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DICLOFENAC SODIUM 25MG GASTRO-RESISTANT TABLETS

Active substance(s): DICLOFENAC SODIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Diclofenac Sodium 25mg and 50mg
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 relieve pain, reduce swelling and ease 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 25mg 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 50mg 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 think you may be 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

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• 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 contain
• 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 (E110) 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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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

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(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.
• an unexpected change in the amount of urine produced and/or its
appearance.
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)
• reduced, blurred or double vision
• swelling of feet or ankles
• a feeling of no energy
• feeling sleepy or drowsy
• rash or raised lumps on your skin
• a feeling of being uncomfortable, general aches and pains
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
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, methylpropylhydroxycellulose phthalate, dibutyl phthalate, talc, Opaspray Orange ((K-1R2433) 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 25mg strength and ‘BL’ on one side and
‘50’ on the reverse for 50mg 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 25mg Gastro-resistant Tablets; PL 17907/0343
Diclofenac Sodium 50mg Gastro-resistant Tablets; PL 17907/0344
This leaflet was last revised in April 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.

V4 25-04-16 D0

IXXXXX

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 35kg body weight):
25 mg tablet only: Doses vary with the age and weight of the child. The
usual dose is 2mg/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.

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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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