Viruzine Forte

Package Leaflet: Information for the Patient

Viruzine Forte, 1000 mg, Tablets

Inosine Pranobex

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 5 to 14 days there is no improvement or you feel worse, contact your doctor.

Table of Contents of the Leaflet

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

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

Viruzine Forte is an antiviral and immunostimulant medicine (stimulates the activity of the immune system).
Viruzine Forte contains the active substance - inosine pranobex, which inhibits in vitrothe multiplication of pathogenic viruses for humans from the Herpesgroup.
Indications for the use of Viruzine Forte:

• as an adjunct in patients with impaired immunity, in the case of recurrent upper respiratory tract infections,
• in the treatment of herpes labialis and facial skin caused by the herpes simplex virus (Herpes simplex). Viruzine Forte can only be used in patients who have been previously diagnosed with herpes simplex virus infection.

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

2. Important information before taking Viruzine Forte

When not to take Viruzine Forte

• If you are allergic (hypersensitive) to the active substance (inosine pranobex) or 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 you currently have an acute attack of gout (severe joint pain with swelling and redness of the skin, and in large joints, there is an accumulation of effusion) or tests have shown an increased level of uric acid in the blood.

Warnings and precautions

Before starting treatment with Viruzine Forte, discuss it with your doctor or pharmacist:

• if you have had gout attacks or increased uric acid levels in the past, as the medicine may cause a transient increase in uric acid levels in serum and urine,
• if you have had kidney stones in the past,
• if you have kidney function disorders. In this case, your doctor will closely monitor you,
• if treatment is long-term (3 months or longer). Your doctor will recommend regular blood tests and will monitor kidney and liver function. During long-term treatment, kidney stones may form,
• if you have observed symptoms of an allergic reaction, such as rash, itching, difficulty breathing, swelling of the face, lips, throat or tongue. In this case, you should immediately stop treatment and consult your doctor.

Viruzine Forte and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about medicines you plan to take.
Particularly, inform your doctor or pharmacist about the following medicines, as they may interact with Viruzine Forte:

• allopurinol or other medicines used to treat gout;
• medicines that increase uric acid excretion, including diuretics, such as furosemide, torasemide, etacrynic acid, hydrochlorothiazide, chlortalidone, indapamide;
• medicines that affect the immune system, such as those used after organ transplantation;
• azidothymidine used to treat AIDS.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Viruzine Forte during pregnancy and breastfeeding, unless your doctor considers that the benefits of taking this medicine outweigh the possible risks.

Driving and using machines

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

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 you are unsure, consult your doctor or pharmacist.
Adults, including the elderly (over 65 years)
The recommended dose is 50 mg/kg body weight per day.
Usually, the dose is 3 tablets (3 g) per day (i.e., 1 tablet 3 times a day).
The maximum dose is 4 tablets (4 g) per day (i.e., 1 tablet 4 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 syrup is recommended.
Method of administration
Oral administration.
The dividing line on the tablet is only to facilitate breaking the tablet if you have difficulty swallowing it whole.
Duration of treatment
Usually, the duration of treatment is from 5 to 14 days. After the symptoms have subsided, the administration of this medicine is usually continued for another 1 to 2 days.

Overdose of Viruzine Forte

No cases of overdose have been reported so far. If you have any doubts, contact your doctor immediately.

Missed dose of Viruzine Forte

If you miss a dose, take it as soon as you remember, unless it is close to the time for your next dose. Do not take a double dose to make up for a missed dose.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Any medicine can cause an allergic reaction, but severe allergic reactions after taking Viruzine Forte are very rare.
Consult your doctor immediatelyif you experience any of the following symptoms:

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

The following side effects may occur:

• Very common (occurring in more than 1 in 10 patients): increased uric acid levels in the blood, increased uric acid levels in the urine.
• Common (occurring in less than 1 in 10 patients): increased liver enzyme activity, increased urea levels in the blood, rash, itching, joint pain, vomiting, nausea, abdominal discomfort, fatigue (tiredness), weakness (malaise), headache, dizziness.
• Uncommon (occurring in less than 1 in 100 patients): diarrhea, constipation, drowsiness, difficulty sleeping (insomnia), nervousness,

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increased urine output (polyuria).

• Frequency not known (cannot be estimated from the available data): abdominal pain, swelling of the face, lips, eyelids, or throat (angioedema), hives, allergic reaction, sudden allergic reaction affecting the whole body (anaphylactic reaction), skin redness (flushing).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Viruzine Forte

Keep this medicine out of the sight and reach of children.
There are no special precautions for storage of the 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 month.
Medicines should not be disposed of via wastewater 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 of the medicine is inosine pranobex (a complex containing inosine and 4-acetamidobenzoic acid 2-hydroxypropyldimethylammonium in a molar ratio of 1:3). One tablet contains 1000 mg of inosine pranobex.
• The other ingredients of the medicine (excipients) are: potato starch, mannitol, povidone K-30, magnesium stearate.

What Viruzine Forte looks like and contents of the pack

The tablet is oval, biconvex, white, with a smooth surface, and a dividing line on one side.
PVC/PVDC/Aluminum blister pack in a cardboard box.
The pack contains 10 or 30 tablets.

Marketing authorization holder and manufacturer

“PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
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Information about the medicine
tel.: 22 742 00 22
e-mail: [email protected]

Date of last revision of the leaflet:

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