Please read this leaflet carefully before you start to take this medicine, even if you have taken NORPROLAC® tablets before. If you have any questions or are unsure about anything, ask your doctor or pharmacist (chemist) for advice.

The active ingredient contained in NORPROLAC® is quinagolide. Tablets are available in 4 strengths. They contain quinagolide hydrochloride equivalent to:-

25 micrograms quinagolide

50 micrograms quinagolide

75 micrograms quinagolide

150 micrograms quinagolide

The tablets also contain colloidal anhydrous silica, magnesium stearate, methylhydroxypropylcellulose, maize starch, microcrystalline cellulose and lactose.

The 25 microgram (pink) tablets contain red iron oxide and the 50 microgram (blue) tablets contain indigos lake as colouring agents.

The NORPROLAC® "starter pack" contains 3 tablets of 25 micrograms and 3 tablets of 50 micrograms. 75 microgram and 150 micrograms tablets are in packs of 30 tablets.

NORPROLAC® is a medicine used to reduce secretion of the hormone prolactin. (See "Why does your doctor want you to use NORPROLAC® tablets?")

Product Licence and Product Authorisation Holder:

SANDOZ PHARMACEUTICALS

Sandoz Pharmaceuticals (UK) Limited

Frimley Business Park

Frimley Camberley

Surrey GU16 5SG

Distributed in Ireland by: Manufactured by:

SANDOZ PRODUCTS (IRELAND LIMITED) SANDOZ AG

AIRTON ROAD CH-4002

Tallaght BASLE

Dublin 24 Switzerland

NORPROLAC® is used to treat patients with conditions which result from having high levels of prolactin in the blood. Prolactin is a hormone produced by the pituitary gland. High levels may cause excess milk production, changes in menstrual bleeding patterns, infertility and reduced sexual drive.

Tell your doctor before you start using NORPROLAC® tablets if the answer to any of the following questions is yes:

• Do you suspect that you have had an allergic reaction to, or have been upset by any of the ingredients in NORPROLAC® (listed in ‘What’s in your medicine’)?
• Do you have liver or kidney problems?
• Do you suffer or have you ever suffered from any psychiatric conditions?
• Are you planning to become pregnant? NORPROLAC® may increase fertility. Women of child-bearing age who do not wish to become pregnant should use a reliable method of contraception.
• Are you pregnant? Information on the use or NORPROLAC® in pregnancy is limited. It is recommended that NORPROLAC® is stopped when pregnancy is confirmed, however, some pacients may need NORPROLAC® therapy during pregnancy. If you become pregnant whilst taking NORPROLAC® you should tell your doctor as soon as possible.
• Are you breast-feeding? It is not known whether the active ingredient in NORPROLAC® passes into breast milk. NORPROLAC® reduces production of breast-milk and patients should not try to breast-feed whilst taking this medicine.
• Are you taking any other medicines (either bought or prescribed)? Some medicines used for psychiatric conditions may reduce the effect of NORPROLAC®

Effect of alcohol:-
Drinking alcohol may increase the side effects of this medicine. If this happens, you should avoid drinking alcohol whilst taking the medicine .

Follow the instructions given to you by your doctor. The label on your medicine should tell you how much medicine to take and when to take it. If it does not, or you are not sure, ask your doctor or pharmacist.

If your doctor has given you a "starter pack", the dose is 25 micrograms (one pink tablet) daily for the first 3 days, followed by 50 micrograms daily (one blue tablet) for the next 3 days. From day 7, the recommended dose is 75 micrograms daily, which may then be increased by your doctor. Some patients may need 300 micrograms daily or higher. You should not change the dose yourself.

NORPROLAC® tablets should be taken once a day at bedtime with some food.

• remove the tablet from the foil (as shown in picture)

If you forget to take a dose, take it as soon as you remember. If you do not remember until it is almost time for your next dose, take your next dose as usual and carry on as before. Do not double the dose to make up for the one you missed.

If you accidentally take too much of your medicine tell your doctor immediately or go to your nearest Casualty Department.

Side-effects are most common during the first few days of treatment and tend to disappear when treatment is continued.

The most common side-effects are feelings of sickness, headache, dizziness and tiredness.

Less common side-effects include loss of appetite, abdominal pain, constipation, diarrhoea, difficulty in sleeping, increased water retention, flushing and nasal congestion.

NORPROLAC® may cause your blood pressure to fall when you stand up, which may result in fainting, particularly in the first few days of therapy or following an increase in your dosage. Therefore, the doctor will check on your blood pressure at these times.

A small number of patients taking NORPROLAC® have experienced a change in mental status, which reverses when treatment is stopped,

Tell your doctor or pharmacist if you suffer from any of these side effects or from any other side-effects not mentioned in this leaflet.

Leave your tablets in the blister. Only remove them when it is time to take your medicine.

Store your medicine between 15° C and 30° C. Do not store in a refrigerator.

Keep your medicine in a safe place where children cannot reach it. Your medicine could harm them.

Do not use this medicine after the expiry date shown on the carton/blister foil.

REMEMBER:
This medicine is only for you. Only a doctor can prescribe it for you. Never give it to anyone else. It may harm them, even if their symptoms appear to be the same as yours.

If you have any questions or are unsure about anything regarding your medicine ask your doctor or pharmacist.

Product Licence/Authorisation Numbers

NORPROLAC® 25 µg tablets PL 0101/0380 PA 13/51/t

NORPROLAC® 50 µg tablets PL 010t/0381 PA 13/5t/1

NORPROLAC® 75 µg tablets: PL 0101/0382 PA 3/51/2

NORPROLAC® 150 µg tablets PL0101/0383 PA13/51/3

NORPROLAC® is a registered Trade Mark.