Piroxicam 0.5% gel

Երկիր: Միացյալ Թագավորություն

Լեզու: անգլերեն

Աղբյուրը: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ակտիվ բաղադրիչ:

Piroxicam

Հասանելի է:

Mawdsley-Brooks & Company Ltd

ATC կոդը:

M02AA07

INN (Միջազգային անվանումը):

Piroxicam

Դոզան:

5mg/1gram

Դեղագործական ձեւ:

Cutaneous gel

Կառավարման երթուղին:

Cutaneous

Դաս:

No Controlled Drug Status

Ռեկվիզորի տեսակը:

Valid as a prescribable product

Ապրանքի ամփոփագիր:

BNF: 10030200

Տեղեկատվական թերթիկ

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Details
PIROXICAM 0.5% 60G & 112G GEL PIL - UK
Black
Code Area
BBBA5624
S.Anson
24.07.19
22.08.19
S.Anson
148 x 280
11pt
IL/Tiofarma BV
24.07.19
22.08.19
4
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 BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
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 only.
Do not pass it on to others. It may harm them,
even if their signs of illness 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.
WHAT IS IN THIS LEAFLET:
1. What Piroxicam 0.5% Gel is and what it is used for
2.
What you need to know 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. Content of the pack and other information
1. WHAT PIROXICAM 0.5% GEL IS AND WHAT IT
IS 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
rheumat

Ապրանքի հատկությունները

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