Decorenone

Package leaflet: Information for the patient

Decorenone 50 mg/10 ml oral solution

ubidecarenone
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if your symptoms worsen.

Contents of this leaflet:

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

1. What Decorenone is and what it is used for

Decorenone is a medicinal product containing ubidecarenone, used for the treatment of metabolic and functional disorders of the myocardium (heart muscle tissue). This medicine is used in cases of congenital coenzyme Q10 deficiency.
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Decorenone

Do not take Decorenone

• if you are allergic to ubidecarenone 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 Decorenone.
Other medicines and Decorenone
Inform 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, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
During the first 3 months of pregnancy, take Decorenone only if clearly needed and under direct medical supervision.
Driving and using machines
The effects of Decorenone on the ability to drive and use machines are unknown.
Decorenone contains sorbitol, castor oil, and sodium
This medicine contains 1750 mg of sorbitol per vial, equivalent to 175 mg/ml.
Sorbitol is a source of fructose. If your doctor has told you that you have an intolerance to certain sugars or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients are unable to metabolize fructose, speak with your doctor before taking this medicine.
Castor oil may cause gastrointestinal disturbances and diarrhea.
This medicine contains 20 mg of sodium benzoate per vial, equivalent to 2 mg/ml.
Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborns up to 4 weeks of age.
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. essentially "sodium-free".

3. How to take Decorenone

Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 bottle per day.
If you take more Decorenone than you should
Cases of overdose have not been reported.
In case of accidental ingestion/overdose of Decorenone, contact your doctor immediately or go to the nearest hospital.
If you forget to take Decorenone
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everyone experiences them.
The following adverse reactions have been reported:
Rare (may affect up to 1 in 1,000 people)

• gastric disturbances with loss of appetite, nausea, and diarrhea;
• skin rashes (allergy-related skin irritations).

Following the instructions contained 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, talk to your doctor or pharmacist.
You may also report side effects directly through the national reporting system at the website
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide further information on the safety of this medicine.

5. How to store Decorenone

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
The shelf life applies to the product in its original, undamaged packaging, stored correctly.
This medicine does not require any special storage conditions.
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 Decorenone contains

• The active substance is ubidecarenone. Each single-dose vial contains 50 mg of ubidecarenone.
• The other components are: sorbitol 70% (non-crystallizable), polyoxyl 40 hydrogenated castor oil, sodium benzoate, succinic acid, orange flavor, ammonium glycyrrhizinate, disodium edetate, sodium dehydroacetate, sodium saccharin, purified water.

Description of the appearance of Decorenone and contents of the pack
Oral solution in a single-dose vial.
Each pack contains 10 single-dose vials of 10 ml.
Marketing Authorization Holder
Italfarmaco S.p.A.
Viale F. Testi, 330
20126 Milan,
Italy
Manufacturer
ICE S.p.A.
Cantone Moretti, 29
10015 Ivrea (TO),
Italy