Isoprinosine

Package Leaflet: Information for the Patient

Isoprinosine, 1000 mg, Granules for Oral Solution, in Sachet

Inosine Pranobex

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

• Keep this Package Leaflet, as You May Need to Read it Again.
• In Case of Any Doubts, Consult a Doctor or Pharmacist.
• This Medication has been Prescribed Specifically for You. Do Not Pass it on to Others. The Medication may Harm Another Person, even if their Symptoms are the Same.
• If the Patient Experiences any Adverse Reactions, Including those not Listed in this Package Leaflet, Inform a Doctor or Pharmacist. See Section 4.

Package Leaflet Contents

• 1. What is Isoprinosine and What is it Used for
• 2. Important Information Before Using Isoprinosine
• 3. How to Use Isoprinosine
• 4. Possible Adverse Reactions
• 5. How to Store Isoprinosine
• 6. Package Contents and Other Information

1. What is Isoprinosine and What is it Used for

Isoprinosine Contains the Active Substance Inosine Pranobex, which has Antiviral and Immune System Stimulating Properties.
The Indications for Use of Isoprinosine are:

• Skin and Mucous Membrane Infections Caused by Herpes Simplex Virus Type I (Herpes Labialis) or Type II (Genital Herpes) and Varicella-Zoster Virus;
• Other Viral Infections (e.g., Subacute Sclerosing Panencephalitis);
• Supporting Treatment in Patients with Impaired Immunity.

2. Important Information Before Using Isoprinosine

When Not to Use Isoprinosine

• If the Patient is Allergic to Inosine Pranobex or any of the Other Ingredients of this Medication (Listed in Section 6). Symptoms of an Allergic Reaction may Include: Rash, Itching, Difficulty Breathing, Swelling of the Face, Lips, Throat, or Tongue.
• If the Patient Currently has an Acute Gout Attack or has Elevated Uric Acid Levels in the Blood.

Warnings and Precautions

Before Starting Treatment with Isoprinosine, Discuss the Following with a Doctor or Pharmacist:

• If the Patient has a History of Gout Attacks or Elevated Uric Acid Levels. Isoprinosine may Cause a Temporary Increase in Uric Acid Levels in the Blood and Urine.
• If the Patient has a History of Kidney Stones.
• If the Patient has Kidney Function Impairment. In this Case, the Doctor will Closely Monitor the Patient's Condition.
• If Treatment is Long-Term (3 Months or Longer). The Doctor will Recommend Regular Blood Tests and Monitor Kidney and Liver Function. During Long-Term Treatment, Kidney Stones may Form.
• If Allergic Reaction Symptoms are Observed, such as Rash, Itching, Difficulty Breathing, Swelling of the Face, Lips, Throat, or Tongue. In this Case, Treatment should be Discontinued and a Doctor Consulted.

Isoprinosine and Other Medications

Inform the Doctor about all Medications Currently being Taken or Recently Taken, as well as any Planned Medications. Especially Inform the Doctor about the Following Medications, as they may Interact with Isoprinosine:

• Allopurinol or Other Medications Used to Treat Gout;
• Medications that Increase Uric Acid Excretion, Including Diuretics, such as Furosemide, Torasemide, Etacrynic Acid, Hydrochlorothiazide, Chlortalidone, and Indapamide;
• Medications that Affect the Immune System, such as those Used after Organ Transplantation;
• Zidovudine (AZT, Azidothymidine) Used to Treat AIDS.

Pregnancy, Breastfeeding, and Fertility

If the Patient is Pregnant, Breastfeeding, or Planning to Become Pregnant, Consult a Doctor or Pharmacist Before Using this Medication.

Driving and Operating Machinery

Isoprinosine has no Significant Effect on the Ability to Drive and Operate Machinery.

Isoprinosine Granules for Oral Solution Contain Mannitol and Sulfur Dioxide (E220).

One Sachet of Isoprinosine Contains 259 mg of Mannitol, which may Cause a Mild Laxative Effect.
This Medication Contains Small Amounts of Sulfur Dioxide (a Component of the Citrus Flavor), which may Rarely Cause Severe Hypersensitivity Reactions and Bronchospasm.

3. How to Use Isoprinosine

This Medication should Always be Used as Directed by a Doctor. In Case of Doubts, Consult a Doctor or Pharmacist.
Isoprinosine is Intended for Oral Use Only.
The Dose is Determined Based on the Patient's Body Weight and the Severity of the Disease.
The Daily Dose is Divided into Equal Single Doses Taken Several Times a Day.
Adults, Including the Elderly
The Recommended Dose is 50 mg per kg of Body Weight per Day.
Usually, the Daily Dose is 3 g per Day (i.e., 1 Sachet 3 Times a Day).
The Maximum Daily Dose is 4 g per Day (i.e., 1 Sachet 4 Times a Day).
Dosing in Subacute Sclerosing Panencephalitis
In Subacute Sclerosing Panencephalitis, During the Acute Phase of the Disease, the Doctor may Increase the Dose to 100 mg per kg of Body Weight per Day (Maximum 4 g per Day), Divided into Equal Doses Taken Every 4 Hours.
Method of Administration

• Open the Sachet Before Use.
• Isoprinosine Granules should be Dissolved in Cold or Lukewarm Water. The Contents of the Sachet should be Poured into a Glass of Water and Mixed to Ensure Better Dissolution of the Granules. After Dissolution in Water, a Clear, Colorless Solution with a Citrus Scent is Formed.
• The Prepared Solution should be Consumed Immediately After Preparation.
• Do Not Store the Medication for Later Use.
• Only Water should be Used to Prepare the Solution. This Medication can be Taken with or Without Food.

Duration of Treatment
Depends on the Patient's Response to Treatment and is Determined Individually by the Doctor. Usually, the Duration of Treatment is from 5 to 14 Days. After the Symptoms have Resolved, Treatment is Usually Continued for Another 1 to 2 Days.

Using a Higher than Recommended Dose of Isoprinosine

No Cases of Overdose have been Reported. In Case of Any Doubts, Consult a Doctor or Pharmacist Immediately.

Missing a Dose of Isoprinosine

If a Dose is Missed, it should be Taken as Soon as Remembered, Unless it is Almost Time for the Next Dose. Do Not Take a Double Dose to Make up for a Missed Dose.

Stopping Treatment with Isoprinosine

If Treatment is Stopped, the Expected Therapeutic Effect may not be Achieved, or the Disease Symptoms may Worsen. Before Deciding to Stop Treatment, Consult a Doctor.
In Case of Any Further Doubts Regarding the Use of this Medication, Consult a Doctor or Pharmacist.

4. Possible Adverse Reactions

Like all Medications, Isoprinosine can Cause Adverse Reactions, although not Everybody will Experience them.
Consult a Doctor Immediatelyif any of the Following Symptoms Occur:

• Sudden Appearance of Wheezing,
• Difficulty Breathing,
• Swelling of the Eyelids, Face, or Lips,
• Rash or Itching (especially if it Affects the Whole Body).

Reported Adverse Reactions

Very Common (Occurring in more than 1 in 10 Patients):
‐
Increased Uric Acid Levels in the Blood;
‐
Increased Uric Acid Levels in the Urine.
Common (Occurring in less than 1 in 10 Patients but more than 1 in 100 Patients):

• Increased Liver Enzyme Activity;
• Increased Urea Levels in the Blood;
• Rash, Itching;
• Joint Pain;
• Vomiting, Nausea, Discomfort in the Upper Abdomen;
• Fatigue (Weakness), Malaise (General Feeling of Illness);
• Headache, Dizziness of Vestibular Origin.

Uncommon (Occurring in less than 1 in 100 Patients but more than 1 in 1,000 Patients):
‐
Diarrhea, Constipation;
‐
Drowsiness or Difficulty Falling Asleep (Insomnia), Nervousness;
‐
Increased Urine Output (Polyuria).
Frequency Not Known (Cannot be Estimated from the Available Data):
‐
Abdominal Pain;
‐
Swelling of the Face, Lips, Eyelids, or Throat (Angioedema);
‐
Hives, Allergic Reaction, Anaphylactic Reaction;
‐
Dizziness;
‐
Redness of the Skin (Flush).

Reporting Adverse Reactions

If any Adverse Reactions Occur, Including those not Listed in this Package Leaflet, Inform a Doctor or Pharmacist. Adverse Reactions can be Reported Directly to the Department of Medicinal Product Monitoring, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +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 will Help to Gather More Information on the Safety of this Medication.

5. How to Store Isoprinosine

Store the Medication in a Place that is Inaccessible to Children.
Do Not Use this Medication after the Expiration Date Stated on the Carton and Sachet after "Expiration Date (EXP)". The Expiration Date Refers to the Last Day of the Specified Month.
No Special Precautions for Storage are Required.
Medications should not be Disposed of via Wastewater or Household Waste. Ask a Pharmacist how to Dispose of Medications that are no Longer Needed. This will Help Protect the Environment.

6. Package Contents and Other Information

What Isoprinosine Contains

• The Active Substance of Isoprinosine is Inosine Pranobex (a Complex Containing Inosine and 4-Acetamidobenzoic Acid 2-Hydroxypropyldimethylammonium in a Molar Ratio of 1:3). One Sachet Contains 1000 mg of Inosine Pranobex.
• The Other Ingredients are: Mannitol, Sucralose (E955), Povidone K30, Citrus Flavor [Containing, among others, Sulfur Dioxide (E220)].

What Isoprinosine Looks Like and What the Package Contains

Isoprinosine is White or Off-White Granules with a Citrus Scent, Completely Soluble in Water.
Isoprinosine is Packaged in Sachets and Available in Cartons of 24 Sachets.

Marketing Authorization Holder

Ewopharma International, s.r.o.
Prokopa Vel’kého 52
811 04 Bratislava
Slovakia

Manufacturer

Lusomedicamenta Sociedade Técnica Farmacêutica S.A.
Estrada Consiglieri Pedroso, 66, 69-B, Queluz de Baixo
2730-055 Barcarena
Portugal
To Obtain More Detailed Information about this Medication, Contact the Representative of the Marketing Authorization Holder in Poland:
Ewopharma AG Sp. z o.o.
ul. Leszno 14
01-192 Warsaw
Phone: 22 620 11 71
Date of Last Update of the Package Leaflet: