Akvir forte raspberry flavored

Patient Information Leaflet

AKVIR FORTE raspberry-flavoured, 500 mg/5 ml, syrup
Inosinum pranobexum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this 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 consult 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 or if your condition worsens after 5 to 14 days, consult your doctor.

Table of Contents

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

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

AKVIR FORTE raspberry-flavoured is an antiviral and immunostimulating medicine (it enhances immune system function).
AKVIR FORTE raspberry-flavoured contains the active substance inosine pranobex, which inhibits in vitro replication of human pathogenic viruses of the Herpes group.
Indications for AKVIR FORTE 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 FORTE 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 your condition worsens after 5 to 14 days, consult your doctor.

2. Important information before using AKVIR FORTE raspberry-flavoured

When not to use AKVIR FORTE raspberry-flavoured

• 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 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 raspberry-flavoured, discuss this with your doctor or pharmacist.

• If the patient has had gout attacks or increased uric acid levels in the past. AKVIR FORTE raspberry-flavoured may cause a transient increase in uric acid levels in blood and urine.
• If the patient has previously suffered from 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 should be 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 develop during prolonged treatment.

Children
Do not use this medicine in children under 1 year of age.

AKVIR FORTE raspberry-flavoured and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
In particular, inform the doctor about the following medicines, as they may interact with AKVIR FORTE raspberry-flavoured:

• allopurinol or other medicines used to treat gout;
• drugs that increase uric acid excretion, including diuretics such as furosemide, torasemide, ethacrynic acid, hydrochlorothiazide, chlorthalidone, indapamide;
• drugs 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 her doctor or pharmacist before using this medicine.
Do not take AKVIR FORTE raspberry-flavoured 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 raspberry-flavoured has no effect or has a negligible effect on the ability to drive or operate machinery.

AKVIR FORTE raspberry-flavoured 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 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 (a 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.
The medicine contains a small amount of ethanol (alcohol) as a component of the raspberry flavour, less than 100 mg per dose.

3. How to use AKVIR FORTE raspberry-flavoured medicine

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 your 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 people
The recommended daily dose is 50 mg/kg body weight per day (0.5 ml per 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 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 with the packaging.
In 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 raspberry-flavoured
Cases of inosine pranobex overdose have not been reported so far. If in doubt or if feeling unwell, contact a doctor immediately.
Missed dose of AKVIR FORTE raspberry-flavoured
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.
Stopping the use of AKVIR FORTE raspberry-flavoured
If treatment is stopped prematurely, the expected therapeutic effect may not be achieved, or disease symptoms may worsen.
If you have any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience 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 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 less than 1 in 10 people):

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

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 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);
• epigastric 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 Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]
Adverse reactions may 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 FORTE raspberry-flavoured

Keep this 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 conditions apply for 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 3 months.
Medicines must 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 pack and other information

What AKVIR FORTE raspberry-flavoured medicine contains

• The active substance is inosine pranobex. Each ml of syrup contains 100 mg of inosine pranobex.
• The other ingredients are: sucrose, sodium citrate, citric acid monohydrate, sodium saccharin (E 954), methylparaben (E 218), propylparaben (E 216), raspberry flavour (composition: ethanol, 2-propanol, natural components and other flavouring ingredients), purified water.

What AKVIR FORTE raspberry-flavoured medicine looks like and contents of the pack
A clear, colourless to pale yellow raspberry-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 cap made of HDPE/LDPE with a closure liner made of foamed LDPE and a tamper-evident ring made of HDPE, child-resistant. 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 package leaflet for the patient.

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 more detailed information about the medicine and its 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