Sinucod

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT SINECOD (SINECOD)

Composition:

Active substance: butamirate citrate;

1 ml of syrup contains 1.5 mg of butamirate citrate;

Excipients: sorbitol solution 70% (E 420), glycerol, sodium saccharin, benzoic acid (E 210), vanillin, ethanol 96%, sodium hydroxide 30%, purified water.

Pharmaceutical form. Syrup.

Main physicochemical properties: clear solution, colorless to slightly brownish-yellow.

Pharmacotherapeutic group. Agents used for cough and colds. Antitussives. ATC code R05DB13.

Pharmacological Properties

Pharmacodynamics

A non-narcotic centrally-acting antitussive agent. However, the exact mechanism of action remains unknown.

The active ingredient of Synecode is butamirate citrate, which suppresses cough and differs in structure and pharmacological action from opium alkaloids. Butamirate citrate is believed to act on the central nervous system. It produces a non-specific anticholinergic and bronchospasmolytic effect, thereby improving respiratory function. Synecode does not cause habituation or dependence.

Butamirate citrate has a wide therapeutic range; therefore, Synecode is well tolerated at therapeutic doses and is well suited as a cough suppressant for children.

Pharmacokinetics

Butamirate is rapidly absorbed, distributed throughout the body, and subsequently hydrolyzed mainly into 2-phenylbutyric acid and diethylaminoethoxyethanol, both of which also possess antitussive activity. 2-Phenylbutyric acid is further partially metabolized via hydroxylation. Butamirate and 2-phenylbutyric acid are highly bound to plasma proteins.

The effect of food on bioavailability has not been confirmed. The metabolism of butamirate to 2-phenylbutyric acid and diethylaminoethoxyethanol is completely proportional within the dose range of 22.5–90 mg.

Measurable concentrations of butamirate in blood appear within 5 to 10 minutes after administration of 22.5 mg, 45 mg, 67.5 mg, and 90 mg doses. Maximum plasma concentrations are reached within 1 hour for all four doses, with a mean maximum plasma concentration of 16.1 ng/mL following the 90 mg dose.

The mean maximum plasma concentration of 2-phenylbutyric acid is reached within 1.5 hours, with the highest exposure observed after the 90 mg dose (3052 nanograms/mL).

The mean maximum plasma concentration of diethylaminoethoxyethanol is reached within 0.67 hours, with the highest exposure observed after the 90 mg dose (160 nanograms/mL).

Metabolites are excreted primarily via the kidneys. Butamirate can be detected in urine up to 48 hours after administration. Based on measurements, the elimination half-life is 1.48–1.93 hours for butamirate, 23.26–24.42 hours for 2-phenylbutyric acid, and 2.72–2.90 hours for diethylaminoethoxyethanol.

There is no evidence of the influence of hepatic or renal impairment on the pharmacokinetic parameters of butamirate.

Clinical characteristics

Indications.

Symptomatic treatment of cough (including dry cough) of various origins.

Contraindications.

Hypersensitivity to the active substance or to any of the excipients of the medicinal product.

Special precautions for use

Since butamirate suppresses the cough reflex, concomitant use of expectorants should be avoided, as this may lead to mucus stasis in the airways, increasing the risk of bronchospasm and respiratory tract infection.

The syrup contains sweeteners – sodium saccharin and sorbitol (284 mg per 1 ml), therefore it can be prescribed to patients with diabetes mellitus. Sorbitol may cause gastrointestinal discomfort and mild laxative effect.

Sorbitol is a source of fructose; therefore, the product should not be used in patients with hereditary fructose intolerance. It should also not be used in patients with rare hereditary problems of lactose intolerance or glucose-galactose malabsorption.

The medicinal product contains a small amount of ethanol (alcohol) (less than 100 mg per dose), i.e. less than 100 mg per dose. The medicinal product contains less than 1 mmol of sodium (23 mg) per dose, i.e. the sodium content is negligible.

If cough persists for more than 7 days, consult a physician.

Patients whose symptoms worsen or do not improve within 7 days and/or are accompanied by fever, rash, or persistent headache should undergo additional investigations to identify the underlying cause.

Keep out of reach and sight of children.

Interaction with other medicinal products and other forms of interaction

Concomitant use of expectorants should be avoided. The exact mechanism of interaction with other medicinal products has not been studied, but the central mechanism of action of the cough-suppressant drug may be enhanced by strong depressants, including alcohol.

Use during pregnancy or breastfeeding

The safety of using Sinecod during pregnancy or breastfeeding has not been evaluated in specific studies. Animal studies do not indicate direct or indirect harmful effects on pregnancy or fetal health.

Sinecod may be used during pregnancy only on a physician's prescription when there are clear indications for such treatment. If the expected benefit to the pregnant woman outweighs the potential risk to the fetus, the lowest effective dose and shortest duration of treatment should be considered.

It is unknown whether the active substance and/or its metabolites pass into breast milk.

For safety reasons, the benefits and risks of using Sinecod during breastfeeding should be carefully weighed. The use of the drug during breastfeeding is possible only upon medical advice, if, in the physician’s opinion, the expected positive effect for the mother outweighs the potential risk for the infant. In such a case, the lowest effective dose and shortest duration of treatment should be considered.

Ability to affect reaction speed when driving or operating machinery

May cause fatigue and affect reaction ability when driving or operating machinery.

Dosage and Administration

For oral use only.

Children aged 3 to 6 years: 5 mL (7.5 mg) three times daily; maximum daily dose – 15 mL (22.5 mg);

Children aged 6 to 12 years: 10 mL (15 mg) three times daily; maximum daily dose – 30 mL (45 mg);

Adolescents aged 12 years and older: 15 mL (22.5 mg) three times daily; maximum daily dose – 45 mL (67.5 mg).

Adults: 15 mL (22.5 mg) four times daily; maximum daily dose – 60 mL (90 mg).

The measuring cup should be washed and dried after each use and after use by another person.

The maximum duration of treatment without a doctor's prescription should not exceed 1 week.

The medicine should preferably be taken before meals.

The lowest effective dose should be used for the shortest duration necessary to achieve the desired effect.

Do not exceed the stated dose.

Children

The drug in this pharmaceutical form is not intended for children under 3 years of age. Another pharmaceutical form, namely, Synecode oral drops for children, may be used.

Overdose

Overdose of Synecode may cause the following symptoms: drowsiness, nausea, vomiting, diarrhea, dizziness, and arterial hypotension.

Further treatment should be carried out according to clinical indications.

There is no specific antidote for butamirate overdose. In case of overdose, symptomatic treatment and monitoring of vital functions are required.

Adverse Reactions.

Central and peripheral nervous system (isolated cases: ≥ 1/10000, < 1/1000): dizziness, somnolence.

Gastrointestinal disorders (isolated cases: ≥ 1/10000, < 1/1000): nausea, diarrhea.

Immune system disorders (isolated cases: ≥ 1/10000, < 1/1000): anaphylactic shock.

Skin and subcutaneous tissue disorders (isolated cases: ≥ 1/10000, < 1/1000): angioneurotic edema, rash, urticaria, pruritus.

Shelf life. 3 years.

Storage conditions. Store in a place inaccessible to children and out of their sight, at a temperature not exceeding 30 °C.

Packaging. 100 ml or 200 ml in a bottle with a cap and a measuring cup; 1 bottle in a cardboard box.

Availability. Over-the-counter.

Manufacturer.

Haleon CH S.a.r.l. / Haleon CH S.a.r.l.

Manufacturer's address and place of business.

Route de l’Etraz 2, Nyon, 1260, Switzerland / Route de l’Etraz 2, Nyon, 1260, Switzerland