Active Ingredient and Strength	DICLOFENAC POTASSIUM - 50 MG
Dosage Form	POWDER, FOR SOLUTION
Manufacturer and Country	MIPHARM S.P.A. - ITALY
Registration Number	SIN13913P
Licence Holder	NOVARTIS (SINGAPORE) PTE LTD
Forensic Classification	PRESCRIPTION ONLY MEDICINES
Anatomical Therapeutic Chemical (ATC) code	M01AB05

INDICATIONS

As a short-term treatment (up to one week) for the relief of acute pain states in which there is an inflammatory component.

Treatment of acute migraine attacks (with or without aura).

Symptomatic treatment of primary dysmenorrhoea.

DOSAGE REGIMEN AND ADMINISTRATION

Dosage regimen

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 WARNINGS AND PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

General target population

Adults

The recommended initial daily dose is 100 to 150 mg. In milder cases, 50 to 100 mg daily are usually sufficient. The daily dose should generally be divided in up to 3 separate doses.

In primary dysmenorrhoea, 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 total 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.

In migraine, an initial dose of 50 mg should be taken at the first signs of an impending attack. In cases where pain relief within 2 hours after the first dose is not sufficient, a further dose of 50 mg may be taken. If needed, further doses of 50 mg may be taken at intervals of 4 to 6 hours, not exceeding a total dose of 200 mg per day.

Special populations

Renal impairment

Voltfast is contraindicated in patients with renal failure (GFR <15 mL/min/1.73 m²) (see section 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 Voltfast to patients with renal impairment (see section WARNINGS AND PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment

Voltfast is contraindicated in patients with hepatic failure (see section 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 Voltfast to patients with mild to moderate hepatic impairment (see section WARNINGS AND PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Pediatric patients (below 18 years)

Voltfast 50 mg powder for oral solution is not recommended for use in children and adolescents below 14 years of age; other forms of diclofenac such as oral drops or suppositories could be used in these patients.

For adolescents aged 14 years and over, a daily dose of 50 to 100 mg is usually sufficient. The total daily dose should generally be given as 1 to 2 divided doses.

The use of Voltfast 50 mg powder for oral solution in migraine attacks has not been established in children and adolescents.

Geriatric patients (65 years of age or above)

No adjustment of the starting dose is generally required for elderly patients. However, caution is indicated on basic medical grounds, especially for frail elderly patients or those with a low body weight. Although the pharmacokinetics of Voltfast are not impaired to any clinically relevant extent in elderly patients, Voltfast should be used with particular caution in such patients who generally are more prone to adverse reactions. (see section WARNINGS AND PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Established cardiovascular disease or significant cardiovascular risk factors

The use of high dose diclofenac (150mg/day) for more than 4 weeks is contraindicated in patients with established cardiovascular disease (congestive heart failure, established ischemic heart disease, peripheral arterial disease) or uncontrolled hypertension. If diclofenac treatment is needed, patients with established cardiovascular disease, uncontrolled hypertension or significant cardiovascular risk factors (e.g. hypertension, hyperlipidaemia, diabetes mellitus and smoking) should be treated only after careful consideration and at doses ≤100 mg daily when the treatment continues for more than 4 weeks. As the cardiovascular risks of diclofenac may increase with dose and duration of exposure, diclofenac should always be prescribed at the lowest effective daily dose and for the shortest duration possible (see section WARNINGS AND PRECAUTIONS – CARDIOVASCULAR EFFECTS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Method of administration

Empty contents of one Voltfast® sachet into a glass of drinking water. Dissolve well before drinking. The solution may remain slightly opalescent, but this should not influence the efficacy of the preparation. The solution should be swallowed preferably before meals. Reconstituted solution may be stored for up to 24 hours at or below 25°C.

CONTRAINDICATIONS

Known hypersensitivity to the active substance or to any of the excipients.
Active gastric or intestinal ulcer, bleeding or perforation (see sections WARNINGS AND PRECAUTIONS and ADVERSE DRUG REACTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Last trimester of pregnancy (see section PREGNANCY, LACTATION, FEMALES AND MALES OF REPRODUCTIVE POTENTIAL – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Hepatic failure.
Renal failure (GFR <15 mL/min/1.73 m²).
Severe cardiac failure (see section WARNINGS AND PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Like other non-steroidal anti-inflammatory drugs (NSAIDs), Voltfast is also contraindicated in patients in whom the use of acetylsalicylic acid or other NSAIDs can precipitate asthma, angioedema, urticaria, or acute rhinitis (i.e., NSAID-induced cross-reactivity reactions)(see sections WARNINGS AND PRECAUTIONS and ADVERSE DRUG REACTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
All NSAIDs should not be used in perioperatively in patients who have recently undergone coronary artery bypass graft (CABG) surgery and revascularisation procedures.
The use of high dose diclofenac (150mg/day) for more than 4 weeks is contraindicated in patients with established cardiovascular disease (congestive heart failure, established ischemic heart disease, peripheral arterial disease) or uncontrolled hypertension (see sections DOSAGE AND ADMINISTRATION - SPECIAL POPULATIONS and WARNINGS AND PRECAUTIONS - CARDIOVASCULAR EFFECTS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).