Diclofenac Sodium Tablets 25mg
Package Leaflet: Information for the Patient Diclofenac Sodium 25 mg Tablets
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, nurse or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
The name of your medicine is Diclofenac Sodium 25mg Tablets. It will be referred to as Diclofenac Sodium Tablets for ease hereafter.
What is in this leaflet:
1. What Diclofenac Sodium tablet is and what it is used for
2. What you need to know before you are take Diclofenac Sodium tablets
3. How to take Diclofenac Sodium tablets
4. Possible side effects
5. How to store Diclofenac Sodium tablets
6. Contents of the pack and other information
1. What Diclofenac Sodium tablet is and what it is used for
Diclofenac Sodium is used in adults in the treatment of rheumatoid arthritis, osteoarthrosis, low back pain and other acute musculo skeletal disorders, acute gout, control of pain and inflammation in orthopaedic, dental and other minor surgery.
Diclofenac is used in children aged 9 years in the treatment of fever associated with infections of ear, nose or throat. It is also used in children aged 9 years either as a single drug or along with opiate medicines for the relief of post operative pain. It is used in children to treat juvenile chronic arthritis.
2. What you need to know before you are given Diclofenac Sodium Do not take Diclofenac Sodium Tablets
• if you are allergic to of Diclofenac Sodium or any of the other ingredients of Diclofenac Sodium Tablets (listed in section 6)
• if you have now, or have ever had, a stomach (gastric) or duodenal (peptic) ulcer, or bleeding in the digestive tract (this can include blood in vomit, bleeding when emptying bowels, fresh blood in stools or black, tarry stools)
• if you have had any allergic reaction to ibuprofen, aspirin, or other NSAIDs (including difficulty in breathing, runny nose, swelling of the face or throat, or rash)
• if you have asthma
• if you have kidney or liver problems.
• if you are dehydrated or have recently lost a lot of blood
• if you have severe heart failure
• if you have a condition where you don’t stop bleeding normally (such as haemophilia)
• if you have had a stroke
• if you are taking other non steroidal anti-inflammatory drugs
• if you are taking anticoagulant drugs (medicines for preventing blood clots, such as heparin and warfarin)
• if you are more than 6 months pregnant
• if you are breast-feeding
• if you are taking medicines known as SSRIs used to treat depression.
•if you have been told by your doctor that you have an intolerance to some sugars •if you have had stomach or bowel problems after you have taken other NSAIDs.
• 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)
If any of the above apply to you or if you are not sure, talk to your doctor, nurse or pharmacist before you are given Diclofenac Sodium Tablets.
Make sure your doctor knows, before you are given diclofenac
• If you smoke
• If you have diabetes
• If you have angina, blood clots, high blood pressure, raised cholesterol or raised triglycerides.
Side effects may be minimised by using the lowest effective dose for the shortest duration necessary.
If you have heart problems, previous stroke or think that you might be at risk of these conditions (for example if you have high blood pressure, diabetes or high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.
Warnings and precautions
Talk to your doctor, nurse or pharmacist before taking Diclofenac Sodium Tablets:
• If you suffer from any of the following: blood abnormalities, bleeding conditions, Crohn’s disease, inflammation of the colon.
• If you have a history of any of the following: stomach or bowel ulcers, vomiting of blood or black, tarry faeces and Gastro-intestinal ulcers,
• If you have kidney, liver or heart problems.
• If you are pregnant
• If you have a history of high blood pressure and/or heart failure.
• If you suffer from or have previously suffered from asthma.
• If you suffer from systemic lupus erythematous or mixed connective tissue disorders.
• If you are elderly.
• If you have a condition called porphyria • If you have undergone major surgery
•If you are particularly prone to infections (diclofenac may suppress the signs and symptoms of an infection)
•If you have angina, blood clots, high blood pressure, raised cholesterol or raised triglycerides Other medicines and Diclofenac Sodium Tablets
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes any herbal products or medicines bought without a prescription.
• Medicines used to treat high blood pressure (e.g. beta-blockers angiotensin converting enzyme (ACE) inhibitors)
• Diuretics (drugs which increase urine production).
• Medicines used for heart conditions e.g. digoxin
• Medicines used to treat depression e.g. lithium
• Methotrexate (used in the treatment of cancer and autoimmune disorders)
• Ciclosporin or tacrolimus (immunosuppressive drugs used to prevent rejection after transplant surgery).
• Mifepristone (used in abortions)
• Other non-steroidal anti-inflammatory drugs.
• Corticosteroids (steroidal medicines)
• Medicines used to thin the blood (anticoagulants)
• Quinolone antibiotics (drugs used to treat infections)
• Medicine to treat diabetes e.g. Pioglitazone or Rosiglitazone
• Phenytoin (medicines to treat epilepsy)
• Colestipol and cholestyramine (medicines to lower cholesterol level)
• CYP2C9 inhibitors: e.g Sulfinpyrazone and voriconazole
• Medicines known as SSRIs used to treat depression
Other Special Warnings:
Pregnancy, breast feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Pregnancy
Diclofenac Sodium should only be used during pregnancy when your doctor decides the benefits to you are greater than any possible risk to the unborn baby.
Do not take Diclofenac Sodium Tablets during the last 3 months of pregnancy as it may affect your baby’s blood circulation and kidneys.
Breast-feeding
Do not take Diclofenac Sodium Tablets during breast-feeding as diclofenac passes into the breast milk in small amounts.
Fertility
Taking Diclofenac Sodium Tablets may make it more difficult to conceive. You should talk to your doctor if you are planning to become pregnant, or if you have problems getting pregnant.
Driving and using machines:
Diclofenac sodium may make you feel drowsy or dizzy, or cause headaches or problems with vision. If you are affected, do not drive or operate machinery.
Diclofenac Sodium Tablets contains Lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product
3. How to take Diclofenac Sodium
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is a total of 75 to 150mg daily in two or three divided doses for adults, including older people.
Use in children aged 9 and over
•For the treatment of post operative pain and juvenile chronic arthritis, 1 to 3mg per kg bodyweight in divided doses
•For the treatment of fever associated with infections of ear, nose or throat, maximum of 2mg per kg body weight per day in 3 divided dosage.
The tablet is to be swallowed preferably with or after food.
If you take more Diclofenac Sodium than you should tell your doctor or your nearest hospital casualty department. Take your medicine pack with you so that hospital staff can see what you have taken.
If you forget to take Diclofenac Sodium
Do not take a double dose to make up for a forgotten tablet
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines Diclofenac Sodium Tablets can cause side-effects although not everybody gets them.
Some side effects can be serious
Stop taking Diclofenac Tablets and tell your doctor straight away if you notice any of the side effects
• Stomach pain, indigestion, heartburn, wind, nausea (feeling sick) or vomiting (being sick)
• Any sign of bleeding in the stomach or intestine, for example, when emptying your bowels, blood in vomit (recognised by dark coffee grounds), blood in faeces or black, tarry faeces (stools / motions)
• All medicines can cause allergic reactions although serious allergic reactions are very rare. Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) should be reported to a doctor immediately
• Yellowing of your skin or the whites of your eyes
• Persistent sore throat or high temperature
• An unexpected change in the amount of urine produced and/or its appearance.
If you notice that you are bruising more easily than usual or have frequent sore throats of infections, tell your doctor.
The following side effects have also been reported:
Common (affects less than 1 in 10 people)
• Stomach pain, heartburn, nausea (feeling sick), vomiting (being sick), diarrhoea, indigestion, wind, loss of appetite
• Headache, dizziness, vertigo
• Skin rash or spots
• Raised levels of liver enzymes in the blood.
Rare (affects less than 1 in 1,000 people)
• Stomach ulcers or bleeding (there have been very rare reported cases resulting in death, particularly in the elderly)
• Blood in vomit or black, tarry faces
• Drowsiness, tiredness
• Hypotension (low blood pressure, symptoms of which may include faintness, giddiness or light headedness)
• Skin rash and itching
• Fluid retention, symptoms of which include swollen ankles
• Liver function disorders, including hepatitis and jaundice.
• Asthma including shortness of breath
• Shock characterized by low blood pressure, rapid heart rate, cold, clammy skin, weak pulse or fainting
• Oedema (swelling)
Very rare (affects less than 1 in 10,000 people)
•Tingling or numbness in the skin,
•tremor,
•blurred or double vision,
•hearing loss or impairment,
•tinnitus (ringing in the ears)
•sleeplessness
•nightmares
•mood changes
•depression
•anxiety
•mental disorders,
•disorientation •loss of memory •fits
•inflammation of the lining of the brain - meningitis (symptoms include headaches together with a dislike of bright lights, fever and a stiff neck)
•Constipation
•inflammation of the tongue •mouth ulcers •taste changes
•lower gut disorders (including inflammation of the colon)
•worsening of Crohn's disease which is characterized by abdominal pain, diarrhea, bloody stools or fever.
•Severe upper abdominal pain, disorders of the food pipe, narrowing of the bowel). Palpitations (fast or irregular heart beat)
•chest pain
•hypotension (low blood pressure)
•hypertension (high blood pressure),
•inflammation of blood vessels (vasculitis)
•inflammation of the lung (pneumonitis)
•congestive heart failure,
•blood disorders (including anaemia, decrease in platelet count and white blood cell count)).
•Kidney or liver disorders
•presence of blood or protein in the urine.
•Serious skin rashes including Stevens-Johnson syndrome and Lyell’s syndrome and other skin rashes which may be made worse by exposure to sunlight.
•Hair loss
•Inflammation of the pancreas •Increased risk of heart attack or stroke
Not known: frequency cannot be estimated from the available data
•Impotence
•inflammation of the nerves in the eye •throat disorders •confusion, hallucinations,
•disturbances in sensation,
•malaise (weakness)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist, This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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 Diclofenac Sodium tablets
•Keep this medicine out of the sight and reach of children.
•Keep your tablets in the original pack they came in and do not put them in another container •Do not use this medicine after the expiry date shown on the label. Once opened, any unused tablets should be discarded.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment
6 Contents of the pack and other information
What Diclofenac Sodium tablets contains
The active substance is Diclofenac sodium.
Other ingredients of the each tablet also contains Lactose, Microcrystalline Cellulose, Maize Starch, Magnesium Stearate (E572), Colloidal Silicon Dioxide, Cellulose Acetate Phthalate, Carbowax 6000, Castor Oil, Orange Dispersion.
What Diclofenac Sodium tablets looks like and contents of the pack
The tablets are available in 25mg strengths in polypropylene tamper evident containers of 100, 84, 70, 56, 42, 28, 21, 15 and 14 tablets or in blister packs of 84, 70, 56, 42, 28, 21, 15 and 14 tablets.
Marketing authorisation holder
Mercury Pharmaceuticals Limited
Capital House
85 King William Street
London
EC4N 7BL
UK
PL 12762/0420
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder
Mercury Pharmaceuticals Ltd,
Capital House,
85 King William Street,
London
EC4N 7BL,
UK
This leaflet was last revised in February 2015