Ubimaior

Package leaflet: Information for the user

Ubimaior 50 mg hard capsules

Ubidecarenone
Please read this leaflet carefully before taking 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 they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Ubimaior is and what it is used for

Ubimaior is a medicinal product containing ubidecarenone (coenzyme Q10).
Ubimaior is indicated in subjects with a congenital deficiency of coenzyme Q10.

2. What you need to know before taking Ubimaior

Do not take Ubimaior

• 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 Ubimaior.
Other medicines and Ubimaior
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
During the first three months of pregnancy, take this medicine only if clearly needed and under direct medical supervision.
Driving and using machines
Ubimaior does not affect the ability to drive vehicles or use machinery.
Ubimaior contains lactose
This medicine contains lactose (milk sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Ubimaior

Take this medicine exactly as instructed by your doctor, who will tell you the correct dose. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one capsule daily, unless otherwise prescribed by your doctor.
If you take more Ubimaior than you should
If you accidentally take too high a dose of Ubimaior, contact your doctor.
If you forget to take Ubimaior
Do not take a double dose to make up for the missed capsule.
If you stop taking Ubimaior
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 everyone gets them.
Following the instructions contained in this leaflet reduces the risk of side effects.
If you experience the following side effects while taking Ubimaior, STOP treatment and consult your doctor:

Effects affecting the skin

• skin lesions (rashes).

Effects affecting the stomach and intestine

• stomach discomfort;
• loss of appetite;
• nausea;
• diarrhoea.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult 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 more information on the safety of this medicine.

5. How to store Ubimaior

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions. Store in the
original packaging to protect it from light.
Do not use this medicine after the expiry date stated on the carton after the word
EXP. The expiry date refers to the last day of that month. This date applies to the product
in its original, undamaged packaging and correctly stored.
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 Ubimaior contains

• The active substance is: Ubidecarenone (50 mg per capsule)
• The other components are: Lactose (see section “Ubimaior contains lactose”), insoluble polyvinylpyrrolidone, polyvinylpyrrolidone, talc, hydrated colloidal silica, sodium lauryl sulfate, magnesium stearate, erythrosine (E127), iron oxide (E172), titanium dioxide (E171), gelatin.

Description of the appearance of Ubimaior and pack contents
Ubimaior 50 mg hard capsules, packaged in blisters of 14 capsules.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
CHIESI FARMACEUTICI S.p.A.
Via Palermo 26/A – 43122 Parma
Manufacturer
Doppel Farmaceutici S.r.l., via Volturno, 48 – Quinto De Stampi - Rozzano (MI)