EXIPAN

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

PIROXICAM

Available from:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

ATC code:

M02AA07

Pharmaceutical form:

GEL

Composition:

PIROXICAM 0.5 %W/W

Administration route:

DERMAL

Prescription type:

Not required

Manufactured by:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

Therapeutic group:

PIROXICAM

Therapeutic area:

PIROXICAM

Therapeutic indications:

For local treatment of inflammatory conditions accompanied by pain.

Authorization date:

2014-09-30

Summary of Product characteristics

Prescribing Information
1.
NAME OF THE MEDICINAL PRODUCT
EXIPAN 0.5 %W/W Gel
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Piroxicam 0.5% W/W
Each 1 g gel contains 5 mg Piroxicam.
Excipient with known effect:
Exipan contains
83
180.
mg/g Alcohol 95%, 0.28 mg/g Methyl Parahydroxybenzoate and
0.14 mg/g Propyl Parahydroxybenzoate.
For the full list of excipients, see section 6.1.
_ _
3. PHARMACEUTICAL FORM
3.1.
Preparations
Clear -Yellowish Gel for topical application
4. CLINICAL PARTICULARS
4.1.
Therapeutic Indications
Exipan Gel is a non-steroidal anti-inflammatory agent.
For local treatment of inflammatory conditions accompanied by pain.
4.2.
Posology and Method of Administration
Posology:
•
Adults
No occlusive dressings should be applied.
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 Exipan Gel in
children have not been
established.
•
Elderly
No special precautions are required.
Method of administration
Exipan 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). Exipan Gel should not be given to patients in whom
aspirin and other nonsteroidal
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 the use of systemic administration of
piroxicam. These reactions
have not been associated with topical piroxicam, but the possibility
of occurring with topical
piroxicam cannot be ruled out.
Patients sho