IMUNOVIR 500 mg Tablets

Each tablet contains 500mg Inosine Acedoben Dimepranol (INN, also known as inosine pranobex*) which is the p-acetamidobenzoic acid salt of N,N-dimethylamino-2-propanol [DIP.PAcBA] and β-inosine in a 3:1 molar ratio.

*British Approved Name (BAN) the non-proprietary designation

For excipients, see section 6.1

White to off-white tablets with a faint amine odour, engraved with a score-line on one side and 'DN' on the other.

The score-line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Imunovir tablets are indicated in the management of:

a) Mucocutaneous infections due to herpes simplex virus (type 1 and/or type II).

b) Genital warts as adjunctive therapy to podophyllin or carbon dioxide laser.

c) Subacute sclerosing panencephalitis (SSPE).

Adults:

Mucocutaneous herpes simplex: 1 g q.d.s. (4g daily), for 7 -14 days.

Genital warts: 1g t.d.s. (3g daily), for 14-28 days as adjunctive therapy to podophyllin or carbon dioxide laser.

Subacute sclerosing panencephalitis (SSPE): 50-100mg/kg daily, in divided does every 4 hours.

Children:

No information is available in children.

Elderly:

No dosage alterations are necessary in the elderly.

There are no known contraindications to therapy with this drug.

As the inosine component of Imunovir is metabolised to uric acid, it should be used with caution in patients with renal impairment, a history of gout or hyperuricaemia.

None known.

Although animal tests have shown no teratogenic effect, the use of Imunovir in women where pregnancy is suspected or confirmed should be avoided.

Not applicable.

The only consistently observed drug-related side effect is a transient elevation (usually remaining within normal range) of urine and serum uric acid levels, which usually return to baseline values a few days after the end of treatment.

Side effects recorded in >1% of clinical studies of 3 months or longer and reported infrequently in postmarketing surveillance:

Side effects recorded in <1% of clinical studies of 3 months or longer and reported rarely in postmarketing surveillance:

There has been no experience of overdosage with Imunovir. However serious adverse effects apart from increased levels of uric acid in the body, seem unlikely in view of the animal toxicity studies. Treatment should be restricted to symptomatic and supportive measures.

Imunovir is an agent demonstrating anti-viral activity and possessing immunopotentiating action in viral diseases.

Following a single oral dose of inosine acedoben dimeparanol, peak plasma conditions of inosine occur after 1 hour. However, 2 hours after administration, plasma concentrations decrease to undetectable amounts. Inosine acedoben dimeparanol has a very short plasma half-life of 50 minutes following an oral dose. The major excretion product of the inosine moiety is uric acid, while the p-acetamidobenzoic acid and N,N-dimethylamino-2-propanol components are excreted in the urine as glucuronidated and oxidised products, respectively, as well as being excreted unchanged.

There is no pre-clinical data of relevance to the prescriber which is additional to that included in other sections of the SPC.

Povidone, Mannitol, Wheat Starch, Magnesium Stearate

None are known.

5 years.

This medicinal product does not require any special storage conditions.

100 (5 x 20) tablets in transparent, colourless PVC/PVDC blister packs sealed with aluminium foil.

None

Newport Pharmaceuticals Limited,

Frans Maas House,

Swords Business Park,

Swords, Co. Dublin

Ireland.

17232/0001

15^th November 1983/ 29^th September 2009

January 2011