NOTICE
ANSM - Updated on: 20/07/2017
Name of the medicinal product
EXTRANASE 900 nK, gastro-resistant coated tablet
Bromelaines
framed
Read this leaflet carefully before you start taking this medicine. It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, ask your pharmacist.
· If symptoms worsen or persist, consult a physician.
· If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.
Review summary
In this notice :
1. WHAT IS EXTRANASE 900 nK, gastro-resistant coated tablet AND IN WHAT CASES IS IT USED?
2. BEFORE YOU TAKE EXTRANASE 900 nK, gastro-resistant coated tablet?
3. HOW TO TAKE EXTRANASE 900 nK, coated gastro-resistant tablet?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE EXTRANASE 900 nK, gastro-resistant coated tablet?
6. ADDITIONAL INFORMATION
1. WHAT IS EXTRANASE 900 nK, gastro-resistant coated tablet AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic group
ENZYMOTHERAPY for anti-edema
(M. Musculoskeletal System)
Therapeutic indications
Supportive treatment of edema following trauma or surgery.
2. BEFORE YOU TAKE EXTRANASE 900 nK, gastro-resistant coated tablet?
List of information needed before taking the medication
If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.
Cons-indications
Never take EXTRANASE 900 nK, an enteric coated tablet in the following cases:
· allergy to any of the components,
· child under 6 years of age.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST
Precautions for use; special warnings
Take special care with EXTRANASE 900 nK, coated gastro-resistant tablet:
Precautions for use
The use of this medication is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase / isomaltase deficiency (rare hereditary diseases).
This medication should be used with caution in patients with renal, hepatic or coagulation disorder.
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
Interaction with other medicines
Taking or using other medicines:
TO AVOID POSSIBLE INTERACTIONS BETWEEN SEVERAL MEDICINAL PRODUCTS, IT MUST BE INFORMED SYSTEMATICALLY OF ANY OTHER TREATMENT IN PROGRESS AT YOUR DOCTOR OR YOUR PHARMACIST.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
This medication should be used with caution during pregnancy and lactation.
Generally speaking, during pregnancy and breast-feeding, you should always seek advice from your doctor or pharmacist before taking this medication.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
List of excipients with known effect : lactose, sucrose.
3. HOW TO TAKE EXTRANASE 900 nK, coated gastro-resistant tablet?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
The daily dosage, as an indication is:
Adults: 3 tablets 3 times a day.
In children from 6 to 15 years: 1 tablet 3 times a day.
Method and route of administration
ORAL TRACK
The tablets should be swallowed with a little water without crushing them.
Duration of treatment
Do not use for prolonged periods without medical advice.
Symptoms and Instructions for Overdose
If you take more EXTRANASE 900 nK, enteric coated tablet than you should:
Potential overdose may include gastric disturbances (vomiting, pain and nausea).
If you have taken more than EXTRANASE 900 nK, you should contact your physician if you have any gastro-resistant coated tablets.
Instructions for omission of one or more doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, this medicine may cause side effects, although not everybody gets them.
· in particular, the risk of allergy necessitating cessation of treatment.
Declaration of side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr . By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE EXTRANASE 900 nK, gastro-resistant coated tablet?
Keep out of the reach and sight of children.
Expiration date
Do not use EXTRANASE 900 nK, enteric coated tablet after the expiry date which is stated on the outer packaging.
Storage conditions
Store at a temperature not exceeding 30 ° C.
If necessary, warnings against visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What does EXTRANASE 900 nK contain, gastro-resistant coated tablets?
The active substance is :
Bromelaines ................................................. .................................................. ...................... 900 nanokatals
For a gastro-resistant coated tablet.
The other components are :
Macrogol 4000, corn starch, talc, magnesium stearate, lactose, cellulose acetate phthalate, gum arabic, beta-carotene (E160), sucrose, titanium dioxide (E171), polysorbate 60 , carnauba wax, white beeswax.
Pharmaceutical form and content
What is EXTRANASE 900 nK, gastro-resistant coated tablet and contents of the pack?
This medication is in the form of an enteric coated tablet. Box of 40 or 80 tablets.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
ROTTAPHARM
40-44 WASHINGTON STREET
75008 PARIS
exploiting
MYLAN MEDICAL SAS
40-44 Washington Street
75008 PARIS
Maker
FULTON MEDICINALI SPA
VIA MARCONI, 28/9
20020 ARESE (MI)
ITALY
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the Ansm website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.