Diclofenac Potassium 50 Mg Tablets
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Adacium™ Rapid 50mg tablets
Diclofenac potassium
Read all of this leaflet carefully before you
start taking this medicine.
• Keep this leaflet. You may need to read it again.
If you have further questions, please ask your doctor or your pharmacist.
• This medicine has been prescribed only for you personally and you should not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
• If you have any of the side effects, or if you notice any not listed, please tell your doctor or pharmacist.
In this leaflet:
1. What Adacium™ Rapid tablets are and what they are used for
2. Before you take Adacium™ Rapid tablets
3. How to take Adacium™ Rapid tablets
4. Possible side effects
5. How to store Adacium™ Rapid tablets
6. Further Information
I.What Adacium™ Rapid tablets are and what they are used for
Adacium™ Rapid tablets belong 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 spondylytis and pyrophosphate arthropathy.
The tablets can also be used to relieve the symptoms associated with migraine attacks in adults.
2. Before you take Adacium™ Rapid tablets
Do not take Adacium™ Rapid tablets if you:
1 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
1 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
• 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)
• are pregnant, and in the last three months (last trimester) of pregnancy.
Make sure your doctor knows, before you are given Adacium™ Rapid tablets if you:
• smoke
have diabetes
have angina, blood clots, high blood pressure, raised cholesterol or raised triglycerides
• 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
1 have or have had asthma, COPD which affects your breathing, a chest infection or hayfever
• suffer from liver porphyria (disorder of the red blood pigment)
have had or need to have surgery
are elderly (over 65), particularly if you are frail or
underweight
are being treated with diuretics (water tablets) or COX-2 inhibitors such as celecoxib.
Medicines such as Adacium™ Rapid tablets 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.
Side effects may be minimised by using the lowest effective dose for the shortest duration necessary. Medicines such as Adacium™ Rapid tablets may very
rarely cause an allergic reaction (hypersensitivity) in patients who have not taken the medicine before. Taking Adacium™ Rapid tablets may also mask the symptoms of an infection.
Whilst you are taking these tablets, your doctor may want to give you a check-up from time to time. Adacium™ Rapid tablets are not recommended for children under the age of 14.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription Especially:
colestipol and cholestyramine - these may reduce the effect of Adacium™ Rapid tablets medicines to treat diabetes - a dose adjustment of these medicines may be necessary as blood sugar may drop too low
anticoagulants and anti-platelet medicines - (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 lithium (medicine to treat depression) the blood levels of these medicines may be increased if taken with Adacium™ Rapid tablets cytotoxic medicines (e.g. methotrexate to treat cancers) - should not be taken less than 24 hours before or after Adacium™ Rapid tablets -the blood levels of these medicines may be increased if taken with Adacium™ Rapid tablets ciclosporin - a dose adjustment may be necessary as 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 failure. Use with Adacium™ Rapid tablets may worsen heart failure or increase blood levels of these medicines Tacrolimus (an immunosuppressant) - these may increase the risk of kidney damage Zidovudine (an antiretroviral drug used to treat HIV) - combination with Adacium™ Rapid tablets may increase the risk of blood disorders Digoxin - the blood level of digoxin may be increased if taken with Adacium™ Rapid tablets Selective Serotonin Reuptake Inhibitors (SSRIs) (medicines to treat depression) - may increase the risk of bleeding in the stomach Phenytoin (an epilepsy medicine) - the blood level of this medicine may be increased if taken with Adacium™ Rapid tablets Potent CYP2C9 Inhibitors (e.g. sulfinpyrazone and voriconazole) - the blood level of Diclofenac may be increased if taken with these medicines. Laboratory tests
Frequent liver and kidney function tests and monitoring of blood counts are necessary if taken foi more than a few days.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
It is not recommended that you take Adacium™ Rapid tablets during the first 6 months of pregnancy as the risk of miscarriage or impact on development of your baby is increased. However, your doctor may prescribe Adacium™ Rapid tablets for you during the first six months of pregnancy if he/she feels the benefit to you outweighs the risk. You must not however take Adacium™ Rapid tablets during the last 3 months of pregnancy as damage to the foetus and reduced labour may occur. Breastfeeding
Small amounts of diclofenac may pass into breast milk and so Adacium™ Rapid tablets should not be used whilst breastfeeding.
Female fertility
Adacium™ Rapid tablets 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, feel like you may fall asleep, fatigue and visual disturbances which may affect their ability to drive or operate machinery. Make sure you are not affected before driving or operating machinery.
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Important information about some of the ingredients
If you are allergic to peanut or soya do not take this medicine, as it contains soya.
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3. How To Take Adacium™ Rapid tablets
Always take Adacium™ Rapid tablets exactly as your doctor has told you. If you are unsure check with your doctor or pharmacist. Adacium™ Rapid 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 'elieve 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 - 75mg to 150mg a day in two or three doses. Elderly patients - a lower dose may be used. If you □re 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 1 OOmg daily, in two or three doses.
• 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 hourly. 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 Adacium™ Rapid tablets than you should:
Contact your doctor, emergency room or pharmacist if you have taken more Adacium™ Rapid tablets than stated in this leaflet or more than what your doctor has prescribed (and you feel unwell).
If you forget to take Adacium™ Rapid tablets
Do not take a double dose to make up for forgotten dose. Continue the treatment as advised by your doctor.
• feeling sleepy or drowsy
• rash or raised lumps on your skin
• a feeling of being uncomfortable, general aches and pains.
Very Rare (affecting less than 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.
Unknown
sudden loss of vision confusion hallucinations change in taste generally feeling unwell.
Medicines such as Adacium™ Rapid 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.
4. Possible side effects
Like all medicines, Adacium™ Rapid tablets 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:
mild cramping and tenderness of the abdomen, starting shortly after the start of the treatment with Adacium™ Rapid 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) 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
• 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 (affecting 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 (affecting up to 1 in 1000 people)
reduced, blurred or double vision swelling of feet or ankles
a feeling of no energy_
5. How to store Adacium™ Rapid tablets
Keep out of the reach and sight of children.
This medicine has no special storage precautions.
Do not use after the expiry date stated on the carton. 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. Further information What Adacium™ Rapid tablets contain
The active substance (the ingredient that makes the tablet work) is diclofenac. Each tablet contains 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 El 71, talc, lecithin soya E322, iron oxide red, iron oxide yellow and xanthan gum E415. What Adacium™ Rapid tablets look like and contents of the pack The 50mg tablets are reddish brown, round, unscored, biconvex 9mm film coated tablets.
Pock 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
Focus Pharmaceuticals Limited, Capital House,
85 King William Street, London EC4N 7BL,
United Kingdom.
Manufacturer
Actavis hf„ Reykjavikurvegi 78, PO Box 420, IS-222, Hafnarfjordur, Iceland.
This leaflet was last revised in August 2016.
Other sources of information For information in large print, audio CD or Braille please telephone 00 44 (0)1283 495 280 or email medinfo@focuspharma.co.uk.
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