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KERAL 25 MG GRANULES FOR ORAL SOLUTION

Active substance(s): DEXKETOPROFEN TROMETAMOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Keral 25 mg granules for oral solution
Dexketoprofen trometamol

Read all of this leaflet carefully before you start taking this medicine
Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their
symptoms are the same as yours.

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.


In this leaflet:
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
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 for short term symptomatic treatment of mild to moderate acute pain, such as acute muscular pain
or joint pain, painful periods (dysmenorrhoea), toothache.
2.

BEFORE YOU TAKE KERAL

Do not take Keral:

If you are allergic (hypersensitive) to dexketoprofen trometamol or to any of the other ingredients of
Keral (see section 6);
If you are allergic to the acetylsalicylic acid (aspirin) or to other non-steroidal anti-inflammatory

medicines;
If you 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 or have suffered in the past from a peptic ulcer, stomach or bowel bleeding or 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 fluids;
If you are in the third trimester of pregnancy or breast feeding;

If you are less than 18 years of age.

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Take special care with 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 cerebrovascular accident (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 connective tissue);

If you have suffered in the past from a chronic inflammatory disease of the bowel (ulcerative colitis,
Crohn’s disease);

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).
Taking other medicines
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 a dose adjustment if used together.
Always inform your doctor, dentist or pharmacist if you are using any of the following medicines in addition
to Keral:
Inadvisable combinations:
Acetylsalycilic acid (aspirin), corticostereoids or other anti-inflammatory drugs
Warfarin or 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 problems
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


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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.
Taking Keral with food and drink
If you have acute pain, take the sachets on an empty stomach, i.e. at least 15 minutes before meals, as this
helps the medicine start working a little faster.
Children and adolescents
Do not take Keral if you are less than 18 years of age.
Pregnancy and breast-feeding
Do not use Keral during the third trimester of pregnancy or when breast feeding.
Ask your doctor or pharmacist for advice before taking any medicine:

tell your doctor if you are pregnant or if you are planning to become pregnant, as Keral may not be right
for you.

you must not take Keral if you are breast-feeding. Ask your doctor for advice.
Driving and using machines
Keral may slightly affect your ability to drive and handle machines, due to the possibility of dizziness
drowsiness and visual disturbances 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.
Important information about some of the ingredients of KERAL
This medicine contains sucrose. If you have been told by your doctor that you have intolerance to some
sugars, contact your doctor before taking this medicine.

3.

HOW TO TAKE KERAL

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 sachets you must take daily, and for how long.
The recommended dosage is generally 1 sachet (25 mg of dexketoprofen) every 8 hours, with no more than 3
sachets 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 sachets (50 mg).
In elderly patients this initial dose can later be increased to that generally recommended (75 mg of
dexketoprofen) if Keral has been well tolerated.
If your pain is intense and you need quicker relief, take the sachets on an empty stomach (at least 15 minutes
before food) because they will be more easily absorbed (see section 2 “Taking Keral with food and drink”).

Instructions for a correct use
Dissolve the whole contents of each sachet in a glass of water; shake well to help to dissolve.
The obtained solution should be immediately ingested after reconstitution.
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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 sachet. 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 product, ask your doctor or pharmacist.

4.

POSSIBLE SIDE EFFECTS

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. Since the list is based in part
on side effects from the tablet formulation of Keral, and Keral granules is absorbed faster than the tablets, it
is possible that the actual frequency of (gastrointestinal) side effects could be higher with Keral granules.
This table tells you how many patients might get these side effects:
Common side effects
Uncommon side effects
Rare side effects
Very rare side effects

affects 1 to 10 users in 100
affects 1 to 10 users in 1,000
affects 1 to 10 users in 10,000
affects less than 1 user in 10,000

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), 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),
interruption of kidney function (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, liver cell injury (hepatitis), 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 longterm 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.
4

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.
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.
5.

HOW TO STORE KERAL

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 sachets. The expiry date refers
to the last day of that month.
This medicinal product does not require any special storage conditions.
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.
6.

FURTHER INFORMATION

What Keral contains
Each sachet contains 25 mg of dexketoprofen (as dexketoprofen trometamol).
The other ingredients are Ammonium glycyrrhizinate, neohesperidin-dihydrochalcone, quinoline yellow
(E104), lemon aroma, sucrose and silica, colloidal hydrated.
Each sachet contains 2.5 g of sucrose.
What Keral looks like and contents of the pack
Keral 25 mg is supplied in sachets containing lemon yellow coloured granules.
Keral 25 mg is supplied in packs containing 2, 4, 10, 20, 30, 40, 50, 100 and 500 sachets. Not all pack sizes
may be marketed.
Marketing Authorisation Holder:
Menarini International Operations Luxembourg S.A.
1, Avenue de la Gare,
L-1611 Luxembourg
Manufacturer:
LABORATORIOS MENARINI, S.A.
Alfons XII 587, 08918-Badalona (Barcelona), SPAIN

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This medicinal product is authorised in the Member States of the EEA under the following names:

Austria
Belgium
Cyprus
Czech Republic
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy

Ketesse
Ketesse
Nosatel
Dexoket
Ketesse
Dolmen
Ketesse
Ketesse
Sympal
Nosatel
Ketodex
Ketesse
Keral
Ketesse

Latvia
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Slovak Republic
Slovenia
Spain
Sweden
United Kingdom

This leaflet was last approved in 04/2011.

6

Dolmen
Dolmen
Ketesse
Keral
Stadium
Ketesse
Dexak
Ketesse
Dexadol
Menadex
Ketesse
Ketesse
Keral

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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