Ibufen D suspension for oral administration 100 mg/5 ml 120 ml No. 1
Name
Ibufen d.
Release form
Suspension for oral administration.
Dosage
100 mg / 5 ml 120 ml. Packing quantity: 1 pc.
Manufacturer
Medana Pharma S.A.
INN
Ibuprofen.
FTG
Npvp.
Description
A suspension of white or almost white color with an orange odor.
Compound
5 ml of suspension contain: 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 group
Nonsteroidal anti-inflammatory and antirheumatic drugs. Propionic acid derivatives.
Pharmacological properties
Ibuprofen is a propionic acid derivative that has analgesic, antipyretic and anti-inflammatory effects. The mechanism of the anti-inflammatory effect 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 into 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 of taking the drug. Ibufen® D does not contain sugar or dyes.
Indications for use
• Fever of various origins (also with viral infections and post-vaccination reactions) • Pain of various origins of weak and moderate intensity with: - headache, sore throat and muscles, eg. for viral infections - pain in muscles, joints as a result of injuries to the musculoskeletal system (overexertion, 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 to any of the excipients listed in the “Composition” section. A 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). Peptic ulcer of the stomach and (or) duodenum in the present or in the past (two or more confirmed episodes of peptic ulcer or ulcer bleeding) with perforation or bleeding, also associated with previously prescribed NSAID therapy. Severe liver failure, severe renal failure. Severe heart failure (NYHA class IV). Cerebrovascular or other bleeding. Hemorrhagic diathesis or disorders of the hematopoietic system of unknown origin. Severe dehydration (due to vomiting, diarrhea, or insufficient fluid intake). III trimester of pregnancy.
Cautions for use
When using the drug, caution should be exercised in patients with: • systemic lupus erythematosus and mixed connective tissue disease • gastrointestinal diseases, as well as chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease) • hypertension and (or) heart failure • renal failure • insufficiency liver • a blood clotting disorder (ibuprofen may prolong bleeding time) • an inherited disorder of porphyrin metabolism (eg, acute intermittent porphyria) • immediately after surgery. Taking the drug at the recommended dose as soon as possible to reduce symptoms reduces the risk of side effects (see below: effects on the gastrointestinal tract and circulatory system). The incidence and intensity of side effects can be reduced by using the minimum therapeutic dose over a shorter period of use. Taking the drug in persons with bronchial asthma and other allergic diseases in the active stage or a history can cause bronchospasm. There is a risk of gastrointestinal bleeding, ulceration or perforation; in case of gastrointestinal bleeding or ulceration, the drug should be stopped immediately. Patients with a history of gastrointestinal diseases 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 taking other drugs that potentially increase the risk of gastrointestinal problems or bleeding, such as corticosteroids and antithrombotics such as warfarin or antiplatelet drugs such as acetylsalicylic acid.Taking anti-inflammatory/pain-relieving drugs such as ibuprofen may 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 dose and duration of treatment. You should discuss treatment with your doctor or pharmacist before taking Ibufen® D if the patient: - has heart problems, including heart failure, angina (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 artery disease (poor circulation in the feet due to narrowed or blocked arteries); - family members have high blood pressure, diabetes, high blood cholesterol, heart disease or stroke, or if the patient smokes. Simultaneous long-term use of different analgesic drugs can lead to kidney damage and the risk of renal failure (postanalgesic 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 teenagers who are dehydrated 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) have been reported extremely rarely in association with the use of NSAID drugs. The greatest risk of these severe reactions occurs at the beginning of therapy, in most cases in the first month of using 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 and soft tissue infections are possible as complications of chickenpox. At present, it is impossible to exclude the influence of drugs from the NSAID group on the intensification of these infections. 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 anti-rheumatic 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) have been noted, so you should inform your doctor about any visual disturbance. Long-term use of analgesics may result in headaches that 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 The suspension contains maltitol. The drug should not be prescribed to patients with rare genetic fructose intolerance. The suspension also contains sodium benzoate. In this regard, it should be used with caution in patients with hypersensitivity, especially in children with atopic changes, asthma, etc. Use during pregnancy and breastfeeding If the patient is pregnant, breastfeeding, suspects that she may be pregnant, or is planning a pregnancy, 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, you should not take the drug, as this may increase the risk of complications in the mother and child during the perinatal period. Breastfeeding Ibuprofen is excreted in small quantities into 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. Effect on the ability to drive vehicles and operate machinery 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 psychomotor reaction and ability may deteriorate. to driving a vehicle or servicing moving machinery. This information is of particular importance if the drug is taken with alcohol. Interactions with other medicinal products and other types of interactions The doctor or pharmacist should be informed of all medications currently or recently used, as well as medications that the patient plans to use. It is especially important to tell your doctor if you are taking: • acetylsalicylic acid or other NSAIDs, including selective cyclooxygenase-2 inhibitors • antihypertensive drugs • diuretics (for example, furosemide) • anticoagulants (for example, warfarin) • lithium (used for mental illness) • methotrexate ( used in cancer) • zidovudine (an antiviral drug) • corticosteroids • antiplatelet drugs and selective serotonin reuptake inhibitors (SSRIs) • cardiac glycosides (eg digoxin) • cyclosporine (immunosuppressive drug) • mifepristone (a hormonal drug used in gynecology) • tacrolimus (an immunosuppressive drug used in transplant patients) • quinolones (eg, ciprofloxacin). Directions for use and dosage: Ibufen® D should always be used in accordance with your doctor's recommendations. If in doubt, consult a doctor. For oral use. 5 ml of suspension contain 100 mg of ibuprofen. Before use, shake until a homogeneous suspension is obtained. The medicine 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 body weight. The drug is prescribed in single doses according to the scheme below: Infants from 3 to 6 months (5-7.6 kg): 3 times 2.5 ml per day (which corresponds to 150 mg of ibuprofen per day). Infants from 6 to 12 months (7.7-9 kg): 3 to 4 times 2.5 ml per day (which corresponds to 150-200 mg of ibuprofen per day). Children from 1 year to 3 years (10-15 kg): 3 times 5 ml per day (which corresponds to 300 mg of ibuprofen per day). Children from 4 to 6 years old (16-20 kg): 3 times 7.5 ml during the day (which corresponds to 450 mg of ibuprofen per day). Children from 7 to 9 years old (21-29 kg): 3 times 10 ml per day (which corresponds to 600 mg of ibuprofen per day). Children from 10 to 12 years old (30-40 kg): 3 times 15 ml per day (which corresponds to 900 mg of ibuprofen per day). Special groups of patients: 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 renal impairment: There is no need to reduce the dose in patients with mild to moderate renal impairment. Patients with hepatic impairment: There is no need to reduce the dose in patients with mild to moderate hepatic impairment. The dose can be repeated every 6-8 hours, maintaining an interval of at least 4 hours between subsequent doses. Do not take a double dose to compensate for a missed dose! If symptoms persist or worsen in children 3 to 5 months after taking the drug within 24 hours, consult a doctor. If symptoms persist for more than 3 days while taking the drug in a child aged 6 months to 12 years, you should consult a doctor. Children under 6 months can use the medicine 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, you should consult a doctor.
Instructions for use of the syringe dispenser
1. Unscrew the cap of the bottle (press downwards and turn counterclockwise). 2. Press the dispenser firmly into the opening of the bottle neck. 3. Shake the contents of the bottle vigorously. 4. To fill the dispenser, the bottle must be turned upside down, and then carefully move the dispenser piston down, pour in the contents until the desired mark is reached on the scale. 5. Turn the bottle over to its original position and remove the dispenser from it, 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 on the cap, and the dispenser should be rinsed with water and dried. If during treatment the patient feels 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 you accidentally take too much of the drug, you should immediately consult a doctor. Most patients may experience: • nausea, vomiting, abdominal pain or diarrhea • tinnitus, headache and gastrointestinal bleeding. 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, the following may occur: • metabolic acidosis • increase in prothrombin time/INR • acute renal failure or liver damage • in patients with bronchial asthma, an exacerbation of symptoms of the disease may occur. There is no specific antidote. Symptomatic and supportive treatment is used. The doctor should weigh the advisability of administering activated carbon within 1 hour after an overdose of the drug.
Side effect
Like all medicines, Ibufen® D may cause side effects, although not everyone gets them. The list of reported side effects contains all 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 reported incidence, which is beyond very rare reports, concerns 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 suppository form. 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 in nature. The most commonly observed adverse reactions are from the gastrointestinal tract. Stomach ulcers, perforation, or gastrointestinal bleeding may occur, sometimes fatal, especially in the elderly. After using ibuprofen, the following symptoms are described: nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, tarry stools, bloody vomiting, ulcerative stomatitis, exacerbation of ulcerative colitis and Crohn's disease. Gastritis has been observed infrequently. The risk of bleeding from the gastrointestinal tract depends particularly on the dosage range and period of use of the drug. Edema, hypertension and heart failure have been reported in association with NSAID treatment. Based on clinical and epidemiological data, it has been established that the use of ibuprofen, especially long-term and in 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 decreasing order of severity: very often (≥1/10), often (≥1/100 to
Storage conditions
Store in original packaging to protect from light, at temperatures below 25°C. Keep out of the reach of children. Medicines should not be flushed down the drain or thrown into the trash. You should ask your pharmacist what to do with unused medications. This is important for environmental protection.
Best before date
3 years. An opened bottle must be used within 6 months. Do not use after the expiration date stated on the package. Expiration date means the last day of the specified month.
Vacation conditions
Over the counter.
Buy Ibufen D susp.d/pr.orally 100mg/5ml in bottle. 120ml per pack. No. 1 in pharmacy
Price for Ibufen D susp.d/pr.orally 100mg/5ml in bottle. 120ml per pack. No. 1
Instructions for use for Ibufen D susp.d/orally 100mg/5ml in bottle. 120ml per pack. No. 1
Nosological classification (ICD-10)
- G43 Migraine
- J02.9 Acute pharyngitis, unspecified
- J06 Acute upper respiratory tract infections of multiple and unspecified localization
- J11 Influenza, virus not identified
- K00.7 Teething syndrome
- K08.8.0* Toothache
- M25.5 Joint pain
- M79.1 Myalgia
- M79.2 Neuralgia and neuritis, unspecified
- R50 Fever of unknown origin
- R51 Headache
- T14.3 Dislocation, sprain and damage to the capsular-ligamentous apparatus of a joint of an unspecified area of the body
- T14.9 Injury, unspecified
- T88.1 Other complications associated with immunization, not elsewhere classified
Precautionary measures
Use with caution in case of liver cirrhosis with portal hypertension, liver and/or renal failure, heart failure, nephrotic syndrome, hyperbilirubinemia, gastric and duodenal ulcers (history), gastritis, enteritis, colitis, blood diseases (leukopenia, anemia). , pregnancy (II-III trimesters), during breastfeeding. In patients with bronchial asthma or other diseases associated with bronchospasm, the risk of developing bronchospasm may be increased.
During long-term treatment, monitoring of the peripheral blood picture and the functional state of the liver and kidneys is necessary. When symptoms of gastropathy appear, careful monitoring is indicated (esophagogastroduodenoscopy, blood test with determination of hemoglobin, hematocrit, stool test for occult blood).
If there is no antipyretic effect within 2 days and no analgesic effect within 3 days, you should consult a doctor. If side effects occur, you should stop taking the drug and consult a doctor.
Overdose
Symptoms:
abdominal pain, nausea, vomiting, lethargy, headache, tinnitus, depression, drowsiness, metabolic acidosis, hemorrhagic diathesis, decreased blood pressure, acute renal failure, liver dysfunction, tachycardia, bradycardia, atrial fibrillation; convulsions, apnea and coma (especially typical for children under 5 years of age).
Treatment:
gastric lavage, administration of activated carbon, alkaline drinking, symptomatic therapy (correction of acid-base balance, blood pressure).
Pharmacokinetics
After oral administration, more than 80% is absorbed from the gastrointestinal tract. Cmax in blood plasma is achieved when taken on an empty stomach - after 45 minutes, when taken after meals after 1.5–2.5 hours. Protein binding - 90%. Slowly penetrates into the joint cavity, but in the synovial fluid it creates higher concentrations than in the blood plasma (Cmax in the synovial fluid is reached after 2–3 hours). Metabolized mainly in the liver. Subject to pre- and post-systemic metabolism. After absorption, about 60% of the pharmacologically inactive R-form is slowly transformed into the active S-form. Excreted by the kidneys (60–90% in the form of metabolites and products of their combination with glucuronic acid, to a lesser extent with bile, unchanged - no more than 1%). It has a two-phase elimination kinetics with T1/2 of 2–2.5 hours, after taking a single dose it is completely eliminated within 24 hours. The antipyretic effect of Ibufen develops after 30 minutes and lasts 6–8 hours.
pharmachologic effect
Antipyretic, analgesic, anti-inflammatory.
Blocks arachidonic acid cyclooxygenase and reduces PG synthesis. The antipyretic effect is due to a decrease in the concentration of PG in the cerebrospinal fluid, a decrease in excitation of the thermoregulation center, which results in the normalization of body temperature. The analgesic effect is associated with a decrease in the production of PG classes E, F, I, biogenic amines, a change in the sensitivity of nociceptors and the prevention of the development of hyperalgesia. The analgesic effect is most pronounced for inflammatory pain. The anti-inflammatory effect is due to a decrease in the secretion of inflammatory mediators and a decrease in the activity of the exudative and proliferative phase of the inflammatory process. The antipyretic and analgesic effect appears earlier and at lower doses than the anti-inflammatory effect, which occurs on days 5–7 of treatment.
Interaction
It should not be combined with other NSAIDs (acetylsalicylic acid reduces the anti-inflammatory effect and increases side effects). When taken simultaneously with diuretics, the diuretic effect is reduced and the risk of developing renal failure increases. Weakens the effect of antihypertensive drugs, incl. ACE inhibitors (at the same time reduces their excretion by the kidneys), beta-adrenergic agents, thiazides. Enhances the effect of oral hypoglycemic agents (especially sulfonylurea derivatives) and insulin, indirect anticoagulants, antiplatelet agents, fibrinolytics (increases the risk of hemorrhagic complications), the toxic effect of methotrexate and lithium preparations, increases the concentration of digoxin in the blood.
Inducers of microsomal oxidation (phenytoin, ethanol, barbiturates, zixorin, rifampicin, phenylbutazone, tricyclic antidepressants) increase the risk of severe hepatotoxic complications (increase the production of hydroxylated active metabolites), inhibitors of microsomal oxidation reduce it. Caffeine enhances the pain-relieving effect.
Contraindications
Hypersensitivity (including to acetylsalicylic acid or other NSAIDs), peptic ulcer of the stomach and duodenum, severe failure of the liver, kidneys, cardiovascular system, arterial hypertension, hemophilia, hypocoagulation, hemorrhagic diathesis, deficiency of glucose-6-phosphate dehydrogenase , bronchospastic reactions after the use of acetylsalicylic acid or other NSAIDs (“aspirin asthma”), Quincke’s edema, nasal polyps, hearing loss, infancy (up to 6 months, with body weight below 7 kg).
Side effects
From the side of the central nervous system:
headache, dizziness, sleep disturbance, anxiety, drowsiness, depression, agitation, visual impairment (reversible toxic amblyopia, blurred vision or double vision).
From the hematopoietic organs:
heart failure, tachycardia, increased blood pressure; anemia, thrombocytopenia, agranulocytosis, leukopenia.
From the gastrointestinal tract:
nausea, vomiting, loss of appetite, heartburn, abdominal pain, diarrhea, constipation, flatulence, liver dysfunction, peptic ulcers, gastric bleeding.
From the urinary system:
acute renal failure, allergic nephritis, nephrotic syndrome (edema), polyuria, cystitis.
Allergic reactions:
itching, rash, bronchospastic syndrome, allergic rhinitis, Quincke's edema, Steven-Johnson syndrome, Lyell's syndrome.
