Cimetidine
Consumer Medicine Information Leaflet
NOTICE: This Consumer Medicine Information (CMI) is intended for persons
living in Australia. This page contains answers to some common
questions about . It does
not contain all the information that is known about
. It does not take the
place of talking to your doctor or pharmacist. All medicines have risks
and benefits. Your doctor has weighed the risk of you using this medicine
against the benefits he/she expects it will have for you. If you have
any concerns about using this medicine, ask your doctor or pharmacist.
Bookmark or print this page, you may need to read it again.
WHAT TAGAMET IS USED FOR
TAGAMET contains cimetidine as the active ingredient.
TAGAMET helps heal peptic ulcers and relieves the pain and discomfort they cause. Peptic ulcers can also be called gastric
ulcers or duodenal ulcers depending on where they occur. A gastric ulcer occurs in the stomach. A duodenal ulcer occurs
in the duodenum which is the tube leading out of the stomach. These can be caused in part by the acid made in the stomach.
TAGAMET is also used to treat reflux oesophagitis or reflux disease. This 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. Heartburn
usually occurs after eating or at night. TAGAMET relieves these symptoms and helps heal any damage to the food pipe.
TAGAMET is also used to treat a rare condition called Zollinger-Ellison syndrome. In this condition the stomach produces
very large amounts of acid.
TAGAMET belongs to a class of medicines called H2 antagonists or H2 blockers. It works by reducing the amount of acid produced
by your stomach. This helps to reduce pain and allows any damage to heal.
Your doctor may have prescribed TAGAMET for another reason. Ask your doctor if you have any questions about why TAGAMET has
been prescribed for you.
There is no evidence that TAGAMET is addictive.
BEFORE TAKING TAGAMET
DO NOT TAKE TAGAMET IF:
you have had an allergic reaction to cimetidine or any of the other ingredients contained in this medicine. The ingredients
are listed at the end of this leaflet. Cimetidine is also contained in Magicul. Signs of an allergic reaction may include
an itchy skin rash, shortness of breath and swelling of the face or tongue.
If you have taken cimetidine before and became unwell, tell your doctor or pharmacist before taking the first dose.
the expiry date printed on the pack has passed.
the packaging is torn or shows signs of tampering.
TAGAMET should not be given to children unless instructed to by your doctor. There is only a small amount of information
available about the use of TAGAMET in children.
Do not give this medicine to anyone else; your doctor has prescribed it specifically for you and your condition.
BEFORE YOU START TAKING TAGAMET TELL YOUR DOCTOR IF:
you are or think you may be pregnant or if you intend to become pregnant. Your doctor will discuss with you the possible risks
and benefits of using TAGAMET during pregnancy.
you are breast feeding. Your baby can absorb cimetidine from breast milk if you are breast feeding.
you have any kidney or liver problems. The dose of TAGAMET may need to be adjusted if you have kidney problems.
you are on a low salt diet. Effervescent TAGAMET tablets contain sodium (salt).
you have phenylketonuria. Effervescent TAGAMET tablets contain aspartame.
TAKING OTHER MEDICINES WITH TAGAMET:
Do not take Tagamet with the heart medication dofetilide.
TAGAMET may affect the way other medicines work. Your doctor or pharmacist will be able to tell you what to do when taking
TAGAMET with other medicines.
It is very important to tell your doctor if you are taking any other medicines, if you have taken other medicines until recently,
or if you start new ones - these include other medicines or supplements you have been given or those medicines that you buy
without a prescription. In particular mention if you are taking medicines which:
lower blood pressure or treat heart conditions (e.g. nifedipine)
control epilepsy (eg. phenytoin)
thin blood (eg. warfarin)
treat breathing problems (eg. theophylline)
relieve arthritis or other pain
treat depression or anxiety
contain chlormethiazole or metformin
Antacids should be taken at least 1 hour before or after taking cimetidine. Some antacids may reduce the absorption of cimetidine.
HOW TO TAKE TAGAMET
Follow your doctors' instructions about how and when to use TAGAMET. Read the direction label carefully. If you have any
concerns about how to take this medicine talk to your doctor or pharmacist.
HOW MUCH TO TAKE
To treat an ulcer the usual dose of TAGAMET is 800 mg each day. This can be taken once daily at bed-time or as 400 mg in
the morning and 400 mg at bed-time.
To prevent an ulcer from forming again the usual dose is 400 mg at bed-time.
In reflux disease, the usual adult dose is 800 mg each day. This can be taken once daily at bed-time or as 400 mg in the
morning and 400 mg at bed-time.
For short term relief of heartburn or other symptoms of reflux disease the dose is 200mg up to four times per day. A second
tablet should not be taken for at least one hour. TAGAMET does not provide instant relief of symptoms.
For other conditions the dose prescribed by your doctor may be different.
HOW TO TAKE IT
Take the green TAGAMET tablets with a full glass of water or another liquid. The 800 mg tablets can be broken in half (along
the break-line). Do not chew the tablets.
Dissolve the large white effervescent TAGAMET tablets in half a glass of water before swallowing. The tablet will dissolve
completely.
TAGAMET can be taken with or without food. Food does not alter the effects of TAGAMET.
Take TAGAMET at the same time each day. Taking your medicine at the same time each day will give the best effect. It will
also help you to remember when to take your medicine.
If you are having haemodialysis, the tablets should be taken after dialysis.
HOW LONG TO TAKE IT
If you are taking TAGAMET for relief of heartburn and other symptoms of reflux disease you should not continue treatment longer
than 2 weeks. If your symptoms have not improved with TAGAMET or continue you should see your doctor.
If you are taking TAGAMET to heal an ulcer you will need to take it for 4 to 8 weeks.
If you are taking TAGAMET to treat reflux disease you may need to take it for up to 12 weeks.
If you are taking TAGAMET to stop an ulcer coming back or for Zollinger-Ellison syndrome, your doctor will let you know how
long you need to take the tablets. Your doctor will need to assess your condition regularly.
Keep taking TAGAMET for as long as your doctor tells you to. Do not stop taking TAGAMET just because you feel better.
IF YOU FORGET TO TAKE IT
If it is almost time for your next dose, leave out the dose you missed and take your next dose when you are meant to. Otherwise,
take the dose as soon as you remember, and then go back to taking it as you normally would.
Do not try to make up for missed doses by taking more than one dose at a time.
Taking more than the prescribed dose can increase the chance of unwanted side effects.
OVERDOSE
Immediately telephone your doctor or Poisons Information Centre or go to the emergency department at your nearest hospital
if you or anyone else has taken a large amount of TAGAMET. Do this even if there are no signs of discomfort or poisoning.
WHILE YOU ARE USING TAGAMET
THINGS YOU MUST DO:
Take TAGAMET exactly as your doctor has prescribed.
Tell your doctor or pharmacist you are taking TAGAMET, before starting any other medicines. Some medicines may affect the
way other medicines work.
Tell your doctor if you become pregnant while taking TAGAMET.
Tell your doctor immediately if you develop any of the following. These may be complications of your condition:
ongoing stomach pains
unexpected weight loss
passing black motions
vomiting blood
THINGS TO BE CAREFUL OF:
Be careful driving or operating machinery until you know how TAGAMET affects you. TAGAMET may cause dizziness or drowsiness
in some people. Make sure you know how you react to TAGAMET before you drive a car or operate machinery.
OTHER THINGS YOU CAN DO TO HELP:
Avoid or reduce drinking alcohol. Drinking alcohol may worsen your symptoms.
Avoid or reduce smoking. Smoking can affect ulcer healing.
Change your eating habits. Eat smaller meals and eat slowly. Avoid food that causes you stomach pain and discomfort.
Talk to your doctor or pharmacist about other measures that may help you.
SIDE EFFECTS
Besides their main effect, medicines may have some unwanted effects. Unwanted effects do not always occur in every person.
Most unwanted effects following TAGAMET are mild, and may disappear without stopping TAGAMET. However, some side effects
may need medical treatment. Tell the doctor about any effect which is troublesome or ongoing.
MILD EFFECTS
Tell your doctor if you notice any of the following that are troublesome or ongoing:
headache, tiredness, dizziness or drowsiness
vomiting or feeling sick, flatulence (wind), diarrhoea or constipation
mild skin rash, muscle aches and pains, hair loss
in men: enlarged breasts and sexual problems (these have been reported rarely)
MORE SERIOUS EFFECTS
Tell your doctor immediately if you notice any of the following:
depressed mood or confusion
fast heart beat, slow heart beat or irregular heart beat
unusual bleeding or bruising
yellowing of the skin and eyes also called jaundice
fever
Stop taking TAGAMET and contact a doctor immediately or go to the emergency department of your nearest hospital if any of
the following happens:
swelling of limbs, face, mouth or throat
shortness of breath or breathing difficulties
hives or severe skin reactions
These reactions are signs of a severe allergic reaction to TAGAMET. Allergy to TAGAMET is rare.
Other rare events that have been reported with TAGAMET include:
inflammation of the liver, pancreas or kidney
blood disorders
You should tell your doctor or pharmacist as soon as possible if any of these, or any other unusual events or problems occur
during or after treatment with TAGAMET.
STORAGE
Keep your tablets in the original pack until it is time to take them.
Keep the pack in a cool dry place where it stays below 30 degrees C.
Do not leave it in the car on a hot day. Do not store medicine in the bathroom or near a sink. Heat and dampness can destroy
some medicines.
Keep all medicines out of the reach of children, such as in a locked cupboard.
If your doctor tells you to stop taking TAGAMET ask your pharmacist what to do with any tablets that are left over.
PRODUCT DESCRIPTION
WHAT IT LOOKS LIKE
TAGAMET comes as:
a round, pale green tablet containing 200 mg of cimetidine. The tablet is marked SKF 200 on one side.
a capsule-shaped, pale green tablet containing 400 mg of cimetidine The tablet is marked TAGAMET on one side and SK&F 400
on the other side.
OTHER INGREDIENTS:
The tablets contain the colouring agents: titanium dioxide CI 77891, indigo carmine CI 73015, iron oxide black CI 77499 and
iron oxide yellow CI 77492.
They also contain: cellulose-microcrystalline, starch-maize, povidone, sodium lauryl sulfate, magnesium stearate, sodium starch
glycollate and carnauba wax.
CI = Colour Index (Society of Dyers and Colourists)
TAGAMET tablets do not contain sucrose, lactose, gluten, or tartrazine.
FURTHER INFORMATION
TAGAMET tablets come in the following packs: 200 mg in packs of 120 (AUST R 13016) and 400 mg in packs of 60 (AUST R 13017).
SPONSOR
GlaxoSmithKline Australia Pty Ltd
1061 Mountain Highway
Boronia VIC 3155
Phone (03) 9721 6000
Tagamet is a registered trade mark of the GlaxoSmithKline Group of Companies.
Leaflet amended: 18 June 2007
TAGAMET tablets Issue 7(M)