Q10®

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Q10®

Q10® 10 mg Capsules

Ubidecarenone

PACKAGE LEAFLET

Q10 10 mg capsule

Ubidecarenone

Read all of this leaflet carefully before you start taking this medicine.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist.

What is in this leaflet

1. What Q10 is and what it is used for

2. Before you take Q10

3. How to take Q10

4. Possible side effects

5. How to store Q10

6. Other information

1. What Q10 is and what it is used for

Q10 is indicated in the treatment of diseases where there is a deficiency in coenzyme Q10:

–     in mitochondrial cytopathies, namely myocardiopathies and encephalopathies due to disorders of the cell respiratory chain.

Pharmacotherapeutic classification: 3.1.2 Other cardiac preparations.

2. Before you take Q10

Do not take Q10:

– if you have allergy (hypersensitivity) to ubidecarenone or any of the other ingredients of the medicine.

Take special care with Q10

– if you suffer from biliary obstruction or hepatic impairment since potential accumulation of ubidecarenone may occur.

Other medicines and Q10

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those without medical prescription. If you are receiving warfarin the administration of Q10may lead to a decrease in the anticoagulant action of this substance, given the structural similarity that ubidecarenone has with Vitamin K2.

Q10 with food and drink

Not relevant.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Q10 should only be used during the first quarter of pregnancy if the doctor considers that its benefit is justified.

Driving and using machines

No effects have been observed on the ability to drive and use machines.

Important information about some of the ingredients of Q10

This medicinal product contains lactose.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Q10

Always take Q10 exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is 1 capsule 3 times a day. The posology may be different from the one mentioned in the leaflet if stated in a medical prescription. Q10 is to be administered orally. Q10 must be ingested with half a glass of water, after meals, or in accordance with medical prescription. The duration of the treatment varies, depending on the symptoms and medical advice.

If you take more Q10 than you should

In case of an overdose no other severe side effects rather than those mentioned in this leaflet have been observed.

In case the patient experiences any other side effects besides those described in this leaflet, associated with the ingestion doses higher than the ones described in the usual posology of this medicine, the patient must immediately head to the closest hospital/health unit, carrying the medicine package with him.

If you forget to take Q10

Do not take a double dose to make up for a forgotten dose.

When such situation happens, you must follow the usual posology regimen.

If you stop taking Q10

Not applicable.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Q10 can cause side effects in some people.

Ubidecarenone is considered a well tolerated substance and no adverse reactions of the idiosyncratic type are known.

However, with the oral use of ubidecarenone some side effects may occur such as:

  • Gastric disturbances (epigastric discomfort)
  • Nausea
  • Anorexia (which translates into lack of appetite)
  • Diarrhea
  • Cutaneous rash

These undesirable effects have been observed in less than 1% of the patients treated with oral ubidecarenone.

If you get any side effects, or if any of the side effects worsens, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. How to store Q10

Do not store below 25ºC.

Keep out of the reach and sight of children.

Do not use Q10 after the expiry date which is stated on the outer carton. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Other information

What Q10 contains

The active substance is Ubidecarenone, 10 mg.

The other ingredients are: lactose; microcrystalline cellulose; silica, colloidal anhydrous; magnesium stearate and pregelatinised starch.

What Q10 looks like and contents of the pack

Q10 is presented in the form of capsules for oral intake.

Pack sizes of 20 and 60 capsules.

Marketing Authorisation Holder and Manufacturer

SIDEFARMA – Sociedade Industrial de Expansão Farmacêutica, S.A.

Rua da Guiné, nº 26, 2689-514 Prior Velho.

Should you need any other information on this medicine, please contact the Marketing Authorization Holder local representative or the Marketing Authorization Holder.

This leaflet was last approved in 31/08/2006