QUINAGOLIDE

Since dopaminergic stimulation may lead to symptoms of orthostatic hypotension, the dosage of NORPROLAC should be initiated gradually with the aid of the 'starter pack', and given only at bedtime. Adults The optimal dose must be titrated individually on the basis of the prolactin- lowering effect and tolerability.

With the 'starter pack' treatment begins with 25 micrograms/day for the first 3 days, followed by 50 micrograms/day for a further 3 days. From day 7 onwards, the recommended dose is 75 micrograms/day. If necessary, the daily dose may then be increased stepwise until the optimal individual response is attained.

The usual maintenance dosage is 75 to 150 micrograms/day. Daily doses of 300 micrograms or higher doses are required in less than one- third of the patients. In such cases, the daily dosage may be increased in steps of 75 to 150 micrograms at intervals not shorter than 4 weeks until satisfactory therapeutic effectiveness is achieved or reduced tolerability, requiring the discontinuation of treatment, occurs.

Elderly Experience with the use of NORPROLAC in elderly patients is not available. Children Experience with the use of NORPROLAC in children is not available. Method of Administration NORPROLAC should be taken once a day with some food at bedtime.

01%. The adverse reactions reported with the use of NORPROLAC are characteristic for dopamine receptor agonist therapy. They are usually not sufficiently serious to require discontinuation of treatment and tend to disappear when treatment is continued.

Very common undesirable effects are nausea, vomiting, headache, dizziness and fatigue. They occur predominantly during the first few days of the initial treatment or, as a mostly transient event, following dosage increase. If necessary, nausea and vomiting may be prevented by the intake of a peripheral dopaminergic antagonist, such as domperidone, for a few days, at least 1 hour before ingestion of NORPROLAC.

Common undesirable effects include anorexia, abdominal pain, constipation or diarrhoea, insomnia, oedema, flushing, nasal congestion and hypotension. 4 Special warnings and precautions for use). Rarely NORPROLAC has been associated with somnolence.

In very rare cases, treatment with NORPROLAC has been associated with the occurrence of acute psychosis, reversible upon discontinuation. Impulse control disorders Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists including NORPROLAC.

4. ‘Special warnings and precautions for use’).

Fertility may be restored by treatment with NORPROLAC. Women of child- bearing age who do not wish to conceive should therefore be advised to practice a reliable method of contraception. Since orthostatic hypotension may result in syncope, it is recommended to check blood pressure both lying and standing during the first days of therapy and following dosage increases.

In a few cases, including patients with no previous history of mental illness, treatment with NORPROLAC has been associated with the occurrence of acute psychosis, usually reversible upon discontinuation. Particular caution is required in patients who have had psychotic episodes in their previous history.

3 Contraindications). NORPROLAC has been associated with somnolence. Other dopamine agonists can be associated with sudden sleep onset episodes, particularly in patients with Parkinson’s disease. Patients must be informed of this and advised to exercise caution whilst driving or operating machines during treatment with NORPROLAC.

Patients who have experienced somnolence must not drive or operate machines. 7 Effects on the ability to drive and use machines). Impulse control disorders Patients should be regularly monitored for the development of impulse control disorders.

Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists including NORPROLAC.

Dose reduction/tapered discontinuation should be considered if such symptoms develop. Dopamine agonist withdrawal syndrome (DAWS) has been reported following discontinuation of dopamine agonists. Non-motor adverse effects may occur when discontinuing dopamine agonists.

Symptoms which have been reported with other dopamine agonists include apathy, anxiety, depression, fatigue, sweating and pain which may be severe. When treatment with quinagolide is stopped there is a possible risk that DAWS may occur in some patients.

Hypersensitivity to the drug. 6 Pregnancy and lactation).