Spazgo

Instructions for Medical Use of the Medicinal Product SPASGO (SPASGO)

Composition:

Active substances: paracetamol, dicycloverine hydrochloride;

One tablet contains 500 mg of paracetamol and 20 mg of dicycloverine hydrochloride;

Excipients: maize starch, gelatin, sodium methylparaben (E 219), sodium propylparaben (E 217), sodium metabisulfite (E 223), polyvinylpyrrolidone (K-30), magnesium stearate, talc, sodium starch glycolate.

Pharmaceutical form. Tablets.

Main physicochemical properties: round, flat tablets of white or almost white color, with a score on one side and beveled edges.

Pharmacotherapeutic group. Analgesics and antipyretics. Paracetamol combinations without psychotropic agents. ATC code N02BE51.

Pharmacological properties.

Pharmacodynamics.

Paracetamol acts as an analgesic and antipyretic agent. The analgesic and antipyretic effects of paracetamol (a non-opiate, non-salicylate analgesic) are associated with the drug's action on the thermoregulatory center in the hypothalamus and its ability to inhibit prostaglandin synthesis.

Dicyclomine hydrochloride is a tertiary amine. It has anticholinergic activity, reduces smooth muscle tone, relieves pain, and blocks antagonistic activity. Dicyclomine hydrochloride selectively paralyzes M-cholinoreactive structures by blocking the transmission of impulses from postganglionic cholinergic nerves to the effector organs they innervate. It causes relaxation of smooth muscles, producing a spasmolytic effect in spasms of the smooth muscles of the stomach, intestines, biliary tract, genitourinary system, and blood vessels.

Clinical characteristics.

Indications.

Pain syndromes with a spastic component of various origins:

• headache;
• dental pain;
• muscle pain, neuralgia;
• rheumatic pain, radiculitis;
• renal colic;
• menstrual pain.

Contraindications.

Glaucoma, tachycardia, urinary tract obstruction, myasthenia, hypersensitivity to the components of the drug, severe impairment of kidney and/or liver function, glucose-6-phosphate dehydrogenase deficiency, alcoholism, blood disorders, including anemia and leukopenia. Obstructive diseases of the gastrointestinal tract, urogenital tract, and biliary tract. Peptic ulcer of the stomach or duodenum. Reflux esophagitis. Acute bleeding. Benign prostatic hyperplasia with tendency to urinary retention. Paralytic intestinal obstruction. Severe liver and kidney diseases. Congenital hyperbilirubinemias (Gilbert’s, Dubin-Johnson, and Rotor’s syndromes).

Interaction with other medicinal products and other types of interactions.

Features of drug interactions are determined by the properties of its components.

Paracetamol, included in the formulation, reduces the efficacy of diuretics and increases the risk of hepatotoxic reactions when used concomitantly with barbiturates, diphenyl, carbamazepine, rifampicin, and other inducers of microsomal liver enzymes, as well as anticonvulsants. The absorption rate of paracetamol may increase when used concomitantly with metoclopramide and domperidone, and decrease when used with cholestyramine. The analgesic effect of paracetamol is enhanced when combined with codeine, ascorbic acid, scopolamine, chlorphenamine, propyphenazone, and caffeine. Concurrent 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, increasing the risk of bleeding. Occasional use is not significant. Concurrent use of paracetamol with nonsteroidal anti-inflammatory drugs increases the risk of renal complications. Concurrent use of paracetamol with hepatotoxic agents increases the toxic effects of drugs on the liver. Caution is advised when using paracetamol concomitantly with flucloxacillin, as this combination has been associated with metabolic acidosis with a high anion gap due to pyroglutamic acidosis, especially in patients with risk factors (see section "Special precautions").

The effect of dicyclomine hydrochloride is enhanced by amantadine, antipsychotic agents, benzodiazepines, MAO inhibitors, narcotic analgesics, nitrates and nitrites, sympathomimetics, tricyclic antidepressants, anticholinergics, corticosteroids; and reduced by antacids. Dicyclomine hydrochloride enhances the effect of digoxin.

Special precautions for use.

Consult a physician regarding the possibility of using the drug in patients with impaired kidney or liver function.

Consult a physician before using the drug if the patient is taking warfarin or similar agents with anticoagulant effects.

When using paracetamol, monitoring of peripheral blood picture and liver function is required. Concurrent use with other paracetamol-containing medications is not recommended due to the risk of exceeding the maximum dose.

If the drug is prescribed for longer than 3 days, medical supervision of the patient's condition is necessary.

Use with caution in elderly patients and in individuals who abuse alcohol.

Prescribe with caution in patients with heart failure, pyloric stenosis, or impaired kidney or liver function.

May exacerbate gastroesophageal reflux.

The risk of hepatotoxic effects of paracetamol is increased in patients with alcoholic liver disease.

Paracetamol may affect laboratory test results for blood glucose and uric acid levels.

Cases of metabolic acidosis with a high anion gap (high anion gap metabolic acidosis (HAGMA)) due to 5-oxoprolinuria have been reported in patients with severe conditions such as severe renal failure and sepsis, or in patients with malnutrition or other causes of glutathione deficiency (e.g., chronic alcoholism) who received paracetamol at therapeutic doses for prolonged periods or in combination with flucloxacillin. If HAGMA due to 5-oxoprolinuria is suspected, immediate discontinuation of paracetamol is recommended, along with careful monitoring of the patient's condition. Measurement of 5-oxoproline levels in urine may be useful in identifying 5-oxoprolinuria as the underlying cause of HAGMA in patients with multiple risk factors.

Prescribe with caution in patients with arterial hypotension, predisposition to bronchospasm, or increased individual sensitivity to nonsteroidal anti-inflammatory drugs. With prolonged use, monitor peripheral blood cell counts and kidney function.

Dicyclomine should be prescribed with caution in patients with ulcerative colitis (risk of paralytic obstruction), or hiatal hernia associated with reflux esophagitis.

In patients taking anticholinergic drugs, psychosis, confusion, ataxia, coma, euphoria, weakness, insomnia, agitation, and inappropriate emotional responses may occur (symptoms usually resolve within 12–24 hours after dose reduction).

Prescribe with caution in high ambient temperatures (due to reduced sweating, the risk of hyperthermia and heat stroke increases).

Patients who take analgesics daily for mild forms of arthritis should consult a physician.

Do not exceed the recommended doses.

If symptoms persist, consult a physician.

If headache becomes persistent, consult a physician.

Use during pregnancy or breastfeeding.

The drug should not be used in women during pregnancy or breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

Since the drug may reduce psychomotor reaction speed in sensitive patients, it is advisable to refrain from driving vehicles or operating machinery requiring concentration of attention during treatment with this drug.

Method of Administration and Dosage.

The medication should be taken orally, swallowed with a small amount of liquid (200 ml).

Adults and children aged 15 years and older: 1 tablet as needed depending on pain severity, 1 to 4 times daily.

Children aged 7 to 13 years: ½ tablet, 1 to 2 times daily.

Children aged 13 to 15 years: 1 tablet, 1 to 3 times daily.

The maximum daily dose for adults is 2 tablets taken 4 times daily.

The duration of treatment is determined individually by a physician, depending on the patient's condition and response.

Children.

The medication is contraindicated in children under 7 years of age.

Overdose.

Symptoms of overdose due to paracetamol. Liver damage is possible in adults who have ingested 10 g or more of paracetamol, and in children who have ingested more than 150 mg/kg body weight. In patients with risk factors (long-term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. John's wort, or other drugs inducing liver enzymes; chronic excessive alcohol consumption; glutathione deficiency (digestive disorders, cystic fibrosis, HIV infection, fasting, cachexia)), ingestion of 5 g or more of paracetamol may lead to liver damage.

Symptoms within the first 24 hours include pallor, nausea, vomiting, anorexia, and abdominal pain. Liver damage may become evident 12–48 hours after overdose. Disturbances in glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, hemorrhage, hypoglycemia, coma, and death. Acute renal failure with acute tubular necrosis may manifest as severe lumbar pain, hematuria, proteinuria, and may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have also been reported.

With prolonged use of high doses, hematological disorders may include aplastic anemia, pancytopenia, agranulocytosis, neutropenia, leukopenia, and thrombocytopenia. Central nervous system effects may include dizziness, psychomotor agitation, and disorientation. Urinary system effects may include nephrotoxicity (renal colic, interstitial nephritis, capillary necrosis).

In case of overdose, prompt medical assistance is required. The patient should be immediately hospitalized, even if early symptoms of overdose are absent. Symptoms may be limited to nausea and vomiting or may not reflect the severity of overdose or risk of organ damage. Activated charcoal should be considered if excessive paracetamol was ingested within the past hour. Plasma paracetamol concentration should be measured 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be administered within 24 hours after paracetamol ingestion, but maximum protective effect is achieved when administered within 8 hours. The efficacy of the antidote decreases significantly after this time. If necessary, intravenous N-acetylcysteine should be administered according to the established dosage regimen. In the absence of vomiting, oral methionine may be used as an alternative in remote areas outside hospital settings.

Symptoms of overdose due to dicyclomine hydrochloride. Tachycardia, bradycardia, arrhythmia, altered respiratory rate, dry mouth, agitation, drowsiness, loss of accommodation, photophobia, and seizures.

Overdose is characterized by a biphasic pattern: initially, central nervous system stimulation occurs, manifesting as restlessness, illusions, hallucinations, persistent mydriasis, tachycardia, and arterial hypertension. This is followed by central nervous system depression progressing to coma.

Within the first 24 hours: pallor, nausea, anorexia, vomiting, and abdominal pain; after 12–48 hours: kidney and liver damage leading to hepatic failure (increased activity of liver transaminases and dehydrogenases, elevated bilirubin and prothrombin levels); tachycardia, arrhythmias; altered respiratory rate; pancreatitis.

Dryness of the skin and mucous membranes, increased intraocular pressure, headache, dizziness, central nervous system stimulation, and urinary retention may also occur.

Treatment: gastric lavage followed by administration of activated charcoal, symptomatic therapy, administration of methionine 8–9 hours after overdose and N-acetylcysteine 12 hours after overdose (as antidotes for paracetamol), monitoring of respiratory and cardiovascular systems (adrenaline must not be used). In case of seizures, diazepam should be administered.

Adverse Reactions

Related to paracetamol.

Gastrointestinal disorders: Rarely – nausea, vomiting, loss of appetite, constipation, diarrhea, or flatulence; increased liver enzyme activity, usually without development of jaundice; hepatonecrosis (a dose-dependent effect). With long-term use of high doses of the drug – epigastric pain, hepatotoxic effects.

Blood and lymphatic system disorders: Very rarely – hemolytic anemia, sulfhemoglobinemia, and methemoglobinemia (cyanosis, dyspnea, chest pain), thrombocytopenia; in isolated cases – aplastic anemia, pancytopenia, neutropenia, agranulocytosis, leukopenia.

Renal and urinary disorders: Renal colic, aseptic pyuria, interstitial glomerulonephritis; very rarely – nephrotoxic effects, papillary necrosis.

Hypersensitivity reactions: Rarely – skin rashes, mucosal rashes (usually generalized rash, erythematous rash, urticaria), pruritus, hyperemia; very rarely – bronchial obstruction, erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome); in isolated cases – anaphylactic shock, angioneurotic edema.

Central nervous system disorders: (usually occurring with high-dose intake): dizziness, psychomotor agitation, and disorientation.

Endocrine disorders: In isolated cases – hypoglycemia, up to hypoglycemic coma.

Respiratory system disorders: Bronchospasm in patients sensitive to aspirin and other nonsteroidal anti-inflammatory drugs.

Other: In isolated cases – general weakness, increased sweating.

Metabolism and nutrition disorders: Metabolic acidosis with high anion gap* (frequency unknown).

* Cases of metabolic acidosis with high anion gap as a result of pyroglutamic acidosis have been observed in patients with risk factors who used paracetamol (see section "Special precautions"). Pyroglutamic acidosis may occur due to low glutathione levels in these patients.

Related to dicyclomine hydrochloride.

Skin and subcutaneous tissue disorders: Hypersensitivity reactions, skin redness.

Gastrointestinal disorders: Nausea, dry mouth, taste disturbances, thirst, dyspepsia, constipation, anorexia, increased liver enzyme activity (usually without jaundice), hepatonecrosis (dose-dependent effect), vomiting, abdominal pain, flatulence.

Eye disorders: Pupil dilation with loss of accommodation and light sensitivity, increased intraocular pressure, blurred vision, diplopia, mydriasis, cycloplegia (paralysis of accommodation).

Central nervous system disorders: Dizziness, drowsiness, headache, paresthesia, sensory disturbances, nervousness, dyskinesia, lethargy, insomnia, general weakness, increased fatigue, syncope (loss of consciousness), numbness, gait disturbances.

Hypersensitivity reactions: Skin pruritus, skin rashes, urticaria, urticarial eruptions, dry skin and other dermatological manifestations, severe allergic reactions or drug idiosyncrasy, including anaphylaxis.

Cardiac and vascular disorders: Transient bradycardia, tachycardia, arrhythmia, palpitations, flushing.

Renal and urinary disorders: Urination difficulties, urinary incontinence, urinary retention, impotence.

Psychiatric disorders: Speech disorders, confusion and/or emotional agitation, hallucinations, mood changes.

Musculoskeletal and connective tissue disorders: Muscle weakness.

Respiratory, thoracic and mediastinal disorders: Dyspnea, apnea, asphyxia, nasal congestion, sneezing, throat hyperemia.

Endocrine disorders: Suppression of lactation.

Reporting of adverse reactions

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continuous monitoring of the benefit-risk balance of the drug. Healthcare professionals and patients, as well as their legal representatives, should report any suspected adverse reactions and lack of efficacy through the Automated Pharmacovigilance Information System at: https://aisf.dec.gov.ua./

Shelf life.

3 years.

Storage conditions.

Keep out of reach of children.

Store in the original packaging at a temperature not exceeding 30°C.

Packaging.

10 tablets in a blister; 1 or 10 blisters per carton.

Dispensing category.

Without prescription – tablets pack of 10.

By prescription – tablets pack of 100.

Manufacturer.

Ananta Medicare Limited.

Manufacturer's address and place of business.

Chak 17 ML, Agro Food Park Road, RIICO Industrial Area, Udaipurwati, Sri Ganganagar-335002 (Rajasthan), India.

Marketing Authorization Holder.

Ananta Medicare Ltd.

Address of the Marketing Authorization Holder and/or its representative.

Suite 1, 2 Station Court, Imperial Wharf, Townmead Road, Fulham, London, United Kingdom.

Instructions

for medical use of the medicinal product

SPAZGO

(SPASGO)

Composition:

Active substances: paracetamol, dicyclomine hydrochloride;

One tablet contains 500 mg of paracetamol and 20 mg of dicyclomine hydrochloride;

Excipients: maize starch, gelatin, sodium methylparaben (E 219), sodium propylparaben (E 217), sodium metabisulfite (E 223), polyvinylpyrrolidone (K-30), magnesium stearate, talc, sodium starch glycolate.

Pharmaceutical form. Tablets.

Main physicochemical properties: round, flat tablets, white or almost white, with a score line on one side and a bevelled edge.

Pharmacotherapeutic group. Analgesics and antipyretics. Paracetamol combinations without psychotropic agents. ATC code N02BE51.

Pharmacological properties.

Pharmacodynamics.

Paracetamol acts as an analgesic and antipyretic agent. The analgesic and antipyretic effects of paracetamol (a non-opioid, non-salicylate analgesic) are associated with the drug's influence on the thermoregulatory center in the hypothalamus and its ability to inhibit prostaglandin synthesis.

Dicyclomine hydrochloride is a tertiary amine. It has anticholinergic activity, reduces smooth muscle tone, relieves pain, and blocks antagonistic activity. Dicyclomine hydrochloride selectively paralyzes M-cholinoreactive structures, blocking impulse transmission from postganglionic cholinergic nerves to the effector organs they innervate. It causes relaxation of smooth muscles, producing a spasmolytic effect in spasms of the smooth muscles of the stomach, intestines, biliary tract, genitourinary system, and blood vessels.

Clinical characteristics.

Indications.

Pain syndromes with a spastic component of various origins:

• headache;
• dental pain;
• muscle pain, neuralgia;
• rheumatic pain, radiculitis;
• renal colic;
• menstrual pain.

Contraindications.

Glaucoma, tachycardia, urinary tract obstruction, myasthenia gravis, hypersensitivity to the components of the drug, severe impairment of kidney and/or liver function, glucose-6-phosphate dehydrogenase deficiency, alcoholism, blood disorders, including anemia and leukopenia. Obstructive diseases of the gastrointestinal tract, urogenital tract, and biliary tract. Peptic ulcer of the stomach or duodenum. Reflux esophagitis. Acute bleeding. Benign prostatic hyperplasia with tendency to urinary retention. Dynamic intestinal obstruction. Severe liver and kidney diseases. Congenital hyperbilirubinemias (Gilbert, Dubin-Johnson, and Rotor syndromes).

Interaction with other medicinal products and other forms of interaction.

Specific features of drug interactions are determined by the properties of its components.

Paracetamol, included in the drug formulation, reduces the effectiveness of diuretics and increases the risk of hepatotoxic reactions when used concomitantly with barbiturates, phenytoin, carbamazepine, rifampicin, and other inducers of microsomal liver enzymes, as well as anticonvulsants. The absorption rate of paracetamol may increase when used concomitantly with metoclopramide and domperidone, and decrease when used with cholestyramine. The analgesic effect of paracetamol is enhanced when combined with codeine, ascorbic acid, scopolamine, chlorphenamine, propyphenazone, and caffeine. Concurrent use of paracetamol with azithimidine may lead to the development of neutropenia. The anticoagulant effect of warfarin and other coumarins is enhanced with prolonged regular use of paracetamol, increasing the risk of bleeding. Occasional use is not significant. Concurrent use of paracetamol with nonsteroidal anti-inflammatory drugs increases the risk of renal complications. Simultaneous use of paracetamol with hepatotoxic agents increases the toxic effect of drugs on the liver. Caution is required when using paracetamol concomitantly with flucloxacillin, as this combination has been associated with metabolic acidosis with a high anion gap due to pyroglutamic acidosis, especially in patients with risk factors (see section "Special precautions").

The effect of dicyclomine hydrochloride is enhanced by amantadine, antipsychotic agents, benzodiazepines, MAO inhibitors, narcotic analgesics, nitrates and nitrites, sympathomimetics, tricyclic antidepressants, anticholinergics, corticosteroids; it is reduced by antacids. Dicyclomine hydrochloride enhances the effect of digoxin.

Special precautions for use.

Consult a physician regarding the possibility of using the drug in patients with impaired kidney or liver function.

Consult a physician before using the drug if the patient is taking warfarin or similar anticoagulant agents.

Peripheral blood picture and liver function should be monitored during paracetamol use. Concomitant use with other medications containing paracetamol is not recommended due to the risk of overdose.

If the drug is prescribed for longer than 3 days, medical supervision of the patient's condition is required.

Use with caution in elderly patients and in individuals who abuse alcohol.

Prescribe with caution in patients with heart failure, pyloric stenosis, or impaired kidney or liver function.

May exacerbate gastroesophageal reflux.

The risk of hepatotoxic effects of paracetamol is increased in patients with alcoholic liver disease.

Paracetamol may affect laboratory test results for blood glucose and uric acid levels.

Cases of high anion gap metabolic acidosis (HAGMA) due to pyroglutamic acidosis have been reported in patients with severe underlying conditions such as severe renal failure and sepsis, or in patients with malnutrition or other causes of glutathione deficiency (e.g., chronic alcoholism) who received prolonged therapeutic doses of paracetamol or a combination of paracetamol and flucloxacillin. If HAGMA due to pyroglutamic acidosis is suspected, immediate discontinuation of paracetamol is recommended, along with careful monitoring of the patient. Measurement of 5-oxoproline levels in urine may be useful in identifying pyroglutamic acidosis as the underlying cause of HAGMA in patients with multiple risk factors.

Prescribe with caution in patients with arterial hypotension, predisposition to bronchospasm, or increased individual sensitivity to nonsteroidal anti-inflammatory drugs. With prolonged use, monitor peripheral blood cell counts and kidney function.

Dicyclomine should be used cautiously in patients with nonspecific ulcerative colitis (risk of paralytic obstruction) and in patients with diaphragmatic hiatal hernia accompanied by reflux esophagitis.

In patients taking anticholinergic drugs, psychosis, confusion, ataxia, coma, euphoria, weakness, insomnia, agitation, and inappropriate emotional responses may occur (symptoms usually subside within 12–24 hours after dose reduction).

Prescribe with caution in high ambient temperatures (due to reduced sweating, the risk of hyperthermia and heat stroke increases).

Patients taking analgesics daily for mild forms of arthritis should consult a physician.

Do not exceed the recommended doses.

If symptoms persist, consult a physician.

If headache becomes persistent, consult a physician.

Use during pregnancy or breastfeeding.

The drug should not be used in women during pregnancy or breastfeeding.

Ability to influence reaction speed when driving or operating machinery.

Given that the drug may reduce psychomotor reaction speed in sensitive patients, it is advisable to refrain from driving vehicles or operating machinery requiring concentration during treatment.

Dosage and Administration

The medication should be taken orally, swallowed with a small amount of liquid (200 ml).

Adults and children aged 15 years and older: 1 tablet depending on the severity of pain, from 1 to 4 times daily.

Children aged 7 to 13 years: ½ tablet from 1 to 2 times daily.

Children aged 13 to 15 years: 1 tablet from 1 to 3 times daily.

The maximum daily dose for adults is 2 tablets taken 4 times daily.

The duration of treatment is determined individually by a physician, depending on the patient's condition and response.

Children.

The medication is contraindicated in children under 7 years of age.

Overdose.

Symptoms of overdose caused by paracetamol. Liver damage is possible in adults who have ingested 10 g or more of paracetamol, and in children who have ingested more than 150 mg/kg body weight. In patients with risk factors (long-term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. John’s wort, or other drugs inducing liver enzymes; chronic excessive alcohol consumption; glutathione depletion (digestive disorders, cystic fibrosis, HIV infection, fasting, cachexia)), ingestion of 5 g or more of paracetamol may lead to liver damage.

Symptoms within the first 24 hours include pallor, nausea, vomiting, anorexia, and abdominal pain. Liver damage may become evident 12–48 hours after overdose. Disturbances in glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, hemorrhage, hypoglycemia, coma, and death. Acute renal failure with acute tubular necrosis may present with severe flank pain, hematuria, proteinuria, and may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have also been reported.

With prolonged use of the drug in high doses, hematological disorders may include aplastic anemia, pancytopenia, agranulocytosis, neutropenia, leukopenia, and thrombocytopenia. Central nervous system effects may include dizziness, psychomotor agitation, and disorientation. Urinary system effects may include nephrotoxicity (renal colic, interstitial nephritis, capillary necrosis).

In case of overdose, prompt medical assistance is required. The patient should be immediately transported to a hospital, even if early symptoms of overdose are absent. Symptoms may be limited to nausea and vomiting or may not reflect the severity of the overdose or risk of organ damage. Administration of activated charcoal should be considered if the excessive dose of paracetamol was ingested within the past hour. Plasma paracetamol concentration should be measured at least 4 hours after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be administered within 24 hours after paracetamol ingestion, but maximum protective effect is achieved when administered within 8 hours. The efficacy of the antidote decreases significantly after this time. If required, N-acetylcysteine should be administered intravenously according to the established dosing regimen. In the absence of vomiting, oral methionine may be used as an alternative in remote areas outside hospital settings.

Symptoms of overdose caused by dicyclomine hydrochloride. Tachycardia, bradycardia, arrhythmia, changes in respiratory rate, dry mouth, excitation, drowsiness, loss of accommodation, photophobia, seizures.

Overdose is characterized by a biphasic course: initially, central nervous system excitation occurs, manifesting as restlessness, illusions, hallucinations, persistent mydriasis, tachycardia, and arterial hypertension. This is followed by central nervous system depression progressing to coma.

Within the first 24 hours – pallor, nausea, anorexia, vomiting, and abdominal pain; after 12–48 hours – kidney and liver damage leading to hepatic failure (elevated liver transaminase and dehydrogenase activity, increased bilirubin and prothrombin levels); tachycardia, arrhythmias; changes in respiratory rate; pancreatitis.

Dryness of the skin and mucous membranes, increased intraocular pressure, headache, dizziness, central nervous system excitation, urinary retention.

Treatment: gastric lavage followed by administration of activated charcoal, symptomatic therapy, administration of methionine 8–9 hours after overdose and N-acetylcysteine 12 hours after (as antidotes to paracetamol), monitoring of respiratory and cardiovascular systems (adrenaline must not be used). In case of seizures, diazepam should be administered.

Adverse Reactions

Caused by paracetamol.

Gastrointestinal system: Rarely – nausea, vomiting, decreased appetite, constipation, diarrhea, or flatulence; increased liver enzyme activity, usually without development of jaundice; hepatonecrosis (dose-dependent effect). With prolonged use of significant doses – epigastric pain, hepatotoxic effect.

Blood system: Very rarely – hemolytic anemia, sulfhemoglobinemia, and methemoglobinemia (cyanosis, dyspnea, chest pain), thrombocytopenia; in isolated cases – aplastic anemia, pancytopenia, neutropenia, agranulocytosis, leukopenia.

Urinary system: Renal colic, aseptic pyuria, interstitial glomerulonephritis, very rarely – nephrotoxic effect, papillary necrosis.

Allergic reactions: Rarely – skin rashes, mucosal rashes (usually generalized rash, erythematous rash, urticaria), pruritus, hyperemia; very rarely – bronchial obstruction, erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome); in isolated cases – anaphylactic shock, angioneurotic edema.

Central nervous system: (usually occurs with high-dose intake): dizziness, psychomotor agitation, and disorientation.

Endocrine system: In isolated cases – hypoglycemia, up to hypoglycemic coma.

Respiratory system: Bronchospasm in patients sensitive to aspirin and other nonsteroidal anti-inflammatory drugs.

Other: In isolated cases – general weakness, increased sweating.

Metabolism and nutrition disorders: Metabolic acidosis with high anion gap* (frequency unknown).

* Cases of metabolic acidosis with high anion gap as a result of pyroglutamic acidosis have been observed in patients with risk factors who used paracetamol (see section "Special precautions"). Pyroglutamic acidosis may occur due to low glutathione levels in these patients.

Caused by dicyclomine hydrochloride.

Skin and subcutaneous tissue: Allergic reactions, skin redness.

Gastrointestinal system: Nausea, dry mouth, taste disturbances, thirst, dyspepsia, constipation, anorexia, increased liver enzyme activity (usually without jaundice), hepatonecrosis (dose-dependent effect), vomiting, abdominal pain, flatulence.

Eye disorders: Pupil dilation with loss of accommodation and light sensitivity, increased intraocular pressure, blurred vision, diplopia, mydriasis, cycloplegia (paralysis of accommodation).

Central nervous system: Dizziness, drowsiness, headache, paresthesia, sensory disturbances, nervousness, dyskinesia, lethargy, insomnia, general weakness, increased fatigue, syncope (loss of consciousness), numbness, gait disturbances.

Allergic reactions: Skin pruritus, skin rashes, urticaria, urticarial eruptions, dry skin and other dermatological manifestations, severe allergic reactions or drug idiosyncrasy, including anaphylaxis.

Cardiovascular system: Transient bradycardia, tachycardia, arrhythmia, palpitations, flushing.

Urinary system: Urination disorders, urinary incontinence, urinary retention, impotence.

Psychiatric disorders: Speech disorders, confusion and/or emotional excitement, hallucinations, mood changes.

Musculoskeletal and connective tissue disorders: Muscle weakness.

Respiratory, thoracic and mediastinal disorders: Dyspnea, apnea, asphyxia, nasal congestion, sneezing, throat hyperemia.

Endocrine disorders: Suppression of lactation.

Reporting of adverse reactions

Reporting suspected adverse reactions after drug registration is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients or their legal representatives should report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at: https://aisf.dec.gov.ua./

Shelf life.

3 years.

Storage conditions.

Keep out of reach of children.

Store in the original packaging at a temperature not exceeding 30°C.

Packaging.

10 tablets in a blister, 1 or 10 blisters in a carton.

Release category.

Without prescription – tablets № 10.

By prescription – tablets № 100.

Manufacturer.

Flamingo Pharmaceuticals Ltd.

Manufacturer’s address and place of business.

E-28, Opp. Fire Brigade, M.I.D.C., Talodha, Raigad District, Maharashtra, IN– 410208, India.

Marketing Authorization Holder.

Ananta Medicare Ltd.

Address of the Marketing Authorization Holder and/or its representative.

Suite 1, 2 Station Court, Imperial Wharf, Townmead Road, Fulham, London, United Kingdom.