOP taking the syrup and seek medical help immediately if you have any of the following allergic reactions:
• difficulty breathing or swallowing, swelling of the face, lips, tongue or throat
• severe itching of the skin, with a red rash or raised lumps.
Seek immediate medical attention if you have any of the following symptoms:
• unusual bleeding or bruising; or fever, sore throat, mouth ulcers, repeated infections or infections that will not go away . This may be due to changes in your blood
• red spots on the skin which may be painful to touch, joint pain, swollen lymph glands
• yellowing of your skin or eyes, pale faeces and dark urine, unexplained persistent nausea, stomach problems, loss of appetite or unusual tiredness. This may be due to liver changes
• confusion, hallucinations, depression
• in men: enlarged breasts, trouble getting or keeping an erection
• unexpected secretion of breast milk in men or women
• pain behind the ribs radiating towards the back, often worse when lying down, nausea, vomiting, fever. This may be due to inflammation of the pancreas
• unusually slow or fast heartbeat, irregular heartbeat and fainting
• fever, rash, nausea, aches and pains, change in colour of urine, passing more or less urine than usual or passing urine at night. These problems may indicate kidney changes
• aching or weak muscles, or aching joints.
Tell your doctor if you get any of the following side effects:
• mild skin rash
• hair loss.
Side effects with Tagamet Syrup are usually mild and do not last long. 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. m h ra. gov. u k/yel lowca rd
By reporting side effects you can help provide more information on the safety of this medicine.
• The active ingredient is cimetidine (200 mg per 5 ml).
• The other ingredients are:
saccharin sodium, hydrochloric acid, ethanol (alcohol), methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), propylene glycol, sodium chloride, disodium hydrogen phosphate, sorbitol (E420), sucrose, sunset yellow (E110), peach flavour, Mafco Magnasweet 180, ethylene oxide and propylene oxide polymer, and water.
(See end of Section 2 for further information on sodium, ethanol, sorbitol, sucrose, sunset yellow, methyl hydroxybenzoate, propyl hyd roxybenzoate).
What Tagamet Syrup looks like and contents of the pack
Tagamet Syrup is a clear, orange-coloured syrup with a peach-flavour.
It is available in bottles of 600 ml.
Marketing Authorisation Holder
Essential Pharma Ltd, 7 Egham Business Village, Crabtree Road,
Egham, Surrey, TW20 8RB, United Kingdom.
Famar Nederland BV, Industrieweg 1,5531 AD Bladel, The Netherlands.
'Tagamet' is a registered trade mark.