Instructions for use Sinecod oral drops 5 mg/ml bottle 20 ml
Composition
active ingredient: butamirate citrate;
1 ml (20 drops) of solution contains 5 mg of butamirate citrate;
excipients: sorbitol solution (E 420), glycerin, sodium saccharin, benzoic acid (E 210), vanillin, ethanol 96%, sodium hydroxide 30%, purified water.
Dosage form
Oral drops for children.
Main physicochemical properties: transparent solution from colorless to brownish-yellowish color.
Pharmacotherapeutic group
Medicines used for coughs and colds. Cough suppressants. ATX code R05D B13.
Pharmacological properties
Pharmacodynamics
A centrally acting non-opiate antitussive. However, the exact mechanism of action is unknown.
The active ingredient of Sinecod is butamirate citrate, which suppresses cough and differs in its structure and pharmacological action from opium alkaloids. It is believed that this substance acts on the central nervous system. Butamirate citrate causes a nonspecific anticholinergic and bronchospasmolytic effect, which improves respiratory function. Sinecod does not cause habituation or dependence.
Butamirate citrate has a wide therapeutic range; therefore, Sinecod is well tolerated in therapeutic doses and is well suited as a cough suppressant in children.
Pharmacokinetics
Butamirate is rapidly absorbed, distributed in the body and further hydrolyzed mainly to 2-phenylbutyric acid and diethylaminoethoxyethanol, which also have antitussive activity. 2-phenylbutyric acid is further partially metabolized by hydroxylation. Butamirate and 2-phenylbutyric acid in the body are highly bound to blood proteins.
The effect of food on bioavailability has not been confirmed. Metabolism to 2-phenylbutyric acid and diethylaminoethoxyethanol is completely proportional in the dose range of 22.5 mg - 90 mg. Metabolites are excreted mainly by the kidneys. Butamirate is detected in the urine up to 48 hours after administration. According to the results of measurements, the half-life for butamirate is 1.48-1.93 hours, for 2-phenylbutyric acid - 23.26-24.42 hours, for diethylaminoethoxyethanol - 2.72-2.90 hours.
There is no evidence of the influence of liver and kidney dysfunction on the pharmacokinetic parameters of butamirate.
Indication
Symptomatic treatment of cough of various origins in children.
Contraindication
Hypersensitivity to the active or auxiliary substances of the drug, genetic intolerance to fructose, due to the presence of sorbitol in the composition of the drug.
Interaction with other medicinal products and other types of interactions
The simultaneous use of expectorants should be avoided.
Application features
Because butamirate suppresses the cough reflex, concomitant use of expectorants should be avoided, as this may lead to mucus stagnation in the respiratory tract, increasing the risk of bronchospasm and respiratory tract infection.
5 drops of the drug contain 71 mg of sorbitol. Sorbitol is a source of fructose. It should not be used in patients with rare hereditary fructose intolerance.
The drug contains a small amount (less than 100 mg per dose) of ethanol (alcohol).
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially 'sodium-free'.
If the cough persists for more than 7 days, you should consult a doctor.
Patients whose symptoms worsen or do not improve within 7 days and/or are accompanied by fever, rash, or persistent headache should undergo further investigation to identify the underlying cause of the condition.
The medicine should be used in children under two years of age only as prescribed by a doctor.
Keep out of the reach and sight of children.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug is intended for use in children.
Rarely, Synecod products may cause drowsiness. Patients are advised to refrain from driving or operating machinery if they experience drowsiness.
Use during pregnancy or breastfeeding
The drug is intended for use in children.
Animal studies do not indicate direct or indirect harmful effects on pregnancy or the health of the fetus. The safety of the drug during pregnancy has not been evaluated in specific studies involving pregnant women. Therefore, use during pregnancy is not recommended, unless otherwise recommended by a doctor if necessary.
It is not known whether the active substance and/or its metabolites pass into breast milk, therefore, the use of this drug is not recommended during breastfeeding.
Method of administration and doses
The drug is intended for use in children.
For oral use only.
The single dose depends on the child's age and is: children from 2 months to 1 year - 10 drops (2.5 mg) 4 times a day; maximum daily dose: 40 drops (10 mg);
children from 3 to 6 years old - 25 drops (6.25 mg) 4 times a day; maximum daily dose: 100 drops (25 mg). Children from 3 years old can use another dosage form, namely Sinecod, syrup.
The maximum course of treatment without a doctor's prescription should not exceed 1 week.
The lowest dose necessary to achieve effectiveness should be used for the shortest possible treatment period.
Do not exceed the recommended dose.
Children
Not intended for children under 2 months of age.
Children under 2 years of age can only be used as directed by a doctor.
Children over 3 years of age can use another dosage form, namely Sinecod, syrup.
Overdose
An overdose of Sinecod may cause the following symptoms: drowsiness, nausea, vomiting, diarrhea, dizziness, and hypotension.
Further treatment should be carried out according to clinical indications.
There is no specific treatment for butamirate overdose. If an overdose occurs, the patient should be treated symptomatically and vital signs monitored.
Adverse reactions
From the nervous system: (uncommon: ≥ 1/10,000, < 1/1,000) - drowsiness.
Gastrointestinal tract: (uncommon: ≥ 1/10,000, < 1/1,000) - nausea, diarrhea.
On the part of the immune system: (uncommon: ≥ 1/10,000, < 1/1,000) - anaphylactic shock.
Skin and subcutaneous tissue disorders: (uncommon: ≥ 1/10,000, < 1/1,000) - angioedema, skin rash, urticaria, itching.
Expiration date
3 years.
Storage conditions
Store out of the reach and sight of children at a temperature not exceeding 30°C.
Packaging
20 ml in a bottle with a dropper and cap; 1 bottle in a cardboard box.
Vacation category
Without a prescription.
Producer
GSK Consumer Helsker S.A./GSK Consumer Healthcare SA
DOPPEL FARMACEUTICI srl/DOPPEL FARMACEUTICI srl
Location of the manufacturer and its business address
Route de l'Etraz, 1260 Nyon, Switzerland.
Via Martiri delle Foibe, 1 – 29016, Cortemaggiore (province of Piacenza) Italy/Via Martiri delle Foibe, 1 – 29016 Cortemaggiore (PC) Italy
