Sedalgin-Neo tab. No. 10 Balkanpharma-Dupnitsa AD/Bulgaria

pharmachologic effect

The tablets have a combined composition and have antipyretic, analgesic, antimigraine and vasodilating effects. The medication is able to eliminate the symptoms of influenza , acute respiratory infections, and colds.

Caffeine stimulates brain activity, in particular psychomotor centers. The active substance increases performance (mental and physical), reduces the severity of feelings of fatigue and drowsiness , has an analeptic effect, and enhances the effect of analgesics.

Codeine has an analgesic effect by changing the emotional perception of pain, which is achieved by stimulating the antinociceptive system. Suppression of the excitability of the cough center provides an antitussive effect of central origin. Compared to Morphine, the active component is less likely to cause respiratory depression, nausea, miosis, and constipation (when opioid receptors are activated in the intestinal lumen, smooth muscle tissue relaxes, sphincter spasm decreases, and peristalsis decreases). Codeine can enhance the effect of analgesics.

Paracetamol is a non-narcotic analgesic. The mechanism of action is based on blocking cyclooxygenases-1,2 in the nervous system. The antipyretic and analgesic effect is achieved by influencing the centers of thermoregulation and pain.

Metamizole Na belongs to the group of NSAIDs. It has antipyretic and analgesic effects. An antispasmodic effect is observed on the smooth muscles of the biliary and urinary tract.

Phenobarbital has sedative, antiepileptic, muscle relaxant and hypnotic effects.

Side effects

allergic responses , thrombocytopenia (decreased number of blood cells - platelets ), dizziness are rarely observed . With long-term therapy, pathology of the kidneys and renal system may develop, and bronchial asthma attacks may become more frequent. When the medication is abruptly discontinued, withdrawal symptoms are recorded, manifested mainly by headaches . Long-term use may be accompanied by a gradual decrease in the effectiveness of the drug.

Nervous system:

• irritability;
• limb tremors;
• headache;
• fast fatiguability;
• anxiety;
• impaired coordination of movements.

The cardiovascular system:

• agranulocytosis;
• extrasystole;
• arterial hypotension;
• cardiopalmus;
• hemolytic anemia.

Digestive tract:

• constipation;
• epigastric pain;
• vomit;
• anorexia;
• dry mouth;
• diarrhea syndrome;
• changes in liver function.

Bronchospasm is rarely observed. If other negative reactions are registered, consultation with a doctor and independent discontinuation of the drug Sedalgin is required.

SEDALGIN-NEO

special instructions

Before prescribing the drug Sedalgin-Neo®, the benefit-risk ratio of its use should be carefully assessed; if the potential risk of use exceeds the expected benefit, then alternative treatment should be discussed.
Taking Sedalgin-Neo® should be stopped immediately if signs of anaphylaxis (severe allergic reactions that occur suddenly and are accompanied by skin rash, shortness of breath, gastrointestinal and cardiovascular complaints) and agranulocytosis (severe neutropenia, fever, sepsis and others) appear. signs of an infectious disease).

The drug Sedalgin-Neo® should not be taken by patients who have had hypersensitivity reactions after taking medications containing metamizole sodium.

Due to the risk of overdose, caution should be exercised when taking medications containing paracetamol at the same time.

Exceeding recommended doses may cause very serious problems with liver function. In this case, it is necessary to start treatment with an antidote as soon as possible (see section Overdose).

With long-term and frequent use of the drug, it is necessary to monitor the blood picture and indicators of renal and hepatic function.

The drug should be avoided in patients with gastric and duodenal ulcers in the acute phase, as well as in patients with severe renal and liver failure.

During treatment, you should avoid drinking alcohol due to poor tolerability of simultaneous use with the drug.

Metamizole sodium contained in the drug Sedalgin-Neo® may turn the urine red, but this has no clinical significance.

The drug Sedalgin-Neo® should be taken with caution in elderly patients due to the fact that signs of intoxication occur more often in this group of patients.

After long-term use (more than 3 months) of analgesics when taken every other day or more often, a headache may occur or an existing one may worsen. Headache caused by excessive use of analgesics should not be relieved by increasing the dose. In these cases, taking analgesics should be discontinued after consultation with your doctor.

Long-term use of the drug Sedalgin-Neo® can lead to the development of codeine addiction.

Participation of the CYP2D6 isoenzyme in metabolism:

Codeine is metabolized by the CYP2D6 isoenzyme to the active metabolite, morphine. If the patient has insufficient activity of this isoenzyme or this enzyme is absent in the body, then in this case it is impossible to achieve a sufficient analgesic effect during treatment. Presumably 7% of the Caucasian population may have insufficient activity of this isoenzyme. If a patient has a high rate of codeine metabolism, there is an increased risk of developing adverse effects of opioid toxicity, even when taking the drug in recommended doses. In this group of patients, codeine is rapidly metabolized to morphine, and morphine in the blood plasma reaches higher concentrations than in the rest of the population.

Common symptoms of opioid toxicity include: confusion, drowsiness, shallow breathing, constricted pupils, nausea, vomiting, constipation and lack of appetite. In severe cases, circulatory and respiratory collapse may develop, which can be life-threatening and, in very rare cases, fatal.

The expected frequency of high isoenzyme activity in different populations is shown below:

Use in children after surgery:

There have been reports in the literature that taking codeine after tonsillectomy and/or adenoidectomy due to sleep apnea syndrome has in rare cases resulted in life-threatening adverse events, including death. All children received codeine in recommended doses, however, there is an assumption that this group of patients had high metabolic activity, which contributed to the active conversion of codeine to morphine.

Use in children with respiratory impairment:

Codeine and codeine-containing products are not recommended for use in children with respiratory problems, including neuromuscular disorders, severe heart or respiratory disease, upper respiratory or lung infections, multiple traumas, or major surgery. These conditions may worsen symptoms of morphine toxicity.

Due to the presence of wheat starch, the drug should not be taken by patients with celiac enteropathy (a hereditary disease of the small intestine characterized by diarrhea when eating foods containing gluten).

Sodium disulfite contained as an excipient can cause allergic reactions, including anaphylactic shock in patients sensitive to this component.

The drug Sedalgin-Neo® can change the results of doping control tests for athletes.

It makes it difficult to establish a diagnosis in acute abdominal pain syndrome.

Patients suffering from atopic bronchial asthma and hay fever have an increased risk of developing hypersensitivity reactions.

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.

Sedalgin-Neo® (Sedalgin-Neo®)

Before prescribing the drug Sedalgin-Neo®, the benefit-risk ratio of its use should be carefully assessed; if the potential risk of use exceeds the expected benefit, then alternative treatment should be discussed.

Taking Sedalgin-Neo® should be stopped immediately if signs of anaphylaxis (severe allergic reactions that occur suddenly and are accompanied by skin rash, shortness of breath, gastrointestinal and cardiovascular complaints) and agranulocytosis (severe neutropenia, fever, sepsis and others) appear. signs of an infectious disease).

The drug Sedalgin-Neo® should not be taken by patients who have had hypersensitivity reactions after taking medications containing metamizole sodium.

Due to the risk of overdose, caution should be exercised when taking medications containing paracetamol at the same time.

Exceeding recommended doses may cause very serious problems with liver function. In this case, it is necessary to start treatment with an antidote as soon as possible (see section Overdose).

With long-term and frequent use of the drug, it is necessary to monitor blood parameters and indicators of renal and hepatic function.

The drug should be avoided in patients with gastric and duodenal ulcers in the acute phase, as well as in patients with severe renal and liver failure.

During treatment, you should avoid drinking alcohol due to poor tolerability of simultaneous use with the drug.

Metamizole sodium contained in the drug Sedalgin-Neo® may turn urine red, which has no clinical significance.

The drug Sedalgin-Neo® should be taken with caution in elderly patients due to the fact that signs of intoxication occur more often in this group of patients.

After long-term use (more than 3 months) of analgesics when taken every other day or more often, a headache may occur or an existing one may worsen. Headache caused by excessive use of analgesics should not be relieved by increasing the dose. In these cases, taking analgesics should be discontinued after consultation with your doctor.

Long-term use of the drug Sedalgin-Neo® can lead to the development of codeine addiction.

Risk of concomitant use of sedative medications

Concomitant use of codeine and sedative drugs, such as benzodiazepines or related drugs, may lead to sedation, respiratory depression, coma, and death. Because of these risks, coadministration of these sedatives should be limited to patients for whom alternative treatment options are not available. If a decision is made to prescribe this codeine-containing drug concomitantly with sedatives, the lowest effective dose should be used and the duration of treatment should be as short as possible.

Patients should be closely monitored for symptoms and signs of respiratory depression and sedation. In this regard, it is strongly recommended to inform patients and their caregivers about such symptoms (see section Interactions with other medicinal products).

Participation of the CYP2D6 isoenzyme in metabolism

Codeine is metabolized by the CYP2D6 isoenzyme to the active metabolite, morphine. If the patient has insufficient activity of this isoenzyme or this enzyme is absent in the body, then in this case it is impossible to achieve a sufficient analgesic effect during treatment.

Presumably 7% of the Caucasian population may have insufficient activity of this isoenzyme. If a patient has a high rate of codeine metabolism, there is an increased risk of developing adverse effects of opioid toxicity, even when taking the drug in recommended doses. In this group of patients, codeine is rapidly metabolized to morphine, and morphine in the blood plasma reaches higher concentrations than in the rest of the population.

Common symptoms of opioid toxicity include: confusion, drowsiness, shallow breathing, constricted pupils, nausea, vomiting, constipation and lack of appetite. In severe cases, circulatory and respiratory collapse may develop, which can be life-threatening and, in very rare cases, fatal.

The expected frequency of high isoenzyme activity in different populations is shown below:

Use in children after surgery

There have been reports in the literature that taking codeine after tonsillectomy and/or adenoidectomy due to sleep apnea syndrome has in rare cases resulted in life-threatening adverse events, including death. All children received codeine in recommended doses, however, there is an assumption that this group of patients had high metabolic activity, which contributed to the active conversion of codeine to morphine.

Use in children with respiratory impairment

Codeine and codeine-containing products are not recommended for use in children with respiratory problems, including neuromuscular disorders, severe heart or respiratory disease, upper respiratory or lung infections, multiple traumas, or major surgery. These conditions may worsen symptoms of morphine toxicity.

Due to the presence of wheat starch, the drug should not be taken by patients with celiac enteropathy (a hereditary disease of the small intestine characterized by diarrhea when eating foods containing gluten).

Sodium disulfite contained as an excipient can cause allergic reactions, including anaphylactic shock in patients sensitive to this component.

The drug Sedalgin-Neo® can change the results of doping control tests for athletes. It makes it difficult to establish a diagnosis in acute abdominal pain syndrome.

Patients suffering from atopic bronchial asthma and hay fever have an increased risk of developing hypersensitivity reactions.

Analogs

Level 4 ATC code matches:
Phenacetin

Combiflu

Chlorphenamine

Coldflu

Calpol

Fervex

Panadol Extra

Panadol for children

Panadol

Solpadeine

Efferalgan

Milistan

Coldrex Maxgripp

Coldrex Hotrem

Coldrex

AntiGrippin

Unispaz

Pentalgin Plus

Rapidol

Maxicold

• Sedal-M;
• Quintalgin;
• Santoperalgin.