Instructions for use SEDALGIN-NEO (SEDALGIN-NEO)

To date, pharmaceutical companies have developed many drugs that have powerful analgesic and antipyretic effects. “Sedalgin Plus” is considered the most popular and inexpensive. Before using the medicine for treatment, you must read the description of the drug.

pharmachologic effect

The medication has anti-inflammatory, analgesic and antipyretic effects.

Metamizole sodium has a mild anti-inflammatory effect and has an analgesic effect. The mechanism of action is based on the ability of the pyrazolone derivative to inhibit the process of prostaglandin synthesis through inhibition of cyclooxygenase.

Caffeine has a stimulating effect on the nervous system, activating the vasomotor center, cerebral cortex and respiratory center. The active component reduces the severity of feelings of fatigue and drowsiness, increases physical and mental performance. Caffeine enhances the therapeutic effect of non-narcotic analgesics, increasing their bioavailability and increasing the permeability of histohematic barriers.

Thiamine has a beneficial effect on nerve-reflex conductivity and improves metabolism. Also known as vitamin B1.

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!

Pharmacodynamics and pharmacokinetics

The indicators depend on the components that make up the medication.

Metamizole Na is completely absorbed from the digestive tract in a fairly short period of time. The maximum concentration is recorded 1-1.5 hours after administration. The active component binds to plasma proteins and is metabolized in the hepatic system. with bile , 90% through the renal system. The half-life is approximately 10 hours.

Caffeine is almost completely absorbed from the digestive tract. The maximum level of the active component is observed after 30-40 minutes. Caffeine can pass into breast milk and cross the blood-brain barrier . Metabolites are excreted unchanged through the renal system.

For thiamine, after oral administration, absorption reaches high levels and occurs in the lumen of the small intestine. Digestive enzymes release thiamine hydrochloride from its bound state before absorption. The level of thiamine in the blood is quite low. Only free thiamine can be found in plasma, and its phosphorus esters are found in blood cells: leukocytes and erythrocytes . 40% of thiamine can be found in internal organs, and more than 50% in striated muscles. The phosphorylation process takes place in the liver tissue. Thiamine diphosphate has coenzyme activity and is the most active phosphorus ester. Accumulates in the kidneys, heart muscle, liver tissue, spleen, and brain. It is excreted through the renal system, partly through the intestines.

Who should not take the medicine?

"Sedalgin Plus" has quite a lot of contraindications. First of all, those patients who have been diagnosed with intolerance to the active components are not allowed to take it. In addition, the use of the drug is not recommended for the following pathologies:

• problems with the gastrointestinal system;
• dysfunction of hematopoiesis;
• renal, liver failure;
• myocardial infarction;

• atherosclerosis of large vessels;
• ischemia of the brain and heart;
• hypertension;
• high intraocular pressure;
• anemia.

During pregnancy, the use of the medicine is possible only after consultation with a doctor, weighing the possible risks for the fetus and benefits for the mother.

Since the drug passes into breast milk, its use during lactation is prohibited.

Taking the medicine by children under 12 years of age is strictly prohibited.

Indications for use

What is Sedalgin Plus prescribed for? Mainly for pain with:

• dysmenorrhea;
• neuralgia;
• migraine;
• polyneuropathy;
• plexite;
• inflammatory diseases of the musculoskeletal system;
• degenerative pathology of muscle tissue;
• toothache;
• radicular syndrome;
• after surgical interventions.

Contraindications

• thrombocytopenia;
• anemia;
• leukopenia;
• individual hypersensitivity;
• pronounced atherosclerotic changes ;
• hepatic porphyria;
• breast-feeding;
• suspicion of acute surgical pathology;
• intolerance to NSAIDs;
• ulcerative pathology of the gastrointestinal tract;
• sleep disorders;
• carrying a pregnancy ;
• pathological excitability;
• pathology of the hepatic system;
• bronchial asthma;
• glaucoma;
• simultaneous treatment with MAO inhibitors;
• hypertonic disease;
• kidney diseases.

The combined agent is prescribed with caution for:

• achalasia;
• IHD;
• arrhythmias;
• stenosis of the pyloric part of the digestive system;
• hyperplastic changes in prostate tissue;
• bronchospastic reactions;
• hyperthyroidism;
• heart failure (congestive);
• taking medications that depress the functioning of the nervous system;
• gastroesophageal reflux.

Side effects

Hematopoietic system:

• purpura;
• leukopenia;
• thrombocytopenia (decreased platelet );
• hemolytic form of anemia;
• agranulocytosis.

Digestive tract:

• jaundice;
• vomit;
• loss of appetite;
• cholestasis;
• nausea.

Nervous system:

• increased excitability;
• dizziness;
• insomnia.

The cardiovascular system:

• rhythm disturbances;
• feeling of rapid heartbeat.

Allergic responses:

• redness;
• itchy skin;
• anaphylactic shock;
• Quincke's edema;
• bronchospasm.

If other negative reactions occur, the patient should consult a doctor and stop taking Sedalgin Plus.

Directions for use, dosage features

Take Sedalgin Plus orally after meals with the required amount of clean water. The average dosage for adults is 3 tablets per day. For acute pain syndromes, it is allowed to increase the dose to 6 tablets. Children 12-16 years old can take ? tablets 2-3 times a day.

To relieve pain, the drug can be taken for no longer than 5 days; when fighting fever, only 3 days. At the maximum dosage, treatment should not exceed two days.

Overdose

Manifests itself as rashes on the skin. Less commonly recorded are tremors of the limbs , anaphylactic shock, hallucinations , and a clinical picture similar to Meniere's disease. Significantly exceeding recommended dosages can lead to loss of consciousness and serious changes in the heart, nervous system, and blood. It is necessary to cleanse the stomach and intestines of drug residues, prescribe sorbents , and carry out syndromic treatment. A specific antidote for Sedalgin Plus has not been developed. When hemorrhagic gastritis , the stomach is washed with a cold solution of NA chloride (0.9%) and antacids are administered. If necessary, oxygenation is provided and ventilation of the lungs is supported. For epileptic seizures, Phenytoin and Diazepam are administered intravenously. It is important to maintain the level of fluids and salts at the required level.

Exceeding the daily dose

An overdose of the described drug may be accompanied by other unpleasant symptoms. In case of accidental ingestion of a large number of tablets, the following were recorded:

• severe headaches;
• tinnitus;

• feeling of fear, anxiety;
• migraine;
• nausea, vomiting;
• dyspeptic pain;
• tremor, mental excitability;
• convulsions;
• dysuria;
• dehydration.

In case of overdose, you must immediately contact a medical facility. There is no specific antidote. First aid is based on gastric lavage and taking enterosorbent.

Interaction

Metamizole sodium can enhance the toxic effect of other medications. Medicines that increase the toxicity of Sedalgin Plus and disrupt the metabolism of its components:

• Allopurinol;
• antidepressants (tricyclics);
• oral contraceptives.

Inducers of microsomal enzymes (Butadione, barbiturates) weaken the effect of the drug. Metamizole sodium can reduce the level of Cyclosporine in the blood. The analgesic effect of Sedalgin Plus is enhanced when taking tranquilizers and other sedatives.

Medicines with similar effects

In some cases, when taking Sedalgin Plus cannot be permitted, it is necessary to replace the drug with an analogue. Among modern painkillers that are similar in action, we can highlight:

Most often, drug replacement is required in childhood, since taking Sedalgin Plus is prohibited for children under 12 years of age. In this case, you should not choose painkillers on your own; medical consultation is necessary. If there is no effect from therapy, you must contact a medical institution.

Analogs

Level 4 ATC code matches:
Analdim

Reopirin

Tempalgin

Spazgan

Benalgin

Pentalgin ICN

Pentalgin N

Pentalgin

Analgin

Renalgan

Tetralgin

Spasmalin

Maxigan

Sedal-M

Piralgin

Baralgin M

Baralgetas

Revalgin

Andipal

• Benalgin
• Baralgin
• Baralgetas
• Pentalgin