Piroxicam 0.5% gel

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Piroxicam

Available from:

DE Pharmaceuticals

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

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Details
PIROXICAM 0.5% 60G & 112G GEL PIL - UK
Black
Code Area
BBBA3901
R.Wrey
05/02/19
13/02/19
T. Hull
148 x 280
9pt
IL/Tiofarma BV
05/02/19 + 13/02/19
13/02/19
2
Version 2
01.11.2017
Patient Information Leaflet
PIROXICAM
0.5% GEL
Piroxicam
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING THIS MEDICINE.
•
Please keep this leaflet. You may need to read it
again.
•
If you have any further questions, please 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 become severe, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Piroxicam 0.5% Gel is and what is it used for.
2. Before you use Piroxicam 0.5% Gel.
3. How to use Piroxicam 0.5% Gel.
4. Possible side effects.
5. How to store Piroxicam 0.5% Gel.
6. Further information.
1. WHAT PIROXICAM 0.5% GEL IS AND WHAT
IS IT USED FOR
The name of your medicine is Piroxicam 0.5% Gel.
The active ingredient in this medicine is piroxicam.
Piroxicam is one of a group of medicines called
non-steroidal anti-inflammatory drugs. Piroxicam gel
will help to relieve pain and reduce swelling affecting
joints and muscles when rubbed into the skin over the
affected area. It is used for the treatment of
rheumatism (pain or inflammation in or around the
bones, muscles or joints), sprains, strains and mild
o

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Piroxicam 0.5% Gel
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Piroxicam 0.5% w/w
3
PHARMACEUTICAL FORM
Gel
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Piroxicam 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_ _1g 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 use of Piroxicam Gel in
children
have not been established.
_Elderly_
No special precautions are required.
Method of administration
Piroxicam 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.
Piroxicam 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
Piroxicam 0.5% Gel is not suitable for use in children under 12 years
of age.
The gel should not be used for any condition other than those
specified.
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 be advised of the sign