PACKAGE LEAFLET
Read this leaflet carefully because it contains important information to you.
-This medicine can be bought without prescription to treat mild diseases without aid of a physician.
-In spite of this you should use KETO tablets carefully to receive best possible results.
-Keep this leaflet. You may need it again.
-If you have any further questions, ask your pharmacist.
-Take contact to your physician, if your symptoms get worse or do not improve after 7 days.
-If you notice any side effects not listed in this leaflet, or side effects (see section 4) get serious please tell your doctor or pharmacist.
In this leaflet:
1. What KETO is and what it is used for
2. Before you use KETO
3. How to use KETO
4. Possible side effects
5. How to store KETO
6. Further information
1. WHAT KETO IS AND WHAT IT IS USED FOR
KETO tablets contains ketoprofen which is anti-inflammatory painkiller which alleviate inflammation, pain and fever.
Indications:
Temporarily for pain such as muscular pain and pain in joints, headache, rheumatic pain, menstrual pain or toothache.
Temporarily for fever and symptoms of common cold and influenza.
For prolonged use, over a week only by physician's prescription.
2. BEFORE YOU USE KETO
Do not use KETO tablets if:
you are hypersensitive to ketoprofen or any of the other ingredients of the product,
you have asthma or allergy and you have had hypersensitivity reactions of acetylsalicylic acid or other pain relieving medicine (NSAIDs),
doctor have told that you have diathesis for bleeding of gastrointestinal tract,
you have active stomach or duodenal ulcer,
you have earlier had stomach or duodenal ulcer which has re-occurred once or many times
you have previously had gastrointestinal perforation or bleeding (eg. black or bloody stools, vomiting of blood, anemia) when using anti-inflammatory painkillers,
you have trombocytopenia or their dysfunction which ketoprofen can further deteriorate,
you have a bleeding disease (eg. hemophilia or von Willebrandt disease),
you have severe renal or liver dysfunction,
you have severe heart failure or
you are pregnant in last trimester.
Take special care with KETO tablets
Discuss with your doctor before using this medicine, if:
you have liver or renal insufficiency,
you have heart failure because ketoprofen increase oedema and aggravate cardiac insufficience
you use antihypertensives which increase consentration of potassium, such as ACE inhibitors, angiotencin receptor blockers or potassium saving diuretics, since ketoprofen may further elevate potassium level
you have some gastrointestinal disease, such as ulcerative colitis (Colitis ulcerosa) or Crohn΄s disease,
you have previously had adverse effects of gastro-intestinal tract when using non-steroidal anti-inflammatory anagesics (such as heart burn, pain in stomach), since ketoprofen can produce these or deteriorate these adverse effects
you use regularly corticosteroids administered orally or given intramuscularly or in vein, because they can increase risk of gastro-intestinal adverse effects of ketoprofen
Medicines such as KETO 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. Only for temporary and short-term use without physician΄s prescription.
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.
Using other medicines concomitantly
Tell your doctor or in pharmacy about all medicines you are using or you have recently used, from those under prescription, and also from those, which can get without prescription, and from herbal and natural health products.
Other anti-inflammatory painkillers should not be used simultaneously with KETO tablets - only undesirable effects increase, not potency.
Use of Keto tablets concomitantly with some other medicines may increase risk of adverse effects.
These kinds of medicines are:
probenecide (arthritic medicine),
effects of the drugs inhibiting coagulation (eg. warfarin), risk for bleeding increases and concomitant use should be avoided.
antithrombotic medicines (eg. acetyl salisylic acid or clopidogrel) - increased risk to gastrointestinal bleeding. If you are using small dose of acetyl salisylic acid daily (eg. 100 mg) to reduce risk for thrombosis, you have to take it at least one hour before taking KETO tablets.
corticosteroids (given regularly orally or in muscle or vein)
certain anti-depressive medicines (eg. citalopram, fluoxetine, paroxetine, sertraline) which belong in so-called serotonin-selective re-uptake inhibitors (SSRI),
lithium
digoxin (in patients who have renal insufficiency),
diuretics
betablockers,
antihypertensives which increases consentration of potassium such as ACE inhibitors, angiotensin receptor blockers or potassium saving diurethics
methotrexate (do not use KETO tablets on those days when you take methotrexate),
cyclosporine or tacrolimus.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine during pregnancy.
KETO tablets must not be used during the last trimester of pregnancy. The use during pregnancy and breast-feeding should be discussed with a doctor.
KETO belongs to anti-inflammatory painkillers which use can make it difficult to become pregnant. This effect disappears when KETO treatment is stopped.
Driving and using machines
Ketoprofen does not usually affect ability to drive or to operate machinery. Sometimes adverse effects can appear, such as vertigo (see section 4); then you should abstain from driving and using of machines.
3. HOW TO USE KETO TABLETS
Dosage for adults and children over 12 years of age: 1 tablets 1-3 times per day when necessary.
Maximum daily dose (3 tablets daily) should not exceed.
To limit occurrence of gastrointestinal disturbance, tablets should be taken with food or after meal with glass water. Efficacy of the drug remains constant when the drug is taken at the same time of a day. Taken by this way the administration is not forgotten.
For children under 12 years of age only according to prescription of a physician.
Important!
Only in temporary use at most a week if physician isn΄t ordered something else.
The physician may have ordered you a different kind of dosage, which you should follow.
If you take more KETO than you should
In case of overdosage and poisoning contact immediately a physician or hospital emergency room or Poison Information Centre (tel. 09 471 977 or exchange 09-4711) if you or somebody takes too high dose of medicine. Active charcoal which decreases absorption of ketoprofen can be gives as the first aid.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE ADVERSE EFFECTS
Like all medicines, KETO may cause side effects, although not everybody gets them.
Ulcers of stomach and intestinum are the most important adverse effects of non-steroidal anti-inflammatory analgesics. The risk of severe adverse effects increases when high doses are used during long terms, and is multiplied if other anti-inflammatory analgesics are used concomitantly.
Adverse effects of the central nervous system, such as dizziness and vertigo, and renal adverse effects are rare, and they occur merely in high dosage.
The risk of adverse effects in the gastrointestinal tract and in kidneys is increased in patients over 60 years of age.
Medicines such as KETO may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.
Allergic reactions are possible.
Common (appear over 1 of 100 patients) adverse effects have been reported:
heartburn, nausea, abdominal pain or vomiting
Uncommon (appear less than 1 of 100 patients) adverse effects have been reported:
worsing of headache or migraine, dizziness, fatigue and disturbance of memory
constipation, flatulence, gastritis, gastrointestinal ulceration or duodenal ulceration
erythema of skin or slight dermatitis
impairment of renal function, oedema and changes in amount of urine
Rare (appear less than 1 of 1000 patients) adverse effects have been reported:
anemia or decreased number of thrombocytes (with increased risk to bruises and nasal bleeding - contact your doctor as soon as possible )
disappearance of white cells in blood (connected to fever without clear reason, flu-like symptoms and pain in throat) - contact your doctor as soon as possible)
insomnia, restlessness, agitation, depression or disturbance of activity and attention
parestesias (pricking of skin)
visual disturbances, conjunctivitis (red eyes), pain in eyes or bleeding of retina
tinnitus or sensorineural hearing loss
palpitation, deterioration of heart failure (increased swelling and dyspnoea - contact your doctor as soon as possible) or pain in the chest
rising of blood pressure, lower the blood pressure and dizziness when you getting up, blushing and swelling of skin which caused by distend veins
deterioration of asthma - contact your doctor as soon as possible
drying of mouth, inflammation of mouth, pain in the tongue, pain in the gingiva, increased salivation, or changes of appetite
bleeding of gastrointestinal system (vomiting of blood or black or bloody stools - contact your doctor as soon as possible)
gastrointestinal perforations (severe abdominal pain - contact your doctor as soon as possible) or deterioration of colitis
icterus (yellowish skin and sclera), hepatitis or pancreatitis (usually severe abdominal pain) - contact your doctor
itching of skin or urticaria
exfoliative or vesicle reactions of skin and mucosa - contact your doctor as soon as possible
hematuria, renal dysfunction, glomerulonephritis or proteinuria
extra menstruation
acute swelling in skin of face or limbs, eyelid, lips, tongue, mucosa of mouth and respiratory bronchiole (in other words angioedema - contact your doctor as soon as possible)
If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious please tell your doctor or pharmacist.
5. HOW TO STORE KETO
Keep out of the reach and sight of children.
No special instructions for storage.
Do not use the tablets after the expiry date, which is stated on the carton.
Medicines should not be disposed of via drain 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 KETO contains
The active substance is ketoprofen 25 mg in one tablet.
The other ingredients are:
Core:
Pregelatinised starch, glycerol, hydrogenated castor oil, hypromellose, microcrystalline cellulose, sodium lauryl sulphate.
Coating:
Hypromellose, macrogol 4000, polydextrose, colour (titanium dioxide E 171).
KETO tablets are unsweetened and lactose free.
What KETO looks like
White, round, convex tablet with score. Diameter 8 mm.
Pack sizes
15 tablets.
Marketing authorisation holder and Manufacturer
Vitabalans Oy
Varastokatu 8
FI-13500 Hδmeenlinna
Tel: 03 615 600
Fax: 03 618 3130
This leaflet was last approved in
04.07.2007
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