Remeron

[Mirtazapine]

-with regard to the chance of suicide, in particular at the beginning of treatment, only a limited number of Remeron SolTab tablets should be given to the patient

-although antidepressants are not addictive, the abrupt termination of treatment after long-term administration may result in nausea, headache and malaise

-elderly patients are often more sensitive, especially with regard to the side effects of antidepressants. During clinical research with Remeron, side-effects have not been reported more often in elderly patients than in other
age groups; however, experience until now is limited

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-Remeron SolTab contains aspartame (phenylalanine). Each tablet with 15, 30 and 45 mg mirtazapine corresponds to 2.6 mg, 5. 2 mg and 7. 8 mg phenylalanine, respectively. May be harmful for patients with
phenylketonuria.

Interaction with other medicinal products and other forms of interaction

-In vitro data suggest that mirtazapine is a very weak competitive inhibitor of the cytochrome P450 enzymes CYP1A2, CYP2D6 and CYP3A.

Mirtazapine is extensively metabolised by CYP2D6 and CYP3A4 and to a lesser extent by CYP1A2. An interaction study with healthy volunteers showed no influence of paroxetine, a CYP2D6 inhibitor, on mirtazapine pharmacokinetics in steady state. The effect of a CYP3A4 inhibitor on the pharmacokinetics of mirtazapine in the in vivo situation is not known. Caution is needed when strong CYP3A4 inhibitors, such as the HIV protease inhibitors, azole antifungals, erythromycin and nefazodone are co-administered with mirtazapine. Carbamazepine, an inducer of CYP3A4, increased mirtazapine clearance about twofold, resulting in a decrease in plasma levels of 45-60%. When carbamazepine or another inducer of drug metabolism (such as rifampicin or phenytoin) is added to mirtazapine therapy, the mirtazapine dose may have to be increased. If treatment with
an inducer is stopped, mirtazapine dosing may have to be decreased. Bioavailability of mirtazapine increased by more than 50% when co-administered with cimetidine. The mirtazapine dose may have to be decreased when concomitant treatment with cimetidine is started or increased when cimetidine treatment is ended.
In in vivo interaction studies, mirtazapine did not influence the pharmacokinetics of risperidone or paroxetine (CYP2D6 substrate), carbamazepine (CYP3A4 substrate), amitriptyline and cimetidine. No relevant clinical effects or changes in pharmacokinetics have been observed in man with concurrent administration of mirtazapine and lithium.

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