Side effects
The drug rarely causes allergic reactions, gastrointestinal discomfort, dizziness, thrombocytopenia. Long-term use can cause impaired renal and liver function, as well as attacks of bronchial asthma. If you suddenly stop taking the drug, withdrawal symptoms may appear, in this case headache predominates. With long-term use of large doses, resistance to some of the drug's effects may occur.
When taken, the following side effects may occur.
From the nervous system and sensory organs: drowsiness, poor coordination of movements, fatigue, tremor, anxiety, irritability, headache.
From the cardiovascular system and blood (hematopoiesis, hemostasis): hypotension, tachycardia, extrasystole, very rarely - hemolytic anemia, thrombocytopenia, agranulocytosis.
From the gastrointestinal tract: dry mouth, anorexia, nausea, vomiting, epigastric pain, diarrhea or constipation, impaired liver function.
Other: bronchospasm, renal dysfunction.
Sedalgin-Neo tablets No. 10x1
Name
Sedalgin-Neo tablets in sheets in pack No. 10x1
Description
Round flat tablets with a bevel, a score on one side, with a diameter of 13 mm, from white to almost white.
Main active ingredient
Codeine+caffeine+metamizole sodium+phenobarbital+paracetamol
Release form
Pills
special instructions
This medicine is suitable for people with celiac disease (celiac disease). Patients with a wheat allergy (other than celiac disease) should not take this drug. Contained as an excipient, sodium metabisulfite can cause allergic-type reactions, including anaphylactic symptoms in sensitive patients and bronchospasm.
pharmachologic effect
Sedalgin-neo is a combined drug with a clear analgesic and antipyretic effect. In combination, the analgesic effect of the individual components is enhanced, and side effects and the possibility of developing addiction are reduced as a result of the use of smaller doses of the components included in the drug. The combination also exhibits the following effects: some relaxing effect on the smooth muscles of the biliary and urinary tract and uterus; sedative (calming) effect on the central nervous system; a beneficial effect on the blood vessels of the brain and a decrease in intracranial pressure (headache decreases). Caffeine reduces the sedative effects of the other components, and the combination as a whole does not significantly impair performance. Codeine has a clear antitussive effect and enhances the analgesic effect of metamizole and paracetamol.
Indications for use
Sedalgin-neo is used for short-term and symptomatic treatment of pain of various origins that is difficult to treat when individual components are used independently:
- headache, migraine, toothache;
- pain after injuries, operations and burns;
- neuralgia and neuritis, acute pain in joints and muscles;
- pain syndrome in cancer patients.
Directions for use and doses
Always use Sedalgin-neo according to the instructions in this leaflet. If you are unsure about anything, ask your doctor or pharmacist. The drug is taken orally. Usually take one tablet 3-4 times a day. The maximum single dose is 2 tablets, and the maximum daily dose is 6 tablets. The course of treatment lasts no more than 3 days. The tablets are taken during meals with liquid. Children and teenagers The drug is not suitable for children and teenagers! If you miss a dose Do not take double the dose to make up for the missed dose. Do this at your next regular appointment. If you have any additional questions about the use of this medicine, please contact your doctor or pharmacist.
Use during pregnancy and lactation
The active ingredients may cause harm to the fetus when used during pregnancy. They pass into breast milk. For these reasons, Sedalgin-neo is not used during pregnancy and lactation. If a breastfeeding woman is a CYP2D6 “ultra-rapid” metabolizer, higher concentrations of the active metabolite morphine may be present in breast milk and, in very rare cases, this may result in symptoms of opioid toxicity in the infant, which can be fatal.
Impact on the ability to drive vehicles and operate equipment
Most of the components of Sedalgin-neo affect the central nervous system, change sensory and motor reactions, therefore, during treatment with this drug, it is recommended to temporarily refrain from driving a car and working with equipment, or do this with increased attention.
Precautionary measures
Talk to your doctor or pharmacist before taking Sedalgin-neo if: You are allergic to metamizole. Patients who have ever had an allergic reaction to metamizole should not take it again. You are taking other medications that contain metamizole because of the risk of overdose and serious liver damage. You have a peptic ulcer in the active stage. You have kidney or liver damage. You are over 65 years old, due to an increased risk of intoxication. You often use painkillers. Frequent use of pain medications can cause permanent kidney damage and increase the risk of developing kidney failure. “Aspirin” asthma, bronchial asthma in combination with rhinosinusitis and nasal polyps, chronic urticaria, alcohol intolerance. If you have frequent headaches and regular use of painkillers does not help, contact your doctor. To prevent the possible development of chronic headaches, recommended daily doses of pain medications should be closely monitored and significant monthly use of migraine medications should be avoided. The use of the drug should be stopped immediately if there are symptoms of anaphylaxis (sudden severe allergic reaction with skin rash, suffocation, complaints from the gastrointestinal tract and cardiovascular system) and agranulocytosis (sharp decrease in granulocytes - a type of white blood cells, fever, development of infections ). With frequent and long-term use of Sedalgin-neo, monitoring of the blood picture and indicators of kidney and liver function is necessary. Metamizole contained in Sedalgin-neo can turn urine red, which has no clinical significance. Metamizole in the drug may cause hypotensive reactions. In patients with severe coronary artery disease or cerebral artery stenosis, the use of the drug is possible with careful hemodynamic monitoring. With prolonged use of Sedalgin-neo, it is possible to develop dependence and addiction to the codeine it contains. Some people who are metabolizers (called "extra-rapid" metabolizers) may experience symptoms of codeine overdose, such as confusion, drowsiness, shallow breathing, constricted pupils, nausea, vomiting, diarrhea, and loss of appetite, even at recommended doses. In more severe cases, there may be symptoms of poor circulation and respiratory depression, which can be life-threatening and very rarely fatal.
Interaction with other drugs
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even those without a prescription. The components of the combination interfere with the metabolism (absorption) of many drugs, so combined use with other medications should be avoided. Tell your doctor if you are taking any of the following medications: coumarin anticoagulants; cyclosporine (for immune suppression); tricyclic antidepressants; oral contraceptives; allopurinol (against gout); chloramphenicol and other drugs that damage the bone marrow due to increased myelotoxicity (suppression of bone marrow function); aminophenazone (against pain and fever); anti-tuberculosis antibiotic rifampicin; cimetidine (for stomach protection); alcohol and other drugs that damage the liver; barbiturates, benzodiazepines, sleeping pills and sedatives; MAO inhibitors; anticholinergics; non-steroidal anti-inflammatory drugs (such as ketoprofen, ibuprofen, naproxen, diclofenac); griseofulvin (anti-fungus); quinidine (antiarrhythmic drug); doxycycline (antibiotic); estrogens (female sex hormones); phenytoin, carbamazepine (anticonvulsants); phenothiazine (a medicine that affects the psyche); very strong painkillers (narcotic analgesics); sodium valproate and valproic acid. Special instructions for certain groups of patients Use in people with impaired liver or kidney function Before taking any medicine, consult your doctor or pharmacist. In patients with impaired liver and kidney function, Sedalgin-neo should be used with caution. The drug is contraindicated in severe renal and liver failure.
Contraindications
Do not use Sedalgin-neo: if you are allergic (hypersensitivity) to any active or excipient in the drug; if you have any blood diseases (hemorrhagic diathesis, aplastic anemia, leukopenia or agranulocytosis); if you have bronchial AS type); if you have bronchospasm, urticaria and other allergic reactions to salicylates, other narcotic analgesics and NSAIDs, a history of exfoliative dermatitis; in the presence of some rare diseases associated with metabolism (hereditary deficiency of glucose-6-phosphate dehydrogenase, liver porphyria); with severe renal and liver failure; with abuse of narcotic analgesics, sleeping pills and sedatives; during pregnancy; during breastfeeding; if your doctor has told you that you are a CYP2D6 “extra-rapid metabolizer”; in childhood.
Compound
Active ingredients in one tablet: paracetamol 300 mg, metamizole sodium monohydrate 150 mg, caffeine 50 mg, phenobarbital 15 mg, codeine phosphate hemihydrate 10 mg. Excipients: microcrystalline cellulose, wheat starch, povidone, crospovidone, sodium metabisulfite, talc, magnesium stearate.
Overdose
If you take a higher dose than prescribed, consult your doctor immediately! In case of overdose, some of the following symptoms may occur: depression of the central nervous system, expressed by dizziness, drowsiness, slow reactions, suppressed breathing, severe weakness to the point of loss of consciousness, slow pulse, low blood pressure, serious damage to liver function.
Side effect
Like any medicine, Sedalgin-neo can cause side effects, although not everyone gets them. Most often, side effects are temporary and go away when treatment is stopped. The following reactions are possible in some patients: immune system disorders increased risk of anaphylaxis (severe, life-threatening allergic reaction) and agranulocytosis (decreased number of white blood cells with a tendency to infection), which can occur at any stage of treatment and is not dependent on the daily dose; allergic reactions: itching, skin rashes, provoking an asthma attack, dyspnea (suffocation). from the gastrointestinal tract - dry mouth, abdominal pain, nausea, vomiting, constipation or diarrhea, increased liver transaminases. from the nervous system - drowsiness, fatigue, loss of coordination, tremor, anxiety, irritability; with longer use - the development of dependence. from the cardiovascular system - decreased blood pressure, palpitations, extrasystole (uneven pulse). from the kidneys and urinary tract - with prolonged use in high doses, kidney damage is possible (interstitial nephritis, development of renal failure). from the hematopoietic and lymphatic systems - in very rare cases, hemolytic anemia (a decrease in the number of red blood cells, which can lead to pale or yellowing of the skin, weakness, shortness of breath), thrombocytopenia (a decrease in the number of platelets, which increases the risk of bleeding and bruising Phenobarbital may cause exfoliative dermatitis (toxic epidermal necrolysis, Stevens-Johnson syndrome).If any of the side effects become serious, or you experience other side effects not listed in this leaflet, tell your doctor. or your pharmacist. This includes all possible adverse reactions not listed in this leaflet.
Storage conditions
At a temperature not higher than 25°C. Keep out of the reach of children! Shelf life: 3 (three) years. The drug should not be used after the expiration date indicated on the package!
Precautionary measures
With long-term use, monitoring of the blood picture, liver and kidney function is necessary.
During treatment, you should avoid drinking alcohol (tolerance to alcohol decreases).
Most of the components act on the central nervous system, slowing down psychomotor reactions, so it is not recommended to take the drug while working for vehicle drivers and people whose profession is associated with increased concentration.
When taken, urine may turn red.
Interaction
Anxiolytics, sedatives and all medications that depress the functioning of the nervous system can lead to increased sedative effect of Sedalgin Neo and depression of the respiratory center (a life-threatening condition). The drug enhances the effect of alcohol-containing drinks on psychomotor reactions. Metamizole displaces hypoglycemic drugs, indirect anticoagulants, indomethacin, and glucocorticosteroids from binding to proteins, increasing their activity. Oral contraceptives , antidepressants and Allopurinol increase the toxicity of Metamizole Na by changing its metabolism in the hepatic system. The effect of the active component is reduced when taking inducers of microsomal liver enzymes. An increase in toxic effect is observed during treatment with other non-narcotic analgesics.
