Fave di Fuca

NAME OF THE MEDICINE COATED TABLETS

Composition
One coated tablet contains: 126 mg dry extract of Fucus vesiculosus (alginic acid higher than 12%); 170 mg dry extract of Cascara sagrada (anthraglucosides higher than 7%); 222 mg dry extract of Frangola (antra-glucosides higher than 2,5%).

Pharmaceutical form
Fave di Fuca are available in the form of coated tablets for oral use.

Clinical instructions
Therapeutical instructions: Short term treatment for occasional constipation.

Dosage and administration
From 2 to 4 covered tablets, according to necessity. The correct dosage corresponds to the minimum quantity sufficient to guarantee easy evacuation of soft faeces. Initially, it is recommended to use minimum dosage levels. If necessary, dosage can be subsequently increased, without ever exceeding the maximum indicated level. To be taken preferably in the evening. Laxatives should be used only when strictly necessary and treatment must never last longer than 7 days. Prolonged use requires a medical prescription, always preceded by a careful evaluation of single cases. Swallow whole with an adequate quantity of water (i.e. a full glass). A diet rich in liquids helps the efficacy of the medicine.

Contraindications
Hypersensitivity to active principles or any of the excipients. Laxatives are contraindicated in patients affected by sharp abdominal pain of unknown origin, nausea or vomit, intestinal obstruction or stenosis, rectal bleeding of unknown origin, acute dehydration, colitis and enteritis. Contraindicated during pregnancy and breast-feeding . Generally contraindicated in paediatric age.

Special instructions and precautions for use
Instructions: The abuse of laxatives (frequent or prolonged use or excessive dosage) can cause persistent diarrhoea and
subsequent loss of water, mineral salts (especially potassium) and other essential nutritional substances. In the most serious cases, the onset of dehydration or hypopotassemia can cause heart or neuromuscular disorders, especially in the case of contemporary treatment with cardiac glycosides, diuretics or corticosteroids. The abuse of laxatives, especially those acting by contact (stimulating laxatives), can cause addiction (possibly requiring progressive dosage increase), chronic constipation and loss of normal intestinal functions (intestinal atony).

Precautions for use.
If administrated to children under 12 years of age, the medicine can be used only after medical advice. The treatment of chronic or recurrent constipation always
requires medical advice for the correct diagnosis, medicine prescription and control during therapy. Consult your doctor if the need of a laxative arises from an unexpected change in preexisting intestinal rythms (frequency and characteristics of evacuation) lasting more than two weeks, or when the use of the laxative itself has no effect. It is recommended that elderly people or patients in poor health seek medical advice before using the product. Keep the medicine out of the reach of children.

Interaction with other medicines and other forms of interaction
Laxatives can reduce permanence in the intestine and absorption time of other oral medicines taken at the same time. It is thus recommended to avoid taking laxatives together with other medicines: at least 2 hours should pass between administration of a medicine and administration of a laxative. Milk or antiacids can modify the efficacy of the medicine; wait at least one hour before taking the laxative.

Pregnancy and breast-feeding
It is recommended to avoid administration of the product during pregnancy and breast-feeding.

Effects on the ability to drive and use machines
The product does not interfere with the ability to drive or use machines.

Undesired effects
Occasional episodes of isolated cramps or abdominal colics may occur, most frequently in serious cases of constipation. Occasional episodes of nausea and vomit may occur. These effects dissapear simply with the interruption of the treatment.

Excessive dosage
Excessive dosages can cause abdominal pain and diahorrea; the liquids and electrolytes that have been lost
must be replaced. Refer also to the instructions reported in the paragraph “Special instructions and precautions for use”, concerning the abuse of laxatives. In case of excessive dosage of Fave di Fuca, a gastric washout is recommended.

Pharmacological properties
Pharmacodynamic properties
Pharmatherapeutical category: laxative, ATC code: A06AB57.
The extract of cascara, an anthraquinone drug largely used as a laxative, contains active principles consisting in hydroxianthracenic derivates in glucosidic form. By acting directly on the membrane, cascara stimulates intestinal peristalsis and the increase of water excretion, helping the hydration and evacuation of the faeces. Also frangola contains active principles consisting of free anthraquinones and in glucosidic form, which have a regulating effect on intestinal transit. Frangola extract is thus used for its laxative and purgative effects, in high dosages.

Pharmacokinetic properties
Pharmacokinetical studies on phytocomplexes are of difficult execution and evaluation, but the vast clinical
experience acquired in this field testifies favourably in the direction of an adequate absorption and a therapeutically valid kinetic profile.

Preclinical safety data
Studies on animals confirm that Fave di Fuca presents no elements of acute toxicity. During experiments on
rats and mice, in fact, it has been impossibile to determine the DL50, both for speciality and single active components, not even with a dosage of 4000 mg/kg per os. Moreover, speciality is well tolerated in rats and dogs up to a daily dosage of 150 mg/kg by oral administration for 4 months, and has proved free of embryotoxic and teratogen effects.

PHARMACEUTICAL INFORMATION
List of excipients
Talcum; Stearate Sodium; Dry nebulized Arabic Rubber;
Black Iron oxyd (E172); Red Iron oxyd (E172); Methyl parahydroxibenzoate; Propyl parahydroxibenzoate; Ethyl parahydroxibenzoate; Sodium benzoate; propylenic Glycol; Sodium hydroxyd; Anhydroglucose; White Wax; Saccarose.

Incompatibility
Irrelevant.

Period of validity
5 years.

Special precautions for storage
Keep in a dry place, up to 30°C.

Type and content of the package
Coated tablets in blister packs.

Instructions for use and manipulation
No specific instructions.

HOLDER OF THE AUTHORIZATION TO PUT INTO COMMERCE
Pharbenia srl. - Viale Certosa 130 - 20156 Milano Sole agent for sale: Bayer S.p.A. – Viale Certosa 130 – Milano

NUMBER OF THE AUTHORIZATION TO PUT INTO COMMERCE
“Coated tablets” 40 Coated tablet AIC n°008637047
“Coated tablets” 30 Coated tablets AIC n°008637050

DATE OF THE FIRST AUTHORIZATION/RENEWAL OF THE AUTHORIZATION
Renewal: June 2005

DATE OF TEXT REVISION
June 2005