Instructions for Movespasm film-coated tablets No. 10
Composition
active ingredients: simethicone, dicycloverine hydrochloride;
1 film-coated tablet contains simethicone 40 mg, dicycloverine hydrochloride 20 mg;
excipients: microcrystalline cellulose, pregelatinized starch, povidone, magnesium stearate, sodium starch glycolate (type A), colloidal anhydrous silica, lactose monohydrate, croscarmellose sodium, Wincoat WT-1001 (polyethylene glycol 400, titanium dioxide, hypromellose).
Dosage form
Film-coated tablets.
Main physicochemical properties: white, round, biconvex, film-coated tablets.
Pharmacotherapeutic group
Antispasmodics and anticholinergics in combination with other drugs. Antispasmodics in combination with other drugs.
ATX code A03E D.
Pharmacological properties
Pharmacodynamics
Dicyclomine hydrochloride has an antispasmodic effect (relieves spasm of smooth muscles in the gastrointestinal tract, abdominal pain associated with this spasm or with stretching of the gastrointestinal tract wall) and an antisecretory effect on the excretory glands. The action of dicyclomine is achieved due to a specific anticholinergic (antimuscarinic) effect on acetylcholine receptors, as well as a direct antispasmodic effect on smooth muscles. Studies have shown that dicyclomine is equally effective in spasms induced by acetylcholine and barium chloride. The effect of atropine on spasm caused by barium chloride is 200 times weaker than its effect on acetylcholine-induced spasm. The mydriatic effect of dicyclomine and its effect on salivary gland secretion are insignificant compared to the effects of atropine (1/500 and 1/300, respectively).
Simethicone is a surfactant, an antifoam. The mechanism of action is based on reducing the surface tension of gas bubbles, which contributes to 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 after oral administration, with peak plasma concentrations occurring within 60–90 minutes; it is excreted mainly in the urine (79.5% of the administered dose) and partially in the feces (8.4%). The mean elimination half-life is 1.8 hours. The mean 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.
Indication
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, spastic constipation. As an additional treatment of organic diseases of the gastrointestinal tract in colitis, diverticulitis, enteritis, gastritis, peptic ulcers.
Contraindication
Hypersensitivity to the components of the drug.
Paralytic ileus, obstructive diseases of the gastrointestinal tract, pyloric stenosis of the gastrointestinal tract with obstruction, severe ulcerative colitis or toxic megacolon, reflux esophagitis, unstable cardiovascular status with acute bleeding. Renal failure, obstructive kidney diseases. Prostatic adenoma with difficulty urinating, glaucoma, myasthenia gravis, thyrotoxicosis, heart failure.
Interaction with other medicinal products and other types of interactions
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, corticosteroids and other drugs with anticholinergic activity may enhance the effects or side effects of dicyclomine.
Anticholinergic drugs can neutralize the effect of antiglaucoma drugs, so the drug should be prescribed with caution in cases of increased intraocular pressure and concomitant use of corticosteroids.
Anticholinergic agents enhance the effects of digoxin, salicylic acid, pyrazolone, codeine, caffeine and other anticholinergic agents (e.g. atropine sulfate), therefore their simultaneous use with dicycloverine hydrochloride is not recommended.
Dicyclomine can neutralize the effect of drugs that alter gastrointestinal motility, such as metoclopramide. Potentiates the effect of antispasmodics.
Since antacids may reduce the absorption of anticholinergic drugs, their concomitant use should be avoided.
The inhibitory effect of anticholinergic agents on the secretion of hydrochloric acid in the stomach can be neutralized by drugs used to treat achlorhydria and study gastric secretion.
The absorption of levothyroxine in the intestine may be impaired when taken simultaneously with simethicone.
Application features
At high ambient temperatures during treatment with the drug, overheating of the body is possible (increased body temperature and heat stroke due to decreased sweating). If relevant symptoms appear, it is necessary to discontinue use of the drug and consult a doctor.
Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with an ileostomy or colostomy. In such cases, treatment with the drug should not be used.
In individuals with individual hypersensitivity to anticholinergics, the drug may cause such effects on the central nervous system as confusion, disorientation, ataxia, fatigue, or vice versa - euphoria, excitement, insomnia, affective state. These symptoms usually disappear within 12-24 hours after discontinuation of the drug.
Movespasm should be used with caution in patients with autonomic neuropathy, liver or kidney disease, ulcerative colitis (high doses may cause paralytic ileus and the development or exacerbation of a serious complication such as toxic megacolon), arterial hypertension, ischemic heart disease, congestive heart failure, tachyarrhythmias, tachycardia, hiatal hernia, and prostatic hypertrophy.
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Ability to influence reaction speed when driving vehicles or other mechanisms
Dicycloverine hydrochloride can cause drowsiness and blurred vision, therefore it is not recommended to drive vehicles and complex mechanisms that require increased concentration and high speed of psychomotor reactions while taking the drug.
Use during pregnancy or breastfeeding
The safety of treatment with dicyclomine and simethicone during pregnancy has not been established, so the drug should not be used by pregnant women.
Since dicycloverine hydrochloride passes into breast milk, the drug should not be used during breastfeeding.
Method of administration and doses
Adults and children over 12 years of age: 1 tablet up to 4 times a day.
The maximum daily dose is 4 tablets.
It is recommended to take the drug before or after meals. It is not recommended to take the drug for more than 5 days.
Children
Do not use in children under 12 years of age.
Overdose
Overdose is characterized by a two-phase nature: first, central nervous system excitation occurs, which is manifested by restlessness, the appearance of illusions, hallucinations, persistent mydriasis, tachycardia, and arterial hypertension. Then, central nervous system depression occurs, up to a comatose state.
Symptoms: headache, nausea, vomiting and abdominal pain, decreased appetite, pale skin, increased intraocular pressure, dizziness, blurred vision, dilated pupils, hot and dry skin, dry mouth, difficulty swallowing, central nervous system excitation, tachycardia, change in respiratory rate.
Curare-like effects (neuromuscular blockade, feeling of muscle weakness and paralysis) may occur.
Treatment: symptomatic therapy. In the first hours, it is recommended to induce vomiting, perform gastric lavage, and use adsorbents.
Diazepam (0.5% solution, 2 ml) is used to relieve psychomotor agitation.
Adverse reactions
The following side effects relate to the group of anticholinergic drugs, not all of them have been observed with the use of dicycloverine hydrochloride.
On the part of the digestive tract: dry mouth, loss of taste, anorexia, nausea, vomiting, indigestion, feeling of bloating, abdominal pain, constipation.
Central nervous system: tinnitus, headache, drowsiness, weakness, nervousness, psychosis, numbness, dizziness, coma, loss or confusion of consciousness and/or agitation (especially in elderly patients), dyskinesia, insomnia, disorientation, short-term memory loss, hallucinations, dysarthria, ataxia, euphoria, inadequate emotional reactions (symptoms decrease 12-24 hours after dose reduction).
On the part of the organs 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, feeling of increased heartbeat.
From the respiratory system: shortness of breath, apnea, nasal congestion.
Other effects: decreased sweating, sneezing, swelling of the throat mucosa, suppression of lactation.
Expiration date
4 years.
Storage conditions
Store out of the reach of children in the original packaging at a temperature not exceeding 25 °C.
Packaging
10 tablets in a blister, 1 blister in a cardboard box.
Without a prescription.
Producer
Meditop Pharmaceutical Ltd.
Location of the manufacturer and its business address
Hungary, Edi Endre y. 1., Pilisboroszeno, 2097.
