IMUNOVIR 500MG TABLETS
Active substance(s): INOSINE ACEDOBEN DIMEPRANOL
PATIENT LEAFLET: INFORMATION FOR THE USER
IMUNOVIR® 500mg TABLETS
inosine acedoben dimepranol
Please read all of this leaflet carefully before you start taking this medicine. It contains important
information.
_
Keep this leaflet in a safe place because you may need to read it again.
_
If you have any other questions, or if there is something you do not understand, please ask
your doctor or pharmacist.
_
This medicine has been prescribed for you. Never give it to someone else. It may harm them.
It may not be the right medicine for them even if their symptoms are the same as yours.
_
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
This leaflet contains the following information:
1. What are IMUNOVIR TABLETS and what are they used for
2. Things to consider before you take IMUNOVIR TABLETS
3. How to take IMUNOVIR TABLETS
4. Possible side effects
5. How to store IMUNOVIR TABLETS
6. Further information
1. What are IMUNOVIR TABLETS and what are they used for
IMUNOVIR TABLETS may be used for three different conditions. Your doctor may prescribe IMUNOVIR
TABLETS for the treatment of:
•
•
•
Herpes Virus Infections caused by the herpes simplex virus that occur on the genitals (the sex
organs), the skin and mucous membranes.
Warts on the genitals. In treating these warts Imunovir 500mg tablets are used in combination with
other treatment such as podophyllin or carbon dioxide laser.
Subacute Sclerosing Panencephalitis (SSPE), which is a very rare complication of measles.
2. Things to consider before you take 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 IMUNOVIR TABLETS (see Further Information section 6 for the list of ingredients).
You should also ask yourself these questions before taking IMUNOVIR TABLETS. If the answer to
any of these questions is YES, tell your doctor or pharmacist because IMUNOVIR TABLETS might not
be the right medicine for you.
•
Do you suffer from kidney problems, gout, or high levels of uric acid in the blood? Please tell your
doctor if you do.
Using other medicines
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 after application. 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
IMUNOVIR TABLETS contain wheat starch. This medicine is suitable for people with coeliac disease.
Patients with a wheat allergy (different from coeliac disease) should not take IMUNOVIR TABLETS
3. How to take IMUNOVIR TABLETS
Always take IMUNOVIR TABLETS exactly as your doctor has told you. You should 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.
The usual 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.
4. Possible side effects
Like all medicines, IMUNOVIR TABLETS can cause side effects, although not everybody gets them.
The only common side effect 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.
Less common side effects 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
Rare side effects include:
• diarrhoea, constipation,
• an increase in the amount of urine been passed,
• nervousness, drowsiness or insomnia
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor. 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.
5. Storing IMUNOVIR TABLETS
•
•
•
Do not use the tablets after the last day of the month of the expiry date shown on the Carton
and the Blister.
Keep the tablets in a secure place where children cannot get at or see them.
Unless your doctor tells you to, do not keep medicines that you no longer need - give them back
to your pharmacist for safe disposal.
6. Further 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), Swords Business Park, Swords, Co. Dublin, Ireland
THE MANUFACTURER OF THE TABLETS IS
Delpharm Dijon, 6 Boulevard de lʼEurope, 21800 Quétigny, 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: 01/2016
Ref: UK_IM:4.0
IMUNOVIR® 500mg TABLETS
inosine acedoben dimepranol
Please read all of this leaflet carefully before you start taking this medicine. It contains important
information.
_
Keep this leaflet in a safe place because you may need to read it again.
_
If you have any other questions, or if there is something you do not understand, please ask
your doctor or pharmacist.
_
This medicine has been prescribed for you. Never give it to someone else. It may harm them.
It may not be the right medicine for them even if their symptoms are the same as yours.
_
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
This leaflet contains the following information:
1. What are IMUNOVIR TABLETS and what are they used for
2. Things to consider before you take IMUNOVIR TABLETS
3. How to take IMUNOVIR TABLETS
4. Possible side effects
5. How to store IMUNOVIR TABLETS
6. Further information
1. What are IMUNOVIR TABLETS and what are they used for
IMUNOVIR TABLETS may be used for three different conditions. Your doctor may prescribe IMUNOVIR
TABLETS for the treatment of:
•
•
•
Herpes Virus Infections caused by the herpes simplex virus that occur on the genitals (the sex
organs), the skin and mucous membranes.
Warts on the genitals. In treating these warts Imunovir 500mg tablets are used in combination with
other treatment such as podophyllin or carbon dioxide laser.
Subacute Sclerosing Panencephalitis (SSPE), which is a very rare complication of measles.
2. Things to consider before you take 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 IMUNOVIR TABLETS (see Further Information section 6 for the list of ingredients).
You should also ask yourself these questions before taking IMUNOVIR TABLETS. If the answer to
any of these questions is YES, tell your doctor or pharmacist because IMUNOVIR TABLETS might not
be the right medicine for you.
•
Do you suffer from kidney problems, gout, or high levels of uric acid in the blood? Please tell your
doctor if you do.
Using other medicines
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 after application. 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
IMUNOVIR TABLETS contain wheat starch. This medicine is suitable for people with coeliac disease.
Patients with a wheat allergy (different from coeliac disease) should not take IMUNOVIR TABLETS
3. How to take IMUNOVIR TABLETS
Always take IMUNOVIR TABLETS exactly as your doctor has told you. You should 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.
The usual 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.
4. Possible side effects
Like all medicines, IMUNOVIR TABLETS can cause side effects, although not everybody gets them.
The only common side effect 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.
Less common side effects 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
Rare side effects include:
• diarrhoea, constipation,
• an increase in the amount of urine been passed,
• nervousness, drowsiness or insomnia
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor. 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.
5. Storing IMUNOVIR TABLETS
•
•
•
Do not use the tablets after the last day of the month of the expiry date shown on the Carton
and the Blister.
Keep the tablets in a secure place where children cannot get at or see them.
Unless your doctor tells you to, do not keep medicines that you no longer need - give them back
to your pharmacist for safe disposal.
6. Further 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), Swords Business Park, Swords, Co. Dublin, Ireland
THE MANUFACTURER OF THE TABLETS IS
Delpharm Dijon, 6 Boulevard de lʼEurope, 21800 Quétigny, 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: 01/2016
Ref: UK_IM:4.0
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