Piroxicam 0.5% gel

País: Reino Unido

Idioma: inglés

Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes activos:

Piroxicam

Disponible desde:

Torrent Pharma (UK) Ltd

Código ATC:

M02AA07

Designación común internacional (DCI):

Piroxicam

Dosis:

5mg/1gram

formulario farmacéutico:

Cutaneous gel

Vía de administración:

Cutaneous

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 10030200; GTIN: 5060623371616 5060623371609

Información para el usuario

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. 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 Piroxicam Gel is and what it is
used for
2. What you need to know before you
use Piroxicam Gel
3. How to use Piroxicam Gel
4. Possible side effects
5. How to store Piroxicam Gel
6. Contents of the pack and other
information
1. WHAT PIROXICAM GEL IS AND WHAT
IT IS USED FOR
The name of your medicine is Piroxicam
0.5% w/w Gel (referred to as Piroxicam Gel).
Piroxicam belongs to a group of medicines
known as 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.
Piroxicam Gel is used to treat:
-
painful (muscle or joint) conditions
involving inflammation or stiffness
-
osteoarthritis of joints such as the
knees, elbows or wrists
-
sprains, strains and inflammation of
tendons
2. WHAT YOU NEED TO KNOW BEFORE
YOU USE PIROXICAM GEL
DO NOT USE PIROXICAM 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 Piroxicam Gel. Medicines are not
always suitable for everyone. Your doctor
needs to know before you use Piroxicam
Gel if you suffer from or have suffered in the
past from any of the following conditions:
- liver disease

Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Piroxicam 0.5% w/w Gel
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Piroxicam 0.5% w/w
Each gram of gel contains 5 mg of piroxicam (0.5% w/w).
Excipient(s) with known effect
Each gram of gel contains 150 mg propylene glycol
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Gel for topical application
Transparent light yellow gel
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Piroxicam
Gel
is
a
non-steroidal
anti-inflammatory
agent
used
for
the
treatment of a variety of conditions characterised by pain and
inflammation or
stiffness.
It is effective in the treatment of osteoarthritis of superficial
joints, such as
knee, acute musculo-skeletal injuries, periathritis, epicondylitis,
tendonitis and
tenosynovitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_:
No occlusive dressings should be employed. Apply 1 g of gel,
corresponding
to 3 cm, 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 Piroxicam Gel in
children have not been established.
_ _
_Use in the Elderly_:
No special precautions are required
Method of administration
Piroxicam Gel is for external use only.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance(s) 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
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
pirox