Dexalgin granules for solution for oral administration 25mg in bags No. 20

NameDexalgin. Forms of release Granules. MNN Dexketoprofen. FTGNpvp. What the drug is and what it is used for Dexalgin® is an analgesic that belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs). It is used for short-term symptomatic treatment of mild to moderate pain, such as acute muscle or joint pain , with painful menstruation (dysmenorrhea), toothache. What you need to know before you take Dexalgin® should not be used if: you are allergic (hypersensitive) to dexketoprofen trometamol or any of the other ingredients of Dexalgin®; you are allergic to acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs; after taking aspirin or other non-steroidal anti-inflammatory drugs you have had asthma attacks, acute allergic rhinitis (inflammation of the nasal mucosa for a short time), nasal polyps (swelling in the nose due to allergies), urticaria (skin rash), angioedema (swelling of the face , eyes, lips, or tongue, or trouble breathing) or wheezing in the chest; you have had photoallergic or phototoxic reactions (a particular form of skin reddening and/or blistering when exposed to sunlight) while using ketoprofen (non-steroidal anti-inflammatory drug) or fibrates (drugs used to lower blood fat levels); you have a peptic ulcer/bleeding in the stomach or intestines, or if you have had bleeding in the stomach or intestines in the past, an ulcer or perforation; you suffer from chronic digestive disorders (eg, indigestion, heartburn) when using non-steroidal anti-inflammatory drugs (NSAIDs) for pain relief, you develop stomach or intestinal bleeding or perforation; you suffer from chronic inflammatory bowel disease (Crohn’s disease or ulcerative colitis); you have severe heart failure, moderate or severe renal impairment, or severe liver impairment; you have increased bleeding or a blood clotting disorder; You are severely dehydrated (losing a lot of body fluids) due to vomiting, diarrhea, or insufficient fluid intake; You are in your third trimester of pregnancy or are breastfeeding. You are under 18 years of age. Warnings and precautions Talk to your doctor or pharmacist before taking Dexalgin® if: you suffer or have had allergies in the past; You suffer or have suffered from diseases of the kidneys, liver, heart (arterial hypertension and / or heart failure), fluid retention in the body; you are taking diuretics, you are dehydrated and have a decrease in blood volume due to significant fluid loss (for example, due to increased urination, diarrhea or vomiting); you have heart disease, have had a stroke, or think you are at risk for these conditions (for example, high blood pressure, diabetes, high cholesterol, and smoking). In such cases, you should consult your doctor or pharmacist about treatment. Medicines like Dexalgin® may slightly increase the risk of heart attack (myocardial infarction) or stroke. The risk of any complications increases with increasing dose and duration of therapy. Do not exceed recommended doses and duration of treatment. You are an elderly person. The risk of side effects increases. In this case, you should immediately consult a doctor; You are a woman suffering from a violation of the childbearing function (against the background of the use of the drug Dexalgin®, a decrease in the childbearing function is possible, therefore it is not recommended to take it when planning pregnancy and conducting appropriate examinations); you have a violation of hematopoiesis and the formation of blood cells; you have systemic lupus erythematosus or mixed connective tissue disease (immune system disorders accompanied by changes in connective tissue); you have had a chronic inflammatory bowel disease (ulcerative colitis, Crohn’s disease); you suffer or have suffered from other diseases of the stomach or intestines; You have chickenpox because too much NSAIDs can make the infection worse You are taking other medicines that increase the risk of peptic ulcers or bleeding, such as oral steroids, certain antidepressants (such as selective serotonin reuptake inhibitors), drugs that prevent platelet aggregation (aspirin), or anticoagulants (warfarin). In this case, before starting Dexalgin®, consult with your doctor, who may prescribe an additional medicine that has a protective effect on the stomach (for example, misoprostol or medicines that suppress the production of gastric juice). You suffer from asthma in combination with chronic rhinitis, chronic sinusitis and/or nasal polyps and are therefore at a higher risk of allergy to acetylsalicylic acid and/or NSAIDs than the general population. Interactions with other medicines If you are currently taking, have recently taken, or may be taking any other medicines, including those obtained without a prescription, tell your doctor or pharmacist. There are medicines that cannot be combined with each other, and there are those that, when used together, require dose adjustments. .It is not recommended to combine the following drugs with Dexalgin®: Acetylsalicylic acid (aspirin), corticosteroids and other anti-inflammatory drugs; Warfarin, heparin and other drugs that prevent blood clotting; lithium, which is used for certain mood disorders; Methotrexate (an anti-cancer drug or immunosuppressant), used in high doses of 15 mg per week; Hydantoins and phenytoin used in epilepsy; Sulfamethoxazole, used to treat bacterial infections. The following drugs are recommended to be used with caution with Dexalgin®: ACE inhibitors, diuretics and angiotensin II receptor antagonists used for high blood pressure and heart disease; Pentoxifylline and oxpentifylline, used for chronic ulcers due to venous disease; zidovudine, used to treat viral infections; Aminoglycoside antibiotics, used to treat bacterial infections Chlorpropamide and glibenclamide, used in diabetes mellitus Methotrexate, used at low doses, less than 15 mg/week. The co-administration of the following should be well justified: Quinolone antibiotics (eg, ciprofloxacin, levofloxacin) used for bacterial infections; Cyclosporine or tacrolimus, used to treat diseases of the immune system and in organ transplants; Streptokinase and other thrombolytic or fibrinolytic drugs, i.e. agents used to break up blood clots; Probenecid, used for gout; Digoxin, used in chronic heart failure; Mifepristone, used as an abortifacient (to terminate a pregnancy); Antidepressants such as selective serotonin reuptake inhibitors; Antiplatelet agents used to reduce platelet aggregation and blood clots; Beta-blockers used to treat high blood pressure and heart disease. If you have any questions about taking Dexalgin® with other medicines, ask your doctor or pharmacist. Taking the drug with food and drinks In case of acute pain, the drug should be taken on an empty stomach, i.e. no later than 15 minutes before meals, so that the action comes faster. Children and adolescents The use of Dexalgin® in patients under 18 years of age is contraindicated. Pregnancy, lactation and childbearing The use of the drug Dexalgin® in the third trimester of pregnancy and while breastfeeding is contraindicated. effects on female reproductive function – see also Warnings and Precautions. Influence on the ability to drive vehicles and maintain mechanisms Since the use of the drug Dexalgin® may develop side effects such as dizziness and drowsiness, as well as visual impairment, it has some effect on the ability to drive vehicles and maintain mechanisms. If you experience dizziness or drowsiness, refrain from driving and operating machinery until these symptoms disappear. Talk to your doctor.This medicine contains sucroseIf you have an intolerance to any sugars, talk to your doctor before taking this medicine. How to use this medicine This medicine should always be used exactly as directed in this package leaflet, or as directed by your doctor or pharmacist. If you are in any doubt, ask your doctor or pharmacist for advice. Adults over the age of 18 The dose of Dexalgin® you need depends on the type, severity and duration of the pain. Your doctor will tell you how many sachets to take per day and for how long. The usual recommendation is to take 1 sachet (25 mg) every 8 hours, up to a maximum of 3 sachets (75 mg) per day. liver, treatment should be started with a total daily dose of not more than 2 sachets (50 mg). If Dexalgin® is well tolerated in the elderly, the initial dose can be further increased to the dose recommended for ordinary patients (75 mg dexketoprofen). If you suffer from severe pain and want to relieve this pain quickly, take the drug on an empty stomach (at least 15 minutes before a meal), as it is absorbed faster (see section 2, taking Dexalgin® with food and drinks). Children Use this drug in patients under the age of 18 is not allowed. Instructions for the correct use of the drug Dissolve the entire contents of the sachet in a glass of water, mix well for better dissolution. This solution should be taken immediately after preparation ii.What to do in case of an overdose of the drug In case of an overdose of the drug, immediately contact your doctor, pharmacist or the emergency department of the nearest hospital. Be sure to take the container of this drug or this leaflet with you. What to do if you forget to take a drug Do not take a double dose to make up for the missed one. At the appointed time, simply take the next prescribed dose (in accordance with section 3 “How to use Dexalgin®”). If you have any questions about the use of the drug, ask your doctor or pharmacist. Possible side effects Like all medicines, Dexalgin® also has side effects, although not everyone develops them. Possible side effects are listed below, depending on the frequency of their manifestation. Since the list is based in part on side effects reported with Dexalgin® tablets and the granules are absorbed faster than tablets, it is possible that the actual incidence of side effects (gastrointestinal) with Dexalgin® granules may be higher. . The table indicates how many patients they may experience. Side effects that occur frequently (may affect up to 1 in 100 patients, but less than 1 in 10 patients) Nausea and / or vomiting, pain in the upper quadrant of the abdomen, diarrhea, digestive problems (dyspepsia). Uncommon side effects (may affect up to 1 in 1000 people, but in less than 1 in 100 people) Feeling of rotation (vertigo), dizziness, drowsiness, sleep disturbances, nervousness, headaches palpitations, hot flashes, inflammation of the stomach lining (gastritis), constipation, dry mouth, flatulence, skin rash, pain, feeling of fever and chills, deterioration in general well-being (malaise). Side effects that occur rarely (may occur in 1 or more in 10,000 patients, but less than 1 in 1,000 patients) respiratory depression, fluid retention and peripheral edema (eg, ankle edema), laryngeal edema, loss of appetite (anorexia), abnormal sensations, itchy rash, acne, increased sweating, back pain, frequent urination, menstrual irregularities, prostate disorders glands, liver abnormalities (blood test), damage to liver cells (hepatitis), acute kidney failure Very rare side effects (may affect up to 1 in 10,000 patients) sores on the skin, mucous membranes of the mouth, eyes and genitals (Stevens-Johnson and Lyell syndrome), swelling of the face or lips and throat (angioneurotic edema), difficulty breathing due to narrowing of the airways (bronchospasm), shortness of breath, rapid heartbeat, lowering of arterial pressure, inflammation of the pancreas, blurred vision, ringing in the ears (tinnitus), hypersensitivity skin tightness, sensitivity to light, itching, renal disorders. Decreased white blood cell count (neutropenia), low platelets in the blood (thrombocytopenia). such symptoms have occurred with prolonged use of anti-inflammatory drugs and, especially if you are an elderly person, tell your doctor immediately. should be discontinued. According to reports, during the period of use of non-steroidal anti-inflammatory drugs, fluid retention in the body and the appearance of edema (especially in the legs), increased blood pressure and heart failure are possible. Medications like Dexalgin® may slightly increase the risk of a heart attack (myocardial infarction) or cerebrovascular disorders (stroke). patients suffering from systemic connective tissue diseases (systemic lupus erythematosus or mixed connective tissue disease), against the background of the use of anti-inflammatory drugs, in rare cases, fever, headaches and a feeling of neck stiffness may occur. Side effects from the gastrointestinal tract are most often observed. It is possible to develop peptic ulcers, perforation or gastrointestinal bleeding, sometimes – especially in elderly patients – with a fatal outcome. Against the background of the use of the drug, nausea, vomiting, diarrhea, flatulence, constipation, indigestion, abdominal pain, tarry stools, vomiting of blood, ulcerative stomatitis, aggravation of colitis and Crohn’s disease may occur. Inflammation of the gastric mucosa (gastritis) was less commonly observed. As in the case of other NSAIDs, reactions from the blood may occur (purpura, aplastic and hemolytic anemia, rarely agranulocytosis and bone marrow hypoplasia). With aggravation of side effects, as well as with the appearance of side effects If you take any side effects not described in this package leaflet, tell your doctor or pharmacist. Reporting possible side effects If you experience any side effects, tell your doctor or pharmacist. This applies to any possible side effects, including those not listed in this package insert. You can also report side effects directly through the national reporting system. By reporting side effects, you can help gather more information about the safety of this drug. Storage conditions of the drug Keep this drug out of the reach of children. Shelf life 4 years. The drug can not be used after the expiration date indicated on the carton and sachets. The expiration date is the last day of that month. This drug does not require special storage conditions. Do not dispose of any medicinal products in the sewer or with household waste. Talk to your pharmacist about how to dispose of an unused drug. These measures contribute to the protection of the environment. Contents of the pack and other information Contents of the drug One sachet contains 25 mg of dexketoprofen (as dexketoprofen trometamol). .40 – 2.44 g of sucrose with colloidal silicon dioxide. Appearance of the Dexalgin® formulation and contents of the package The granules for the preparation of oral solution are packaged in aluminum foil/polyethylene coated sachets, sealed by heat sealing. One sachet contains the drug in a single dose. The original package contains 10, 20 or 30 portion sachets with a leaflet. Not all package sizes may be available for sale. Dispensing conditionsDexalgin® 25 mg is dispensed by prescription. Buy Dexalgin granules for oral solution 25 mg in bags No. 20 25mg in packs #20