Diclofenac sodium 50mg gastro-resistant tablets

Country: Ingilterra

Lingwa: Ingliż

Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredjent attiv:

Diclofenac sodium

Disponibbli minn:

DE Pharmaceuticals

Kodiċi ATC:

M01AB05

INN (Isem Internazzjonali):

Diclofenac sodium

Dożaġġ:

50mg

Għamla farmaċewtika:

Gastro-resistant tablet

Rotta amministrattiva:

Oral

Klassi:

No Controlled Drug Status

Tip ta 'preskrizzjoni:

Valid as a prescribable product

Sommarju tal-prodott:

BNF: 10010100

Fuljett ta 'informazzjoni

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)

Karatteristiċi tal-prodott

OBJECT 1
DICLOFENAC SODIUM 50MG GASTRO-
RESISTANT TABLETS
Summary of Product Characteristics Updated 06-Feb-2020 | 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
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 conditions resulting from trauma, including
fracture,