Akvir Forte o smaku malinovim

Package Leaflet: Information for the Patient

AKVIR FORTE Raspberry Flavor, 500 mg/5 ml, Syrup

Inosine Pranobex

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the package leaflet or as directed by a doctor or pharmacist.

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

Table of Contents of the Leaflet

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

1. What is AKVIR FORTE Raspberry Flavor and what is it used for

AKVIR FORTE Raspberry Flavor is an antiviral and immunostimulant medicine (stimulates the immune system).
AKVIR FORTE Raspberry Flavor contains the active substance inosine pranobex, which inhibits in
vitrothe replication of pathogenic viruses for humans in the Herpesgroup.

Indications for use of AKVIR FORTE Raspberry Flavor

Supportively in people with weakened immunity, in case of recurring upper respiratory tract infections.
In the treatment of herpes labialis and facial skin caused by the herpes simplex virus (Herpes
simplex).
AKVIR FORTE Raspberry Flavor can only be used in patients who have been previously diagnosed with a herpes simplex virus infection.
If after 5 to 14 days there is no improvement or the patient feels worse, they should consult their doctor.

2. Important information before taking AKVIR FORTE Raspberry Flavor

When not to take AKVIR FORTE Raspberry Flavor

• 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 currently has a gout attack.
• If the patient has an increased uric acid level in the blood.

Warnings and precautions

Before starting treatment with AKVIR FORTE Raspberry Flavor, 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 in the past. AKVIR FORTE Raspberry Flavor may cause a temporary increase in uric acid levels in the blood and urine.
• If the patient has had kidney stones in the past.
• If the patient has kidney function disorders. In such cases, the doctor will closely monitor the patient.
• If symptoms of an allergic reaction 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 the doctor consulted.
• If treatment is long-term (3 months or longer). The doctor will recommend regular blood tests and monitor kidney and liver function. During long-term treatment, kidney stones may form.

Children

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

AKVIR FORTE Raspberry Flavor 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.
In particular, the patient should inform their doctor about the following medicines, as they may interact with AKVIR FORTE Raspberry Flavor:

• allopurinol or other medicines used to treat gout;
• medicines that increase uric acid excretion, including diuretics, such as furosemide, torasemide, etacrynic acid, hydrochlorothiazide, chlortalidone, indapamide;
• medicines that affect the immune system, such as those used after organ transplantation or to treat atopic dermatitis;
• zydovudine used to treat AIDS.

Pregnancy, breastfeeding, and fertility

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.
This medicine should not be taken during pregnancy and breastfeeding, unless advised by a doctor. The doctor will assess whether the benefits of taking the medicine outweigh the potential risks.

Driving and using machines

AKVIR FORTE Raspberry Flavor has no or negligible influence on the ability to drive and use machines.

AKVIR FORTE Raspberry Flavor contains sucrose, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), sodium, and ethanol

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the 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 (also late reactions).
The medicine contains 37.4 mg of sodium (the main component of common salt) in every 30 ml of syrup. This corresponds to 1.87% of the maximum recommended daily intake of sodium in the diet for adults.
The medicine contains small amounts of ethanol (alcohol), as a component of the raspberry flavor, less than 100 mg per dose.

3. How to take AKVIR FORTE Raspberry Flavor

This medicine should always be taken exactly as described in the package leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
Oral administration.
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.
Adults, including the elderly
The recommended daily dose is 50 mg/kg body weight per day (0.5 ml per 1 kg body weight per day), taken 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 taken in 3 or 4 divided doses, so 30 ml should be divided into three parts, i.e., 10 ml in the morning, 10 ml at noon, and 10 ml in the evening.

Do not exceed the maximum dose of 40 ml per day.

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, taken in 3 or 4 equal divided doses per day.
The following table shows the dosage based on the patient's body weight.
* To measure the recommended volume, the polypropylene measuring cup attached to the package should be used.
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.
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 the symptoms of the disease have subsided.

Use in children

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

Overdose of AKVIR FORTE Raspberry Flavor

So far, no cases of inosine pranobex overdose have been reported. In case of any doubts or discomfort, the patient should immediately consult their doctor.

Missing a dose of AKVIR FORTE Raspberry Flavor

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

Stopping treatment with AKVIR FORTE Raspberry Flavor

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Any medicine can cause an allergic reaction.
Treatment should be stopped and a doctor consultedif any of the following symptoms occur:

• sudden wheezing;
• difficulty breathing;
• swelling of the eyelids, face, or lips;
• rash or itching (especially if it affects the whole body).

The following side effects may occur:
Very common(may affect more than 1 in 10 people):

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

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

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

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

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

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

• angioedema (a severe allergic reaction that causes swelling of the face, lips, tongue, or throat, which can lead to difficulty swallowing and breathing), hypersensitivity, urticaria, anaphylactic reaction (a sudden, life-threatening allergic reaction that affects the whole body);
• redness of the skin (erythema);
• abdominal pain.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store AKVIR FORTE Raspberry Flavor

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton. The expiry date refers to the last day of the month.
There are no special storage instructions for the medicine.
Store the bottle in the outer packaging to protect it from light.
The shelf life of the medicine after opening the bottle is 3 months.
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 FORTE Raspberry Flavor contains

• The active substance of the medicine 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), methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), raspberry flavor (composition: ethanol, 2-propanol, natural and other flavoring ingredients), purified water.

What AKVIR FORTE Raspberry Flavor looks like and what the package contains

A clear and colorless to light yellow syrup with a raspberry flavor.
The medicine is available in a 125 ml glass bottle, type III, containing 100 ml of syrup. The bottle is closed with an HDPE/LDPE cap with a foam LDPE seal and an HDPE ring, child-resistant. A graduated polypropylene measuring cup with a capacity of 20 ml is attached to the package. The bottle is placed in a carton with a patient leaflet.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA SA
ul. Pelplińska 19
83-200 Starogard Gdański

Manufacturer

Medana Pharma SA
ul. Władysława Łokietka 10
98-200 Sieradz

To obtain more detailed information about the medicine and its names in the Member States of the European Economic Area, please contact the local representative of the marketing authorization holder:

POLPHARMA Biuro Handlowe Sp. z o.o.
ul. Bobrowiecka 6
00-728 Warsaw
phone: 22 364 61 01
Date of last revision of the leaflet:October 2019