Active ingredient
- dexketoprofen trometamol
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 16239/0007.
Keral
Package Leaflet: Information For The User
Keral 25 mg film-coated tablets
Dexketoprofen
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet:
1. What Keral is and what it is used for
2. What you need to know before you take Keral
3. How to take Keral
4. Possible side effects
5. How to store Keral
6. Contents of the pack and other information
1. What Keral is and what it is used for
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.
2. What you need to know before you take Keral
Do not take Keral:
Warnings and precautions
Talk to your doctor or pharmacist before taking Keral:
Children and adolescents
Keral has not been studied in children and adolescent. 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 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.
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.
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.
With regard to potential effects on female fertility, see also section 2, “Warnings and precautions”.
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 take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist 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 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 “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, mainly upper quadrants abdominal 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, inflammation of the stomach lining (gastritis), constipation, dry mouth, flatulence, skin rash, tiredness, pain, feeling feverish and shivering, generally feeling unwell (malaise).
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 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 cerebrovascular accident (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.
The most commonly-observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal, particularly in the elderly, may occur. Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, worsening of colitis and Crohn’s disease have been reported following administration. Less frequently, inflammation of the stomach lining (gastritis) has been observed.
As with other NSAIDs haematological reactions (purpura, aplastic and haemolytic anaemia, and rarely agranulocytosis and medullar hypoplasia) may appear.
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.
5. How to store Keral
Keep this medicine out of the sight and reach of children.
Do not use this medicine 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.
PVC-aluminium blister: do not store above 30 °C. Keep the blister packs in the outer carton in order to protect from light.
Aclar-aluminium blister: this medicine does not require any special storage conditions.
Do not throw away any medicines 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 Keral contains
What Keral looks like and contents of the pack
White, round, scored film-coated tablet.
Keral is available in packs containing 4, 10, 20, 30, 50 and 500 film-coated tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Manufacturer:
or
This medicinal product is authorised in the Member States of the EEA under the following names:
Spain (RMS), Austria, Belgium, Denmark, Finland, France, Iceland, Italy, Luxemburg, Norway, Portugal, Sweden: Ketesse
Cyprus, Greece: Nosatel
Czech Republic: Dexoket
Germany: Sympal
Estonia, Latvia, Lithuania: Dolmen
Hungary: Ketodex
Ireland, Malta, United Kingdom: Keral The Netherlands: Stadium
Poland: Dexak
Slovakia: Dexadol
Slovenia: Menadex
This leaflet was last revised in 05/2018.
Menarini House, Mercury Park, Wycombe Lane, Wooburn Green, Buckinghamshire, HP10 0HH
+44 (0) 1628 856402
0800 085 8678
0800 085 8678
0800 085 8678