SEDALʹ̱GIN-NEO

Active material: Paracetamol, Metamizole, Caffeine, Phenobarbital, Codeine
When ATH: N02BB72
CCF: Combined preparation with analgesic effect
When CSF: 03.02.01.03.01
Manufacturer: BALKANPHARMA-DUPNITZA AD (Bulgaria)

Pharmaceutical form, composition and packaging

◊ Pills round, flat, from white to almost white, with bilateral facet and Valium on one side.

Excipients: wheat starch, krospovydon, sodium bisulfite, povidone, magnesium stearate, talc, microcrystalline cellulose.

10 PC. – блистеры (1) – пачки картонные.

Pharmacological properties

Farmakodinamika

Combination drug with analgesic and antipyretic effects and less pronounced anti-inflammatory and sedative effect. These effects have mostly included in the drug paracetamol and analgin (metamizol), that, ingibiruâ cyclooxygenase (especially the brain), disrupt the synthesis of prostaglandins. Phenobarbital in small doses has a sedative effect and potentiates the effect of the components of analgesia. Caffeine, expanding the blood vessels of the brain, reduces headache, arises as a result of vasoconstriction, and reduces the intracranial pressure. It stimulates psychomotor, enhances mental and physical performance, It prevents the development of other components of sedation. Codeine phosphate through opioid receptors has analgesic and sedative effect and potentiates the analgesic effect of paracetamol and dipyrone. Combining multiple analgesics with other components on the one hand increases the efficiency of analgesia, а с другой – уменьшает побочные явления и риск возникновения лекарственной зависимости.

Pharmacokinetics

Some components of the formulation rather quickly absorbed in the gastrointestinal tract. Undergo relatively rapid metabolism. Excreted primarily in the urine. Period polueliminirovaniya codeine 3-4 no, кофеина – 3-6 no, парацетамола – 1,5-3 hours and dipyrone 1-4 no.

Indications

Headache and toothache, migraine, neuralgia and neuritis, pain after burns, injuries and surgical interventions, rheumatic and phantom pain, colds, flowing with pain and fever, dysmenorrhoea.

Contraindications

Hypersensitivity to any component of the drug, gyemorragichyeskii diatyez, anemia, renal failure and liver, bronchial asthma.

Precautions and warnings

Chronic administration of the drug to control blood picture and indicators of kidney and liver function. The drug is not prescribed for the presence of active gastric ulcer or duodenal ulcer. At high doses, especially at the beginning of treatment, possible slowing of psychomotor reactions. Avoid prescribe it for children under 14 years. In view of reducing the tolerance to alcohol, it should not be used during treatment with. Since the product contains analginum, it may be painted red urine, that is not dangerous.

Pregnancy and lactation

The drug is not prescribed to pregnant and lactating women. Contained in combination phenobarbital, codeine phosphate and caffeine are harmful to embryos, fetus and newborn. Most of the components goes into the milk. Caffeine can cause neonatal reflux effect.

Driving cars and work performance, requiring concentration

Most of the components acting on the central nervous system, changes of psychomotor reactions, it is not recommended to take the drug while driving and operating machines, requiring attention.

Interaction with other drugs

Simultaneous use of the drug with anticoagulants, cortisone derivatives, analgesics, NSAIDs, metotreksatom, antipsychotics and alcohol can change their concentration in the blood plasma and thus effect; under these conditions increases the risk of side effects.

Dosing and Administration

Inside during meals, with some liquid. Adults take, When necessary one tablet. If no satisfactory effect, You can take 1 tablet 4 once a day. The maximum single dose - 2 tablets, а суточная – 6 tablets.

Side effect

The drug is rarely causes allergic reactions, gastrointestinal discomfort, dizziness, thrombocytopenia. Long-term use can cause renal failure and liver, and bronchial asthma. In a sudden discontinuation may occur withdrawal symptoms; In this case the predominant headache.

Chronic administration of high doses may appear to some resistance to the effects of the combination. When you receive may cause:

• со стороны нервной системы – сонливость, violation up to a total loss of coordination, fatigue, tremor, anxiety, irritability, headache;
• со стороны сердечно-сосудитстой системы – гипотония, tachycardia, arrythmia;
• со стороны системы кроветворения – очень редко гемолитическая анемия, thrombocytopenia, agranulocytosis;
• со стороны желудочно-кишечного тракта – сухость во рту, epigastric pain, loss of appetite, nausea, vomiting, diarrhea, constipation, abnormal liver function;
• со стороны дыхательной системы – бронхоспазм (provoking asthma attacks);
• со стороны мочеполовой системы – нарушение функции почек.

Overdose

If overdose occurs depression of the central nervous system, expressed dizziness, sleepiness, slowing of reflexes, sometimes dry mouth, respiratory depression, significant weakness, and sometimes loss of consciousness. Treatment in these cases consists of vomiting, gastric lavage with water with activated charcoal and administration of symptomatic drugs.

Release form and packing

Pills, by 10 pieces per pack.

Storage conditions

In a dry place, at a temperature not exceeding 25 ° C..

Shelf life

3 year from the date of manufacture.

Conditions of supply of pharmacies

Without a prescription.