Neosine forte

Patient Information Leaflet

Neosine forte, 500 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 not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement within 5 to 14 days, or if you feel worse, contact your doctor.

Leaflet Contents

1. What Neosine forte is and what it is used for
2. What you need to know before taking Neosine forte
3. How to take Neosine forte
4. Possible side effects
5. How to store Neosine forte
6. Contents of the pack and other information

1. What Neosine forte is and what it is used for

Neosine forte is an antiviral and immunostimulatory medicine (it stimulates the immune system).
Neosine forte contains the active substance inosine pranobex, which inhibits in vitro replication of human pathogenic viruses from the Herpes group.

Indications for Neosine forte
As an adjunctive treatment in individuals with reduced immunity, in cases of recurrent upper respiratory tract infections.

For the treatment of herpes labialis and facial skin herpes caused by herpes simplex virus (Herpes simplex). Neosine forte may be used only in patients previously diagnosed with herpes simplex virus infection.

If there is no improvement within 5 to 14 days, or if you feel worse, consult your doctor.

2. Important information before taking Neosine forte

When not to take Neosine forte

• If the patient is allergic to the active substance (inosine pranobex) or to any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction may include: skin rash, itching, difficulty breathing, swelling of the face, lips, throat, or tongue.
• If the patient currently has an attack of gout (severe joint pain with swelling and redness of the skin, or effusion in large joints), or if tests have shown increased levels of uric acid in the blood.

Warnings and precautions
Before starting Neosine forte, discuss this with a doctor or pharmacist:

• if the patient has previously had gout attacks or elevated uric acid levels – the medicine may cause transient increases in blood and urine uric acid levels;
• if the patient has previously had kidney stones;
• if the patient has impaired kidney function – during treatment with Neosine forte, the doctor will regularly monitor blood tests and kidney function;
• if treatment is long-term (lasting 3 months or longer), the doctor will order regular blood tests and monitoring of kidney and liver function.

Children
Neosine forte should not be used in children under 1 year of age.
Neosine forte with other medicines
Tell 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.
In particular, inform the doctor if the patient is taking:

• medicines for the treatment of gout (e.g. allopurinol or other xanthine oxidase inhibitors);
• medicines that increase uric acid excretion, including diuretics (which increase urine production), e.g. furosemide, torasemide, ethacrynic acid, hydrochlorothiazide, chlorthalidone, indapamide;
• medicines that suppress immune system function (so-called immunosuppressants, used in organ transplant patients or in atopic dermatitis);
• zidovudine (a medicine used in the treatment of AIDS).

Pregnancy and breastfeeding
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.
Neosine forte should not be taken during pregnancy or breastfeeding without consulting a doctor, who will assess whether the benefits of treatment for the mother outweigh the potential risks to the child.
Driving and operating machinery
This medicine may affect the ability to drive and operate machinery.
If headache, dizziness, or drowsiness occur, the patient should not drive, operate machinery, or perform any tasks requiring concentration. See also section 4.
Neosine forte contains sucrose, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate, and sodium
Sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
The medicine contains 600 mg of sucrose in 1 ml of syrup. This should be taken into account in patients with diabetes.
Methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate
This medicine may cause allergic reactions (including delayed-type reactions).
Sodium
The medicine contains 17.5 mg of sodium (main component of table salt) in 10 ml of syrup.
This corresponds to 0.9% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take Neosine forte

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The medicine should be taken orally.
Recommended dose
Adults, including elderly patients (over 65 years of age):
usually 10 ml of syrup 3 or 4 times daily (0.5 ml of syrup per kg of body weight per day).
The maximum dose is 4 g of pranobex inosine (i.e. 40 ml of syrup) per day.
Children over 1 year of age:
0.5 ml of syrup per kg of body weight per day. The medicine should be administered 3 times daily, according to the table below:
Dose (ml of syrup)
Child's body weight Administer 3 times daily
10 to 14 kg 2.5 ml
15 to 20 kg 2.5 to 3.5 ml
21 to 30 kg 3.5 to 5 ml
31 to 40 kg 5 to 7.5 ml
41 to 50 kg 7.5 to 9 ml
The measuring device supplied with the medicine package should be used for dosing. This ensures accurate dose measurement.
In recurrent herpes infections, it is important to start treatment during the prodromal phase, i.e. before the onset 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.
Taking more Neosine forte than recommended
There is no data available on overdose with Neosine forte. If in doubt or if you feel unwell, contact your doctor immediately.
Missing a dose of Neosine forte
If a dose is missed, take it as soon as possible and continue treatment.
Do not take a double dose to make up for a missed dose.
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 everybody gets them.
The following adverse reactions may occur
Common (occur in not more than 1 in 10 patients):

• transient increase in blood uric acid levels, transient increase in urinary uric acid levels;
• elevated liver enzyme activity or increased blood urea nitrogen levels;
• nausea with or without vomiting;
• abdominal pain;
• itching, skin rash;
• headache or dizziness;
• fatigue, malaise;
• joint pain.

Uncommon (occur in not more than 1 in 100 patients):

• diarrhoea;
• constipation;
• nervousness;
• drowsiness or difficulty sleeping (insomnia);
• excessive urine production (polyuria).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions
not listed in this leaflet, please 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
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Neosine forte

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 on the packaging.
The expiry date refers to the last day of the stated month.
Store below 25°C. Do not store in the refrigerator or freeze.
Shelf life after first opening the container: 3 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 packaging and other information

What Neosine forte contains

• The active substance is inosine pranobex (a complex containing inosine and 2-hydroxypropyl dimethyl ammonium 4-acetamidobenzoate in a molar ratio of 1:3). 1 ml of syrup contains 100 mg of inosine pranobex. 5 ml of syrup contains 500 mg of inosine pranobex.
• Other ingredients: methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), sucrose, sodium saccharin, citric acid, sodium hydroxide, banana flavour AR 2876 [containing, among others, propylene glycol (E 1520),
  eugenol, geraniol, linalool, citronellol, limonene], purified water.

What Neosine forte looks like and contents of the pack

Neosine forte is a colourless to yellow syrup with a banana odour.
The packaging of the medicine consists of a brown glass bottle containing 75 ml, 100 ml, 150 ml or 200 ml of syrup, closed with an aluminium cap, with a measuring spoon included, packed in a cardboard box.

Marketing Authorisation Holder
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
tel. (42) 22-53-100

Manufacturer
Aflofarm Farmacja Polska Sp. z o.o.
ul. Krzywa 2
95-030 Rzgów