Posology : מינונים

4           Dosage and administration

Dosage
As a general recommendation, the dose should be individually adjusted. Adverse effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 6 Warnings and precautions).

General target population
The recommended initial daily dose is 100 to 150 mg. In milder cases, as well as for long-term therapy, 75 to 100 mg daily is usually sufficient.

VOL SUP API JUN41 CL V2                                                                          REF 03092013 The total daily dose should generally be divided into 2 to 3 separate doses. To suppress nocturnal pain and morning stiffness, treatment with tablets during the day can be supplemented by the administration of a suppository at bedtime (up to a total maximum daily dose of 150 mg).
In primary dysmenorrhea, the daily dose should be individually adjusted and is generally 50 to 150 mg. A dose of 50 to 100 mg should be given initially and, if necessary, increased over the course of several menstrual cycles up to a maximum of 200 mg/day. Treatment should be started on appearance of the first symptoms and, depending on the symptomatology, continued for a few days.
Treatment of migraine attacks with Voltaren suppositories should be started with a dose of 100 mg at the first signs of an impending attack. Additional suppositories up to 100 mg may be taken on the same day if required.
Should the patient require further therapy on the following days, the maximum daily dose should be limited to 150 mg in divided doses.
Special populations
Pediatrics
Voltaren 50 mg suppositories are not recommended for children and adolescents below 14 years of age.
Adolescents should be given 0.5 to 2 mg/kg body weight daily, depending on the severity of the disorder, divided into 2 to 3 separate doses, as applicable.
For treatment of juvenile rheumatoid arthritis, the dose can be raised up to a maximum of 3 mg/kg daily, given in divided doses, as applicable.
The maximum daily dose of 150 mg should not be exceeded.
Geriatrics (Patients aged 65 or above)
No adjustment of the starting dose is required for elderly patients (see section 6 Warnings and precautions).


Established cardiovascular disease or significant cardiovascular risk factors Voltaren is contraindicated in patients with established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease (see section 5 Contraindications).
Patients with congestive heart failure (NYHA-1) and patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with diclofenac after careful consideration and only at doses ≤100 mg daily when treatment continues for more than 4 weeks (see section 6 Warnings and precautions).


Renal impairment
Voltaren is contraindicated in patients with renal failure (see section 5 Contraindications). No specific studies have been carried out in patients with renal impairment, therefore, no specific dose adjustment recommendations can be made. Caution is advised when administering Voltaren to patients with mild to moderate renal impairment (see section 6 Warnings and precautions).
Hepatic impairment
Voltaren is contraindicated in patients with hepatic failure (see section 5 Contraindications).No specific studies have been carried out in patients with hepatic impairment, therefore, no specific dose adjustment recommendations can be made. Caution is advised when administering Voltaren to patients with mild to moderate hepatic impairment (see section 6 Warnings and precautions).

Method of administration
The suppositories should be inserted well into the rectum. It is recommended to take the suppositories after passing stools.
Not to be taken by mouth, as per rectal use only.