Fastum 2.5% w/w Gel

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ketoprofen

Available from:

LTT Pharma Limited

ATC code:

M02AA; M02AA10

INN (International Name):

Ketoprofen

Dosage:

2.5 percent weight/weight

Pharmaceutical form:

Gel

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Antiinflammatory preparations, non-steroids for topical use; ketoprofen

Authorization status:

Authorised

Authorization date:

2015-02-06

Patient Information leaflet

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 only.
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:
What Fastum Gel is and what it is used for
What you need to know before you use
Fastum Gel
How to use Fastum Gel
Possible side effects
How to store Fastum Gel
Contents of the pack and other information
WHAT FASTUM GEL IS AND WHAT IT IS USED
FOR
Fastum Gel contains a medicine called ketoprofen.
Fastum Gel belongs to a group of medicines called
Non-Steroidal Anti- Inflammatory Drugs (NSAIDs).
These reduce inflammation and relieve pain.
Fastum Gel is used to relieve the pain of soft tissue
injuries, and acute strains and sprains. Fastum Gel
should only be used by adults and children over 12
years of age.
WHAT YOU NEED TO KNOW BEFORE YOU USE
FASTUM GEL
DO NOT USE FASTUM GEL:
•
If you are allergic to the active substance
ketoprofen or to any of the other ingredients listed
in Section 6, “Further information” for a list of other
ingredients)
•
If you have previously had any photosensitivity
reactions – an abnormal reaction of the skin to
sunlight which may resemble severe sunburn
•
If you are hypersensitive (allergic) to UV blockers
(sun creams) or perfumes
•
If you are allergic to aspirin, other NSAIDs (eg
ibuprofen) or any medicines for pain relief or
inflammation including tiaprofenic acid
•
If you are allergic to fenofibrate (a medicine used
to lower blood cholesterol)
•
you have had wheezing (asthma), runny nose
(rhinitis) or an itchy rash (hives) after taking aspirin
or other NSAIDs (eg ibuprofen)
•
If you intend to use it on skin condit

Summary of Product characteristics

Health Products Regulatory Authority
24 October 2018
CRN008N5J
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fastum 2.5% w/w Gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Fastum Gel contains Ketoprofen 2.5% w/w.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gel
_Product imported from Romania_
A colourless, non-greasy, non-staining gel with an aromatic fragrance
for cutaneous
use.
4 CLINICAL PARTICULARS
As per PA0512/001/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0512/001/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Carbomer 940
Ethanol
Neroli essence
Lavender essence
Trolamine
Purified water
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
Health Products Regulatory Authority
24 October 2018
CRN008N5J
Page 2 of 2
The shelf life expiry date for this product shall be the date shown on
the tube and
outer package of the product on the market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C.
Replace the cap after use.
Keep the gel away from naked flames.
6.5 NATURE AND CONTENTS OF CONTAINER
Soft aluminium tube treated inside with non-toxic epoxyresin,
containing 100g.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
LTT Pharma Limited
Unit 18
Oxleasow Road
East Moons Moat
Redditch, Worcestershire B98 0RE
United Kingdom
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1562/150/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 6
th
February 2015.
10 DATE OF REVISION OF THE TEXT
October 2018