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The product codes for this leaflet are: PL 08829/0046, PL 08829/0045

 

Volsaid Retard 75mg & 100mg tablets

Company Details

Chiesi Limited


Chiesi LimitedCheadle Royal Business ParkHighfieldCheadleSK8 3GY
Telephone:
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Medical Information e-mail:medinfo@chiesi.uk.com
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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 12/2013.

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

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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.

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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.

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.

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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.

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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 stomach or small intestine
  • vomiting blood or dark particles that look like coffee grounds
  • lesions on the gullet
  • blood in the stools or bloody diarrhoea
  • worsening of Crohn’s disease or ulcerative colitis
  • indigestion or heartburn
  • pass black or tarry stools
  • inflammation of the tongue, pancreas or stomach lining
  • abdominal pain (pains in your stomach) or other abnormal stomach symptoms

The following side effects have also been reported, tell your doctor or pharmacist if you notice any of these:

  • sensitivity to sunlight
  • headache
  • tiredness and drowsiness
  • dizziness or “spinning”
  • impaired hearing
  • ringing in the ears
  • difficulty in sleeping
  • fits
  • irritability
  • anxiety
  • depression
  • confusion
  • hallucinations
  • tremors
  • impaired memory
  • loss of feeling
  • feeling disorientated
  • blurred vision
  • constipation
  • mouth ulcers
  • nightmares
  • changes in the way your kidneys work, including kidney failure
  • presence of blood in your urine
  • changes in liver function that may cause yellowing of the skin or eyes or affect the results from liver function tests
  • reduction in red blood cells which can make the skin pale and cause weakness or breathlessness
  • severe reduction in white blood cells which makes infections more likely
  • fever
  • reduction in blood platelets which increases risk of bleeding or bruising
  • feeling your heartbeat
  • severe reduction in blood cells which can cause weakness, bruising or make infections more likely
  • high or low blood pressure
  • impotence
  • chest pain
  • painful inflammation of the optic nerve in your eye
  • feeling sick
  • diarrhoea
  • changes in taste
  • flatulence
  • loss of appetite
  • stiff neck

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.

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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 25°C. 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.
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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
Cheadle Royal Business Park
Highfield
Cheadle
SK8 3GY
UK

Is this leaflet hard to see or read? Phone 0161 488 5555 for help.

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CP0010/3


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