FELDENE GEL

מדינה: ישראל

שפה: אנגלית

מקור: Ministry of Health

מרכיב פעיל:

PIROXICAM

זמין מ:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

קוד ATC:

M02AA07

טופס פרצבטיות:

GEL

הרכב:

PIROXICAM 5 MG/G

מסלול נתינה (של תרופות):

DERMAL

סוג מרשם:

Not required

תוצרת:

FARMASIERRA MANUFACTURING S.L., SPAIN

קבוצה תרפויטית:

PIROXICAM

איזור תרפויטי:

PIROXICAM

סממני תרפויטית:

Variety of conditions characterized by pain and inflammation such as osteoarthritis of superficial joints, acute musculoskeletal injuries, periarthritis, tendinitis and tenosynovitis.

תאריך אישור:

2014-04-30

עלון מידע

Feldene gel PIL CC 130122
2022-0074995
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed without a doctor's prescription
FELDENE GEL
®
PIROXICAM 0.5% (5 MG/G)
Inactive ingredients and allergens: See section 2 under "Important
information about some of this medicine’s
ingredients" and section 6 “Further information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains concise information
about this medicine. If you have any further questions, consult your
doctor or pharmacist.
Use the medicine according to the instructions in the dosing section
of this leaflet. Consult your
pharmacist if you need further information. Contact your doctor if
your symptoms of illness get worse or
do not improve after 4 weeks.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
For application on the skin, to relieve conditions characterized by
pain and inflammation, e.g., relieving
pain and reducing swelling affecting joints and muscles.
THERAPEUTIC GROUP:
Nonsteroidal anti-inflammatory drugs (NSAIDs)
2.
BEFORE
USING
THIS
MEDICINE
DO NOT USE THIS MEDICINE IF:
Do not use the medicine without consulting a doctor before starting
treatment:
● If you suffer, or have suffered in the past, from impaired liver or
kidney function.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
●
Use of piroxicam has been reported to be associated with skin
reactions that may be life-threatening, e.g.,
DRESS syndrome, Stevens-Johnson syndrome and toxic epidermal
necrolysis. The skin rash on the body may
first appear as red, focal spots or round patches with blisters in the
middle. Additional signs to examine include
ulcers in the mouth, throat, nose, genitals and conjunctivitis (red
and swollen eyes). These life-threatening skin
reactions are usually accompanied by flue-like symptoms. The rash may
spread as blisters or skin peeling.
The highest risk of the occurrence of skin reactions is in the first
week of treatment.
● If you developed a serious skin reaction after

מאפייני מוצר

Feldene gel LPD CC 131021
Page 1 of 6
Pfleet 2020-0061718; 2020-00061785, 2020-0061957
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Feldene Gel
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains 5mg piroxicam (0.5% w/w).
Excipients with known effect:
Feldene Gel contains 200mg/g propylene glycol
10mg/g benzyl alcohol and 250 mg/g ethanol 96%.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gel for topical application.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Feldene
Gel
is
indicated
for
a
variety
of
conditions
characterized
by
pain
and
inflammation such as osteoarthritis of superficial joints, acute
musculoskeletal injuries,
periarthritis, tendinitis and tenosynovitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS
No occlusive dressings should be employed. Apply 1g of Gel,
corresponding to 5mg of
piroxicam, and rub into the affected site three to four times daily
leaving no residual
material on the skin. Therapy should be reviewed after 4 weeks.
Paediatric population
_ _
Dosage recommendations and indications for the use of Feldene Gel in
children have not
been established.
ELDERLY
Feldene gel LPD CC 131021
Page 2 of 6
Pfleet 2020-0061718; 2020-00061785, 2020-0061957
No special precautions are required.
Method of administration
Feldene Gel is for external use only.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
The
potential
exists
for
cross
sensitivity
to
aspirin
and
other
non-steroidal
anti-
inflammatory agents
(NSAIDs)
. Feldene Gel should not be given to patients in whom
aspirin and other non-steroidal anti-inflammatory agents induce the
symptoms of asthma,
nasal polyps, angioneurotic oedema or urticaria.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Life-threatening
cutaneous
reactions,
including
drug
reaction
with
eosinophilia
and
systemic
symptoms
(DRESS
syndrome),
Stevens-Johnson
syndrome
(SJS)
and
toxic
epidermal necrolysis (TEN) have been reported with t