IMUNOVIR Tablet Ref.[8507] Active ingredients: Inosine pranobex

• Imunovir may cause a transient elevation of baseline serum and urinary uric acid, usually remaining within the normal range (using 8mg % as the upper limit), particularly in males and in the ageing population of both sexes. The elevation of uric acid levels is due to the catabolic metabolism of the inosine moiety in this product in humans to uric acid. It is not due to a fundamental drug-induced alteration of enzyme or renal clearance function. Therefore, Imunovir may be administered with caution in patients with a history of gout, hyperuricaemia, urolithiasis, or to patients with impaired renal function. During treatment, uric acid levels in these patients should be monitored closely.
• In the case of long term treatment, the serum and/or urine uric acid levels, liver function, blood count and renal functions should be checked on a regular basis in all patients. There is a possibility that ureteric and biliary calculi may occur when patients receive long term treatment.

In some people acute hypersensitivity reactions (urticaria, angioedema, anaphylaxis) may occur. Treatment with Imunovir should be withdrawn in these cases.

Wheat starch in this medicine contains only very low levels of gluten regarded as gluten-free and is very unlikely to cause problems if you have coeliac disease.

One tablet contains no more than 10.5 micrograms of gluten.

If you have a wheat allergy (different from coeliac disease) you should not take this medicine.

The drug should be used with caution with xanthine oxidase inhibitors or uricosuric agents, including diuretics.

Imunovir may be administered after but not concomitantly with immunosuppressive agents, as there may be a pharmacokinetic influence on the desired therapeutic effects.

Concomitant use with AZT increases AZT nucleotide formation through multiple mechanisms involving increased plasma AZT bioavailability and increased intracellular phosphorylation in human blood monocytes.

As a result Imunovir increases the effect of AZT.

Controlled trials monitoring foetal risk and impairment of fertility in humans are not available. It is not known if Imunovir is excreted in human milk. Therefore, Imunovir should not be administered during pregnancy or lactation unless the physician decides the benefits outweigh the potential risk.

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

Imunovir has no or negligible influence on the ability to drive and use machines.

During treatment with Imunovir, the only consistently observed drug-related side effects in adults as well as paediatric population 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.

Very common ≥1/10
Common ≥1/100, <1/10
Uncommon ≥1/1,000, <1/100
Rare ≥1/10,000, <1/1,000
Very rare <1/10,000, including isolated reports
Not Known Cannot be estimated from the available data

Immune system disorders

Not known: Angioedema, Hypersensitivity, Urticaria, Anaphylactic reaction

Psychiatric disorders

Uncommon: Nervousness

Nervous system disorders

Common: Headache, Vertigo

Uncommon: Somnolence, Insomnia

Not Known: Dizziness

Gastrointestinal disorders

Common: Vomiting, Nausea, Epigastric discomfort

Uncommon: Diarrhoea, Constipation

Not known: Abdominal pain upper

Skin and subcutaneous tissue disorders

Common: Rash, Pruritus

Not known: Erythema

Musculoskeletal and connective tissue disorders

Common: Arthralgia

Renal and urinary disorders

Uncommon: Polyuria

General disorders and administration site conditions

Common: Fatigue, Malaise

Investigations

Very Common: Blood uric acid increased, Urine uric acid increased

Common: Blood urea increased, Transaminases increased, Blood alkaline phosphate increased

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

Not applicable.