Kyflam is one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs reduce pain and inflammation.

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1 Package leaflet: Information for the user Kyflam 50 mg Film-coated Tablets Diclofenac Potassium 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 of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. What is in this leaflet: 1. What Kyflam is and what it is used for 2. What you need to know before you take Kyflam 3. How to take Kyflam 4. Possible side effects 5. How to store Kyflam 6. Contents of the pack and other information 1. What Kyflam is and what it is used for Kyflam is one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs reduce pain and inflammation. Kyflam can be used for short-term treatment of the following conditions: Sprains, strains, or other injuries. Pain and swelling after surgery. Painful inflammatory conditions in gynaecology, including painful menstrual periods. Back pain, frozen shoulder, tennis elbow, and other forms of soft-tissue rheumatism. Infections of the ear, nose, or throat. Migraine attacks. Kyflam Tablets may also be used to treat other conditions as determined by your doctor. 2. What you need to know before you take Kyflam Do not use Kyflam if you: are allergic to diclofenac potassium or any of the other ingredients of this medicine (listed in section 6) 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 have or have had problems with your blood circulation (peripheral arterial disease) have ever had an allergic reaction after taking medicines to treat inflammation or pain (e.g. acetylsalicylic acid/aspirin, diclofenac or ibuprofen). Reactions may include asthma, runny nose, skin rash, face swelling. If you think you may be allergic, ask your doctor for advice 1

2 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 symptoms of which may include blood in your stools or black stools have had any breathing problems, runny nose, skin rash, or any other type of allergic reaction after taking aspirin or any other NSAID suffer from severe kidney, heart or liver failure are pregnant, and in the last three months (last trimester) of pregnancy are allergic to peanut or soya, as this product contains soya Warnings and precautions Talk to your doctor or pharmacist before taking Kyflam if you: suffer from any bowel disorders, for example, ulcerative colitis or Crohn's disease suffer from heart, kidney or liver problems have porphyria (a disorder of your metabolism) suffer from any blood or bleeding disorder, including a rare liver condition called porphyria are taking Kyflam simultaneously with other anti-inflammatory medicines including acetylsalicylic acid/aspirin, corticosteroids, blood thinners or SSRIs (see Taking other medicines ) have a history of gastrointestinal disease. Report any unusual symptoms such as gastrointestinal bleeding to your doctor have a history of high blood pressure or heart failure are elderly (over 65) are being treated with diuretics (water tablets) or COX-2 inhibitors such as celecoxib could be dehydrated (e.g. by sickness, diarrhoea, before or after major surgery) have swollen feet have asthma or hay fever (seasonal allergic rhinitis) Make sure your doctor knows, before you are given Kyflam: If you smoke If you have diabetes If you 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. If you develop any skin rash or a lesion on a mucosal membrane (for example, lips, eyes, tongue) or any other allergic reaction, stop taking Kyflam and contact your doctor. Medicines such as Kyflam 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. Because it is an anti-inflammatory medicine, Kyflam may mask the symptoms of infection, for example headache, high temperature. If you feel unwell and need to see a doctor, remember to tell him or her that you are taking these tablets. Elderly people Elderly patients may be more sensitive to the effects of Kyflam than other adults. Therefore, they should follow the doctor s instructions particularly carefully and take the minimum number of tablets that provides relief of symptoms. 2

3 It is especially important for elderly patients to report undesirable effects promptly to their doctor. Whilst you are taking these tablets, your doctor may want to give you a check up from time to time. Children and adolescents Kyflam 50mg Tablets must not be given to children and adolescents below 18 years of age Other medicines and Kyflam Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. In particular, tell your doctor if you are taking any of the following medicines: - Lithium - Medicines to treat heart problems, for example cardiac glycosides such as digoxin - Anticoagulants (blood thinning tablets like warfarin) - Medicines to treat diabetes - Ciclosporin (a medicine primarily used in patients who have received organ transplants) - Methotrexate (a medicine used to treat some kinds of cancer or arthritis) - Antibiotics - Any other NSAID, for example aspirin or ibuprofen - Corticosteroids (e.g. Prednisolone) - Anti-platelet medications (such as aspirin or clopidogrel) - Selective serotonin reuptake inhibitors (SSRIs) (medicines for depression such as Citalopram, Sertraline, Paroxetine and Fluoxetine) - Diuretics (water tablets) - Medicines to treat high blood pressure (e.g. ACE inhibitors, beta blockers) - Mifeprestone (a drug used to induce abortion) - Tacrolimus (a medicine used to treat eczema) - Zidovudine (a medicine used to treat HIV infection) - Phenytoin (a medicine used to treat epilepsy) - Medicines that are inhibitors of the CYP2C9 enzyme: o Fluconazole and Voriconazole (medicines used to treat fungal infections) o Sulfinpyrazone (a medicine used to treat gout) - Medicines that are inducers of the CYP2C9 enzyme: o Rifampicin (an antibiotic) o Carbamazepine (a medicine used to treat epilepsy and bipolar disorders) o Barbiturates (a sedative) Kyflam with food and drink Kyflam tablets should be swallowed whole with liquid. Take with or after food. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should not take Kyflam during the first six months of pregnancy unless advised to do so by your doctor. You MUST NOT take Kyflam during the last three months of pregnancy as damage to the foetus and reduced labour may occur. You should only take Kyflam whilst breastfeeding if advised to do so by your doctor. Female Fertility Kyflam 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. 3

4 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. Kyflam contains soya. If you are allergic to peanut or soya do not take this medicine. 3. How to take Kyflam Always take Kyflam exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Kyflam tablets should be swallowed whole with liquid. Take with or after food. If you have the impression that the effect of Kyflam is too strong or too weak, talk to your doctor or pharmacist. The recommended total daily dose for adults is between 50 and 150 mg taken in divided doses. Use in children and adolescents Kyflam must not be given to children and adolescents below 18 years of age. If you take more Kyflam than you should You should tell your doctor at once or go to your nearest hospital casualty department. If you forget to take Kyflam Take another dose as soon as you remember, unless it is nearly time for the next dose. Do not take a double dose to make up for forgotten individual doses. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Some rare or very rare side effects could be serious: Unusual bleeding or bruising. High fever or persistent sore throat. Allergic reaction with swelling of the face, lips, mouth, tongue or throat often associated with rash and itching, which may cause difficulty to swallow, hypotension (low blood pressure), fainting. Wheezing and feelings of tightness in the chest (signs of asthma or bronchospasm). Chest pain (signs of heart attack). Sudden and severe headache, nausea, dizziness, numbness, inability or difficulty to speak, paralysis (signs of cerebral attack). Stiff neck (signs of viral meningitis). Convulsions. Hypertension (high blood pressure). Red or purple skin (possible signs of blood vessel inflammation). Skin rash with blisters, blistering of the lips, eyes and mouth. Skin inflammation with flaking or peeling. Severe stomach pain, bloody or black stools, vomiting blood. Yellowing of the skin or eyes (signs of hepatitis). 4

5 Blood in urine, excess of protein in the urine, severe decreased urine output (signs of kidney disorders). If you experience any of these, tell your doctor straight away. Other common side effects: These are likely to affect between 1 and 10 in every 100 people Headache, dizziness, nausea, vomiting, diarrhoea, indigestion, abdominal pain, flatulence, loss of appetite, change in liver function (e.g. level of transaminases), skin rash Other rare side effects: These are likely to affect between 1 and 10 in every 10,000 people Drowsiness, stomach pain, swelling of arms, hands, legs and feet (oedema). Other very rare side effects These are likely to affect less than 1 in 10,000 people Disorientation, depression, difficulty sleeping, nightmares, irritability, psychotic disorder, tingling or numbness of the hands or feet, memory impairment, anxiety, trembling, taste disorders, vision or hearing disorders, constipation, mouth sores, ulcer of the oesophagus (the tube that carries food from the throat to the stomach), palpitations, hair loss, redness, swelling and blistering of the skin (due to increased sensitivity to sun). Medicines such as Kyflam may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects, you can help provide more information on the safety of this medicine. FREEPOST, Pharmacovigilance Section, Irish Medicines Board, Kevin O Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2, Ireland. Tel: , Fax: , Website: imbpharmacovigilance@imb.ie. 5. How to store Kyflam Keep out of the sight and reach of children. Do not store above 25ºC. Blisters: Store in the original package in order to protect from moisture. Bottle: Keep the container tightly closed in order to protect from moisture. Do not use this medicine after the expiry date which is stated on the carton and blister foil or bottle label after EXP. The expiry date refers to the last day of that month. Do not throw away any medicine 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 Kyflam contains The active substance is diclofenac potassium. Each tablet contains 50 mg diclofenac potassium. The other ingredients are: 5

6 Tablet core: Silica colloidal anhydrous, Sodium starch glycolate Type A, Povidone, Starch maize, Calcium hydrogen phosphate anhydrous, Magnesium stearate. Film-coating: Polyvinyl alcohol partially hydrolysed, Titanium dioxide (E171), Talc, Lecithin soya (E322), Iron oxide red (E172), Xanthan gum (E145), Iron oxide yellow (E172) What Kyflam looks like and contents of the pack Kyflam 50 mg Film-coated Tablets are reddish brown, circular and biconvex. Pack sizes: Kyflam 50 mg Film-coated Tablets are available in blister packs of 56 tablets. Marketing Authorisation Holder: Actavis Group PTC ehf., Reykjavikurvegi 76-78, 220 Hafnarfjordur, Iceland Manufacturer: Actavis hf, Reykjavikurvegur 78, 220 Hafnarfjordur, Iceland This leaflet was last revised in October