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PACKAGE LEAFLET: INFORMATION FOR THE USER

Enantyum 12.5 mg granules for oral solution Dexketoprofen

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 to dexketoprofen trometamol or 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;

•    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

•    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. 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 1.20 - 1.22 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 dose is 1 sachet (12.5 mg) every 4-6 hours, with no more than 6 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 4 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 adolescentsThis medicine should not be used 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).

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 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 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 12.5 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 1.20-122 g of sucrose with colloidal silica.

What Enantyum looks like and contents of the pack

Enantyum 12.5 mg is supplied in sachets containing lemon yellow coloured granules.

Enantyum 12.5 mg is supplied in packs containing 2, 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, Hungary, Iceland, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain,

Sweden, United Kingdom: Enantyum

Estonia, Slovak Republic, Slovenia: Ketesse

Greece: Viaxal

Norway: Orodek

Poland: Ketesse SL

This leaflet was last revised in 12/2015.

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