Q10^® Forte, 30 mg of Ubidecarenone (Coenzyme Q10), capsule.

Each capsule of Q10^® Forte contains 30 mg of ubidecarenone (coenzyme Q10) and excipient q.s. for one capsule.

Q10^® Forte is presented in the form of a capsule for oral use.

Q10^® Forte belongs to the pharmacotherapeutic group IV – 1 – b (medicinal products for the cardiovascular system – other cardiac preparations (cardiotonic and therapeutic adjuvants).

ATC code: C01EB09

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

Address: Rua da Guiné, nº 26 – 2689-514 Prior Velho

Country: Portugal

Q10^® Forte 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.

• as adjuvant treatment of hypercholesterolemia, in patients receiving prolonged treatment with HMG-CoA reductase inhibitors, which inhibit the synthesis of coenzyme Q10.

• as adjuvant or coadjuvant treatment of congestive cardiac insufficiency in patients not responding well to conventional therapy, particularly if medicated with HMG-CoA reductase inhibitors (statins).

Q10^® Forte is contraindicated in cases of hypersensitivity to the active substance or any of the other ingredients of the medicine.

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.

In patients receiving warfarin the administration of Q10^® Forte may lead to a decrease in the anticoagulant action of this substance, given the structural similarity that ubidecarenone has with Vitamin K₂.

Special care with the use of Q10^® Forte is advised in patients with biliary obstruction and in patients with hepatic impairment since potential accumulation of ubidecarenone may occur.

During pregnancy and breast-feeding ask your doctor before taking any medicine.

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

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

The excipients in Q10^® Forte are: lactose anhydrous; microcrystalline cellulose; silica, colloidal anhydrous; magnesium stearate; pregelatinised starch.

The recommended dose for Q10^® Forte 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^® Forte is for oral use.

Q10^® Forte must be ingested with half a glass of water.

Q10^® Forte must be taken after meals, or in accordance with the doctor’s prescription.

The duration of treatment varies according to symptoms and medical advice.

Whenever one or more doses are forgotten, the usual posology regimen must be followed.

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 have any further questions on the use of this medicine, 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 not mentioned in this leaflet, talk to your doctor or pharmacist.

Check the expiry date which is stated on the outer carton of the medicine.

Do not use this medicine after the expiry date is over.

Keep this medicine out of the sight and reach of children.

Do not store below 25ºC.

Do not throw away any medicines into household waste.

Return medicines with an expired date to the pharmacy.

Date of last revision

March 2004