Package leaflet: Information for the user. Diklofenak T Actavis 25 mg mg film-coated tablets. diclofenac potassium

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1 PACKAGE LEAFLET

2 Package leaflet: Information for the user Diklofenak T Actavis 25 mg mg film-coated tablets diclofenac potassium RX 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. OTC Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - 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. - You must talk to a doctor if you do not feel better or if you feel worse after X days. What is in this leaflet 1. What / / is and what it is used for 2. What you need to know before you take / / 3. How to take / / 4. Possible side effects 5. How to store / / 6. Contents of the pack and other information 1. What / / is and what it is used for / / is a pain-reliever which reduces inflammatory conditions in muscles, joints or connective tissue. / / is used in adults against: - acute inflammatory conditions involving pain in joints or muscles - menstrual pains - acute migraine attacks with or without forewarning. / / 25 mg film-coated tablets are used in children and adolescents from 9 years of age against: - pain related to inflammatory infections of the ear, nose or throat. Your child s doctor may prescribe other medicines simultaneously to treat the underlying infection. / / should not be used to treat fever alone where inflammation is not present - severe or sudden pain after minor surgeries. 2. What you need to know before you take / /

3 Do not use / /: - if you are allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6). - if you are allergic to peanuts or soya - 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) - if you have or have a history of a stomach ulcer or duodenal ulcer, an increased tendency to bleeding/perforation or a history of gastrointestinal bleeding/perforation related to previous use of painkillers (NSAIDs) - if you previously have had an allergic reaction such as asthma, sneezing or a rash on taking painkillers containing acetylsalicylic acid or drugs for pain/ inflammation within the group of NSAIDs (non-steroidal anti-inflammatory drugs) - if your kidney function is severely impaired - if your liver function is severely impaired - if you are pregnant, and if there is less than three months to delivery Warnings and precautions Side effects may be minimised by using the lowest effective dose for the shortest duration necessary. Higher doses than recommended dose are generally associated with an increased risk of side effects. Make sure your doctor knows, before you are given diclofenac - If you smoke - If you have diabetes - If you have angina, blood clots, high blood pressure, raised cholesterol or raised triglycerides - If you have gastrointestinal problems or heartburn/discomfort in the stomach - If you have Crohn s disease or ulcerative colitis - If you have asthma, liver disease or kidney disease - If you have diseases that result in a increased tendency to bleed - If you have porphyria Elderly persons should be aware of the greater risk of side effects that comes with increasing age. Serious skin reactions have been reported very rarely in association with the use of NSAIDs. Stop using / / if you get any skin rash or any sign of hypersensitivity and contact a doctor. If you get gastrointestinal problems, stop taking / / and seek advice from a doctor. Prolonged use of any type of pain killers for headaches can make the headache worse. If this situation is experienced or suspected, medical advice should be obtained and treatment should be discontinued. Like other anti-inflammatory agents, / / can mask the signs or symptoms of infection. Contact your doctor immediately: - if you get stomach aches or start bleeding from the gastrointestinal tract while you are being treated with / / - if you get a rash or other allergic reactions. Always inform the relevant person that you are being treated with / / when you are subjected to blood tests or urine tests. Other medicines and / / Tell your doctor or pharmacist if you are using, have recently used or might take any other medicines. This also applies to non-prescription medicines, medicines bought abroad, natural medicines, strong vitamins and minerals.

4 Talk with your doctor if you take: - diuretics (water pills), including potassium-sparing diuretics - blood-thinning medicines (e.g. warfarin, clopidogrel and ticlopidine) - lithium (anti-depression medicine) - selective serotonin reuptake inhibitors, SSRI (to treat depression or various anxiety disorders) - medicine to treat diabetes (tolbutamide, glibenclamide, glimepiride) - medicine to treat high blood pressure (ACE inhibitors and angiotensin II antagonists) - cholestyramine and colestipol (medicines to treat elevated cholesterol) - ciclosporin and tacrolimus (medicines suppressing the immune response) - Cortisone preparations taken by mouth or given as injections ex. prednisone (medicine against immunoreactions and inflammatory reactions) - acetylsalicylic acid and other medicine against pains and swellings (NSAID) - digoxin (heart medicine) - methotrexate (to treat arthritis, severe skin diseases and cancer) - medicines to treat infections (e.g. ciprofloxacin and levofloxacin). - phenytoin, a medicine used to treat epilepsy - voriconzole, used for the treatment of fungal infections, and sulfinpyrazone, used for the treatment of gout (potent CYP2C9 inhibitors) Your doctor may adjust the dose of your medicine. NSAIDs (e.g. ibuprofen, acetylsalicylic acid) may reduce the effects of diuretics (water pills) and other antihypertensive medicine such as ACE inhibitors and angiotensin II antagonist. In some patients with reduced kidney function (dehydrated patients and elderly patients) the combination with ACE inhibitors and angiotensin II antagonist or other NSAIDs may result in further deterioration of the kidney function. This condition is usually reversible. The combination should be administered with caution especially in the elderly. Patients should be adequately hydrated and the kidney function should also be monitored after initiation of concomitant therapy and periodically thereafter. / / with food and drink You may take / / with food and drink. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. / / must not be used during the last three months of the pregnancy. / / should be avoided by women who are trying to become pregnant or who are pregnant. Treatment with / / during any phase of pregnancy may only take place on the prescription of a doctor. / / should not be used whilst breast-feeding, as it passes into the breast milk in small amounts and may cause side effects in the infant. / / 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 to become pregnant. Driving and using machines In some patients, / / may have side effects that can affect the ability to operate machines and drive safely, such as visual disturbances, dizziness, vertigo and drowsiness. If you experience any of these side effects, you should not drive or operate machines. / / contains soya oil. Do not take / / if you are allergic to peanuts or soya. 3. How to take / /

5 RX: Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. OTC: Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is: Adults Acute inflammatory conditions in muscles and joints mg daily divided into 2-3 doses. Migraine 50 mg at the first sign of migraine. If the pains have not reduced after two hours, another 50 mg can be taken. The maximum daily dose is 150 mg. Elderly patients The dose may need to be reduced. Follow your doctor s instructions. Use in children / / 25 mg film-coated tablets can be used in children and adolescents from 9 years of age to treat the conditions described in section 1 above, but only as prescribed by your child s doctor. Your child s doctor will decide the appropriate dose for your child, based on body weight. The usual dose is 2 mg per kilogram of body weight a day. This is usually divided into three or four separate doses. Reduced renal and hepatic function The dose may need to be reduced. Follow your doctor s instructions. Tablets should be swallowed whole with water, preferably before a meal. If you take more / / than you should Contact your doctor, emergency room or pharmacist if you have taken more / / than stated in this leaflet or more than prescribed by your doctor. Symptoms of an overdose include: - Nausea and vomiting - Dizziness - Erratic and fumbling movement developing into unconsciousness and seizures - Impact on hepatic and renal functions - Too low blood pressure - Respiratory difficulties - Disorders in the blood s ability to coagulate. If you forget to take / / If you have forgotten to take / /, you must take the next dose as planned. Do not take a double dose to make up for forgotten doses. If you stop taking / / If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. Possible side effects

6 Like all medicines, this medicine can cause side effects, although not everybody gets them. Some side effects can be serious. Stop using / / and tell your doctor straight away if you notice: - Mild cramping and tenderness of the abdomen, starting shortly after the start of the treatment with / / 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). Stomach bleeding can occur at any time during treatment with or without warning symptoms. This generally has more serious consequences in elderly patients. A doctor must be contacted if this occurs, or if any other unexpected symptoms occur. / / may cause a reduction in the number of white blood cells and your resistance to infection may be decreased. If you experienced an infection with symptoms such as fever and serious deterioration of your general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary problems you should see your doctor immediately. A blood test will be taken to check possible reduction of white blood cells (agranulocytosis). It is important to inform your doctor about your medicine. Medicines such as / / 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. The most common side effects of / / are gastrointestinal discomfort. Common side effects (may affect up to 1 in 10 people): Headache, dizziness, vertigo, pain and discomfort from the upper region of the abdomen, nausea, vomiting, diarrhoea, stomach cramps, indigestion, flatulence, loss of appetite, rash or itching, change in liver enzymes. Uncommon side effects (may affect up to 1 in 100 people): Bleeding in the stomach and intestines, bloody vomiting, dark, blood-stained stools or vomit, bloody diarrhoea, hives, hepatitis with or without jaundice, acute, severe hypersensitivity reaction such as asthma, anaphylactic shock, and low blood pressure, water retention in the body. Rare side effects (may affect up to 1 in 1,000 people): Palpitations, chest pains, high blood pressure, heart failure, anaemia, reduced number of white blood cells, reduced number of blood platelets, drowsiness, pneumonia, asthma and difficulty breathing, inflammation of the stomach lining (gastritis), ulcers in the stomach or intestines which may be accompanied with bleeding or perforation, damage to the oesophagus, bleeding inflammation of the colon, deterioration of Crohn s disease or inflammatory bowels disease, mouth ulcer, inflammation of the tongue, narrowing of the intestine, constipation, skin rash, serious skin disorder (Steven-Johnson s syndrome), peeling of the skin (toxic epidermal necrolysis), red or purple discolorations on the skin (purpura and allergic purpura), hair loss, eczema, light sensitivity reactions, chronic severe hepatitis, liver disorder, jaundice, blood vessel inflammation. Very rare side effects (may affect up to 1 in 10,000 people): Heart attack, swelling of the face, lips, tongue or throat which can cause great difficulty breathing (angioneurotic oedema), stroke, numbness, impairment of memory, irritability, seizures, depression, anxiety, nightmares, tremor, taste dysfunctions, blurred vision, reduced hearing, tinnitus, acute reduced kidney function, blood or protein in urine, psychotic reactions, disorientation, insomnia, inflammation of the kidneys, severe kidney disorder (nephrotic syndrome) and damage to kidney tissue, impotence (causal connection to diclofenac is uncertain), an inflammation of the lining of the brain characterized by headache, stiff neck and fever (aseptic meningitis), death of liver cells (hepatic necrosis), liver failure, inflammation of the pancreas, skin redness. Reporting of side effects

7 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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine. 5. How to store / / Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month. 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 / / 25 mg contains - The active substance is diclofenac potassium. - The other ingredients are: Sodium starch glycollate, colloidal anhydrous silica, povidone, maize starch, anhydrous calcium hydrogen phosphate, magnesium stearate (E470b), polyvinyl alcohol, titanium dioxide (E171), talcum (E553b), xanthane rubber (E415), soyalecithin (E322), red iron oxide (E172), yellow iron oxide (E172). What / / looks like and contents of the pack Appearance Pink, round, biconvex, film-coated tablets, 6 mm in diameter Pack sizes Blister pack (Al/Al): 6, 10, 12, 20, 30, 50 or 100 film-coated tablets PP container with LDPE lid and drying agent: 10, 20, 30, 50 or 100 film-coated tablets Not all pack sizes may be marketed. Marketing authorisation holder and manufacturer To be completed nationally This leaflet was last revised in

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