Instructions for Meteoksan capsules No. 60
Composition
active ingredients: 1 capsule contains phloroglucinol dihydrate 80 mg, simethicone 125 mg;
excipients: colloidal anhydrous silicon dioxide, talc, microcrystalline cellulose, calcium hydrogen phosphate, gelatin, sulfur dioxide (E 220), titanium dioxide (E 171).
Dosage form
Capsules.
Main physicochemical properties: white opaque capsules, size 0, containing white powder.
Pharmacotherapeutic group
Remedies for the treatment of functional disorders of the gastrointestinal tract.
ATX code A0ZA X.
Pharmacological properties
Pharmacodynamics.
Meteoksan is a combination drug that includes the non-atropine antispasmodic phloroglucinol dihydrate and simethicone, which prevents the accumulation of gases in the intestines.
Simethicone is a non-toxic, inert, silicon-based surfactant that prevents the formation and promotes the destruction of gas bubbles. By reducing surface tension, it causes gas bubbles to coalesce in the gastrointestinal tract, which causes dispersion and release of gas in a physiological way.
Simethicone prevents the formation of image defects that occur due to gas bubbles during ultrasound or X-ray examinations.
Phloroglucinol dihydrate slows down the excessive motility of the colon and large intestine, which typically occurs in response to food intake in patients with functional bowel disorders.
Clinical studies confirm the relaxing effect on the smooth muscles of the gastrointestinal tract.
Pharmacokinetics.
After oral administration, phloroglucinol is rapidly absorbed and metabolized during the first pass through the liver, excreted from the body as metabolites mainly in the urine. The time to reach the maximum concentration in the blood plasma Tmax is 1 hour, with a Cmax value of 2.74 mg/ml, the half-life T½ is 2 hours. Systemic bioavailability after oral administration is 30%.
Simethicone is not absorbed in the body and is excreted unchanged after passing through the gastrointestinal tract.
Indication
For the adjunctive treatment of functional intestinal symptoms, including flatulence and diarrhea.
Contraindication
Hypersensitivity to the active substances or any of the excipients of the medicinal product.
Concomitant use of opioid analgesics.
First trimester of pregnancy and breastfeeding.
Intestinal obstruction, obstructive conditions of the gastrointestinal tract.
Interaction with other medicinal products and other types of interactions
The interaction of phloroglucinol with strong analgesics such as morphine or its derivatives should be avoided due to a possible spasmogenic effect.
Simethicone may bind levothyroxine in the gastrointestinal tract and reduce its absorption. It is necessary to separate the intake of simethicone and levothyroxine by an interval of at least four hours.
Application features
Patients with a history of serious allergic and skin reactions (e.g. angioedema, exanthema) should be closely monitored.
Use during pregnancy or breastfeeding
Pregnancy
There are no clinical data on the use of simethicone during pregnancy. Animal studies do not indicate a risk of reproductive toxicity.
Animal studies have not shown any embryotoxic or teratogenic effects of phloroglucinol. However, due to the lack of clinical data on use in pregnant women, the use of phloroglucinol during the first trimester of pregnancy is not recommended.
Therefore, the drug should be avoided during the first three months of pregnancy.
It is necessary to consult a doctor regarding the use of Meteoxan in the 2nd and 3rd trimesters of pregnancy.
Breastfeeding period.
In the absence of studies, the use of Meteoxan should be avoided during breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
Metheoxane has little or no effect on the ability to drive or use machines.
Method of administration and doses
The medicine should be taken orally with a small amount of water. Take 2 capsules 3 times a day before meals or when in pain.
The maximum daily dose is 6 capsules, which corresponds to 480 mg of phloroglucinol dihydrate and 750 mg of simethicone.
Children.
The safety and effectiveness of Meteoxan in children have not been established.
Overdose
To date, no cases of overdose are known.
Side effects
Adverse reactions are classified by organ system and frequency of occurrence: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to ≤ 1/100), rare (≥ 1/10,000 to ≤ 1/1000), very rare (≤ 1/10,000), frequency unknown (cannot be estimated from the available data).
From the immune system.
Frequency unknown: anaphylactic shock.
Frequency unknown: hypersensitivity reactions such as skin rash, urticaria, pruritus, angioedema, acute generalized exanthematous pustulosis, bronchospasm.
Expiration date
2 years.
Do not use the medicine after the expiry date stated on the packaging.
Storage conditions
Store at a temperature not exceeding 25 °C, out of the reach of children. Do not freeze!
Packaging
15 capsules in a blister, 1, 2 or 4 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
Alfasigma S.p.A.
Location of the manufacturer and address of its place of business.
Via Enrico Fermi, 1, Alanno, 65020, Italy.
