active substances: 1 tablet contains pnaorama bromide 50 mg or 100 mg;
excipients: core tablet: cellulose microcrystalline, first Latinized starch, lactose monohydrate, silica colloidal anhydrous, talc, magnesium stearate; shell: main bottled, methacry salary copolymer, sodium lauryl sulfate, stearic acid, talc, harakterom ethyl cellulose, microcrystalline cellulose, titanium dioxide (E 171), sunset yellow (E 110).
Dosage form. Tablets, film-coated.
Pharmacotherapeutic group. Drugs that are used in functional intestinal disorders. ATC code A03A X04.
Symptomatic treatment of pain, intestinal disorders and gastrointestinal discomfort associated with dysfunction of the intestine.
Symptomatic treatment of pain with dysfunction of the biliary tract.
Preparing for x-ray examination of the bowel with the barium.
Hyper sensitivity to the active substance or to any excipients of the drug components.
Method of application and doses.
Tablets of 50 mg
Adults: the recommended dose is 3-4 tablets a day.
If necessary, this dose can be increased to 6 tablets per day.
To prepare for x-ray examination of the bowel barium take 4 tablets a day for 3 days before the study.
Children aged 12 years: the recommended dose of 3 tablets per day maximum daily dose – 150 mg.
Pills 100 mg
Adults: the recommended dose is 2 tablets per day in two divided doses morning and evening.
If necessary, this dose can be increased to 3 tablets per day.
To prepare for x-ray examination of the bowel barium take 2 pills a day for 3 days before the study.
Pills should swallow, not liquid and not rassasyvaya with a large glass of water during meals.
During post-marketing use were reported the following adverse reactions. Based on available data, it is impossible to set a precise frequency (unknown).
Violations by the immune system
Such observed violations of the gastrointestinal tract, such as abdominal pain, diarrhea, nausea, vomiting and dysphagia.
Violations from skin and hypodermic tissues
Was observed skin reactions such as rash, itching, hives and erythema.
Now specific information about the symptoms associated with the overdose Dicetel®, is missing. Specific antidote is unknown, symptomatic treatment is recommended.
Use during pregnancy or breast-feeding.
Clinical data on use in pregnant women do not exist. Animal studies regarding effects on pregnancy, development of the embryo and fetus, childbirth or postnatal development is insufficient. The potential risk for humans is unknown. Dicetel® should be used during pregnancy only if absolutely necessary.
Moreover, it is necessary to bear in mind the presence of bromide. The purpose pnaorama bromide at the end of pregnancy can affect the nervous system of neonates (hypotension, sedation).
Information on excretion pnaorama bromide in breast milk of human or animal inadequate. Physico-chemical and available pharmacodynamic and Toxicological data indicate the possibility of excretion in breast milk and risk to the child cannot be excluded. Dicetel® should not be used during breast-feeding.
There is no experience of using Dicetel® for children up to 12 years, so the drug should not be used in this age group.
Features of the application.
Patients with rare hereditary diseases such as galactose intolerance, lactase deficiency, syndrome or Lapp malabsorption of glucose-galactose should not take this drug.
The ability to influence the rate of reaction at management of motor transport or operating other mechanisms.
Studies of the effects on ability to drive and work with mechanical devices was conducted.
Interaction with other medicinal products and other forms of interaction.
In clinical studies confirmed the absence of any interaction between pawero the bromide and digitalis preparations, oral antidiabetic agents, insulin, oral anticoagulants and heparin.
The simultaneous use of holnolulu of the drug can increase antispasmodic action. There was no effect on laboratory tests to determine levels of the drug.
The pharmacological properties.
Paveral bromide is an antispasmodic that acts selectively on the gastrointestinal tract. As a calcium antagonist it inhibits the absorption of calcium into the cells of smooth muscles. Animals paveras directly or indirectly reduces the effects of stimulation of the sensitive afferent nerve fibers. The drug has anticholinergic effects and does not affect the cardiovascular system.
After oral administration paveral bromide is rapidly absorbed, maximum concentration in plasma achieved after 1 hour. The drug is extensively metabolized and excreted through the liver. The half excretion is 1.5 hours. The absolute bioavailability form for oral administration is very low (< 1%). The main route of excretion in the feces.
Binding pnaorama bromide with blood plasma proteins is high (95-96 %).
Main physico-chemical properties: orange, film-coated, for oral use tablets with marking of 50 or 100 (for tablets at 50 and 100 mg, respectively) on the one hand and the letter S and Δ under it with the other hand.
The expiration date. 5 years.
The storage conditions. Keep at temperature not exceeding 30 ºc. To protect from light keep the blisters in a cardboard box. Keep out of reach of children.
Packing. Of 20 tablets in blister, 1 blister in a cardboard box.