Akvir

Leaflet attached to the packaging: patient information

AKVIR, 500 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 a doctor or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 5 to 14 days, they should consult a doctor.

Table of contents of the leaflet

• 1. What is Akvir and what is it used for
• 2. Important information before taking Akvir
• 3. How to take Akvir
• 4. Possible side effects
• 5. How to store Akvir
• 6. Package contents and other information

1. What is Akvir and what is it used for

Akvir is an antiviral and immunostimulant medicine (stimulating the immune system). Akvir contains the active substance inosine pranobex, which inhibits the growth of pathogenic viruses for humans, including the Herpesgroup, in vitro. Indications for use: as an adjunct in patients with reduced immunity, in cases of recurring upper respiratory tract infections. For the treatment of herpes labialis and facial skin caused by the herpes simplex virus. Akvir can only be used in patients who have been previously diagnosed with herpes simplex virus infection. If there is no improvement or the patient feels worse after 5 to 14 days, they should consult a doctor.

2. Important information before taking Akvir

When not to take Akvir:

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

Warnings and precautions

Before starting treatment with Akvir, the patient should discuss it with their doctor or pharmacist:

• if the patient has had gout attacks or increased uric acid levels in the blood or urine in the past; Akvir may cause a temporary increase in uric acid levels in the blood and urine;
• if the patient has had kidney stones;
• if the patient has kidney function disorders; in such cases, the doctor will closely monitor the patient;
• if long-term treatment is necessary (3 months or longer); the doctor will recommend regular blood tests and monitor kidney and liver function.
• if allergic reaction symptoms are observed, such as rash, itching, difficulty breathing, swelling of the face, lips, throat, or tongue. In such cases, treatment should be stopped immediately and a doctor consulted.

Children

Akvir should not be used in children under 1 year of age.

Akvir and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The patient should especially inform their doctor if they are taking any of the following medicines, as they may interact with Akvir:

• medicines used to treat gout (allopurinol or other medicines);
• medicines that increase uric acid excretion, including diuretics (which increase urine production), such as furosemide, torasemide, etacrynic acid, hydrochlorothiazide, chlortalidone, indapamide;
• medicines that suppress the immune system (so-called immunosuppressive medicines, used in patients after organ transplantation or with atopic dermatitis);
• azidothymidine (a medicine used to treat patients infected with HIV).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. Akvir should not be taken during pregnancy and breastfeeding, unless the doctor recommends otherwise. The doctor will assess whether the benefits of taking the medicine outweigh the risks.

Driving and using machines

It is unlikely that Akvir will affect the ability to drive or use machines.

3. How to take Akvir

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their 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, taken several times a day.

Recommended dose

Adults, including the elderly (over 65 years): 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 3 times a day. The maximum daily dose is 8 tablets (4 g), i.e., 2 tablets 4 times a day. Children over 1 year: The recommended dose is 50 mg per kg of body weight per day, given in several divided doses. For children who cannot swallow tablets, the medicine is recommended to be given in the form of a syrup (250 mg/5 ml or 500 mg/5 ml). In the case of recurring herpes infections, it is essential to start treatment during the prodromal period, i.e., pain, tingling, itching, or immediately after the first changes appear.

Method of administration

Tablets should be taken with a sufficient amount of liquid. If the patient has difficulty swallowing whole tablets, to facilitate taking the medicine, the tablets can be crushed and dissolved in a small amount of liquid.

Taking a higher dose of Akvir than recommended

There have been no reports of overdose. If the patient has any doubts or feels unwell, they should immediately consult a doctor.

Missing a dose of Akvir

If a dose is missed, it should be taken as soon as possible, unless it is close to the time for the next dose. A double dose should not be taken to make up for a missed dose.

Stopping treatment with Akvir

If treatment is stopped, the expected therapeutic effect may not be achieved, or the symptoms of the disease may worsen. If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Akvir can cause side effects, although not everybody gets them. The patient should immediately consult a doctorif they 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).

Side effects that may occur

Very common (occurring in more than 1 in 10 people):

• increased uric acid levels in the blood, increased uric acid levels in the urine.

Common (occurring in less than 1 in 10 people):

• dizziness, headache;
• itching, skin rash;
• joint pain;
• nausea, vomiting, discomfort in the upper abdomen;
• fatigue (weakness, tiredness), malaise;

• increased urea levels in the blood, elevated liver enzyme activity.

Uncommon (occurring in less than 1 in 100 people):

• nervousness;
• drowsiness, difficulty sleeping (insomnia);
• diarrhea, constipation;
• increased urine output (polyuria).

Frequency not known (cannot be estimated from the available data):

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

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Akvir

The medicine should be stored out of 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 month. There are no special precautions for storing the medicine. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Akvir contains

• The active substance of Akvir is inosine pranobex (a complex containing inosine and 4-acetamidobenzoic acid 2-hydroxypropyldimethylammonium in a molar ratio of 1:3). Each tablet contains 500 mg of inosine pranobex.
• The other ingredients are: mannitol, potato starch, povidone K-25, magnesium stearate.

What Akvir looks like and what the pack contains

Akvir is a white to light cream-colored, oblong, biconvex tablet, without spots or damage. The pack contains 20 or 50 tablets in blisters.

Marketing authorization holder and manufacturer

Polfarmex S.A., ul. Józefów 9, 99-300 Kutno, Tel.: +48 24 357 44 44, Fax: +48 24 357 45 45

Date of the last revision of the leaflet: