Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Imunovir 500mg Tablets
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Inosine acedoben dimepranol may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What you need to know before you take it
e IMUNOVIR Tablets Do not take IMUNOVIR TABLETS : • •
If you are allergic to inosine acedoben dimepranol (the active ingredient) or any of the other ingredients of this medicine (listed in section 6). You currently suffer from gout or high levels or uric acid in your blood.
Warnings and precautions Talk to your doctor or pharmacist before taking IMUNOVIR TABLETS if: •
You suffer from kidney problems, gout, or high levels of uric acid in the blood.
There is a possibility that kidney stones or stones in the gall bladder may occur when patients receive long term treatment (more than 3 months) with IMUNOVIR TABLETS. If you are taking these tablets continuously for a long period of time your doctor will need to regularly check your liver and kidneys and also take regular blood and urine samples. Other medicines and IMUNOVIR Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is particularly important if you are taking drugs that affect the immune system such as Zidovudine (AZT – used to treat HIV). This is because IMUNOVIR TABLETS can affect the way these medicines work. Also, these medicines may affect the way IMUNOVIR TABLETS works. IMUNOVIR TABLETS should be used with caution with xanthine oxidase inhibitors, uricosuric agents and diuretics (these are medicines that may be used to treat gout or control the amount of uric acid in your body). Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed by a doctor. Pregnancy and breast-feeding You should not use IMUNOVIR TABLETS if you are pregnant. Please tell your doctor if you are pregnant. It is not known whether the active substance in IMUNOVIR TABLETS passes into breast milk during use. Please tell your doctor if you are breast-feeding. Driving and using machines IMUNOVIR TABLETS have no known effect on the ability to drive or use machines. Important information about some of the ingredients of IMUNOVIR TABLETS Wheat starch in IMUNOVIR TABLETS 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.
Patients with a wheat allergy (different from coeliac disease) should not take IMUNOVIR TABLETS
How to take it
IMUNOVIR TABLETS Always take IMUNOVIR TABLETS exactly as your doctor has told you. Check with your doctor if you are not sure. Read the label on your pack carefully. IMUNOVIR TABLETS can be taken orally with or without food. If taking tablets is difficult for you, the tablets can be crushed and dissolved in a small amount of pleasant-tasting liquid. Drink all the liquid. The recommended dose is: • • •
Herpes Simplex Infection: Take 2 tablets four (4) times each day for 7-14 days. Genital Warts: Take 2 tablets, three (3) times each day for 14-28 days. SSPE: Your doctor will decide the right dose, depending on your body weight and advise you for how long to take your medication
If you take more IMUNOVIR TABLETS than you should Call the Doctor for advice. If you forget to take IMUNOVIR TABLETS If you forget to take the tablets at the right time, take them as soon as you remember. Then go on as before. Do not take a double dose to make up for a forgotten tablet.
Possible side effects
Like all medicines, IMUNOVIR TABLETS can cause side effects, although not everybody gets them. In some people IMUNOVIR TABLETS may cause allergic reactions (hypersensitivity) which may mean you have difficulty in breathing or swallowing, swelling of the face, lips, throat or tongue, skin rashes, large or itchy wheals on the skin, attacks of sneezing, runny nose and itching eyes. If you experience any of these side effects, stop taking IMUNOVIR TABLETS and contact your doctor or pharmacist immediately. The only very common side effect (affecting more than 1 in 10 people) is increased uric acid levels in the blood and urine which can cause gout and kidney stones. The level of uric acid in the blood returns to normal after the treatment is finished. Common side effects (affecting less than 1 in 10 people) include:
- nausea with or without vomiting, discomfort in the stomach,
- increased liver enzymes and blood urea nitrogen (a measure of the amount of nitrogen in the blood),
- itching, skin rashes,
- headaches, vertigo, fatigue or malaise (feeling unwell),
- painful joints Uncommon side effects (affecting less than 1 in 100 people) include:
- diarrhoea, constipation,
- an increase in the amount of urine been passed,
- nervousness, drowsiness or insomnia Not known (cannot be estimated from the available data):
- allergic reactions which can include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue.
- dizziness
- upper abdominal pain
- flushing or redness of the skin Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.
How to store it
IMUNOVIR TABLETS •
Keep this medicine out of the sight and reach of children.
•
Do not use this medicine after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of that month. Unless your doctor tells you to, do not keep medicines that you no longer need. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
• •
Contents of the pack and other information
What IMUNOVIR TABLETS contain: _ _
The active substance is inosine acedoben dimepranol. Each tablet contains 500 mg inosine acedoben dimepranol. The other ingredients used to make the tablet are povidone, magnesium stearate, mannitol and wheat starch.
What IMUNOVIR TABLETS look like and contents of the pack: IMUNOVIR TABLETS are white, oblong tablets with a score-line on one side and the letters 'DN' imprinted on the other. They are supplied in cardboard cartons containing 100 (5 x 20) tablets in blister packs sealed with aluminium foil.
The Marketing Authorisation Holder is Kora Corporation Ltd (trading as Kora Healthcare), 20 Harcourt Street, Dublin 2, D02 H364, Ireland THE MANUFACTURER OF THE TABLETS IS Delpharm Dijon, 6 Boulevard de l'Europe, 21800 Quetigny, France For any information about this medicinal product, please contact the Marketing Authorisation Holder
- Kora Corporation Ltd (trading as Kora Healthcare): Tel +353 -1- 8900406 Date Leaflet Last Revised: 03/2022
Frequently asked questions about Imunovir 500mg Tablets
How do I take Imunovir 500mg Tablets?
Imunovir 500mg Tablets comes as tablet containing 500mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Imunovir 500mg Tablets?
The active substance in Imunovir 500mg Tablets is inosine acedoben dimepranol.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Imunovir 500mg Tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Imunovir 500mg Tablets without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: inosine acedoben dimepranol
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
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).
4.2. Posology and method of administration
Posology
Adults and the Elderly:
The recommended dosage is 50mg/kg – 100mg/kg of body weight usually 3g/day up to a maximum of 4g/day, administered orally in 3-4 equally divided doses during waking hours.
Mucocutaneous herpes simplex: 1 g administered orally 4 times daily, for 7 - 14 days.
Genital warts: 1g administered orally 3 times daily, for 14-28 days as adjunctive therapy to podophyllin or carbon dioxide laser.
Subacute sclerosing panencephalitis (SSPE): 50-100mg/kg daily, up to a maximum of 3-4 g, in divided doses every 4 hours, with regular monitoring to evaluate patient status and requirement for extended treatment.
The weight of the patient and the severity of the disease are important factors in determining the dosage.
Children:
No information is available in children. Method of administration
Oral use
To make ingestion easier, the tablets may be crushed and dissolved in a small amount of flavoured liquid at the time of administration.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Imunovir should not be used where the patient is presently suffering from gout or has elevated uric acid blood levels.
4.4. Special warnings and precautions for use
a) 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.
b) 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.
4.5. Interaction with other medicinal products and other forms of interaction
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.
4.6. Fertility, pregnancy and lactation
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.
4.7. Effects on ability to drive and use machines
Imunovir has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
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.
Frequency convention (MedDRA)
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
System Organ Class
Frequency
Adverse Reaction
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.
4.9. Overdose
There has been no experience of overdose 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.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Not the same combination. This medicine contains Inosine acedoben dimepranol. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
- INOVIRA 500 mg prescription partial — not the same combinationINOSINUM · taken by mouth
- ISOPRINOSINE EWOPHARMA 500 mg prescription partial — not the same combinationINOSINUM · taken by mouth
- ISOPRINOSINE EWOPHARMA 50 mg/ml prescription partial — not the same combinationINOSINUM · taken by mouth
- RESIVIRTAN 100 mg/ml prescription partial — not the same combinationINOSINUM · taken by mouth
- GROPRINOSIN 50 mg/ml sirop prescription partial — not the same combinationINOSINUM · taken by mouth
- VIRUXAN COPII 50 mg/ml prescription partial — not the same combinationINOSINUM · taken by mouth
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- GroprinosinInosinum 500 mg
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Imunovir 500mg Tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.