Akvir raspberry flavored

Package leaflet: Information for the patient

AKVIR raspberry-flavoured, 250 mg/5 ml, syrup
Inosinum pranobexum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse after 5 to 14 days, consult your doctor.

Contents of the leaflet

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

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

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

2. Important information before using AKVIR o smaku malinowym

When not to use AKVIR o smaku malinowym

• If the patient is allergic to inosine pranobex or to 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 attack of acute gout.
• If the patient has elevated levels of uric acid in the blood.

Warnings and precautions
Before starting treatment with AKVIR o smaku malinowym, please 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 o smaku malinowym 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 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 such cases, 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
Do not use this medicine in children under 1 year of age.

AKVIR o smaku malinowym with other medicines
Tell 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 o smaku malinowym:

• 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.
Do not take AKVIR o smaku malinowym during pregnancy or breastfeeding without consulting a doctor. The doctor will assess whether the benefits of treatment outweigh the potential risks.

Driving and using machines
AKVIR o smaku malinowym has no effect or has a negligible effect on the ability to drive and use machines.

AKVIR o smaku malinowym contains sucrose, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), sodium and ethanol

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 (a 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.
The medicine contains small amounts of ethanol (alcohol) as a component of the raspberry flavouring, less than 100 mg per dose.

3. How to use AKVIR raspberry-flavoured

This medicine should always be taken exactly as described in the patient information leaflet or as directed by a physician 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 single doses administered several times a day.

Adults, including elderly patients
The recommended daily dose is 50 mg/kg body weight (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, therefore divide 60 ml into three parts:
20 ml in the morning, 20 ml at midday, and 20 ml in the evening.
Do not exceed the maximum 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 table below shows dosing according to patient body weight.

* To measure the recommended volume, use the polypropylene dosing spoon provided with the package.
In the case of 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 malinowym
Cases of inosine pranobex overdose have not been reported to date. If you have any doubts or experience feeling unwell, contact your doctor immediately.
Missed dose of AKVIR o smaku malinowym
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 malinowym
If treatment is discontinued prematurely, 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 any medicine, this medicine may cause adverse reactions, although not everyone will experience them.
Any medicine can cause an allergic reaction.
You must stop taking the medicine and 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 (may affect more than 1 in 10 people):

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

Common (may affect less than 1 in 10 people):

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

Uncommon (may affect less than 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 (a severe 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 of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa
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 authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store AKVIR raspberry-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 cardboard
pack. The expiry date refers to the last day of the stated month.
No special temperature storage requirements apply.
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 required. Such measures will help
protect the environment.

6. Contents of the pack and other information

What AKVIR raspberry-flavoured contains

• The active substance is inosine pranobex. Each ml of syrup contains 50 mg of inosine pranobex.
• The other ingredients are: sucrose, sodium citrate, citric acid monohydrate, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), raspberry flavour (composition: ethanol, 2-propanol, natural components and other flavouring substances), purified water.

What AKVIR raspberry-flavoured looks like and contents of the pack
A clear, colourless to pale yellow raspberry-flavoured syrup.
The medicine is available in a 180 ml amber glass bottle of class III, containing 150 ml of syrup. The bottle is closed with a cap made of HDPE/LDPE with a sealing gasket 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 is included in the pack. The bottle is placed in a cardboard box with the 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 and trade names of the medicinal product in the European Economic Area countries, contact the local representative of the Marketing Authorisation Holder:
POLPHARMA Biuro Handlowe Sp. z o.o.
ul. Bobrowiecka 6
00-728 Warsaw
tel. 22 364 61 01