PACKAGE LEAFLET: INFORMATION FOR THE USER
Keral 50 mg/2 ml
solution for injection or concentrate for solution for infusion
Dexketoprofen
1. What Keral is and what it is used for
2. What you need to know before you use Keral
3. How to use 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 acute moderate to severe pain, when taking tablets is not appropriate, such as post-operative pain, renal colic (severe kidney pain) and low back pain.
2. What you need to know before you use Keral
Talk to your doctor before using Keral if you:
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.
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.
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.
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.
Each ampoule of Keral contains 200mg of ethanol, equivalent to 5 ml beer or 2.08 ml wine per dose.
Harmful for those suffering from alcoholism.
To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.
This medicinal product contains less than 1 mmol sodium (23mg) per dose, i.e. essentially “sodium-free”.
3. How to use Keral
Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
Your doctor will tell you what is the dose of Keral that you need, according to the type, severity and duration of your symptoms. The recommended dose is generally 1 ampoule (50 mg) of Keral every 8 - 12 hours. If needed, the injection can be repeated after only 6 hours. Do not exceed a total daily dose of 150 mg of Keral (3 ampoules) in any case.
Use the injection treatment only in the acute period (i.e. no longer than two days). Switch to an oral pain killer when possible.
The elderly with renal dysfunction and patients with kidney or liver problems should not exceed a total daily dose of 50 mg of Keral (1 ampoule).
Keral can be administered either by intramuscular or by intravenous route (technical details for the intravenous injection are given in the section 7).
When Keral is given intramuscularly, the solution should be injected immediately after its removal from the coloured ampoule, by slow injection deep into the muscle.
Only a clear and colourless solution should be used.
This medicine should not be used in children and adolescents (under age 18).
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 use a double dose to make up for a forgotten dose. Use 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 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, injection site pain, injection site reactions, e.g. inflammation, bruising or haemorrhage.
Uncommon side effects: may affect up to 1 in 100 people
Vomiting blood, low blood pressure, fever, blurred vision, dizziness, sleepiness, sleep disturbances, headache, anaemia, abdominal pain, constipation, digestive problems, diarrhoea, dry mouth, flushing, rash, dermatitis, itching, sweating increased, tiredness, pain, feeling cold.
Rare side effects: may affect up to 1 in 1,000 people
Peptic ulcer, peptic ulcer haemorrhage or peptic ulcer perforation, high blood pressure, fainting, too-slow breathing, inflammation of a superficial vein due to a blood clot (superficial thrombophlebitis), isolated heart skip (extrasystole), fast heartbeat, peripheral oedema, laryngeal oedema, abnormal sensation, feeling feverish and shivering, ringing in the ears (tinnitus), itchy rash, jaundice, acne, back pain, renal pain, passing water frequently, menstrual disorders, prostate problems, muscle stiffness, joint stiffness, muscle cramp, abnormal liver tests (blood tests), increased blood sugar level (hyperglyceaemia), decreased blood sugar level (hypoglyceaemia), increased triglyceride fats concentration in blood (hypertriglyceridaemia), ketone bodies in the urine (ketonuria), proteins in the urine (proteinuria), 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 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 (angioedema), breathlessness due to contraction of the muscles around the airways (bronchospasm), shortness of breath, pancreatitis, skin sensitivity reactions and skin over-sensitivity to light, 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 stiffness of the back of the neck.
Tell your doctor immediately if signs of infection occur or get worse whilst using Keral.
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
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 ampoule. The expiry date refers to the last day of that month.
Keep the ampoule in the outer carton in order to protect it from light.
Do not use this medicine if you notice that the solution is not clear and colourless, but shows signs of deterioration (e.g. particles). Keral solution for injection or concentrate for solution for infusion is for single use only and should be used immediately once opened. Discard any unused quantity of the product (please see “disposal” subsection below).
Disposal
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use and how to properly dispose of your used needles and syringes. These measures will help protect the environment.
6. Contents of the pack and other information
The active substance is dexketoprofen trometamol (73,80 mg) corresponding to dexketoprofen (INN) 50 mg.
The other ingredients are alcohol (ethanol), sodium chloride, sodium hydroxide and water for injections.
Keral is a solution for injection or a concentrate for solution for infusion. It is supplied in packs containing 1, 5, 6, 10, 20, 50 and 100 type I glass coloured ampoules each one with 2 ml of a clear and colourless solution. 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) Ketesse
Austria Ketesse
Belgium Ketesse
Cyprus Nosatel
Czech republic Dexoket
Denmark Ketesse
Estonia Dolmen
Finland Ketesse
France Ketesse
Germany Sympal
Greece Nosatel
Hungary Ketodex forte
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