Almetik 60MG/300MG N40 Capsules

Almetik

Almetik composition

contains simethicone: 60 mg alverine citrate, 300 mg purified S substances in 1 capsule: gelatin, glycerin, titanium dioxide (E 171),

Indications for use

for symptomatic treatment of bloating and functional bowel disorders

Contraindications

ALMETIK is contraindicated in cases of intolerance to the active substance of alverine or to any of the excipients in this medicine. or for people with paralytic intestinal obstruction. or for people with allergic reactions—obstruction.

Use during pregnancy and lactation

should not be used. Clinical data have not been provided to date that the alverine citrate–simethicone combination causes developmental defects, and no fetotoxic effects have been reported. It is recommended to avoid use during lactation as a precaution, since there is no information on whether alverine is excreted in breast milk during pregnancy. Information on the effect on the ability to use. There is no information that the ALMETIK preparation affects the ability to drive vehicles and other potentially dangerous mechanisms.

Use in children

Women with potential to become pregnant/Contraception. Risk is unknown for pregnancy and/or for embryonic development of the fetus and/or for birth and/or for postnatal development. Animal studies are insufficient

How to use Almetik and dosage

For adults only: take 1 capsule 2–3 times daily, unless otherwise prescribed by the doctor. For oral use only and should be taken before meals. Additional information about patient groups: Renal impairment: no special use. In the elderly: no use for adults only.

Pharmacological properties

Pharmacodynamics ALMETIK is a combined preparation consisting of two active substances; it is an antispasmodic substance with myotropic properties similar to papaverine. This effect is shown through the smooth muscle fiber of the gastrointestinal system, where the antispasmodic effect is greater than that of papaverine

Additional effects

and it has been determined that it is three times less than papaverine. Since there is no similar effect, it has no effect on gastric acid. In a pharmacokinetic study, it was found that plasma concentration is very low (below 2.5 ng/ml). This result indicates that alverine is not absorbed, or when taken together with simethicone it undergoes a significant first-pass elimination effect in the liver. Simethicone is dimethicone activated with added silicon dioxide; it is an inert substance with no pharmacological activity. By changing the surface tension of gas bubbles in the gastrointestinal tract, it facilitates their coalescence and physiological elimination (e.g., belching, bloating) and allows them to be easily excreted. Pharmacokinetics: Absorption. After oral administration, alverine citrate is absorbed from the gastrointestinal tract. Distribution. Minimal absorption of simethicone has been reported; peak concentration is reached quickly within 1–1.5 hours after oral administration. Biotransformation. Alverine citrate is rapidly converted into its active metabolite; after oral administration, within 1–1.5 hours, it undergoes additional biotransformation to reach peak concentration in plasma. After administration, simethicone does not undergo metabolism. Half-life. Plasma elimination and excretion into breast milk are not known. It is excreted with urine via active renal secretion of alverine citrate metabolites. Simethicone is excreted unchanged in feces. The frequency of adverse reactions is determined by the following parameters: very often (≥ 1/10); often (≥ 1/100–< 1/10); sometimes (≥ 1/1000–< 1/100); rarely (≥ 1/10000–< 1/1000); very rarely cannot be assessed). (< 1/10000); unknown (according to available data, frequency is unknown): allergic reactions, headache, vertigo, nausea, angioedema, rash, itching. Hepatobiliary disorders: Rarely—liver disorders that return to normal after discontinuation of the medicinal product. In some cases—urticaria, sometimes laryngeal edema and the “benefit-risk” ratio of the product after registration of the means is continuously monitored; it is important to provide information about additional effects in order to ensure continuous monitoring.

Information about this should be submitted to the Pharmacovigilance Department of the Analytical Expertise Center, address: 34, Jafar Jabbarli St. Fax: (99412) 596-07-16. Tel.: (99412) 596-05-20.

e-mail: [email protected]; Website: ww.az

Interaction with other medicinal products

There is no interaction with other medicinal products. Additional information about patient groups has not been studied. Interaction studies in specific populations. General recommendations