PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

RIDUTOX 600 mg/4 ml powder and solvent for injectable solution

Glutathione
Generic medicine
Please read this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What RIDUTOX is and what it is used for
What you need to know before using RIDUTOX
How to use RIDUTOX
Possible side effects
How to store RIDUTOX
Contents of the pack and other information

1. What RIDUTOX is and what it is used for

RIDUTOX contains the active substance glutathione, which belongs to a class of medicines used to prevent nerve disorders (neuropathies) that may occur following treatment with anticancer drugs such as cisplatin or similar agents, by protecting nerve cells.

2. What you need to know before using RIDUTOX

Do not use RIDUTOX
If you are allergic to the active substance glutathione or to any of the other ingredients of this
medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using RIDUTOX.

Other medicines and RIDUTOX
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Do not use this medicine during pregnancy or breastfeeding unless absolutely necessary and only as directed
by your doctor, who will evaluate the benefits of treatment against the potential risks.

Driving and using machines
This medicine does not affect, or affects negligibly, your ability to drive or operate machinery.

3. How to use RIDUTOX

Use this medicine exactly as instructed by your doctor.
If you have any doubts, consult your doctor or pharmacist.
Adults
The recommended dose is 1-2 vials per day administered by intramuscular injection, slow intravenous injection, or intravenous infusion.
If you use more RIDUTOX than you should
If you think you have accidentally taken too much RIDUTOX, contact your doctor immediately or go to the nearest hospital. Take this leaflet with you. If necessary, the doctor may provide symptomatic treatment. For any doubts regarding the use of RIDUTOX, consult your doctor, nurse, or pharmacist.
If you forget to take RIDUTOX
Since the injection will be administered by a nurse or doctor, it is unlikely that you will receive an excessive dose or miss a dose. However, if you are concerned, discuss this with your doctor.
If you stop using RIDUTOX
If you have any questions about using this medicine, speak to your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Below are the side effects associated with glutathione.
Rare (may affect up to 1 in 1,000 people):

skin rashes. Following the instructions contained in this leaflet may reduce the risk of side effects.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store RIDUTOX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack following "Exp.".
The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What RIDUTOX contains
The active substance is reduced glutathione (sodium salt). Each vial of powder contains 600 mg of
glutathione.
The other component is water for injections, contained in the solvent ampoule.
Description of the appearance of RIDUTOX and contents of the package
Powder and solvent for intramuscular and/or intravenous administration.
RIDUTOX is supplied as a box containing 10 vials of powder and 10 ampoules of solvent for injectable solution.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
So.Se.PHARM S.r.l. – Via dei Castelli Romani, 22 – 00071 Pomezia (RM) – Italy
Manufacturers
ESSETI Farmaceutici S.r.l.
Via Campobello, 15 - 00071 Pomezia (RM) – Italy
Biomedica Foscama Industria Chimico-Farmaceutica S.p.A.
Via Morolense, 87 – 03013 Ferentino (FR) – Italy