Consumer Medicine Information
ZELMAC®
6mg Tablets
Tegaserod
What is in this leaflet
This leaflet answers some common questions about Zelmac.
It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking Zelmac against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
What Zelmac is used for
Zelmac is used in women below the age of 55 to treat a condition called irritable bowel syndrome (IBS).
IBS is a common disorder of the gastrointestinal tract. In people with IBS, there is a disturbance in the contractions that normally move food along the gastrointestinal tract during digestion. The bowels also become extra sensitive to common stimuli such as food and stress.
Symptoms of IBS include abdominal pain and discomfort, bloating and altered bowel function, which can range from constipation to diarrhoea and may even alternate between the two.
Zelmac is also used in women below the age of 55 to treat straining, hard or lumpy stools and infrequent defecation in patients suffering from chronic constipation.
Zelmac works by improving altered bowel function. It is useful for women whose main symptoms are abdominal pain/discomfort and constipation.
Ask your doctor if you have any questions about why Zelmac has been prescribed for you.
Your doctor may have prescribed it for another reason.
Zelmac is only available with a doctor's prescription. It is not addictive.
There is not enough information to recommend the use of this medicine for a child.
Before you take Zelmac
When you must not take it
Do not take Zelmac if you have an allergy to tegaserod (the active ingredient) or to any of the other
ingredients of Zelmac listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing,
swelling of the face, lips, tongue or other parts of the body, rash, itching or hives on the skin.
Do not take Zelmac if you are pregnant.
There is not enough information to recommend its use during pregnancy.
Do not breast-feed while you are taking Zelmac.
The active ingredient in Zelmac is likely to pass into breast milk and could affect your baby.
Do not take Zelmac if you have severe liver or kidney disease.
There is not enough information to recommend its use in patients with severe liver or kidney disease.
Do not take Zelmac if you currently have a heart disease, or if you had a heart attack or a stroke in the past.
Do not take Zelmac if you are at risk of a heart attack or stroke (for example, if you have high blood pressure or high cholesterol).
Do not take Zelmac after the expiry date printed on the pack or if the packaging is torn or shows signs of
tampering.
In that case, return it to your pharmacist.
Use in elderly patients is not recommended and should be restricted to women below the age of 55
Before you start to take it
Tell your doctor if you have lactose intolerance.
Each tablet of Zelmac contains about 38 mg of lactose.
Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a
prescription from a pharmacy, supermarket or health food shop.
It is possible that some medicines and Zelmac could interfere with one another. Your doctor and pharmacist can advise
you.
If you have not told your doctor about any of these things, tell him/her before you take Zelmac.
How to take Zelmac
Follow all directions given to you by your doctor and pharmacist carefully.
These instructions may differ from the information contained in this leaflet.
If you do not understand the instructions on the label, ask your doctor or pharmacist for help.
How to take it
Take one tablet of Zelmac twice daily with a glass of water just before a meal (e.g. breakfast and dinner).
If you forget to take it
If you forget a tablet, simply take the next tablet just before your next meal and then go back to your usual schedule.
Do not take a double dose to make up for the one that you missed.
This may increase the chance of you getting an unwanted side effect.
If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.
How long to take it
Your doctor will check your progress to make sure the medicine is working. If you respond to the medicine, you will usually take Zelmac continuously for 12 weeks. However, if you are not responding to Zelmac after taking it for 4 weeks, your doctor will usually stop it.
If you take too much (Overdose)
Immediately telephone your doctor or the National Poisons and Hazardous Chemicals Information Centre (telephone number 0800 POISON or 0800 764 766), or go to the Accident and Emergency at your nearest hospital if you think that you or anyone else may have accidentally taken too much Zelmac. Do this even if there are no signs of discomfort or poisoning.
Keep the telephone numbers for these places handy.
Some of the symptoms of an overdose may include diarrhoea, headache, abdominal pain and dizziness or light-headedness.
While you are taking Zelmac
Things you must do
If you become pregnant while taking Zelmac, stop taking it and see your doctor.
Your doctor can discuss with you the risks and benefits of taking this medicine during pregnancy.
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Zelmac.
Tell any other doctor, dentist or pharmacist who treats you that you are taking Zelmac.
Tell your doctor if you develop any heart problems, such as pressure or pain in the chest and/or shortness of breath after taking Zelmac.
Things you must not do
Do not use Zelmac to treat any other complaints unless your doctor tells you to.
Do not give this medicine to anyone else even if they have the same condition as you do.
Things to be careful of
Be careful driving, operating machinery or doing jobs that require you to be alert until you know how Zelmac affects you.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Zelmac.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical
treatment if you get some of the side effects.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you are troubled by any of the following side effects:
- diarrhoea
- pain in the abdomen
- nausea (feeling sick)
- wind
- headache
- dizziness
- back pain
- flu-like symptoms or symptoms of a cough or cold
In clinical trials, most of the above side effects did not happen more often in people who took Zelmac than in people who took a placebo. The only common side effect of Zelmac was diarrhoea, which usually happened only once during the first few days of treatment.
Tell your doctor immediately if you experience the following:
- symtoms of heart attack or other heart problems such as pressure or pain in the chest, shortness of breath,
- symptoms of stroke such as weakness or loss of feeling have been reported rarely in patients with cardiovascular risk factors (e.g. high blood pressure, high cholesterol, previous or existing heart disease)
- signs of allergic reactions including rash, hives, itching and breathing difficulties.
- rectal bleeding, bloody diarrhoea
- symptoms of hepatits (nausea, loss of appetite, feeling unwell
- change in liver function test
- worsening of abdominal pain
Tell your doctor if you notice anything else that is making you unwell.
Other side effects not listed above may happen in some people.
After using Zelmac
Storage
- Keep your tablets in the original container in a cool dry place below 30°C.
- Do not store Zelmac or any other medicine in the bathroom or near a sink.
- Do not leave it in the car or on window sills.
Keep the medicine where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Disposal
If your doctor tells you to stop taking Zelmac or you find that it has passed the expiry date, ask your pharmacist what to do with any medicine you have left over.
Product description
What it looks like
Zelmac tablets are round, flat, whitish to slightly yellowish marbled tablets, marked with "EH" on one side and "NVR" on the other. Zelmac is available in blister packs containing 30 tablets.
Ingredients
Zelmac tablets contain 6 mg of the active ingredient, tegaserod (as tegaserod maleate). They also contain:
- crospovidone
- glyceryl monostearate
- hypromellose
- lactose
- poloxamer
- macrogol 4000
Sponsor
Zelmac is supplied in New Zealand by:
NOVARTIS New Zealand Limited
Private Bag 47909
Ponsonby
6-8 Mackelvie Street
Grey Lynn
AUCKLAND
Telephone 0800 652 422.
® = Registered Trademark
This leaflet was prepared on 5 May 2008 based on the currently approved data sheet for this product