Product Information: Idebenone

Product Information
An amazing anti-oxidant

This product has been widely used in the Far East to protect aging individuals from a wide variety of complaints. Idebenone is a cerebral stimulant and increases brain energy levels, and it is also used for strokes. Idebenone is one of the safest and most potent antioxidants known to man Idebenone is a cerebral stimulant that increases brain energy levels and has a rejuvenating effect on the whole body

Idebenone is one of the safest and most potent antioxidants known to man.

Idebenone is a synthetic variant of one of life's most essential biochemicals, Coenzyme Q10 (Co Q10). Co Q10 is an important antioxidant component of the lipid (fatty) membranes that surround all cells, as well as the lipid membranes surrounding the various organelles ("little organs"), such as mitochondria and microsomes, inside cells.

Co Q10 is also an important member of the Electron Transport Chain (ETC) within mitochondria, which are the ‘power plants’ of the cell. Most of the oxygen we breathe is used inside the electron transport chain to produce much of the ATP bioenergy that powers virtually every activity of our cells and bodies.

When blood flow is seriously reduced to any part of the body - as in a heart attack, stroke, trauma, shock or chronic poor blood circulation - cellular/ mitochondrial oxygen (O2) levels quickly drop in the affected region. Free radicals quickly damage cell/organelle structure and function, as well as rapidly halt ATP energy generation by the electron transport chain. Brain and spinal cord cells are especially prone to such damage, and may be irreparably damaged or even destroyed within minutes.

Studies have shown that in such circumstances Idebenone prevents the free radical damage and maintains relatively normal cell ATP levels. In short, while Idebenone can effectively substitute for Co Q10's positive and life essential functions, it doesn't have Co Q10's free radical producing feature which occurs under hypoxic (low oxygen) conditions.

Idebenone's potential benefits fall into five categories:

1. Anti-aging
2. Energy enhancement
3. Cognition enhancement
4. Organ protector
5. Protector against excitatory amino acid neurotoxicity

Anti-aging benefits
The mitochondrial power plants produce over 90% of all cellular ATP bioenergy. They are also generally the richest sites in Co Q10 (or Idebenone). Mitochondrial DNA (mtDNA) allows mitochondria to reproduce themselves.

Over the course of a lifetime our mtDNA becomes ever more damaged, and the mitochondria produced become ever more ineffective in their energy generation.

Studies comparing heart tissue from young people with that from elderly people have shown almost no significant mitochondrial dysfunction in young hearts, with significant, often severe mitochondrial dysfunction in elderly hearts. The cells that are most susceptible to mitochondrial energy depletion with advancing age are the brain, skeletal muscle and heart muscle cells.

Idebenone, therefore, provides an anti-aging effect here in several ways. Unlike Co Q10, even under the low oxygen conditions that may occur periodically over a lifetime, Idebenone will serve as a powerful mitochondrial free radical quencher, lessening the ever-increasing mtDNA damage that occurs with age. Idebenone will work even better than Co Q10 within the electron transport chain to keep energy production high, even under hypoxic conditions. This is especially critical to brain and heart cells that may be rapidly damaged during low ATP production episodes that occur due to poor tissue oxygenation.

A variety of studies using brain cells (animal and human) have shown Idebenone's ability to enhance brain structure and function. These tests have demonstrated that Idebenone can enhance serotonin production, even under far less than optimal conditions, such as in patients with cerebrovascular dementia.

Dosage:
Take one 30mg tablet two or three times daily

Side effects:
Possible gastrointestinal disturbances, dizziness, headaches, anxiety and uneasiness and sleep alterations.

Caution:
Although studies in animals have shown no harmful effects, this product should not be taken during the first three months of pregnancy and during nursing, only when absolutely necessary and always under a doctor’s supervision.

Manufacturers Insert

CERESTABON / IDEBENONE

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.

The above information is the translation of the manufacturer's insert. It is provided under the supplying company's terms and conditions and should not replace the advice of your personal physician.

IDEBENONE/ MNESIS®

Chemical:
Idebenone

Excipients:
Monohydrate lactose, carboxymethyl cellulose, pre-gelatinized, starch, magnesium stearate, sucrose, titanium dioxide, talc, gum arabic, magnesium carbonate, phtalic polyvinyl acetate.

Properties:
Idebenone is a chemical derivative of benzochinone. Numerous laboratory and volunteer based research tests have shown that Idebenone is able to correct biochemical alterations associated with cerebral suffering. In fact it contrasts with the minimal synthesis of ATP, the minimal use of glucose and the increase of lactic acid. Laboratory test have also shown that Idebenone inhibits lipid peroxidation, protecting the neuronal membrane and the mitochondrions from the damage caused by the lipoperoxide products, used in treating ischaemia. It has finally been demonstrated that Idebenone improves learning time and memory activity in aging experimental animals and in those suffering from cerebral ischaemia. Such an effect is traced back to a positive influence of that carried out in the comparison of the synthesis, and the turnover of serotonin and acetylcholine. Recent clinically controlled studies have confirmed the effectiveness of Idebenone in syndromes involving mental deterioration due to numerous causes, characterized by cognitive- behavioral disturbances (loss of memory, attention span, concentration, and psycho-affective disorders).

Pharmakonetics:
Taken by mouth, Idebenone is quickly absorbed and the maximum plasmatic levels are observed approximately 4 hours following the dosage. The product is metabolized into the hepatic area. Taking the product after the evening meal improves its absorption. Idebenone does not tend to accumulate even when taken over a prolonged period. Experimental date has shown that Idebenone crosses the haemoencephalic barrier and is distributed in significant concentrations at the level of the brain tissue. Elimination normally takes place by means of the kidneys.

Information for the User:
This product is recommended for the treatment of cognitive behavioral loss due to vascular and degenerative cerebral pathologies.

Directions:
Recommended dosage is 1 tablet twice a day after meals.

Warning:
Although studies in animals have shown no harmful effects, this product should not be taken during the first three months of pregnancy and during nursing, only when absolutely necessary and always under a doctor’s supervision.

Contraindications:
Individual hypersensitivity to the product.

Side Effects:
Taking this product may cause the following side effects- gastrointestinal disturbances, dizziness, headaches, anxiety, and uneasiness and sleep alterations. There are possible alterations of certain laboratory parameters owing to transaminase and of haemochrome. Such side effects are mild and disappear when treatment is stopped.