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FALCOL®
DIFUCREM
Aceclofenac
COMPOSITION
Per 100 g of cream:
Aceclofenac (INN) ...........................................1.5 g
Excipients: polyoxyethylated sorbitan palmitostearate, cetyl stearyl alcohol,
liquid vaseline, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate
(E-216), purified water.
PHARMACEUTICAL
FORM AND CONTENT OF THE CONTAINER
Container containing 60 g of cream.
ACTIVITY
Aceclofenac has antipain, antiinflammatory and antirheumatic activity.
The administration of aceclofenac in cream form allows the local treatment
of painful and inflammatory processes.
MARKETING
AUTHORISATION HOLDER AND MANUFACTURER
Marketing authorisation holder: FARMA-LEPORI, S.A.
C. Osi, 7
08034 Barcelona
Manufactured
by: Industrias Farmacéuticas ALMIRALL PRODESFARMA, S.L.
C. Treball, s/n
08960 Sant Just Desvern (Barcelona)
THERAPEUTIC
INDICATIONS
All types of local painful and inflammatory processes, including trauma
and acute or chronic musculoskeletal inflammatory condition, such as tendinitis,
tenosynovitis, sprains, dislocations, periarthritis, distensions, lumbago
and torticollis.
CONTRAINDICATIONS
It should not be applied to patients that have shown hypersensitivity
to aceclofenac or other non-steroidal antiinflammatories, including acetyl
salicylic acid.
PRECAUTIONS
It should not be applied to the eyes, mucosas or open wounds. Similarly,
its use is not advisable if there is skin irritation in the area where
it is to be applied. In case of hypersensitivity, treatment should be
suspended.
INTERACTIONS
No interactions between Falcol® Difucrem and other drugs are known.
WARNINGS
Pregnancy and lactation: The data available to date are
insufficient, whereby the product should not be used during pregnancy
or lactation.
Effects
on the capacity to drive: The application of Falcol® Difucrem
does not affect driving.
Use
in children: The doses or indications recommended for children
have not yet been established.
Use
in the elderly: Treatment with Falcol® Difucrem does not
require special care.
POSOLOGY
Apply between 1.5 - 2 g of cream (approximately between 5 and 7 cm) topically
by means of a smooth massage on the affected area, three times a day,
depending on the size of the area.
OVERDOSE
No cases of overdose have been reported. In case of overdose, symptomatic
treatment should be given. In the event of overdose or accidental intake,
go to a medical centre immediately or call the Toxicology Information
Service on 91 562 04 20, indicating the medicine and the amount taken.
UNDESIRABLE
EFFECTS
In some cases it may produce mild or moderate irritation, redness and
pruritus which remit on interruption of the treatment.
In isolated cases, photosensitivity reactions have been observed. If you
notice any side effects not mentioned in this leaflet, please inform your
doctor or pharmacist.
STORAGE
Do not store above 30ºC.
EXPIRY
This medicine should not be used after the expiry date indicated on the
box.
OTHER
PRESENTATIONS
Falcol® comprimidos, boxes with 20, 40 and 500 coated tablets of 100
mg
Falcol® sobres, boxes with 20 and 40 sachets of 100 mg
Falcol® inyectable, box with 4 lyophilized vials of 150 mg and 4 solvent
ampoules, and box with 100 lyophilized vials of 150 mg and 100 solvent
ampoules.
Keep
medicines out of the reach of children
Revised
text in April 2004.
Farma-Lepori,
S.A.
C. Osi, 7- 08034 Barcelona
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