API
Bronchicum Elixir (Liquid for oral use)
Therapeutic indications
Bronchicum Elixir is an herbal medicine recommended in the treatment of respiratory infections following exposure to cold. Bronchicum Elixir is used to treat symptoms of acute bronchitis and respiratory infections with thick phlegm following exposure to cold.
Posology & method of administration
Infants from 6 to 12 months: 1.0 ml 6 times a day (approx. 6 -10 kg).
Children from 1 to 4 years: 2.5 ml 6 times a day (approx. 8 – 16 kg).
Children over 5 years, adolescents and adults: 7.5 ml 4 times a day.
Method of administration
Bronchicum Elixir should be taken in divided doses spread evenly throughout the day, using the dose dispenser provided. There is no restriction on the duration of use. The patient's attention is drawn to the following in the information leaflet: "...you should seek medical advice if symptoms last more than 1 week. In any event you must take note of the information in the warnings and undesirable effects sections". If necessary, gently tap the bottom of the bottle to pour out the liquid. Bronchicum Elixir contains herbal extracts; occasional formation of flakes or deposits has no effect on efficacy. There are no adequate data for specific dosage recommendations in patients with restricted kidney function or liver function.
Contraindications
This medicinal product must not be used in patients with hypersensitivity to the active substances or other plants of the Lamiaceae (Labitae) family, or to any of the excipients.
Special Warnings and Precautions for Use
Bronchicum Elixir contains 4.9% (VN) alcohol. Patients with rare hereditary fructose intolerance, glucose galactose malabsorption or congenital sucrase-isomaltase deficiency should not take Bronchicum Elixir. 1 ml contain 1.1 g of a mix of sucrose, glucose and fructose. This should be taken into account in patients with diabetes mellitus.
Fertility, Pregnancy and Lactation
Pregnancy and lactation:
There are no studies on the use of thyme and primrose products during pregnancy and breastfeeding. The use is therefore not recommended.
Fertility
There are no data available concerning the effect on fertility.
Effects on Ability to Drive and Use Machines
Bronchicum Elixir has no effect on the ability to drive and operate machines.
Undesirable effects
Hypersensitivity reactions such as exanthema, urticaria and angioedema may occur associated with dyspnea. Gastrointestinal effects, such as cramps, nausea, vomiting and diarrhea have also been observed. No information is available on the frequency, of these possible side effects.
Children: In infants under 12 months of age, vomiting is common (≥ 1/ 100 to < 1/10).
- Ask your physician or pharmacist about the proper dose, use and precautions of this medication.
- Always read leaflet information before using the medication. Egyptian Drug authority leaflet approval date:13/3/2022.
- Consumers should report any suspected adverse reactions to the Egyptian Pharmacovigilance Center (EPVC) & Pharmacovigilance department of Sanofi.