SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

IMUNOVIR 500 mg Tablets

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

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 P-inosine in a 3:1 molar ratio.

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

For excipients, see section 6.1

3    PHARMACEUTICAL FORM

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.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Imunovir tablets are indicated in the management of:

a)    Mucocutaneous infections due to herpes simplex (type I and/or type II)

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

c)    Subacute sclerosing panencephalitis (SSPE).

Posology and method of administration

Adults:

Mucocutaneous herpes simplex: 1g 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 pan encephalitis (SSPE): 50-100mg/kg daily, in divided doses every 4 hours.

Children:

No information is available in children.

Elderly:

No dosage alterations are necessary in the elderly.

4.3 Contraindications

There are no known contraindications to therapy with this drug.

4.4 Special warnings and precautions for use

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.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Fertility, Pregnancy and lactation

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

4.7 Effects on ability to drive and use machines

Not applicable.

4.8 Undesirable effects

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 post-marketing surveillance:

Nausea with or without vomiting, epigastric discomfort. Elevation of transaminases, alkaline phosphatase or blood urea nitrogen (BUN) level.

Itching, skin rashes.

Headaches, vertigo, fatigue or malaise.

Arthralgia.

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

Diarrhoea, constipation.

Nervousness, drowsiness or insomnia. Polyuria (increased urine volume).

4.9 Overdose

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.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

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

5.2 Pharmacokinetic properties

Following a single oral dose of inosine acedoben dimepranol, peak plasma conditions of inosine occur after 1 hour. However, 2 hours after administration, plasma concentrations decrease to undetectable amounts. Inosine acedoben dimepranol 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.

5.3 Preclinical safety data

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

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Povidone, Mannitol, Wheat Starch, Magnesium Stearate

6.2 Incompatibilities

None are known.

6.3 Shelf life

5 years.

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container

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

Special precautions for disposal

None.

7 MARKETING AUTHORISATION HOLDER

KoRa Corporation Ltd. (trading as KoRa Healthcare) Swords Business Park,

Swords, Co. Dublin Ireland.

8    MARKETING AUTHORISATION NUMBER(S)

PL 39972/0001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

29/09/2009

10 DATE OF REVISION OF THE TEXT

09/08/2012