Package leaflet: Information for the user

Viruzine Forte, 1000 mg, tablets
Inosinum pranobexum
Please read all of this leaflet carefully before taking this medicine because 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 so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any adverse reactions 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, you should contact your doctor.

Contents of the leaflet

What Viruzine Forte is and what it is used for
Important information before taking Viruzine Forte
How to take Viruzine Forte
Possible side effects
How to store Viruzine Forte
Contents of the pack and other information

1. What Viruzine Forte is and what it is used for

Viruzine Forte is an antiviral and immunostimulatory medicine (it enhances immune system function).
Viruzine Forte contains the active substance inosine pranobex, which inhibits in vitro replication of human pathogenic viruses from the Herpes group.
Indications for Viruzine Forte:

as an adjunctive treatment in individuals with reduced immunity suffering from recurrent upper respiratory tract infections,
for the treatment of herpes labialis and facial skin herpes caused by herpes simplex virus (Herpes simplex). Viruzine Forte may only be used in patients previously diagnosed with herpes simplex virus infection.

If there is no improvement after 5 to 14 days, or if you feel worse, you should consult your doctor.

2. Important information before using Viruzine Forte

When not to use Viruzine Forte

If the patient is allergic (hypersensitive) to the active substance (pranobex of inosine) 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.

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If the patient currently has an attack of gout (severe joint pain with swelling and redness of the skin, and effusion in large joints), or tests have shown increased levels of uric acid in the blood.

Warnings and precautions
Before starting treatment with Viruzine Forte, discuss this with a doctor or pharmacist:

if the patient has previously had gout attacks or elevated uric acid levels, as the drug may cause transient increases in serum and urinary uric acid concentration,
if the patient has previously had kidney stones,
if the patient has impaired kidney function. In such a case, the doctor will closely monitor the patient,
if treatment is long-term (3 months or longer). The doctor will recommend regular blood tests and will monitor kidney and liver function. Kidney stones may develop during prolonged treatment,
if symptoms of an allergic reaction occur, such as rash, itching, difficulty breathing, swelling of the face, lips, throat or tongue. In such a case, treatment must be stopped immediately and medical advice sought.

Viruzine Forte and other medicines
Tell the 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.
Especially inform the doctor or pharmacist about the following medicines, as they may interact with Viruzine Forte:

allopurinol or other medicines used in the treatment of gout;
medicines increasing uric acid excretion, including diuretics, e.g. furosemide, torasemide, ethacrynic acid, hydrochlorothiazide, chlorthalidone, indapamide;
medicines affecting the immune system, e.g. those used after organ transplantation;
zidovudine used in the treatment of AIDS.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Viruzine Forte should not be taken during pregnancy or breastfeeding, unless the doctor considers that the benefits of using the medicine outweigh the possible risks.

Driving and operating machinery
Viruzine Forte has no effect or has a negligible effect on the ability to drive vehicles and operate machinery.

3. How to take Viruzine Forte

This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Adults, including elderly patients (over 65 years of age)
The recommended dose is 50 mg/kg body weight per day.
The usual dose is 3 tablets (3 g) per day (i.e. 1 tablet three times a day).
The maximum dose is 4 tablets (4 g) per day (i.e. 1 tablet four times a day).
Children over 1 year of age
The recommended dose is 50 mg/kg body weight per day, given in divided doses.
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For children who cannot swallow tablets, inosine pranobex is recommended in syrup form.
Method of administration
Oral administration.
The score line on the tablet is intended only to facilitate breaking the tablet if the patient has
difficulty swallowing it whole.
Duration of treatment
The usual duration of treatment is 5 to 14 days. After symptoms have subsided, this medicine is
usually continued for an additional 1 to 2 days.
Taking more Viruzine Forte than recommended
Cases of overdose have not been reported to date. If in any doubt, contact your doctor immediately.
Missing a dose of Viruzine Forte
If you miss a dose of this medicine, take it as soon as you remember, unless it is almost time for the
next dose. Do not take a double dose to make up for a missed dose.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Any medicine may cause an allergic reaction; however, severe allergic reactions after taking the medicine
Viruzine Forte occur very rarely.
You should consult a doctor immediately if any of the following symptoms occur:

sudden wheezing,
difficulty breathing,
swelling of the eyelids, face or lips,
rash or itching (especially if affecting the whole body).

The following adverse reactions may occur:

Very common (affecting more than 1 in 10 people): increased blood uric acid levels, increased uric acid levels in urine.
Common (affecting no more than 1 in 10 people): increased liver enzyme activity, increased blood urea levels, rash, itching, joint pain, vomiting, nausea, discomfort in the upper abdomen, fatigue (tiredness), weakness (malaise), headache, dizziness.
Uncommon (affecting no more than 1 in 100 people): diarrhoea, constipation, drowsiness, difficulty sleeping (insomnia), nervousness,
increased urine volume (polyuria).
Frequency not known (cannot be estimated from available data): abdominal pain, swelling of the face, lips, eyelids or throat (angioedema), urticaria, allergic reaction, sudden severe allergic reaction affecting the whole body (anaphylactic reaction), skin redness (erythema).

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions 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,
tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Viruzine Forte

Keep this medicine out of sight and reach of children.
There are no special requirements for storage of this medicinal product.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Viruzine Forte contains

The active substance is inosine pranobex (a complex containing inosine and 4-acetamidobenzoate 2-hydroxypropyldimethylammonium in a molar ratio of 1:3). Each tablet contains 1000 mg of inosine pranobex.
Other ingredients (excipients) are: potato starch, mannitol, povidone K-30, magnesium stearate.

What Viruzine Forte looks like and contents of the pack
White, oval, biconvex tablet with a smooth surface, marked with a dividing line on one side.
PVC/PVDC/Aluminium blister in a cardboard box.
The pack contains 10 or 30 tablets.

Marketing Authorisation Holder and Manufacturer
„PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
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Information on the medicinal product
tel.: 22 742 00 22
e-mail: [email protected]
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