Syncotal

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT CYNKOTAL (SYNCOTAL)

Composition:

Active substances: rectified eucalyptus oil, rectified sweet orange oil, rectified lemon oil, rectified myrtle oil;

One soft gelatin capsule contains: rectified eucalyptus oil — 198 mg; rectified sweet orange oil — 96 mg; rectified lemon oil — 3 mg; rectified myrtle oil — 3 mg;

Excipient: rapeseed oil;

Capsule shell composition: gelatin, glycerol 99.5%, purified water, sodium alginate, purified stearic acid, ethylcellulose, medium-chain triglycerides, oleic acid.

Pharmaceutical form. Soft gelatin capsules.

Main physico-chemical properties: soft oval-shaped gelatin capsule with a transparent shell, intact seams, and opaque exterior;

capsule contents — a clear, slightly viscous liquid with a characteristic odor of eucalyptus and lemon.

Pharmacotherapeutic group. Expectorants, excluding combined preparations containing antitussives. ATC code R05CA.

Pharmacological Properties

Pharmacodynamics

Sincotal is a herbal secretolytic agent containing eucalyptus oil, purified orange oil, lemon oil, and myrtle oil. Medicinal products with this composition are used in the treatment of acute and chronic bronchitis and sinusitis. The active ingredients exhibit secretolytic, secretomotor, and mucolytic properties due to enhanced mucociliary clearance. Therefore, the medicinal product may significantly improve clinical symptoms. The product also exerts antioxidant and anti-inflammatory effects.

Pharmacokinetics

Absorption

The essential components of the active substance, namely the monoterpenes contained in the essential oils, are rapidly and completely absorbed after oral administration.

Distribution

Studies of sputum samples from patients with cystic fibrosis and measurements of exhaled air concentrations demonstrate the possibility of detecting essential oil components in sputum or exhaled air under laboratory conditions.

Metabolism

The component limonene, present in the essential oils contained in the medicinal product Sincotal, is rapidly metabolized. Dihydroperillic acid and perillic acid are the main metabolites of limonene, with approximately 35% of the limonene present in plasma being excreted in this form. Limonene-1,2-diol is also a major plasma metabolite (approximately 18% of the initial limonene concentration is excreted). Methyl esters of perillic acid and dihydroperillic acid are detected in plasma after limonene administration, but they account for less than 5% of the initially administered limonene.

Excretion

After oral administration, limonene in humans is primarily excreted in urine. Within 24 hours, approximately 60% is excreted in urine, 5% in feces, and approximately 2% via exhaled CO₂.

Clinical characteristics.

Indications.

As part of complex therapy for acute and chronic bronchitis, and inflammation of the paranasal sinuses (sinusitis).

Contraindications.

Hypersensitivity to the components of the medicinal product, particularly to 1,8-cineole. Severe diseases of the stomach, intestines, and biliary tract; severe impairment of liver function.

Do not use in children who have previously experienced seizures (febrile or otherwise).

Interaction with other medicinal products and other forms of interaction.

Sincotal may be taken concomitantly with other medicinal products only after careful assessment of the benefit-risk ratio. Results of experimental animal studies and investigations involving volunteers indicate a potential induction of hepatic cytochrome P450 enzymes due to high doses of the component 1,8-cineole. Laboratory studies of eucalyptus oil have demonstrated inhibition of CYP3A4 at a concentration of 100 μg/mL. Such an effect has not been observed in humans when the product is used appropriately. Adequate interaction studies are lacking.

Special precautions for use

Sincotal should not be taken for longer than 14 days without consulting a doctor. If symptoms worsen, or if dyspnea, fever, purulent or bloody sputum occur, consult a physician.

If symptoms persist for more than 1 week during treatment with the medicinal product, consult a physician.

In case of bronchial asthma, whooping cough or other respiratory tract diseases associated with increased sensitivity and/or airway narrowing, the drug should be used only as prescribed by a physician.

Sincotal should be used with caution in inflammatory conditions and mild ulcerative gastrointestinal disorders.

This medicinal product contains 0.0111 mmol (or 0.257 mg) / dose of sodium. Caution is advised when administering to patients on a sodium-controlled diet.

Use during pregnancy or breastfeeding

Use during pregnancy

There is no experience with the use of the medicinal product in pregnant women. In animal studies, the component 1,8-cineole was shown to cross the placenta. Although there is no evidence of harmful effects on the fetus, Sincotal is not recommended during pregnancy.

Use during breastfeeding

Due to the lipophilic properties of the active substance, its passage into breast milk should be considered. Therefore, Sincotal should not be used during breastfeeding.

Fertility

There are no data on the effect of the medicinal product on fertility.

Ability to affect reaction speed when driving or operating machinery
Studies on the influence of the medicinal product on the ability to drive vehicles or operate machinery have not been conducted.

Dosage and Administration

For children aged 6 to 10 years (Sincotal should be administered only to children who are able to swallow the capsule independently): 1 capsule twice daily. For adults and children aged 10 years and older with clinical signs of acute inflammation: 1 capsule 3–4 times daily. To facilitate morning expectoration of mucus, it is recommended to take the last capsule of Sincotal in the evening before bedtime.

In chronic conditions, take 1 capsule twice daily. The same dosage is recommended for long-term therapy.

To facilitate morning expectoration of mucus in chronic bronchitis, an additional capsule of Sincotal is recommended to be taken in the evening before bedtime.

Sincotal capsules should be taken 30 minutes before meals, swallowed with a large amount of cool water or other beverages.

The medicinal product should be used during the symptomatic phase of the illness and for 2–4 days after symptoms have resolved.

Children

The medicinal product is indicated for children aged 6 years and older (provided they are able to swallow the capsule independently).

Overdose

The following information refers to the toxicity of the main component of the medicinal product — eucalyptus oil.

Children. Following ingestion of 2–3 mL (7–10 capsules) of eucalyptus oil, mild central nervous system (CNS) disturbances such as drowsiness have been reported. Ingestion of 5 mL (17 capsules) may lead to significant CNS disturbances up to loss of consciousness.

Adults. Following ingestion of a dose of eucalyptus oil exceeding the recommended daily dose by 8 times (48 capsules), severe symptoms of overdose may occur, including ataxia, miosis or mydriasis, mucosal inflammation with nausea, vomiting, abdominal pain, diarrhea, and other gastrointestinal disturbances. Other possible symptoms include apnea, tachypnea, cardiac arrhythmias, loss of consciousness, and other CNS disturbances. Ingestion of very high doses may lead to coma and seizures.

Treatment. Due to the risk of aspiration, vomiting should be avoided after ingestion. Gastric lavage is recommended following endotracheal intubation. After ingestion by children exceeding 5 mL (>17 capsules) or by adults exceeding 15 mL (>50 capsules) of eucalyptus oil, administration of activated charcoal or another enterosorbent is recommended. High fluid intake is also advised (except milk and fat-containing solutions, as they may enhance absorption). Hemodialysis and symptomatic treatment may be required in severe cases.

Side effects

The frequency of adverse reactions was assessed according to the following categories:

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 not known (cannot be estimated from the available data).

Immune system disorders

Uncommon: allergic reactions such as dyspnea, facial swelling, rash, urticaria, itching.

Frequency not known: anaphylactic reactions.

Nervous system disorders

Uncommon: headache or dizziness.

Gastrointestinal disorders

Common: complaints of stomach pain or epigastric discomfort.

Uncommon: gastritis or gastroenteritis, nausea, vomiting, diarrhea or other digestive disturbances; taste disturbances.

Hepatobiliary disorders

Rare: exacerbation of cholelithiasis.

Renal and urinary disorders

Rare: exacerbation of nephrolithiasis.

Reporting of adverse reactions

Reporting suspected adverse reactions after marketing authorization is highly important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients, as well as their legal representatives, are encouraged to report any suspected adverse reactions and lack of efficacy via the automated pharmacovigilance information system at the following link: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Do not use after the expiry date stated on the packaging.

Storage conditions. Store at temperatures not exceeding 25 °C. Keep out of the reach and sight of children.

Packaging. 10 capsules per blister, 2 or 4 blisters per cardboard box.

Pharmaceutical category. Over-the-counter (without prescription).

Manufacturer. Dr. Gustav Klein GmbH & Co. KG

Manufacturer's address and place of business. Steinenfeld 3, 77736 Zell am Harmersbach, Germany.