The following 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 / CERESTABON Cerestabon Idebenone 30 mg: Available in boxes of 20 and 60 tablets. INGREDIENTS: Each tablet contains 30 mg of Idebenone. PHARMACEUTICAL FORM Tablets to be taken by mouth. PHARMACEUTICAL-THERAPEUTIC CATEGORY Cerestabon belongs to the pharmaceutical-therapeutic category of analeptic drugs (II-7). THERAPEUTIC INDICATIONS For treating symptoms associated with vascular and degenerative cerebral pathologies such as reduced volition, speech impairments, memory loss, reduced attention span, psychomotor activity, and depression associated with: - Cerebral arteriosclerosis
- Consequences of stroke and cerebral haemorrhage
- Cognitive deficit related to senility
- Chronic cerebrovascular disease
- Multi-infarction dementia
- Mild or moderate senile dementia of the Alzheimer's type
CONTRAINDICATIONS Hypersensitivity to the main active ingredient, Idebenone. In such cases, Cerestabon treatment should be stopped. SIDE EFFECTS Gastrointestinal: Nauseas, anorexia, epigastralgia and diarrhoea may occur.
Central nervous system: May occasionally produce agitation. Rare cases have been reported of involuntary movements such as tremors, convulsions, hyperkinesias, delirium, poriomania, hallucinations, headaches, giddiness, restlessness, insomnia or drowsiness.
Blood: May occasionally cause erythrocytopenia and leukocytopenia.
Liver: May occasionally cause an increase of seric transaminases (TGO-S, TGP-S), (-GT, seric albumin and LDH
Kidneys: May occasionally cause kidney failure.
Other: Uneasiness, increased cholesterol and triglycerides. DRUG INTERACTIONS AND OTHER INTERACTIONS No cases of drug interactions have been described. SPECIAL PRECAUTIONS FOR USE Given the lack of studies on the use and safety of Cerestabon in children and infants, Cerestabon should be administered with caution to this age group. EFFECTS ON PREGNANT WOMEN, NURSING MOTHERS, CHILDREN, THE ELDERLY, AND PATIENTS WITH SPECIAL PATHOLOGIES: Pregnancy: Since it has not been proven that CERESTABON is safe to use during Pregnancy, pregnant women should not take this pharmaceutical product or by those who believe they may be pregnant, unless the doctor believes that the potential benefits of the product will outweigh any possible risks.
Lactation: Because animal testing has shown that Cerestabon is transferred to mother's milk, this pharmaceutical product should be used with caution when treating women during lactation.
Children: No studies are available on the use and safety of Cerestabon when taken by children.
Elderly patients: Long-term studies have shown that Cerestabon is a safe pharmaceutical product for long-term use by the elderly.
Pharmacokinetic studies have revealed that the pharmacokinetic profile is not altered.
Patients with special pathologies
Hepatic insufficiency: Clinical testing on patients with chronic hepatic pathology or cirrhosis in the absence of portal hypertension show that Idebenone is metabolised, does not accumulate, and that pharmacokinetic parameters are not significantly altered.
Altered renal functions: Clinical tests on patients with moderately altered renal function (21-40 ml/min/1.73m2) have not revealed any significant alteration in the pharmacokinetic profile of Idebenone. EFFECTS ON DRIVING OR OPERATING MACHINERY None LIST OF EXCIPIENTS, THE KNOWLEDGE OF WHICH IS NECESSARY FOR PROPER USE OF THIS PHARMACEUTICAL PRODUCT Contains sucrose and lactose RECOMMENDED DOSAGE: The recommended daily dosage for adults is 90 mg. This dosage can be modified, depending on the patient's age and clinical condition. Cerestabon Idebenone 30 mg: 1 tablet, three times daily. Swallow the tablet whole with a little liquid after meals. Do not chew. No maximum dose has been established. Patients are urged not to exceed the recommended dosage, unless the doctor indicates otherwise. DIRECTIONS FOR USE: To be taken by mouth.
Swallow the tablet whole, without chewing, with a little liquid. BEST TIME FOR TAKING THIS MEDICATION The tablets should be taken after meals. WHEN ONE OR MORE DOSES HAVE BEEN MISSED Begin taking the pharmaceutical product once again, without altering the dosage initially prescribed by your doctor. DIRECTIONS FOR STOPPING TREATMENT The effects caused by stopping CERESTABON treatment are unknown. WHAT TO DO IN THE EVENT OF OVERDOSE AND/OR POISONING, MAIN SYMPTOMS, EMERGENCY MEASURES AND REMEDIES The symptoms of poisoning as a result of overdose of this pharmaceutical product have not been described. WARNING The user should report any adverse side effects to his doctor or chemist, especially any side effects that are not included in this insert. Check the expiry date on the box. SPECIAL STORAGE PRECAUTIONS: Store at room temperature Overview | 
