Akvir

Package leaflet: information for the patient

AKVIR, 500 mg, tablets
Inosinum pranobexum
Please read this 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 the doctor or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, 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, consult your doctor.

Table of contents

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

1. What Akvir is and what it is used for

Akvir is an antiviral and immunostimulant medicine (boosting the body's immune response).

The drug Akvir contains the active substance inosine pranobex, which inhibits in vitro replication of human pathogenic viruses from the Herpes group.
Indications for use of Akvir
As an adjunct in individuals with reduced immunity, in cases of recurrent upper respiratory tract infections.
In the treatment of herpes labialis and facial skin herpes caused by herpes simplex virus (Herpes simplex).
Akvir may be used only in patients in whom herpes simplex virus infection has previously been diagnosed.
If there is no improvement within 5 to 14 days, or if the patient feels worse, consult a physician.

2. Important information before using Akvir medicine

When not to use Akvir:

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

Warnings and precautions
Before starting treatment with Akvir, consult a doctor or pharmacist:

• if the patient has previously experienced gout attacks or elevated levels of uric acid in the blood or urine; Akvir may cause transient increases in uric acid levels in the blood and urine;
• if the patient has previously had kidney stones (nephrolithiasis);
• if the patient has impaired kidney function; in such cases, the doctor will monitor the patient carefully;
• if long-term treatment (3 months or longer) is required; the doctor will recommend regular blood tests and will monitor kidney and liver function;
• if symptoms of an allergic reaction occur, such as rash, itching, difficulty breathing, or swelling of the face, lips, throat or tongue. In such cases, treatment must be stopped immediately and medical advice must be sought.

Children
Akvir should not be used in children during the first year of life.
Akvir and other medicines
Inform the doctor or pharmacist about all medicines currently used, recently used, or planned for use. In particular, inform the doctor if the patient is taking any of the following medicines, as they may interact with Akvir:

• 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, chlortalidone, indapamide;
• medicines that suppress immune system function (so-called immunosuppressants, used in organ transplant patients or in atopic dermatitis);
• zidovudine (a medicine used in the treatment of HIV-infected patients).

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Akvir should not be taken during pregnancy or breastfeeding, unless otherwise advised by a doctor.
The doctor will assess whether the benefits of treatment outweigh the potential risks.

Driving and operating machinery
It is unlikely that Akvir will affect the ability to drive or operate machinery.

3. How to take Akvir

This medicine should always be taken exactly as described in this patient information 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.
Recommended dose
Adults, including elderly people (over 65 years of age)
The recommended dose is 50 mg per kg of body weight per day.
The usual daily dose is 6 tablets (3 g), i.e. 2 tablets three times a day.
The maximum daily dose is 8 tablets (4 g), i.e. 2 tablets four 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, it is recommended to administer the medicine in the form of syrup 250 mg/5 ml or 500 mg/5 ml.
In recurrent herpes infections, it is important to start treatment during the prodromal phase, i.e. before the appearance of symptoms such as pain, tingling, itching, or immediately after the first skin lesions appear.
Method of administration
Tablets should be taken with an adequate amount of liquid. If difficulty swallowing whole tablets occurs, to facilitate administration, the tablets may be crushed and dissolved in a small amount of liquid.

Overdose of Akvir
Cases of overdose have not been reported to date. If in doubt or if feeling unwell, contact a doctor immediately.
Missed dose of Akvir
If a dose is missed, it should be taken as soon as remembered, unless the time for the next dose is approaching. Do not take a double dose to make up for the missed dose.
Discontinuation of Akvir
If treatment is discontinued, the expected therapeutic effect may not be achieved, or disease symptoms may worsen.
If you have any further questions regarding 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.
You should consult a doctor immediately if any of the following symptoms occur:

• sudden onset of 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 (occur in more than 1 in 10 people):

• increased concentration of uric acid in blood, increased concentration of uric acid in urine.

Common (occur in not more than 1 in 10 people):

• dizziness, headache;
• skin itching, skin rash;
• joint pain;
• vomiting, nausea, discomfort in the upper abdomen;
• fatigue (tiredness, weakness), malaise;
• increased blood urea concentration, elevated liver enzyme activity.

Uncommon (occur in not more than 1 in 100 people):

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

Frequency unknown (cannot be estimated from available data):

• swelling of the face, lips, eyelids, or throat which may cause difficulty in breathing (angioedema), allergic reaction, urticaria, sudden allergic reaction affecting the whole body (anaphylactic reaction) – see information at the beginning of this section;
• dizziness;
• skin redness (flushing);
• pain in the upper abdomen.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C
PL-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 authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Akvir
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 after: “Expiry date (EXP)”. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines should not be disposed of via wastewater 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 Akvir contains

• The active substance is inosine pranobex (a complex containing inosine and 2-hydroxypropyl dimethylammonium 4-acetamidobenzoate 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 Akvir looks like and contents of the pack
Akvir is a white to off-white, elongated, biconvex tablet, free from spots and defects.
The pack contains 20 or 50 tablets in blisters.
Marketing Authorisation Holder and Manufacturer
Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Tel.: +48 24 357 44 44
Fax: +48 24 357 45 45