Pack Size: 60x 30mg capsules

Description:: Idebenone is a synthetic variant of Coenzyme Q10, having all its protective qualities and more. Idebenone is also a powerful anti-oxidant, and known to be 30 to 100 times more potent than vitamin E or vinpocetine.

Directions: Take 1 capsule, one to four times a day.

Supplement facts:

Serving size: 1 Capsule

Other ingredients: Rice flour in a gelatine capsule.

Disclaimer: This product and its statements have not been evaluated by the FDA. This product is not intended to treat, cure or prevent any disease.

Note: Keep out of reach of children. Not for use by pregnant or lactating women.

COMPOSITION
Each tablet contains 30 mg of Idebenone.

PHARMACEUTICAL FORM
Tablets to be taken orally.

PHARMACEUTICAL CATEGORY
Cerestabon belongs to the pharmaceutical category of analeptic medicines (II-7).

THERAPEUTICAL INDICATIONS
Treatment of symptoms associated with the cerebral pathology of vascular or degenerative aetiology such as lack of initiative; speech, memory, attention or psycho-motor activity disorders; or mood changes, associated with:

• Cerebral arteriosclerosis.
• Consequences arising from cerebral infarction or cerebral haemorrhage.
• Cognitive senile deficit.
• Chronic cerebral-vascular disease.
• Multi-coronary dementia.
• Slight or moderate Alzheimer’s-type dementia.

CONTRAINDICATIONS
Individual hypersensitivity to the main principle, Idebenone. In such cases Cerestabon treatment should be interrupted.

ADVERSE EFFECTS
Gastrointestinal: Possible cases of nausea, anorexia, epigastria and diarrhoea.
CNS: Occasional cases of nervousness. Rare cases have been reported of trembling, convulsions, hyper-kinesia, delirium, poriomania, hallucinations, headache, dizziness, restlessness, insomnia or drowsiness.
Blood: Occasional cases of erythrocytopenia and leucocytopenia.
Liver: Occasional cases of elevation of seric values of transaminases (TGO-S, TGP-S). gamma-GT, of seric albumin and LDH.

MEDICAL AND OTHER INTERACTIONS
Medical interactions have not been described.

PRECAUTIONS
Given that sufficient research has not been carried out concerning the safety of Cerestabon for children, Cerestabon must be administered with extreme care in paediatric patients.

EFFECTS ON PREGNANT WOMEN, NURSING MOTHERS, CHILDREN, THE ELDERLY, AND PATIENTS WITH SPECIAL PATHOLOGIES
Pregnancy: Because Cerestabon has still not been established as safe during pregnancy, it should not be taken by pregnant women or those who believe that they might be pregnant unless the doctor decides that the potential benefits may outweigh possible risks.
Breast-feeding: Since animal research has shown that Cerestabon is transferred to mother’s milk, this pharmaceutical product should be used with caution in the treatment of nursing mothers.
Children: As yet, there have been no studies carried out concerning the use and safety of Cerestabon for children.
Elderly patients: Prolonged studies show that Cerestabon is safe for administration to the elderly.
Pharmaco-kinetic studies have also revealed that the pharmaco-kinetic use of Cerestabon remains unaltered.
Patients with special pathologies:
Hepatic insufficiency: Clinical hepatic testing related to illnesses such as chronic hepatic pathology or cirrhosis in the absence of portal hypertension indicates that Idebenone is metabolised, not accumulated, and pharmaceutical parameters are not significantly modified.
Alteration of renal function: Clinical tests on patients with moderate alteration of the renal function (21-40 ml/min/1.73m2), show no significant alteration of the pharmaceutical profile of Idebenone.

EFFECTS ON THE CAPACITY TO DRIVE OR OPERATE MACHINERY
None.

LIST OF EXCIPIENTS THE KNOWLEDGE OF WHICH SHOULD BE KNOWN FOR THE CORRECT USE OF THIS PRODUCT
Sucrose and lactose.

REGULAR DOSAGE:
The usual recommended dosage for adults is 90 mg/day. This dosage may be modified depending on the age or clinical condition of the patient.
Cerestabon: Idebenone 30 mg. 1x 30-mg tablet, three times daily. It should be swallowed whole with a small amount of liquid following meals.
A maximum dosage has not been established. Do not exceed the usual dosage unless otherwise instructed by your doctor.

ADMINISTRATION METHOD
Administration: Orally. Swallow the tablet whole, if necessary with a small amount of liquid. Do not chew it.

WHEN TO TAKE THIS PRODUCT
Tablets should be taken immediately after meals.

AVERAGE DURATION OF TREATMENT
Not specified.

WHAT TO DO IN THE EVENT OF OMITTING ONE OR MORE DOSES
Start taking this product once again without altering the dosages initially recommended by your doctor.

STOPPING TREATMENT
There have been no reports on the effects of withdrawal resulting from stopping Cerestabon treatment
OVERDOSE AND/OR POISONING: SYMPTOMS, EMERGENCY METHODS AND REMEDIES
No reports are available concerning cases of toxicity resulting from overdose of this medicine.
Warning: Should the patient notice any adverse effect not described in this insert, he should consult his doctor or chemist. He is also advised to check the expiry date on the box.

SPECIAL STORAGE PRECAUTIONS
Store at room temperature.