Volsaid Retard 75 tablets

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Diclofenac sodium

זמין מ:

Chiesi Ltd

קוד ATC:

M01AB05

INN (שם בינלאומי):

Diclofenac sodium

כמות:

75mg

טופס פרצבטיות:

Modified-release tablet

מסלול נתינה (של תרופות):

Oral

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 10010100; GTIN: 5028613001073

עלון מידע

PACKAGE LEAFLET: INFORMATION FOR THE USER
VOLSAID RETARD 75 MG & 100 MG TABLETS
diclofenac sodium
IMPORTANT THINGS YOU NEED TO KNOW ABOUT VOLSAID
• VOLSAID IS A NON-STEROIDAL ANTI-INFLAMMATORY MEDICINE, prescribed
to
reduce swelling and ease inflammation in conditions affecting the
joints and muscles.
• YOU NEED TO TAKE IT REGULARLY to get the maximum benefit.
DO NOT STOP
TAKING IT without talking to your doctor.
• VOLSAID CAN CAUSE SERIOUS SIDE EFFECTS IN SOME PEOPLE (read
Section 4 for
details). If you experience difficulty in breathing, an allergic
reaction such as
skin rashes, signs of bleeding from your intestines or vomit blood
contact your
doctor immediately.
• If you are elderly, suffer from kidney, liver or heart problems,
YOUR DOCTOR
MAY REGULARLY MONITOR YOUR CONDITION to check you are taking the
correct
dose of Volsaid.
• TAKING OTHER MEDICINES, including other NSAIDs, may sometimes
cause
problems. CHECK with your doctor or pharmacist before taking any other
medicines.
• If you are (or might become) PREGNANT WHILE TAKING VOLSAID, it is
important to
TALK TO YOUR DOCTOR ABOUT THIS.
NOW READ THE REST OF THIS LEAFLET. It includes other important
information on the
safe use of this medicine that might be especially important for you.
THIS LEAFLET
WAS LAST UPDATED ON 08/2016.
WHAT IS IN THIS LEAFLET:
1. WHAT VOLSAID IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VOLSAID
3. HOW TO TAKE VOLSAID
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE VOLSAID
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT VOLSAID IS AND WHAT IT IS USED FOR
Volsaid Retard Tablets contain diclofenac sodium which belongs to a
group of medicines
called non-steroidal anti-inflammatory drugs (NSAIDs) that reduce pain
and inflammation.
They are called modified release tablets because they are manufactured
in a way that
allows the diclofenac sodium to be released and slowly absorbed by the
body over a
period of several hours.
Volsaid Retard Tablets relieve pain, reduce swelling and ease
inflammation in the
foll

מאפייני מוצר

OBJECT 1
VOLSAID RETARD 75 MG TABLET
Summary of Product Characteristics Updated 02-Nov-2016 | Chiesi
Limited
1. Name of the medicinal product
VOLSAID RETARD 75
2. Qualitative and quantitative composition
Each modified-release tablet contains 75 mg diclofenac sodium.
For excipients see section 6.1
3. Pharmaceutical form
Modified-release tablet
White, triangular tablet. One side is marked "DIC 75" and the reverse
side is plain.
4. Clinical particulars
4.1 Therapeutic indications
Diclofenac sodium is a non-steroidal anti-inflammatory drug (NSAID)
recommended for the treatment of:
- rheumatoid arthritis, osteoarthritis and ankylosing spondylitis
- acute gout
- low back pain
- the relief of pain in fractures
- acute musculo-skeletal disorders and trauma including periarthritis
(particularly frozen shoulder),
bursitis, tendinitis, tenosynovitis, dislocations, sprains and strains
- the control of pain and inflammation in orthopaedic, dental and
other minor surgery
4.2 Posology and method of administration
Route of Administration
For oral administration
Dosage Recommendations
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).
_Adults_
One tablet to be taken once or twice a day swallowed whole, preferably
with or after food.
_Children_
Diclofenac sodium is not suitable for use in children.
_The Elderly_
The elderly are at increased risk of the serious consequences of
adverse reactions. If an NSAID is
considered necessary, the lowest effective dose should be used and for
the shortest possible duration. The
patient should be monitored regularly for GI bleeding during NSAID
therapy.
4.3 Contraindications
Hypersensitivity to diclofenac sodium or to any of the excipients.
Active, or history of recurrent peptic ulcer/haemorrhage (two or more
distinct episodes of proven
ulceration or bleeding.
NSAIDs are contraindicated in patients who have previously shown
hypersensitivity reactions (e.g.,
ast