Preservex 100mg tablets

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Aceclofenac

Saadav alates:

CST Pharma Ltd

ATC kood:

M01AB16

INN (Rahvusvaheline Nimetus):

Aceclofenac

Annus:

100mg

Ravimvorm:

Oral tablet

Manustamisviis:

Oral

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 10010100; GTIN: 5055946801100

Infovoldik

ARTWORK INFORMATION PANEL
DESCRIPTION:
PRINTING COLOURS
NON PRINTING COLOURS
INLINE CONTROL CODE
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EQUATE WITH CMYK
PROOF:
REGULATORY TEXT:
ITEM NUMBER:
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DESIGNER:
FONTS:
DATE:
MANUFACTURER’S TECHNICAL CHECK:
Manufacturer confirms the printability and
technical compliance of this packaging material
for correct use during packaging process.
Date and Signature
PIL Preservex 60 tab GB Mock Up
uk-pl-preservex-04.2018.docx
Graphik semibold, Graphik medium, Graphik regular, Graphik light
Laura Garcia - LuDesign
Mock Up
160x250 (x2)
12.11.2018
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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 any further questions, 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 Preservex is and what it is used for
2. What you need to know before you take
Preservex
3. How to take Preservex
4. Possible side effect
5. How to store Preservex
6. Contents of the pack and other information
1. WHAT PRESERVEX IS AND WHAT IT IS USED FOR
Preservex belongs to a group of medicines
called non-steroidal anti-inflammatory drugs
(NSAIDs). They have anti-inflammatory and
painkiller properties causing a lowering of
swelling, redness (inflammation) and pain.
The medicine/active ingredient of Preservex
is aceclofenac.
Preservex works by blocking the production
of hormone-like substances called
prostaglandins. Prostaglandins have many
functions in the body including an
important role in both the way the body
responds to inflammation and also the
reabsorption of calcium in some diseases of
the bone
Preservex is used to relieve pai

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
PRESERVEX® 100 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100 mg of aceclofenac.
3
PHARMACEUTICAL FORM
Preservex film-coated tablets 100 mg are presented as white round
film-coated
tablets, 8 mm in diameter.
4.1
THERAPEUTIC INDICATIONS
Preservex is indicated for the relief of pain and inflammation in
osteoarthritis,
rheumatoid arthritis and ankylosing spondylitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Preservex film-coated tablets are supplied for oral administration.
Posology
When Preservex was administered to fasting and fed healthy volunteers
only the rate and not
the extent of aceclofenac absorption was affected.
Undesirable effects may be minimised by using the lowest effective
dose for the shortest
duration necessary to control symptoms (see section 4.4
Special warnings and precautions for
use).
ADULTS
The recommended dose is 200 mg daily, taken as two separate 100 mg
doses, one tablet in the
morning and one in the evening.
PAEDIATRIC POPULATION
There are no clinical data on the use of Preservex in children and
therefore it is not
recommended for use in children.
ELDERLY
The elderly, who are more likely to be suffering from impaired renal,
cardiovascular or
hepatic function and receiving concomitant medication, are at
increased risk of the serious
consequences of adverse reactions. If an NSAID is considered
necessary, the lowest effective
dose should be used and for the shortest possible duration. The
patient should be monitored
regularly for GI bleeding during NSAID therapy.
The pharmacokinetics of Preservex are not altered in elderly patients,
therefore it is not
considered necessary to modify the dose or dose frequency.
RENAL INSUFFICIENCY
There is no evidence that the dosage of Preservex needs to be modified
in patients with mild
renal impairment, but as with other NSAIDs caution should be exercised
(see also
Precautions).
HEPATIC INSUFFICIENCY
There is some evidence that the dose of Prese