FASTUM GEL

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

LeBasi Pharmaceuticals (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

GEL

Composition:

EACH 100 g GEL CONTAINS KETOPROFEN 2,5 g

Authorization status:

Registered

Authorization date:

1994-01-08

Patient Information leaflet

Lebasi Pharmaceuticals (Pty) Ltd
Fastum Gel
Date approved: 2022/10/28
Each 100 g gel contains 2,5 g ketoprofen
Approved PIL
Page 1 of 8
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S1
FASTUM GEL, 2,5 G/100 G
KETOPROFEN
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
FASTUM GEL is available without a doctor’s prescription, for you to
treat a mild illness.
Nevertheless, you still need to use FASTUM GEL carefully to get the
best results from it.
•
Keep this leaflet. You may need to read it again.
•
Do not share FASTUM GEL with any other person.
•
Ask your health care provider or pharmacist if you need more
information or advice.
•
You must see a doctor if your symptoms worsen or do not improve after
7 days.
WHAT IS IN THIS LEAFLET
1.
What FASTUM GEL is and what it is used for
2.
What you need to know before you use FASTUM GEL
3.
How to use FASTUM GEL
4.
Possible side effects
5.
How to store FASTUM GEL
6.
Contents of the pack and other information.
1.
WHAT FASTUM GEL IS AND WHAT IT IS USED FOR
FASTUM GEL contains ketoprofen and belongs to a group of medicines
called anti-inflammatory
and antirheumatic (against rheumatism) medicines.
FASTUM GEL is used for the relief of localised pain and inflammation
associated with acute
Lebasi Pharmaceuticals (Pty) Ltd
Fastum Gel
Date approved: 2022/10/28
Each 100 g gel contains 2,5 g ketoprofen
Approved PIL
Page 2 of 8
musculoskeletal injuries.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE FASTUM GEL
DO NOT USE FASTUM GEL
•
If you are hypersensitive (allergic) or if you have a history of
hypersensitivity (allergic)
reactions to ketoprofen or any of the other ingredients of FASTUM GEL
(listed in section 6).
•
If you are hypersensitive (allergic) or if you have a history of
hypersensitivity (allergy) to other
substances that are chemically related to ketoprofen such as
fenofibrate, tiaprofenic acid,
acetylsalicylic acid (aspirin) or other nonsteroidal anti-inflammatory
drugs (NSAIDs).
•
If you have had a photosensitivity reaction (ski

Summary of Product characteristics

Lebasi Pharmaceuticals (Pty) Ltd
Fastum Gel
Date approved: 2022/10/28
Each 100 g gel contains 2,5 g ketoprofen
Approved PI
Page 1 of 9
APPROVED PROFESSIONAL INFORMATION FOR FASTUM GEL
SCHEDULING STATUS
S1
1.
NAME OF THE MEDICINE
FASTUM GEL
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 100 g gel contains 2,5 g ketoprofen.
Excipients with known effects:
Neroli fragrance and lavandin fragrance (containing citral,
citronellols, coumarin, farnesol, geraniol,
d-limonene and linalool).
Contains 307 mg ethanol per 1 g.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gel.
A mucilaginous, colourless, almost transparent gel with an aromatic
flavour.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the relief of localised pain and inflammation associated with
acute musculoskeletal injuries.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Treatment should not exceed 7 days.
_PERSONS 12 YEARS AND OLDER: _
Lebasi Pharmaceuticals (Pty) Ltd
Fastum Gel
Date approved: 2022/10/28
Each 100 g gel contains 2,5 g ketoprofen
Approved PI
Page 2 of 9
Apply to the affected area once or twice daily by gently massaging in
order to help absorption.
Apply 5 to 15 cm of gel with each application (100 mg to 300 mg
ketoprofen).
_ _
METHOD OF ADMINISTRATION
Topical.
4.3
CONTRAINDICATIONS
•
Hypersensitivity or history of hypersensitivity to ketoprofen or to
any of the excipients listed in
section 6.1.
•
History of photosensitivity reactions.
•
Known hypersensitivity reactions, such as asthma symptoms, allergic
rhinitis and urticaria, to
ketoprofen, fenofibrate, tiaprofenic acid, acetylsalicylic acid or
other nonsteroidal anti-
inflammatory drugs (NSAIDs).
•
History of skin allergy to ketoprofen, tiaprofenic acid, fenofibrate,
UV blockers or perfumes.
•
Sun exposure, even in case of hazy sun, including UV light from
solarium, during the
treatment and 2 weeks after its discontinuation (see section 4.4).
•
Application to pathologically altered skin, such as dermatosis, eczema
or acne, around the
eyes, t