Neosine forte

Package Leaflet: Information for the Patient

Neosine Forte, 1000 mg, Tablets

Inosine Pranobex

Read the Package 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 Package Leaflet or as Advised 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 Undesirable Effects, Including those not Listed in this Package Leaflet, the Doctor or Pharmacist Should be Informed. See Section 4.
• If After 5 to 14 Days there is no Improvement or the Patient Feels Worse, a Doctor Should be Consulted.

Table of Contents of the Package 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 Undesirable Effects
• 5. How to Store Neosine Forte
• 6. Contents of the Package and Other Information

1. What is Neosine Forte and What is it Used For

Neosine Forte is an Antiviral and Immune System Enhancer (Stimulates the Activity of the Immune System).
Neosine Forte Contains the Active Substance - Inosine Pranobex, which Inhibits the Replication of Pathogenic Viruses for Humans in the HerpesGroup.

Indications for Use of Neosine Forte

• 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 Forte 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, a Doctor Should be Consulted.

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 Attack of Gout (Severe Joint Pain with Swelling and Redness of the Skin or the Presence of Effusion in Large Joints) or Tests have Shown Elevated Uric Acid Levels in the Blood.

Warnings and Precautions

Before Starting to Take Neosine Forte, the Patient Should Discuss it with a Doctor or Pharmacist:

• If the Patient has had Gout Attacks or Elevated Uric Acid Levels - the Medication may Cause Transiently Elevated Uric Acid Levels in the Blood and Urine;
• If the Patient has had Kidney Stones;
• If the Patient has Kidney Function Disorders - During the Use of Neosine Forte, the Doctor will Regularly Examine the Blood and Monitor Kidney Function;
• If the Treatment is Long-Term (Lasts 3 Months or Longer), the Doctor will Prescribe Regular Blood Tests and Monitor Kidney and Liver Function.

Children

Neosine Forte Should Not be Used in Children Under 1 Year of Age.

Neosine Forte and Other Medications

The Patient Should Inform the Doctor or Pharmacist about all Medications Currently Being Taken or Recently Taken, as well as any Medications Planned to be Taken.

Particularly, the Patient Should Inform the Doctor if they 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 in the Treatment of AIDS).

Pregnancy and Breastfeeding

If the Patient is Pregnant or Breastfeeding, Thinks they may be Pregnant, or is Planning to have a Child, they Should Consult a Doctor or Pharmacist Before Using this Medication.
Neosine Forte Should Not be Taken During Pregnancy and Breastfeeding Without Consulting a Doctor, who will Assess whether the Benefits of Using the Medication in the Mother Outweigh the Risk to the Child.

Driving and Operating Machinery

The Medication may Affect the Ability to Drive and Operate Machinery.
If Headache, Dizziness, or Drowsiness Occur, the Patient Should Not Drive, Operate Machinery, or Perform Other Activities that Require Concentration. See also Section 4.

Neosine Forte Contains Wheat Starch

This Medication Contains Very Small Amounts of Gluten (Derived from Wheat Starch). Therefore, it is Very Unlikely to Cause any Problems in Patients with Celiac Disease.
One Tablet Contains no More than 20.6 Micrograms of Gluten.
Patient with a Wheat Allergy (Other than Celiac Disease) Should Not Use this Medication.

3. How to Take Neosine Forte

This Medication Should Always be Taken Exactly as Described in this Package Leaflet or as Advised by a Doctor or Pharmacist. In Case of Doubt, the Patient Should Consult a Doctor or Pharmacist.
The Medication 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., 1 Tablet 3 Times a Day.
No More than 4 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 Forte Syrup is Recommended.

Method of Administration

The Tablet Should be Taken with a Large Amount of Liquid, Preferably Water. If there are Difficulties with Swallowing the Whole Tablet, to Facilitate the Intake of the Medication, the Tablet can 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 Medication for 1 to 2 Days After the Symptoms of the Disease have Disappeared.

Taking a Higher than Recommended Dose of Neosine Forte

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

Missing a Dose of Neosine Forte

In Case of a Missed Dose, the Patient Should Take the Dose as Soon as Possible and Continue the Treatment.
A Double Dose Should Not be Taken to Make up for a Missed Dose.
In Case of any Further Doubts Related to the Use of this Medication, the Patient Should Consult a Doctor or Pharmacist.

4. Possible Undesirable Effects

Like all Medications, Neosine Forte can Cause Undesirable Effects, Although they may not Occur in Every Patient.

The Following Undesirable Effects may Occur

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

• Transiently Elevated Uric Acid Levels in the Blood;
• Increased Activity of Liver Enzymes or Elevated Urea Levels in the Blood;
• Nausea with or without Vomiting;
• Abdominal Pain;
• Itching, Skin Rash;
• Headache or Dizziness;
• Fatigue, Poor Health;
• Joint Pain.

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

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

Reporting Undesirable Effects

If any Undesirable Effects Occur, Including those not Listed in this Package Leaflet, the Doctor or Pharmacist Should be Informed.
Undesirable Effects can be Reported Directly to the Department of Monitoring of Undesirable Effects of 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
Undesirable Effects can also be Reported to the Marketing Authorization Holder.
Reporting Undesirable Effects will Help to Gather More Information on the Safety of the Medication.

5. How to Store Neosine Forte

The Medication Should be Stored in a Place that is Inaccessible to Children.
Store in a Temperature Below 25°C, in the Original Packaging.
Do not Use this Medication After the Expiration Date Stated on the Blister Pack and on the Carton after EXP. The Expiration Date Refers to the Last Day of the Specified Month.
Batch - Means the Batch Number.
EXP - Means the Expiration Date.
Medications Should Not be Disposed of in the Drain or Household Waste Containers. The Patient Should Ask the Pharmacist how to Dispose of Unused Medications. This will Help Protect the Environment.

6. Contents of the Package 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). One Tablet Contains 1000 mg of Inosine Pranobex.
• Other Ingredients are: Wheat Starch, Mannitol, Povidone 30, Magnesium Stearate.

What Neosine Forte Looks Like and What the Package Contains

Neosine Forte is in the Form of Tablets. The Tablets are Prolonged, Oval, Convex on Both Sides, White, with a Break Line on one Side. The Break Line Only Facilitates the Crushing of the Tablet to Make it Easier to Swallow, and does not Divide it into Equal Doses.
The Medication Package is: 10, 20, or 30 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 the Last Update of the Package Leaflet: