Package leaflet: Information for the patient

Tationil 600 mg/4 ml powder and

solvent for injectable solution
Glutathione
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 may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Tationil is and what it is used for

Tationil is used in adults to prevent diseases affecting one or more nerves following treatment with cisplatin (a drug used to treat cancer) or its analogues.

2. What you need to know before taking Tationil

Do not take Tationil

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 Tationil.
Children and adolescents
The use of Tationil is not recommended in children and adolescents, as safety and efficacy have not been established in this patient group.
Other medicines and Tationil
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Although experimental research has not shown embryotoxic or fetotoxic effects for glutathione, as with all new medicines, its use during pregnancy and breastfeeding is not recommended.
Driving and using machines
Tationil does not impair the ability to drive or operate machinery.

3. How to take Tationil

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1-2 vials per day.
It can be administered into a muscle (intramuscular route), into a vein (slow intravenous injection or added to intravenous infusion), or as otherwise prescribed by the physician.
If you take more Tationil than you should
In case of overdose, contact your doctor immediately or go to the nearest hospital, where appropriate medical care will be provided.
If you forget to take Tationil
Do not take a double dose to make up for the missed dose.
If you stop treatment with Tationil
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
During treatment with Tationil, the following side effects may occur, which disappear upon discontinuation of therapy:
Effects related to the skin:

skin rashes

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You can also report side effects directly through the national reporting system at the website
www.agenziafarmaco.gov.it/it/responsabili .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tationil

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
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 any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Pack contents and other information

What Tationil contains

The active substance is: Glutathione (sodium salt) 600 mg
The other component is: water for injections

Description of the appearance of Tationil and pack contents
Tationil is supplied as vials containing a white powder and ampoules containing a clear, colourless injectable solution. It is available in the following pack: 10 vials of 600 mg powder and 10 ampoules of 4 ml solvent.
Teofarma S.r.l.
Via F.lli Cervi, 8 - 27010 Valle Salimbene (PV).
Manufacturer
Teofarma S.r.l.
Viale Certosa, 8/A - 27100 Pavia
Doppel Farmaceutici S.r.l.
Via Volturno, 48
20089 Quinto de’ Stampi – Rozzano (MI)