Ibufen D oral suspension 100mg/5ml 120ml №1

Name:
Ibufen e. Release form Suspension for oral administration. Dosage 100 mg / 5 ml 120 ml. Qty per package: 1 pc. ProducerMedana pharma s.a. INNIBuprofen. FTGNpvp.
Description:
Suspension of white or almost white color with an orange smell. 5 ml suspension contains: active ingredient: ibuprofen 100 mg excipients: macrogol glycerol hydroxystearate, xanthan gum, glycerol, sodium benzoate, citric acid monohydrate, sodium phosphate dihydrate or sodium phosphate dodecahydrate, sodium saccharinate, liquid maltitol, orange flavor, purified water. Pharmacotherapeutic groupNon-steroidal anti-inflammatory and antirheumatic drugs. Derivatives of propionic acid. Pharmacological properties Ibuprofen is a derivative of propionic acid, which has analgesic, antipyretic and anti-inflammatory effects. The mechanism of the anti-inflammatory action of ibuprofen is associated with inhibition of the synthesis and release of prostaglandins due to inhibition of the activity of cyclooxygenase, which catalyzes the conversion of arachidonic acid to prostaglandins, but the existence of other mechanisms is not excluded. It has been proven that the antipyretic and analgesic effect of ibuprofen begins within 30 minutes from the moment of taking the drug. Ibufen® D does not contain sugar and dyes. Indications for use Fever of various origins (also with viral infections and post-vaccination reactions) Pain of various origins of mild to moderate intensity with: – headache, sore throat and muscles, for example. with viral infections – pain in the muscles, joints as a result of injuries of the musculoskeletal system (overstrain, dislocation – post-traumatic pain of soft tissues, postoperative pain – toothache, pain after tooth extraction, pain during teething – ear pain with inflammation of the middle ear. Contraindications Hypersensitivity to the active substance, other non-steroidal anti-inflammatory drugs (NSAIDs) or any of the excipients listed in the “Composition” section. History of allergies in the form of a runny nose, urticaria or bronchial asthma after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs) Current or past peptic ulcer of the stomach and/or duodenum (two or more confirmed episodes of peptic ulcer or ulcer bleeding) with perforation or bleeding, also associated with previous NSAID therapy.Severe liver failure, severe renal failure ness. Severe heart failure (NYHA class IV). Cerebrovascular or other bleeding. Hemorrhagic diathesis or disorders of the hematopoietic system of uncertain origin. Severe dehydration (as a result of vomiting, diarrhea or insufficient fluid intake). III trimester of pregnancy. Precautions when using the drug Caution should be exercised in patients with: systemic lupus erythematosus and mixed connective tissue disease diseases of the gastrointestinal tract, as well as chronic inflammatory bowel diseases (ulcerative colitis, Crohn’s disease) hypertension and (or) heart failure kidney failure liver failure coagulation disorder blood (ibuprofen may prolong bleeding time) hereditary disorder of porphyrin metabolism (for example, acute intermittent porphyria) immediately after surgery. Taking the drug at the recommended dose as soon as necessary to reduce symptoms reduces the risk of side effects (see below: effects on the gastrointestinal tract and circulatory system). The frequency of occurrence and intensity of side effects can be reduced by using the minimum therapeutic dose for a shorter duration of use. Taking the drug in people with bronchial asthma and other allergic diseases in the active stage or in history can cause bronchospasm. There is a risk of bleeding from the gastrointestinal tract, ulceration or perforation, in case of bleeding from the gastrointestinal tract or ulceration, the drug should be stopped immediately. Patients with a history of gastrointestinal disease should be informed of the need to notify the physician of any unusual gastrointestinal symptoms (in particular, bleeding, especially during the initial period of therapy. Such patients should take the minimum dose of the drug. The drug should be used with caution in patients concomitantly taking other medicines that potentially increase the risk of gastrointestinal disturbances or bleeding, such as corticosteroids and antithrombotic drugs such as warfarin, or antiplatelet drugs such as acetylsalicylic acid Taking anti-inflammatory/pain medications such as ibuprofen may be accompanied by a slight increase in the risk of heart attack or stroke, especially when taken in high doses.Do not exceed the recommended doses and duration of treatment.You should discuss treatment with your doctor or pharmacist before taking Ibufen® D, if you the patient: – has heart problems, including heart failure, angina pectoris (chest pain), and if the patient has previously had a heart attack, coronary artery surgery, stroke of any type (including a “mini-stroke” or transient ischemic attack “TIA”) or the patient has peripheral arterial disease (poor circulation in the feet due to narrowing or blockage of the arteries); – have high blood pressure, diabetes, high blood cholesterol, heart disease or stroke in family members, or if the patient smokes. Simultaneous long-term use of different analgesic drugs can lead to kidney damage and the risk of kidney failure (post-analgesic nephropathy). NSAIDs may mask symptoms of infection and fever. Ibuprofen, the active ingredient in Ibufen® D, may temporarily inhibit platelet function (platelet aggregation). In this regard, patients with bleeding disorders require careful medical supervision. Children and adolescents with dehydration are at risk of kidney failure. Severe skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrosis (Lyell’s syndrome) in connection with the use of drugs from the NSAID group were extremely rare. The greatest risk of these severe reactions occurs at the beginning of therapy, in most cases in the first month of the drug. If the first symptoms occur: skin rash, damage to the mucous membrane or other symptoms of hypersensitivity, the drug should be discontinued. In some rare cases, severe skin infections and soft tissue infections are possible as complications of chickenpox. At present, the influence of drugs from the NSAID group on the intensification of these infections cannot be excluded. In view of this, it is recommended to avoid the use of Ibufen® D in patients with chickenpox. Ibufen® D belongs to a group of drugs (non-steroidal anti-inflammatory and antirheumatic drugs) that can have a negative effect on fertility in women. This effect is transient and disappears after the end of treatment. When using ibuprofen, isolated cases of toxic amblyopia (deterioration of visual acuity) were noted, so any visual disorder should be reported to the doctor. As a result of prolonged use of analgesics, headaches may occur, which should not be treated with higher doses of ibuprofen. Information on excipients that are important for the safe and effective use of the medicinal product Suspension contains maltitol. The drug should not be prescribed to patients with rare genetic fructose intolerance. The suspension also contains sodium benzoate. Therefore, it should be used with caution in patients with hypersensitivity, especially in children with atopic changes, asthma, etc. Use during pregnancy and lactation If the patient is pregnant, breastfeeding, suspects that she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using the drug. Pregnancy During the first 6 months of pregnancy, the use of the drug is not recommended. In the third trimester of pregnancy, the drug should not be taken, as this may increase the risk of complications in the mother and child in the perinatal period. Breastfeeding Small amounts of ibuprofen are excreted in the milk of nursing mothers. There are no known cases of adverse effects in breastfed infants. Therefore, there is no need to stop breastfeeding during short-term treatment with ibuprofen. Influence on the ability to drive vehicles and maintain mechanisms Due to the fact that when using the drug Ibufen® D in high doses, side effects from the central nervous system, such as fatigue and dizziness, may be observed, in isolated cases, the speed of the psychomotor reaction and the ability to driving a vehicle or operating machinery. This information is of particular importance in the case of taking the drug with alcohol. Interaction with other drugs and other types of interaction The doctor or pharmacist should be informed about all drugs currently or recently used, as well as the drugs that the patient plans to use. In particular, tell your doctor if you are taking: acetylsalicylic acid or other NSAIDs, including selective cyclooxygenase-2 inhibitors antihypertensive drugs diuretics (such as furosemide) anticoagulants (such as warfarin) lithium (used for mental illness) methotrexate (used for cancer) zidovudine (an antiviral drug) corticosteroids antiplatelet drugs and selective serotonin reuptake inhibitors (SSRIs) cardiac glycosides (such as digoxin) cyclosporine (an immunosuppressive drug) mifepristone (a hormonal drug used in gynecology) tacrolimus (an immunosuppressive drug used in transplant patients) ) quinolones (for example, ciprofloxacin). Method of application and dosage Ibufen® D should always be used in accordance with the recommendations of a physician. In case of doubt, a doctor should be consulted. For oral use. 5 ml suspension contains 100 mg ibuprofen. Shake before use until a homogeneous suspension is obtained. The drug is taken after meals, with plenty of liquid. The dose is set depending on the age and body weight of the child. A single dose of Ibufen® D is 5-10 mg/kg of the child’s body weight 3-4 times a day. The maximum daily dose of the suspension is 20-30 mg/kg of body weight. The drug is prescribed in single doses according to the scheme below: Infants from 3 to 6 months (5-7.6 kg): 2.5 ml 3 times a day (corresponding to 150 mg ibuprofen per day). Infants from 6 to 12 months (7.7-9 kg): 2.5 ml 3 to 4 times a day (corresponding to 150-200 mg of ibuprofen per day). Children from 1 to 3 years (10-15 kg): 3 times 5 ml during the day (corresponding to 300 mg of ibuprofen per day). Children from 4 to 6 years (16-20 kg): 7.5 ml 3 times a day (corresponding to 450 mg of ibuprofen per day). Children from 7 to 9 years old (21-29 kg): 10 ml 3 times a day (corresponding to 600 mg of ibuprofen per day). Children from 10 to 12 years old (30-40 kg): 15 ml 3 times a day (corresponding to 900 mg of ibuprofen per day). Special patient groups: Juvenile rheumatoid arthritis in children: usually 30-40/mg/kg/day, in 3-4 divided doses. Post-vaccination fever: one dose of 2.5 ml. If necessary, another dose of 2.5 ml after 6 hours. Patients with impaired renal function: in patients with mild to moderate impaired renal function, there is no need to reduce the dose. Patients with impaired liver function: in patients with mild to moderate hepatic impairment, there is no need to reduce the dose. The dose can be repeated every 6-8 hours, with an interval of at least 4 hours between successive doses. Do not use a double dose to compensate for the missed one! If symptoms persist or worsen in children aged 3 to 5 months after taking the drug for 24 hours, you should consult a doctor. If, while taking the drug in a child from 6 months to 12 years, the symptoms persist for more than 3 days, you should consult a doctor. Children under 6 months of age can use the drug after consulting a doctor in accordance with his recommendations. Do not exceed the recommended dose. The drug is intended for short-term therapy. If symptoms persist or worsen, a doctor should be consulted. Instructions for using the dispenser in the form of a syringe1. Unscrew the cap from the vial (press, pushing down and turn counterclockwise). 2. Press the dispenser firmly into the opening of the bottle neck. 3. Shake the vial vigorously. 4. To fill the dispenser, the bottle must be turned upside down, and then carefully move the dispenser piston down, pour the contents until the desired mark on the scale is reached. 5. Turn the bottle upside down and remove the dispenser from it by carefully unscrewing it. 6. Place the tip of the dispenser in the child’s mouth, and then, slowly pressing the piston, introduce the contents of the dispenser. 7. After use, the bottle should be closed by screwing the cap, and the dispenser should be rinsed with water and dried. If during treatment it seems to the patient that the effect of the drug is too strong or weak, he should consult a doctor. Overdose Cases of drug overdose are rare, but if too large a dose of the drug is accidentally taken, you should immediately consult a doctor. Most patients may experience: nausea, vomiting, abdominal pain or diarrhea, tinnitus, headache, and bleeding from the gastrointestinal tract. Severe poisoning affects the central nervous system and is manifested by: drowsiness, very rarely, agitation, disorientation or coma, the appearance of convulsions. During long-term use may appear: metabolic acidosis increased prothrombin time / INR acute renal failure or liver damage in patients with bronchial asthma, exacerbation of symptoms of the disease may occur. There is no specific antidote. Apply symptomatic and supportive treatment. The doctor must weigh the advisability of administering activated charcoal within 1 hour after an overdose of the drug. Side effects Like all medicines, Ibufen® D can have side effects, although not everyone gets them. The list of these side effects contains all the undesirable effects observed during treatment with ibuprofen, as well as those observed during long-term high dose therapy used in patients with rheumatic disease. The indicated frequency of occurrence, which goes beyond very rare reports, concerns the short-term use of daily doses up to a maximum dose of 1200 mg of ibuprofen in oral form and up to a maximum dose of 1800 mg in the form of suppositories. In relation to the following adverse reactions of the drug, it should be borne in mind that in most cases the reactions depend on the dose and their manifestation is individual. The most commonly reported adverse reactions are from the gastrointestinal tract. Gastric ulcers, perforation or gastrointestinal bleeding may occur, in some cases fatal, especially in the elderly. The following symptoms have been described after ibuprofen use: nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, tarry stools, hematemesis, ulcerative stomatitis, exacerbation of non-specific ulcerative colitis and Crohn’s disease. Infrequently observed gastritis. The risk of bleeding from the gastrointestinal tract is particularly dependent on the dosage range and the period of use of the drug. In connection with the treatment of NSAIDs, edema, arterial hypertension and heart failure have been reported. Based on clinical and epidemiological data, it has been established that the use of ibuprofen, especially long-term and high doses (2400 mg per day), may be associated with a slight increase in the risk of arterial embolism (for example, myocardial infarction or stroke). It should be noted that in each group, the frequency of manifestations and side effects are presented in order of decreasing severity: very often (≥1/10), often (≥1/100 to <1/10), infrequently (≥1/1000 to <1 /100), rarely (≥1/10,000 to <1/1,000), very rare (<1/10,000) Infections and parasitic infestations Very rare: exacerbations associated with infection of inflammatory conditions (eg, necrotizing fasciitis) have been described when using non-steroidal anti-inflammatory drugs. Perhaps this is due to the mechanism of action of non-steroidal anti-inflammatory drugs. If during the use of ibuprofen symptoms of infection appear or increase, the patient should immediately consult a doctor. It should be assessed whether there are indications for the use of anti-infective treatment (antibiotic therapy). During the period of ibuprofen use, symptoms of aseptic meningitis were noted with neck stiffness, nausea, vomiting, headache, fever, or confusion. It is possible that patients with autoimmune disorders (systemic lupus erythematosus, mixed connective tissue disease) are predisposed to this. Blood and lymphatic system disorders Very rare: changes in blood morphological parameters (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first signs may be: fever, sore throat, superficial ulcers of the oral mucosa, flu-like symptoms, severe fatigue, epistaxis, skin hemorrhages. During long-term treatment, blood morphological parameters should be regularly monitored. Immune system disorders Uncommon: hypersensitivity reactions with skin rashes and itching, also asthma attacks (also appearing in combination with a drop in blood pressure). If these hypersensitivity reactions occur, you should immediately consult a doctor and do not take Ibufen® D. Very rarely: severe, systemic hypersensitivity reactions. They can appear in the form of swelling of the face, tongue, larynx with impaired airway patency, tachycardia, a drop in blood pressure up to and including life-threatening shock. If one of these symptoms appears, which may occur even after the first use of the drug, it is necessary to provide immediate medical attention. Psychiatric disorders Very rare: psychotic disorders, depression. Nervous system disorders Uncommon: Nervous system disorders such as headache, dizziness, insomnia, agitation, irritability or fatigue. On the part of the organ of vision Infrequently: visual disturbances. Hearing and vestibular disorders Rare: tinnitus. Cardiac disorders Very rare: palpitations, heart failure, myocardial infarction, stroke. Vascular disorders Very rare: arterial hypertension. Gastrointestinal disorders Common: Stomach and intestinal symptoms such as: heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation and minor bleeding, which in exceptional cases can lead to anemia. Uncommon: Gastrointestinal ulceration, potentially with bleeding and perforation. Ulcerative stomatitis, exacerbation of colitis and Crohn's disease, gastritis. Very rarely: esophagitis, pancreatitis, formation of diaphragm-like narrowing of the intestine. In the event of acute pain in the epigastric region, tarry stools or hematemesis, stop taking the drug and consult a doctor immediately. Liver and biliary tract disorders Very rare: abnormal liver function, liver damage, especially after long-term treatment, liver failure, acute hepatitis. Skin and subcutaneous tissue disorders Very rare: bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. In exceptional cases, chickenpox can cause serious infectious complications of the skin and soft tissues (see also "Infections and parasitic infestations"). Renal and urinary tract disorders Rare: very rarely, damage to the tissues of the kidney (necrosis of the renal papillae) and an increase in the concentration of uric acid in the blood can occur. Very rarely: the appearance of edema, especially in patients with hypertension or kidney failure, nephrotic syndrome, interstitial nephritis, which may be accompanied by acute renal failure. In this regard, kidney function should be monitored regularly. If you experience any of the above or other adverse events not listed in this package leaflet, you should inform your doctor about them. Storage conditions Store in the original packaging to protect from light, at temperatures below 25°C. Keep out of the reach of children. Medicines must not be flushed down the drain or thrown into the wastebasket. You should ask the pharmacist what to do with unused medicines. This is important for environmental protection. Shelf life 3 years. An opened vial must be used within 6 months. Do not use after the expiry date stated on the packaging. Expiration date means the last day of the specified month. Terms of sale Without a prescription. Buy Ibufen D oral suspension 100mg/5ml 120ml №1 Price for Ibufen D oral suspension 100mg/5ml 120ml №1