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ENANTYUM 25 MG GRANULES FOR ORAL SOLUTION

Active substance(s): DEXKETOPROFEN TROMETAMOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Enantyum 25 mg granules for oral solution
Dexketoprofen
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.
What Enantyum is and what it is used for
2.
What you need to know before you take Enantyum
3.
How to take Enantyum
4.
Possible side effects
5.
How to store Enantyum
6.
Contents of the pack and other information
1.

What Enantyum is and what it is used for

Enantyum 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.

What you need to know before you take Enantyum

Do not take Enantyum:

If you are allergic (hypersensitive) to dexketoprofen trometamol or to any of the other ingredients of this
medicine (listed in section 6);

If you are allergic to the acetylsalicylic acid (aspirin) 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 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 a peptic ulcer/ stomach or bowel bleeding or if you have suffered in the past from stomach or
bowel bleeding, ulceration or perforation;

If you 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;

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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;

Warnings and precautions
Talk to your doctor or pharmacist before taking Enantyum:

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 Enantyum 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 (Enantyum 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 Enantyum: 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).

If you suffer from asthma combined with chronic rhinitis, chronic sinusitis, and/or nasal polyposis as you
have a higher risk of allergy to acetylsalicylic acid and/or NSAIDs than the rest of the population.
Administration of this medicine can cause asthma attacks or bronchospasm, particularly in patients
allergic to acetylsalicylic acid or NSAIDs.
Children and adolescents
Enantyum 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 Enantyum
Tell your doctor or pharmacist if you are taking or 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 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 Enantyum:
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 (anti-cancer medicine or immunosuppressant), used at high doses of 15 mg/week

Hydantoins and phenytoin, used for epilepsy
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Sulphametoxazole, used for bacterial infections
Combinations requiring precautions:

ACE inhibitors, diuretics 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

Methotrexate, used at low doses, less than 15 mg/week
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

Beta-blockers, used for high blood pressure and heart problems
If you have any doubt about taking other medicines with Enantyum, consult your doctor or pharmacist.
Taking Enantyum 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.
Pregnancy, breast-feeding and fertility
Do not use Enantyum during the third trimester of 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. With regard to potential effects on female
fertility, see also section 2, “Warnings and precautions”.
Driving and using machines
Enantyum 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.
Enantyum contains sucrose
If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before
taking this medicine.
Contains 2.40 – 2.44 g of sucrose per dose. This should be taken into account in patients with diabetes
mellitus.
3.

How to take Enantyum

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Adults over age 18
The dose of Enantyum 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).

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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 Enantyum 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 Enantyum with food and
drink”).
Use in children and adolescents
This medicine should not be used in children and adolescents (under age 18).
Instructions for a correct use
Dissolve the whole contents of each sachet in a glass of water; shake/stir well to help to dissolve.
The obtained solution should be immediately ingested after reconstitution.
If you use more Enantyum 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 Enantyum
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 Enantyum”).
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, Enantyum 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 Enantyum, and Enantyum granules is absorbed faster than the tablets, it is
possible that the actual frequency of (gastrointestinal) side effects could be higher with Enantyum granules.

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).

4

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 Enantyum 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 Enantyum 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 Enantyum

Keep 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 sachets. The expiry
date refers to the last day of that month.
This medicinal product 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 to protect the environment.

6.

Contents of the packs and other information

What Enantyum 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 2.40 – 2.44 g of sucrose with colloidal silica.
What Enantyum looks like and contents of the pack
Enantyum 25 mg is supplied in sachets containing lemon yellow coloured granules.
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Enantyum 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
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria, Belgium, Denmark, France, Hungary, Iceland, Ireland, Italy, Luxembourg, Netherlands, Portugal,
Spain, Sweden, United Kingdom: Enantyum
Czech Republic, Estonia, Latvia, Lithuania, Slovak Republic, Slovenia: Ketesse
Greece: Viaxal
Norway: Orodek
Poland: Ketesse SL
This leaflet was last revised in 12/2015.

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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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