Eloprine

Package leaflet: Information for the user

ELOPRINE, 500 mg, tablets
Inosinum pranobexum
Please read this leaflet carefully before using this medicine, as it contains important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 5 to 14 days, or if you feel worse, consult your doctor.

Leaflet contents

1. What Eloprine is and what it is used for
2. Important information before taking Eloprine
3. How to take Eloprine
4. Possible side effects
5. How to store Eloprine
6. Contents of the pack and other information

1. What Eloprine is and what it is used for

Eloprine contains as its active substance inosine pranobex, which exhibits antiviral activity and stimulates the immune system.
Eloprine contains the active ingredient inosine pranobex, which inhibits in vitro replication of human pathogenic Herpes viruses.

Indications for Eloprine
As an adjunctive treatment in individuals with reduced immunity, in cases of recurrent upper respiratory tract infections.
For the treatment of herpes labialis and facial skin herpes caused by herpes simplex virus.
Eloprine may only be used in patients who have previously been diagnosed with herpes simplex virus infection.
If there is no improvement after 5 to 14 days, or if you feel worse, consult your doctor.

2. Important information before using Eloprine

When not to use Eloprine:

• if the patient is allergic to inosine pranobex or to any of the other ingredients of this medicine (listed in section 6); symptoms of an allergic reaction may include: rash, itching, difficulty breathing, swelling of the face, lips, throat or tongue;
• if the patient currently has an attack of gout (severe joint pain with swelling and redness of the skin, or effusion in large joints), or tests have shown increased levels of uric acid in the blood.

Warnings and precautions
Before starting treatment with Eloprine, discuss this with your doctor or pharmacist:

• if the patient has previously experienced gout attacks or elevated levels of uric acid in the blood or urine; Eloprine may cause transient increases in uric acid levels in the blood and urine;
• if the patient has previously had kidney stones;
• if the patient has impaired kidney function; in such cases, the doctor will monitor the patient closely;
• if treatment is long-term (3 months or longer); the doctor will recommend regular blood tests and will monitor kidney and liver function.

Children
Eloprine should not be used in children during the first year of life.
Eloprine and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. In particular, inform the doctor about the following medicines, as they may interact with Eloprine:

• medicines used to treat gout (allopurinol or other drugs);
• medicines that increase uric acid excretion, including diuretics (which increase urine production), e.g. furosemide, torasemide, ethacrynic acid, hydrochlorothiazide, chlorthalidone, indapamide;
• medicines that suppress immune system function (so-called immunosuppressants, used in organ transplant patients or in atopic dermatitis);
• zidovudine (a medicine used to treat patients infected with HIV virus).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Eloprine should not be taken during pregnancy or breastfeeding, unless otherwise directed by a doctor.
The doctor will assess whether the benefits of using the medicine outweigh the risks.
Driving and operating machinery
It is unlikely that Eloprine will affect the ability to drive or operate machinery.
Eloprine contains mannitol (E 421)
One Eloprine tablet contains 80 mg of mannitol, which may have a mild laxative effect.

3. How to take Eloprine

This medicine should always be taken exactly as described in the patient leaflet or as advised by
your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The dose is determined based on the patient's body weight and depends on the severity of the disease.
The daily dose should be divided into equal single doses administered several times a day.
Adults, including elderly people (over 65 years of age)
The recommended dose is 50 mg per kg of body weight per day.
Typically, the daily dose is 6 tablets (3 g) taken throughout the day (i.e. 2 tablets 3 times a day).
The maximum daily dose is 8 tablets (4 g) per day (i.e. 2 tablets 4 times a day).
Children over 1 year of age
The recommended dose is 50 mg per kg of body weight per day, given in several equal divided doses.
For children who cannot swallow tablets, administration of the medicine in the form of syrup 250 mg/5 ml or 500 mg/5 ml is recommended.
Method of administration
The medicine should be taken orally.
The tablet should be taken with an adequate amount of liquid. If difficulty occurs in swallowing the whole tablet, to facilitate administration, the tablets may be crushed and dissolved in a small amount of liquid.

Use in children
Eloprine must not be used in children during the first year of life.
Use of a higher than recommended dose of Eloprine
Cases of overdose have not been reported so far. If in doubt or if you experience any discomfort, contact your doctor immediately.
Missed dose of Eloprine
If a dose is missed, take it as soon as you remember, unless it is almost time for the next dose. Do not use a double dose to make up for the missed dose.
Discontinuation of Eloprine
If treatment is discontinued, the expected therapeutic effect may not be achieved or symptoms of the disease may worsen.
If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Other possible adverse effects of Eloprine are listed below.
Very common (occur in more than 1 in 10 people):

• transient increase in blood and urinary uric acid levels;

Common (occur in no more than 1 in 10 people):

• elevated liver enzyme activity or increased blood urea nitrogen levels;
• nausea with or without vomiting;
• abdominal pain;
• skin itching;
• skin rash;
• headache;
• dizziness;
• fatigue or malaise;
• joint pain.

Uncommon (occur in no more than 1 in 100 people):

• diarrhoea;
• constipation;
• nervousness;
• drowsiness or difficulty sleeping (insomnia);
• increased urine volume (polyuria).

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: (22) 49 21 301
Fax: (22) 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Eloprine
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following "EXP". The expiry date refers to the last day of the specified month.
No special storage conditions apply.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Eloprine contains

• The active substance is inosine pranobex (a complex containing inosine, 4-acetamidobenzoic acid salt with N,N-2-dimethylamino-2-propanol in a molar ratio of 1:3). Each tablet contains 500 mg of inosine pranobex.
• Other ingredients: mannitol, potato starch, povidone K-25, magnesium stearate.

What Eloprine looks like and contents of the pack
Eloprine is a white or light cream, elongated, biconvex tablet.
The pack contains 10, 20, 30, 50 or 100 tablets in blisters.

Marketing Authorisation Holder and Manufacturer
Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Poland
Tel.: 24 357 44 44
Fax: 24 357 45 45
e-mail: [email protected]