Dicloflex Retard 100mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Diclofenac sodium

Available from:

Dexcel-Pharma Ltd

ATC code:

M01AB05

INN (International Name):

Diclofenac sodium

Dosage:

100mg

Pharmaceutical form:

Modified-release tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010100; GTIN: 5033847000051

Patient Information leaflet

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 DICLOFLEX is and what it is used for
2. What you need to know before you take DICLOFLEX
3. How to take DICLOFLEX
4. Possible side effects
5. How to store DICLOFLEX
6. Contents of the pack and other information
1. WHAT DICLOFLEX IS AND WHAT IT IS USED FOR
Diclofenac sodium, the active ingredient in DICLOFLEX tablets, is one
of a group of medicines called
non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs reduce pain and
inflammation. DICLOFLEX
tablets are especially formulated to release the diclofenac sodium
slowly.
DICLOFLEX 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.
DICLOFLEX tablets are not suitable for children.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DICLOFLEX
DO NOT TAKE DICLOFENAC SODIUM IF:
• you are allergic to diclofenac sodium, aspirin, ibuprofen or to
any other NSAID, or any of the other
ingredients of DICLOFLEX tablets (these are listed under section 6
"CONTENTS OF THE PACK AND
OTHER INFORMATION" of th

Summary of Product characteristics

OBJECT 1
DICLOFLEX RETARD 100 MG
Summary of Product Characteristics Updated 03-Jan-2018 | Dexcel Pharma
Ltd
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 elderly