Voltarol 100mg suppositories

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Diclofenac sodium

Prieinama:

Lexon (UK) Ltd

ATC kodas:

M01AB05

INN (Tarptautinis Pavadinimas):

Diclofenac sodium

Dozė:

100mg

Vaisto forma:

Suppository

Vartojimo būdas:

Rectal

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 10010100

Pakuotės lapelis

5. HOW TO STORE VOLTAROL SUPPOSITORIES
EXPIRY DATE
Do not use this medicine after the expiry date
shown on the carton or Suppository label. If your
doctor tells you to stop taking this medicine, return
any unused medicine to your pharmacist for safe
disposal. Only keep this medicine, if your doctor
tells you to. If your medicine becomes discoloured
or shows any other signs of deterioration, consult
your pharmacist who will tell you what to do.
STORAGE
•
KEEP OUT OF THE SIGHT AND REACH OF
CHILDREN
•
Do not store above 30°C
•
Protect from heat
IMPORTANT
Remember this medicine is for you. Only a doctor
can prescribe it. Never give your medicine to other
people. It may harm them, even if their symptoms
are the same as yours. This leaflet does not tell
you everything about your medicine. If you have
any questions or are not sure about anything, ask
your doctor or pharmacist. He/she will have
additional information about this medicine and will
be able to advise you.
6. FURTHER INFORMATION
WHAT VOLTAROL SUPPOSITORIES CONTAINS
Each suppository contains 100mg of diclofenac
sodium as the active ingredient.
Voltarol Suppositories also has the following
inactive ingredient: suppository mass 5.
WHAT VOLTAROL SUPPOSITORIES LOOKS LIKE AND
CONTENTS OF THE PACK
Voltarol Suppositories are a white to yellowish,
torpedo-shaped, with smooth surface and slightly
fatty odour and are sealed in a composite foil.
Voltarol Suppositories comes in foil packs of 10
Suppositories.
MANUFACTURER AND LICENCE HOLDER
This medicine is manufactured by Novartis
Pharma S.A.S., 8-10 Rue Henri Sainte-Claire
Deville, 92500 Rueil Malmaison, France and are
procured from within the EU and repackaged by
the Product Licence Holder: Lexon (UK) Limited,
Unit 18, Oxleasow Road, East Moons Moat,
Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.
PL 15184/1089
Voltarol is a registered trademark of

Prekės savybės

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