Neosine forte

Package Leaflet: Information for the Patient

Neosine Forte, 500 mg/5 ml, Syrup

Inosine Pranobex

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

This medication should always be taken exactly as described in this patient leaflet or as advised 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 you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 5 to 14 days there is no improvement or you feel worse, contact your doctor.

Table of Contents of the Leaflet

• 1. What is Neosine Forte and what is it used for
• 2. Important information 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 is Neosine Forte and what is it used for

Neosine Forte is an antiviral and immunostimulant medication (stimulates the immune system's activity).
Neosine Forte contains the active substance inosine pranobex, which in vitro inhibits the replication of pathogenic viruses for humans in the Herpes group.

Indications for Use of Neosine Forte

Supportively in individuals with reduced immunity, in cases of recurring upper respiratory tract infections.
In the treatment of herpes labialis and facial skin caused by the herpes simplex virus. Neosine Forte 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 a 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 any of the other ingredients of this medication (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 acute gout attack (severe joint pain with swelling and redness of the skin or the occurrence of effusion in large joints) or if tests have shown increased uric acid levels in the blood.

Warnings and Precautions

Before starting to take Neosine Forte, discuss it with your doctor or pharmacist:

• if you have had gout attacks or increased uric acid levels - the medication may cause transient increases in uric acid levels in the blood and urine;
• if you have had kidney stones;
• if you have kidney function disorders - during Neosine Forte treatment, your doctor will regularly check your blood and monitor kidney function;
• if the treatment is long-term (lasting 3 months or longer), your doctor will prescribe regular blood tests and monitoring of kidney and liver function.

Children

Do not use the medication in children under 1 year of age.

Neosine Forte and Other Medications

Tell your doctor or pharmacist about all medications you are currently taking, have recently taken, or plan to take.

Particularly, Tell Your Doctor If You Are Taking:

• medications for gout (e.g., allopurinol or other xanthine oxidase inhibitors);
• medications that increase uric acid excretion, including diuretics (which increase urine production), e.g., furosemide, torasemide, etacrynic acid, hydrochlorothiazide, chlortalidone, indapamide;
• immunosuppressive medications (used in organ transplant patients or in atopic dermatitis);
• azidothymidine (a medication used in the treatment of AIDS).

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medication.
Do not take Neosine Forte during pregnancy and breastfeeding without consulting your doctor, who will assess whether the benefits of taking the medication for the mother outweigh the risks for the baby.

Driving and Using Machines

The medication may affect your ability to drive and use machines.
If you experience headache, dizziness, or drowsiness, do not drive, operate machinery, or perform other activities that require concentration. See also section 4.

Neosine Forte Contains Sucrose, Methyl Parahydroxybenzoate (E 218), Propyl Parahydroxybenzoate, and Sodium

Sucrose
If you have previously been diagnosed with intolerance to some sugars, consult your doctor before taking the medication.
The medication 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
The medication may cause allergic reactions (possible late reactions).
Sodium
The medication contains 17.5 mg of sodium (the main component of common 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

Always take this medication exactly as described in this patient leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Take the medication orally.

Recommended Dose

Adults, including the elderly (over 65 years):
usually 10 ml of syrup 3 or 4 times a day (0.5 ml of syrup per kg of body weight per day).
The maximum dose is 4 g of inosine pranobex (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 medication should be given 3 times a day, according to the following table:

Dose (ml of Syrup)

Take 3 Times a Day, Child's Body Weight

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
Use the measuring cup provided with the medication packaging to measure the dose accurately.
In the case of recurring herpes infections, it is essential to start treatment during the prodromal period, i.e., before the onset of symptoms such as 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 medication for 1 to 2 days after the symptoms have resolved.

Taking a Higher Than Recommended Dose of Neosine Forte

There are no data on overdosing with Neosine Forte. In case of any doubts or discomfort, contact your doctor immediately.

Missing a Dose of Neosine Forte

If you miss a dose, take it as soon as possible and continue treatment.
Do not take a double dose to make up for the missed dose.
In case of further doubts about using this medication, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Neosine Forte can cause side effects, although not everybody gets them.

The Following Side Effects May Occur

Frequently(occurring in no more than 1 in 10 patients):

• transient increase in uric acid levels in the blood, transient increase in uric acid levels in the urine;
• elevation of liver enzyme activity or urea levels in the blood;
• nausea with or without vomiting;
• abdominal pain;
• itching, skin rash;
• headache or dizziness;
• fatigue, malaise;
• joint pain.

Less Frequently(occurring in no more than 1 in 100 patients):

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

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Medicinal Product Monitoring, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych (Office for Registration of Medicinal Products, Medical Devices, and Biocides),
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.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 this medication.

5. How to Store Neosine Forte

Keep the medication out of the sight and reach of children.
Do not use this medication after the expiry date stated on the label and carton.
The expiry date refers to the last day of the month.
Store below 25°C. Do not store in a refrigerator or freeze.
Shelf life after first opening the package: 3 months.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications no longer required. This will help protect the environment.

6. Contents of the Pack and Other Information

What Neosine Forte Contains

• The active substance of the medication is inosine pranobex (a complex containing inosine and 4-acetamidobenzoic acid 2-hydroxypropyldimethylammonium 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 are: methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), sucrose, sodium saccharin, citric acid, sodium hydroxide,

banana flavor AR 2876 [contains, among others, 1,2-propylene glycol (E 1520), eugenol, geraniol, linalool, citronellol, limonene], purified water.

What Neosine Forte Looks Like and What the Pack Contains

Neosine Forte is a colorless to yellow syrup with a banana flavor.
The medication packaging is: a brown glass bottle containing 75 ml, 100 ml, 150 ml, or 200 ml of syrup, closed with an aluminum cap, with a measuring cup in a cardboard box.

Marketing Authorization Holder

Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
phone: (42) 22-53-100

Manufacturer

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

Date of Last Revision of the Leaflet: