Sinecod

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

Composition:

Active substance: butamirate citrate;

1 ml (20 drops) of solution contains 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. Oral drops for children.

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

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

Pharmacological properties.

Pharmacodynamics.

A non-opioid antitussive agent with central action. However, the exact mechanism of action is unknown.

The active ingredient of Synecode is butamirate citrate, which suppresses cough and is structurally and pharmacologically distinct from opium alkaloids. The substance is believed to act on the central nervous system. Butamirate citrate produces nonspecific anticholinergic and bronchospasmolytic effects, 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 for the treatment of cough in children.

Pharmacokinetics.

Butamirate is rapidly absorbed, distributed throughout the body, and subsequently hydrolyzed predominantly to 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 protein-bound in the body.

The effect of food on bioavailability has not been confirmed. Metabolism to 2-phenylbutyric acid and diethylaminoethoxyethanol is entirely proportional within the dose range of 22.5–90 mg. Metabolites are excreted primarily via the kidneys. Butamirate is detectable in urine up to 48 hours after administration. According to measurement results, 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 impact of hepatic or renal impairment on the pharmacokinetic parameters of butamirate.

Clinical characteristics

Indications.

Symptomatic treatment of cough of various origins in children.

Contraindications.

Hypersensitivity to the active or excipient substances of the medicinal product, hereditary fructose intolerance, due to the presence of sorbitol in 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.

Five drops of the medicinal product contain 71 mg of sorbitol. Sorbitol is a source of fructose. The product should not be used in patients with rare hereditary fructose intolerance.

The medicinal product contains a small amount (less than 100 mg per dose) of ethanol (alcohol).

The medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. the sodium content is considered negligible.

If cough persists for more than 7 days, a physician should be consulted.

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.

The medicinal product should be used in children under 2 years of age only under medical supervision.

Keep out of the 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 cough-suppressant action of the medicinal product may be enhanced by strong depressants, including alcohol.

Use during pregnancy or lactation

The product is intended for use in children.

Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy or fetal health. Safety during pregnancy has not been evaluated in specific clinical studies involving pregnant women. Therefore, use during pregnancy is not recommended except when specifically advised by a physician.

It is unknown whether the active substance and/or its metabolites are excreted in breast milk; therefore, the use of this medicinal product is not recommended during breastfeeding.

Effect on ability to drive and use machines

The product is intended for use in children.

May cause fatigue and affect the ability to drive or operate machinery.

Dosage and Administration

The medicinal product is intended for use in children.

For oral use only.

The single dose depends on the child's age and is as follows:

• Children from 2 months to 1 year: 10 drops (2.5 mg) four times daily; maximum daily dose – 40 drops (10 mg);
• Children from 1 to 3 years: 15 drops (3.75 mg) four times daily; maximum daily dose – 60 drops (15 mg);
• Children from 3 to 6 years: 25 drops (6.25 mg) four times daily; maximum daily dose – 100 drops (25 mg).
  Children aged 3 years and older may be administered an alternative dosage form, namely, Synecod syrup.

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

The lowest effective dose should be used for the shortest possible duration of treatment.

Do not exceed the recommended dose.

Children

Not intended for children under 2 months of age.

For children under 2 years of age, use only under medical supervision.

Children aged 3 years and older may be administered an alternative dosage form, namely, Synecod syrup.

Overdose

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

Further management should be based on clinical indications.

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

Side effects.

From the nervous system (rare: ≥ 1/10,000, < 1/1,000) – dizziness, drowsiness.

From the gastrointestinal tract (rare: ≥ 1/10,000, < 1/1,000) – nausea, diarrhea.

From the immune system (rare: ≥ 1/10,000, < 1/1,000) – anaphylactic shock.

From the skin and subcutaneous tissue: (rare: ≥ 1/10,000, < 1/1,000) – angioneurotic edema, rash, urticaria, pruritus.

Shelf life. 3 years.

Storage conditions. Store out of reach and sight of children at a temperature not exceeding 30 °C.

Packaging. 20 ml in a bottle with dropper and cap; 1 bottle per cardboard box.

Prescription status. 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