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VOLSAID RETARD 75

Active substance(s): DICLOFENAC SODIUM

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567_FR00267_V8_VOLSAID_567_FR00267_V8 16/06/15 15:11 Page1

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 07/2015.

In this leaflet:
1. What Volsaid is and what it is used for
2. Before you take Volsaid
3. How to take Volsaid
4. Possible side effects
5. How to store Volsaid
6. Further 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
following conditions affecting the joints and muscles:
• rheumatoid arthritis, osteoarthritis, ankylosing spondylitis (form of spinal arthritis),
acute gout
• low backache, sprains and strains, soft tissue sports injuries, frozen shoulder,
dislocations and fractures
• conditions affecting the tendons, e.g. tendonitis, tenosynovitis, bursitis
They are also used to treat pain and inflammation associated with orthopaedic, dental
and other minor surgery.

2. Before you take Volsaid
Do not take Volsaid:
• if you are allergic to diclofenac sodium, aspirin, ibuprofen, any other NSAID or any of
the other ingredients in the tablets (these are listed in section 6, Further Information)
Signs of an allergic reaction include breathing problems, a runny nose, swelling of the
face or throat, or a skin rash
• if you have now, or ever had, a peptic ulcer (ulcer in your stomach or duodenum) or
bleeding in your stomach, or have had two or more episodes of peptic ulcers, stomach
bleeding or perforation
• if you have had stomach or bowel problems after you have taken other NSAIDs
• if you suffer from porphyria, an inherited blood disorder that can cause increased
sensitivity to light
• if you have severe heart failure, liver or kidney failure
• if you are in the last trimester of your pregnancy.
• if you have established heart disease and/or cerebrovascular disease e.g. if you
have had a heart attack, stroke, mini-stroke (TIA) or blockages to blood vessels to the
heart or brain or an operation to clear or bypass blockages
• if you have or have had problems with your blood circulation (peripheral arterial
disease)
Take special care with Volsaid and always tell your doctor if:
• you have kidney or liver problems
• you suffer from Crohn’s disease or any other disease of the bowel or intestine
• you have recently undergone major surgery
• you have a history of any blood or bleeding disorder
• you have, or have ever suffered from asthma
• if you have Lupus (SLE) or any similar condition
• if you are in the first six months of your pregnancy
• you are planning to become pregnant or if you have problems becoming pregnant.
Volsaid may make it more difficult to become pregnant.
Make sure your doctor knows, before you are given Volsaid:
• if you smoke
• if you have diabetes
• if you have angina, blood clots, high blood pressure, raised cholesterol or raised
triglycerides
Medicines such as Volsaid may be associated with a small increased risk of heart attack
or stroke. Any risk is more likely with high doses and prolonged treatment. Do not
exceed the recommended dose or duration of treatment.
If you are elderly, suffer from kidney, liver or heart problems or have been taking this
medicine or similar NSAIDs for a long time, your doctor may want to perform regular tests
to monitor your condition and may need to carry out blood tests from time to time.
Taking other medicines
Before starting treatment, please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained without a prescription.
If you have to go to a doctor, dentist or hospital for any reason, tell them that you are
taking Volsaid.
In particular, tell your doctor if you are taking:
• lithium or medicines known as SSRIs, to treat depression
• methotrexate, to treat some inflammatory diseases and cancers
• aspirin, ibuprofen or tacrolimus, any other NSAIDs or COX-2(cyclo-oxygenase-2)
inhibitor
• ciclosporin, to treat some inflammatory diseases and after transplants
• quinolone antibiotics, such as ciprofloxacin to treat bacterial infections
• water tablets (diuretics), such as amiloride
• anticoagulants, such as warfarin, to stop the blood clotting
• medicines to treat diabetes, such as gliclazide
• aminoglycosides, such as gentamycin to treat bacterial infections
• probenecid, to treat gout
• medicines to treat high blood pressure, such as beta-blockers
• cardiac glycosides, such as digoxin to treat heart problems
• mifepristone, used to terminate pregnancy
• oral steroids, such as prednisolone
• zidovudine, used to treat viral infections
• anti-platelet agents such as aspirin, used to reduce the formation of blood clots.
Please read the back of this leaflet

567_FR00267_V8_VOLSAID_567_FR00267_V8 16/06/15 15:11 Page2

Side effects may be minimised by using the lowest effective dose for the shortest duration
necessary.
Pregnancy and breast-feeding:
If you are pregnant or breast-feeding, or could become pregnant, talk to your doctor
before taking your tablets
Driving and using machines:
If you experience headaches, blurred vision, dizziness or drowsiness after taking these
tablets, then do not drive or operate machinery.

3. How to take Volsaid
Always take your tablets exactly as your doctor has told you to. You should check with
your doctor or pharmacist if you are not sure.
Dosage
• Volsaid is formulated so that you only have to take your tablets once or twice a day.
This depends on which strength tablet you are taking. The label on the carton will tell
you how many tablets you should take and when.
• Take your tablets at the same time each day, with or after food.
• Swallow your tablets whole, do not break or chew your tablets.
• Do not stop treatment even if you feel better unless told to do so by your doctor.
Adults and the elderly
• Volsaid Retard 75 mg tablet
The usual daily dose is one tablet once or twice a day. If you are taking your tablets
twice a day, it is important that the second dose is taken 12 hours after the first dose and
that no more than 2 tablets are taken in any 24 hour period.
• Volsaid Retard 100 mg tablet
The usual daily dose is one tablet once a day.
If you are elderly and are frail or have a low body weight your doctor will prescribe the
lowest effective dose for you to take. Your doctor may want to monitor you for any
bleeding from your stomach during the first four weeks of your treatment and may need
to carry out blood tests from time to time.
Children must not take this medicine.
If you take more Volsaid than you should
If you accidentally take more Volsaid than you should, contact your nearest casualty
department or tell your doctor or pharmacist immediately. Remember to take the pack
and any remaining tablets with you.
If you forget to take Volsaid
Do not worry. Simply leave out that dose completely and then take your next dose at the
right time. Do not take a double dose to make up for a missed dose.

4. Possible side effects
Like all medicines, Volsaid can cause side effects, although not everyone gets them.
Allergic reactions have been reported. If you experience any of these, contact your
doctor or nearest casualty department immediately.
- tight chest, severe difficulty breathing or anaphylaxis where symptoms may be a
rapid pulse, profuse sweating, fever and if severe, shock and collapse
- skin rashes, a serious illness with blistering of the skin, mouth, eyes and genitals
(Stevens-Johnson Syndrome), itching, "nettle" rash or hives, a serious reaction causing
swelling of the face or throat, unusual bruising, peeling, scaling, blistering and hair loss.
If you experience any of the following serious side effects stop taking your tablets and
contact your doctor or nearest casualty department immediately.
• perforation or ulcers of the • blood in the stools or
• inflammation of the tongue,
stomach or small intestine
pancreas or stomach lining
bloody diarrhoea
• abdominal pain (pains in
• vomiting blood or dark
• worsening of Crohn’s
your stomach) or other
particles that look like
disease or ulcerative colitis
abnormal stomach
• indigestion or heartburn
coffee grounds
symptoms
• pass black or tarry stools
• lesions on the gullet
The following side effects have also been reported, tell your doctor or pharmacist if you
notice any of these:
• nightmares
• reduction in blood platelets
• sensitivity to sunlight
• changes in the way your
which increases risk of
• headache
kidneys work, including
bleeding or bruising
• tiredness and drowsiness
kidney failure
• feeling your heartbeat
• dizziness or “spinning”
• presence of blood in your
• severe reduction in blood
• impaired hearing
urine
cells which can cause
• ringing in the ears
• changes in liver function
weakness, bruising or
• difficulty in sleeping
that may cause yellowing
make infections more likely
• fits
of the skin or eyes or
• high or low blood pressure
• irritability
affect the results from
• impotence
• anxiety
liver function tests
• chest pain
• depression
• reduction in red blood cells • painful inflammation of the
• confusion
which can make the skin
optic nerve in your eye
• hallucinations
pale and cause weakness • feeling sick
• tremors
or breathlessness
• diarrhoea
• impaired memory
• severe reduction in white
• changes in taste
• loss of feeling
blood cells which makes
• flatulence
• feeling disorientated
infections more likely
• loss of appetite
• blurred vision
• fever
• stiff neck
• constipation
• mouth ulcers
Medicines such as Volsaid may be accociated with a small increased risk of heart attack
(“myocardial infarction”) or stroke.
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.
Reporting of side effects
If you get any side effects talk to your doctor, pharmacist, or nurse. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly via
the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you
can help provide more information on the safety of this medicine.

5. How to store Volsaid





Keep out of the sight and reach of children.
Do not use Volsaid after the expiry date which is stated on the blister and
carton. The expiry date refers to the last day of that month.
Do not store above 25ºC. Store in the original packaging.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help
protect the environment.

6. Further Information
What Volsaid contains:
The active substance in your tablets is diclofenac sodium. Each tablet contains 75 mg or
100 mg of diclofenac sodium.
The other ingredients are talc, ethylcellulose, magnesium stearate, povidone, stearic acid,
hypromellose (E464), diethyl phthalate, macrogol 4000, titanium dioxide (E171), red iron
oxide (E172) and yellow iron oxide (E172).
What Volsaid looks like and the contents of the pack:
Volsaid Retard 75 mg tablets are white, triangular tablets, marked with ‘DIC 75’ on one
side. Volsaid Retard 100 mg tablets are pale red, round, biconvex tablets, marked with
‘DIC 100’ on one side. They are packed in blister packs of 28, 30, 50, 56, 60, 84, 100, 250,
500 and 1000 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
The Marketing Authorisation holder and manufacturer is Chiesi Limited, 333 Styal Road,
Manchester, M22 5LG, UK.

Is this leaflet hard to see or read? Phone 0161 488 5555 for help.
FR00267.V8 / CP0010/4

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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