Diclofenac Sodium Tablets 25mg
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PROPOSED
Tell your doctor or pharmacist before taking this medicine if:
PATIENT INFORMATION LEAFLET
Diclofenac Sodium 25 mg Tablets Diclofenac Sodium 50 mg Tablets
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE KEEP THIS LEAFLET UNTIL YOU HAVE FINISHED ALL THE PRESCRIBED COURSE OF DICLOFENAC SODIUM IF YOU HAVE ANY QUESTIONS CONCERNING YOUR MEDICINE ASK YOUR DOCTOR OR PHARMACIST FOR MORE INFORMATION
What is in your medicine?
Your (ablets are called Diclofenac Sodium Tablets. Each tablet contains the active ingredient Sodium Diclofenac. Each tablet also contains: Anhydrous lactose, microcrysiallinc cellulose, maize starch, magnesium stearate, colloidal anhydrous silica, cellulose acetate phthalate, macrogol 6000, castor oil, hydroxypropylccllulose, titanium dioxide El71 and sunset yellow El 10.
The tablets are available in 25 mg and 50 mg strengths in containers and blister packs of 14,15,21,28,42,56, 70,84 and 100 tablets.
Who Makes it?
The product licence holder is Chatfield Pharmaceuticals Limited, Kramer Mews. London SW5 9JL, England.
The manufacturer is DDSA Pharmaceuticals Limited. 310 Old Brompton Road, London SW5 9JQ.
How does Diclofenac Sodium work?
Diclofenac is a non-steroidal anti-inflammatory agent (NSA1D) which is used to relieve pain and inflammation.
Why have you been prescribed Diclofenac Sodium?
Diclofenac Sodium is used in adults in the treatment of rheumatoid arthritis, osteoarthrosis, low back pain and other acute musculo-skcletal disorders, acute gout, control of pain and inflammation in orthopaedic, dental and other minor surgery. It is used in children to treat juvenile chronic arthritis.
If you are not sure why you have been prescribed Diclofenac Sodium, then please ask your doctor.
1. You suffer from heart, liver or kidney disease.
2. You suffer from porphyria.
3. You suffer from any of the following: Blood abnormalities, bleeding conditions. Crohn's disease or inflammation of the colon.
4. If you have a history of any of the following: Stomach or abdominal ulcers, vomiting blood (hacmatemcsis) or bloody diarrhoea (melaena).
Can you take Diclofenac Sodium with other medicines?
It is very important to tell your doctor or pharmacist about all the medicines you are taking, whether prescribed by your doctor or bought without a prescription from the pharmacy or elsewhere.
There are some medicines that can interfere with Diclofenac Sodium. These include: Lithium, digoxin. cyclosporin, other non-steroidal anti-inflammatory drugs (NSAIDs). quinolonc antibiotics, mifepristone, methotrexate, diuretics (water retention), anticoagulants (medicine to thin the blood) or medicines for diabetes.
When and how to take these tablets
Swallow tablets whole. Do not bite or chew them.
Adults, including the elderly:
A total of 75 to 150 mg daily in two or three divided doses. Children:
1 to 3 mg/kg body weight per day in divided doses.
Remember
Always follow your doctor's advice on how to take your medicine; it may be different to the above.
If you are elderly, your doctor may want to give you a check-up from time to time during the first 4 weeks of treatment, as you may be prone to internal bleeding
If you forget to take a dose or take too many tablets contact your doctor or pharmacist at once for advice.
Keep taking these tablets for as long as your doctor advises.
What side effects can Diclofenac Sodium have?
Like all medicines. Diclofenac Sodium tablets can sometimes cause unwanted effects, but these are usually rare.
If you notice any of the effects below or any other side effects contact your doctor or pharmacist at once for advice.
Before taking your medicine
Do not take this medicine if:
1. You have ever had any unusual or allergic reactions to Diclofenac Sodium or any of the other ingredients of these tablets.
2. You arc pregnant or breast feeding
3. You suffer from active or suspected ulcer or gastro intestinal bleeding.
4. You are an asthmatic in whom attacks of asthma, urticaria or acute rhinitis arc precipitated by aspirin or other NSAIDs.
The most common side effects are headache, slight dizziness or stomach upsets such as mild abdominal pain, indigestion, heartburn, nausea, vomiting and diarrhoea. Minor skin reactions may occur occasionally but skin reactions of a more serious nature arc very rarely seen.
Less common side effects include stomach ulcers, tiredness, sleepiness, water retention, bloody diarrhoea and bleeding from the stomach or intestine, which can result in bloody stools.
Allergic reactions include: Wheezing, shortness of breath, runny nose, various types of skin rashes, itching or bruising.
PROPOSBD
Liver and kidney problems sometimes with jaundice (yellowing of the skin and eyes) have also been rcporlcd.
Very rarely these tablets can cause: Lower gut disorders, inflammation of the pancreas, mouth ulcers, swollen tongue, constipation, disorientation, tingling or numbness in the fingers, memory loss, blurred vision, hearing loss, tinnitus (ringing in the cars), sleeplessness, mood changes, nightmares, shaking, convulsions, taste changes, hair loss, sensitivity to sunlight, high blood pressure, irregular heartbeat, chest pains and blood disorders.
Sunset yellow El 10 can cause allergic-type reactions including asthma. Allergy is more common in those people who arc allergic to aspirin.
Storing your medicine
You must keep this medicine in a safe place where children cannot get it. Your medicine could harm them.
Do not store your tablets above 25° C. Keep the container lightly dosed. Store in the original package.
Do not use this medicine after the expiry date on the label.
A reminder
REMEMBER these tablets are only for you. Only a doctor may prescribe them for you. Never give them to anyone else, even if they have the same symptom as you have.
Diclofenac Sodium 25 mg Tablets PL 02142/0015 Diclofenac Sodium 50 mg Tablets PL 02142/0016
This leaflet was revised in October 2003