Diclofenac Sodium 50mg Gastro-Resistant Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER_
Diclofenac Sodium 25 mg and 50 mg
_Gastro-resistant 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 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Diclofenac Sodium Tablets are and what they are used for
2. What you need to know before you 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 Tablets are and
what they are used for
Diclofenac sodium, the active ingredient in Diclofenac Sodium Tablets, is one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs reduce pain and inflammation.
Diclofenac Sodium Tablets relieves pain, reduces swelling and eases inflammation in conditions affecting the joints, muscles and tendons including:
• Rheumatoid arthritis, osteoarthritis, acute gout, ankylosing spondylitis
• Backache, sprains and strains, soft tissue sports injuries, frozen shoulder, dislocations and fractures
• Tendonitis, tenosynovitis, bursitis.
They are also used to treat pain and inflammation associated with dental and minor surgery.
In children aged 9 years and above, Diclofenac Sodium 25 mg tablets are used for short term treatment of fever and pain related to inflammatory infections of ear, nose and throat (e.g, pharyngotonsillitis, otitis media) and relief of acute post-operative pain.
Diclofenac sodium 50 mg tablets are not recommended for use in children.
2. What you need to know before you take
Diclofenac Sodium tablets Do not take Diclofenac Sodium Tablets if:
• you are allergic to Diclofenac sodium, aspirin, ibuprofen or any other NSAID, or to any of the other ingredients of Diclofenac Sodium Tablets (listed in section 6). Signs of a hypersensitivity reaction include swelling of the face and mouth (angioedema), breathing problems, runny nose, skin rash or any other allergic type reaction
• 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 faeces or black, tarry faeces)
• you have severe kidney or liver failure
• you are more than six months pregnant
• you have had stomach or bowel problems after you have taken other NSAIDs
• 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
• you have or have had problems with your blood circulation (peripheral arterial disease)
Warnings and precautions
Talk to your doctor or pharmacist before taking Diclofenac Sodium Tablets if you:
• suffer from any stomach or bowel disorders including ulcerative colitis or Crohn's disease (this includes abdominal pain, diarrhoea, vomiting or weight loss)
• have kidney or liver problems, or you are elderly
• have a condition called porphyria (this includes abdominal pain, vomiting, neuropathy and mental disturbances)
• suffer from any blood or bleeding disorder. If you do, your doctor may ask you to go for regular check-ups while you are taking these tablets.
• ever had asthma
• are breast-feeding
• have heart problems, or 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.
• have Lupus (SLE) or any similar condition
• smoke, have diabetes
• 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.
Other medicines and Diclofenac Sodium Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. In particular, tell your doctor or pharmacist if you are taking:
• Medicines to treat diabetes
• Anticoagulants (blood thinning tablets like warfarin)
• Diuretics (water tablets)
• Lithium (used to treat some mental problems)
• Methotrexate (for some inflammatory diseases and some cancers)
• Ciclosporin and tacrolimus (used to treat some inflammatory diseases and after transplants)
• Trimethoprim (a medicine used to prevent or treat urinary tract infections)
• Quinolone antibiotics (for infections)
• Any other NSAID or COX-2 (cyclo-oxgenase-2) inhibitor, for example aspirin or ibuprofen
• Mifepristone (a medicine used to terminate pregnancy)
• Cardiac glycosides (for example digoxin), used to treat heart problems
• Medicines known as SSRIs used to treat depression
• Oral steroids (an anti-inflammatory drug)
• Medicines used to treat heart conditions or high blood pressure, for example betablockers or ACE inhibitors.
• Sulfinpyrazone (a medicine used to treat gout) or voriconazole (a medicine used to treat fungal infections).
• Phenytoin (a medicine used to treat seizures)
• Colestipol/cholestyramine (used to lower cholesterol)
Pregnancy, breast feeding and fertility
• Although not common, abnormalities have been reported in babies whose mothers have taken NSAIDs during pregnancy. You should not take Diclofenac Sodium Tablets during the last 3 months of pregnancy as it may affect the baby's circulation.
• Taking Diclofenac Sodium Tablets may make it more difficult to become pregnant. You should talk to your doctor if you are planning to become pregnant, or if you have problems getting pregnant.
Driving and using machines
Very occasionally people have reported that Diclofenac Sodium Tablets have made them feel dizzy, tired or sleepy. Problems with eyesight have also been reported. If you are affected in this way, you should 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.
• Sunset yellow FCF (E1l0) which may cause allergic reactions Other special warnings
• You should take the lowest dose of Diclofenac Sodium Tablets for the shortest possible time, particularly if you are underweight or elderly.
• Medicines such as Diclofenac Sodium Tablets may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. This risk is more likely with high doses and prolonged treatment. Always follow the doctor's instructions on how much to take and how long to take it for.
• Whilst you are taking these medicines your doctor may want to give you a check-up from time to time.
• If you have a history of stomach problems when you are taking NSAIDs, particularly if you are elderly, you must tell your doctor straight away if you notice any unusual symptoms.
• Because it is an anti-inflammatory medicine, Diclofenac Sodium Tablets may reduce the symptoms of infection, for example, headache and high temperature. If you feel unwell and need to see a doctor, remember to tell him or her that you are taking Diclofenac Sodium Tablets.
• The 50 mg tablets are not suitable for use in children.
| 3. How to take Diclofenac Sodium Tablets |
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Keep taking your tablets for as long as you have been told, unless you have any problems. In that case, check with your doctor.
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SAME SIZE ARTWORK 260 x 160 mm Front
Take the tablets before or with food. Swallow the tablets whole with a drink of water. Do not crush or chew the tablets.
The usual doses are:
Adults
75 mg to 150 mg daily divided into two or three doses. The number of tablets which you take will depend on the strength the doctor has given you.
Elderly
Your doctor may advise you to take a dose that is lower than the usual adult dose if you are elderly. Your doctor may also want to check closely that the Diclofenac Sodium Tablets are not affecting your stomach.
Children aged 9-12 years (min 35 kg body weight):
25 mg tablet only: Doses vary with the age and weight of the child. The usual dose is 2 mg/kg body weight per day in three divided doses.
50 mg tablet is not recommended for use in children .
The doctor may also prescribe another drug to protect the stomach to be taken at the same time, particularly if you have had stomach problems before, or if you are elderly, or taking certain other drugs as well.
If you take more Diclofenac Sodium Tablets than you should If you, or anyone else, accidentally takes too much, tell your doctor or your nearest hospital casualty department. Take your medicine pack with you so that people can see what you have taken.
If you forget to take Diclofenac Sodium Tablets If you forget to take a dose, take one as soon as you remember. If it is nearly time for your next dose, though,just take the next dose and forget about the one you missed. Do not take a double dose to make up for a forgotten dose. Do not take more than 150 mg (three 50 mg tablets or six 25 mg tablets) in 24 hours.
| 4. Possible side effects |
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you suffer from any of the following rare, or very rare, side effects at any time during your treatment, STOP TAKING the medicine and seek immediate medical help:
• chest pains
• drooping in your mouth or eye, unable to lift your arms, blurred speech or unable to speak as these are symptoms of a stroke
• pass blood in your faeces (stools / motions)
• pass black tarry stools
• vomit any blood or dark particles that look like coffee grounds
• an allergic reaction such as itching, rash, low blood pressure, swelling of the face, lips, tongue, mouth and throat, which may cause shortness of breath or difficulty swallowing
• a form of meningitis (aseptic) causing a combination of symptoms such as headache, fever, stiff neck, tiredness, muscle pain, sore throat and disorientation.
• yellowing of the skin or the whites of your eyes
• stomach pain, indigestion, heartburn, wind, nausea (feeling sick), vomiting
(being sick) or other abnormal stomach symptoms.
• asthma or asthma that has been made worse by this medicine.
• severe rash, sometimes seen as pinky red spots with clear or violet centres.
• serious illness with blistering of the skin, mouth. eyes and genitals (Stevens-Johnson Syndrome and Toxic epidermal necrolysis) which may be made worse by exposure to sunlight.
• an unexpected change in the amount of urine produced and/or its appearance.
Mild cramping and tenderness of the abdomen, starting shortly after the start of the treatment with Diclofenac Sodium Tablets and followed by rectal bleeding or bloody diarrhoea usually within 24 hours of the onset of abdominal pain (frequency not known, cannot be estimated from the available data).
Tell your doctor if you experience any of the following symptoms:
Common (may affect up to 1 in 10 people)
• headache
• feeling, or being, sick
• diarrhoea
• pain or swelling of your stomach or abdomen, heartburn
• anorexia
• dizziness or feeling light-headed
Rare (may affect up to 1 in 1,000 people)
• swelling of feet or ankles
• a feeling of no energy
• feeling sleepy or drowsy
• rash or raised lumps on your skin
Very Rare (may affect up to 1 in 10,000 people)
• constipation
• if you have an irritable bowel disease, such as colitis or Crohn's disease, the symptoms may get worse
• depression, anxiety, memory loss, or confusion
• anaemia making you feel tired or lethargic
• your heart beats too quickly or irregularly; chest pains
• impotence (difficulty getting an erection)
• ringing in the ears
• strange visions or sounds
• difficulty sleeping
• mouth ulcers or a sore mouth
• pins and needles or sensitivity to touch
• your blood does not clot easily
• low resistance to infections, fever
• spotting or unexplained bruising of the skin, nose bleeds
• hair loss
• taste disturbances
• raised or low blood pressure
Not known (Frequency cannot be estimated from the available data)
• sudden loss of vision
• confusion
• hallucinations
• change in taste
• generally feeling unwell
Medicines such as Diclofenac sodium tablets may be associated with a small increased risk of heart attack or stroke.
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 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 Diclofenac Sodium Tablets |
• Keep this medicine out of the sight and reach of children
• Do not use this medicine after the expiry date (EXP) which is stated on the carton. The expiry date refers to the last day of that month.
• Do not store above 250C. Store in a dry place.
• 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. Each tablet contains either 25 mg (milligrams) or 50 mg of diclofenac sodium.
The other ingredients are anhydrous lactose, microcrystalline cellulose, maize starch, magnesium stearate, colloidal silicon dioxide, methylpropyl-hydroxycellulose phthalate, dibutyl phthalate, talc, Opaspray Orange ((K-1R-2433) contains E110 (sunset yellow FCF) and E171 (Titanium dioxide)), ethanol denatured with acetone, polyethylene glycol 6000.
What Diclofenac Sodium Tablets looks like and contents of the pack
• Diclofenac sodium tablets are orange round tablets marked 'BL' on one side and '25' on the reverse for the 25 mg strength and 'BL' on one side and '50' on the reverse for 50 mg strength.
• Diclofenac sodium tablets come in blister packs containing 28, 84 or 100 tablets and securitainers containing 100 tablets.
• Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Name and address: Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road,
Berkhamsted, Hertfordshire, HP4 1EG, UK Telephone: 0044 (0)1442 200922
Fax: 0044 (0)1442 873717
Email: info@bristol-labs.co.uk
Diclofenac Sodium 25 mg Gastro-resistant Tablets; PL 17907/0343 *
Diclofenac Sodium 50 mg Gastro-resistant Tablets; PL 17907/0344 This leaflet was last revised in September 2016
To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.
V7 27-09-16 D0
SAME SIZE ARTWORK
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