VOLTAROL 50 Milligram Tablets Gastro-Resistant

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

DICLOFENAC SODIUM

Beszerezhető a:

Novartis Pharmaceuticals UK Ltd

ATC-kód:

M01AB05

INN (nemzetközi neve):

DICLOFENAC SODIUM

Adagolás:

50 Milligram

Gyógyszerészeti forma:

Tablets Gastro-Resistant

Recept típusa:

Product subject to prescription which may be renewed (B)

Terápiás terület:

Acetic acid derivatives and related substances

Engedélyezési státusz:

Authorised

Engedély dátuma:

1994-10-03

Betegtájékoztató

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Both Production Site:
Kurtkoy
WO:
1555093
CTM:
Vural, Merve
Comp. Description:
LFT_VOLTAROL FCT 50MG IE
Printing Colours:
Black
Comp. No. New:
1813396 IE
Comp. No. Old:
1809086 IE
Format/Dimension:
594 x 148 mm
Tech. Drawing No.:
N/A
Technical Colours:
Cutting
Guides
Min. Font Size Text:
10 pt
Font Type:
News Gothic
Version No.: 2
Date: 17 Nov 2016
J.N.: 295112
Braille: 
N/A
! PLEASE  TURN  OVERPRINTING  ON !
Telephone [phone]
[e-mail]
www.perigord-as.com
Unit 1, Lyncon Court
IDA Business & Technology Park
Snugborough Rd
Blanchardstown
Dublin 15
1813396 IE (1236)
RISK OF HEART ATTACK OR STROKE WITH VOLTAROL
There is a small increased risk of heart attack or stroke 
when you are taking any medicine like Voltarol. The risk is 
higher when you are taking higher doses for a long time. 
Always follow the doctor’s instructions on how much 
to take and how long to take it for. If, at any time while 
taking Voltarol you experience any signs or symptoms of 
problems with your heart or blood vessels such as chest 
pain, shortness of breath, weakness, or slurring of speech, 
contact your doctor immediately.
SIGNS OF INFECTION
Because it is an anti-inflammatory medicine, Voltarol may 
reduce the symptoms of infection, for example, headache 
and high temperature. If you feel unwell and need to see 
a doctor, remember to tell him or her that you are taking 
Voltarol.
TESTS AND CHECKS
If you have significant risks for heart disease, your doctor 
will periodically re-evaluate whether you should continue 
treatment with Voltarol.
If you have any liver impairment, kidney impairment or blood 
impairment, you will have blood tests during treatment. 
These will monitor the function of your liver, kidney or your 
blood count. Your doctor will take these blood tests into 
consideration to decide if Voltaral needs to be discontinued 
or if the dose needs to be changed.
IF YOU ARE ELDERLY OR UNDERWEIGHT
If you are e

Termékjellemzők

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Voltarol 50 mg Gastro-Resistant Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Voltarol Tablets 50 mg contain 50mg diclofenac sodium.
Each tablet also contains 25mg lactose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet.
Circular,
slightly biconvex,
light
brown,
gastro-resistant
tablet
with beveled edges,
embossed ‘CG’ on one side and
‘GT’ on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Relief of all grades of pain and inflammation in a wide range of
conditions.
Treatment of:
•
Inflammatory and degenerative
forms
of
rheumatism:
rheumatoid arthritis,
juvenile
rheumatoid arthritis,
ankylosing spondylitis, osteoarthritis, spondylarthritis and psoriatic
arthropathy.
•
Acute attacks of gout.
•
Post-traumatic and post-operative pain, inflammation, and swelling,
e.g. following dental or orthopaedic surgery.
•
Painful and/or inflammatory conditions in gynaecology, e.g. primary
dysmenorrhoea or adnexitis and associated
menorrhagia.
•
As an adjuvant in severe painful inflammatory infections of the ear,
nose, or throat, e.g. pharyngotonsillitis, otitis.
In keeping with general therapeutic principles,
the underlying disease should be treated with basic therapy,
as
appropriate. Fever alone is not an indication.
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).
The tablets should be swallowed whole with liquid, preferably before
meals, and must not be divided or chewed.
_ADULTS:_
Voltarol 25mg and 50mg gastro-resistant tablets: 75-150mg daily in two
or three divided doses. The recommended
maximum daily dose of Voltarol is 150mg.
This may be administered using a combination of dosage forms, e.g.
tablets
and suppositories.
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