Akvir forte with strawberry flavor

Package leaflet: Information for the patient

AKVIR FORTE strawberry-flavoured, 500 mg/5 ml, syrup
Inosinum pranobexum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient information leaflet or as
directed by the doctor or pharmacist.

• Keep this leaflet so that it can be consulted again if necessary.
• If advice or further information is needed, please consult a pharmacist.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.
• If there is no improvement or if the patient feels worse after 5 to 14 days, contact the doctor.

Contents of the leaflet

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

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

AKVIR FORTE strawberry-flavoured is an antiviral medicine and an immunostimulant (it enhances the activity of the immune system).
AKVIR FORTE strawberry-flavoured contains the active substance inosine pranobex, which inhibits in vitro replication of pathogenic human viruses from the Herpes group.
Indications for AKVIR FORTE 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 FORTE strawberry-flavoured may be used only in patients who have previously been diagnosed with herpes simplex virus infection.
If there is no improvement or if the patient feels worse after 5 to 14 days, consult the doctor.

2. Important information before using AKVIR FORTE strawberry-flavoured medicine

When not to use AKVIR FORTE strawberry-flavoured medicine

• 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 levels of uric acid in the blood.

Warnings and precautions
Before starting treatment with AKVIR FORTE strawberry-flavoured medicine, discuss this with
your doctor or pharmacist.

• If the patient has previously experienced gout attacks or elevated levels of uric acid in the blood. AKVIR FORTE strawberry-flavoured medicine may cause a transient increase in blood and urinary uric acid levels.
• 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 symptoms of an allergic reaction occur, such as rash, itching, difficulty breathing, or swelling of the face, lips, throat or tongue. In this case, treatment must be stopped immediately and medical advice sought.
• 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 form during prolonged treatment. Children This medicine must not be used in children under 1 year of age.

AKVIR FORTE strawberry-flavoured medicine and other medicines
Inform your 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 FORTE strawberry-flavoured medicine:

• 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, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Do not take AKVIR FORTE strawberry-flavoured medicine during pregnancy or breastfeeding without consulting a doctor. The doctor will assess whether the benefits of treatment outweigh the potential risks.
Driving and operating machinery
AKVIR FORTE strawberry-flavoured medicine has no effect or negligible effect on the ability to
drive or operate machinery.
AKVIR FORTE strawberry-flavoured medicine 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 3000 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 37.4 mg of sodium (main component of table salt) in each 30 ml of syrup. This corresponds to 1.87% of the maximum recommended daily dietary intake of sodium for adults.

3. How to take AKVIR FORTE strawberry-flavoured

This medicine should always be taken exactly as described in the patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Oral use.
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 individual doses administered several times a day.

Adults, including elderly people
The recommended daily dose is 50 mg/kg body weight (0.5 ml per 1 kg body weight per day), given in 3 or 4 divided doses. The maximum dose is 4 g (i.e. 40 ml of syrup) per day.

For example:
If the patient weighs 60 kg, according to the recommendation they should take:
0.5 ml x 60 kg body weight = 30 ml of syrup per day
The medicine should be given in 3 or 4 divided doses, so 30 ml should be divided into three parts: 10 ml in the morning, 10 ml at midday, and 10 ml in the evening.
Do not exceed the maximum daily dose of 40 ml.

Children over 1 year of age
The recommended dose is 50 mg/kg body weight per day, usually 0.5 ml per 1 kg body weight, given in 3 or 4 equal divided doses throughout the day.
The table below shows dosing according to the patient's body weight.

* To measure the recommended volume, use the polypropylene dosing cup provided in the package.
In cases of recurrent herpes infections, it is important to start treatment during the prodromal phase, before the appearance of symptoms such as pain, tingling, itching, or immediately after the first lesions appear.
Duration of treatment
Treatment usually lasts from 5 to 14 days. It is recommended to continue taking the medicine for 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 FORTE strawberry-flavored
There have been no reports of inosine pranobex overdose so far. If you have any doubts or experience any adverse effects, contact your doctor immediately.
Missed dose of AKVIR FORTE strawberry-flavored
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 a missed dose.
Discontinuation of AKVIR FORTE strawberry-flavored
If treatment is interrupted, the expected therapeutic effect may not be achieved, or symptoms of the disease may worsen.
If you have any further doubts 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 may cause an allergic reaction.
You should stop taking the medicine and consult a doctor 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 (may affect more than 1 in 10 people):

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

Common (may affect up to 1 in 10 people):

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

Uncommon (may affect up to 1 in 100 people):

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

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

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

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of 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 FORTE strawberry-flavoured

Keep the medicine out of the 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 stated month.
There are no special temperature requirements for storage of 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 4 months.
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 package and other information

What AKVIR FORTE strawberry-flavoured contains

• The active substance is inosine pranobex. Each ml of syrup contains 100 mg of inosine pranobex.
• Other ingredients are: sucrose, sodium citrate, citric acid monohydrate, sodium saccharin (E 954), methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), strawberry flavour (components: propylene glycol (E 1520), flavouring substances), purified water.

What AKVIR FORTE strawberry-flavoured looks like and contents of the pack
Clear, colourless to pale yellow strawberry-flavoured syrup.
The medicine is available in a 125 ml amber glass bottle of class III, containing 100 ml of syrup. The bottle is closed with a screw cap made of HDPE/LDPE with a sealing plug 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 package. The bottle is placed in a cardboard box with the patient information leaflet enclosed.
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA SA
Pelplińska Street 19
83-200 Starogard Gdański
Manufacturer
Medana Pharma SA
Władysława Łokietka Street 10
98-200 Sieradz
For further information about the medicine and its names in the countries of the European Economic Area, please contact the local representative of the Marketing Authorisation Holder:
POLPHARMA Biuro Handlowe Sp. z o.o.
Bobrowiecka Street 6
00-728 Warsaw
tel. 22 364 61 01