Ketoprofen 2.5% gel

Држава: Велика Британија

Језик: Енглески

Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активни састојак:

Ketoprofen

Доступно од:

Phoenix Healthcare Distribution Ltd

АТЦ код:

M02AA10

INN (Међународно име):

Ketoprofen

Дозирање:

25mg/1gram

Фармацеутски облик:

Cutaneous gel

Пут администрације:

Cutaneous

Класа:

No Controlled Drug Status

Тип рецептора:

Valid as a prescribable product

Резиме производа:

BNF: 10030200

Информативни летак

148
148
210
210
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the
same as yours.
• If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor.
IN THIS LEAFLET:
1. What Ketoprofen Gel is and what it is used for
2. Before you use Ketoprofen Gel
3. How to use Ketoprofen Gel
4. Possible side effects
5. How to store Ketoprofen Gel
6. Contents of the pack and other information
1. WHAT KETOPROFEN GEL IS AND WHAT IT IS USED FOR
Ketoprofen Gel is a homogeneous and colourless gel for application to
the surface of the skin only. It contains ketoprofen which
belongs to a non-steroidal group of anti-inflammatory drugs (NSAIDs),
like aspirin, which help to reduce pain and inflammation.
Ketoprofen Gel is used for pain relief in:
• soft tissue injuries including sports injuries and sprains and
strains
• musculo-tendonitis
• swelling
• backache
• conditions affecting the joints and/or connective tissues e.g.
arthritis (inflammation of the joints).
2. BEFORE YOU USE KETOPROFEN GEL
DO NOT USE KETOPROFEN GEL • If you have a history of allergy or hypersensitivity to
Ketoprofen or to any of the other ingredients of Ketoprofen Gel
(see section 6), tiaprofenic acid, fenofibrate, UV blockers or
perfumes. Symptoms of this would include a rash,
swallowing or breathing problems, swelling of your lips, face, throat
or tongue
• If you have ever had asthma, urticaria (skin rash), or runny nose
and sneezing after taking aspirin or other NSAIDs
• On an area where you have any skin conditions, eczema or acne,
open wounds or infections
• In your eyes, mouth, nose, or on the anal or genital areas; if
this happens, WASH WITH PLENTY OF CLEAN WATER.

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ketoprofen 2.5% w/w Gel
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ketoprofen 25 mg/g
For excipients, see 6.1
3
PHARMACEUTICAL FORM
Gel
Homogenous transparent gel with an odour of lavender and alcohol
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic relief of pain in such conditions as soft tissue injuries,
including
sport injuries, sprains, strains, musculo-tendonitis, swelling,
backache and
rheumatic pain.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For cutaneous use.
Penetration of the gel by gentle and prolonged massage on the painful
or inflamed
surface for up to seven days.
Two to four daily applications of approximately 2 to 4g gel,
representing
approximately 5 to 10cm. The usual maximum dose is 15g per day.
Children (under 15 years): Not recommended, as safety in children has
not been
established.
4.3
CONTRAINDICATIONS
•
Known allergy to Ketoprofen, to substances of similar activity to
aspirin.
•
History of hypersensitivity to any of the excipients.
•
History of any photosensitivity reactions.
•
Known hypersensitivity reactions, such as symptoms of asthma, allergic
rhinitis to ketoprofen, fenofibrate, tiaprofenic acid, acetylsalicylic
acid, or
to other NSAIDs (including when taken by mouth).
•
History of skin allergy to ketoprofen, tiaprofenic acid, fenobrate or
UV
blocker or perfumes.
•
Sun exposure, even in the case of hazy sun, including UV light from
solarium, during the treatment and 2 weeks after its discontinuation
(see
Section 4.4. Special warnings and precautions for use).
•
Third trimester of pregnancy (see section 4.6).
•
Patholgical skin changes such as dermatosis, eczema or acne, infected
skin
lesions, or open wounds.
•
Not to be applied neither to mucous membranes, anal or genital areas,
nor
on the eyes .
•
Not to be used with occlusive dressings.
•
Treatment should be discontinued immediately upon development of any
skin reaction including cutaneous reactions after co-application of
octocryl