Active ingredients: Bromelain
ANANASE 40 mg coated tablets
Indications Why is Ananase used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
Ananase belongs to the class of proteolytic enzymes
THERAPEUTIC INDICATIONS
Inflammatory edema processes in the medical and surgical fields.
Contraindications When Ananase should not be used
Hypersensitivity to the active substance or to any of the excipients.
The product is contraindicated in patients with haemophilia and with haemorrhagic diathesis, in the case of severe hepatopathies and nephropathies; peptic ulcer.
If you have been told by your doctor that you have "intolerance to some sugars, contact your doctor before taking this medicine (see Special warnings).
Precautions for use What you need to know before taking Ananase
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 and 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.
Interactions Which drugs or foods can modify the effect of Ananase
Tell your doctor or pharmacist if you have recently taken any type of medicine, even those without a prescription.
The association of ANANASE with anticoagulants often requires an adequate adjustment of the dosage.
Warnings It is important to know that:
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine. Ananase can be used during pregnancy or breastfeeding only after consulting your doctor and evaluating with him the risk / benefit ratio in your case.
Consult your doctor if you suspect you are pregnant or want to plan a maternity leave.
Driving and using machines
Ananase does not affect the ability to drive or use machines.
Important information about some of the ingredients of Ananase
The product contains lactose and sucrose; If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine (see Contraindications.
Dose, Method and Time of Administration How to use Ananase: Posology
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
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.
Overdose What to do if you have taken an overdose of Ananase
In case of accidental ingestion / intake of an overdose of Ananase, notify your doctor immediately or go to the nearest hospital.
Side Effects What are the side effects of Ananase
Like all medicines, Ananase can cause side effects, although not everybody gets them.
Cases of nausea, vomiting, diarrhea and, rarely, cases of menorrhagia and metrorhagia have been reported. Occasionally allergic skin reactions, erythema, itching and in rare cases asthma attacks may occur.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Expiry and Retention
Expiry: See the expiry date printed on the package
The expiry date refers to the product in intact packaging, correctly stored.
WARNING: Do not use the medicine after the expiry date shown on the package
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
KEEP THE MEDICINAL PRODUCT OUT OF THE REACH AND SIGHT OF CHILDREN
COMPOSITION
Each ANANASE coated tablet contains:
ACTIVE PRINCIPLE
Bromelain 40,000 mg (equal to 40 U.P.F.U.)
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, Opalux AS-23014 (Sucrose, Quinoline Yellow, Titanium Dioxide, Orange Yellow S, Povidone, Sodium Benzoate) Wax powder, Sucrose.
PHARMACEUTICAL FORM
Coated tablets.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
PINEAPPLE 40 MG COATED TABLETS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ANANASE coated tablet contains:
ACTIVE PRINCIPLE
Bromelain mg 40,000 (equal to 40 U.P.F.U.).
EXCIPIENTS
Lactose;
sucrose.
For the full list of excipients see section 6.1.
03.0 PHARMACEUTICAL FORM
Coated tablets.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Inflammatory edema processes in the medical and surgical fields.
04.2 Posology and method of administration
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
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 is reserved for adults (see section 4.4).
04.3 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).
Due to the presence of 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).
04.4 Special warnings and appropriate precautions for use
In pregnant and infancy women use only when clearly needed and under direct medical supervision. Experience on the use of Ananase in children is limited; until sufficient data on safety and efficacy are acquired, the use of the medicinal product is 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 suffering from severe liver disease or renal insufficiency suggests the interruption of treatment and the institution of a suitable therapy. Patients with rare hereditary problems of galactose intolerance, deficiency of
Lapp lactase, 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).
04.5 Interactions with other medicinal products and other forms of interaction
The association of ANANASE with anticoagulants often requires an adequate adjustment of the dosage.
04.6 Pregnancy and lactation
For bromelain, no clinical data on exposed pregnancies are available. Animal studies (rats and rabbits) did not show embryotoxic or teratogenic effects. Therefore, Ananase should be administered during pregnancy and breastfeeding only if clearly needed and under direct medical supervision.
04.7 Effects on ability to drive and use machines
Ananase does not affect the ability to drive or use machines.
04.8 Undesirable effects
Cases of nausea, vomiting, diarrhea and, rarely, cases of menorrhagia and metrorrhagia have been reported. Occasionally there may be skin allergic situations, erythema, itching and in rare cases asthma attacks.
* whose frequency cannot be estimated from the available data.
04.9 Overdose
There are no known cases of accidental and intentional overdose in humans with onset of toxic symptoms.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: other haematological agents - enzymes.
ATC: B06AA.
Bromelain administered i.p. and orally at doses of 5-10 mg / kg it reduces the edema and inflammation caused by histamine, formalin, dextran, carrageenan and egg albumin in the animal. At the level of inflammatory tissue, it reduces vasodilation, increase in capillary permeability, leukocyte migration and local pain by inhibiting the formation of bradykinin and serotonin.
05.2 Pharmacokinetic properties
The absorption of bromelain after oral administration presents a great individual variability. The plasma half-life is between 6 and 9 hours.
05.3 Preclinical safety data
LD50 for oral administration: no toxicity at doses above 10 mg / kg for all animals tested.
For other routes of administration (i.p. and i.v.): the LD50 varies according to the animals from 20 to 85 mg / kg.
In prolonged oral administration in rodent and non-rodent animals no variation was noted, compared to controls, for the physical-biological parameters.
Fetal toxicity: absent.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Anhydrous dibasic calcium phosphate, 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).
06.2 Incompatibility
Not relevant.
06.3 Period of validity
5 years.
The expiry date indicated refers to the product in intact packaging, correctly stored.
06.4 Special precautions for storage
This medicine does not require any special storage conditions.
06.5 Nature of the immediate packaging and contents of the package
Box of 20 coated tablets
06.6 Instructions for use and handling
No special instructions
07.0 MARKETING AUTHORIZATION HOLDER
ROTTAPHARM S.p.A. - Galleria Unione, 5 - 20122 Milan
08.0 MARKETING AUTHORIZATION NUMBER
AIC: 020501021
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Date of first authorization: November 20, 1971
Renewal of the authorization: May 2010
10.0 DATE OF REVISION OF THE TEXT
March 2011
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