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DEKO

    • DEKO is used for short-term sympromatic treatment
    • of acute mild to moderate muscle and joint pain,
    • painful menstruation (dysmenorrhea), and toothache.
  • CONTENT

    What DEKO looks like and contents of the pack Granules for oral solution are available as single doses in thermo-sealed triple-layer sachets (PE/Al/PAP). DEKO is available in packages containing 10 and 2 sachets. Not all types of packaging can be marketed.

    Method of use

    DEKO is a pain-relieving medicinal product from the group of non-steroidal anti-inflammatory drugs (NSAIDs). DEKO is used for short-term sympromatic treatment of acute mild to moderate muscle and joint pain, painful menstruation (dysmenorrhea), and toothache.

  • Package leaflet: Information for the patient

    DEKO 25 mg granules for oral solution in sachet

    Dexketoprofen

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

    Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.  

    - Keep this leaflet. You may need to read it again.  

    - Ask your pharmacist if you need more information or advice.

    - 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.

    - You must talk to a doctor if you do not feel better or if you feel worse after 3-4 days.

     

    What is in this leaflet

     1. What DEKO is and what it is used for  

    2. What you need to know before you take DEKO  

    3. How to take DEKO  

    4. Possible side effects  

    5. How to store DEKO  

    6. Contents of the pack and other information

     

     1. What DEKO is and what it is used for

     DEKO is a pain-relieving medicinal product from the group of non-steroidal anti-inflammatory drugs (NSAIDs).

    DEKO is used for short-term sympromatic treatment of acute mild to moderate muscle and joint pain, painful menstruation (dysmenorrhea), and 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 DEKO  

     Do not take DEKO:

    - if you are allergic (hypersensitive) to dexketoprofen trometamol or any of the other ingredients of DEKO (listed in section 6);

    - if you are allergic to acetylcalicylic acid or to other non-steroidal anti-inflammatory medicines (NSAIDs);

    - if you have asthma or have suffered asthma attacks, acute allergic rhinitis (inflammation of the nose for a short period), 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 acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);

    - if you have experienced photoallergic or phototoxic reactions (a specific skin reddening and/or blistering after exposure to sunlight) when taking ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (medicines used to lower blood lipid levels);

    - 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 severe kidney problems or serious liver problems;

    - if you have a bleeding disorder or a blood clotting disorder;

    - if you are severely dehydrated (i.e. if you have lost a lot of body fluids) due to vomiting, diarrhoea or insufficient intake of fluids;

    - if you are pregnant in the third trimester or breastfeeding.

     Warnings and precautions  

    Talk to your doctor or pharmacist before taking DEKO:

    - if you have an allergy or have had allergic reactions 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 are dehydrated and have reduced blood volume due to excessive fluid loss (e.g. frequent 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, high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist. Medicines such as DEKO 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 as you may be more prone to side effects (see section 4). If any adverse drug reaction occurs, consult your doctor immediately;

    - if you are a woman who has problems conceiving (DEKO may impair your reproductive capacity. Therefore, it should not be taken if you are planning a pregnancy or having infertility tests);

    - if you suffer from a disorder in blood formation or the formation of blood cells;

    - if you suffer from systemic lupus erythematosus or mixed connective tissue disease (immune system disorders that affect connective tissue);

    - if you have had chronic intestinal inflammation (ulcerative colitis or Crohn’s disease) in the past;

    - if you have or have suffered in the past from other stomach or bowel problems;

    - if you have chickenpox, as NSAIDs can exceptionally make the infection worse;

    - if you are taking other medicines that increase the risk of peptic ulcer or bleeding (e.g. oral corticosteroids, some antidepressants (those of the SSRI type, i.e. Selective Serotonin Reuptake Inhibitors), anti-inflammatory medicines (e.g. acetylsalicylic acid or anticoagulants such as warfarin). In such cases, consult your doctor before taking DEKO. Your doctor may advise you to take an additional medicine to protect your stomach (e.g. misoprostol or medicines that suppress the secretion of stomach acid)

     Children and adolescents

    The safety and efficacy of DEKO in children and adolescents have not been established. Therefore, DEKO should not be taken by children and adolescents.

     Other medicines and DEKO

    Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Some medicines should not be taken with others or a dose adjustment is required if they are used at the same time.

    Always inform your doctor or pharmacist if you are taking any of the following medicines at the same time as DEKO:

     Combinations not recommended:

    • acetylsalicylic acid, corticosteroids or other anti-inflammatory medicinal products;

    • warfarin, heparin, or other anticoagulants;

    • lithium, used to treat certain mood disorders;

    • methotrexate (a medicines used against cancer or to suppress the immune system) in high doses of 15 mg/week;

    • hydantoin and phenytoin, used for epilepsy;

    • sulphametoxazole, used for bacterial infections.

    Combinations that require special 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;

    • aminoglycoside antibiotics, used to treat bacterial infections;

    • chlorpropamide and glibenclamide, used for diabetes;

    • methotrexate, used at low doses, less than 15 mg/week.

    Combinations to be administered with caution:

    • quinolone antibiotics (e.g. ciprofloxacin, levofloxacin) used for bacterial infections;

    • cyclosporin or tacrolimus, used in the treatment of diseases of the immune system and in organ transplantation;

    • streptokinase and other thrombolytics 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 to induce abortion (termination of pregnancy);

    • antidepressants of the selective serotonin reuptake inhibitors typre (SSRIs);

    • antiplatelet drugs used to suppress platelet aggregation and the formation of blood clots;

    • beta-blockers, used for high blood pressure and heart problems.

    If you have any doubts about taking other medicines with DEKO, consult your doctor or pharmacist.

     DEKO with food, drink and alcohol

    In case of acute pain, the sachet is taken on an empty stomach, 15 minutes before a meal. This will slightly increase the effect of the medicinal product.

     Pregnancy, breast-feeding and fertility

    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.

    Do not take DEKO during the third trimester of pregnancy or while breastfeeding.

    For possible effects on female fertility, see section 2 “Warnings and precautions”.

     Driving and using machines

    It is possible that DEKO may slightly affect your ability to drive and operate machines, due to the possible occurrence of dizziness, drowsiness or visual disturbances. If you notice the appearance of such side effects, do not drive or use machines until the symptoms subside. Consult your doctor.

     DEKO contains sucrose

    If you have an intolerance to some sugars, consult your doctor before taking  this medicine.

    DEKO contains 2,414 g of sucrose per dose. This should be considered when taken by patients with diabetes mellitus.

     3. How to take DEKO

     Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.  

     Adults over 18 years old

    Dissolve the contents of the sachet in a glass of water, mix/shake well, then drink immediately.

    The recommended dose is 1 sachet (25 mg) every 8 hours, but no more than 3 sachets daily (75 mg).

    Consult your doctor if after 3-4 days you do not feel better or your condition worsens. Your doctor will tell you how many sachets you should take per day and for what period of time.

    The dose of DEKO depends on the pain’s type, strength, and duration.

    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, the initial dose can be increased to the total recommended daily dose (75 mg dexketoprofen) if DEKO is well tolerated by the body.

    In case the pain is intense and you need quick relief, take the sachet on an empty stomach (at least 15 minutes before a meal) as it will be absorbed faster (see section 2).

     Use in children and adolescents

    Do not take DEKO if you are under 18 years of age.

     If you take more DEKO than you should

    Tell your doctor or pharmacist immediately or go to the emergency department of the nearest hospital if you have taken more than the recommended adult dose. Do not forget to take the package of the medicinal product or the leaflet with you.

     If you forget to take DEKO

    Do not take a double dose to make up for a forgotten dose. Take the next regular dose as directed (see section 3).

     If you stop taking DEKO

    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 described according to their frequency of occurrence. The description is made according to the occurrence of adverse drug reactions from the tablet form of dexketoprofen trometamol. DEKO granules are absorbed faster than tablets, therefore it is possible that the actual frequency of side effects (gastrointestinal) could be higher.

     Common side effects: may affect up to 1 in 10 people

    Nausea and/or vomiting, pain mainly in the upper abdomen, diarrhoea, digestive problems (dyspepsia).

     Uncommon side effects: may affect up to 1 in 100 people

    Spinning sensation (vertigo), dizziness, drowsiness, sleep disturbances, nervousness, headache, palpitations, flushing, inflammation of the stomach lining (gastritis), constipation, dry mouth, flatulence, skin rash, tiredness, pain, feeling feverish and shivering, general weakness (fatigue).

     Rare side effects: may affect up to 1 in 1 000 people

    Peptic ulcer, peptic ulcer perforation or bleeding (which may present as vomiting blood and black stools), feeling sick, high blood pressure, slow breathing, fluid retention and peripheral swelling (e.g., swollen ankles), swelling of the larynx, loss of appetite (anorexia), abnormal sensation, itchy rash, acne, increased sweating, back pain, frequent urination, menstrual disorders, prostate problems, abnormal liver function tests (blood tests), liver cells damage (hepatitis), acute renal failure.

     Very rare side effects: may affect up to 1 in 10 000 people

    Anaphylactic reaction (a hypersensitivity reaction that can also lead to loss consciousness), open sores on the skin, mouth and genital area (Stevens-Johnson and Lyell’s syndromes), swelling of the face or lips and throat (angioedema), difficulty breathing due to narrowing of the airways (bronchospasm), shortness of breath, rapid heartbeat, low blood pressure, inflammation of the pancreas, blurred vision, ringing in the ears (tinnitus), sensitive skin, sensitivity to light, itching, kidney problems. Decreased number of white blood cells (neutropenia), decreased number of platelets in the blood (thrombocytopenia).

     Tell your doctor immediately if you experience any stomach/intestinal side effects at the start of treatment (e.g., stomach pain, heartburn or bleeding), if you have previously suffered from any of the side effects due to long-term use of anti-inflammatory drugs, and especially if you are elderly.

     Stop using DEKO as soon as you notice the appearance of a skin rash, lesions on the mucous membrane of the mouth or on the genitals, or any sign of an allergy.

     Fluid retention and oedema (especially of the ankles and feet), increased blood pressure and heart failure have been reported during treatment with non-steroidal anti-inflammatory drugs (NSAIDs).

    Medicines such as DEKO are associated with a slightly increased risk of heart attack (“myocardial infarction”) or cerebrovascular accident (stroke).

    In patients with immune system disorders that affect the connective tissue (systemic lupus erythematosus or mixed connective tissue disease), anti-inflammatory drugs may rarely increase the temperature, cause headache and stiff neck.

    The most frequently observed side effects are gastrointestinal in origin. Peptic ulcers, perforation, or gastrointestinal bleeding may occur, sometimes fatal, especially in the elderly.

    Nausea, vomiting, diarrhoea, flatulence, constipation, indigestion, abdominal pain, black stools, vomiting of blood, ulcerative stomatitis, worsening of colitis or Crohn’s disease have been reported following administration.

    As with other NSAIDs, haematological reactions (purpura, aplastic and haemolytic anaemia, and rarely – agranulocytosis and bone marrow hypoplasia) may occur.

    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:

    Bulgarian Drug Agency,

    8, Damyan Gruev str.,

    1303 Sofia,

    tel. +359 2 890 34 17,

    website: www.bda.bg

    By reporting side effects, you can help provide more information on the safety of this medicine.

    5. How to store DEKO

     Keep this medicine out of the sight and reach of children.

    This medicinal product does not require any special storage conditions.

    Do not use this medicine after the expiry date which is stated on the carton and on the sachets after EXP. The expiry date refers to the last day of that month.

    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 DEKO contains  

    - Active substance: each sachet of granules for oral solution contains 25 mg of dexketoprofen (as dexketoprofen trometamol).  

    - Excipients: ammonium glycyrrhizate,  neohesperidin dihydrochalcone, sucrose, silicon dioxide, colloidal anhydrous, lemon flavor.

    What DEKO looks like and contents of the pack

    Granules for oral solution are available as single doses in thermo-sealed triple-layer sachets (PE/Al/PAP).

    DEKO is available in packages containing 10 and 2 sachets.

    Not all types of packaging can be marketed.

     

    Marketing Authorisation Holder and Manufacturer

    Fortex Nutraceuticals LTD.

    10, Prohladen kat str.,

    1362 Sofia, Bulgaria

     

    This leaflet was last revised in October 2021.

     

     

    1. What DEKO contains 

    -Active substance: each sachet of granules for oral solution contains 25 mg of dexketoprofen (as dexketoprofen trometamol).

    -Excipients: ammonium glycyrrhizate, neohesperidin dihydrochalcone, sucrose, silicon dioxide, colloidal anhydrous, lemon flavor.