Spazgo (paracetamol, dicyclomine hydrochloride) tablets №100

Description

Spazgo (paracetamol, dicyclomine hydrochloride) tablets №100

Composition

active substances: paracetamol, dicyclomine hydrochloride;

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

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

Dosage form

Tablets.

Basic physical and chemical properties: round, flat, white or almost white tablets, with a dash on one side, with a chamfer.

Pharmacotherapeutic group

Analgesics and antipyretics. Paracetamol, combinations without psycholeptics.
ATX code N02B E51.

Pharmacological properties

This drug belongs to the combined drugs of the group of analgesics, based on the active substances – paracetamols, in combination without psycholeptics.
Paracetamol, which is part of it, has an analgesic and antipyretic effect. This substance has the ability to increase the pain threshold, as well as antipyretic properties, acting on the centers of the hypothalamus, which are responsible for regulating body temperature.
Paracetamol does not inhibit platelet aggregation, nor does it affect prothrombin and does not produce an ulcerogenic effect on the gastrointestinal tract.
Dicyclomine hydrochloride (dicyclomine) is able to reduce the number of smooth muscle spasms in the gastrointestinal tract, is an antagonist of cholinergic, or muscarinic, receptors. Produces a direct effect on smooth muscle, probably being an antagonist of bradykinin and histamine.

Indications

This drug is used to eliminate the symptoms of pain and spasms.
It can be used as an analgesic and antispasmodic for acute, chronic, mild or moderate pain of various origins, in particular due to:

• diseases of the musculoskeletal system – rheumatism, polyarthritis, radiculitis;
• injuries;
• surgical operations;
• gynecological diseases (dysmenorrhea);
• headache, migraine;
• toothache;
• myalgia (muscle pain);
• colic and spasms – hepatic, renal, intestinal, bladder;
• dyskinesia of the biliary tract;
• oncological diseases.

Contraindications

Not applicable if the patient has hypersensitivity (allergy) to one of the components that make up the drug.
Also does not apply if a person has:

• ulcer of the stomach or duodenal ulcer in the acute stage, intestinal obstruction;
• liver failure;
• with simultaneous treatment with hepatotoxic drugs;
• severe renal dysfunction;
• severe blood clotting disorders, anemia, leukopenia;
• glaucoma;
• gastrointestinal diseases;
• hypertrophy of the prostate;
• severe heart failure, angina pectoris, tachycardia;
• alcoholism, drug addiction;
• fever, flu or SARS;
• suspicion of surgical pathology.

Not used in pediatrics up to 7 years.

Application during pregnancy and lactation

It is contraindicated to use for the treatment of pregnant or lactating women. It can impair fertility, therefore it is not recommended for women who are planning a pregnancy.

Method of administration and dosage

This drug Spasgo is used orally, after meals, with a sufficient amount of liquid.
Take 1-2 tablets 1-4 times a day, dissolved in a glass of water. The maximum dose per day is 3 tablets.
Start taking 4 tablets a day. Maximum per day is permissible to take no more than 8 tablets per day (provided that the drug is well tolerated).
Children’s dosages:

• from 7 to 13 years old – half a tablet 1-2 times a day;
• 13-15 years old – 1 tablet 1-3 times a day;
• from 15 and older – 1-2 tablets, 1-4 times a day.

The maximum duration of the course of treatment is 5 days. At the same time, the duration of treatment should be as short as possible. If, after taking within 2 weeks, there is no effect from the admission, it is canceled.
The elderly and those with mild to moderate renal impairment do not require dose adjustment.
You should not take the drug with creatinine clearance less than 30 ml per minute.

Overdose

An overdose of the specified drug can cause symptoms such as:

• drowsiness, lethargy, pallor;
• nausea, vomiting, epigastric pain;
• gastrointestinal bleeding;
• arterial hypertension;
• acute renal failure;
• respiratory depression;
• metabolic acidosis, disorders of glucose metabolism;
• liver failure;
• cardiac arrhythmia, pancreatitis;
• nephritis;
• anaphylactic reactions, coma.

Long-term use can cause pancytopenia, agranulocytosis, neutropenia,
Symptomatic therapy, peritoneal dialysis is recommended. Hemodialysis is not effective. In a state of excitement, convulsions – take diazepam. In case of an overdose of paracetamol, it is necessary to monitor the state of the respiratory system.
No antidote has been identified.
It is necessary to wash the stomach, take enterosorbents.

Side effects

Therapy with this drug, in case of manifestations of a hypersensitivity reaction, can cause allergic reactions in the form of:

• rash, itching, erythema, dermatitis, angioedema, edema of the face, mucous membrane of the mouth, tongue, toxic epidermal necrolysis;
• dyspeptic symptoms – nausea, vomiting, diarrhea;
• gastritis, stomatitis, stomach ulcer, gastrointestinal bleeding;
• jaundice, hepatitis;
• hypoglycemia;
• drowsiness, headache, encephalopathy;
• anxiety, nervousness, nightmares;
• edema, dysuria, hematuria, urinary retention, oliguria, renal failure;
• anemia, eosinophilia, purpura, thrombocytopenia;
• anaphylactic shock;
• dyspnea, asthma, bronchospasm;
• tachycardia, arterial hypertension, hot flashes, collapse;
• asthenia, hypothermia;
• tachycardia, headache, paresthesia, dry mouth, thirst, urticaria, anorexia;
• muscle weakness, erectile dysfunction;
• diplopia, mydriasis, increased intraocular pressure, apnea, nasal congestion, redness of the throat;
  oppression of lactation.

If you have any unusual side effects as a result of taking this drug, you should consult your doctor about possible changes in the treatment regimen.