Diclofenac sodium 50mg gastro-resistant tablets

Држава: Велика Британија

Језик: Енглески

Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активни састојак:

Diclofenac sodium

Доступно од:

Dexcel-Pharma Ltd

АТЦ код:

M01AB05

INN (Међународно име):

Diclofenac sodium

Дозирање:

50mg

Фармацеутски облик:

Gastro-resistant tablet

Пут администрације:

Oral

Класа:

No Controlled Drug Status

Тип рецептора:

Valid as a prescribable product

Резиме производа:

BNF: 10010100

Информативни летак

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 DICLOFENAC SODIUM 50MG is and what it is used for
2. What you need to know before you take DICLOFENAC
SODIUM 50mg
3. How to take DICLOFENAC SODIUM 50mg
4. Possible side effects
5. How to store DICLOFENAC SODIUM 50mg
6. Contents of the pack and other information
1. WHAT DICLOFENAC SODIUM 50MG IS AND WHAT IT IS
USED FOR
Diclofenac
sodium,
the
active
ingredient
in
DICLOFENAC
SODIUM 50mg, is one of a group of medicines called non-
steroidal anti-inflammatory drugs (NSAIDs). NSAIDs reduce pain
and inflammation.
DICLOFENAC
SODIUM
50mg
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.
2.
WHAT
YOU
NEED
TO
KNOW
BEFORE
YOU
TAKE
DICLOFENAC SODIUM 50MG
DO NOT TAKE DICLOFENAC SODIUM 50MG IF:
• you are allergic to diclofenac sodium, aspirin, ibuprofen or any
other NSAID, or to any of the other ingredients of DICLOFENAC
SODIUM
50mg
tablets
(these
are
listed
under
section
6
"CONTENTS OF THE PACK AND OTHER INFORMATION" of
the leaflet)

Карактеристике производа

OBJECT 1
Diclofenac Sodium 50mg Gastro-
Resistant Tablets
Summary of Product Characteristics Updated 27-Apr-2021 | Dexcel Pharma
Ltd
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Diclofenac Sodium 50mg Gastro-Resistant Tablets
Fenactol Tablets 50mg
2. Qualitative and quantitative composition
Diclofenac sodium 50 mg
Excipients(s) with known effect:
Each tablet contains approximately 88 mg Lactose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Gastro-resistant tablet.
Round,biconvex, reddish-brown coloured tablet, marked "DICL50" 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 co