Feldene 0.5% gel

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Piroxicam

Available from:

Waymade Healthcare Plc

ATC code:

M02AA07

INN (International Name):

Piroxicam

Dosage:

5mg/1gram

Pharmaceutical form:

Cutaneous gel

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10030200

Patient Information leaflet

14:57
14 MAR 2020
Package leaflet: Information for the patient
UNITED KINGDOM
Feldene
®
0.5% w/w Gel
piroxicam
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 only. Do not pass it on to others. It
may harm them, even if their signs of
illness are the same as yours.
• 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.
What is in this leaflet
1. What Feldene Gel is and what it is used for
2. What you need to know before you use
Feldene Gel
3. How to use Feldene Gel
4. Possible side effects
5. How to store Feldene Gel
6. Contents of the pack and other information
1.
What Feldene Gel is and what
it is used for
Feldene Gel is one of a group of medicines
called non-steroidal anti-inflammatory drugs
(NSAIDs). This means it will help to relieve
pain and reduce swelling affecting joints and
muscles when rubbed into the skin over the
affected area.
Feldene Gel is for the treatment of rheumatism,
sprains, strains and mild osteoarthritis of joints
(knees, wrists, ankles etc).
2.
What you need to know before
you use Feldene Gel
Do not use Feldene Gel
• If you are allergic to piroxicam or any of
the other ingredients of this medicine
(listed in section 6), any other form of
piroxicam, aspirin or any other medicines
used to treat painful joints and muscles.
This may have been itching, reddening of
the skin or difficulty in breathing.
Warnings and precautions
Talk to your doctor or pharmacist before
taking Feldene Gel. Medicines are not always
suitable for everyone. Your doctor needs
to know before you use Feldene Gel if you
suffer from or have suffered in the past from
any of the following conditions:
• liver disease.
• kidney disease.
Potentially life-threatening skin rashes
(Stevens

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Feldene 0.5% w/w Gel.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains 5 mg piroxicam (0.5% w/w).
Excipient with known effect:
Propylene glycol 200 mg/g
Benzyl alcohol 10 mg/g
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 a non-steroidal anti-inflammatory agent indicated for a
variety of conditions
characterised by pain and inflammation, or stiffness. It is effective
in the treatment of
osteoarthritis
of
superficial
joints
such
as
the
knee,
acute
musculoskeletal
injuries,
periarthritis, epicondylitis, tendinitis and tenosynovitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults
No occlusive dressings should be employed. Apply 1 g of Gel,
corresponding to 3cm, 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
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 (Stevens-Johnson syndrome (SJS)
and toxic epidermal
necrolysis (TEN)) have been reported with the systemic administration
of piroxicam. These
reactions have not been associated with topical piroxicam, but the
possibility of occurring with
topical piroxicam cannot be excluded.
Patients should