INSTRUCTION

for medical use of the medicinal product

 SPASGO

 

Composition:

active substance: paracetamol, dicyclomine hydrochloride;

1 tablet contains paracetamol 500 mg and dicyclomine hydrochloride 20 mg;

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

 

Pharmaceutical form. Tablets.

Basic physical and chemical properties: round, flat, white or almost white tablets with a score line on one side and facet on the other.

 

Pharmacotherapeutic group. Analgesics and antipyretics. Paracetamol combinations excluding psycholeptics. ATC code: N02B E51.

 

Pharmacological properties.

Pharmacodynamics.

Paracetamol has an analgesic and antipyretic effect. Analgesic and antipyretic action of paracetamol (non-opiate, non-salicylate analgesics) is connected with its influence on thermoregulatory centre in the hypothalamus and the ability to inhibit the synthesis of prostaglandins.

Dicyclomine hydrochloride is a tertiary amine. It has an anticholinergic activity and reduces the tonus of smooth muscles, eliminates pain, blocks an antagonist activity. Dicyclomine hydrochloride selectively paralyzes M-cholinoreactive structures, by blocking the transmission of impulses of postganglionic cholinergic nerves to innervate effector organs. It causes relaxation of smooth muscles, by exhibiting antispasmodic effect in smooth muscle spasms of the stomach, intestine, biliary tract, urogenital and circulatory systems.

 

Clinical particulars.

Indications.

Pain syndromes with spastic component of different aetiology:

• - Headache;
• - Toothache;
• - Muscle pain, neuralgia;
• - Rheumatic pain, radiculitis;
• - Renal colic;
• - Menstrual pain.

 

Contraindications.

Glaucoma, tachycardia, urinary tract obstruction, myasthenia gravis, hypersensitivity to the preparation components, severe renal and/or liver failure, glucose-6-phosphatedehydrogenase deficiency, alcoholism, blood disorders including anaemia and leukopenia. Obstructive gastrointestinal, urogenital, biliary diseases. Peptic ulcer of the stomach or duodenum. Reflux esophagitis. Acute haemorrhage. Benign prostatic hypertrophy with a tendency to urinary retention. Dynamic ileus. Severe liver and renal diseases. Congenital hyperbilirubinemia (Gilbert syndrome, Dubin-Johnson and Rotor syndromes).

 

Interaction with other medicinal products and other forms of interaction.

Peculiarities of interaction of the drug are caused by the properties of its components.

Paracetamol, which enters into the composition of the drug, reduces the diuretics efficacy and increases the risk of hepatotoxic reactions in co-administration of barbiturates, biphenyl, carbamazepine, rifampicin and other inducers of microsomal liver enzymes and anticonvulsants. The rate of absorption of paracetamol may be increased in concomitant use of metoclopramide and domperidone, and decreased in concomitant use of cholestyramine. The effect of paracetamol is enhanced in concomitant use of codeine, ascorbic acid, scopolamine, chlorphenamine, propyphenazonum and caffeine. Concomitant use of paracetamol with azidothymidine may lead to neutropenia. Anticoagulant effect of warfarin and other coumarins is enhanced due to prolonged regular use of paracetamol. Increased risk of bleeding. Periodic intake is not important. Concomitant use of paracetamol with NSAIDs increases the risk of complications in the kidneys. Concomitant use of paracetamol with hepatotoxic agents increases the toxic effect on the liver. Caution is advised when paracetamol is used concomitantly with flucloxacillin, as such co-administration is associated with high anion gap metabolic acidosis resulting from pyroglutamic acidosis, particularly in patients with risk factors (see section “Precautions for use”).

Dicyclomine hydrochloride effect is enhanced by amantadine, antipsychotic agents, benzodiazepines, MAO inhibitors, narcotic analgesics, nitrates and nitrites, sympathomimetic, tricyclic antidepressants, anticholinergics, corticosteroids; and it is reduced by antacids. Dicyclomine hydrochloride increases digoxin activity.

 

Precautions for use.

It is necessary to consult your doctor regarding the use for patients with impaired renal and liver function.

Before using the medicinal product, patients should consult a doctor if they are taking warfarin or similar medicinal products with an anticoagulant effect.

During treatment with paracetamol, monitoring of peripheral blood counts and liver function is required. Concomitant use with other medicinal products containing paracetamol is not recommended due to the risk of exceeding the recommended dose.

If the medicinal product is prescribed for more than 3 days, the patient’s condition must be monitored by a doctor.

Caution should be exercised in elderly patients and in individuals who abuse alcohol.

The product should be used with caution in patients with heart failure, pyloric stenosis, or impaired renal or hepatic function.

It may increase gastroesophageal reflux.

The risk of paracetamol-induced hepatotoxicity is increased in patients with alcoholic liver disease.

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

Cases of high anion gap metabolic acidosis (HAGMA) resulting from pyroglutamic acidosis have been reported in patients with severe conditions such as severe renal failure and sepsis, or in malnourished patients or those with other causes of glutathione deficiency (e.g. chronic alcoholism), who used paracetamol at therapeutic doses for extended periods, or in those taking a combination of paracetamol and flucloxacillin. If HAGMA due to pyroglutamic acidosis is suspected, paracetamol should be discontinued immediately and the patient’s condition should be closely monitored. Measurement of urinary 5-oxoproline levels may help identify pyroglutamic acidosis as the underlying cause of HAGMA in patients with multiple risk factors.

The product should be prescribed with caution in patients with arterial hypotension, a tendency to bronchospasm, and in those with increased individual sensitivity to non-steroidal anti-inflammatory drugs. During prolonged use, peripheral blood counts and renal function should be monitored.

Dicyclomine should be used with caution in patients with nonspecific ulcerative colitis (risk of paralytic ileus) and in patients with hiatal hernia accompanied by reflux oesophagitis.

Psychosis, confusion, ataxia, coma, euphoria, weakness, insomnia, agitation, and inappropriate emotional reactions may occur in patients taking anticholinergic medicinal products (symptoms usually resolve within 12–24 hours after dose reduction).

Caution is advised in conditions of high ambient temperature (reduced sweating may increase the likelihood of hyperthermia and heat stroke).

Patients taking analgesics daily for mild arthritis should consult a doctor.

Do not exceed the recommended doses.

If symptoms persist, seek medical advice.

If headache becomes persistent, consult a doctor.

 

Pregnancy and lactation.

Do not use for pregnant and breastfeeding women

 

Effects on ability to drive and use machines.

Given that the medicinal product may reduce the speed of psychomotor reactions in susceptible patients, it is advisable to refrain from driving vehicles and operating other machinery requiring concentration during treatment.

 

Method of administration and dosage.

The medicinal product should be taken orally with a small amount of liquid (200 ml).

Adults and children aged 15 years and older: 1 tablet 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 4 times daily.

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

 

Children.

Do not use for children under 7 years old.

 

Overdose.

Symptoms of overdose caused by paracetamol.

Hepatic injury is possible in adults who have taken 10 g or more of paracetamol and in children who have taken more than 150 mg/kg body weight. In patients with risk factors (prolonged treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. John’s wort or other hepatic enzyme-inducing medicinal products; regular excessive alcohol consumption; glutathione depletion such as digestive disorders, cystic fibrosis, HIV infection, starvation or cachexia), intake of 5 g or more of paracetamol may result in liver damage.

Early symptoms of overdose during the first 24 hours include pallor, nausea, vomiting, anorexia and abdominal pain. Hepatic injury may become apparent 12–48 hours after overdose. Glucose metabolism disorders and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, coma and death. Acute renal failure with acute tubular necrosis may develop, presenting with severe lumbar pain, haematuria and proteinuria, and may occur even without severe liver injury. Cardiac arrhythmia and pancreatitis have also been reported.

When the medicinal product is taken in high doses for a prolonged period, haematological disorders such as aplastic anaemia, pancytopenia, agranulocytosis, neutropenia, leukopenia and thrombocytopenia may occur. High doses may also cause dizziness, psychomotor agitation and disorientation (central nervous system), and nephrotoxicity (renal colic, interstitial nephritis, capillary necrosis).

In the event of overdose, urgent medical care is required. The patient should be taken to hospital immediately, 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 the risk of organ injury. Activated charcoal should be considered if excessive paracetamol has been ingested within 1 hour. Plasma paracetamol concentration should be measured 4 hours or more after ingestion (earlier measurements are unreliable). Treatment with N-acetylcysteine may be used within 24 hours of ingestion, with maximum protective effect when given within 8 hours. Antidote effectiveness decreases sharply thereafter. If necessary, N-acetylcysteine should be administered intravenously according to established dosing guidelines. If vomiting is absent, oral methionine may be used as an appropriate alternative in remote areas outside the hospital.

Symptoms of overdose caused by dicyclomine hydrochloride.

Tachycardia, bradycardia, arrhythmia, altered respiratory rate, dry mouth, agitation, drowsiness, loss of accommodation, photophobia, seizures.

Overdose is biphasic: initially, central nervous system stimulation occurs, manifested by restlessness, illusions, hallucinations, persistent mydriasis, tachycardia and arterial hypertension. This is followed by central nervous system depression up to a comatose state.

During the first 24 hours: pallor, nausea, anorexia, vomiting and abdominal pain. After 12–48 hours: renal and hepatic injury with development of hepatic failure (increased hepatic transaminases, dehydrogenase, bilirubin and prothrombin levels); tachycardia, arrhythmias; altered respiratory rate; pancreatitis.

Dry skin and mucous membranes, increased intraocular pressure, headache, dizziness, central nervous system agitation, 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 to paracetamol), monitoring of respiratory and cardiovascular function (adrenaline must not be used). Diazepam should be administered in case of seizures.

 

Adverse reactions.

Caused by paracetamol.

Gastrointestinal disorders: rare – nausea, vomiting, loss of appetite, constipation, diarrhea or flatulence, increased hepatic enzymes activity, usually without development of jaundice, hepatonecrosis (dose-dependent effect). Epigastric pain and hepatotoxic effects may occur in the long-term intake of high doses of the drug.

Blood system disorders: very rare – haemolytic anaemia, sulphohemoglobinemia and methemoglobinemia (cyanosis, shortness of breath, pain in the heart), thrombocytopenia; in rare cases - aplastic anaemia, pancytopenia, neutropenia, agranulocytosis, leukopenia.

Renal and urinary disorders: renal colic, aseptic pyuria, interstitial glomerulonephritis, very rare - nephrotoxicity, papillary necrosis.

Allergic reactions: rare – skin rash, rash on the mucous membranes (usually generalized rash, urticaria), itching, hyperaemia; very rare – bronchial obstruction, multiforme exudative erythema (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome); in rare cases - anaphylactic shock, angioedema.

Central nervous system disorders: dizziness, psychomotor agitation and disorientation (usually develops when taking high doses).

Endocrine system disorders: in rare cases – hypoglycaemia, up to hypoglycaemic coma.

Respiratory system disorders: bronchospasm in patients sensitive to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs.

Other: in rare cases – general weakness, increased sweating.

Metabolism and nutrition disorders: high anion gap metabolic acidosis* (frequency – unknown).

* Cases of high anion gap metabolic acidosis resulting from pyroglutamic acidosis have been observed in patients with risk factors who used paracetamol (see section “Precautions for use”). Pyroglutamic acidosis may occur due to low glutathione levels in these patients.

Caused by dicyclomine hydrochloride.

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

Gastrointestinal disorders: nausea, dry mouth, dysgeusia, thirst, dyspepsia, constipation, anorexia, increased hepatic enzymes activity, usually without development of 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, paraesthesia, disturbance of sensitivity, nervousness, dyskinesia, lethargy, insomnia, weakness, increased fatigue, syncope (loss of consciousness), numbness, gait disturbance.

Allergic reactions: itching, skin rash, urticaria, dry skin and other dermatological manifestations of severe allergic reactions or drug idiosyncrasy reaction, including anaphylaxis.

Cardiovascular disorders: temporary bradycardia, tachycardia, arrhythmia, palpitation, hot flushes.

Renal and urinary disorders: urination disorders, urinary incontinence, urinary retention, impotence.

Psychiatric disorders: speech disorders, confusion and/or emotional arousal, hallucinations, mood changes.

Musculoskeletal and connective tissue disorders: weakness in muscles.

Respiratory, thoracic and mediastinal disorders: dyspnoea, apnoea, asphyxia, nasal congestion, sneezing, hyperaemia of throat.

Endocrine system disorders: suppression of lactation.

 

Adverse Reactions Reporting

Adverse reactions reporting after the registration of a medicinal product is of great importance. It enables the monitoring of the benefit/risk ratio associated with the use of the medicinal product. Healthcare professionals, pharmacists, as well as patients or their legal representatives, should report all suspected adverse reactions and cases of lack of efficacy of the medicinal product via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

 

Shelf-life.

3 years.

 

Storage conditions.

Store in the original package at temperature not exceeding 30 °С. Keep out of the reach of children.

 

Package.

10 tablets in a blister, 1-10 blisters in a pack.

 

Terms of dispensing. 

No prescription – tablets № 10.

On prescription – tablets № 100.

 

 

Date of last update.

21.08.2025