Package leaflet: Information for the patient

Thiomed 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 other people, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Thiomed is and what it is used for

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

2. What you need to know before taking Thiomed

Do not use Thiomed
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 taking Thiomed.

Children
This medicine is not recommended for children, as its effects have not been established in this age group.

Other medicines and Thiomed
Inform 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, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not use this medicine during pregnancy or breastfeeding, unless strictly necessary and only as directed by a physician who will weigh the benefits of treatment against potential risks.

Driving and using machines
This medicine generally has no effect or has a negligible effect on the ability to drive and use machinery.

3. How to use Thiomed

Use this medicine exactly as instructed by your doctor or nurse. If you have
any doubts, consult your doctor or nurse.
Adults
The recommended dose is 1–2 vials per day for intramuscular or slow intravenous injection or for intravenous infusion.
The dosage depends on age, body weight, and health status, and must be coordinated with the dose and administration schedule of the antitumour drug.
Instructions for use
Administration should occur within 15–30 minutes before the start of the antitumour drug administration.

For intramuscular or intravenous bolus injection, the contents of the vial must be dissolved in the solvent provided in the vial of water for injections included in the package.
For intravenous infusion, this solution must be further diluted in at least 20 ml of water for injections.

The reconstituted solution must be used immediately after preparation. The reconstituted solution must be clear, colourless, and free from visible particles. It is intended for a single, uninterrupted administration, and any unused portion must be discarded.
This medicine must not be mixed with other products, as potential incompatibilities are unknown.
All necessary precautions must be taken to ensure sterility before and during administration.
If you use more Thiomed than you should
If you think you have accidentally received an excessive dose of Thiomed, contact your doctor immediately or go to the nearest hospital. Take this leaflet with you.
If needed, the doctor may provide symptomatic treatment.
If you forget to take Thiomed
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, speak to your doctor.
If you have any questions about how to use this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, Thiomed can cause side effects, although not everyone experiences them.
The following are the side effects associated with glutathione.
Not known (frequency cannot be estimated from the available data):

nausea, vomiting;
allergic reactions (hypersensitivity), including skin rashes, appearance of swollen areas on the skin causing itching (urticaria);
headache (cephalaea);
fever, pain and infection at the infusion site, formation of blood clots in veins (venous thrombosis), inflammation of veins at the infusion site and surrounding areas (venous phlebitis and extravasation with possible extravascular spread).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. Side effects can also be reported directly via the national reporting system at the website www.agenziafarmaco.gov.it/it/responsabili. Reporting side effects helps to provide more information on the safety of this medicine.

5. How to store Thiomed

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "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. Contents of the pack and other information

What Thiomed contains

The active substance is glutathione. Each vial of powder contains 600 mg of glutathione (as sodium salt).
The other component is water for injections, contained in the solvent ampoule.

Description of the appearance of Thiomed and contents of the pack
Thiomed is presented as a box containing vials of powder and solvent ampoules for injectable solution.
Pack sizes:

5 vials of 600 mg glutathione with 5 solvent ampoules containing 4 ml of water for injections
10 vials of 600 mg glutathione with 10 solvent ampoules containing 4 ml of water for injections

Marketing Authorization Holder
Esseti Farmaceutici s.r.l. – Via Raffaele De Cesare, 7 – 80132 Napoli
Manufacturer
Laboratorio Italiano Biochimico Farmaceutico Lisapharma S.p.A. - Via Licinio 11 – 22036 Erba (Co)