HYDROXYZINE MEVON FILM-COATED TABLETS 25 MG [SIN16328P]

Product Info

HYDROXYZINE MEVON FILM-COATED TABLETS 25 MG

[SIN16328P]

4.1 Therapeutic indications

• To assist in the management of anxiety in adults.

• As a sedative used as premedication.

• As symptomatic relief in atopic pruritus.

The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.

Hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anaesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent.

4.2 Posology and method of administration

Hydroxyzine MEVON film-coated tablets should be used at the lowest effective dose and for the shortest possible duration (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• In adults, the maximum daily dose should not exceed 100 mg per day.
  For symptomatic relief in atopic pruritus: Starting dose of 25 mg at night, increasing as necessary to 25 mg three to four times daily.
  For symptomatic treatment of anxiety: 50–100 mg daily in divided doses.
  For premedication before surgery: 100 mg given in divided doses.

• In children (from 30 months of age) (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information):
  The maximum daily dose should not exceed 100 mg per day.

  For symptomatic treatment of pruritus:
  In children up to 40 kg in weight, the maximum daily dose is 2 mg/kg/day in divided doses.
  In children over 40 kg in weight, the maximum daily dose is 100 mg/day.

  For premedication before surgery:
  1 mg/kg/day in divided doses.

  The dosage of Hydroxyzine MEVON film-coated tablets must be adapted to the patient’s response.
  For a shorter effect, half the usual dose can be given.

• In elderly:
  Use of hydroxyzine in the elderly is not recommended. However, if needed, it is advised to start with half the recommended dose due to a prolonged action.
  In the elderly, the maximum daily dose is 50 mg per day (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Renal impairment:
  Dosage should be reduced in patients with moderate or severe renal function impairment due to decreased excretion of its metabolite cetirizine.

• Hepatic impairment:
  In patients with hepatic dysfunction, it is recommended to reduce the daily dose by 33%.

4.3 Contraindications

Hydroxyzine MEVON film-coated tablets is contraindicated in:

• History of hypersensitivity to hydroxyzine or to any of the excipients, to cetirizine, to other piperazine derivatives, to aminophylline, or to ethylenediamine.

• Pregnancy and lactation (see section 4.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Severe hepatic or renal failure.

• Prostate adenoma with urinary retention.

• Narrow angle glaucoma.

• Patients with porphyria.

• Children below 12 months.

• Concomitant therapy with monoamine oxidase inhibitors (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Patients with known acquired or congenital QT interval prolongation.

• Patients with a known risk factor to QT interval prolongation including a known cardiovascular disease, significant electrolytes imbalance (hypokalaemia, hypomagnesaemia), family history of sudden cardiac death, significant bradycardia, concomitant use with drugs known to prolong the QT interval and/or induce Torsade de Pointes (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Hydroxyzine MEVON film-coated tablets include lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.