Neosine forte

Patient Information Leaflet

Neosine forte, 1000 mg, tablets
Inosinum pranobexum
Please read this leaflet carefully before taking the medicine, as it contains important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by the physician or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including those 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, consult your doctor.

Table of Contents

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

Neosine forte is an antiviral and immunostimulatory medicine (it enhances the activity of the immune system).
Neosine forte contains the active substance inosine pranobex, which inhibits the replication of pathogenic human 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.
• In the treatment of herpes labialis and facial skin herpes caused by herpes simplex virus (Herpes simplex). Neosine forte may only be used 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 (pranobex of inosine) 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 accumulation of fluid in large joints), or tests have shown increased levels of uric acid in the blood.

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

• if the patient has had gout attacks or elevated uric acid levels – the medicine may cause a temporary increase in uric acid concentration in blood and urine;
• 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 as well as monitoring of kidney and liver function.

Children
Neosine forte should not be used in children under 1 year of age.
Neosine forte 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 if the patient is taking:

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

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her 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 using the medicine for the mother outweigh the 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 wheat starch
This medicine contains very small amounts of gluten (derived from wheat starch). Therefore, it is highly unlikely to cause problems in patients with coeliac disease.
Each tablet contains no more than 20.6 micrograms of gluten.
Patients with wheat allergy (other than coeliac disease) should not take this medicine.

3. How to take Neosine forte

This medicine should always be taken exactly as described in this patient information leaflet, or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The medicine should be taken orally.
Recommended dose
Adults, including elderly people (over 65 years of age)
The recommended dose is 50 mg per kg of body weight per day – usually 1000 mg, i.e. 1 tablet three times a day.
Do not take more than 4 tablets per day.
Children over 1 year of age
The recommended dose is 50 mg per kg of body weight per day, given in several divided doses.
For children who cannot swallow tablets, it is recommended to administer Neosine forte syrup.
Method of administration
The tablet should be taken with a large amount of fluid, preferably water. If difficulty occurs in swallowing the whole tablet, to facilitate administration, the tablet may be crushed and dissolved in a small amount of water.
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 resolved.
Taking more than the recommended dose of Neosine forte
There is no data available regarding overdose with Neosine forte.
If you have any doubts or experience discomfort, contact your doctor.
Missed dose of Neosine forte
If a dose is missed, take it as soon as possible and continue the treatment.
Do not take a double dose to make up for a missed dose.
If you have any further questions about 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 everyone will experience them.
The following adverse reactions may occur
Common (occur in 1 to 10 out of 100 patients):

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

Uncommon (occur in 1 to 10 out of 1,000 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, 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 this medicine out of sight and reach of children.
Store below 25°C in the original packaging.
Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of the specified month.
LOT - means batch number.
EXP - means expiry date.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Neosine forte contains

• The active substance in the medicinal product is inosine pranobex (a complex containing inosine and 2-hydroxypropyl dimethyl ammonium 4-acetamidobenzoate in a molar ratio of 1:3). Each tablet contains 1000 mg of inosine pranobex.
• Other components: wheat starch, mannitol, povidone 30, magnesium stearate.

What Neosine forte looks like and contents of the pack
Neosine forte is in the form of tablets. The tablets are elongated, oval, biconvex, white in colour, with a score line on one side. The score line is intended only to facilitate breaking for easier swallowing and does not ensure equal dose division.
Pack sizes: 10, 20 or 30 tablets 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. Szkolna 31
95-054 Ksawerów