Luvox 100 mg Film-Coated Tablets

LUVOX is indicated in adults for the treatment of major depressive episodes and for the short-term treatment of severe, disabling obsessive-compulsive disorder, where the obsessions or compulsions cause marked distress, are time-consuming or significantly interfere with social or occupational functioning.

Contraindications

• Hypersensitivity to fluvoxamine maleate or to any of the excipients (see section 6.1).
• Pregnancy and lactation.
• Patients under the age of 18 years (see section 4.4).
• Safety in patients with liver dysfunction and moderate to pronounced renal function impairment has not been established.
• Safety has not been established in epileptics.
• LUVOX tablets are contraindicated in combination with tizanidine and monoamine oxidase inhibitors (MAOIs) (see section 4.5). Patients should not receive LUVOX together with or within 2 weeks of terminating treatment with monoamine oxidase inhibitors. At least one week should elapse between discontinuation of LUVOX and initiation of therapy with a monoamine oxidase inhibitor.
• LUVOX tablets should not be used in combination with pimozide (see section 4.5).

Special warnings and precautions for use

Suicide/suicidal thoughts or clinical worsening Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide (suicide-related events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is general clinical experience that the risk of suicide may increase in the early stages of recovery.

Method of administration

LUVOX tablets should be swallowed with water and without chewing.

Posology

Major depressive episodes The effective daily dose usually varies between 100 mg and 200 mg and should be adjusted to the individual response of the patient up to a maximum of 300 mg. The minimum recommended starting dose is 100 mg per day and can be given as a single dose, preferably in the evening. It is advisable that a total daily dose of more than 150 mg is given in 2 or 3 divided doses.

Obsessive-compulsive disorder The effective dosage usually lies between 100 mg and 200 mg, with some patients requiring up to 300 mg per day. The recommended starting dose is 50 mg per day for 3 to 4 days. The dosage should be increased gradually until the effective dosage is achieved, with a maximum of 300 mg per day. If no improvement is observed within 10 weeks, treatment with LUVOX should be reconsidered.

Undesirable effects

Nausea with or without vomiting is the most frequently seen symptom associated with LUVOX treatment. This may diminish within the first two weeks of treatment. In children reports of hostility, suicidal ideations and self-harm may occur. The most common side effects seen during clinical studies with LUVOX, more than an isolated case is listed below, by system organ class and by frequency. Frequencies are defined as: very common (> 1/10), common (> 1/100, 1/1 000, < 1/100), rare (< 1/1 000).

Metabolism and nutrition disorders:

Common: anorexia

Psychiatric disorders:

Rare: mania

Nervous system disorders:

Common: agitation, anxiety, dizziness, headache, insomnia, nervousness, somnolence, tremor Uncommon: ataxia, confusion, extrapyramidal symptoms, hallucinations Rare: convulsions

Cardiac disorders:

Common: palpitations/ tachycardia

Vascular disorders:

Uncommon: (Orthostatic) hypotension

Gastrointestinal disorders:

Common: abdominal pain, constipation, diarrhoea, dry mouth, dyspepsia, nausea, vomiting

Hepatobiliary disorders:

Rare: abnormal hepatic function

Skin and subcutaneous tissue disorders:

Common: sweating Uncommon: cutaneous hypersensitivity reactions (including rash, pruritus, angioedema) Rare: photosensitivity

Musculoskeletal and connective tissue disorders:

Uncommon: arthralgia, myalgia

Reproductive system and breast disorders:

Uncommon: abnormal (delayed) ejaculation Rare: galactorrhoea

General disorders and administration site conditions:

Common: asthenia, malaise

Special precautions for storage

Store below 30 °C in original packs, protect from direct sunlight.