Diclofenac Potassium 50 Mg Tablets
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Diclofenac potassium 25mg & 50mg tablets
What is in this leaflet:
1. What Diclofenac potassium tablets are and what they are used for
2. What you need to know before you take Diclofenac potassium tablets
3. How to take Diclofenac potassium tablets
4. Possible side effects
5. How to store Diclofenac potassium tablets
6. Contents of the pack and other Information
1. What Diclofenac potassium tablets are and what they are used for
Diclofenac potassium belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which are used to reduce pain and inflammation in the following conditions:
• Sprains, strains and other injuries
• Pain and inflammation following surgery
• Gout
• Other painful conditions affecting the joints and muscles such as backache, rheumatoid arthritis, osteoarthritis, ankylosing spondylytisand pyrophosphate arthropathy.
Children ages 9 years and above - The 25 mg tablet only can be used for the short term treatment of fever related to infections of the Ear, Nose and Throat.
The tablets can also be used to relieve the symptoms associated with migraine attacks in adults.
2. What you need to know before you take Diclofenac potassium tablets
Do not take Diclofenac potassium tablets if you:
• are allergic (hypersensitive) to diclofenac potassium or any of the other ingredients in the tablet (see section 6)
• have 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
• have previously had a reaction (asthma, hives or a cold) caused by an allergy to salicylates (e.g. aspirin) or other non-steroidal pain killers
• suffer from severe kidney, heart or liver failure
• are pregnant, and in the last three months (last trimester) of pregnancy.
Warnings and precautions
Talk with your doctor or pharmacist before taking
Diclofenac potassium tablets if you:
• have a history of gastrointestinal disease e.g. ulcerative colitis or Crohn's disease
• have reduced heart, kidney, or liver function
• suffer from any blood clotting disorder
• have or have had asthma
• suffer from liver porphyria (disorder of the red blood pigment)
• have had or need to have surgery
• are elderly (over 65)
• if you are being treated with diuretics (water tablets) or COX-2 inhibitors such as celecoxib.
Medicines such as diclofenac may be associated with a small increased risk of heart attack (“myocardial infarction”) 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 have heart problems, have had a 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.
Whilst you are taking these tablets, your doctor may want to give you a check-up from time to time.
Children
Diclofenac potassium 50 mg tablets are not recommended for children under the age of 14
Other medicines and Diclofenac potassium tablets
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.This includes medicines obtained without a prescription.
Especially:
• medicines to treat diabetes - a dose adjustment of these medicines may be necessary as blood sugar may drop too low
• anticoagulants - (e.g. warfarin) - these may increase the risk of bleeding
• diuretics (water tablets) - the effect of these may be decreased. Potassium-sparing diuretics may increase the potassium levels in the blood
• cholesterol lowering medication (e.g.Colestipol and cholestyramine) these medicines can delay or decrease the effect of diclofenac. It is recommended that diclofenac is taken at least 4 to 6 hours after taking these medicines.
• lithium (medicine to treat depression ) the blood levels of these medicines may be increased if taken with Diclofenac
• SSRIs (medicine to treat depression e.g. citalopram)-these may increase the risk of bleeding in the stomach
• cytotoxic medicines (e.g. methotrexate to treat cancers) - should not be taken less than 24 hours before or after Diclofenac potassium tablets -the blood levels of these medicines may be increased if taken with Diclofenac
ciclosporin - this may harm kidney function quinolones (to treat infections, e.g.ciprofloxacin and
levofloxacin) - these may cause convulsions (fits) steroid tablets - these may increase the risk of bleeding in the stomach
other NSAIDs (e.g. aspirin) - these may increase the risk of side effects
medicines to treat high blood pressure
(ACE-inhibitors, beta blockers) - the blood pressure lowering effect may be reduced mifepristone (used to induce abortion) - effect of mifepristone may be reduced by NSAIDs cardiac glycosides (e.g. digoxin) used to treat heart falure. Use with Diclofenac may worsen heart failure or increase blood levels of these medicines. phenytoin (a medicine used to treat seizures). sulfinpyrazone (a medicine used to treat gout) or voriconazole (a medicine used to treat fungal infections).
tacrolimus (an immunosuppressant) - these may increase the risk of kidney damage.
• zidovudine (an antiretroviral drug used to treat HIV) -combination with Diclofenac may increase the risk of blood disorders.
Laboratory tests
Frequent liver and kidney function tests and monitoring of blood counts are necessary if taken for more than a few days.
Pregnancy, breastfeeding and fertility
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
You should not take Diclofenac during the first 6 months of pregnancy unless directed by your doctor.
Do not take Diclofenac during the last 3 months of pregnancy as damage to the foetus and reduced labour may occur.
Breast-feeding
You should not take Diclofenac whilst breastfeeding. Female fertility
Diclofenac may make it more difficult to become pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant.
Driving and using machines
Some patients may experience side effects such as dizziness, drowsiness and visual disturbances which may affect their ability to drive or operate machinery. Make sure you are not affected before driving or operating machinery.
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, please 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.
Important information about some of the ingredients
If you are allergic to peanut or soya do not take this medicine, as it contains soya. This medicine contains 0.075 mmol (2.92mg) potassium per 25mg tablet and 0.150 mmol (5.85mg) potassium per 50mg tablet. This should be taken into account if you have reduced kidney function or are on a controlled potassium diet.
3. How To Take Diclofenac potassium tablets
Always take Diclofenac potassium tablets exactly as your doctor has told you. If you are unsure check with your doctor or pharmacist. Diclofenac potassium tablets must not be taken long-term, blood tests should be carried out if taken for more than a few days.
To minimise side-effects, you should take the lowest effective dose for the shortest time necessary to relieve your symptoms.
The tablets must be swallowed whole with a glass of water, with or after food.
The usual dose is:
To treat pain and inflammation Adults - 75 mg to 150 mg a day in two or three doses. Elderly patients - a lower dose may be used. If you are frail or have a low body weight, your doctor may ask you to go back to see him regularly for the first 4 weeks of treatment, to make sure that you are not experiencing any side effects.
Children over 14 years of age - 75mg to 100mg daily, in two or three doses.
To treat Ear, Nose and Throat infections.
Children aged 9 years and above - ( min 35Kg Body Weight) -- a maximum of 75 mg a day in three separate doses
Diclofenac potassium 50 mg tablets are not recommended for children under the age of 14.
To treat the symptoms of migraine in adults
50mg taken when the first signs of a migraine attack appear. Another 50mg taken 2 hours after the first dose if needed and then every 4 to 6 hours. You should not take more than 200mg in 24 hours.
These tablets are not suitable for the treatment of migraine in children.
If you take more Diclofenac potassium tablets than you should:
Contact your doctor, emergency room or pharmacist if you have taken more Diclofenac potassium tablets than stated in this leaflet or more than what your doctor has prescribed
If you forget to take Diclofenac potassium tablets
Do not take a double dose to make up for a forgotten dose. Continue the treatment as advised by your doctor.
4. Possible side effects
Like all medicines, Diclofenac potassium tablets can cause side effects, although not everybody gets them.
Stop taking Diclofenac potassium tablets and tell your doctor straight away if you notice:
• 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 dark particles that look like coffee grounds or black, tarry faeces
• Allergic reactions which can include skin rash, itching, bruising, painful red areas, peeling or blistering
• Wheezing or shortness of breath (bronchospasm)
• Swollen face, lips, hands or fingers
• 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 or infections, tell your doctor.
• Any type of fit or seizure
• a form of meningitis (aseptic) causing a combination of symptoms such as headache, fever, stiff neck, tiredness, muscle pain, sore throat and disorientation.
The side effects listed below have also been reported.
Common (occurs in less than 1 in 10 people)
• Stomach pain, heartburn, nausea, vomiting, diarrhoea, indigestion, wind, loss of appetite
• Headache, dizziness, spinning sensation (vertigo)
• Skin rash
• Raised levels of liver enzymes in the blood.
Rare (occurs in less than 1 in 1000 people)
• Stomach ulcers or bleeding (there have been very rare reported cases resulting in death, particularly in the elderly)
• Drowsiness, tiredness
• 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 (yellowing of the skin or whites of the eyes caused by liver or blood problems which would lead to tiredness, loss of appetite, stomach pain, joint pain
Very rare (occurs in less than 1 in 10 000 people):
Effects on the nervous system:
Tingling or numbness in the fingers, tremor, blurred or double vision, hearing loss or impairment, tinnitus (ringing in the ears), difficulty sleeping, nightmares, mood changes, depression, anxiety, mental disorders, disorientation and loss of memory, fits, headaches together with a dislike of bright lights, fever and a stiff neck, disturbances in sensation of taste.
Effects on the stomach and digestive system:
Constipation, inflammation of the tongue, mouth ulcers, taste changes, lower gut disorders (including inflammation of the colon), difficulty swallowing, inflammation of the pancreas (pancreatitis) which may cause a swollen painful stomach.
Effects on the heart, chest or blood:
Palpitations (fast or irregular heart beat), chest pain, high blood pressure, inflammation of blood vessels (vasculitis), inflammation of the lung (pneumonitis) causing fever, difficulty breathing and cough, heart failure, blood disorders (including anaemia), heart attack, stroke.
Effects on the liver or kidneys:
Kidney or liver disorders, presence of blood or protein in the urine.
Effects on skin or hair:
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.
Other effects:
Medicines such as diclofenac may be associated with a small increased risk of heart attack or stroke.
If you have any of the side effects, or if you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
5. How to store Diclofenac potassium tablets
Keep out of the sight and reach of children.
This medicine has no special storage precautions.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Unused tablets should be taken back to the pharmacist for safe disposal.
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 to protect the environment.
6. Contents of the pack and other information
What Diclofenac potassium tablets contain
The active substance (the ingredient that makes the tablet work) is Diclofenac. Each tablet contains 25mg or 50mg Diclofenac potassium.
The tablets also contain silica colloidal anhydrous, sodium starch glycollate, povidone, maize starch, calcium hydrogen phosphate anhydrous, magnesium stearate, polyvinyl alcohol partially hydrolysed, titanium dioxide E171, talc, lecithin soya E322, Iron oxide red E172, Iron oxide yellow E172 and Xanthan gum E415.
What Diclofenac potassium tablets look like and contents of the pack
The 25mg tablets are pink, round, unscored, biconvex 6mm film coated tablets.
The 50mg tablets are reddish brown, round, unscored, biconvex 9mm film coated tablets.
Pack sizes
Blister packs: 7, 12, 21, 28, 30, 50, 56, 60, 84 and 100 film coated tablets.
Plastic bottles: 100 and 500 film-coated tablets (Not all packs sizes may be available)
Marketing Authorisation Holder
Aptil Pharma Limited, 9th Floor, CP House,
97-107 Uxbridge Road, Ealing, London W5 5TL
Manufacturer
APC Pharmaceuticals & Chemicals (Europe) Ltd.,
9th Floor, CP House,
97-107 Uxbridge Road, Ealing, London W5 5TL
This leaflet was last revised in 01/2013
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