Pentalgin-FS extra (metamizole sodium, paracetamol) capsules № 10

Description

Pentalgin-FS extra composition
active substances: paracetamol, metamizole sodium monohydrate, caffeine, phenobarbital, codeine phosphate;
1 capsule contains paracetamol 150 mg, metamizole sodium monohydrate in 150 mg, caffeine 25 mg, phenobarbital 5 mg, codeine phosphate 4 mg;
excipients: potato starch, povidone, stearic acid, calcium stearate;
capsule composition: gelatin, titanium dioxide (E 171).

Dosage form
Capsules.

Pharmacological properties
The drug Pentalgin-FS has analgesic, antipyretic, anti-inflammatory, antispasmodic, sedative effect. Pentalgin-FS is a combination drug that combines the properties of the active ingredients.

• Metamizole sodium and paracetamol are components of the group of non-narcotic analgesics that have a pronounced anti-inflammatory, antipyretic effect, have analgesic activity.
• Codeine phosphate enhances the action of non-narcotic analgesics (blocks opiate receptors, stimulates the antinociceptive system and alters the emotional perception of pain).
• Caffeine causes dilation of blood vessels in skeletal muscle, brain, heart, and kidneys; increases mental and physical performance, helps to eliminate fatigue and drowsiness; increases blood pressure in hypotension; increases the permeability of histohematological barriers and increases the bioavailability of non-narcotic analgesics, which enhances the therapeutic effect.
• Phenobarbital has a sedative effect.

Indication Pentalgin-FS
Moderate pain of various origins: headache, toothache, neuralgia, myalgia, arthralgia, dysmenorrhea; as an antipyretic.

Contraindication
Hypersensitivity to codeine or to other opioid analgesics, to pyrazolone derivatives or to any of the components of the drug; the period after surgery on the biliary tract, peptic ulcer of the stomach and duodenum in the acute stage, conditions in which inhibition of peristalsis should be avoided or in which bloating develops; risk of paralytic intestinal obstruction, severe renal and / or hepatic impairment, congenital hyperbilirubinemia (including Gilbert’s syndrome), acute pancreatitis, diabetes mellitus, acute respiratory depression, respiratory diseases with dyspnea, obstructive syndrome opioids during an asthma attack); organic diseases of the cardiovascular system, including severe atherosclerosis; decompensated heart failure, acute myocardial infarction, cardiac arrhythmia, high blood pressure, severe hypotension, glucose-6-phosphate dehydrogenase deficiency, porphyria, hyperthyroidism, blood diseases (including agranulocytosis, leukopenia). thrombocytopenia, severe anemia (including hemolytic)); myasthenia gravis, glaucoma, traumatic brain injury or conditions accompanied by increased intracranial pressure (in addition to the risk of respiratory depression and increased intracranial pressure, codeine may affect the pupillary response and other vital responses in assessing neurological status); depression, depressive disorders with a patient’s tendency to suicidal behavior, states of heightened arousal, sleep disturbances, epilepsy, alcohol, drug, drug dependence (including in the anamnesis), state of alcohol intoxication; old age. The use of the drug is contraindicated if acute surgical pathology is suspected in the patient, before diagnosis.
The drug Pentalgin-FS is contraindicated in the following groups of patients: – children under 12 years of age, – children aged 12 to 18 years who underwent tonsillectomy and / or adenoidectomy to prevent obstructive sleep apnea, – children aged 12 to 18 years with compromised respiratory function, – women during pregnancy or breast-feeding, – patients of any age who have a very rapid metabolism with CYP2D6. Do not use concomitantly with monoamine oxidase inhibitors (MAOIs) and for 2 weeks after discontinuation of MAOIs.

Children
The drug Pentalgin-FS is indicated for use in children aged 12 to 18 years for the treatment of acute moderate pain that is not relieved by other analgesics such as paracetamol or ibuprofen (as single drugs).
The drug Pentalgin-FS is contraindicated in children under 12 years of age, as there is a risk of serious and life-threatening adverse reactions due to the variable and unpredictable route of conversion of codeine to morphine in patients of this age group.

Method of application and dosage
Take the drug Pentalgin-FS orally after a meal, drinking plenty of water. At insignificant and short-term pain Pentalgin-FS extra capsules to accept 1-2 capsules at once. At a long pain syndrome (neuralgia, arthralgia, myalgia), at a fever to appoint on 2 capsules 1-3 times a day. The drug should be taken at intervals of at least 4 hours between doses and not used for more than 5 days as an analgesic and more than 3 days as an antipyretic. The maximum daily dose is 12 capsules.

Overdose:

• Symptoms of metamizole sodium overdose: nausea, vomiting, dysphagia, gastralgia / gastritis, hypothermia, severe hypotension, palpitations, tachycardia, dyspnea, tinnitus, oliguria, anuria, weakness, drowsiness, delirium, possible disturbance of consciousness acute agranulocytosis, hemorrhagic syndrome, acute renal and hepatic failure, respiratory muscle paralysis.
  Treatment: induction of vomiting, gastric lavage, use of saline laxatives, enterosorbents, forced diuresis, blood alkalinization, symptomatic therapy aimed at maintaining vital functions. In severe cases, it is necessary to use hemodialysis, hemoperfusion, peritoneal dialysis. In case of convulsive syndrome, the need for intravenous diazepam and fast-acting barbiturates should be considered.
• Paracetamol overdose. If a patient takes the medicine in a dose higher than the recommended dose, they should see a doctor immediately because of the risk of liver damage. Liver damage is possible in adults who took 10 g or more of paracetamol and in children who took paracetamol at a dose of more than 150 mg / kg body weight. Taking 5 g or more of paracetamol may cause liver damage in patients with risk factors (long-term use of carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. John’s wort or other drugs that induce liver enzymes; regular use of excessive amounts of alcohol and alcohol deficiency; such as eating disorders, HIV, starvation, cystic fibrosis, cachexia).
  Symptoms of paracetamol overdose in the first 24 hours: paleness, nausea, vomiting, loss of appetite and abdominal pain. Liver damage may become apparent 12 to 48 hours after an overdose. Glucose metabolism disorders and metabolic acidosis may occur. In severe poisoning, liver failure can progress to encephalopathy, hemorrhage, hypoglycemia, coma, and death. Acute renal failure with acute tubular necrosis can be manifested by severe low back pain, hematuria, proteinuria and develop even in the absence of severe liver damage. Cardiac arrhythmia and pancreatitis were also noted.
  With long-term use of paracetamol in large doses by hematopoietic organs may develop aplastic anemia, pancytopenia, agranulocytosis, leukopenia (including neutropenia), thrombocytopenia. At reception of large doses from CNS dizziness, psychomotor excitement and disturbance of orientation are possible; from the urinary system – nephrotoxicity (renal colic, interstitial nephritis, papillary necrosis).
  In case of overdose, emergency medical care is required. The patient should be taken to a hospital immediately, even if there are no early symptoms of overdose. Symptoms may be limited to nausea and vomiting or may not reflect the severity of the overdose or the risk of organ damage.
  Treatment. Activated charcoal treatment should be considered if an overdose of paracetamol has been taken within 1 hour. Plasma paracetamol concentrations should be measured 4 hours or later after administration (earlier concentrations are inaccurate). N-acetylcysteine ​​treatment can be used within 24 hours after taking paracetamol, but the maximum protective effect occurs when using it within 8 hours after taking. The effectiveness of the antidote decreases sharply after this time. If necessary, the patient should be administered intravenous N-acetylcysteine ​​in accordance with current guidelines. In the absence of vomiting, methionine can be used orally as a suitable alternative in remote areas outside the hospital.
• Symptoms of caffeine overdose: nervousness, anxiety, insomnia, agitation, irritability, affect, anxiety, dizziness, tremor, muscle twitching, cramps, ringing in the ears, redness of the face, hyperthermia, rapid breathing, increased urination, urinary incontinence epigastric pain, vomiting, arrhythmias (including tachycardia, extrasystole), psychomotor agitation. Clinically important symptoms of caffeine overdose are also associated with paracetamol liver damage.
  Treatment. In case of caffeine overdose, the use of β-adrenoceptor antagonists may alleviate the cardiotoxic effect.
• Symptoms of phenobarbital overdose: nausea, headache, ataxia, nystagmus, weakness, respiratory depression with the risk of stopping, cardiovascular depression, including arrhythmia, lowering blood pressure to colaptoid state, slowing heart rate, hypothermia, decreased diuresis up to coma.
  Treatment: gastric lavage, symptomatic therapy (primarily monitoring of basic vital functions of the body (respiration, pulse, blood pressure).
• Codeine overdose. Severe CNS depression, including respiratory depression, may develop with concomitant use of other sedatives (including alcohol) or significant overdose. The clinical triad of opioid overdose is coma, punctate pupils, and respiratory depression (may cause cyanosis) with subsequent pupil dilation with hypoxia. Other symptoms of opioid overdose: hypothermia, confusion, convulsions (especially in children), severe dizziness, severe drowsiness, hypotension and tachycardia (possible but unlikely), nervousness or anxiety, emotional arousal, hallucinations, bradynocardia, insufficiency difficulty breathing, severe weakness. There may be shortness of breath, apnea, collapse, urinary retention; rarely – pulmonary edema; there may be signs of histamine release. Cases of rhabdomyolysis, which progressed to renal failure, have been reported with opioid overdoses.
  Overdose is exacerbated by concomitant use of alcohol and psychotropic drugs.
  Treatment: general symptomatic and supportive measures, including measures to support the respiratory center and monitor vital signs until the condition stabilizes.
  Activated charcoal should be taken if no more than 1 hour has elapsed since codeine was taken by an adult at a dose exceeding 350 mg and by a child at a dose exceeding 5 mg / kg body weight. Naloxone should be used in case of coma or respiratory depression. Naloxone is a competing antagonist and has a short half-life, so repeated doses may need to be re-administered to patients with severe poisoning. The patient’s condition should be monitored for at least 4 hours after administration of naloxone or for at least 8 hours in cases of prolonged-release naloxone.

Side effects
Most often, side effects are temporary and disappear after stopping treatment.

• From the nervous system: increased intracranial pressure, headache, dizziness, incoordination, ataxia, tremor, convulsions (especially in children), hyperkinesis (in children), slow reactions, weakness, asthenia, drowsiness, insomnia (in children, patients old age), the development of tolerance or dependence.
• On the part of the visual organs: narrowing of the pupils, impaired visual acuity, photosensitivity, visual impairment (including blurring, doubling of the contours of visible objects), miosis, nystagmus.
• From the organs of hearing and labyrinth: vertigo.
• Mental disorders: cognitive impairment (including decreased concentration, hallucinations), nightmares, paradoxical arousal, irritability, anxiety, anxiety, irritability, confusion, sudden mood swings, euphoria, dysphoria, depression.
• From the gastrointestinal tract: anorexia, dry mouth, heaviness or pain in the epigastrium, nausea, vomiting, diarrhea or constipation, the development of paralytic intestinal obstruction, stomach cramps, pancreatitis.
• From the hepatobiliary system: liver dysfunction, hepatitis (with uncontrolled intake), spasm of the biliary tract, increased activity of liver enzymes, usually without the development of jaundice.
• Metabolism and nutrition disorders: anorexia.
• From the cardiovascular system: feeling of tightness in the chest, orthostatic hypotension, hypotension, collapse, hypertension, arrhythmias (tachy- or bradycardia, extrasystole, etc.), palpitations, redness of the skin.
• From the blood and lymphatic system: lymph node enlargement, leukopenia, granulocytopenia, thrombocytopenia, agranulocytosis, leukocytosis, lymphocytosis, anemia (including hemolytic anemia, megaloblastic anemia, heartburn, sulfobia) ), bleeding, bruising.
• From the respiratory system: bronchospasm in patients sensitive to acetylsalicylic acid and other NSAIDs, difficulty breathing, shortness of breath, respiratory depression (at high doses).
• On the part of the urinary system: interstitial nephritis, spasm of the urinary tract, difficulty urinating, urinary retention, oliguria, anuria, dysuria, antidiuretic effect, increased urination, red urine, proteinuria, increased creatinine clearance, increased eczreptinia and increased excretion .
• From the reproductive system: sexual dysfunction, erectile dysfunction, decreased libido and potency.
• From the endocrine system: hypoglycemia up to hypoglycemic coma, hyperglycemia.
• From the immune system: anaphylaxis, hypersensitivity reactions, including skin itching, rash on the skin and mucous membranes (usually generalized rash, erythematous, urticaria), maculopapular rash (considered a symptom of hypersensitivity syndrome associated with petero) codeine), angioneurotic edema, exudative erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome), shortness of breath, provocation of bronchospasm, dyspnea, tachypnea, lupus yunctivitis.
• From the skin and mucous membranes: photosensitization, redness of the face, exfoliative dermatitis, allergic reactions such as rash, urticaria, itching, sweating, swelling of the face.
• From the musculoskeletal system: uncontrolled muscle movements, muscle rigidity (at high doses); with prolonged use there is a risk of osteogenesis and rickets.
• General disorders: malaise, fatigue, hypo- or hyperthermia.

Prolonged use of the drug Pentalgin-FS for the treatment of headache may lead to its aggravation.
With prolonged uncontrolled use of high doses of the drug may have seizures, respiratory depression, may develop liver dysfunction, hypoglycemia, up to hypoglycemic coma, addiction (weakening of the analgesic effect), withdrawal syndrome.
With long-term use of phenobarbital may develop drug dependence, folate deficiency, impotence.
With long-term use of codeine, as a rule, tolerance develops and some of the most common side effects – drowsiness, nausea, vomiting, confusion.
Regular long-term use of codeine leads to the development of dependence and tolerance and to a state of anxiety and irritability after stopping treatment. Keep in mind that tolerance decreases rapidly after stopping codeine, so re-administration of a previously acceptable dose may be fatal.

Withdrawal syndrome
With the abrupt withdrawal of phenobarbital can usually occur withdrawal syndrome, which is accompanied by the emergence of nightmares, nervousness.
Abrupt discontinuation of codeine may result in withdrawal syndrome. Possible symptoms: tremor, insomnia, anxiety, irritability, anxiety, depression, loss of appetite, nausea, vomiting, diarrhea, sweating, tearing, rhinorrhea, sneezing, yawning, piloerection, mydriasis, weakness, fever, muscle cramps dehydration, increased heart rate, respiratory rate and blood pressure.
If side effects occur, the patient should consult a doctor about further use of the drug.

Expiration date
2 years.

Storage conditions                                                                                                                                                   Keep Pentalgin-FS out of the reach of children, in the original package at a temperature not exceeding 25 ° C.