tab.: 6, 10, 12, 20 or 24 pcs. Reg. No.: Р N000343/01

Clinical and pharmacological group:

Analgesic-antipyretic combined composition

Release form, composition and packaging

Pills from white to white with a yellow or cream tint, biconvex, capsule-shaped with flat side surfaces, with a mark on one side and the engraving “PENTALGIN” on the other.

Excipients: potato starch, povidone (low molecular weight medical polyvinylpyrrolidone), stearic acid, calcium stearate.

6 pcs. - contour cellular packaging (1) - cardboard packs.
6 pcs. - contour cell packaging (2) - cardboard packs.
10 pcs. - contour cellular packaging (1) - cardboard packs.
10 pcs. - contour cell packaging (2) - cardboard packs.
12 pcs. - contour cellular packaging (1) - cardboard packs.
12 pcs. - contour cell packaging (2) - cardboard packs.
10 pcs. - contour cell packaging (500) - cardboard boxes.
12 pcs. - contour cell packaging (500) - cardboard boxes.
6 pcs. - contour cell packaging (500) - cardboard boxes.

Description of the active components of the drug " Pentalgin ® -icn»

Pharmacological action

The combined drug has an analgesic, antipyretic, and anti-migraine effect.

Paracetamol- analgesic-antipyretic. Blocks COX mainly in the central nervous system, affecting the centers of pain and thermoregulation; has analgesic and antipyretic effects.

Metamizole sodium- analgesic-antipyretic, pyrazolone derivative. Has a pronounced analgesic effect.

Caffeine- a psychostimulant, improves the well-being of patients and reduces headaches of vascular origin (including migraine).

Phenobarbital- barbiturate, increases the analgesic effectiveness of metamizole sodium and paracetamol.

Codeine has an analgesic effect due to the stimulation of opioid receptors in various parts of the central nervous system, leading to stimulation of the antinociceptive system and a change in the emotional perception of pain.

Indications

— pain syndrome of various origins of weak and moderate intensity (including arthralgia, myalgia, radiculitis, algodismenoria, neuralgia, headache, toothache);

- colds and conditions accompanied by fever.

Dosage regimen

Prescribe 1 tablet. 1-3 times/day. The maximum daily dose is 4 tablets.

The drug should not be taken for more than 5 days as an analgesic and for more than 3 days as an antipyretic without a doctor’s prescription and supervision.

Side effect

From the side of the central nervous system: dizziness, drowsiness.

From the cardiovascular system: palpitations, tachycardia.

From the digestive system: nausea, vomiting, constipation.

From the hematopoietic system: leukopenia, granulocytopenia, agranulocytosis.

Allergic reactions: rash, itching, urticaria.

Other: with prolonged uncontrolled use in high doses - addiction (weakening of the analgesic effect), drug dependence (codeine), liver and/or kidney failure.

Contraindications

- severe liver failure;

- severe renal failure;

- bronchial asthma;

- anemia, leukopenia;

- conditions accompanied by respiratory depression;

- cranial hypertension;

- acute myocardial infarction;

- arrhythmias;

- glaucoma;

- alcohol intoxication;

- deficiency of glucose-6-phosphate dehydrogenase;

- pregnancy;

- lactation period (breastfeeding);

- children under 12 years of age;

- hypersensitivity to the components of the drug.

WITH caution The drug should be used for gastric and duodenal ulcers in remission, for arterial hypertension, and in elderly patients.

Pregnancy and lactation

Contraindicated for use during pregnancy and lactation (breastfeeding).

Use for liver dysfunction

Contraindication: severe liver failure.

Use for renal impairment

Contraindication: severe renal failure.

Use in old age

WITH caution the drug should be used in elderly patients.

Application for children

Contraindication: children under 12 years of age.

Special instructions

With long-term (more than 1 week) treatment, monitoring of the peripheral blood picture and the functional state of the liver is necessary.

When taking the drug Pentalgin ® -ICN, it is possible to change the results of doping control tests in athletes.

Taking the drug Pentalgin ® -ICN makes it difficult to establish a diagnosis for acute abdominal pain syndrome.

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

Impact on the ability to drive vehicles and operate machinery

When using the drug, patients should refrain from potentially hazardous activities that require increased attention and speed of psychomotor reactions.

Overdose

Symptoms: nausea, vomiting, gastralgia, tachycardia, arrhythmia, depression of the respiratory center.

Treatment: gastric lavage, administration of intestinal adsorbents, and, if necessary, symptomatic therapy.

Drug interactions

Conditions for dispensing from pharmacies

The drug is available with a prescription.

Storage conditions and periods

The drug should be stored out of the reach of children, in a dry place, protected from light. Shelf life - 3 years.

Drug interactions

With the simultaneous use of drugs that have a depressant effect on the central nervous system (including sedatives and tranquilizers), the severity of the sedative effect and inhibitory effect on the respiratory center is likely to increase. Strengthens the effect of ethanol on the psychomotor reaction. Metamizole sodium reduces the concentration of cyclosporine.

Metamizole sodium, displacing oral hypoglycemic drugs, indirect anticoagulants, corticosteroids and indomethacin from protein binding, increases their activity. Tricyclic antidepressants, oral contraceptives, and allopurinol disrupt the metabolism of metamizole sodium in the liver and increase its toxicity.

Concomitant use of Pentalgin ® -ICN with other non-opioid analgesics may lead to increased toxic effects.

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

General characteristics. Compound:

Active ingredients: 300 mg metamizole sodium, 300 mg paracetamol, 50 mg caffeine (in terms of dry matter), 8 mg codeine phosphate (in terms of dry matter), 10 mg phenobarbital.

Excipients: potato starch, povidone (low molecular weight medical polyvinylpyrrolidone), stearic acid, calcium stearate.

Pharmacological properties:

Pharmacodynamics. The combined drug has an analgesic, antipyretic, and anti-migraine effect.

Paracetamol is a non-narcotic analgesic; blocks cyclooxygenase mainly in the central nervous system, affecting the centers of pain and thermoregulation; has an analgesic and antipyretic effect.

Metamizole sodium is a non-steroidal anti-inflammatory drug with a pronounced analgesic effect.

Caffeine improves the well-being of patients and reduces headaches of vascular origin (including).

Phenobarbital increases the analgesic effectiveness of metamizole sodium and paracetamol.

Codeine - has an analgesic effect due to the stimulation of opiate receptors in various parts of the central nervous system, leading to stimulation of the antinociceptive system and a change in the emotional perception of pain.

Indications for use:

Pentalgin®-ICN is used for pain of various origins of weak and moderate intensity (including pain in the joints, muscles, radiculitis, menstrual pain, neuralgia, headaches and toothaches).

Pentalgin®-ICN can be used for colds accompanied by fever.

Important! Get to know the treatment

Directions for use and dosage:

The drug is usually taken 1 tablet 1-3 times a day. The maximum daily dose is 4 tablets.

The drug should not be taken for more than 5 days as an analgesic and for more than 3 days as an antipyretic without a doctor’s prescription and supervision.

Features of application:

With long-term (more than 1 week) treatment, monitoring of the peripheral blood picture and the functional state of the liver is necessary. May change the results of athletes' drug control tests.

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.

Impact on the ability to drive vehicles. Wed and fur.Due to the possibility of developing a sedative effect, during treatment it is not recommended to drive vehicles or engage in other potentially hazardous activities that require increased concentration, speed of psychomotor and motor reactions.

Side effects:

Allergic reactions (rash, itching,), drowsiness, palpitations, ; , .

With prolonged uncontrolled use in high doses - addiction (weakening of the analgesic effect), drug dependence (codeine); liver and/or kidney failure.

Interaction with other drugs:

Strengthens the effect of ethanol on the psychomotor reaction.

Metamizole sodium reduces the concentration of cyclosporine.

Metamizole sodium, displacing oral hypoglycemic drugs, indirect anticoagulants, glucocorticosteroids and indomethacin from protein binding, increases their activity. Tricyclic antidepressants, oral contraceptives, and allopurinol disrupt the metabolism of metamizole in the liver and increase its toxicity.

Concomitant use of the drug with other non-narcotic analgesics may lead to increased toxic effects.

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

Contraindications:

Hypersensitivity, severe hepatic and/or

/ Pentalgin-ICN

Pentalgin-ICN Pentalgin-ICN

Manufacturer

Pharmstandard-Leksredstva, Russia

Pharmacological group

Analgesic

Active ingredient

metamizole sodium, codeine, phenobarbital, caffeine, paracetamol

"Pentalgin-ICN" is an effective drug that has a strong analgesic and antipyretic effect, relieves pain of various etiologies. Pentalgin-ICN is especially effective for severe pain, including migraine. Can be used for colds. Dispensed from pharmacies by prescription, taken only according to indications; to prescribe, you must contact your doctor.

Composition of Pentalgina-ICN

Pentalgin-ICN tablets are white or white with a yellowish or creamy tint, biconvex in the shape of a capsule with flat side surfaces, with a score line on one side and PENTALGIN engraving on the other. One tablet contains:

metamizole sodium 300 mg,
caffeine 50 mg,
paracetamol 300 mg,
codeine 8 mg,
phenobarbital 10 mg,
auxiliary components.

Tablets can be purchased in packs of 12 in a blister pack. 1 package together with instructions for use is sold in a cardboard box.

Pharmacological action

Pentalgin-ICN is a combination drug that has analgesic, antimigraine and antipyretic effects.

Paracetamol has an analgesic and antipyretic effect.
Metamizole sodium has a pronounced analgesic effect.
Codeine stimulates opioid receptors in various parts of the central nervous system, which leads to activation of the antinociceptive system and a change in the emotional perception of pain.
Codeine and phenobarbital increase the analgesic effect of metamizole sodium and paracetamol.
Caffeine dilates blood vessels in skeletal muscles, kidneys, heart, and brain.

Pentalgin-ICN increases mental and physical performance, eliminates fatigue and drowsiness. The drug increases the permeability of histohematological barriers and increases the bioavailability of non-opioid analgesics, thereby enhancing the therapeutic effect. It also reduces headaches of vascular origin (including migraines). Biotransformed in the liver, excreted by the kidneys, penetrates the placental barrier

Indications for use

Pentalgin-ICN is indicated for use in mild to moderate pain of various origins, including pain in the joints, muscles, radiculitis, menstrual pain, neuralgia, dental pain and headaches (including migraines). Can be used for colds accompanied by fever.

Contraindications

Pentalgin-ICN has the following contraindications:

Hypersensitivity to the components of the drug
Portal hypertension, severe arterial hypertension
Erosive and ulcerative lesions of the gastrointestinal tract (in the acute phase), gastrointestinal bleeding
Bronchial asthma, bronchospasm
Alcohol intoxication
Glaucoma
Liver and kidney dysfunction
Severe organic diseases of the cardiovascular system (including acute myocardial infarction), arrhythmia
Traumatic brain injury
Anemia, leukopenia
Glucose-6-phosphate dehydrogenase deficiency
Children's age up to 12 years
Pregnancy, lactation period

Take with caution for mild to moderate arterial hypertension and in old age. A doctor's consultation is required.

Use during pregnancy and lactation: The drug is contraindicated during pregnancy and lactation. Passes into breast milk.

Instructions for use

Pentalgin-ICN is taken orally, 1 tablet 1-3 times a day. The maximum daily dose is 4 tablets. Pentalgin-ICN is not recommended for use for more than five days as an analgesic and for more than three days as an antipyretic without a doctor’s prescription and supervision.

Side effect

Side effects are possible when using Pentalgin-ICN:

Allergic reactions, including Steven-Johnson syndrome, Lyell's syndrome; bronchospasm.
From the side of the central nervous system: drowsiness, dizziness
From the cardiovascular system: palpitations
From the digestive tract: nausea, vomiting, gastralgia, hepatotoxicity, erosive and ulcerative lesions of the gastrointestinal tract
From the hematopoietic organs: leukopenia, thrombocytopenia, anemia
Causes addiction and drug dependence when taken for a long time.

Overdose

Overdose symptoms:

nausea
vomit
gastralgia
drowsiness
tachycardia
heart rhythm disturbances
respiratory depression
weakness.

Treatment for overdose: induction of vomiting, gastric lavage through a tube, administration of adsorbents (activated carbon), symptomatic therapy aimed at maintaining vital functions.

Interaction with other drugs

Concomitant use of Pentalgin-ICN with other non-opioid analgesics may lead to increased toxic effects. Sedatives and tranquilizers enhance the analgesic effect of the drug. The simultaneous use of metamizole with cyclosporine reduces the level of the latter in the blood. Barbiturates, phenylbutazone and other inducers of microsomal liver enzymes weaken the effects of metamizole sodium. Tricyclic antidepressants, oral contraceptives, and allopurinol increase the toxicity of metamizole sodium, which is included in the drug.

Special instructions

During treatment with the drug, you should avoid drinking alcohol. With long-term use (more than 5 days), it is necessary to monitor the peripheral blood picture and liver function indicators. The use of the drug may change the results of doping control of athletes.

In some cases, a decrease in concentration and speed of psychomotor reactions is possible, therefore, during the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions. Taking the drug may make it difficult to establish a diagnosis for acute abdominal pain syndrome.

Conditions for dispensing from pharmacies

Pentalgin-ICN is dispensed from pharmacies strictly according to a prescription. Form 148-1/у-88. There is a dispensing norm for 1 prescription, taking into account an indivisible package of 20 tablets.

Storage conditions

The drug should be stored in a dry place, out of reach of children, at a temperature not exceeding 25 C. Do not use the drug after the expiration date indicated on the package.

Analogues of the drug

Pentalgin-ICN has the following analogues:

"Sedal-M" (Bulgaria) - tablets No. 10, No. 20
"Sedalgin-NEO" (Bulgaria) - tablets No. 10, No. 20

The combined drug has an analgesic, antipyretic, and anti-migraine effect.

Paracetamol is an analgesic-antipyretic. Blocks COX mainly in the central nervous system, affecting the centers of pain and thermoregulation; has analgesic and antipyretic effects.

Metamizole sodium is an analgesic-antipyretic, a pyrazolone derivative. Has a pronounced analgesic effect.

Caffeine is a psychostimulant, improves the well-being of patients and reduces headaches of vascular origin (including migraine).

Phenobarbital is a barbiturate that increases the analgesic effectiveness of metamizole sodium and paracetamol.

Codeine has an analgesic effect due to the stimulation of opioid receptors in various parts of the central nervous system, leading to stimulation of the antinociceptive system and a change in the emotional perception of pain.

Pharmacokinetics

Data on the pharmacokinetics of the drug Pentalgin ® -ICN are not provided.

Release form

Tablets are white to off-white with a yellow or cream tint, biconvex, capsule-shaped with flat sides, scored on one side and engraved “PENTALGIN” on the other.

Excipients: potato starch, povidone (low molecular weight medical polyvinylpyrrolidone), stearic acid, calcium stearate.

Dosage

Prescribe 1 tablet. 1-3 times/day. The maximum daily dose is 4 tablets.

The drug should not be taken for more than 5 days as an analgesic and for more than 3 days as an antipyretic without a doctor’s prescription and supervision.

Overdose

Symptoms: nausea, vomiting, gastralgia, tachycardia, arrhythmia, depression of the respiratory center.

Treatment: gastric lavage, administration of intestinal adsorbents, and, if necessary, symptomatic therapy.

Interaction

Concomitant use of Pentalgin ® -ICN with other non-opioid analgesics may lead to increased toxic effects.

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

Side effects

From the side of the central nervous system: dizziness, drowsiness.

From the cardiovascular system: palpitations, tachycardia.

From the digestive system: nausea, vomiting, constipation.

From the hematopoietic system: leukopenia, granulocytopenia, agranulocytosis.

Allergic reactions: rash, itching, urticaria.

Other: with prolonged uncontrolled use in high doses - addiction (weakening of the analgesic effect), drug dependence (codeine), liver and/or kidney failure.

Indications

pain syndrome of various origins of weak and moderate intensity (including arthralgia, myalgia, radiculitis, algodismenoria, neuralgia, headache, toothache);
colds and conditions accompanied by fever.

Contraindications

severe liver failure;
severe renal failure;
bronchial asthma;
anemia, leukopenia;
conditions accompanied by respiratory depression;
cranial hypertension;
acute myocardial infarction;
arrhythmias;
glaucoma;
alcohol intoxication;
deficiency of glucose-6-phosphate dehydrogenase;
pregnancy;
lactation period (breastfeeding);
children under 12 years of age;
hypersensitivity to the components of the drug.

The drug should be used with caution for gastric and duodenal ulcers in remission, for arterial hypertension, and in elderly patients.

Features of application

Use during pregnancy and breastfeeding

Contraindicated for use during pregnancy and lactation (breastfeeding).

Use for liver dysfunction

Contraindication: severe liver failure.

Use for renal impairment

Contraindication: severe renal failure.

Use in children

Contraindication: children under 12 years of age.

Use in elderly patients

The drug should be used with caution in elderly patients.

Special instructions

With long-term (more than 1 week) treatment, monitoring of the peripheral blood picture and the functional state of the liver is necessary.

When taking the drug Pentalgin ® -ICN, it is possible to change the results of doping control tests in athletes.

Taking the drug Pentalgin ® -ICN makes it difficult to establish a diagnosis for acute abdominal pain syndrome.

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

Impact on the ability to drive vehicles and operate machinery

When using the drug, patients should refrain from potentially hazardous activities that require increased attention and speed of psychomotor reactions.

Pentalgin-ICN is a combined pharmaceutical drug intended for pain relief.

What are the composition and release form of Pentalgin-ICN?

The active ingredients in Pentalgin-ICN are represented by the following compounds: paracetamol - 300 milligrams, caffeine - 50 mg, metamizole sodium - 300 mg, phenobarbital - 10 mg, codeine phosphate - 8 mg. The designations are based on the calculation for 1 tablet. Auxiliary components: calcium stearate, potato starch, povidone, stearic acid.

The drug Pentalgin-ICN is available in white tablets with a slight yellow tint, on one side of which there is the designation “PENTALGIN”. The medicine is sold in packs of 12 pieces. A doctor's prescription is required to purchase.

What is the effect of Pentalgin-ICN?

The combined drug has the following pharmacological effects: antipyretic, analgesic (pain reliever), and anti-migraine. The effect of a pharmaceutical product is determined by its chemical composition.

Paracetamol is a strong analgesic, the mechanism of action of which is due to its effect on the processes of synthesis of cyclooxygenase, a special enzyme responsible for the processes of synthesis of prostaglandins.

A decrease in the amount of prostaglandins suppresses the processes of transmission and generation of electrical impulses in some structures of the brain, which inhibits the activity of pain centers and thermoregulation.

Paracetamol is quickly destroyed by tissue peroxidases, which blocks the appearance of the anti-inflammatory effect, but thanks to this, the pharmaceutical drug almost does not irritate the gastric mucosa and does not lead to electrolyte disturbances.

Metamizole sodium is a strong analgesic, a paracetamol synergist. Its action, as in the case of the previous component of the pharmaceutical drug, is aimed at suppressing the electrical activity of pain centers in the brain.

Caffeine is a stimulant of the central nervous system, its action is aimed at improving the patient’s well-being, eliminating depression and depressive mood. In addition, it is known that this substance can suppress headaches of vascular origin, in particular migraine.

Phenobarbital is another synergist of paracetamol and metamizole sodium, which does not have an analgesic effect. Among the pharmacological effects of this substance, weak sedative, antiepileptic and minor hypnotic should be noted.

Codeine is a non-narcotic analgesic, the action of which is due to its effect on opioid receptors, which leads to stimulation of the so-called antinociceptive system and changes the degree of perception of pain.

Data on the pharmacokinetics (methods of biological transformation and routes of elimination) of the drug Pentalgin-ICN are not provided.

What are the indications for use of Pentalgin-ICN?

Pentalgin-ICN tablets instructions for use allow use for medicinal purposes to relieve pain of moderate and mild severity in the following cases:

Headache, including migraine;
Algodismenorrhea (painful periods);
Neuralgia of various localizations;
Myalgia (muscle pain);
Arthralgia (joint pain);
Toothache;
Injuries and burns;
Fever of various origins.

You can take this drug only after prior consultation with a specialist, since there are a significant number of conditions that in one way or another limit the use of this medicine.

What are the contraindications for use of Pentalgin-ICN?

The instructions for use of the drug Pentalgin-ICN (tablets) do not allow use for medicinal purposes in the following cases:

Bronchial asthma;
Severe renal failure;
Anemic conditions;
Alcohol intoxication;
Glaucoma;
Myocardial infarction in the acute period;
Pregnancy;
Age 12 or less;
Lactation period;
Respiratory depression;
Glaucoma;
Traumatic brain injury;
Individual intolerance;
Heart rhythm disturbance.

Relative contraindications: gastric ulcer, arterial hypertension, old age.

What is the use of Pentalgin-ICN? What is the dosage for Pentalgin-ICN?

The usually recommended dosage is 1 tablet up to 3 times a day. In severe cases, it is possible to take 4 tablets of the drug, which is the maximum daily dosage. The maximum duration of treatment is 5 days (as a pharmaceutical anesthetic) and 3 days (as an antipyretic drug). If treatment is ineffective, you should stop taking the medication and consult a doctor.

Pentalgin-ICN - drug overdose

Symptoms are: vomiting, tachycardia, respiratory depression, abdominal pain. Treatment: inducing vomiting and gastric lavage (if no more than 2 hours have passed since administration), taking enterosorbents (for example, activated carbon), as well as other measures of symptomatic therapy.

What are the side effects of Pentalgin-ICN?

Taking Pentalgin-ICN tablets may cause the following side effects: skin rashes and other allergic reactions, tachycardia, nausea, vomiting, constipation, dizziness and drowsiness, changes in laboratory blood parameters.

Special instructions

Professional competitive athletes should avoid using this medication as it may result in false positive drug tests.

In addition, experts classify Pentalgin as a prohibited drug while driving. Therefore, patients whose professional activities involve the need to operate dangerous mechanisms or vehicles should exercise the maximum degree of caution (the appearance of weakness and drowsiness), and even better, refrain from working for a while.

How to replace Pentalgin-ICN, what analogues should I use?

Pentalgin-Nova, Pentamialgin, Sedalgin-Neo, Pentalfen-MEZ, Pentalgin-FC, Sedal-M, Pentalgin-MEZ, Pentalgin-Vero, and also Pentalgin-NS.

Conclusion

The use of painkillers should be supervised by a specialist. The reason for this limitation lies in the ability of analgesics to mask a dangerous pathology, which will lead to the loss of precious time.