Groprinosin

Package Leaflet: Information for the Patient

GROPRINOSIN, 500 mg, Tablets

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 the Patient Leaflet or as Advised by the Doctor or Pharmacist.

• Keep this Leaflet, so you can Read it Again if you Need to.
• If you Need Advice or Additional Information, Consult a Pharmacist.
• If you Experience any Side Effects, including those not Listed in the Leaflet, Inform your Doctor or Pharmacist. See Section 4.
• If there is no Improvement or you Feel Worse after 5 to 14 Days, Consult a Doctor.

Table of Contents of the Leaflet

• 1. What is Groprinosin and what is it used for
• 2. Important Information before Taking Groprinosin
• 3. How to Take Groprinosin
• 4. Possible Side Effects
• 5. How to Store Groprinosin
• 6. Package Contents and Other Information

1. What is Groprinosin and what is it used for

Groprinosin is an Antiviral and Immune System Enhancer (it Stimulates the Activity of the Immune System).
Groprinosin Contains the Active Substance – Inosine Pranobex, which Inhibits In Vitrothe Replication of Pathogenic Viruses for Humans, including the HerpesGroup.

Indications for Use of Groprinosin

Supportively in Patients 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. Groprinosin can only be Used in Patients who have Previously been Diagnosed with a Herpes Simplex Virus Infection.
If there is no Improvement or you Feel Worse after 5 to 14 Days, Consult a Doctor.

2. Important Information before Taking Groprinosin

When not to Take Groprinosin

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

Warnings and Precautions

If you have any of the Following Conditions, Discuss them with your Doctor or Pharmacist before Taking Groprinosin.

• If you have had Gout Attacks or Elevated Uric Acid Levels in the Blood or Urine in the Past. Groprinosin may Cause a Temporary Increase in Uric Acid Levels in the Blood and Urine.
• If you have had Kidney Stones in the Past.
• If you have Kidney Function Disorders. In this Case, your Doctor will Closely Monitor you.
• If the Treatment is Long-term (3 Months or Longer). Your Doctor will Recommend Regular Blood Tests and will Monitor Kidney and Liver Function. During Long-term Treatment, Kidney Stones may Form.
• If you have Observed Symptoms of an Allergic Reaction, such as a Rash, Itching, Difficulty Breathing, Swelling of the Face, Lips, Throat, or Tongue. In this Case, Stop the Treatment and Consult a Doctor Immediately.

Children

Do not Use this Medication in Children under 1 Year of Age.

Groprinosin and other Medications

Tell your Doctor or Pharmacist about all Medications you are Currently Taking, have Recently Taken, or Plan to Take.

• Medications Used to Treat Gout (Allopurinol or other Medications);
• Medications that Increase Uric Acid Excretion, including Diuretics (that Increase Urine Production), such as Furosemide, Torasemide, Etacrynic Acid, Hydrochlorothiazide, Chlortalidone, Indapamide;
• Medications that Suppress the Immune System (so-called Immunosuppressive Medications, Used in Organ Transplant Patients or in Atopic Dermatitis);
• Azidothymidine (a Medication Used to Treat HIV-infected Patients).

Pregnancy and Breastfeeding

If you are Pregnant, Breastfeeding, Think you may be Pregnant, or Plan to have a Child, Consult a Doctor or Pharmacist before Taking this Medication.
Do not Take Groprinosin during Pregnancy and Breastfeeding, unless your Doctor has Told you to. Your Doctor will Assess whether the Benefits of Taking the Medication Outweigh the Potential Risks.

Driving and Operating Machines

It is Unlikely that Groprinosin will Affect your Ability to Drive or Operate Machines.

3. How to Take Groprinosin

Always Take this Medication Exactly as Described in the Patient Leaflet or as Advised by the Doctor or Pharmacist. If you have any Doubts, Consult a Doctor or Pharmacist.
Take the Medication Orally.
Swallow the Tablet with a Sufficient Amount of Liquid, Preferably Water. If you have Difficulty Swallowing the Whole Tablet, you can Crush it and Dissolve it in a Small Amount of Liquid to Make it Easier to Take.

Recommended Dose

Adults, including the Elderly (over 65 Years)
The Recommended Dose is 50 mg/kg Body Weight per Day.
Usually, the Daily Dose is 6 Tablets (3 g) per Day (i.e., 2 Tablets 3 Times a Day).
The Maximum Daily Dose is 8 Tablets (4 g) per Day (i.e., 2 Tablets 4 Times a Day).
Children over 1 Year of Age
The Recommended Dose is 50 mg/kg Body Weight per Day, Divided into Several Doses.
For Children who Cannot Swallow Tablets, it is Recommended to Take Groprinosin in Syrup Form.

Duration of Treatment

Usually, the Treatment Duration is 5 to 14 Days.
After the Symptoms have Subsided, Continue Taking the Medication for another 1 to 2 Days.

Overdose of Groprinosin

So far, no Cases of Overdose have been Reported. If you have any Doubts, Contact a Doctor Immediately.

Missed Dose of Groprinosin

If you Miss a Dose, Take it as Soon as you Remember, unless it is Almost Time for the Next Dose. Do not Take a Double Dose to Make up for the Missed Dose.

Stopping Groprinosin Treatment

If you Stop the Treatment, the Expected Therapeutic Effect may not be Achieved, or the Disease Symptoms may Worsen.
If you have any Further Doubts about Taking this Medication, Consult a Doctor or Pharmacist.

4. Possible Side Effects

Like all Medications, Groprinosin can Cause Side Effects, although not Everybody gets them.
Any Medication can Cause an Allergic Reaction, but Severe Allergic Reactions to Groprinosin are Very Rare.
Consult a Doctor Immediately if you Experience any of the Following Symptoms:

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

Reported Side Effects:

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 in the Blood, Increased Urea Levels in the Blood,
• Nausea, Vomiting,
• Discomfort in the Upper Abdomen,
• Itching of the Skin,
• Skin Rash (as the only Symptom),
• Headache,
• Dizziness,
• Fatigue, Malaise,
• Joint Pain.

Uncommon(occurring in less than 1 in 100 Patients but more than 1 in 1000 Patients):

• Diarrhea,
• Constipation,
• Nervousness,
• Sleepiness or Difficulty Falling Asleep (Insomnia),
• 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, Anaphylactic Shock, Redness of the Skin (Erythema).

Reporting Side Effects

If you Experience any Side Effects, including those not Listed in the Leaflet, Inform your Doctor or Pharmacist. Side Effects can be Reported Directly to the Department of Pharmacovigilance 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. Side Effects can also be Reported to the Marketing Authorization Holder. By Reporting Side Effects, you can Help Provide more Information on the Safety of this Medication.

5. How to Store Groprinosin

Store the Medication in a Place that is Inaccessible to Children.
Do not Use this Medication after the Expiration Date Stated on the Packaging after "EXP".
The Expiration Date is the Last Day of the Specified Month.
Do not Store above 25°C.
Medications should not be Disposed of via Wastewater or Household Waste. Ask your Pharmacist how to Dispose of Medications that are no Longer Needed. This will Help Protect the Environment.

6. Package Contents and Other Information

What Groprinosin 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 500 mg of Inosine Pranobex.
• Other Ingredients are: Potato Starch, Povidone K-25, Magnesium Stearate.

What Groprinosin Looks Like and what the Package Contains

Oval, White or Almost White, Convex Tablets, with a Score Line on one Side. The Score Line on the Tablet is only to Facilitate Breaking it, not to Divide it into Equal Doses.
Groprinosin is Packaged in Aluminum/PVC/PE/PVDC Blister Packs in a Cardboard Box.
The Box Contains 20, 30, 50, or 60 Tablets and a Patient Leaflet.

Marketing Authorization Holder and Manufacturer

GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
tel.: (22) 755 50 81
In order to Obtain more Detailed Information about the Medication, please Contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Tel. +48 (22)755 96 48
[email protected]

Date of the Last Update of the Leaflet:

((Marketing Authorization Holder's Logo))
((Pharmacode))