Universal reference book for medicines
Product name: SEDAL-M® (SEDAL-M®)

Active substance: comb.
drug
Type: Analgesic-antipyretics of combined composition

Manufacturer: SOPHARMA (Bulgaria) manufactured by MILVE Pharmaceuticals (Bulgaria)
Composition, form of production and packaging
Tablets are
white or almost white, round, flat, with a smooth surface, with a facet and a risk.

1 tab.

paracetamol 300 mg

metamizole sodium 150 mg

caffeine 50 mg

phenobarbital 15 mg

codeine phosphate 10 mg

[PRING] lactose, corn starch, povidone K25, sodium carboxymethyl starch, magnesium stearate, glycerol.

10 pieces.
- blisters (1) - packs of cardboard.
10 pieces.
- blisters (2) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2014.

PHARMACHOLOGIC EFFECT

Combined drug, analgesic (including with migraine), antipyretic effect.
Eliminates the symptoms of acute respiratory disease and influenza.
Paracetamol has an analgesic and antipyretic effect.

Metamizole sodium is an analgetic-antipyretic, has analgesic effect, and also has an antispasmodic effect on the smooth muscles of the urinary and biliary tract.

Caffeine has a general tonic effect (reduces drowsiness and fatigue, increases mental and physical performance, increases heart rate, increases blood pressure in arterial hypotension).

Phenobarbital has a sedative and spasmolytic
act.
Codeine has an analgesic effect and improves the tolerance of pain.

PHARMACOKINETICS

Data on the pharmacokinetics of Sedal-M are not available.

INDICATIONS

The relief of mild to moderate pain syndrome of different etiology:

- headache;

- toothache;

- Migraine;

- pain in the muscles and joints;

- neuralgia;

- painful menstruation;

- radiculitis;

- traumatic and postoperative pain;

Fever and pain syndrome in acute inflammatory diseases of the upper respiratory tract, other infectious and inflammatory diseases and influenza.

DOSING MODE

If necessary, take 1 tab.
If there is no clinical effect, you can take 1 tablet. 4 times / day. The maximum single dose is 2 tablets, daily - 6 tablets.
The maximum duration of treatment should not exceed 5 days with the appointment of the drug as an analgesic and 3 days in the appointment as an antipyretic.Change the dose in the interval between doses prescribed by the doctor.

Tablets are taken orally during a meal, washed down with liquid.

SIDE EFFECT

From the side of the central nervous system: dizziness, drowsiness, decreased speed of psychomotor reactions.
With prolonged uncontrolled admission in high doses, addiction is possible (weakening analgesic effect), drug dependence (due to the codeine included in the preparation).
From the cardiovascular system: a feeling of heartbeat.

On the part of the hematopoiesis system: leukopenia, granulocytopenia, agranulocytosis.

On the part of the digestive system: nausea, vomiting, constipation;
possibly - violations of the liver (with long uncontrolled admission in high doses).
From the urinary system: it is possible - a violation of kidney function (with long uncontrolled admission in high doses).

Allergic reactions: rash, itching, hives.

The patient should inform the attending physician about the appearance of side effects (including those not listed above).

CONTRAINDICATIONS

- severe renal dysfunction;

- pronounced violations of the liver function;

- Stomach ulcer and duodenal ulcer in the phase of exacerbation;

- bronchospasm;

- conditions accompanied by respiratory depression;

- Blood diseases (leukopenia, hemolytic anemia);

- increased intracranial pressure;

- craniocerebral trauma;

acute myocardial infarction;

- arrhythmia;

- arterial hypertension;

- deficiency of glucose-6-phosphate dehydrogenase;

- a condition of alcoholic intoxication;

- children's age till 12 years;

- Pregnancy;

- lactation period (breastfeeding);

- Hypersensitivity to the components of the drug.

With caution appoint the drug to patients with impaired renal and hepatic function, with peptic ulcer or duodenal ulcer
guts in the phase of remission, as well as to the elderly.
PREGNANCY AND LACTATION

The drug is contraindicated for use in pregnancy and lactation (breastfeeding).

APPLICATION FOR FUNCTIONS OF THE LIVER

For violations of kidney function, the drug is administered with caution.
The use of the drug in severe impairment of kidney function is contraindicated.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

For violations of liver function, the drug is administered with caution.
The use of the drug in severe violations of the liver is contraindicated.
APPLICATION FOR CHILDREN

Contraindication: children under 12 years.

APPLICATION IN ELDERLY PATIENTS

With caution appoint the drug to the elderly.

SPECIAL INSTRUCTIONS

With prolonged (more than 5 days) taking the drug, you need to monitor the picture of peripheral blood and the liver and kidney function.

Taking the drug may make it difficult to establish a diagnosis with abdominal pain syndrome, incl.
with the syndrome "acute abdomen."
In patients with atopic bronchial asthma and pollinosis, there is an increased risk of developing hypersensitivity reactions.

Taking Sedal-M can change the results of doping control tests in athletes.

Impact on the ability to drive vehicles and manage mechanisms

Most of the components of Sedal-M medication affect the central nervous system, changing the speed of psychomotor reactions, so it is not recommended to take the drug during work that requires increased attention (driving, working with mechanisms).

OVERDOSE

Symptoms: depression of the central nervous system (dizziness, drowsiness, slowing of reflexes);
sometimes - dry mouth, respiratory depression, significant weakness;rarely - loss of consciousness.
Treatment: artificial vomiting, gastric lavage with water, reception of activated charcoal, symptomatic therapy.

DRUG INTERACTION

Pharmacodynamic interaction

Simultaneous use of Sedal-M with other non-opioid analgesics may lead to an increase in toxic effects.

With simultaneous use of tricyclic antidepressants, oral contraceptives and allopurinol increase the toxicity of metamizole sodium.

Barbiturates, phenylbutazone and other inducers of microsomal liver enzymes weaken the action of metamizole sodium.

With repeated use of paracetamol, which is part of the drug, can enhance the effect of anticoagulants (derivatives of dicumarin).

When combined, sedatives and tranquilizers increase the analgesic effect of Sedal-M.

Pharmacokinetic interaction

With joint application, adsorbents, astringents and enveloping agents can reduce absorption from the digestive tract
which is part of the preparation codeine.
With the simultaneous use of metamizole sodium, which is part of the drug, and cyclosporine, the concentration of cyclosporine in the blood plasma decreases.

Caffeine accelerates the absorption of ergotamine.

Metoclopramide accelerates the absorption of paracetamol.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored in a dry, protected from light, out of reach of children at a temperature of no higher than 25 ° C.
Shelf life - 3 years.
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