Ananase 20 Compresse Rivestite 40mg

PINEAPPLE 40 MG COATED TABLETS

Therapeutic indications:
Inflammatory edema processes in the medical and surgical fields.

Dosage:
Adults: The optimal starting posology is 1 coated tablet, four times a day. 1 coated tablet 2-3 times a day as maintenance therapy. The coated tablets should be swallowed whole, preferably on an empty stomach. Children: There is limited experience with the use of Ananase in children; until sufficient data on safety and efficacy are acquired, the use of the medicinal product is reserved for adults (see section 4.4).

Active principles:
Each ANANASE coated tablet contains: ACTIVE SUBSTANCE 40 mg Bromelain (equal to 40 UPFU). EXCIPIENTS Lactose Sucrose For a full list of excipients, see section 6.1

Excipients:
Dibasic calcium phosphate anhydrous, Lactose monohydrate, Dibasic calcium phosphate dihydrate, Macrogol 4000, Corn starch, Colloidal silica, Talc, Magnesium stearate, Stearic acid, Eudragit L30 D-55, Triethyl citrate, Simethicone, Gelatin, Sucrose, Wax powder, Opalux AS-23014 (Sucrose, Quinoline Yellow, Titanium Dioxide, Orange Yellow S, Polyvinylpyrrolidone, Sodium Benzoate).

Contraindications:
Hypersensitivity to the active substance or to any of the excipients. The product is contraindicated in patients with haemophilia and with haemorrhagic diathesis as in the case of severe liver and nephropathies; peptic ulcer. Due to the presence of lactose among the excipients of Ananase, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption, should not take this medicine (see section 4.4). sucrose among the excipients of Ananase patients with rare hereditary problems of fructose intolerance, glucose / galactose malabsorption or sucrase-isolactase insufficiency should not take this medicinal product (see section 4.4)

Storage:
This medicine does not require any special storage conditions.

Warnings:
In pregnant women and in infancy use only in case of real need and under direct medical supervision. Experience with the use of Ananase in children is limited; until sufficient data on safety and efficacy are acquired, the use of the medicinal product should be reserved for adults. It is advisable to check the coagulation indices in patients with haemophilia and haemorrhagic diathesis. Bromelain should be used with particular caution in patients with severe liver disease or renal insufficiency. The possible appearance of manifestations of hypersensitivity of various types and locations suggests the interruption of the treatment and the institution of a suitable therapy. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product (see section 4.3). Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomatase insufficiency should not take this medicinal product (see section 4.3).

Interactions:
The association of ANANASE with anticoagulants often requires an adequate adjustment of the dosage.

Side effects:
Cases of nausea, vomiting, diarrhea and, rarely, cases of menorrhagia and metrorrhagia have been reported. Occasionally, skin allergic situations, erythema, itching and in rare cases asthma attacks may occur.
Very common ≥1 / 10
Common ≥1 / 100 to ≤1 / 10
Uncommon ≥1 / 1,000 to ≤1 / 100
Rare ≥ 1 / 10,000 to ≤ 1 / 1,000
Very rare ≤1 / 10,000
Not known *
Gastrointestinal disorders

Nausea Vomiting Diarrhea




Respiratory, thoracic and mediastinal disorders



Asthmatic attack


Skin and subcutaneous tissue disorders



Allergic skin reaction Erythema Pruritus


Reproductive system and breast disorders



Menorrhagia Metrorrhagia


* whose frequency cannot be estimated from the available data Reporting of suspected adverse reactions. Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the Italian Medicines Agency - Website: http://www.agenziafarmaco.gov.it/it/responsabili.

Overdose:
There are no known cases of accidental and intentional overdose in humans with the appearance of toxic symptoms.

Pregnancy and breastfeeding:
For bromelain, no clinical data on exposed pregnancies are available. Studies on animals (rats and rabbits) did not show embryotoxic or teratogenic effects. Therefore, Ananase should be administered during pregnancy and lactation only if clearly needed and under direct medical supervision.