Gluthion

Package leaflet: Information for the patient

Gluthion 300 mg/3ml powder and solvent for injectable solution, 600 mg/4ml powder and solvent for injectable solution

Glutathione
Please read this leaflet carefully before you are given 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, 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, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Gluthion is and what it is used for
2. What you need to know before you are given Gluthion
3. How to use Gluthion
4. Possible side effects
5. How to store Gluthion
6. Contents of the pack and other information

1. What Gluthion is and what it is used for

Gluthion contains glutathione and is indicated for the prevention of nerve disorders (neuropathies) that may occur as a result of using medicines for cancer treatment (chemotherapy), such as cisplatin or similar medicinal products.

2. What you should know before Gluthion is administered to you

Do not use Gluthion:

• if you are allergic to 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 Gluthion.
Other medicines and Gluthion
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions are known.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
During pregnancy and breastfeeding, your doctor will prescribe Gluthion only if clearly necessary.
Driving and using machines
This medicine has no effect or has a negligible effect on the ability to drive and use machines.

3. How Gluthion is administered

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Recommended doses are:
In more severe cases: 1-2 vials of 600 mg daily, administered intramuscularly or by slow intravenous injection, or added to intravenous infusions.
In mild cases: half the above dose.
If you use more Gluthion than you should
No cases of overdose have been reported.
If you forget to use Gluthion
If you have any doubts about the use of this medicine, contact your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur during treatment with Gluthion and disappear when treatment is discontinued:

• nausea
• vomiting
• headache (cephalalgia)
• skin rashes

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
You can also report side effects directly via the national reporting system at:
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Gluthion

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp.". The expiry date refers to the last day of that month.
The reconstituted solution is stable for approximately 2 hours if stored at room temperature, and stable for at least 8 hours if stored at temperatures between +0°C and +5°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Gluthion contains
Gluthion 300 mg/3 ml powder and solvent for injectable solutions

• The active substance is sodium glutathione. Each vial contains 321.5 mg of sodium glutathione equivalent to 300 mg of glutathione.
• The other component is water for injections (3 ml), contained in the solvent vial.

Gluthion 600 mg/4 ml powder and solvent for injectable solutions

• The active substance is sodium glutathione. Each vial contains 643 mg of sodium glutathione equivalent to 600 mg of glutathione.
• The other component is water for injections (4 ml), contained in the solvent vial.

Description of the appearance of Gluthion and contents of the pack
Gluthion is presented as a powder and solvent for injectable solutions.
Pack sizes:

• 10 vials containing 300 mg of glutathione with 10 solvent vials containing 3 ml of water for injections.
• 10 vials containing 600 mg of glutathione with 10 solvent vials containing 4 ml of water for injections.

Marketing Authorization Holder
Laboratorio Farmaceutico C.T. S.r.l.
Via Dante Alighieri, 71
Sanremo (IM)

Manufacturer
Laboratorio Italiano Biochimico Farmaceutico Lisapharma S.p.A.
Via Licinio, 11
Erba (CO)
Laboratorio Farmaceutico C.T. S.r.l.
Via Dante Alighieri, 71
Sanremo (IM)

The following information is intended exclusively for healthcare professionals

For intramuscular use, the product must be completely dissolved with its solvent vial: the solution appears clear and colourless.
For intravenous use, the product may be dissolved with its solvent (water for injections) and injected slowly by direct route, or administered by infusion by adding it to at least 20 ml of sterile infusion solution.