This is an X-PIL, which is a text only patient information leaflet, designed for people with sight problems.
Table of Contents
Keral 25 mg tablets
Dexketoprofen trometamol
1. What Keral is and what it is used for 2. Before you take Keral 3. How to take Keral 4. Possible side effects 5. How to store Keral 6. Further information
Keral is a pain killer from the group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
It is used to treat mild to moderate pain, such as muscular pain, painful periods (dysmenorrhoea), toothache.
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:
Combinations requiring precautions:
Associations to be considered carefully:
If you have any doubt about taking other medicines with Keral, consult your doctor or pharmacist.
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.
Do not take Keral if you are less than 18 years of age.
Do not use Keral during pregnancy or when breast feeding.
Ask your doctor or pharmacist for advice before taking any medicine:
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.
Always use Keral exactly as your doctor has told you. You should 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 dosage 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 tolerated.
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 “Taking Keral with food and drink”).
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.
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 use Keral”).
If you have any further questions on the use of this product, ask your doctor or pharmacist.
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, stomach pain, diarrhoea, digestive problems (dyspepsia).
Uncommon side effects:
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 (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 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:
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 are elderly.
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.
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.
Keep out of the reach and sight of children.
Do not use Keral after the expiry date which is stated on the carton and on the blister. The expiry date refers to the last day of that month.
Do not store above 30 °C. Keep the blister packs in the outer carton in order to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
The active substance is dexketoprofen trometamol (36.90 mg) corresponding to dexketoprofen (INN) 25 mg.
The other ingredients are maize starch, microcrystalline cellulose, sodium starch glycollate, glycerol palmitostearate, hypromellose, titanium dioxide, propylene glycol, macrogol 6000.
Keral is supplied in packs containing 4, 10, 20 or 50 film-coated tablets. Not all pack sizes may be marketed. The tablets can be divided into equal halves.
Marketing Authorisation Holder:
Manufacturer:
or
This medicinal product is authorised in the Member States of the EEA under the following names:
Spain (RMS) Ketesse
Austria Ketesse
Belgium Ketesse
Cyprus Nosatel
Czech republic Dexoket
Denmark Ketesse
Estonia Dolmen
Finland Ketesse
France Ketesse
Germany Sympal
Greece Nosatel
Hungary Ketodex
Iceland Ketesse
Ireland Keral
Italy Ketesse
Latvia Dolmen
Lithuania Dolmen
Luxembourg Ketesse
Malta Keral
Norway Ketesse
Poland Dexak
Portugal Ketesse
Slovakia Dexadol
Slovenia Menadex
Sweden Ketesse
The Netherlands Stadium
United Kingdom Keral
This leaflet was last approved in 07/2011.
Link to this document from your website:http://www.medicines.ie/medicine/7912/XPIL/Keral+25mg+Tablets/