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Medical expert of the article

Internist infectious disease
, medical expert
Last reviewed: 15.08.2021

Sedal-m is an analgesic drug with anti-inflammatory properties. Consider the indications for the use of the drug, dosage, side effects.

Sedal-m is a complex preparation with analgesic, antipyretic and sedative properties. Included in the pharmacotherapeutic category of non-narcotic analgesic, antipyretic NSAIDs. An analgetic-antipyretic contains five components (metamizole sodium, paracetamol, codeine, phenobarbital and caffeine) that provide its therapeutic effect.


ATC classification

N02BB72 Метамизол натрия в комбинации с психолептиками

Active ingredients

Метамизол натрия

Indications of the sedala-M

Sedal-m is indicated for use in arresting pain in patients with severe head and muscle pain, migraine, neuritis, neuralgia. It helps with algodismorrhoea with painful sensations that have developed because of the suffered injuries, burns and surgical interventions. It is used as an analgesic and antipyretic drug for patients with inflammatory lesions of the upper respiratory tract of various etiologies.


Release form

Sedal-m has a tablet form of release. Tablets in contour cell packs of 10 pieces each, in one bundle of 1 or 2 cell blisters. Each tablet contains such active ingredients: paracetamol 300 mg, metamizole sodium 150 mg, caffeine 50 mg, phenobarbital 15 mg, codeine phosphate 10 mg and auxiliary components.


Since the preparation has a combined composition, the pharmacodynamics is represented by the interaction of all active components. The drug has antipyretic, analgesic, anti-inflammatory and sedative effects. These properties provide paracetamol and metamizole (analgin), which belong to non-narcotic analgesics. By inhibiting cyclooxygenase in the CNS, they destroy the synthesis of prostaglandins.

Low doses of phenobarbital provide a sedative effect. Codeine refers to opoid analgesics, has analgesic, analgesic and antitussive properties. Caffeine stimulates the central nervous system, improves performance, improves cerebral circulation and tone of the cerebral vessels, and helps concentration. This substance enhances the properties of non-steroidal anti-inflammatory drugs. Caffeine dilates the vessels of the brain, reduces headaches. Small doses of phenobarbital have a sedative effect and potentiate the effect of analgesic components of the drug.

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After ingestion, individual Sedal-m combinations are quickly and completely absorbed from the gastrointestinal tract. Pharmacokinetics of the drug indicates its rapid metabolism. It is excreted by the kidneys with urine. The half-life period for all components of the drug is different: paracetamol 1,5-3 hours, metamizole 1-4 hours, caffeine 3-6 hours, codeine 3-4 hours.

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Use of the sedala-M during pregnancy

Sedal-m is not recommended for use during pregnancy and breastfeeding. This is due to the potential risks to the fetus. The medicine is prescribed in the case when the expected benefit for the mother is much higher than the possible consequences for the future child.


Sedal-m is contraindicated for use with individual intolerance to its active components and drugs from the NSAID group. The drug is not prescribed for patients with severe renal and hepatic impairment, hemorrhagic diathesis, anemia, deficiency of glucose-6-phosphate dehydrogenase and bronchial asthma.

Tablets are contraindicated for the elimination of pain syndrome in patients younger than 14 years. Not prescribed for pregnant women and women breastfeeding. With special care are used to treat patients with peptic ulcer of the stomach and duodenum.

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Side effects of the sedala-M

As a rule, Sedal-m is well tolerated by patients. Side effects are rare, and usually in patients with hypersensitivity to the components of the drug or with prolonged therapy.

Adverse reactions are manifested by such symptoms:

  • Violation of coordination of movements and orientation in space.
  • Dizziness and headaches.
  • Disturbance of sleep and wakefulness.
  • Tremor of extremities.
  • Increased fatigue and anxiety.
  • Tachycardia.
  • Reduced blood pressure.
  • Hemolytic anemia.
  • Discomfort and pain in the epigastric region.
  • Increased dryness of the oral mucosa.
  • Nausea, vomiting, diarrhea.
  • Skin allergic reactions.

To eliminate the above symptoms, it is necessary to stop taking the drug, carry out symptomatic therapy and seek medical advice from a doctor.


Dosing and administration

Since Sedal-m refers to prescription drugs, the way of application and dose depends on the medical prescriptions. The drug is taken orally. To minimize the risk of side effects from the digestive tract, tablets should be taken after meals, washed down with water.

As a rule, patients are prescribed 1 tablet 3 times a day. If necessary, the dosage can be increased to 2 tablets 2-3 times a day. The maximum allowable daily dosage is 7 tablets per day. If the medicine is used for a long period of time, then it is necessary to monitor the blood picture, the function of the liver and kidneys.

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The use of elevated doses of Sedal-m leads to an overdose. It is manifested by the development of increased drowsiness, headaches and dizziness, nausea, asthenia, dryness of the oral mucosa, respiratory depression, bradycardia development are possible.

There is no specific antidote, so gastric lavage and enterosorbents are indicated. To normalize the level of active components of blood, a forced diuresis is shown. To eliminate other signs of intoxication, symptomatic therapy is performed.


Interactions with other drugs

When interacting with other drugs, Sedal-m may increase the risk of adverse reactions. It is also possible to change the pharmacokinetic properties of oral anticoagulants, cortisone derivatives, ethyl alcohol, non-narcotic analgesics, neuroleptics. With combined use of Sedal-m with other medications, it is necessary to take into account the interaction of each individual active substance of the drug with a particular drug. 

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Storage conditions

Tablets should be kept in the original packaging in a place protected from sunlight, moisture and inaccessible to children. Storage conditions imply compliance with the temperature regime of not more than 25 ° C.

Shelf life

Sedal-m is released from pharmacies only on the prescription. Shelf life of the drug is 36 months from the date of its production (indicated on the package and blister with tablets). The overdue medicine is not allowed.

Pharmacological group

НПВС — Пиразолоны в комбинациях

Pharmachologic effect

Жаропонижающие препараты
Анальгезирующие (ненаркотические) препараты
Противомигренозные препараты


Милве Фармацевтические заводы, АО, Болгария


To simplify the perception of information, this instruction for use of the drug "Sedal-M" translated and presented in a special form on the basis of the official instructions for medical use of the drug. Before use read the annotation that came directly to medicines.

Description provided for informational purposes and is not a guide to self-healing. The need for this drug, the purpose of the treatment regimen, methods and dose of the drug is determined solely by the attending physician. Self-medication is dangerous for your health.

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