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KERAL 25MG FILM-COATED TABLETS

Active substance(s): DEXKETOPROFEN TROMETAMOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

KERAL

25 mg film-coated tablets

Dexketoprofen (as trometamol)

Read all of this leaflet carefully before you start taking this medicine because
it contains important information for you.





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 only. Do not pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed
in this leaflet. See section 4.

What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Keral is and what it is used for
What you need to know before you take Keral
How to take Keral
Possible side effects
How to store Keral
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.
You must talk to a doctor if you do not feel better or if you feel worse after 3-4 days.

2.

What you need to know before you take Keral

Do not take Keral:












If you are allergic to dexketoprofen trometamol 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 nonsteroidal anti-inflammatory medicines;
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 nonsteroidal 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 pregnant or breast feeding;
If you are less than 18 years of age.

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 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 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).

Children and adolescents

Do not take Ketesse if you are less than 18 years of age.

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:

Acetylsalycilic 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 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

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 pregnancy or when breast feeding.
If you are pregnant or breast-feeding, 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.
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 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 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 may not be used 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 (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
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.

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.
Do not store above 30 °C. Keep the blister packs in the outer carton in order protect from light.
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
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.

What Keral looks like and contents of the pack
Keral is supplied in packs containing 4, 10, 20, 30, 50 and 500 film-coated tablets. Not all pack sizes may be
marketed. The tablets can be divided into equal halves.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Menarini International Operations Luxembourg S.A.
1, Avenue de la Gare - L-1611 Luxembourg
Manufacturer:
LABORATORIOS MENARINI, S.A.,
Alfonso XII 587, 08918-Badalona (Barcelona), SPAIN
or
A. MENARINI MANUFACTURING LOGISTICS and SERVICES srl,
Via Campo di Pile s/n Loc. Campo di Pile - L’AQUILA, Italy

This medicinal product is authorised in the Member States of the EEA under
the following names:
Spain (RMS)
Austria
Belgium
Cyprus
Czech republic
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland

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

Italy
Latvia
Lithuania
Luxembourg
Malta
Norway
Poland
Portugal
Slovakia
Slovenia
Sweden
The Netherlands
United Kingdom

This leaflet was last revised in 10/2014.
A. Menarini Farmaceutica Internazionale SRL
Menarini House, Wooburn Green, Buckinghamshire HP10 0HH

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

+ Expand Transcript

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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