Neosine

Package Leaflet: Information for the Patient

Neosine, 500 mg, Tablets

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 this package leaflet for the patient, or as directed by a doctor or pharmacist.

• This package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any not listed in this package 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 Package Leaflet

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

1. What Neosine is and what it is used for

Neosine is an antiviral and immunostimulant medicine (stimulating the immune system's activity).
Neosine contains the active substance inosine pranobex, which inhibits the multiplication of pathogenic viruses for humans in the Herpesgroup.

Indications for use of Neosine

• Supportively in individuals with reduced immunity, in the case of recurring upper respiratory tract infections.
• In the treatment of herpes labialis and facial skin caused by the herpes simplex virus (Herpes simplex). Neosine should only be used in patients who have previously been 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 Neosine

When not to take Neosine

• If the patient is allergic to the active substance (inosine pranobex) or 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 acute gout attack (severe joint pain with swelling and redness of the skin or the occurrence of effusion in large joints) or tests have shown increased uric acid levels in the blood.

Warnings and precautions

Before starting to take Neosine, the patient should discuss it with their doctor or pharmacist:

• If the patient has had gout attacks or increased uric acid levels - the medicine may cause a temporary increase in uric acid levels in the blood and urine;
• If the patient has had kidney stones;
• If the patient has kidney function disorders - during Neosine treatment, the doctor will regularly check the blood and monitor kidney function;
• If the 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 should not be used in children under 1 year of age.

Neosine 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.

Particularly, the patient should inform their doctor if they are taking:

• Medicines for the treatment of gout (e.g., allopurinol or other xanthine oxidase inhibitors);
• Medicines that increase uric acid excretion, including diuretics (increasing urine production), e.g., furosemide, torasemide, etacrynic acid, hydrochlorothiazide, chlortalidone, indapamide;
• Medicines that suppress the immune system (so-called immunosuppressive medicines, used in patients after organ transplantation or with atopic dermatitis);
• Azidothymidine (a medicine used in the treatment of AIDS).

Pregnancy and breastfeeding

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 using this medicine.
Neosine should not be taken during pregnancy and breastfeeding without consulting a doctor, who will assess whether the benefits of using the medicine for the mother outweigh the risks for the child.

Driving and using machines

The medicine may affect the ability to drive and use machines.
If the patient experiences headache, dizziness, or drowsiness, they should not drive, operate machines, or perform other activities that require concentration. See also section 4.

Neosine contains wheat starch

This medicine contains very small amounts of gluten (from wheat starch). It is therefore very unlikely to cause any problems in patients with celiac disease.
One tablet contains no more than 10.3 micrograms of gluten.
Patient with a wheat allergy (other than celiac disease) should not take this medicine.

3. How to take Neosine

This medicine should always be taken exactly as described in this package leaflet for the patient, or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The medicine should be taken orally.

Recommended dose

Adults, including the elderly (over 65 years)
The recommended dose is 50 mg per kg of body weight per day - usually 1000 mg, i.e., 2 tablets 3 times a day.
No more than 8 tablets should be taken 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, Neosine syrup is recommended.

Method of administration

The tablet should be taken with a large amount of liquid, preferably water. If the patient has difficulty swallowing the whole tablet, the tablet can be crushed and dissolved in a small amount of water to facilitate taking the medicine.

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 disappeared.

Taking a higher dose of Neosine than recommended

There are no data on the overdose of Neosine.
In case of any doubts or discomfort, the patient should immediately contact their doctor.

Missing a dose of Neosine

In case of a missed dose, the patient should take the dose as soon as possible and continue treatment. A double dose should not be taken to make up for the missed dose.
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, Neosine can cause side effects, although not everybody gets them.

The following side effects may occur

Frequently(in 1 to 10 out of 100 patients):

• Temporary increase in uric acid levels in the blood;
• Increased activity of liver enzymes 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(in 1 to 10 out of 1,000 patients):

• Diarrhea;
• Constipation;
• Nervousness;
• Drowsiness or difficulty sleeping (insomnia);
• Increased urine production (polyuria).

Reporting side effects

If the patient experiences any side effects, including any not listed in this package leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Neosine

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C.
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 month.
Lot - means batch number.
EXP - means expiry date.
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. Contents of the pack and other information

What Neosine contains

• The active substance of Neosine is inosine pranobex (a complex containing inosine and 4-acetamidobenzoic acid 2-hydroxypropyldimethylammonium in a molar ratio of 1:3). One tablet contains 500 mg of inosine pranobex.
• The other ingredients are: wheat starch, mannitol, povidone, magnesium stearate.

What Neosine looks like and contents of the pack

Neosine is in the form of tablets. The tablets are elongated, oval, biconvex, with a dividing line on one side. The dividing line on the tablet is only to facilitate breaking it, for easier swallowing, and not for dividing into equal doses.
The pack contains: 20 or 50 tablets 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. Szkolna 31
95-054 Ksawerów

Date of last revision of the package leaflet: