Voltarol 100mg suppositories

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Diclofenac sodium

Available from:

Dowelhurst Ltd

ATC code:

M01AB05

INN (International Name):

Diclofenac sodium

Dosage:

100mg

Pharmaceutical form:

Suppository

Administration route:

Rectal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010100

Patient Information leaflet

VOLTAROL
® SUPPOSITORIES
12.5, 25, 50 AND 100 MG
(DICLOFENAC SODIUM)
PATIENT INFORMATION LEAFLET
WHAT YOU NEED TO KNOW ABOUT VOLTAROL
SUPPOSITORIES
Your doctor has decided that you need this
medicine to help treat your condition.
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU
START TO USE THESE SUPPOSITORIES. IT CONTAINS
IMPORTANT INFORMATION. Keep the leaflet in a safe
place because you may want to read it again.
If you have any other questions, or if there is
something you don’t understand, please ask
your doctor or pharmacist.
This medicine has been prescribed for you.
Never give it to someone else. It may not be the
right medicine for them even if their symptoms
seem to be the same as yours.
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Voltarol Suppositories are, and what
they are used for
2. Things to consider before you start to use
Voltarol Suppositories
3. How to use Voltarol Suppositories
4. Possible side effects
5. How to store Voltarol Suppositories
6. Further information
1. WHAT VOLTAROL SUPPOSITORIES ARE AND
WHAT THEY ARE USED FOR
Diclofenac sodium, the active ingredient in Voltarol
Suppositories, is one of a group of medicines called
non-steroidal anti-inflammatory drugs (NSAIDs).
NSAIDs reduce pain and inflammation.
• Voltarol Suppositories relieve pain, reduce
swelling and ease inflammation in conditions
affecting the joints, muscles and tendons
including:
– Rheumatoid arthritis, osteoarthritis, acute
gout, ankylosing spondylitis
– Backache, sprains and strains, soft tissue
sports injuries, frozen shoulder, dislocations
and fractures
– Tendonitis, tenosynovitis, bursitis.
• They are also used to treat pain and
inflammation associated with dental and
minor surgery.
• In children aged 1 to 12 Voltarol
Suppositories 12.5 and 25 mg are used to
treat juvenile chronic arthritis.
• In children aged over 6 they can also be
used alone, or in combination with other
painki

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Voltarol
®
Suppositories 100mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active substance is
sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate (diclofenac
sodium).
Each suppository contains 100mg diclofenac sodium Ph.Eur.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suppositories.
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_: Not indicated.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
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).
Not to be taken by mouth, as per rectal administration only.
The suppositories should be inserted well into the rectum. It is
recommended to insert the suppositories after
passing stools.
ADULTS:
75-150mg daily, in divided doses. 100mg suppositories may also be
given as a once daily treatment, usually
at night. Where necessary, therapy may be combined with 25mg or 50mg
tablets or suppositories up to the
maximum dose of 150mg per day.
SPECIAL POPULATIONS
ELDERLY
Although the pharmacokinetics of Voltarol 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 patients or those with a low body
weight (see also se