Instructions for Trigan-D tablets strip No. 100
Composition
active ingredient: paracetamol, dicyclomine hydrochloride;
1 tablet contains paracetamol 500 mg, dicyclomine hydrochloride 20 mg;
excipients: sodium starch glycolate, polyvinylpyrrolidone, microcrystalline cellulose, colloidal anhydrous silicon dioxide, corn starch, magnesium stearate.
Dosage form
Pills.
Main physicochemical properties: white or almost white, round tablets with a score on one side, with beveled edges and a flat surface.
Pharmacotherapeutic group
Analgesics and antipyretics. Paracetamol, combinations without psycholeptics.
ATX code N02B E51.
Pharmacological properties
A combined drug that has analgesic and antispasmodic effects.
Paracetamol acts as an analgesic and antipyretic. The analgesic and antipyretic effects of paracetamol (a non-opiate, non-salicylate analgesic) are associated with the drug's effect on the thermoregulatory center in the hypothalamus and its ability to inhibit prostaglandin synthesis.
Dicyclomine hydrochloride is a tertiary amine. It has anticholinergic activity and reduces smooth muscle tone, eliminates pain, blocks antagonistic activity. Dicyclomine hydrochloride selectively paralyzes M-cholinergic structures, blocking the transmission of impulses from postganglionic cholinergic nerves to the effector organs innervated by them. Causes relaxation of smooth muscles, exhibiting an antispasmodic effect in spasms of smooth muscles of the stomach, intestines, biliary tract, urogenital and vascular systems.
Indication
Pain syndromes with a spastic component of various origins:
headache;
toothache;
muscle pain, neuralgia;
rheumatic pain, radiculitis;
renal colic;
menstrual pain.
Contraindication
Hypersensitivity to the components of the drug. Glaucoma, tachycardia, urinary tract obstruction, benign prostatic hypertrophy with a tendency to urinary retention, myasthenia gravis, severe renal and/or hepatic dysfunction, glucose-6-phosphate dehydrogenase deficiency, alcoholism, blood diseases, severe anemia (including hemolytic), leukopenia; dynamic intestinal obstruction, paralytic intestinal obstruction, pyloric stenosis of the gastrointestinal tract with obstruction, severe ulcerative colitis, obstructive diseases of the gastrointestinal tract and biliary tract with impaired patency, peptic ulcer of the stomach or duodenum, reflux esophagitis; acute bleeding; congenital hyperbilirubinemia (Gilbert, Dubin-Johnson, and Rotor syndromes), myasthenia gravis, thyrotoxicosis, heart failure.
Interaction with other medicinal products and other types of interactions
The peculiarities of the drug interaction are due to the properties of its components.
Paracetamol, which is part of the drug, reduces the effectiveness of diuretics, and also increases the risk of hepatotoxic reactions when taken together with anticonvulsants (barbiturates, phenytoin, carbamazepine), rifampicin, which stimulate the activity of liver microsomal enzymes, may increase the toxic effect of paracetamol on the liver due to an increase in the degree of conversion of the drug into hepatotoxic metabolites. Simultaneous use of high doses of paracetamol with isoniazid increases the risk of developing hepatotoxic syndrome. With simultaneous use of paracetamol with hepatotoxic drugs, the toxic effect of drugs on the liver increases. Do not use simultaneously with alcohol.
Barbiturates reduce the antipyretic effect. The rate of absorption of paracetamol may increase when used together with metoclopramide and domperidone and decrease when used together with cholestyramine. The effect of paracetamol is enhanced when combined with codeine, ascorbic acid, scopolamine, chlorphenamine, propyphenazone and caffeine. Simultaneous use of paracetamol with azidothymidine may lead to the development of neutropenia. The anticoagulant effect of warfarin and other coumarins is enhanced with prolonged regular use of paracetamol, with an increased risk of bleeding. Periodic administration does not show such an effect. Parallel use of paracetamol with non-steroidal anti-inflammatory drugs increases the risk of kidney complications.
Dicyclomine hydrochloride may enhance the effects of monoamine oxidase inhibitors (imipramine, amitriptyline), sedatives (sodium bromide, valerian tincture), and ethyl alcohol.
The effect of dicyclomine hydrochloride may be enhanced by drugs that have anticholinergic activity, such as amantadine, antiarrhythmics (e.g. quinidine), neuroleptic antihistamines (phenothiazines), benzodiazepines, monoamine oxidase inhibitors (MAOIs), narcotic analgesics (meperidine), nitrates and nitrites, sympathomimetics, tricyclic antidepressants.
Since antacids may reduce the absorption of dicyclomine hydrochloride, their concomitant use should be avoided.
The inhibitory effect of dicyclomine on gastric acid secretion may neutralize drugs used to treat achlorhydria and study gastric secretion.
Dicyclomine hydrochloride enhances the effects of digoxin and anticholinergics. The simultaneous use of dicyclomine with other anticholinergics is not recommended.
Dicyclomine hydrochloride may affect the gastrointestinal absorption of various prolonged-release drugs, such as digoxin, which may lead to an increase in the urinary concentration of the latter.
The drug enhances the effect of salicylic acid, pyrazolone, codeine, caffeine. Potentiates the effect of antispasmodics.
Dicyclomine hydrochloride reduces the effect of antiglaucoma drugs, so the drug should be prescribed with caution in cases of increased intraocular pressure and simultaneous use of corticosteroids.
Application features
Due to the fact that the drug contains paracetamol, monitoring of peripheral blood counts and liver function is required during use. For the same reason, the drug should not be used together with other drugs containing paracetamol and used, for example, to reduce fever, treat pain, flu and cold symptoms or insomnia. Simultaneous use with other drugs containing paracetamol may lead to overdose. Overdose of paracetamol may cause liver failure, which may require a liver transplant or be fatal.
Do not exceed the indicated doses.
If the symptoms of the disease do not disappear, consult a doctor.
Patients who are constantly taking analgesics for mild arthritis should consult a doctor before using this medicine.
Use of the drug for more than 3 days requires mandatory medical supervision.
If you develop a persistent headache, you should consult a doctor.
It should be noted that patients with liver disease are at increased risk of hepatotoxicity of paracetamol; the drug may affect the results of laboratory tests for blood glucose and uric acid.
Caution should be exercised in elderly patients. When prescribing to elderly patients, no dosage adjustment is required. Caution should be exercised in the presence of difficulty urinating, prostatic hyperplasia without urinary retention, mild to moderate ulcerative colitis, mild to moderate kidney or liver disease. Patients with such disorders should consult a doctor before using the drug.
Cases of liver dysfunction/liver failure have been reported in patients with reduced glutathione levels, such as those with severe wasting, anorexia, low body mass index, or chronic alcoholism.
Patients with reduced glutathione levels, such as those with severe infections such as sepsis, are at increased risk of metabolic acidosis when taking paracetamol. Symptoms of metabolic acidosis include deep, rapid or difficult breathing, nausea, vomiting, loss of appetite. You should seek medical attention immediately if these symptoms occur.
Dicyclomine hydrochloride may exacerbate gastroesophageal reflux.
The drug should be prescribed with caution to patients with autonomic neuropathy, arterial hypertension, ischemic heart disease with tachyarrhythmias, tachycardia, a tendency to bronchospasm, as well as with increased individual sensitivity to nonsteroidal anti-inflammatory drugs.
It should be noted that patients taking anticholinergic drugs, including dicyclomine, may experience psychosis, confusion, disorientation, ataxia, coma, euphoria, weakness, insomnia, agitation, inadequate emotional manifestations, and affective state (symptoms decrease within 12–24 hours after dose reduction).
Dicyclomine should be prescribed with caution in cases of hiatal hernia accompanied by reflux esophagitis.
At high ambient temperatures, dicyclomine hydrochloride, by reducing sweating, causes an increase in body temperature with the risk of heat stroke. If relevant symptoms appear, you should stop taking the drug and consult a doctor.
Before using the drug, it is necessary to consult a doctor if the patient is using warfarin or similar drugs that have an anticoagulant effect.
Use during pregnancy or breastfeeding
The medicine should not be used by women during pregnancy and breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
Considering that the drug may reduce the speed of psychomotor reactions in sensitive patients, it is better to refrain from driving vehicles, working with complex mechanisms, and other work that requires concentration of attention during treatment.
Method of administration and doses
Adults and children over 15 years of age: 1–2 tablets, depending on the severity of the pain, 1 to 4 times a day. When treating adults, it is advisable to start with 4 tablets per day. The maximum dose can be increased to 8 tablets per day, provided that it is well tolerated and there are no side effects.
Children
- ages 7 to 13: ½ tablet 1–2 times a day;
- aged 13 to 15 years: 1 tablet 1–3 times a day.
The duration of treatment is determined by the doctor individually, depending on the patient's condition and response. If the effectiveness of treatment is not achieved within 2 weeks or there are signs of side effects at a dose of less than 4 tablets per day, the drug should be discontinued.
Children
Not recommended for use in children under 7 years of age.
Overdose
Signs and symptoms of overdose are due to the properties of the individual components of the drug.
Paracetamol: Liver damage is possible in adults after taking 10 g of paracetamol and in children after taking more than 150 mg/kg of body weight. The risk of paracetamol overdose is higher in patients with non-cirrhotic alcoholic liver disease.
In patients with risk factors [long-term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. John's wort or other drugs that induce liver enzymes; regular intake of excessive amounts of ethanol; glutathione cachexia (digestive disorders, cystic fibrosis, HIV infection, starvation and cachexia)], taking 5 g or more of paracetamol can cause severe liver damage. Symptoms of overdose in the first 24 hours: pallor of the skin, anorexia, nausea, vomiting, diarrhea, feeling of discomfort in the epigastric region (lasting up to 1 day), abdominal pain. Liver damage may become apparent 12–48 hours after overdose. Disorders of glucose metabolism and metabolic acidosis may occur.
The following symptoms may be observed: increased activity of hepatic transaminases, lactate dehydrogenase, bilirubin levels, as well as a decrease in prothrombin levels (duration from 1 to 2 days); hepatotoxic effect, which is characterized by general symptoms (pain, weakness, adynamia) and specific symptoms (hepatomegaly, jaundice, increased activity of liver enzymes).
In severe poisoning, liver failure may progress to hepatic encephalopathy (impaired thinking, depression of higher nervous activity, agitation and stupor), disseminated intravascular coagulation (DIC), hypoglycemia, hemorrhage, arrhythmia, seizures, respiratory depression, coma, cerebral edema, hypocoagulation, collapse and lead to death. Occasionally, liver failure develops rapidly and may be complicated by renal failure.
Acute renal failure with acute tubular necrosis may present with severe back pain, hematuria, and proteinuria, and may occur even in the absence of severe liver damage. Cardiac arrhythmias and acute pancreatitis, usually accompanied by liver dysfunction and hepatotoxicity, have been reported.
With prolonged use of the drug in high doses, aplastic anemia, pancytopenia, agranulocytosis, neutropenia, leukopenia, and thrombocytopenia may develop from the hematopoietic system. When taking large doses, dizziness, psychomotor agitation, and disorientation may occur from the central nervous system; nephrotoxicity (renal colic, interstitial nephritis, capillary necrosis) may occur from the urinary system.
Dicyclomine hydrochloride. Tachycardia, bradycardia, arrhythmia, change in respiratory rate, dry mouth, agitation, drowsiness, loss of accommodation, photophobia, convulsions, dry skin and mucous membranes, increased intraocular pressure, headache, dizziness, excitation of the central nervous system, urinary retention, psychomotor agitation, disorientation.
Overdose develops in two stages: first, there is excitation of the central nervous system, manifested by anxiety, hallucinations, the occurrence of persistent mydriasis, tachycardia, and arterial hypertension. Then, the excitation is replaced by a phase of central nervous system depression up to a comatose state.
Treatment. Paracetamol overdose requires immediate medical attention. Treatment should be started as soon as possible. The patient should be taken to 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. Gastric lavage and activated charcoal should be considered (if the overdose of paracetamol was taken within 1 hour). Paracetamol concentrations should be measured 4 hours or later after ingestion (earlier concentrations are unreliable). If necessary, N-acetylcysteine should be administered intravenously to the patient within 24 hours of ingestion, but the maximum protective effect occurs when it is administered within 8 hours of ingestion while monitoring the respiratory and circulatory systems (adrenaline should not be used). The effectiveness of the antidote decreases sharply after this time. In case of convulsions, diazepam is prescribed. In the absence of vomiting, oral methionine may be used as a suitable alternative in remote areas outside the hospital.
There is no specific antidote to dicyclomine hydrochloride.
If necessary, symptomatic therapy and peritoneal dialysis are performed.
General supportive measures should also be taken.
Adverse reactions
The drug is usually well tolerated. Side effects associated with the active substances included in the drug appear, as a rule, with prolonged use of the drug in high doses.
Paracetamol
From the digestive tract: nausea, vomiting, decreased appetite, constipation, diarrhea or flatulence. With prolonged use of high doses of the drug - pain in the epigastric region.
From the liver and biliary tract: increased activity of liver enzymes, usually without the development of jaundice, impaired liver function, hepatonecrosis (dose-dependent effect), hepatotoxic effect.
On the part of the endocrine system: hypoglycemia (up to hypoglycemic coma).
From the blood and lymphatic system: hemolytic anemia, thrombocytopenia; aplastic anemia, pancytopenia, sulfhemoglobinemia and methemoglobinemia (cyanosis, shortness of breath, heart pain), neutropenia, agranulocytosis, leukopenia, bruising, bleeding.
From the urinary system: difficulty urinating, renal colic, aseptic pyuria, interstitial glomerulonephritis; nephrotoxic effect, papillary necrosis.
On the part of the immune system: hypersensitivity reactions, allergic reactions, including skin rash, rash on the mucous membranes, itching, urticaria, hyperemia; bronchial obstruction, erythema multiforme exudative (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome); anaphylaxis, generalized rash, angioedema, angioedema, erythematous rash.
Respiratory and thoracic disorders: bronchospasm in patients sensitive to aspirin and other nonsteroidal anti-inflammatory drugs.
From the side of the central nervous system (usually when taking high doses): dizziness, psychomotor agitation and disorientation, tinnitus, psychosis, coma.
Others: general weakness.
Dicyclomine hydrochloride
Skin and subcutaneous tissue disorders: rash, pruritus, urticaria, severe allergic reactions or drug idiosyncrasy, including anaphylaxis.
On the part of the digestive tract: dry mouth, thirst, taste disturbances, digestive disorders, anorexia, nausea, vomiting, flatulence, constipation, abdominal pain.
On the part of the organs of vision: blurred vision, diplopia, mydriasis, cycloplegia of vision (paralysis of accommodation), increased intraocular pressure.
From the side of the central nervous system and psyche: dizziness, fatigue, impaired sensitivity, impaired gait stability, dyskinesia, tingling sensation, numbness in the extremities, tinnitus, headache, dysphasia, dysarthria, ataxia, euphoria, inadequate emotional reactions (symptoms decrease 12–24 hours after dose reduction), insomnia, drowsiness, hallucinations, general weakness, mood changes, nervousness, disorientation, short-term memory loss, psychosis, confusion and/or agitation, dyskinesia, lethargy, loss of consciousness, coma.
From the cardiovascular system: tachycardia, arrhythmia, palpitations.
Urinary system disorders: urinary incontinence, urinary retention.
Musculoskeletal and connective tissue disorders: muscle weakness.
On the part of the respiratory system and chest organs: dyspnea, apnea, asphyxia, nasal congestion, sneezing, throat hyperemia.
From the endocrine system: suppression of lactation, impotence.
Others: feeling of hot flashes, decreased sweating.
Expiration date
3 years.
Storage conditions
Store in a dry place, protected from light, at a temperature not exceeding 30 ° C. Keep out of the reach of children.
Packaging
10 tablets in a strip; 1 or 10 strips in a cardboard box.
Vacation category
No. 10 - without a prescription.
No. 100 - by prescription.
Producer
Cadila Pharmaceuticals Limited, India.
1389, Trasad Road, Dholka - 382 225, Ahmedabad, Gujarat, India/1389, Trasad Road, Dholka - 382 225, Ahmedabad, Gujarat, India.
