Suprima-kof - instructions for use, dose, side effects, contraindications

Excipients: calcium hydrophosphate 10 mg, corn starch 100 mg, microcrystalline cellulose 30 mg, croscarmellose sodium 12 mg, methyl parahydroxybenzoate 0.18 mg, propyl parahydroxybenzoate 0.02 mg, magnesium stearate 3 mg, talc 5 mg, sodium carboxymethyl starch 5 mg.

Description:Round tablets with bevelled edges with a risk on one side from white to white with a yellowish hue of color.

Pharmacotherapeutic group:Expectorant, mucolytic agent

ATX: & nbsp

R.05.C.B.06 Ambroxol

Pharmacodynamics:

Mucolytic agent. Has a secreto-motor, secretolitic and expectorant action; stimulates serous cells of the glands of the mucous membrane of the bronchi, increases the content of mucous secretions and the release of surfactant (surfactant) in the alveoli and bronchi; normalizes the disturbed the ratio of serous and mucous components of sputum. Activating hydrolyzing enzymes and increasing the release of lysosomes from Clara cells, reduces the viscosity of phlegm. Increases the motor activity of the ciliated epithelium, increases mucociliary transport. After oral administration, the action occurs 30 minutes later, with rectal administration - 10-30 minutes and lasts for 6-12 hours. With parenteral administration, the effect occurs quickly and lasts for 6-10 hours.

Pharmacokinetics:Absorption is high (for any route of administration), the time needed to reach the maximum concentration (TCmah) 2 h, the connection with plasma proteins - 80%. Penetrates through the blood-brain barrier, placental barrier, excreted in breast milk. Metabolism - in the liver, forms dibromantranilic acid and glucuronic conjugates. The half-life (T1 / 2) is 7-12 hours.It is excreted by the kidneys: 90% in the form of water-soluble metabolites, in unchanged form - 5%. Period elimination half-life increases with severe chronic renal failure, not changes when liver function is impaired.

Indications:Diseases of the respiratory tract with the formation of viscous sputum: acute and chronic bronchitis, pneumonia; chronic obstructive pulmonary disease, bronchial asthma with difficulty in sputum discharge, bronchiectasis.

Contraindications:

Hypersensitivity to ambroxol and / or other components of the drug, pregnancy (I trimester). Children under 5 years.

Carefully:Stomach ulcer and duodenal ulcer, renal and / or hepatic insufficiency.

Pregnancy and lactation:

The use of Suprema-Cof in the II and III trimesters of pregnancy, as well as during lactation, is necessary with caution and only when the alleged, The benefit to the mother exceeds the potential risk to the fetus or child.

Dosing and Administration:

Inside, during meals, with a small amount of liquid.

Adults and children over the age of 12 years in the first 2-3 days appoint 1 tablet 3 times a day (90 mg / day.).In the future, they switch to a two-time 1 tablet per day (60 mg / day) or 1/2 tablet 3 times a day (45 mg / day). In severe cases, the dose is not reduced throughout the course of treatment.

Children from 6 to 12 years old in the first 2-3 days appoint 1/2 tablet 2-3 times a day (30-45 mg / day.). Subsequently, they switch to a two-time dose of the drug in 1/2 tablets per day (30 mg / day).

Side effects:Allergic reactions: skin rash, hives, angioedema, in some cases - allergic contact dermatitis, anaphylactic shock. Rarely - weakness, headache, diarrhea, dry mouth and respiratory tract, exanthema, rhinorrhea, constipation, dysuria. With prolonged use in high doses - heartburn, gastralgia, nausea, vomiting.

Overdose:

Symptoms: nausea, vomiting, diarrhea, indigestion. Treatment: artificial vomiting, gastric lavage in the first 1-2 hours after taking the drug; reception of fat-containing products. Symptomatic therapy.

Interaction:Joint use with antitussive drugs (for example, containing codeine) leads to difficulty in withdrawing sputum against a background of decreasing cough.Increases penetration into the bronchial secretion, amoxicillin, cefuroxime, erythromycin and doxycycline.

Special instructions:Ambroxol should be used with caution in patients with a weakened cough reflex or disturbed mucociliary transport due to the possibility of sputum congestion.

Effect on the ability to drive transp. cf. and fur:The drug does not affect the ability to drive vehicles and work with mechanisms.

Form release / dosage:Tablets 30 mg.

Packaging:

10 tablets per blister. For 1 or 2 blisters are placed in a pack of cardboard instructions for medical use.

Storage conditions:

In a dry place, at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LS-001243

Date of registration:16.09.2011

The owner of the registration certificate:SHREYA LIFE SENENSIZ Pvt.Ltd. SHREYA LIFE SENENSIZ Pvt.Ltd. India

Manufacturer: & nbsp

SHREYA LIFE SCIENCES, Pvt.Ltd. India

Representation: & nbspSHREYA LIFE SENENSIZ Pvt.Ltd. SHREYA LIFE SENENSIZ Pvt.Ltd. India

Information update date: & nbsp23.09.2015

Illustrated instructions

Instructions

Suprima-kof (Suprima-kof)