2. What you need to know before you take Keral
Do not take Keral:
- If you are allergic to dexketoprofen or any of the other ingredients of this medicine (listed in section 6);
- If you are allergic to acetylsalicylic acid or to other non-steroidal anti-inflammatory medicines;
- If you have asthma or 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;
- If you have suffered from photoallergic or phototoxic reactions (a particular form of reddening and/or blistering of the
skin exposed to sunlight) while taking ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (drugs used to lower the level of
fats in the blood);
- If you have a peptic ulcer/stomach or bowel bleeding or if you have suffered in the past from stomach or bowel bleeding,
ulceration or perforation;
- If you have chronic digestive problems (e.g. indigestion, heartburn);
- If you have suffered in the past from stomach or bowel bleeding or perforation, due to previous use of non-steroidal
anti-inflammatory drugs (NSAIDs) used for pain;
- If you have bowel disease with chronic inflammation (Crohn’s disease or ulcerative colitis);
- If you have serious heart failure, moderate or serious kidney problems or serious liver problems;
- If you have a bleeding disorder or a blood clotting disorder;
- If you are severely dehydrated (have lost a lot of body fluids) due to vomiting, diarrhoea or insufficient intake of
- If you are in the third trimester of pregnancy or breast feeding.
Warnings and precautions
Talk to your doctor or pharmacist before taking Keral:
- If you suffer from allergy, or if you have had allergy problems in the past;
- If you have kidney, liver or heart problems (hypertension and/or heart failure) as well as fluid retention, or have
suffered from any of these problems in the past;
- If you are taking diuretics or you suffer from very poor hydration and reduced blood volume due to an excessive loss of
fluids (e.g. from excessive urination, diarrhoea or vomiting);
- 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;
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 are elderly: you may be more likely to suffer from side effects (see section 4). If any of these occur, consult
your doctor immediately;
- If you are a woman with fertility problems (Keral may impair your fertility, therefore you should not take it if you are
planning to become pregnant or you are doing fertility tests);
- If you suffer from a disorder in the formation of blood and blood cells;
- If you have systemic lupus erythematosus or mixed connective tissue disease (immune system disorders that affect
- If you have suffered in the past from a chronic inflammatory disease of the bowel (ulcerative colitis, Crohn’s
- If you have or have suffered in the past from other stomach or bowel problems;
- If you have varicella (chickenpox), since exceptionally NSAIDs could worsen the infection;
- If you are taking other medicines that increase the risk of peptic ulcer or bleeding, e.g. oral steroids, some
antidepressants (those of the SSRI type, i.e. Selective Serotonin Reuptake Inhibitors), agents that prevent blood clots such as aspirin or
anticoagulants such as warfarin. In such cases, consult your doctor before taking Keral: he/she may want you to take an additional medicine
to protect your stomach (e.g. misoprostol or medicines that block the production of stomach acid).
- If you suffer from asthma combined with chronic rhinitis, chronic sinusitis, and/or nasal polyposis as you have a higher
risk of allergy to acetylsalicylic acid and/or NSAIDs than the rest of the population. Administration of this medicine can cause asthma
attacks or bronchospasm, particularly in patients allergic to acetylsalicylic acid or NSAIDs.
Children and adolescents
Keral has not been studied in children and adolescents. Therefore, safety and efficacy have not been established and the product
should not be used in children and adolescents.
Other medicines and Keral
Tell your doctor or pharmacist if you are taking, have recently taken or might take 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
- Acetylsalicylic 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
- Pentoxifylline and oxpentifylline, used to treat chronic venous ulcers
- Zidovudine, used to treat viral infections
- Aminoglycosides antibiotics, used to treat bacterial 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.
Keral with food and drink
Take the tablets with an adequate amount of water. Take your tablets with food, as it helps to decrease the risk of stomach or
bowel side effects. However, if you have acute pain, take the tablets on an empty stomach, i.e. at least 30 minutes before meals, as this
helps the medicine start working a little faster.
Pregnancy, breast-feeding and fertility
Do not use Keral during the final three months of the pregnancy or when breast feeding. Ask your doctor for advice.
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before
taking this medicine, as Keral may not be right for you.
Use of Keral should be avoided by women who are planning a pregnancy or are pregnant. Treatment at any time in pregnancy should
only take place as directed by a doctor.
The use of Keral is not recommended while attempting to conceive or during investigation of infertility.
Driving and using machines
Keral may slightly affect your ability to drive and handle machines, due to the possibility of dizziness or drowsiness as side
effects of treatment. If you notice such effects, do not drive or use machines until the symptoms wear off. Ask your doctor for advice.
3. How to take Keral
Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
The dose of Keral that you need 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 (25 mg) every 8 hours, with no more than 3 tablets daily (75 mg).
If you are elderly, or if you suffer from kidney or liver problems, you should start treatment with a total daily dose of no more
than 2 tablets (50 mg).
In elderly patients this initial dose can later be increased to that generally recommended (75 mg) if Keral has been well
If your pain is intense and you need quicker relief, take the tablets on an empty stomach (at least 30 minutes before food) because
they will be more easily absorbed (see section 2 “Keral with food and drink”).
Use in children and adolescents
This medicine should not be used in children and adolescents (under age 18).
If you use more Keral than you should
If you use too much of this medicine, tell your doctor or pharmacist immediately or go to the emergency department of your nearest
hospital. Please remember to take this medicine pack or this leaflet with you.
If you forget to use Keral
Do not take a double dose to make up for a forgotten tablet. Take the next regular dose when it is due (according to section 3 “How
to take Keral”).
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.
Possible side effects are listed below according to how likely they are to occur.
Common side effects: may affect up to 1 in 10 people
Nausea and/or vomiting, stomach pain, diarrhoea, digestive problems (dyspepsia).
Uncommon side effects: may affect up to 1 in 100 people
Spinning sensation (vertigo), dizziness, sleepiness, disturbed sleep, nervousness, headache, palpitations, flushing, stomach
problems, constipation, dry mouth, flatulence, skin rash, tiredness, pain, feeling feverish and shivering, generally feeling unwell
Rare side effects: may affect up to 1 in 1,000 people
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 swelling (e.g. swollen ankles), laryngeal oedema, loss of appetite (anorexia),
abnormal sensation, itchy rash, acne, increased sweating, back pain, passing water frequently, menstrual disorders, prostate problems,
abnormal liver function tests (blood tests), liver cell injury (hepatitis), acute renal failure.
Very rare: may affect up to 1 in 10,000 people
Anaphylactic reaction (hypersensitive reaction which may also lead to collapse), open sores on skin, mouth, eyes and genital areas
(Stevens Johnson and Lyell’s syndromes), face swelling or swelling of the lips and throat (angioedema), breathlessness due to narrowing of
the airways (bronchospasm), shortness of breath, fast heartbeat, low blood pressure, inflammation of the pancreas, blurred vision, ringing
in the ears (tinnitus), sensitive skin, sensitivity to light, itching, kidney problems. Reduced white blood cell count (neutropenia), fewer
platelets in the blood (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
Stop using Keral as soon as you notice the appearance of a skin rash, or any lesion inside the mouth or on the genitals, or any sign
of an allergy.
During treatment with non-steroidal anti-inflammatory drugs, fluid retention and swelling (especially in the ankles and legs),
increased 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 immune system disorders that affect connective tissue (systemic lupus erythematosus or mixed connective tissue
disease), anti-inflammatory medicines may rarely cause fever, headache and neck stiffness.
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. Website: www.mhra.gov.uk/yellowcard. By reporting side effects
you can help provide more information on the safety of this medicine.