No-Spa Tablet 40mg #24

Form

tableti

Dosage mg

40

Pack

24

Composition One tablet contains: Active substance - 40 mg Drotaverine hydrochloride Excipients: magnesium stearate (E470), talc (E553), povidone (E1201), corn starch, lactose monohydrate. Pharmacotherapeutic group: Medication for the treatment of functional gastrointestinal disorders. Papaverine and its derivatives. Pharmacological action Mechanism of action: Drotaverine is an isoquinoline derivative that exhibits antispasmodic action on smooth muscles by inhibiting the enzyme phosphodiesterase IV (PDE IV). Inhibition of PDE IV leads to an increased concentration of cAMP, which inactivates the light chain of myosin kinase and causes relaxation of smooth muscles. In vitro, drotaverine inhibits PDE IV without inhibiting the isoenzymes PDE III and PDE V. PDE IV is functionally very important for reducing the contractility of smooth muscles, and its selective inhibitors may be useful for treating hyperkinetic diseases and various symptoms caused by spasmodic conditions of the gastrointestinal tract. The isoenzyme PDE-III hydrolyzes cAMP in the smooth muscles of the myocardium and blood vessels, which explains why drotaverine is an effective antispasmodic agent without serious cardiovascular side effects and with strong cardiovascular therapeutic activity. The preparation is effective in spasms of smooth muscles of both nervous and muscular etiology, caused by impaired nervous regulation and self-regulation. Regardless of the type of vegetative innervation, drotaverine acts on the smooth muscles of the gastrointestinal, biliary, urogenital, and vascular systems. Due to its vasodilating effect, it improves blood circulation in tissues. Compared to papaverine, its action is stronger, absorption is faster and more complete, and it binds less to plasma proteins. The advantage of drotaverine is that it does not have a stimulating effect on the respiratory system, which was observed after parenteral administration of papaverine. Pharmacokinetics Absorption: Drotaverine is rapidly and completely absorbed after both oral administration and intramuscular injection. Distribution: Drotaverine is highly bound to plasma proteins, especially albumin (95-98%), alpha- and beta-globulins. Maximum plasma concentration is reached 45-60 minutes after administration. Biotransformation and elimination: Drotaverine is metabolized in the liver, and its half-life is 8-10 hours. After the first pass through the liver, 65% of the dose remains unchanged in the blood. Within 72 hours, drotaverine is practically completely eliminated from the body, with more than 50% excreted in the urine and approximately 30% in the feces. Drotaverine is mainly excreted in the form of metabolites; the parent compound is not detected in the urine. Indications for use: • Spasm of smooth muscles associated with biliary tract diseases: cholecystolithiasis, cholangiolithiasis, cholecystitis, pericholecystitis, cholangitis, papillitis; • Spasm of smooth muscles of the urinary tract: nephrolithiasis, ureterolithiasis, pyelitis, cystitis, bladder tenesmus. • For gastrointestinal smooth muscle spasms: peptic ulcer disease of the stomach and duodenum, gastritis, spasm of the cardiac and pyloric parts of the stomach, enteritis, colitis, spastic colitis with constipation and mucous colitis with meteorism; • Tension-type headache (muscle tension headache, psychogenic, stress, chronic daily headache, transformed migraine); • In gynecology: painful menstruation. Contraindications: • Hypersensitivity to the active substance or any of the excipients; • Severe hepatic or renal insufficiency; • Severe heart failure. Dosage and administration: Adults The usual daily dose is 120-240 mg, i.e., 3-6 tablets per day, taken in 2-3 divided doses. The single dose for adults is 40-80 mg (1-2 tablets). Children Clinical studies on the use of drotaverine in children have not been conducted. In cases where drotaverine administration is necessary in children: Children aged 6-12 years: The recommended daily dose in children over 6 years of age is 80 mg, i.e., 2 tablets per day, taken twice. The single dose in children aged 6-12 years is 40 mg (1 tablet). Children over 12 years of age: The recommended daily dose in children over 12 years of age is 160 mg, i.e., 4 tablets per day, taken 2-4 times. The single dose in children over 12 years of age is 40-80 mg, i.e., 1-2 tablets. Children under 6 years of age: There is no data on the use of the preparation in children. Overdose: Overdose of drotaverine can cause disorders of heart rhythm and conduction, including complete block of the bundle of His and cardiac arrest, which can lead to a fatal outcome. In case of overdose, the patient should be under observation and receive symptomatic and supportive treatment. Inducing vomiting and/or gastric lavage is recommended. Side effects: • Gastrointestinal disorders: Rarely: nausea, constipation • Nervous system disorders: Rarely: headache, dizziness, insomnia • Cardiovascular system disorders: Rarely: palpitations, decreased blood pressure • Immune system disorders: Rarely: allergic reaction (angioedema, urticaria, rash, itching) (see section "Contraindications"). If side effects occur, the administration of the preparation should be discontinued. If any of the listed adverse reactions occur, or if any reactions not listed in this leaflet occur, consult your doctor! Interactions with other medicinal products: Caution is advised when using the preparation with levodopa, as the antiparkinsonian effect of the latter is reduced, and an increase in tremor or rigidity is observed. Special warnings and precautions: - The use of the preparation in patients with low blood pressure requires caution. - The preparation contains 52 mg of lactose. When taken at the recommended dosage, each dose contains up to 156 mg of lactose. In patients with lactose intolerance, this may cause gastrointestinal complaints. - This form is not suitable for patients with lactose deficiency, galactosemia, or glucose/galactose malabsorption syndrome. - In children, the preparation should be used strictly as directed, as the use of drotaverine in this patient group has not been sufficiently studied (see "Indications for use" and "Dosage and administration"). Clinical studies on the use of the preparation in children have not been conducted. Pregnancy, breastfeeding and fertility: According to retrospective clinical studies and animal studies, oral administration of drotaverine during pregnancy does not cause direct or indirect adverse effects on the course of pregnancy, embryonic development, childbirth, and postnatal development. However, caution is required when prescribing the preparation during pregnancy. Due to the lack of adequate clinical data, its use during breastfeeding is not recommended. There is no data on the effect of the preparation on fertility. Effect on ability to drive or operate machinery: If dizziness occurs, refrain from potentially hazardous activities such as driving or operating machinery. Shelf life: 3 years. Do not use after the expiry date. Storage conditions: Keep out of reach of children! Tablets in PVC/aluminum blister packs: Store at a temperature not exceeding 25°C, protected from light. Tablets in a bottle: Store at a temperature not exceeding 25°C, protected from light. Dispensing category: Pharmaceutical product group III, available without a prescription. Marketing authorization holder: "Opella Healthcare Commercial Ltd." Manufacturer: "Opella Healthcare Hungary Ltd.