Meteospasmyl, 60 mg+300 mg capsules 60 pcs

ATX code: [A03AX58]

Pharmacotherapeutic group

Spasmolytic medicine.

Pharmacological properties

A combined drug. It has antispasmodic effect, reduces gas in the intestine.

Alverine is myotropic antispasmodic whose action is not accompanied by atropine-like effect or ganglioblocating activity. It reduces the increased tone of the smooth muscles of the intestine.

Simethicone is hydrophobic polymeric substance with low surface tension, which reduces gas formation in the intestine and covers the walls of the digestive tract with a protective film.

Indications

Functional disorders of the gastrointestinal tract, manifested by abdominal pain, increased gas formation, belching, nausea, constipation, diarrhea, or their alternation.

Preparation for x-ray, ultrasound or instrumental examination of the abdominal organs.

Pharmacological effect

ATX code: [A03AX58]

Pharmacotherapeutic group

Antispasmodic.

PHARMACOLOGICAL PROPERTIES

Combined drug. Has an antispasmodic effect, reduces gas formation in the intestines.

Alverine is a myotropic antispasmodic, the action of which is not accompanied by an atropine-like effect or ganglion-blocking activity. Reduces increased tone of intestinal smooth muscles.

Simethicone is a hydrophobic polymer substance with low surface tension that reduces gas formation in the intestines and covers the walls of the digestive canal with a protective film.

Special instructions

Increased levels of the liver enzymes alanine aminotransferase and aspartic aminotransferase have been reported in patients receiving alverine/simethicone. This may be due to a simultaneous increase in the level of total bilirubin in the blood serum. If the level of hepatic aminotransferases increases to values ​​exceeding the upper threshold values ​​by 3 or more times, as well as in the case of jaundice, treatment with the drug should be discontinued.

Impact on the ability to drive vehicles and machinery

The drug has a slight effect on the ability to drive vehicles and machinery. In some patients, dizziness was reported while using the drug. This type of impairment can affect the ability to drive vehicles and operate machinery.

Active ingredient

Alverine citrate, Simethicone

Composition

Active ingredients:

Alverine citrate 60 mg,

Simethicone 300 mg.

Shell composition:

Gelatin 167.02 mg,

Glycerol 84.12 mg,

Titanium dioxide 1.86 mg,

Purified water q.s.

Pregnancy

Due to the low systemic exposure of simethicone, no effects are expected to develop when taking the drug during pregnancy and breastfeeding. The results of experimental studies do not give any reason to believe that alverine has any teratogenic effect or has a toxic effect on the fetus. However, similar clinical studies have not been conducted. There is also no data on the release of alverine into breast milk. The use of the drug during pregnancy and breastfeeding is not recommended.

Contraindications

Individual intolerance to alverine citrate and other components of the drug.
Children under 14 years old.

Side Effects

The frequency of adverse reactions was determined in accordance with the recommendations of the World Health Organization:

Very common: (≥1/10)

Common: (≥1/100 to <1/10)

Uncommon: (≥1/1000 to <1/100)

Rare: (≥1/10000 to <1/1000)

Very rare, including isolated reports: (< 1/10,000)

Frequency not determined: Frequency cannot be estimated from available data.

Disorders of the liver and biliary tract

Very rare: cytolytic hepatitis.

Laboratory and instrumental data

Frequency not determined: increased levels of transaminases, alkaline phosphatase and bilirubin.

Skin and subcutaneous tissue disorders

Frequency not determined: angioedema, skin rash, urticaria and itching.

Immune system disorders

Very rare: anaphylactic type reactions, anaphylactic shock.

Hearing and balance disorders

Frequency not determined: dizziness.

Nervous system disorders

Frequency not determined: headache.

Gastrointestinal disorders

Frequency not determined: nausea.

If these or any other undesirable reactions occur when using the drug, you should consult a doctor.

Notification in case of suspected side effects

It is important to report adverse events after drug approval to ensure ongoing monitoring of the drug’s risk-benefit ratio. Health care professionals are asked to report all cases of side effects observed with the use of the drug through national adverse reaction reporting systems and/or to the company address listed below.

Interaction

No clinically significant interaction of the drug with other drugs has been established.

Overdose

Cases of vertigo have been reported when taking doses significantly higher than recommended.

Appropriate supportive measures should be taken if overdose is suspected. These measures include monitoring the patient and symptomatic treatment, if necessary.

Storage conditions

At a temperature not exceeding 25 °C, out of the reach of children.

Shelf life

3 years. Do not use after the expiration date stated on the package.

Manufacturer

Galenic Laboratories Vernin, France