Voltarol Rapid 50mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Diclofenac potassium

Available from:

Stephar (U.K.) Ltd

ATC code:

M01AB05

INN (International Name):

Diclofenac potassium

Dosage:

50mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010100

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE
USER
VOLTAROL
® RAPID 50MG TABLETS
(diclofenac potassium)
WHAT YOU NEED TO KNOW ABOUT VOLTAROL RAPID TABLETS
Your doctor has decided that you need this medicine to help treat
your condition.
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE YOUR
MEDICINE. 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.
The name of your medicine is Voltarol Rapid 50mg Tablets but will be
referred to as Voltarol Rapid Tablets throughout the remainder of this
leaflet.
Votarol Rapid Tablets are also available in a 25mg strength.
IN THIS LEAFLET:
1. What Voltarol Rapid Tablets are, and what they are used for
2. Things to consider before you start to take Voltarol Rapid Tablets
3. How to take Voltarol Rapid Tablets
4. Possible side effects
5. How to store Voltarol Rapid Tablets
6. Further information
1.
WHAT VOLTAROL RAPID TABLETS ARE AND WHAT THEY ARE USED FOR
Diclofenac potassium, the active ingredient in Voltarol Rapid Tablets,
is
one of a group of medicines called non-steroidal anti-inflammatory
drugs
(NSAIDs). NSAIDs reduce pain and inflammation.
Voltarol Rapid Tablets relieve pain, reduce swelling and ease
inflammation in:
•
Rheumatoid arthritis, osteoarthrosis, acute gout, low back pain,
ankylosing spondolytis
•
Migraine
•
Conditions affecting the joints and muscles such as 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 inflam

Summary of Product characteristics

1.
TRADE NAME OF THE MEDICINAL PRODUCT
Voltarol
®
Rapid Tablets 50mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50mg of diclofenac potassium
Chemical name:
Potassium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Coated tablet
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rheumatoid arthritis
Osteoarthrosis
Low back pain
Migraine attacks
Acute musculo-skeletal disorders and trauma such as periarthritis
(especially frozen shoulder), tendinitis,
tenosynovitis, bursitis, sprains, strains and dislocations; relief of
pain in fractures
Ankylosing spondylitis
Acute gout
Control of pain and inflammation in orthopaedic, dental and other
minor surgery
Pyrophosphate arthropathy and associated disorders
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).
For oral administration
The tablets should be swallowed whole with liquid, preferably before
meals, and must not be chewed or
divided.
Adults
The recommended daily dose is 100-150mg in two or three divided doses.
For milder cases, 75-100 mg daily
in two or three divided doses is usually sufficient.
In migraine an initial dose of 50 mg should be taken at the first
signs of an impending attack. In cases where
relief 2 hours after the first dose is not sufficient, a further dose
of 50 mg may be taken. If needed, further
doses of 50 mg may be taken at intervals of 4-6 hours, not exceeding a
total dose of 200 mg per day.
SPECIAL POPULATIONS
Paediatrics
For children over 14 years of age, the recommended daily dose is
75-100 mg in two or three divided doses.
Voltarol Rapid tablets are not recommended for children under 14 years
of age.
The use of Voltarol Rapid (all forms) in migraine attacks has not been
established in children.
Elderly
Although the pharmacokinetics of Voltarol are not impaired to any
clinic