Active ingredients: Seaprose S
FLAMINASE 30 mg gastro-resistant tablets
Indications Why is Flaminase used? What is it for?
Flaminase contains the active substance seaprose S which is an anti-inflammatory.
Flaminase is used in acute and chronic respiratory diseases to help thin the mucus (secretolytic effect).
The medicine is used to treat inflammation and swelling caused by fluid accumulation (edema and swelling) in several conditions:
- post-operative bone fractures, edema and bruises (hematomas).
- inflammation with accumulation of pus around the teeth and on the gums (abscess), after tooth removal, delay, difficulty or irregularity in tooth eruption
- acute and chronic inflammation of the mucous membrane of the nose and ear
- inflammation of the veins (thrombophlebitis)
- breast swelling with increased pressure (breast engorgement), surgical incision to help delivery (episiotomy).
- inflammation of the bladder (cystitis).
Contraindications When Flaminase should not be used
Do not take Flaminase:
- if you are allergic to seaprose S or any of the other ingredients of this medicine
- if you suffer from haemophilia or have a tendency to bleed excessively (haemorrhagic diathesis)
- if you have severe kidney disease, liver disease
- if you suffer from a peptic ulcer
Precautions for use What you need to know before taking Flaminase
Talk to your doctor or pharmacist before using Flaminase.
Interactions Which drugs or foods can modify the effect of Flaminase
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Warnings It is important to know that:
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
The medicine should be administered in cases of real need, under direct medical supervision.
Driving and using machines
Flaminase does not affect the ability to drive or use machines.
Dose, Method and Time of Administration How to use Flaminase: Posology
Always take this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
Adults
The recommended daily dose for adults is 1 to 3 tablets, in 2 or more divided doses, or as advised by your doctor.
Children
The recommended daily dose for children is 0.5 mg / kg of body weight, in 2 or more divided doses, or as advised by your doctor.
Overdose What to do if you have taken too much Flaminase
If you use more Flaminase than you should
If you or someone else has taken more Flaminase tablets than you should, contact a doctor or go to the nearest hospital, taking the pack with you if possible.
If you forget to take Flaminase
Do not take a double dose to make up for a forgotten tablet. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Side Effects What are the side effects of Flaminase
Like all medicines, this medicine can cause side effects, although not everybody gets them.
In predisposed subjects, skin reactions of an allergic nature may occur.
The side effects are:
- Mild gastrointestinal disturbances such as anorexia (loss of appetite), stomach pain, heartburn, nausea, vomiting and diarrhea
- In predisposed subjects, skin reactions of an allergic nature may occur.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system www.aifa.gov.it/responsabili.
By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package after EXP :.
The expiry date refers to the last day of that month.
Store at a temperature not exceeding 25 ° C
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
What Flaminase contains
- The active substance is seaprose S. One tablet contains 30 mg of seaprose S.
- The other ingredients are: maltose, calcium carboxymethylcellulose, magnesium stearate, methacrylic acid copolymer, talc, triethyl citrate, sodium hydroxide.
What Flaminase looks like and contents of the pack
Gastro-resistant tablets.
20 tablets of 30 mg in PVC and aluminum blisters.
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
FLAMINASE
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains: seaprose S 30 mg.
03.0 PHARMACEUTICAL FORM
Gastro-resistant tablets.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Pneumology: as an adjuvant, as a secretolytic, in acute and chronic respiratory diseases.
In inflammations, swellings and edema in several therapeutic areas and precisely:
Traumatology - Orthopedics - Surgery: post-operative fractures, edema and hematomas.
Dentistry: periapical processes, gingival alveolus abscesses, after dental avulsions, disodontiasis.
Otolaryngology: acute and chronic inflammation of the nasal mucosa and ear.
Angiology: thrombophlebitis.
Obstetrics and gynecology: breast engorgement, episiotomy.
Urology: cystitis.
04.2 Posology and method of administration
ADULTS: 30-90 mg / day divided into 2 or more administrations over 24 hours.
CHILDREN: 0.5-2 mg / kg / day divided into 2 or more doses, according to medical prescription.
04.3 Contraindications
Individual ascertained hypersensitivity to the product. Subjects with haemophilia and with haemorrhagic diathesis, severe hepatopathies and nephropathies, peptic ulcer.
04.4 Special warnings and appropriate precautions for use
Nothing to report.
04.5 Interactions with other medicinal products and other forms of interaction
No significant pharmacokinetic interactions are known.
04.6 Pregnancy and lactation
In pregnant women and in very early childhood, the product should be administered in cases of real need, under direct medical supervision.
04.7 Effects on ability to drive and use machines
The use of seaprose S, throughout the day, does not interfere with the waking state of the subject.
04.8 Undesirable effects
FLAMINASE is generally well tolerated; Mild gastrointestinal disturbances have been reported such as: anorexia, gastralgia, heartburn, nausea, vomiting and diarrhea and allergic skin reactions in predisposed subjects.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address: http://www.agenziafarmaco.gov.it/it/responsabili
04.9 Overdose
No cases of overdose have been reported.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
ATC code: B06AA49
Seaprose S is a proteolytic enzyme produced and isolated from Aspergillus melleus cultures and obtained by purification, in a monocrystalline form which experimentally demonstrated a proteolytic, anti-inflammatory, mucolytic and anti-edema activity.
05.2 Pharmacokinetic properties
Intestinal absorption studies with 125 I-labeled seaprose S reveal that the drug is transported within the mesenteric vascular system through the vascular wall, maintaining its immunoreactivity.
05.3 Preclinical safety data
Toxicological tests carried out on various animal species have shown that seaprose S is well tolerated and has no teratogenic and mutagenic activity. The oral LD50 in mice and rats is greater than 5000 mg / kg and by the endoperitoneal route is respectively 26.42 mg / kg and 26.67 mg / kg. Studies of subacute oral toxicity in rats with doses between 50 and 450 mg / kg / day and chronic oral toxicity in rats and dogs with doses between 25 and 100 mg / kg / day did not reveal any alterations or pathological signs.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Maltose, calcium carboxymethylcellulose, magnesium stearate, methacrylic acid copolymer, talc, triethyl citrate, sodium hydroxide.
06.2 Incompatibility
There are no known chemical-physical incompatibilities of seaprose S towards other compounds.
06.3 Period of validity
24 months
06.4 Special precautions for storage
Store at a temperature not exceeding 25 ° C.
06.5 Nature of the immediate packaging and contents of the package
PVC and aluminum blisters
Packaging: 20 tablets of 30 mg
06.6 Instructions for use and handling
None.
07.0 MARKETING AUTHORIZATION HOLDER
GRÜNENTHAL ITALIA S.r.l. - Via Carlo Bo, 11 - 20143 Milan
08.0 MARKETING AUTHORIZATION NUMBER
"30 mg tablets", 20 tablets - A.I.C. n. 026420048
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
First Authorization: 18.01.1988
Renewal: 1 06 2010
10.0 DATE OF REVISION OF THE TEXT
March 26, 2015
