Flogoprofen Cutaneous Spray, Solution 50mg/ml

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ETOFENAMATE

Available from:

Chiesi Espana S.A. c/Berlin 38-48. 7 Planta 08029. Barcelona, Spain

ATC code:

M02AA06

INN (International Name):

ETOFENAMATE 50 mg/ml

Pharmaceutical form:

CUTANEOUS SPRAY, SOLUTION

Composition:

ETOFENAMATE 50 mg/ml

Prescription type:

OTC

Therapeutic area:

TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN

Authorization status:

Authorised

Authorization date:

2006-11-03

Patient Information leaflet

PACKAGE LEAFLET:
INFORMATION FOR THE USER
FLOGOPROFEN SOLUTION
Etofenamate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or
pharmacist has told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
-
You must talk to a doctor if you do not feel better or if you feel
worse after 7
days.
WHAT IS IN THIS LEAFLET:
1.
What Flogoprofen is and what it is used for
2.
What you need to know before you use Flogoprofen
3.
How to use Flogoprofen
4.
Possible side effects
5.
How to store Flogoprofen
6.
Contents of the pack and other information
1.
WHAT FLOGOPROFEN IS AND WHAT IT IS USED FOR
Flogoprofen is an anti-inflammatory with analgesic properties used for
the topical
treatment of painful and inflammatory processes.
Flogoprofen is indicated in adults and adolescents (over 12 years) for
the local relief of
mild and occasional pain and inflammation caused by: minor bruises,
blows, strains,
torticollis or other contractures, low back pain and mild sprains by a
twist.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE FLOGOPROFEN
DO NOT USE FLOGOPROFEN:
-
If you are allergic to etofenamate or any other of the ingredients of
this medicine
(listed in section 6).
-
If the area to which the solution is to be applied is irritated or has
a wound or
any skin disease.
-
In the mucous membranes or the eyes.
-
If you have suffered any allergic reaction caused by acetylsalicylic
acid or other
anti-inflammatory medicine.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using Flogoprofen.
-
Use only on intact skin. Do not apply to open wounds, mucous membranes
or
irritated skin.
-
Avoid contact with the eyes. In the event of contact with the eyes,
wash
thoroughly

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Flogoprofen 50 mg/ml Cutaneous spray solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of Cutaneous spray solution contains 50 mg of etofenamate
EXCIPIENTS WITH KNOWN EFFECT:
Each ml of solution contains 100 mg of dimethyl sulfoxide and 100 mg
of propyl ene glycol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Flogoprofen 50 mg/ml Cutaneous spray solution: Clear slightly
yellowish solution with an aroma
of turpentine oil.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicine is indicated in adults and adolescents (over 12 years)
for the local relief of mild
and occasional pain and inflammation caused by: minor bruises, blows,
strains, torticollis or other
contractures , low back pain and mild sprains caused by a twist.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Cutaneous use.
Adults and adolescents (over 12 years):
Apply a thin layer of gel or solution 3 or 4 times a day on the
affected area and massage gently
until absorbed.
Wash hands after each application.
Do not apply for more than 7 consecutive days.
Children (younger than 12 years):
Do not administer to children because of the lack of safety and
efficacy datari_nttJt\i.Sr_po.pllll joJ - .
I
I
Adults over 65 years:
No dose modification is required for this group of patients.
4.3
Contraindications
Hypersensitivity to etofenamate or to any of the medicine's
excipierits.
It should not be applied to mucous membranes, wounds, irritated areas
or areas of sunburn or
dermatosis.
Do
not administer to
patients with
previous allergic
reactions (rhinitis, asthma,
pruritus,
angioedema, urticaria, shock or other), caused by acetylsalicylic acid
or other NSAIDs, due
to the possibility of cross hypersensitivity.
4.4
Special warnings and precautions for use
Use only on intact skin. Do not apply to open wounds, mucous membranes
or eczematous
skin.
Avoid contact with the eyes and mucous membranes. In the event of
contact with the eyes or
mucous membranes, wash