KERAL 25 mg tablets
Dexketoprofen
This leaflet contains useful information about this medicine. You should keep the leaflet inside the carton, since you may need to read it again. This leaflet does not contain all the information about your medicine. If you are uncertain about anything or want further information, please consult your doctor or pharmacist.
What is Keral and what is it for?
Each tablet contains:
Dexketoprofen trometamol (36.9 mg) corresponding to dexketoprofen 25 mg.
Excipients: maize starch, microcrystalline cellulose, sodium starch glycollate, glycerol distearate, hypromellose, titanium dioxide, propylene glycol, macrogol 6000.
Keral is supplied in packs containing 4, 10, 20, 50 scored, film-coated tablets.
The tablets can be divided into equal halves. Not all pack sizes may be marketed.
Dexketoprofen trometamol, the active ingredient of KERAL 25 mg tablets, is an analgesic from the group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). KERAL 25 mg is a medicine for the treatment of pain.
Marketing Authorisation Holder:
Manufacturer:
or
What is Keral used for?
Treatment of mild to moderate pain, such as muscular pain, painful periods (dysmenorrhoea), toothache.
Before taking Keral?
Do not use KERAL 25 mg tablets if you:
- Are allergic to this product or any of its components, aspirin or other non-steroidal antiinflammatory medicines.
- Have suffered attacks of asthma, acute allergic rhinitis (a short period of inflamed lining of the nose), nasal polyps (lumps within the nose due to allergy), urticaria (skin rash), angioedema (swollen face, eyes, lips, or tongue, or respiratory distress) or wheezing in the chest after taking aspirin or other non-steroidal anti-inflammatory
medicines. - Have or have previously suffered from a peptic ulcer/bleeding, dyspepsia (indigestion) or bowel problems caused by inflammation (Crohn’s disease or ulcerative colitis).
- Have had bleeding from the stomach or bowel in the past.
- Have severe heart failure, moderate to severe kidney disorders or severely impaired liver function.
- Have a bleeding disorder, a blood clotting disorder.
- Are pregnant or breast feeding.
Before taking this medicine, tell your doctor if:
- You are allergic to any other medicines.
- You have any other allergies.
- You have kidney disease, liver disease, heart disease, high blood pressure, heart failure or swelling due to fluid retention.
- You have a blood disorder, lupus erythematosus or mixed connective tissue disease.
- You are trying to become pregnant.
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. There are some medicines that should not be taken together and others that may need their doses to be altered when taken together.
Always inform your doctor, dentist or pharmacist if you are using or receiving any of the following medicines in addition to Keral:
Inadvisable combinations:
- Acetylsalycilic acid (aspirin), corticosteroids or other anti-inflammatory drugs
- Warfarin, heparin or other medicines used to prevent blood clots
- Lithium, used to treat certain mood disorders
- Methotrexate, used for rheumatoid arthritis and cancer
- Hydantoins and phenytoin, used for epilepsy
- Sulphametoxazole, used for bacterial infections
Combinations requiring precautions
- ACE inhibitors, diuretics, beta-blockers and angiotensin II antagonists, used for high blood pressure and heart problems
- Pentoxifylline and oxpentifylline, used to treat chronic venous ulcers
- Zidovudine, used to treat viral infections
- Chlorpropamide and glibenclamide, used for diabetes
Associations to be considered carefully:
- Quinolone antibiotics (e.g. ciprofloxacin, levofloxacin) used for bacterial infections
- Cyclosporin or tacrolimus, used to treat immune system diseases and in organ transplant
- Streptokinase and other thrombolytic or fibrinolytic medicines, i.e. medicines used to break-up blood clots
- Probenecid, used in gout
- Digoxin, used to treat chronic heart failure
- Mifepristone, used as an abortifacient (to terminate a pregnancy)
- Antidepressants of the selective serotonin reuptake inhibitors type (SSRIs)
- Anti-platelet agents used to reduce platelet aggregation and the formation of blood clots
If you have any doubt about taking other medicines with Keral, consult your doctor or pharmacist.
Take special care
Medicines such as Keral 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, 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.
in pregnancy and when breast feeding:
Do not use KERAL 25 mg tablets during pregnancy or when breast feeding.
in children or adolescents:
KERAL 25 mg tablets should not be given to children or adolescents.
in the elderly:
In principle, your doctor will start your treatment at the recommended lower dose.
If you are elderly, you may be more likely to suffer the symptoms described in the section "Possible side effects".
If any of these occur, consult your doctor immediately.
in patients with kidney or liver problems:
Tell your doctor if you have kidney or liver problems. In principle, your doctor will start your treatment at the recommended lower dose.
Effects on ability to drive or use machines:
In some patients Keral tablets may have a mild or moderate influence on the ability to drive and handle machines, due to the possibility of dizziness or drowsiness. If affected, be extremely careful, or avoid driving or operating machinery.
How To Use Keral
Dosage
The dose of KERAL 25 mg tablets needed depends on the type, severity and duration of your pain. Your doctor will tell you how many tablets you must take daily, and for how long.
The recommended dose is generally 1 tablet every 8 hours, with no more than 3 tablets daily.
The elderly, and patients with kidney or liver problems should start treatment with a total daily dose of no more than 50 mg of KERAL (2 tablets). In all cases, do not exceed a total daily dose of 75 mg of KERAL (3 tablets).
In the case of acute pain, it is recommended that tablets are taken at least 30 minutes before meals.
Instructions if a dose is forgotten
If you miss a dose, take the next regular dose when it is due. Never double the next dose.
Overdose
If you accidentally take an overdose of this medicine, tell your doctor or pharmacist immediately or go to the emergency department of your nearest hospital. Please remember to take the remaining tablets or this leaflet with you.
Possible side effects
Like all medicines, Keral can cause side effects, although not everybody gets them.
Possible side effects are listed below according to how likely they are to occur. This table tells you how many patients might get these side effects:
- Common side effects: more than 1 out of 100 persons and less than 1 out of 10 persons.
- Uncommon side effects: more than 1 out of 1000 persons and less than 1 out of 100 persons.
- Rare side effects: more than 1 out of 10000 persons and less than 1 out of 1000 persons.
- Very rare side effects: more than 1 out of 10000 persons, including isolated reports.
Common side effects:
Nausea and/or vomiting, abdominal pain, diarrhoea, digestive problems (dyspepsia).
Uncommon side effects:
Vertigo, dizziness, sleepiness, sleep disturbances, nervousness, headache, palpitations, flushing, gastritis, constipation, dry mouth, flatulence, skin rash, tiredness, pain, feeling feverish and shivering, generally feeling unwell (malaise).
Rare side effects:
Peptic ulcer, peptic ulcer perforation or bleeding, which may be seen as vomiting blood or black stools, fainting, high blood pressure, too-slow breathing, water retention and peripheral oedema (e.g. swollen ankles), loss of appetite (anorexia), abnormal sensation, itchy rash, acne, sweating increased, back pain, passing water frequently, menstrual disorders, prostate problems, abnormal liver tests (blood tests).
Very rare:
Anaphylactic reaction (hypersensitive reaction which may also lead to a collapse), ulceration of the skin, mouth, eyes and genital areas (Stevens Johnson and Lyell’s syndromes), facial swelling or swelling of the lips and throat (angioneurotic oedema), breathlessness due to contraction of the muscles around the airways (bronchospasm), shortness of breath, fast heartbeat, low blood pressure, pancreatitis, liver cell damage (hepatitis), blurred vision, ringing in the ears (tinnitus), skin sensitivity reactions and skin over-sensitivity to light, itching, renal damage. Reduced white blood cell count
(neutropenia), reduced platelet count (thrombocytopenia).
Tell your doctor immediately if you notice any stomach/bowel side effects at the start of treatment (e.g. stomach pain, heartburn or bleeding), if you have previously suffered from any such side effects due to long-term use of anti-inflammatory drugs, and especially if you are elderly.
Stop using Keral as soon as you notice the appearance of a skin rash, or any lesion on the mucous surfaces (e.g. the surface along the inside of the mouth), or any sign of allergy.
During treatment with non-steroidal anti-inflammatory drugs, fluid retention and swelling (especially in the ankles and legs), a raise in blood pressure and heart failure have been reported.
Medicines such as Keral may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.
In patients with systemic lupus erythematosus or mixed connective tissue disease (immune system disorders that affect connective tissue) anti-inflammatory medicines may rarely cause fever, headache and rigidity of the back of the neck.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Storage
Do not store above 30 °C; keep the blister packs in the outer carton in order to protect from light.
Shelf-life
This medicine must not be used after the expiry date printed on the package.
This medicine has been prescribed for you. Only a doctor can prescribe this medicine.
Do not give this medicine to others even if their symptoms are similar to yours - it may harm them.
Medicines must be kept out of the reach and sight of children
Text revised: July 2007
Marketed by:
0001/07
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