Orion Pharma (UK) Limited

Concomitant treatment with medicines which inhibit MAO A, (or non-selective MAO inhibitors) can cause hypotensive reactions. Hypotension, sometimes sudden in onset, has been reported with conventional selegiline. Special care should be taken when administering selegiline to patients who have labile hypertension, cardiac arrhythmias, severe angina pectoris, psychosis or a history of peptic ulceration.Although serious hepatic toxicity has not been observed, caution is recommended in patients with a history of hepatic dysfunction. Transient or continuing abnormalities with a tendency for elevated plasma concentrations of liver enzymes have been described during long-term therapy with conventional tablets of selegiline.

Since selegiline potentiates the effects of levodopa, the adverse effects of levodopa may be increased. When selegiline is added to the maximum tolerated dose of levodopa, involuntary movements and agitation may occur. Levodopa should be reduced by about 10 to 30% when selegiline is added to the treatment (see section 4.2 Posology and Method of Administration). When an optimum dose of levodopa is reached, adverse effects from the combination are less than those observed with levodopa on its own.

 Oral suspension 10 mg/5 ml contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. Additionally, sucrose may be harmful to the teeth. Oral suspension contains methyl, propyl and butyl parahyroxybenzoate as excipients, which may cause allergic reactions (possibly delayed).
Section 4.6, the following text has been added:'Selegiline is indicated for the treatment of Parkinson's disease which, in most cases, is a disease occurring after childbearing age.
Selegiline should not be used by mothers when breastfeeding as information is lacking concerning whether selegiline passes into breast milk.
Section 4.7, the following text has been changed to:'Even when used correctly, this medicine can affect reaction capacity to the extent that driving or operating machinery is affected and therefore patients should avoid these activities.
Section 4.8, the following text and tabel has chnaged to:'

The following undesirable effects have been reported with selegiline during clinical trials and/or post-marketing use. They are listed below as MedDRA preferred term by system organ class and frequency. Frequencies are defined as: Very common (>1/10), Common (>1/100 to <1/10), Uncommon (>1/1,000 to <1/100), Rare (>1/10,000 to < 1/1,000), Not known (cannot be estimated from the available data).

As selegiline potentiates the effect of levodopa, the side-effects of levodopa may be emphasised unless the dosage of levodopa is reduced. The most common undesirable effect reported for conventional tablets is dyskinesia (4% of patients). Once the optimum levodopa dose level has been established, the side-effects produced by the combination will usually be less than those caused by the levodopa therapy on its own.