Fenactol Retard 100mg tablets

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Diclofenac sodium

Disponible depuis:

Dexcel-Pharma Ltd

Code ATC:

M01AB05

DCI (Dénomination commune internationale):

Diclofenac sodium

Dosage:

100mg

forme pharmaceutique:

Modified-release tablet

Mode d'administration:

Oral

classe:

No Controlled Drug Status

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: 10010100; GTIN: 5060029400057

Notice patient

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
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.
IN THIS LEAFLET
1.
What FENACTOL 75MG SR and FENACTOL
RETARD 100MG are and what they are used for
2.
What you need to know before you take
FENACTOL 75MG SR or FENACTOL RETARD
100MG
3.
How to take FENACTOL 75MG SR or
FENACTOL RETARD 100MG
4.
Possible side effects
5.
How to store FENACTOL 75MG SR and
FENACTOL RETARD 100MG
6.
Contents of the pack and other information
1. WHAT FENACTOL 75MG SR AND FENACTOL
RETARD 100MG ARE AND WHAT THEY ARE
USED FOR
Diclofenac
sodium,
the
active
ingredient
in
FENACTOL 75MG SR and FENACTOL RETARD
100MG tablets, is one of a group of medicines called
non-steroidal
anti-inflammatory
drugs
(NSAIDs).
NSAIDs reduce pain and inflammation. FENACTOL
75MG SR and FENACTOL RETARD 100MG tablets
are especially formulated to release the diclofenac
sodium slowly.
FENACTOL 75MG SR and FENACTOL RETARD
100MG tablets relieve pain, reduce swelling and
ease inflammation in conditions affecting the joints,
muscles and tendons including:
• Rheumatoid
arthritis,
osteoarthritis,
acute
gout
(painful inflammation of the joints especially in the
feet and hands), ankylosing spondylitis (form of
spinal arthritis).
• Backache, sprains and strains, soft tissue sports
injuries, frozen shoulder, dislocations and fractures
• Conditions
affecting
the
tendons
for
example,
tendonitis, tenosynovitis, bursitis.
They are also used to treat pain and inflammation
associated with dental and minor surgery.
FENACTOL 75MG SR and FENACTOL RETARD
100MG tablets are not suitable for childr

Résumé des caractéristiques du produit

OBJECT 1
FENACTOL RETARD 100 MG
Summary of Product Characteristics Updated 02-Jan-2018 | Discovery
Pharmaceuticals
1. Name of the medicinal product
Dicloflex Retard 100 mg
and
Fenactol Retard 100 mg
(own label name for distributor Whatdrug T/A Discovery
Pharmaceuticals)
2. Qualitative and quantitative composition
Diclofenac sodium 100 mg
Excipients(s) with known effect
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Prolonged-release tablet.
Pink, round, biconvex tablet, marked "DICL100" on one face.
4. Clinical particulars
4.1 Therapeutic indications
ADULTS AND ELDERLY
Relief of all grades of pain and inflammation in a wide range of
conditions, including:
(i) arthritic conditions: rheumatoid arthritis, osteoarthritis,
ankylosing spondylitis, acute gout,
(ii) acute musculo-skeletal disorders such as periarthritis (for
example frozen shoulder), tendinitis,
tenosynovitis, bursitis,
(iii) other painful conditions resulting from trauma, including
fracture, low back pain, sprains, strains,
dislocations, orthopaedic, dental and other minor surgery.
CHILDREN
Diclofenac Sodium 100mg prolonged-release tablets are not suitable for
children.
4.2 Posology and method of administration
Posology
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration
necessary to control symptoms (see section 4.4).
_ADULTS:_ One 100 mg diclofenac sodium prolonged-release tablet daily.
If necessary, the daily dosage can
be increased to 150 mg by supplementation with the conventional dosage
forms containing diclofenac
sodium 25 mg or 50 mg.
The recommended maximum daily dose of diclofenac sodium is 150mg.
_SPECIAL POPULATIONS_
_ELDERLY:_ Although the pharmacokinetics of Diclofenac sodium are not
impaired to any clinically relevant
extent in elderly patients, nonsteroidal anti-inflammatory drugs
should be used with particular caution in
such patients who generally are more prone to adverse reactions. In
particular it is recommended that the
lowest effective dosage be used in frail