INSTRUCTION

for medical use of the preparation

SPASGO

Composition of the medicinal preparation.

Active substance: paracetamol, dicyclomine hydrochloride;

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

Auxiliary substances: corn starch, gelatin, sodium methylparaben (E 219), sodium propylparaben (E 217), sodium metabisulfite (E 223), polyvinylpyrrolidone (К-30), magnesium stearate, talc, sodium starch glycolate.

Medicinal form. Tablets.

Round flat tablets of white or off-white color, with a score on one side, with a bevelled edge.

Name and Address of the Manufacturer. Flamingo Pharmaceuticals Ltd.

7/1, Corporate Park, Sion-Trombay Road, Chembur, Mumbai – 400 071, India

E-28, MIDS, Taloja, Mumbai 410208, India.

Name and location of the marketing company. Ananta Medicare Ltd.

Suite 1, 2 Station Court, Imperial Wharf, Townmead Road, Fulham, SW6 2PY, London, United Kingdom.

Pharmacotherapeutical group.

Analgetics and antipyretics. Paracetamol, combinations without psycholeptic.

ATC code N02B E51.

Paracetamol acts as an analgetic and antipyretic agent. The analgetic and antipyretic action of paracetamol (non-opium, non-salicylate analgetic) is conditioned by the influence of the preparation on thermoregulation centre in hypothalamus and it inhibits the synthesis of prostaglandins.

Dicyclomine hydrochloride is a tertiary amine. It has an anticholinergic action and decreases the tone of smooth muscles, relieves pain, blocks antagonistic activity. Dicyclomine hydrochloride paralizes the selectively M-cholinoreactive structures, blocking impulse conduction of prostaglandin cholinergic nerves to their innervated effector organs. It causes smooth muscle relaxation, having spasmolytic effect in case of smooth muscle spasms of the stomach, and intestine, bile-excreting tract, urogenital and vascular systems.

Indications.

Pain syndromes with spastic component of different origin:

• headache;

• toothache;

• muscle pain, neuralgia;

• reumatic pain, radiculitis;

• renal colic;

• menstrual pain.

Contraindications.

Glaucoma, tachycardia, urinary obstruction, myasthenia, hypersensitivity to the components of the preparation, severe hepatic and/or renal dysfunction, glucose-6-phosphate dehydrogenase deficiency, alcoholism, blood disorders, including anemia, leucopenia. Obstructive diseases of gastro-intestinal tract, urogenital and bile-excreting tracts. Peptic ulcer of the stomach or duodenal ulcer. Reflux-esophagitis. Acute hemorrhage. Benign prostatic hypertrophy with a trend to urinary retention. Dynamic intestinal obstruction. Severe hepatic and renal diseases. Congenital hyperbilirubinemias (Gilbert's syndrome, Dubin-Johnson syndrome, Rotor's syndrome).

Proper safety measures at use.

In case of paracetamol use it is necessary to control the picture of peripheral blood and functional state of the liver. It is not recommended for concomitant use with other paracetamol-containing preparations due to possibility of overdose.

In case of indication of the preparation for more than 3 days, doctor’s control of patient’s state is necessary.

The preparation should be used with caution in elderly patients as well as in those, who abuse alcohol.

The preparation is indicated with caution to the patients with cardiac insufficiency, pyloric stenosis, hepatic and renal dysfunction.

The preparation may increase gastroesophageal reflux.

The risk of hepatotoxic action of paracetamol is increased in patients with alcohol-induced liver injury.

Paracetamol may influence the results of laboratory tests for glucose and uric acid content.

The preparation is indicated with caution to the patients with arterial hypotension, bronchospasm tendency, as well as with individual hypersensitivity to nonsteroidal anti-inflammatory drugs. In case of long-term use, it is necessary to control cell composition of peripheral blood and functional state of the liver.

Dicyclomine should be indicated with caution to the patients with nonspecific ulcerative colitis (danger of paralytic obstruction development), hernia of esophageal opening, which is accompanied with reflux-esophagitis.

The preparation is indicated with caution at high ambient temperature (due to decreased perspiration, there is an increased possibility of hyperthermia and thermal shock.

Special precautions.

Use during pregnancy and lactation.

The preparation is not used in women during pregnancy or lactation period.

Ability to influence reaction rate when driving or working with other mechanisms.

Taking into consideration the fact, that the preparation may decrease the rate of psychomotor reaction in sensitive patients, during therapy with the preparation it is better to abstain from driving or working with other mechanisms, which require concentration of attention.

Children.

The preparation is not indicated to children under 7 years old.

Way of introduction and doses.

The preparation is to be taken orally with some liquid (200 ml).

Adults and children over 15 years old: 1 tablet according of the pain severity from 1 to 4 times a day.

Children: from 7 to 13 years old: ½ tablet 1 to 2 times a day.

from 13 to 15 years old: 1 tablet 1 to 3 times a day.

Maximal daily dose for adults is 2 tablets 4 times a day.

The duration of the treatment is determined individually by the doctor according to patient’s state and reaction.

Overdose.

Symptoms of paracetamol-induced overdose. It is well known that toxic action in adults is possible after the intake of 10 – 15 g of paracetamol. In this case there may occur such symptoms as: paleness of cutaneous covering, anorexia, nausea, vomiting, diarrhea, feeling of discomfort in epigastria region; increased activity of hepatic transaminases, lactate dehydrogenase, bilirubin level, as well as decreases prothrombin level; hepatotoxic effect with typical general signs (pain, weakness, adynamia, increased perspiration) and specific (hepatomegaly, jaundice, increased activity of hepatic enzymes) symptoms. Hepatotoxic effect may lead to the development of hepatonecrosis and be complicated with the development of hepatic encephalopathy (disturbed thinking, depression higher nervous activity, agitation and stupor), DIC-syndrome, hypoglycemia, metabolic acidosis, arrhythmia, cramps, suppression breathing function, coma, brain edema, hypocoagulation, collapse. Seldom liver dysfunction may develop instantly and it may be complicated with renal insufficiency.

Symptoms of dicyclomine hydrochloride-induced overdose. Tachycardia, bradycardia, arrhythmia, change of respiratory rate, dryness of the mouth, agitation, drowsiness, loss of accommodation, photophobia, cramps.

Overdose is characterized by two-phase development: first there develops an agitation of the central nervous system, which is manifested by anxiety, development of illusions, hallucinations, stable mydriasis, tachycardia, arterial hypertension. Then there occurs a suppression of the central nervous system up to comatose state.

During first 24 hours: skin paleness, nausea, anorexia, vomiting and stomachache; in 12 - 48 hours: renal and hepatic lesion with the development of hepatic insufficiency (increased activity of hepatic transaminases, dehydrogenase, increased bilirubin and prothrombin concentration level); tachycardia, arrhythmias; change of respiratory rate; pancreatitis.

Dryness of skin and mucous membranes, increase of intraocular pressure, headache, loss of consciousness, agitation of the central nervous system, urinary retention.

Treatment: gastric lavage with further use of activated charcoal, symptomatic therapy, indication of methionine in 8 - 9 hours  after overdose and N-acetylcysteine – in 12 hours (as paracetamol antidotes), monitoring of the state of the respiratory and blood systems (adrenalin should not be used). Diazepam is indicated in case of cramps development.

Side effects.

Paracetamol-induced.

From the side of gastro-intestinal tract: seldom – nausea, vomiting, lost of appetite, constipation, diarrhea or meteorism, increased activity of liver enzymes, as a rule, without jaundice development, hepatonecrosis (bi-dependent effect). In case of long-term use of significant doses of the preparation: pain in epigastria region, hepatotoxic action.

From the side of blood system: very seldom – hemolytic anemia, methemoglobinemia, thrombocytopenia; in single cases – aplastic anemia, pancytopenia, sulfhemoglobinemia, neutropenia, agranulocytosis, leucopenia.

From the side of urinary tracts: renal colic, aseptic pyuria, interstitial glomerulonephritis, very seldom – nephrotoxic action, papillary necrosis.

Allergic reactions: seldom – skin rash, rash on mucous membranes, itching, urticaria, hyperaemia; very seldom – bronchial obstruction, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis; in single cases – anaphylactic shock, angioneurotic edema.

From the side of the central nervous system: (usually develops in case of high dose intake): syncope, psychomotor agitation and disorientation.

Other: in single cases – hypoglycemia, general weakness, increased perspiration.

Dicyclomine hydrochloride-induced.

From the side of skin and subcutaneous fat: allergic reactions, skin reddening.

From the side of gastro-intestinal tract: nausea, dryness of the mouth, taste disorder, feeling of thirst, dyspepsia, constipation, anorexia, increased level of liver enzymes, as a rule, without jaundice development, hepatonecrosis (bi-dependent effect), vomiting , stomachache, meteorism.

From the side of organs of vision: mydriatic pupils with loss of accommodation and light sensitiveness, increase of intraocular pressure, blurred vision, diplopia, mydriasis, cycloplegia of the sight (paralysis of accommodation).

From the side of the central nervous system: syncope, drowsiness, headache, paresthesias, disturbed sensitivity, nervousness, dyskinesia, lethargy, insomnia, general weakness, increased fatigability, syncope states (loss of consciousness), numbness, disorder.

Allergic reactions: skin itching, skin rash, nettle rush, urticarias, dryness of the skin and other dermatological manifestations, sever allergic reactions or medicamentous idiosyncrasy, including anaphylactic reaction.

From the side of cardiovascular system: temporary bradycardia, tachycardia, arrhythmia, feeling of heart rate, hot flushes.

From the side of urinary tracts: urination disorders, urinary incontinence, urinary retention, impotence.

Mental disorders: logopathy, mental confusion and/or emotional agitation, hallucinations, change of the mood.

Disorders from the side of locomotor system and connective tissue: weakness in muscles.

From the side of respiratory system and chest organs: dyspnea, apnea, asphyxia, stuffiness of the nose, sneezing, throat hyperemia.

Disorders from the side of endocrine system: suppression of lactation.

Interaction with other drugs and other forms of interaction.

Peculiarities of preparation’s interaction are conditioned by characteristics of its components.

Paracetamol, which is present in the composition of the preparation, decreases the effectiveness of diuretics, as well as increases the risk of hepatotoxic reactions in case of concomitant use with barbiturates, diphenyl, carbamazepine, rifampicin and other inducers of microsomal liver enzymes, as well as with anticonvulsant preparations. The rate of paracetamol absorbance may increase in case of concomitant use withmetoclopramide and domperidone, and decrease in case of concomitant use with cholestyramine. The effect of paracetamol action increases in case of its combination with codeine, ascorbic acid, scopolamine, chlorphenamine, propyphenazone and caffeine. Concomitant use of paracetamol with azidothimidine may lead to neutropenia development. Anticoagulant effect of warfarin and other coumarin increases in case of long-term regular use of paracetamol. There is an increase risk of bleeding. Periodical intake has no significance. Concomitant use of paracetamol with nonsteroidal anti-inflammatory drugs increases the risk of development of renal complications. In case of concomitant use of paracetamol with hepatotoxic preparations there is an increased toxic influence of the preparations to the liver.

The effect of dicyclomine hydrochloride is increased by amantadine, antipsychotic agents, benzodiazepines, inhibitors of monoamine oxidase, narcotic analgesics, nitrates and nitrites, sympathomimetic agents, tricyclic antidepressants, cholinergic antagonists, corticosteroids; and decreased by antacids. Dicyclomine hydrochloride increases the action of digoxin.

Shelf life. 3 years.

Storage conditions.

Keep out of the reach of children in a dry protected from light place at temperature below 30ºC.

Packing.

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

Terms of dispensing.

Without prescription – tablets No 10.

On prescription – tablets No 100.

The date of the last revision.