Cimetidine 800 Mg Film-Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before
you start taking 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
In this leaflet:
1. What Cimetidine Tablets are and what they are used for
2. What you need to know before you take Cimetidine Tablets
3. How to take Cimetidine Tablets
4. Possible side effects
5. How to store Cimetidine Tablets
6. Contents of the pack and other information
1. What Cimetidine Tablets are and what they are used for
The name of your medicine is Cimetidine film-coated Tablets referred to as Cimetidine Tablets in the leaflet. It contains the active ingredient called Cimetidine.
Cimetidine tablets contain cimetidine which is a histamine H2 antagonist. It helps to reduce the natural production of acid in the stomach.
They are 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 antiinflammatories).
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, breast-feeding and fertility
DO NOT take Cimetidine tablets 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
Cimetidine tablets are unlikely to affect your ability to operate machinery or to drive.
3. How to take Cimetidine Tablets
2. What you need to know before you take Cimetidine Tablets
Do not take Cimetidine Tablets if you:
• have an allergy to cimetidine, or any of the other ingredients (See Section 6)
Warnings and precautions
Before taking the tablets, 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.
Other medicines and Cimetidine Tablets
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 Cimetidine tablets or they may affect how well Cimetidine tablets will work. Tell your
Always take Cimetidine tablets 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.
• Swallow the tablets whole with a drink of water. Take the tablets with meals or at bedtime as advised by your doctor.
Doses
Adults and the elderly: the usual dose is 400 mg twice a day with breakfast, and at bedtime.
Your doctor will tell you the correct dose depending on your condition.
The maximum dose is 2400 mg 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 Cimetidine Tablets than you should
1. Tell your doctor, pharmacist or nearest hospital casualty department immediately.
2. Take the container and any remaining tablets with you so that people can see what you have taken.
3. Do this even if you feel well.
If you forget to take Cimetidine Tablets
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 take a double dose to make up for a forgotten dose.
If you stop taking Cimetidine Tablets
If you stop your treatment too soon, your symptoms may come back.
SAME SIZE ARTWORK 130 x 400 mm
Front
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.
4. Possible side effects
Like all medicines, Cimetidine tablets 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 tablets 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:
• diarrhoea
• dizziness
• tiredness
• mild skin rash
• headache
• hair loss.
Side effects with Cimetidine tablets are usually mild and do not last long.
If any of the side effects get troublesome, please tell your doctor or pharmacist.
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.mhra.gov.uk/ yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
The other ingredients are: starch, povidone, sodium starch glycollate, magnesium stearate, purified water and opadry oy-8839 (E104, E132, E171, E172)
What Cimetidine tablets look like and contents of the pack
• Cimetidine 200 mg Tablets are pale green, circular, biconvex, film-coated tablets, embossed with ‘BL’ on one side and “200” on the reverse.
They are available in packs of 50, 60, 84, 100, 250, 500, 120 & 5000.*
• Cimetidine 400 mg Tablets are pale green, oblong, film-coated tablets, embossed with ‘BL’ on one side and “400” on the reverse They are available in packs of 50, 56, 60, 100, 250, 500, 2500 & 5000.*
• Cimetidine 800 mg Tablets are pale green, oval, film-coated tablets, embossed with ‘BL’ on one side and “800” on the reverse. They are available in packs of 28, 30, 50, 100, 250 & 500.*
*Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Name and address:
Bristol Laboratories Ltd Unit-3, Canalside, Northbridge Road, Berkhamsted, Herts, HP4 1EG, UK. Telephone: 0044(0)1442 200922 Fax: 0044(0)1442 873717
Email: info@bristol-labs.co.uk
Cimetidine 200mg Film-Coated Tablets; PL 17907/0357
Cimetidine 400mg Film-Coated Tablets; PL 17907/0358
Cimetidine 800mg Film-Coated Tablets; PL 17907/0359
This leaflet was last revised in May 2015
To request a copy of this leaflet in Braille, large print or audio format, contact the licence holder at the address (or telephone, fax, email) above.
5. How to store Cimetidine Tablets
• Keep out of the sight and reach of children.
• Do not use Cimetidine Tablets after the expiry date (EXP) which is stated on the pack. The expiry date refers to the last day of that month.
• Do not store above 250C.
• Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
V13 27-05-2015 D0
SAME SIZE ARTWORK 130 x 400 mm Back