UBIMAIOR 50 mg Hard Capsule

Зміст інструкції

1. Ubimaior 50 mg hard capsules
   1. What is Ubimaior and what is it used for
   2. What you need to know before you take Ubimaior
   3. How to take Ubimaior
   4. Possible side effects
   5. How to store Ubimaior
   6. Contents of the pack and other information

Ubimaior 50 mg hard capsules

Ubidecarenone

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Ubimaior and what is it used for

Ubimaior is a medicine based on ubidecarenone (coenzyme Q10).
Ubimaior is indicated in subjects who have been born with a deficiency of coenzyme Q10.

2. What you need to know before you take 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
Tell 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 are pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
During the first three months of pregnancy, take this medicine only if absolutely necessary and
under direct medical supervision.

Driving and using machines
Ubimaior does not alter the ability to drive vehicles or use machines

Ubimaior contains lactose
This medicine contains lactose (milk sugar). If your doctor has diagnosed you with intolerance
to certain sugars, contact them before taking this medicine.

3. How to take Ubimaior

Take this medicine following the instructions of your doctor exactly, who will indicate the
correct dose. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one capsule a day, unless otherwise prescribed by your doctor.

If you take more Ubimaior than you should
If you accidentally take an excessive dose of Ubimaior, contact your doctor.

If you forget to take Ubimaior
Do not take a double dose to make up for the forgotten capsule.

If you stop taking Ubimaior
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 everyone will experience side
effects.
If you experience the following side effects during treatment with Ubimaior, STOPthe
treatment and consult your doctor:

Effects concerning the skin

• skin lesions (skin rashes).

Effects concerning the stomach and intestines

• stomach disorders;
• loss of appetite;
• nausea;
• diarrhea.

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 https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse .
Reporting side effects 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 take this medicine after the expiry date which is reported on the pack after the writing
EXP. The expiry date refers to the last day of that month. This date applies to the
product in intact packaging, correctly stored.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ubimaior contains

• the active ingredient is: Ubidecarenone (50 mg per capsule)
• the other ingredients are: Lactose(see paragraph “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 contents of the pack
Ubimaior 50 mg hard capsules packaged in blisters of 14 capsules.

Marketing Authorisation Holder and manufacturer
Marketing Authorisation 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)