PATIENT INFORMATION LEAFLET

DOSTINEX (cabergoline)

What is your medicine?

The name of your medication is Dostinex. Each tablet contains the active ingredient cabergoline 0.5 mg. Each tablet also contains lactose and leucine.

Each tablet is white, capsule-shaped, and is scored.

Dostinex is available in packs of 2, 4 or 8 tablets in glass bottles.

What kind of medicine is it?

Cabergoline is one of a group of drugs known as prolactin inhibitors. Dostinex prevents or stops lactation (production of milk) by decreasing levels of a hormone known as prolactin. By decreasing levels of prolactin, Dostinex can also restore fertility.

 

What is your medicine for?

Dostinex is used to prevent or stop lactation (production of milk) soon after delivery of your baby or to stop lactation if you are already breast-feeding.

Dostinex is also used for other diseases which are due to increased prolactin levels e.g. missing or irregular periods, infertility, or tumours of the pituitary gland which causes increased production of the hormone prolactin leading to increased production of milk.

Before taking your medicine - tell your doctor if:

• You are hypersensitive to ergot alkaloids e.g. bromocriptine, or any other ingredients.
• Your liver or kidneys are not functioning properly - your doctor will have carried out a series of tests.
• You are taking any medicines to treat psychoses (mental disorders).
• You are taking other medicines e.g. antiemetics (to stop you feeling sick) such as metoclopramide, or certain types of antibiotics e.g. erythromycin, or butyrophenones (e.g. haloperidol or droperidol which are used to treat mental disorders or control severe behavioural problems), or medicines known as ergot alkaloids (these may be found in certain medicines to treat migraine, and ergometrine which is used to prevent or treat bleeding following abortion or after having a baby).
• You have a history of increased blood pressure, tissue swelling (e.g. swollen ankles, face or hands) and kidney problems during and following pregnancy.
• You have a history of change of mental state during pregnancy or following childbirth.
• You suffer with Raynaud's syndrome (exposure to cold affects the blood supply to your fingers and maybe toes which may appear pale or blue, you may feel a tingling, numbness or burning of the affected areas).
• You have a peptic ulcer (you may feel a gnawing pain in the abdomen when you are hungry).
• You suffer with gastrointestinal bleeding (you may notice your stools are black in colour or that you bring up blood when you are sick).
• You have low blood pressure or are taking medicines to lower your blood pressure.

The effect of alcohol is unknown and should be avoided. During treatment with cabergoline take special care when you drive or operate a machine. If you experience excessive drowsiness or even a sudden sleep onset episode, refrain from driving and operating machines, and contact your physician.

If you do not wish to become pregnant, you should use other methods of contraception, your doctor will advise you.

You may need to have a pregnancy test to make sure that you are not pregnant before starting treatment. If you become pregnant during treatment, you should stop taking Dostinex as soon as pregnancy is confirmed. You should not take Dostinex if you wish to continue breastfeeding as it will affect lactation (milk production).

If you wish to become pregnant, you should stop taking Dostinex one month before you try to become pregnant.

You may need to have regular pregnancy tests and smear tests while you receive treatment.

How should you take your medicine?

Dostinex is to be taken by mouth, preferably with meals.

To prevent lactation: 1 mg (2 tablets) on the first day after delivery.

To stop lactation: Half a tablet every 12 hours for 2 days.

To reduce prolactin levels in other conditions: Treatment is started with 0.5 mg once a week in one or two (one half of one 0.5 mg tablet) doses (e.g. on Monday, or on Monday and Thursday). Your doctor will advise you if you need to take more.

Dostinex is not recommended for use in patients under 16 years of age.

Are there any side effects?

While taking your medicine you may experience some of the following side effects:

• Dizziness/vertigo
• Headache
• Nausea
• Abdominal pain
• Vomiting
• Hot flushes
• Increase in heart rate
• Somnolence (excessive drowsiness)
• Sudden sleep onset episodes
• Hair loss or thinning
• Skin rash/itching
• Indigestion and other stomach disorders
• Constipation
• Depression
• Muscle weakness
• Pins and needles
• Nose bleeds
• Partial loss of sight
• Decreased blood pressure/fainting
• Breast pain
• Excess fluid

Blood pressure should be monitored when you first start treatment.

You should contact your doctor should the side effects become troublesome.

Your doctor may decide to temporarily reduce the dose if you have severe side effects, and then gradually increase it again by half a tablet (0.25 mg) each week, fortnightly. Your side effects should then be reduced or disappear.

If you suffer from any other unwanted effects while taking your medicine, please tell your doctor or pharmacist (chemist).

Looking after your medicine

Do not use after the expiry date printed on the carton and label. Do not store above 25°C.

Your Dostinex tablets should always be kept in the bottle. It is important that the desiccant is not removed from the cap.

Keep out of the reach of children.