Remeron - Drug Description

Mirtazapine

• Remeron - Side Effects & Drug Interactions
• Remeron - Warnings & Precautions
• Remeron - Additional Info
• Remeron - Clinical Pharmacology
• Remeron - Overdosage & Contraindications
• Remeron - Indications & Dosage

Remeron (mirtazapine) is an antidepressant, which can be given as treatment for episodes of major depression. The presence of symptoms such as anhedonia, psychomotor inhibition, sleep disturbances (early wakening) and weight loss, increase the chance of a positive response.

Other symptoms are:

loss of interest, suicidal thoughts and changes in mood (better in the evening than in the morning). Remeron begins to exert its effect in general after 1-2 weeks of treatment.

1. NAME OF THE MEDICINAL PRODUCT

Remeron SolTab, 15, 30 and 45 mg orodispersible tablet

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 15, 30 or 45 mg of mirtazapine. For excipients, see 6.1.

3. PHARMACEUTICAL FORM

Orodispersible tablet

Round, white, standard bevelled-edge tablets marked with a code on one side (TZ/ 1 for 15 mg tablets, TZ/ 2 for 30 mg tablets and TZ/ 4 for 45 mg tablets).

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Episode of major depression.

4.2 Posology and method of administration

In order to prevent crushing the tablet, do not push against the tablet pocket (Figure A).

PHARMACEUTICAL PARTICULARS

List of excipients

Remeron SolTab 15, 30 and 45 mg tablets contain: Sugar spheres, hydroxypropyl methylcellulose, polyvinylpyrrolidone (povidone), magnesium stearate, aminoalkyl methacrylate copolymer E (Eudragit E100), aspartame, citric acid, crospovidone, mannitol, microcrystalline cellulose, natural and artificial orange flavour and sodium bicarbonate.

6. 2 Incompatibilities

Not applicable.

6.3 Shelf life

2 years.

6.4 Special precautions for storage

Remeron SolTab should be stored in the original package.

The plastic films contain: PVC (polyvinyl chloride), polyamide and polyester.

The following packages are available for each strength:

-Peel-to-open strips with 6 tablets each.

-Packs containing 6 (1x6), 18 (3x6), 30 (5x6), 48 (8x6) and 96 (16x6)

tablets, respectively.

6.6 Instructions for use and handling and disposal

See 4.2

7. MARKETING AUTHORISATION HOLDER

8. MARKETING AUTHORISATION NUMBER( S)

9. DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION

10. DATE OF REVISION OF THE TEXT

November 2001

Remeron SolTab 15, 30 and 45 mg ORGANON STANDARD SmPC

RA 1065 OS S2 (REF 2.0) 10

Remeron SolTab 15, 30 and 45 mg ORGANON STANDARD SmPC

RA 1065 OS S2 (REF 2.0) 11