contains the active ingredient cabergoline
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about TINEXA.
It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have benefits and risks. Your doctor has weighed the risks of you taking TINEXA against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, talk to your doctor or pharmacist.
Keep this leaflet with your medicine. You may need to read it again.
What TINEXA is used for
TINEXA may be prescribed by your doctor to reduce your body’s level of a hormone known as prolactin. TINEXA may be needed if your levels of prolactin are abnormally high (hyperprolactinaemia).
Abnormally high prolactin may cause menstrual changes in women and impotence in men.
TINEXA can also be prescribed to prevent the production of milk in women after birth, if breast-feeding is to be prevented for medical reasons.
Your doctor may have prescribed TINEXA for another reason. Ask your doctor if you have any questions about why TINEXA has been prescribed for you.
TINEXA is available only with a doctor's prescription.
There is no evidence that TINEXA is addictive.
Before you take TINEXA
When you must not take it
Do not take TINEXA if you are allergic to medicines containing cabergoline, ergot alkaloids (medicines used to treat migraine), or any of the ingredients 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 TINEXA if you have or have had:
any scarring or thickening of the lungs with shortness of breath
heart valve disorder
any swelling or inflammation around the heart or lungs
any abnormal formation of tissue outside the stomach wall.
Do not take TINEXA if you are pregnant or planning to become pregnant. TINEXA may affect your developing baby if you take it during pregnancy.
Do not give this medicine to a child under the age of 16 years.
Do not take TINEXA if the expiry date (Exp.) printed on the pack has passed.
Do not take TINEXA if the packaging is torn or shows signs of tampering.
Before you start to take it
Tell your doctor if you are allergic to any other medicines, foods, dyes or preservatives.
Tell your doctor if you have had any unusual or allergic reactions to anti-Parkinson drugs.
Tell your doctor if you are planning to become pregnant. Your doctor will discuss the risks of taking TINEXA during pregnancy.
Tell your doctor if you are breastfeeding or intend to breastfeed. This medicine prevents the flow of breast milk.
Tell your doctor if you have, or have had, any medical conditions, especially the following:
kidney, heart and liver problems
lung disease or problems with your breathing
Raynaud’s syndrome (associated with extreme numbness, tingling and colour changes in the fingers due to cold)
ulcer or bleeding in the stomach or intestines
high blood pressure after childbirth
history of severe mental illness.
Your doctor may want to take special care if you have any of these conditions.
If you have not told your doctor or pharmacist about any of the above, tell them before you start taking TINEXA.
Taking other medicines
Tell your doctor if you are taking any other medicines, including those you buy without a prescription from a pharmacy, supermarket or health food shop.
Some medicines may be affected by TINEXA, or may affect how well it works. These include:
medicines used to treat mental illness
medicines used to treat high blood pressure
medicines used to treat migraine
medicines used to prevent nausea and vomiting
medicines called macrolide antibiotics which are used to treat bacterial infections (eg. erythromycin).
Your doctor can tell you what to do if you are taking any of these medicines.
If you are not sure whether you are taking any of these medicines, check with your doctor or pharmacist. Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking TINEXA.
How to take TINEXA
How much to take
The dose varies from patient to patient.
Your doctor will tell you how many tablets you need to take each day and when to take them. This depends on your condition and whether or not you are taking any other medicines.
To treat hyperprolactinaemia, the recommended starting dose is half a tablet to four tablets taken twice a week. Your doctor will generally start you on a low dose and may increase it gradually.
To prevent the production of milk, the recommended dose is two tablets taken once, on the first day after delivery.
The maximum recommended dose for TINEXA is six tablets a day.
Follow all directions given to you by your doctor and pharmacist carefully.
If you do not understand the instructions on the label, ask your doctor or pharmacist for help.
How to take TINEXA
TINEXA should be swallowed, preferably with food.
If you forget to take TINEXA
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
Otherwise, take the missed dose as soon as you remember, and then go back to taking your tablets as you would normally.
Do not take a double dose to make up for the dose you missed. This may increase the chance of you getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
How long to take TINEXA for
Keep taking TINEXA for as long as your doctor recommends.
Do not stop taking TINEXA, even if you feel better after a few days, unless advised by your doctor.
If you take too much TINEXA (overdose)
Immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much TINEXA. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
If you take too much TINEXA, you may have nausea, vomiting, stomach pains and dizziness.
While you are taking TINEXA
Things you must do
Before starting any new medicine, tell your doctor or pharmacist that you are taking TINEXA.
Tell all the doctors, dentists and pharmacists who are treating you that you are taking TINEXA.
Use mechanical methods of contraception, such as condoms to prevent pregnancy during and at least one month after taking TINEXA.
Your doctor may recommend routine pregnancy tests during treatment.
Stop taking TINEXA immediately if you become pregnant and consult your doctor.
Visit your doctor regularly so he/she can check on your progress. Regular blood tests or chest x-rays make be required if you show signs of breathing problems.
Things you must not do
Do not stop taking TINEXA, or lower the dose, until your doctor tells you to, even if you feel better.
Do not use TINEXA to treat any other conditions unless your doctor tells you to.
Do not give TINEXA to anyone else, even if they have the same condition as you.
Things to be careful of
Be careful getting up from a sitting or lying position. Dizziness, light-headedness or fainting may occur, especially when you get up quickly. Getting up slowly may help.
Be careful driving or operating machinery until you know how TINEXA affects you. TINEXA may cause drowsiness or affect your ability to respond quickly.
If you feel sleepy while taking TINEXA, do not drive or operate machinery.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking TINEXA. Like all other medicines, TINEXA may have unwanted side effects in some people. 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 notice any of the following and they worry you:
nausea or vomiting
abdominal or stomach pain, heartburn
weakness or tiredness
changes in behaviour such as aggression, depression, gambling addiction, increased sex drive, shopping, eating, medication use, repetitive purposeless activity
These side effects are usually mild and short-lived. However, changes in behaviour may have serious financial and social consequences.
Tell your doctor as soon as possible if you notice any of the following:
irregular heart beat
leg cramps or pain in the fingers or toes
any breathing problems.
The above list includes serious side effects, which may require medical attention.
Other side effects not listed above may also occur in some patients.
Some of these side effects (e.g changes in liver function) can only be found when your doctor does tests from time to time to check your progress.
Tell your doctor if you notice anything that is making you feel unwell.
After using TINEXA
Keep TINEXA 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.
Keep your tablets in the bottle until it is time to take them. If you take the tablets out of the bottle, they may not keep well.
Keep your tablets in a cool dry place where the temperature stays below 25°C and protected from light.
Do not store TINEXA or any other medicine in the bathroom or near a sink.
Do not leave TINEXA in the car or on window sills. Heat and dampness can destroy some medicines.
If your doctor tells you to stop taking TINEXA, or your tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.
What it looks like
TINEXA 0.5 is a white capsule - shaped tablet embossed with ‘C | 5’ on one side and ‘> partial score >’ on the other side.
TINEXA comes in bottles of 2 or 8 tablets.
The active ingredient in TINEXA is cabergoline.
Each tablet contains 0.5 mg of cabergoline.
The tablets also contain:
The tablets do not contain gluten, sucrose, tartrazine or any other azo dyes.
Sigma Pharmaceuticals (Australia) Pty Ltd
96 Merrindale Drive
Croydon Vic 3136
Tel: 03 - 9839 2800 03 - 9839 2800
Australian registration numbers:
TINEXA 0.5 - AUST R 132561
Date of preparation: October 2008.
Published by MIMS/myDr August 2009
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