Orudis 2,5 % Gel

Country: Sweden

Language: Swedish

Source: Läkemedelsverket (Medical Products Agency)

Active ingredient:

ketoprofen

Available from:

Orifarm AB

ATC code:

M02AA10

INN (International Name):

ketoprofen

Dosage:

2,5 %

Pharmaceutical form:

Gel

Composition:

ketoprofen 25 mg Aktiv substans; etanol, vattenfri Hjälpämne

Prescription type:

Receptbelagt

Therapeutic area:

Ketoprofen

Authorization status:

Avregistrerad

Authorization date:

2001-08-10

Summary of Product characteristics

SUMMARY
OF
PRODUCT
CHARACTERISTICS
2
1
NAME
OF
THE
MEDICINAL
PRODUCT
Orudis 2.5% gel
2
QUALITATIVE
AND
QUANTITATIVE
COMPOSITION
1 g gel contains 25 mg ketoprofen.
Excipient(s) with known effect:
Ethanol 313 mg in each 1 g of Orudis gel (see section 4.4)
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL
FORM
Gel for cutaneous use.
A colourless transparent gel with a scent of lavender.
4
CLINICAL
PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the symptomatic treatment of mild to moderate local pain
associated with muscle and/or joints
injuries, e.g., sport injuries.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
The gel should be applied on to the painful or inflamed area two to
three times daily. The amount of
gel should be adjusted so that it covers the painful area. The total
daily dose shall not exceed 15 grams
per day. (7.5 grams correspond to approximately 14 cm gel). The length
of treatment should not
exceed one week.
_Paediatric population_
The safety and efficacy of ketoprofen gel in children have not been
established.
Method of administration
For cutaneous use.
The gel should be massaged onto the skin for a few minutes.
4.3
CONTRAINDICATIONS
The gel is contraindicated in the following cases:
•
history of any photosensitivity reaction
•
known hypersensitivity reactions, such as symptoms of asthma, allergic
rhinitis to ketoprofen,
fenofibrate, tiaprofenic acid, acetylsalicylic acid, or to other NSAID
•
history of skin allergy to ketoprofen, tiaprofenic acid, fenofibrate
or UV blocker or perfumes
3
•
sun exposure, even in case of hazy sun, including UV light from
solarium, during the
treatment and 2 weeks after its discontinuation
•
history of hypersensitivity to one of the excipients
•
on pathological skin changes such as eczema or acne; or in infectious
skin or open wounds
•
third trimester of pregnancy (see section 4.6)
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The gel should be used with caution in patients with reduced heart,
liver or renal function: isolated