Ketoprofen 100mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ketoprofen

Available from:

Alliance Healthcare (Distribution) Ltd

ATC code:

M01AE03

INN (International Name):

Ketoprofen

Dosage:

100mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010100

Patient Information leaflet

Artwork No.
Customer
Description
Market
Language
Size
Min. Font Size
Page No.
Version No.
Date
Software
060118/1
Ennogen
Ketoprofen Leaflet
UK
English
170 x 450 mm
Arial, 9 pt
1 of 1
3
03-05-18
Coreldraw 12
Packaging Development
Quality Assurance (QA)
Quality Control (QC)
Production
e-mail : [e-mail]
Ph : [phone]
Colours Used
Black
Keyline
Ketoprofen Capsules 50mg and 100mg
(Ketoprofen)
PACKAGE LEAFLET: INFORMATION FOR THE USER
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Keep this leaflet. You may need to read it
again.
If you have further questions, please ask your
doctor, pharmacist or nurse.
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,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section
4.
WHAT IS IN THIS LEAFLET:
1.
WHAT KETOPROFEN CAPSULES ARE AND WHAT
THEY ARE USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
KETOPROFEN CAPSULES
3.
HOW TO TAKE KETOPROFEN CAPSULES
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE KETOPROFEN CAPSULES
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
Ketoprofen Capsules contain a medicine called
Ketoprofen. This belongs to a group of medicines
called 'non-steroidal anti-inflammatory drugs'
(NSAIDs).
Ketoprofen Capsules are used to relieve symptoms
of rheumatoid arthritis, osteoarthritis, ankylosing
spondylitis, fibrositis, cervical spondylitis, low back
pain, painful musculoskeletal conditions and period
pain.
Ketoprofen reduces joint pain and inflammation,
and facilitates an increase in mobility and
functional independence.
DO NOT TAKE KETOPROFEN CAPSULES IF YOU:
Are ALLERGIC to Ketoprofen or any of the other
ingredients in this medicine (see Section 6)
If you are allergic to other non−steroidal
anti−inflammatory drugs (NSAIDs), including
aspirin. Signs of an allergic reaction are
breathin

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ketoprofen Capsules BP 100mg.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains ketoprofen BP 50mg.
Excipient(s) with known effect
Lactose
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ketoprofen capsules are recommended for the management of rheumatoid
arthritis, osteoarthritis, ankylosing spondylitis, acute articular and
periarticular
disorders,
fibrositis,
cervical
spondylitis,
low
back
pain,
painful
musculoskeletal conditions and dysmenorrhoea. Ketoprofen reduces joint
pain
and
inflammation,
and
facilitates
increase
in
mobility
and
functional
independence. As with other non-steroidal anti-inflammatory agents, it
does
not cure the underlying disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Undesirable effects may be minimised by using the lowest effective
dose for
the shortest duration necessary to control symptoms (see section 4.4).
Ketoprofen
capsules
should
always
be
taken
with
food
to
reduce
the
occurrence of gastrointestinal disturbance.
_Adults:_
50-100mg twice daily. The dosage can be altered depending on the
patient
weight and on the severity of symptoms.
_Dysmenorrhoea:_
50mg up to 3 times a day. Three to 4 days treatment is normally
required from
the onset of menstruation or symptoms of dysmenorrhoea.
_Elderly:_
The elderly are at increased risk of the serious consequences of
adverse
reactions. If an NSAID is considered necessary, the lowest effective
dose
should be used for the shortest possible duration. The patient should
be
monitored regularly for GI bleeding during NSAID therapy.
_Children:_
Dosage has not been established.
4.3 CONTRAINDICATIONS
Ketoprofen is contraindicated in the following cases:
Hypersensitivity to the active substance or to any of the excipients
listed in
section 6.1
Known allergy to aspirin and to other substances with similar effect
(non-
steroidal anti-inflammatory agents): who have a history of
hypersens