INFORMATION FOR CONSUMERS

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Consumer Medicine Information

Arrow - Cabergoline

cabergoline 0.5 mg tablet

What is in this leaflet

This leaflet answers some common questions about ARROW - CABERGOLINE. 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 using ARROW - CABERGOLINE against the expected benefits.

If you have any concerns about using this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What ARROW - CABERGOLINE is used for

ARROW - CABERGOLINE may be prescribed by your doctor to reduce your body's level of a hormone known as prolactin. ARROW - CABERGOLINE 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.

ARROW - CABERGOLINE can also be prescribed to prevent the production of milk in women after birth, if breast-feeding is to be prevented for medical reasons.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Your doctor may have prescribed it for another reason.

ARROW - CABERGOLINE is only available with a doctor's prescription.

Before you start to use it

When you must not use it

Do not take ARROW - CABERGOLINE if you have an allergy to:

• any medicine containing cabergoline
• any of the ingredients listed at the end of this leaflet
• ergot alkaloids (medicines used to treat migraine)

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 ARROW - CABERGOLINE 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 this medicine if you are pregnant.

It 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.

The safety and effectiveness in children has not been established.

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.

If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if:

1. you are pregnant or intend to become pregnant.
2. you are breast-feeding or intend to breast-feed. This medicine prevents the flow of breast milk.
3. you have or have had any other health problems especially:
   • 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
   • low blood pressure
   • high blood pressure after childbirth
   • history of severe mental illness.

If you have not told your doctor or pharmacist about any of the above, tell them before you start to take ARROW - CABERGOLINE.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines you buy without a prescription from a pharmacy, supermarket or health food shop.

Some medicines and ARROW - CABERGOLINE may interfere with each other. These include:

• medicines used to treat mental illness, eg. antipsychotic medicines for schizophrenia
• medicines used to treat high blood pressure
• ergot alkalaloids, medicines used to treat migraine
• medicines used to prevent nausea and vomiting (eg. metoclopramide)
• medicines called macrolide antibiotics which are used to treat bacterial infections (eg. erythromycin).

These medicines may be affected by ARROW - CABERGOLINE or may affect how well it works. You may need different amounts of your medicine or you may need to take different medicines.

Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking ARROW - CABERGOLINE.

How to take ARROW - CABERGOLINE

Follow all directions given to you by your doctor or pharmacist carefully.

The directions given to you by your doctor or pharmacist on how to take ARROW - CABERGOLINE may differ from the information contained in this leaflet. You may be given a different dosage depending on your condition or how you react to the medicine.

If you do not understand the instructions on the label, ask your doctor or pharmacist for help.

How much to take

To treat high levels of prolactin (hyperprolactinaemia), the recommended starting dose is half a tablet taken twice a week. Your doctor will generally start you on a low dose and may gradually increase your dose.

To prevent the production of milk, the recommended dose is two tablets taken once, on the first day after delivery.

How to take it

Swallow ARROW - CABERGOLINE tablets with a glass of water.

When to take it

Take your medicine with food or a meal.

How long to take it

Continue taking ARROW - CABERGOLINE until your doctor tells you to stop.

If you forget to take it

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 it as soon as you remember, then go back to taking your medicine as you normally would.

Do not take a double dose to make up for the dose that you missed.

This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, speak to your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre for advice telephone 0800 POISON or 0800 764 766 or go to the Accident and Emergency department (Casualty) at your nearest hospital if you think you or anyone else may have taken too much ARROW - CABERGOLINE. Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention. Keep telephone numbers for these services handy. Have the medicine or this leaflet available to give details if needed.

The symptoms of taking too much ARROW - CABERGOLINE may include nausea, vomiting, stomach pains and dizziness.

While you are using ARROW - CABERGOLINE

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking ARROW - CABERGOLINE.

Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.

Follow your doctor's instructions carefully, and have regular check-ups while taking ARROW - CABERGOLINE.

Regular blood tests may be required or chest x-rays if you show signs of breathing problems.

Use barrier methods of contraception, such as condoms, to prevent pregnancy during and after at least one month after taking ARROW - CABERGOLINE.

Your doctor may recommend routine pregnancy tests during treatment.

Stop taking ARROW - CABERGOLINE immediately if you become pregnant and consult your doctor.

Things you must not do

Do not use ARROW - CABERGOLINE to treat any other medical complaints unless your doctor tells you to.

Do not stop taking your medicine until your doctor tells you to, even if you are feeling better.

Do not give ARROW - CABERGOLINE to anyone else, even if they have the same condition as you.

Things to be careful of

If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly.

Be careful driving or operating machinery until you know how ARROW - CABERGOLINE affects you.

ARROW - CABERGOLINE may cause dizziness or affect your ability to respond quickly.

If you feel sleepy while taking ARROW - CABERGOLINE, do not drive or operate machinery.

Side effects

Tell your doctor as soon as possible if you have any problems while taking ARROW - CABERGOLINE, even if you do not think the problems are connected with the medicine or they are not listed in this leaflet.

Like many medicines, ARROW - CABERGOLINE may cause side effects. If they occur, they are likely to be minor and temporary. However, some may be serious and need medical attention.

Do not be alarmed by the following list of possible side effects. You may not experience any of them.

Ask your doctor or pharmacist about any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

• dizziness, fainting
• headache
• nausea or vomiting
• unusual sleepiness
• abdominal pain, or heartburn or pain in the stomach
• constipation
• nosebleed
• weakness or tiredness
• temporary impairment of vision
• breast pain
• hot flushes
• changes in behaviour such as aggression, depression, gambling addiction, increased sex drive
• rash
• hair loss.

The side effects listed above are usually mild and short lived.

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.

Tell your doctor if you notice anything else that is making you feel unwell when you are taking, or soon after you have finished taking ARROW - CABERGOLINE.

Other side effects not listed above may also occur in some patients. Some of these side effects (eg. changes in liver function) can only be found when your doctor does tests from time to time to check your progress.

After using ARROW - CABERGOLINE

Storage

Keep ARROW - CABERGOLINE 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 ARROW - CABERGOLINE in its container until it is time to take it.

Keep ARROW - CABERGOLINE in a cool dry place, where the temperature stays below 25°C and protect from light.

Do not store ARROW - CABERGOLINE, or any medicines, in a bathroom or near the sink. Do not leave ARROW - CABERGOLINE in the car or on window sills.

Heat and dampness can destroy some medicines.

Disposal

Ask your pharmacist what to do with any ARROW - CABERGOLINE which is left over, or if the medicine has passed its expiry date.

Product Description

What it looks like

ARROW - CABERGOLINE tablets are white to off-white, capsule-shaped tablet, embossed with 'C | 5' on one side and '> partial score >' on the reverse side.

ARROW - CABERGOLINE is sold in glass bottles of 2 and 8 tablets.

Ingredients

Each ARROW - CABERGOLINE tablet contains cabergoline 0.5 mg.

Each tablet also contains: lactose and leucine.

Sponsor

Arrow Pharmaceuticals (NZ) Limited
Mt. Eden Central Business Park
33a Normanby Road, Mt. Eden
Auckland, New Zealand

Date of preparation:

31 March 2009