DECORENONE 50 mg Hard Capsule

Зміст інструкції

1. Decorenone 50 mg hard capsules
   1. What is Decorenone and what is it 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. Package contents and other information
2. Decorenone 50 mg/10 ml oral solution
   1. What is Decorenone and what is it used for
   2. What you need to know before you take Decorenone
   3. How to take Decorenone
   4. Possible side effects
   5. How to store Decorenone
   6. Contents of the pack and other information
3. Decorenone 10 mg tablets
   1. What is Decorenone and what is it used for
   2. What you need to know before you take Decorenone
   3. How to take Decorenone
   4. Possible side effects
   5. How to store Decorenone
   6. Contents of the pack and other information

Decorenone 50 mg hard capsules

Ubidecarenone

Read 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 told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better 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 you take 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 is Decorenone and what is it used for

Decorenone is a medicine based on ubidecarenone for the treatment of metabolic and functional alterations 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
Consult your doctor or pharmacist before taking Decorenone.

Other medicines and Decorenone
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 are pregnant, or are planning a pregnancy, or if you are breastfeeding with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
During the first 3 months of pregnancy, take Decorenone only if absolutely necessary and under the direct supervision of your doctor.

Driving and operating machinery
The effects of Decorenone on the ability to drive and operate machines are unknown.

Decorenone contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact them before taking this medicine.

Decorenone contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially ‘sodium-free’.

3. How to take Decorenone

Take this medicine following the instructions provided 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 capsule per day.

If you take more Decorenone than you should
Cases of overdose have not been described.
If you accidentally ingest/take an excessive dose of Decorenone, immediately notify your doctor or go to the nearest hospital.

If you forget to takeDecorenone
Do not take a double dose to make up for a missed dose.
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 gets them.
The following side effects have been reported:

Rare(may affect up to 1 in 1,000 people)

• gastric disorders with loss of appetite, nausea and diarrhoea;
• skin rashes (skin irritation from allergic reaction).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects you can help provide more 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 which is stated on the packaging. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in 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 ingredient is ubidecarenone. Each hard capsule contains 50 mg of ubidecarenone.
• The other ingredients are: lactose, colloidal silicon dioxide, sodium lauryl sulfate, magnesium stearate. The capsule components are: gelatin containing titanium dioxide (E 171), erythrosine (E 127), ferric oxide (E 172).

Description of the appearance of Decorenone and package contents
hard capsules in PVC/Al blisters.
Each pack contains 14 capsules.

Marketing authorisation holder and manufacturer
Italfarmaco S.p.A. – V.le F. Testi, 330 – 20126 Milano

Decorenone 50 mg/10 ml oral solution

ubidecarenone

Read this leaflet carefully before taking this medicine as it contains
important information for you.
Always take this medicine exactly as described in this leaflet, or as your doctor
or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you would like more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See your doctor if you do not feel better or if your symptoms get worse.

Contents of this leaflet:

• 1. What Decorenone is and what it is used for
• 2. What you need to know before you take 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 is Decorenone and what is it used for

Decorenone is a medicine based on ubidecarenone for the treatment of metabolic and functional alterations of the myocardium (heart muscle tissue). This medicine is used in cases of congenital coenzyme Q10 deficiency.
See your doctor if you do not feel better or if you feel worse.

2. What you need to know before you take 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
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, are planning to become pregnant, or are breastfeeding with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
During the first 3 months of pregnancy, take Decorenone only if absolutely necessary and under the direct supervision of your doctor.

Driving and using machines
The effects of Decorenone on the ability to drive and operate 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 are intolerant to some sugars or if you have a diagnosis of hereditary fructose intolerance, a rare genetic disease in which patients cannot metabolize fructose, talk to your doctor before taking this medicine.
Castor oil may cause stomach upset and diarrhea.
This medicine contains 20 mg of sodium benzoate per vial equivalent to 2mg/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 following exactly as indicated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 vial per day.

If you take more Decorenone than you should
Cases of overdose have not been described.
In case of accidental ingestion/intake of an excessive dose of Decorenone, immediately inform your doctor or go to the nearest hospital.

If you forget to takeDecorenone
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported:

Rare(may affect up to 1 in 1,000 people)

• gastric disorders with loss of appetite, nausea and diarrhoea;
• skin rashes (skin irritations on an allergic basis).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more 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 which is stated on the packaging. The expiry date refers to the last day of that month.
The period of validity refers to the product in intact packaging, correctly
stored.
This medicine does not require particular storage conditions..
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Decorenone contains

• The active ingredient is ubidecarenone. Each vial contains 50 mg ubidecarenone.
• The other ingredients are: sorbitol 70%(non-crystallizing),hydrogenated castor oilpolyoxyethylenated 40, sodium benzoate, succinic acid, orange flavour, 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 Authorisation Holder
Italfarmaco S.p.A. - Viale F. Testi, 330 - 20126 Milan

Manufacturer
ABC Farmaceutici S.p.A. - Via Cantone Moretti, 29 - 10090 San Bernardo d’Ivrea (TO)

Decorenone 10 mg tablets

ubidecarenone

Read 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 told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms get worse.

Contents of this leaflet:

• 1. What Decorenone is and what it is used for
• 2. What you need to know before you take 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 is Decorenone and what is it used for

Decorenone is a medicine based on ubidecarenone for the treatment of metabolic and functional alterations of the myocardium (heart muscle tissue). This medicine is used in cases of congenital coenzyme Q10 deficiency.
See your doctor if you do not feel better or if you feel worse.

2. What you need to know before you take 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
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, or are planning a pregnancy, or if you are breastfeeding with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
During the first 3 months of pregnancy, take Decorenone only if absolutely necessary and under the direct supervision of your doctor.

Driving and using machines
The effects of Decorenone on the ability to drive and operate machines are unknown.

Decorenone contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact them before taking this medicine.

3. How to take Decorenone

Take this medicine following exactly as indicated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 tablet three times a day, after meals.
If necessary and only after speaking with your treating doctor, the dose may be increased
to 2 tablets three times a day (up to a maximum of 6 tablets per day).

If you take more Decorenone than you should
Cases of overdose have not been described.
In case of accidental ingestion/intake of an excessive dose of Decorenone, immediately notify
your doctor or go to the nearest hospital.

If you forget to takeDecorenone
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported:

Rare(may affect up to 1 in 1,000 people)

• gastric disorders with loss of appetite, nausea and diarrhoea;
• skin rashes (skin irritations on an allergic basis).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more 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 which is stated on the packaging. The expiry date refers to the last day of that month.
Do not dispose of any medicine in 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 Decorenone contains

• The active ingredient is ubidecarenone. Each tablet contains 10 mg of ubidecarenone.
• The other ingredients are: lactose, microcrystalline cellulose, corn starch, hydroxypropylmethylcellulose, colloidal silicon dioxide, magnesium stearate.

Description of the appearance of Decorenone and contents of the pack
tablets.
in PVC/Al blisters.

Marketing Authorisation Holder
Italfarmaco S.p.A. Viale F. Testi, 330 – 20126 Milano

Manufacturer
Italfarmaco S.p.A. Viale F. Testi, 330 – 20126 Milano