Instructions for use Ditsetel film-coated tablets 50 mg No. 40
Composition
active ingredient: pinaverium bromide;
1 tablet contains pinaverium bromide 50 mg;
excipients: colloidal anhydrous silicon dioxide, microcrystalline cellulose, talc, magnesium stearate, pregelatinized starch, lactose monohydrate;
shell: stearic acid, basic butylated methacrylate copolymer, sodium lauryl sulfate, hydroxypropyl methylcellulose, talc, yellow iron oxide (E 172), red iron oxide (E 172).
Dosage form
Film-coated tablets.
Main physicochemical properties: yellowish-orange film-coated tablet, marked “50” on one side.
Pharmacotherapeutic group
Drugs used in functional gastrointestinal disorders. ATX code A03A X04.
Pharmacological properties
Pharmacodynamics
Pinaverium bromide is an antispasmodic that acts selectively on the gastrointestinal tract. As a calcium antagonist, it inhibits the entry of calcium into the cells of the smooth muscle of the intestine. In animals, pinaverium directly or indirectly reduces the effects of stimulation of sensitive afferent nerve fibers. The drug does not have pronounced anticholinergic effects. It also does not affect the cardiovascular system.
Pharmacokinetics
After oral administration of pinaverium bromide, it is rapidly absorbed, with peak plasma concentrations occurring within 1 hour. The drug is extensively metabolized and excreted via the liver. The elimination half-life is
1.5 hours. Absolute bioavailability of the oral form is very low
(< 1%). The main route of excretion is with feces.
The binding of pinaverium bromide to blood plasma proteins is high (95–97%).
Indication
Symptomatic treatment of pain, temporary intestinal disorders and intestinal discomfort associated with functional bowel disorders.
Symptomatic treatment of pain in biliary tract dysfunction.
Preparation for an X-ray examination of the intestines using barium.
Contraindication
Hypersensitivity to the active substance or to any of the excipients of the medicinal product.
Interaction with other medicinal products and other types of interactions
Clinical studies have confirmed the absence of any interaction between pinaverium bromide and digitalis preparations, oral antidiabetic agents, insulin, oral anticoagulants (e.g. acenocoumarol [antivitamin K]) and heparin.
Concomitant use of an anticholinergic drug may enhance the antispasmodic effect. No effect on laboratory tests for drug levels was observed.
Application features
Due to the risk of esophageal damage, the instructions for use of the drug must be carefully followed. Patients with pre-existing esophageal lesions and/or hiatal hernia should pay special attention to the correct use of the drug.
This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Use during pregnancy or breastfeeding
There are no adequate data from the use of pinaverium bromide in pregnant women. Animal studies are insufficient with respect to effects on pregnancy, embryonal/fetal development, parturition, or postnatal development. The potential risk to humans is unknown. Dicetyl® should not be used during pregnancy unless clearly necessary.
Moreover, it is necessary to take into account the presence of bromide in the preparation. The use of pinaverium bromide at the end of pregnancy may affect the nervous system of the newborn child (hypotension, sedation).
There is insufficient information on the excretion of the drug Ditsetel® into human or animal breast milk. Physicochemical and available pharmacodynamic and toxicological data indicate the possibility of excretion of the drug Ditsetel® into breast milk, and a risk to the breast-fed child cannot be excluded. Ditsetel® should not be used during breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
Studies on the effects on the ability to drive and use machines have not been conducted.
Undesirable drug reactions may occur, including drowsiness (see section "Adverse reactions"). In this condition, the ability to react may be reduced.
Method of administration and doses
Adults
The recommended dose is 1 tablet 3 times a day or 2 tablets 2 times a day.
If necessary, this dose can be increased to 2 tablets 3 times a day.
The tablets should be swallowed without chewing or dissolving, with a glass of water, during meals to avoid contact of pinaverium with the esophageal mucosa (risk of esophageal damage, see section "Adverse reactions").
Children.
The safety and efficacy of the drug in children have not been sufficiently established, and experience is limited. Therefore, the drug is not recommended for use in children.
Overdose
Overdose of the drug may cause gastrointestinal reactions such as nausea, bloating and diarrhea. There is no specific antidote, symptomatic treatment is recommended.
Adverse reactions
Based on pooled data from 46 studies involving 3755 patients treated with pinaverium bromide, adverse reactions are described below, classified according to frequency and MedDRA system organ class. Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) or very rare (<1/10,000).
Gastrointestinal disorders: common – abdominal pain * #, constipation #, dry mouth #, dyspepsia, nausea; uncommon – diarrhoea, vomiting
General disorders and administration site conditions: uncommon – asthenia.
Nervous system disorders: often - headache; infrequently - drowsiness.
* combination of the defined terms: "abdominal pain", "lower abdominal pain" and "upper abdominal pain".
# Gastrointestinal disorders are mainly related to the underlying disease. Similar or lower incidences of abdominal pain, constipation, and dry mouth were reported with the drug compared to placebo.
The following adverse reactions have been spontaneously reported during post-marketing use. The exact frequency of adverse reactions cannot be estimated from the available data (frequency not known).
Gastrointestinal tract
Abdominal pain, diarrhoea, nausea, vomiting and dysphagia have been reported. Esophageal damage is possible if the drug is used without following the appropriate recommendations (see section "Method of administration and dosage").
Skin and subcutaneous tissue disorders
Skin reactions such as rash, pruritus, urticaria and erythema have been observed.
On the part of the immune system
Hypersensitivity.
There have been spontaneous reports of systemic hypersensitivity reactions involving the subcutaneous tissue and other organ systems, such as angioedema and anaphylactic shock.
Minor adverse events were reported and were classified as mild to moderate. These were mainly minor digestive disturbances that could be related to medical conditions, such as constipation (0.4%), heartburn (0.3%), bloating (0.3%).
For other systems: headache (0.3%), drowsiness (0.2%), dizziness (0.2%).
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 30 ° C. To protect from light, the blister should be kept in a cardboard box. Keep out of the reach of children!
Packaging
20 tablets in a blister, 1 or 2 blisters in a cardboard box.
Vacation category
According to the recipe.
Producer
Mylan Laboratories SAS, France.
Location
Route de Belleville, Lieu dit Maillard, 01400, Chatillon-sur-Chalaronne, France.
