Oruvail 2.5% gel

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ketoprofen

Available from:

Waymade Healthcare Plc

ATC code:

M02AA10

INN (International Name):

Ketoprofen

Dosage:

25mg/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

777969
PACKAGE LEAFLET:
INFORMATION FOR THE USER
ORUVAIL® 2.5% GEL
ketoprofen
IS THIS LEAFLET HARD TO
SEE OR READ?
PHONE [phone]
FOR HELP
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE
•
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
symptoms 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 Oruvail Gel is and what it is used for
2. What you need to know before you use Oruvail Gel
3. How to use Oruvail Gel
4. Possible side effects
5. How to store Oruvail Gel
6. Contents of the pack and other information
1. WHAT ORUVAIL GEL IS AND WHAT
IT IS USED FOR
WHAT ORUVAIL GEL IS AND HOW IT WORKS
The name of your medicine is Oruvail 2.5% Gel (called
Oruvail Gel in this leaflet). Oruvail Gel contains the
active substance ketoprofen, it belongs to a group of
medicines
called
‘Non-Steroidal
Anti-Inflammatory
Drugs’ (NSAID’s). It works by blocking some chemicals
in your body that normally cause inflammation and
reduces pain.
WHAT ORUVAIL GEL IS USED FOR
It is used to treat the swelling, pain, heat, redness and
stiffness in your joints and muscles in the following:
•
Arthritis (inflammation of the joints)
•
Pain from injuries such as sports injuries, sprains and
strains
2. WHAT YOU NEED TO KNOW BEFORE
YOU USE ORUVAIL GEL
DO NOT USE THIS MEDICINE AND TELL YOUR DOCTOR
IF:
You are allergic (hypersensitive) to:
– ketoprofen,
tiaprofenic
acid,
fenofibrate,
UV
blockers or perfumes
– aspirin
– any other Non-Steroidal Anti-Inflammatory Drug
(NSAID) such as ibuprofen or indometacin
– any of the other ingredients of Oruvail Gel (listed
in Section 6 below)
Signs
of
an
allergic
reaction
include:
a
rash,
swallowing or breathing problems, swelling of your
lip

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Oruvail 2.5% Gel
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ketoprofen 2.5% w/w
3
PHARMACEUTICAL FORM
Gel
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ketoprofen is a non-steroidal anti-inflammatory drug. It has
anti-inflammatory and
analgesic actions.
Relief of acute painful musculoskeletal conditions caused by trauma,
such as sports
injuries, sprains, strains and contusions.
Pain of non serious arthritis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults:
To be applied two to four times daily to the skin in the painful or
inflamed region for up to 7 days. Apply gently but massage well to
ensure gel penetration. The usual recommended dose is 15g per day
(7.5 grams correspond to approximately 14cm of gel).
Elderly:
There are no specific dosage recommendations for the elderly.
Children:
Not recommended as safety in children has not been established.
4.3
CONTRAINDICATIONS
Oruvail Gel must not be used in patients with:
•
history of photosensitivity reactions
•
known hypersensitivity reactions, such as symptoms of asthma, allergic
rhinitis to ketoprofen, fenofibrate, tiaprofenic acid, acetylsalicylic
acid, or to
other Non-Steroidal Anti-Inflammatory agents (NSAIDs)
•
history of skin allergy reactions to ketoprofen, tiaprofenic acid,
fenofibrate,
UV blockers or perfumes
•
sun exposure, even hazy sun, including UV light from solarium, during
treatment and for 2 weeks after its discontinuation (see Section 4.4
Special
warnings and precautions for use).
•
history of hypersensitivity to any of the excipients
•
third trimester of pregnancy (see section 4.6)
•
pathological skin changes such as eczema or acne; or in infected skin
or open
wounds.
•
Oruvail gel should not be applied to mucous membranes, anal or genital
areas, eyes or used with occlusive dressings.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
•
Hands should be washed thoroughly after each application of the Gel.
•
Treatment should be discontinued immediately upon develop