Combispasm Gastrocomfort film-coated tablets 20 pcs.

Pharmacodynamics of Combispasm Gastrocomfort. Dicyclomine hydrochloride has an antispasmodic effect (eliminates spasm of smooth muscles in the gastrointestinal tract, abdominal pain associated with this spasm or stretching of the gastrointestinal tract wall) and an antisecretory effect on the excretory glands. The action of dicyclomine consists in a specific anticholinergic (antimuscarinic) effect on cholinergic receptors, as well as a direct antispasmodic effect on smooth muscles.

Simethicone is a surfactant, defoamer. The mechanism of action is based on reducing the surface tension of gas bubbles, promotes the free removal of gases from the gastrointestinal tract or their absorption by the intestinal wall. Simethicone improves the quality of radiographs and sonograms, provides better distribution of contrast agents on the intestinal mucosa.

Pharmacokinetics. Dicyclomine hydrochloride is rapidly absorbed from the gastrointestinal tract when taken orally, C _max in blood plasma is reached after 60-90 minutes, excreted mainly in the urine (79.5% of the administered dose), partially in the feces (8.4%). T _½ – 1.8 hours. The average volume of distribution is 3.65 l / kg.

Simethicone is a physiologically and chemically inert substance; it is not absorbed and is excreted unchanged after passing through the digestive tract.

Treatment of conditions accompanied by spasm of smooth muscles of the gastrointestinal tract and flatulence, as well as associated abdominal pain.

Treatment of spastic conditions of the gastrointestinal tract, including colitis, intestinal colic, irritable bowel syndrome, and spastic constipation.

In the complex treatment of organic diseases of the gastrointestinal tract, such as colitis, diverticulitis, enteritis, gastritis, and peptic ulcer disease.

Adults and children over 12 years of age: the drug is prescribed 1 tablet up to 4 times a day before or after meals. The maximum daily dose is 4 tablets. The duration of treatment is up to 5 days.

Hypersensitivity to the active substances or other components of the drug, intestinal obstruction, obstructive diseases of the urinary tract, prostate adenoma with difficulty urinating, renal failure, obstructive diseases of the gastrointestinal tract, severe ulcerative colitis or toxic megacolon, reflux esophagitis, unstable cardiovascular system with acute bleeding, glaucoma, myasthenia gravis, thyrotoxicosis, heart failure.

On the part of the digestive system: dry mouth, loss of taste, anorexia, nausea, vomiting, indigestion, feeling of bloating, abdominal pain, constipation.

From the side of the central nervous system: tinnitus, headache, drowsiness, weakness, nervousness, psychosis, numbness, dizziness, coma, confusion and / or agitation (especially in the elderly), dyskinesia, insomnia, disorientation, short-term memory loss, hallucinations, dysarthria, ataxia, euphoria, inadequate emotional reactions (symptoms decrease 12-24 hours after reducing the dose).

On the part of the organ of vision: blurred vision, double vision, pupil dilation, accommodation paralysis, increased intraocular pressure (short-term atropine-like effects that disappear after discontinuation of dicyclomine).

Skin/allergic reactions: hypersensitivity reactions, including allergic dermatitis, pruritus, rash, urticaria, erythema, drug idiosyncrasy, angioedema, anaphylactic shock.

From the genitourinary system: difficulty urinating, urinary retention.

Cardiovascular system: tachycardia, palpitations.

Respiratory system: shortness of breath, apnea, nasal congestion.

Other effects: decreased sweating, nasal congestion, sneezing, swelling of the throat mucosa, suppression of lactation.

The drug should be used with caution in patients with autonomic neuropathy, liver or kidney disease; with ulcerative colitis (use in high doses can cause paralytic ileus and the development or exacerbation of such a serious complication as toxic megacolon); with angina pectoris, coronary artery disease, congestive heart failure, tachyarrhythmia, hiatal hernia and prostatic hypertrophy.

At high ambient temperatures during treatment, overheating of the body is possible (increased body temperature and heat stroke due to decreased sweating). If relevant symptoms appear, discontinue use of the drug and consult a doctor.

Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in individuals with an ileostomy or colostomy. In such cases, treatment with the drug is inappropriate and may be harmful.

In individuals with individual hypersensitivity to anticholinergics, the drug may cause CNS effects such as confusion, disorientation, ataxia, increased fatigue, or vice versa – euphoria, excitement, insomnia, affective state. Usually these symptoms disappear within 12-24 hours after discontinuation of the drug.

Use during pregnancy and breastfeeding. The safety of the drug in pregnant women has not been established, so it should not be used during pregnancy.

Since dicyclomine hydrochloride passes into breast milk, the drug is contraindicated during breastfeeding.

Children. The drug is used in children over 12 years of age.

Ability to influence the reaction rate when driving or operating other mechanisms. Dicyclomine hydrochloride may cause drowsiness and blurred vision. When using the drug, you should not drive or operate other mechanisms.

Amantadine, class I antiarrhythmic drugs (e.g. quinidine), antihistamines, antipsychotics (e.g. phenothiazines), benzodiazepines, MAO inhibitors, narcotic analgesics (e.g. meperidine), nitrates and nitrites, sympathomimetics, tricyclic antidepressants and other drugs with anticholinergic activity may enhance the effect or increase the severity of side effects of dicyclomine.

Anticholinergic agents, including Dicyclomine, can neutralize the effect of antiglaucoma agents, so the drug should be prescribed with caution in cases of increased intraocular pressure and concomitant use of corticosteroids.

Anticholinergics, including dicyclomine, may alter the absorption of some drugs in the gastrointestinal tract, in particular long-acting digoxin, which may cause an increase in plasma digoxin concentrations.

Dicyclomine may neutralize the effects of drugs that alter gastrointestinal motility, such as metoclopramide.

Since antacids may reduce the absorption of anticholinergics, including dicyclomine, their concomitant use should be avoided.

The inhibitory effect of anticholinergic agents, including dicyclomine, on gastric acid secretion may neutralize drugs used in the treatment of patients with achlorhydria and for the study of gastric secretion.

The absorption of levothyroxine in the intestine may be impaired when taken simultaneously with simethicone.

Symptoms: headache, nausea, vomiting, dry mouth, difficulty swallowing, blurred vision, dilated pupils, hot and dry skin, dizziness, tachycardia, change in respiratory rate, psychomotor agitation. possible curare-like effect (neuromuscular blockade, feeling of weakness in the muscles and paralysis).

Treatment: symptomatic, in the first hours it is recommended to induce vomiting and wash the stomach.

In the original packaging at a temperature not exceeding 25 °C.