Oruvail 2.5% gel

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ketoprofen

Available from:

Sanofi

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; GTIN: 5013011002890 5013011002685

Patient Information leaflet

756696
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 any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
IN THIS LEAFLET:
1. What Oruvail Gel is and what it is used for
2. Before you use Oruvail Gel
3. How to use Oruvail Gel
4. Possible side effects
5. How to store Oruvail Gel
6. Further 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
a
medicine called ketoprofen. This 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. 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
lips, face, throat or tongue
You have or have ever had asthma or other allergies
You hav

Summary of Product characteristics

OBJECT 1
ORUVAIL 2.5% GEL
Summary of Product Characteristics Updated 07-Apr-2020 | SANOFI
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
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 es