HYDROXIA

PACKAGE LEAFLET

Package leaflet: information for the patient

HYDROXIA 600 mg/4 ml

powder and solvent for injectable solution
Glutathione
Equivalent medicine
Please read this leaflet carefully before using this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult 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 effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What HYDROXIA is and what it is used for
2. What you need to know before using HYDROXIA
3. How to use HYDROXIA
4. Possible side effects
5. How to store HYDROXIA
6. Package contents and other information

1. What HYDROXIA is and what it is used for

HYDROXIA contains the active substance glutathione (as the sodium salt) and belongs to a group of
medicines used to prevent nerve disorders (neuropathies) that may occur as a result of treatment with
anti-cancer drugs such as cisplatin or similar medicines.
If you do not feel better or feel worse after treatment, speak to your doctor.

2. What you should know before using HYDROXIA

Do not use HYDROXIA

• if you are allergic to the active substance 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 HYDROXIA.
Children
In children, safety and efficacy have not been established.
Other medicines and HYDROXIA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
No cases of pharmacological interactions with glutathione have been reported. At recommended doses, HYDROXIA does not interfere with the therapeutic activity of anticancer drugs.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Available data indicate that glutathione does not cause adverse effects in pregnant women or during breastfeeding.
Driving and using machines
HYDROXIA does not affect or affects negligibly the ability to drive or use machines.
HYDROXIA contains sodium
HYDROXIA contains 46 mg of sodium per vial, equivalent to 2.3% of the maximum daily intake recommended by the WHO, which corresponds to 2 g of sodium for an adult.

3. How to use HYDROXIA

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Adults
The recommended dose is:

• In more severe cases: 1–2 vials daily by intramuscular injection, slow intravenous injection, or added to intravenous infusions, or as otherwise prescribed by your doctor.
• In milder cases: half the above dose.

Instructions for use

1. Reconstitute the solution in the vial of powder by drawing up the water from the ampoule of solvent using a syringe equipped with a suitable needle.
2. Remove the aluminium cap from the vial and disinfect the rubber stopper with an alcohol-soaked cotton swab.
3. Insert the needle of the syringe into the vial through the center of the rubber stopper, directing the water flow against the glass wall of the vial.
4. Gently shake to ensure complete dissolution.
5. Administer the resulting solution by intramuscular or slow intravenous injection.
   • For intramuscular administration, the contents of the vial must be dissolved in the solvent provided in the ampoule of water for injections included in the package.
   • For intravenous administration, the contents of the vial may be dissolved in the solvent provided in the ampoule of water for injections included in the package and injected slowly by direct route, or may be further diluted in at least 20 ml of sterile infusion solution.

The reconstituted solution must be used immediately after preparation. The reconstituted solution should be clear, colourless, and free from visible particles. It is intended for single, uninterrupted administration, and any unused portion must be discarded.
Do not use if cloudiness or precipitate is observed.

If you use more HYDROXIA than you should
No cases of overdose have been reported. If necessary, symptomatic treatment may be administered.
If you are accidentally given more HYDROXIA than prescribed, contact your doctor or go to the nearest hospital immediately.

If you have any doubts about the use of HYDROXIA, consult your doctor, nurse, or pharmacist.

If you forget to take HYDROXIA
Since the injection will be administered by a nurse or doctor, it is unlikely that a dose will be missed. However, if you are concerned, speak to your doctor.

If you stop using HYDROXIA
If you have any doubts about using this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Below are the side effects associated with glutathione.

• Very rarely skin rashes, which generally disappear when the drug is discontinued
• Pain at the injection site
• Rare cases of nausea, vomiting and headaches
• Fever, injection site infections, formation of blood clots in the veins (venous thrombosis), inflammation of the veins (venous phlebitis) and extravasation.

If an immediate adverse reaction occurs during intravenous infusion, the doctor or pharmacist will stop administration and, if possible, retain the unused product for potential testing.
Following the instructions provided in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following address:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store HYDROXIA

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. The expiry date refers to the product in its original intact packaging, properly stored.
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. Contents of the pack and other information

What HYDROXIA contains
The active substance is sodium glutathione 646 mg, equivalent to glutathione 600 mg.
The other component is water for injections, contained in the solvent vial.
Description of the appearance of HYDROXIA and contents of the pack
The carton contains 10 vials of powder and 10 solvent vials of 4 ml.
Marketing Authorization Holder
ESSETI Farmaceutici S.r.l., Via R. De Cesare, 7, 80132 Napoli (NA), Italy
Esseti Farmaceutici S.r.l., Via Campobello, 15 – 00071 Pomezia (Rome)
Biomedica Foscama, Via Morolense, 87 - 03013 Ferentino (Frosinone)