Ananase - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Unwanted Effects Shelf Life

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.

More information about Ananase can be found in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION 03.0 PHARMACEUTICAL FORM 04.0 CLINICAL PARTICULARS 04.1 Therapeutic indications 04.2 Posology and method of administration 04.3 Contraindications 04.4 Special warnings and appropriate precautions for use 04.5 Interactions with other medicinal products and other forms of interaction04.6 Pregnancy and lactation04.7 Effects on ability to drive and use machines04.8 Undesirable effects04.9 Overdose05.0 PHARMACOLOGICAL PROPERTIES05.1 Pharmacodynamic properties05.2 Pharmacokinetic properties05.3 Preclinical safety data06.0 INFORMATION PHARMACEUTICALS 06.1 Excipients 06.2 Incompatibilities 06.3 Shelf life 06.4 Special precautions for storage 06.5 Nature of the immediate packaging and contents of the package 06.6 Instructions for use and handling 07.0 MARKETING AUTHORIZATION HOLDER08 .0 MARKETING AUTHORIZATION NUMBER 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OF THE TEXT 11.0 FOR RADIOPharmaceuticals, FULL DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON ESTEMPORANEA PREPARATION AND CONTROL

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.


Organic systemic classification 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 * Pathologies gastrointestinal there Nausea, vomiting, diarrhea Respiratory, thoracic and mediastinal disorders Asthmatic attack Skin and subcutaneous tissue disorders Allergic skin reaction, erythema, itching Pathologies Itching of the reproductive system and breast Menorrhagia, metrorrhagia

* 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

11.0 FOR RADIO DRUGS, COMPLETE DATA ON THE INTERNAL RADIATION DOSIMETRY

12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON EXEMPORARY PREPARATION AND QUALITY CONTROL

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