Enstar SR 75 tablets

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Diclofenac sodium

Dostupné z:

Ennogen Pharma Ltd

ATC kód:

M01AB05

INN (Medzinárodný Name):

Diclofenac sodium

Dávkovanie:

75mg

Forma lieku:

Modified-release tablet

Spôsob podávania:

Oral

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 10010100

Príbalový leták

Enstar SR 75mg Tablets (DICLOFENAC SODIUM)
PACKAGE LEAFLET: INFORMATION FOR THE USER
!
You have a history of bleeding from the
stomach or bowels when taking NSAIDs
previously
!
You are in your last three months of pregnancy
!
You think you may be allergic to diclofenac
sodium, aspirin, ibuprofen or any other NSAID,
or to any of the other ingredients of this
medicine (listed in section 6). Signs of an
allergic reaction include swelling of the face
and mouth (angioedema), breathing problems,
chest pain, runny nose, skin rash or any other
allergic type reaction
!
You have or previously have had a peptic ulcer
bleeding or perforation in your stomach or
intestine.
!
If you have further questions, ask your doctor,
pharmacist or nurse.
!
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.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
!
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.
1.
WHAT ENSTAR SR 75MG TABLETS ARE AND WHAT
THEY ARE USED FOR
!
Keep this leaflet. You may need to read it
again.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
ENSTAR SR 75MG TABLETS
5.
HOW TO STORE ENSTAR SR 75MG TABLETS
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT ENSTAR SR 75MG TABLETS ARE
AND WHAT THEY ARE USED FOR
WHAT IS IN THIS LEAFLET:
3.
HOW TO TAKE ENSTAR SR 75MG TABLETS
4.
POSSIBLE SIDE EFFECTS
Enstar SR 75mg Tablets belong to a group of
medicines called non-steroidal anti-inflammatory
drugs (NSAIDs). Enstar SR 75mg Tablets are used
to relieve symptoms caused by osteoarthritis,
rheumatoid arthritis and ankylosing spondylitis
(rheumatism of the spine) such as swelling,
stiffness or joint pain. It does not cure arthritis and
will help you only as long as you continue to take it.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE ENSTAR SR 75MG TABLETS
DO NOT TAKE

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Enstar SR 75mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 75mg of the active substance Diclofenac sodium.
Excipient(s) of known effect
Lactose monohydrate
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Light pink, round, biconvex prolonged release tablets with D3 embossed
on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Adults:
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.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
Adults: One tablet once or twice daily, taken whole with liquid,
preferably at
meal times.
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 and for the shortest possible duration. The
patient should
be monitored regularly for GI bleeding during NSAID therapy.
Children: Diclofenac sodium is not recommended for use in children as
dosage
recommendations and indications for use in this group of patients have
not
been established.
To be taken preferably with or after food.
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).
4.3.
CONTRAINDICATIONS
•
Hypersensitivity to the active substance or to any of the excipients
listed in
section 6.1. Active, gastric or intestinal ulcer, bleeding or
perforation.
•
History of gastrointestinal bleeding or perforation, related to