Флогопрофен гель инструкция по применению

Название медикамента

Flogoprofen

Состав

Etofenamate

Терапевтические показания

Ревматические заболевания мягких тканей и костно-мышечной системы, миозит, миалгия, люмбаго, ишиас, тендосиновит, бурсит, болезни позвоночного столба и суставов, вызванные перегрузкой или дегенерацией (спондилезы, артрозы), ушибы, растяжения.

Способ применения и дозы

Наружно, полоску геля 5–10 см длиной (1650–3300 мг) наносят на болезненный участок и сильно растирают. Курс — от нескольких дней до нескольких месяцев.

Противопоказания

Гиперчувствительность, беременность, детский возраст.

Побочные эффекты

Покраснение кожи, аллергические реакции.

Фармокологическая группа

Patient Information leaflet

                                PACKAGE LEAFLET: INFORMATION FOR THE USER
FLOGOPROFEN 50 MG/G GEL
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 gel 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 w
                                
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Summary of Product characteristics

                                SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Flogoprofen 50 mg/g Gel
Flogoprofen 50 mg/ml Cutaneous spray solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of gel contains 50 mg of etofenamate.
EXCIPIENTS WITH KNOWN EFFECT:
Each gram of gel contains 100 mg of dimethyl sulfoxide.
For the full list of excipients, see section 6.1.
Each ml of Cutaneous spray solution contains 50 mg of etofenamate
EXCIPIENTS WITH KNOWN EFFECT
Each ml of solution contains 100mg of dimethyl sulfoxide and 100 mg of
propylene
glycol. For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Flogoprofen 50 mg/g gel: transparent and colourless gel.
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 more than 7 consecutive days.
Children (younger 12 years):
Do not administer to children because of the lack of safety and
efficacy data in this
population.
Adults over 65 years:
No dose modification is required for this group of patients.
4.3 CONTRAINDICATIONS
-
Hipersensitivity to etofenamate or to any of the medicine’s
excipients.
-
It should not be applied to mucous membranes, 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 hipersensitivity.
4.4 SPECIAL W
                                
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