Anacervix Forte, coated tablets

NAME OF THE MEDICAL PRODUCT
Anacervix Forte (Piracetam + Vincamine)

Anacervix is an original medicine, of clear therapeutic interest, constituted by the active ingredient of vinca minor L (vincamine) and Piracetam (2 – pyrrolidin- Acetamide).

Vincamina is a true cerebral metabolic oxygenator, which by its selective vasoregulator action on the encephalic area improves irrigation and the nutrition of the cerebral parenchyma.

Piracetam is a specific activator of the synergism and metabolism of the cerebral cortex, which increases cellular energetic reserves and the oxidoreduction potential, thus enhancing the associative function of the brain and the transference of information from a cerebral hemisphere to the other. It reinforces the resistance of brain cells to anoxia and reduces the post-anoxic recovery period

Anacervix is, therefore, an effective treatment of vascular processes that occur with hypoxia and metabolic alterations, both in the senile and pre-senile age and as in all cases where there is an alteration in brain oxygenation and metabolism and a decrease of the mental functions.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains:
Active substances: Piracetam: 600 mg and Vincamine: 15 mg

PHARMACEUTICAL FORM AND CONTENT
Coated tablets. Package with blisters of 20 or 60 tablets.

PHARMACOTHERAPEUTIC CLASS
Group IV-4-a) Cerebral and/or peripheral vasodilatators.

MARKETING AUTHORIZATION HOLDER
L. Lepori, Lda
Rua João Chagas, 53, Piso 3
1495-072 Algés

THERAPEUTIC INDICATIONS
Progressive and chronic cerebral impairment; cerebral impairment due to acute vascular accidents and brain traumatisms; organic and psychological disorders of cerebral hypoxia; learning difficulties; behaviour disorders, neuronal intoxications, etc.

CONTRAINDICATIONS AND SIDE EFFECTS
Cerebral neoformation with intracraneal hypertension. Its use is not recommended in case of severe hepatic or renal impairment. Although no teratogenic effects were reported, it is advisable not to administer during pregnancy and lactation.

DRUG INTERACTIONS AND OTHER FORMS OF INTERACTION
Anacervix may potentiate the action of barbiturates and antagonize the effect of amphetamines.

SPECIAL PRECAUTIONS FOR USE
Its use is not recommended in case of severe hepatic or renal impairment.

Keep the medicine out of reach and sight of children.

EFFECTS ON PREGNANT WOMEN, BREAST-FEEDING WOMEN, CHILDREN, ELDERLY PATIENTS AND PATIENTS WITH SPECIAL PATHOLOGIES
Although no teratogenic effects were reported, it is advisable not to administer the product during pregnancy and lactation.

EFFECTS ON THE ABILITY TO DRIVE AND USE MACHINES
The use of Anacervix does not impair the ability to drive and use machines.

MEDICINAL PRODUCTS AND FOOD ABLE TO ALTER THE EFFECT OF THE DRUG
The medication effect can be altered by milk or antacids; allow a one-hour at least interval before taking the laxative.
Concomitant use of diuretics, cardiac glycosides or adrenocorticosteroids may foster development of electrolytic disequilibrium.
Laxatives can reduce intestinal residence time, and thus absorption, of other medicinal products concomitantly administered oral.
Therefore, avoid the concomitant ingestion of laxatives and other medications: after taking a medicinal product, allow a 2-hour at least interval before ingesting the laxative.
If you are using other medications, ask your doctor or pharmacist for advice.

LIST OF EXCIPIENTS
Polyvinylpirrolidone (Kolidon 30), Corn starch, Pure Lactose (Granulac 200) and vegetable magnesium stearate. Coating: Hypromelose E4M Premium, Ethylcellulose, Tween 80, Cellulose Acetophtalate and Ricin oil.

USUAL POSOLOGY, WITH REFERENCE TO MAXIMUM DOSE
3 tablets during main meals.

Oral route administration.

INDICATION OF THE MOST FAVOURABLE MOMENT FOR THE ADMINISTRATION OF THE MEDICINE
During main meals.

DURATION OF THE AVERAGE TREATMENT WHEN IT SHOULD BE LIMITED
Not applicable

INDICATION OF HOW TO DISCONTINUE THE TREATMENT WHEN ITS DISCONTINUATION CAUSES WITHDRAWAL EFFECTS
Not applicable.

MEASURES TO ADOPT IN CASE OF OVERDOSAGE AND/OR INTOXICATION, EMERGENCY SYMPTOMS AND ANTIDOTES
The possible administration of very high doses (many times superior to those used in the clinical practice may lead to digestive disorders, diarrhoea and hypotension. In these cases, diuresis should be induced and eventually it should be administered 0.25 mg of atropine sulphate.

ADVICE TO THE PATIENT
If you notice any side effect not mentioned in this leaflet, please inform your doctor or pharmacist.

Check if the product is within the expiry date mentioned in the package. Keep the medicines out of reach and sight of children.

Medicine subject to medical prescription.

SPECIAL PRECAUTIONS FOR STORAGE

Do not store above 25ºC.

DATE OF THE LAST REVISION OF THE LEAFLET: December 2003.

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