Neosine

Package Leaflet: Information for the Patient

Neosine, 250 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 Further 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 There is no Improvement or You Feel Worse after 5 to 14 Days, Contact Your Doctor.

Table of Contents of the Leaflet

• 1. What is Neosine and What is it 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 is Neosine and What is it Used for

Neosine is an Antiviral and Immune System Enhancer (it Stimulates the Activity of the Immune System).
Neosine Contains the Active Substance Inosine Pranobex, which Inhibits the Growth of Pathogenic Viruses for Humans, Including the HerpesGroup In Vitro.

Indications for Use of Neosine

Supportively in Patients with Reduced Immunity, in Case of Recurring Upper Respiratory Tract Infections.
In the Treatment of Herpes Labialis and Facial Skin Caused by the Herpes Simplex Virus. Neosine Should Only be Used in Patients who have Previously been Diagnosed with Herpes Simplex Infection.
If There is no Improvement or You Feel Worse after 5 to 14 Days, Consult Your Doctor.

2. Important Information Before Taking Neosine

When Not to Take Neosine

• If You are 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 You Currently have an Acute Gout Attack (Severe Joint Pain with Swelling and Redness of the Skin or Exudation in the Large Joints) or Tests have Shown Increased Uric Acid Levels in the Blood.

Warnings and Precautions

Before Starting to Take Neosine, Discuss it with Your Doctor or Pharmacist:

• If You have had Gout Attacks or Increased Uric Acid Levels - the Medication may Cause Transient Increased Uric Acid Levels in the Blood and Urine;
• If You have had Kidney Stones;
• If You have Kidney Function Disorders - During Neosine Treatment, Your Doctor will Regularly Check Your Blood and Monitor Kidney Function;
• If the Treatment is Long-term (Lasts 3 Months or Longer), Your Doctor will Prescribe Regular Blood Tests and Kidney and Liver Function Checks.

Children

Do not Use the Medication in Children Under 1 Year of Age.

Neosine and Other Medications

Tell Your Doctor or Pharmacist About all Medications You are Currently Taking or have Recently Taken, as well as any Medications You Plan to Take.

Particularly Tell Your Doctor if You are Taking:

• Medications for the Treatment of Gout (e.g., Allopurinol or Other Xanthine Oxidase Inhibitors);
• Medications that Increase Uric Acid Excretion, Including Diuretics (that Increase Urine Production), e.g., Furosemide, Torasemide, Etacrynic Acid, Hydrochlorothiazide, Chlortalidone, Indapamide;
• Medications that Suppress the Immune System (So-called Immunosuppressive Medications, Used in Patients After Organ Transplantation or with Atopic Dermatitis);
• Azidothymidine (a Medication Used to Treat AIDS).

Pregnancy and Breastfeeding

If You are Pregnant or Breastfeeding, Think You may be Pregnant or are Planning to have a Child, Consult Your Doctor or Pharmacist Before Using this Medication.
Do not Take Neosine During Pregnancy and Breastfeeding Without Consulting Your Doctor, who will Assess whether the Benefits of Using the Medication for the Mother Outweigh the Risk to the Child.

Driving and Operating Machines

The Medication may Affect Your Ability to Drive and Operate Machines.
If You Experience Headache, Dizziness or Drowsiness, Do not Drive, Operate Machines or Perform Other Activities that Require Concentration. See also Section 4.

Neosine Contains Sucrose, Methyl Parahydroxybenzoate (E 218), Propyl Parahydroxybenzoate, Propylene Glycol (E 1520) and Sodium

The Medication Contains Sugar Sucrose

If You have Previously been Diagnosed with Intolerance to Some Sugars, Consult Your Doctor Before Taking the Medication.
The Medication Contains 3315 mg of Sucrose in 5 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-type Reactions).

Propylene Glycol (E 1520) and as a Component of Banana Flavor AR2876

The Medication Contains 512 mg of Propylene Glycol in 5 ml of Syrup.
Before Administering the Medication to a Child Under 5 Years of Age, Consult a Doctor or Pharmacist, Especially if the Child is Taking Other Medications Containing Propylene Glycol or Alcohol.
Pregnant or Breastfeeding Women Should not Take this Medication Without a Doctor's Recommendation.
The Doctor may Decide to Perform Additional Tests on such Patients.
Patients with Liver or Kidney Function Disorders Should not Take this Medication Without a Doctor's Recommendation. The Doctor may Decide to Perform Additional Tests on such Patients.

Sodium

The Medication Contains 10.3 mg in 5 ml of Syrup.
The Medication Contains 41.2 mg of Sodium (the Main Component of Table Salt) in 20 ml of Syrup. This Corresponds to 2.06% of the Maximum Recommended Daily Intake of Sodium in the Diet for Adults.

3. How to Take Neosine

This Medication Should Always be Taken Exactly as Described in this Patient Leaflet or as Advised by a Doctor or Pharmacist. If You have any Doubts, Consult a Doctor or Pharmacist.
The Medication Should be Taken Orally.

Recommended Dose

Adults, Including the Elderly (Over 65 Years):
Usually 20 ml of Syrup 3 or 4 Times a Day (1 ml of Syrup per kg of Body Weight per Day).
The Maximum Dose is 4 g of Inosine Pranobex (i.e., 80 ml of Syrup) per Day.
Children Over 1 Year of Age:
1 ml of Syrup per kg of Body Weight per Day. The Medication Should be Administered 3 Times a Day, According to the Following Table:

Child's Body Weight

Dose (ml of Syrup)

Administer 3 Times a Day

10 to 14 kg
5 ml
15 to 20 kg
5 to 7.5 ml
21 to 30 kg
7.5 to 10 ml
31 to 40 kg
10 to 15 ml
41 to 50 kg
15 to 17.5 ml
For Dosage, Use the Measuring Cup Provided with the Medication Package. This Allows for Accurate Measurement of the Dose.

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 of the Disease have Disappeared.

Taking a Higher Dose of Neosine than Recommended

There are no Data on Overdose of Neosine.
In Case of any Doubts or Poor Health, Contact a Doctor Immediately.

Missing a Dose of Neosine

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 any Further Doubts Related to the Use of this Medication, Consult a Doctor or Pharmacist.

4. Possible Side Effects

Like all Medications, this Medication can Cause Side Effects, Although not Everybody gets them.

The Following Side Effects may Occur

Frequent(in 1 to 10 out of 100 Patients):

• Transient Increase in Uric Acid Levels in the Blood and Urine;
• Increased Activity of Liver Enzymes or Urea Nitrogen Levels in the Blood;
• Nausea with or Without Vomiting;
• Abdominal Pain;
• Itching, Skin Rash;
• Headache or Dizziness;
• Fatigue, Poor Health;
• Joint Pain.

Uncommon(Occurring in 1 to 10 out of 1,000 Patients):

• Diarrhea;
• Constipation;
• Nervousness;
• Drowsiness or Difficulty Falling Asleep (Insomnia);
• Increased Urine Production (Polyuria).

Reporting Side Effects

If You Experience any Side Effects, Including those not Listed in this Leaflet, Tell Your Doctor or Pharmacist, or Nurse. 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
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 the Medication.

5. How to Store Neosine

Store the Medication in a Place that is Inaccessible to Children.
Do not Use After the Expiration Date Stated on the Label and Carton. The Expiration Date is the Last Day of the Specified Month.
Store at a Temperature Below 25°C. Do not Store in the Refrigerator. Do not Freeze.
Medications Should not be Disposed of in Sewers or Household Waste Containers. Ask a Pharmacist how to Dispose of Unused Medications. This will Help Protect the Environment.

6. Contents of the Pack and Other Information

What Neosine 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 50 mg of Inosine Pranobex. 5 ml of Syrup Contains 250 mg of Inosine Pranobex.
• Other Ingredients are: Methyl Parahydroxybenzoate (E 218), Propyl Parahydroxybenzoate, Sucrose, Citric Acid, Sodium Hydroxide, Propylene Glycol (E 1520), Banana Flavor AR2876 [Contains, Among Others, 1.2 g of Propylene Glycol (E 1520), Eugenol, Geraniol, Linalol, Citronellol, Limonene], Purified Water.

What Neosine Looks Like and What the Pack Contains

Neosine is a Syrup with a Banana Flavor and a Slightly Bitter Taste.
The Product Package is: a Brown Glass Bottle Containing 150 ml of Syrup, Closed with a White Aluminum Cap with a Provided Measuring Cup Made of Polypropylene with a Capacity of 15 ml (with a Scale Allowing for Dosage of the Product in Volumes of 2.5 ml and Multiples of this Volume), 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 the Last Update of the Leaflet: