Akvir with strawberry flavor

Package leaflet: Information for the patient

AKVIR strawberry-flavoured, 250 mg/5 ml, syrup
Inosinum pranobexum
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or as directed by the
physician or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please contact your pharmacist.
• If you experience any adverse reactions, including any possible 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 of the leaflet

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

1. What AKVIR strawberry-flavoured is and what it is used for

AKVIR strawberry-flavoured
is an antiviral and immunostimulant medicine (it enhances the activity of the immune system).
AKVIR strawberry-flavoured contains the active substance inosine pranobex, which inhibits in vitro
the replication of human pathogenic viruses of the Herpes group.
Indications for AKVIR strawberry-flavoured
As an adjunctive treatment 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 strawberry-flavoured 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 AKVIR o smaku truskawkowym

When not to use AKVIR o smaku truskawkowym

• If the patient is allergic to 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.
• If the patient is currently experiencing an acute attack of gout.
• If the patient has elevated blood uric acid levels.

Warnings and precautions
Before starting treatment with AKVIR o smaku truskawkowym, discuss this with a doctor or pharmacist.

• If the patient has previously experienced gout attacks or elevated levels of uric acid in the blood. AKVIR o smaku truskawkowym may cause transient increases in blood and urinary uric acid levels.
• 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 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 sought.
• If treatment is prolonged (3 months or longer). The doctor will recommend regular blood tests and will monitor kidney and liver function. Prolonged treatment may lead to the formation of kidney stones. Children This medicine should not be used in children under 1 year of age.

AKVIR o smaku truskawkowym and other medicines
Inform the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for future use.
Especially inform the doctor about the following medicines, as they may interact with AKVIR o smaku truskawkowym:

• allopurinol or other medicines used in the treatment of gout;
• medicines that increase uric acid excretion, including diuretics such as furosemide, torasemide, ethacrynic acid, hydrochlorothiazide, chlorthalidone, indapamide;
• medicines affecting the immune system, e.g. used after organ transplantation or in the treatment of atopic dermatitis;
• 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.
AKVIR o smaku truskawkowym should not be taken during pregnancy or breastfeeding without prior consultation with a doctor. The doctor will assess whether the benefits of treatment outweigh the potential risks.

Driving and operating machinery
AKVIR o smaku truskawkowym has no effect or negligible effect on the ability to drive or operate machinery.

AKVIR o smaku truskawkowym contains sucrose, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216) and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
5 ml of the medicine contains 3250 mg of sucrose. This should be taken into account in patients with diabetes.
The medicine contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216), which may cause allergic reactions (including delayed-type reactions).
The medicine contains 35.16 mg of sodium (main component of table salt) in each 60 ml of syrup.
This corresponds to 1.76% of the maximum recommended daily dietary intake of sodium for adults.

3. How to take AKVIR strawberry-flavoured

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Oral administration.
The dose is based on the patient's body weight and depends on the severity of the disease.
The daily dose should be divided into equal individual doses administered several times a day.

Adults, including elderly people
The recommended daily dose is 50 mg/kg body weight per day (1 ml per 1 kg body weight per day),
given in 3 or 4 divided doses. The maximum daily dose is 4 g per day (i.e. 80 ml of syrup per day).

For example:
If the patient weighs 60 kg, according to the recommendation they should take:
1 ml x 60 kg body weight = 60 ml of syrup per day
The medicine should be given in 3 or 4 divided doses, so divide 60 ml into three parts:
20 ml in the morning, 20 ml at noon, and 20 ml in the evening.
Do not exceed the maximum daily dose of 80 ml per day.

Children over 1 year of age
The recommended dose is 50 mg/kg body weight per day, usually 1 ml per 1 kg body weight, given in 3 or 4 equal divided doses throughout the day.

The following table shows dosing according to the patient's body weight.

* To measure the recommended volume, use the polypropylene measuring spoon provided with the packaging.
In recurrent herpes infections, it is important to start treatment during the prodromal phase, i.e. pain, tingling, itching, or immediately after the appearance of the first lesions.
Duration of treatment
Treatment usually lasts from 5 to 14 days. It is recommended to continue taking the medicine for another 1 to 2 days after symptoms have subsided.
Use in children
This medicine should not be used in children under 1 year of age.
Use of a higher than recommended dose of AKVIR o smaku truskawkowym
There have been no reported cases of inosine pranobex overdose to date. If in doubt or if feeling unwell, contact a doctor immediately.
Missed dose of AKVIR o smaku truskawkowym
If a dose is missed, take it as soon as possible, unless it is almost time for the next dose. Do not take a double dose to make up for the missed dose.
Discontinuation of AKVIR o smaku truskawkowym
If treatment is discontinued, the expected therapeutic effect may not be achieved, or 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 experiences them.
Any medicine can cause an allergic reaction.
You should stop taking the medicine and consult a doctor 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 (may occur in more than 1 in 10 patients):

• increased blood uric acid levels, increased urinary uric acid levels.

Common (may occur in less than 1 in 10 patients):

• headache, dizziness;
• itching, rash;
• joint pain;
• vomiting, nausea, upper abdominal discomfort;
• fatigue, malaise;
• increased blood urea levels, increased liver enzyme activity in blood.

Uncommon (may occur in less than 1 in 100 patients):

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

Frequency unknown (cannot be estimated from available data):

• angioedema (a serious allergic reaction causing swelling of the face, lips, tongue, or throat, which may cause difficulty in swallowing and breathing), hypersensitivity, urticaria, anaphylactic reaction (a sudden, life-threatening allergic reaction affecting the whole body);
• skin redness (erythema);
• upper abdominal pain.

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 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
e-mail: [email protected]
Adverse reactions can also be reported to the Marketing Authorisation Holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store AKVIR o smaku truskawkowym

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label and the outer carton. The expiry date refers to the last day of the specified month.
No special temperature storage requirements apply to this medicine.
Store the bottle in the outer packaging to protect it from light.
The shelf life of the medicine after first opening the bottle is 6 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What AKVIR strawberry-flavoured contains

• The active substance is inosine pranobex. Each ml of syrup contains 50 mg of inosine pranobex.
• Other ingredients are: sucrose, sodium citrate, citric acid monohydrate, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), strawberry flavour (components: propylene glycol (E 1520), flavouring substances), purified water.

What AKVIR strawberry-flavoured looks like and contents of the pack
A clear, colourless to light yellow strawberry-flavoured syrup.
The medicine is available in an amber glass bottle (Type III) with a capacity of 180 ml, containing 150 ml of syrup. The bottle is closed with a screw cap made of HDPE/LDPE, with a seal made of foamed LDPE and a tamper-evident ring made of HDPE, child-resistant closure. A graduated measuring cup made of polypropylene with a capacity of 20 ml and graduations is included in the pack. The bottle is contained in a cardboard box with an enclosed patient information leaflet.
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA SA
ul. Pelplińska 19
83-200 Starogard Gdański
Manufacturer
Medana Pharma SA
ul. Władysława Łokietka 10
98-200 Sieradz
For further information about the medicine and its trade names in the European Economic Area countries, please contact the local representative of the Marketing Authorisation Holder:
POLPHARMA Biuro Handlowe Sp. z o.o.
ul. Bobrowiecka 6
00-728 Warszawa
tel. 22 364 61 01