Carminativum bebinoz

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT KARMINATIVUM BABYNOS (CARMINATIVUM BABYNOS)

Composition:

Active substances:* 1 g of solution (24 drops) contains liquid extracts (1 : 1, ethanol 50%): bitter fennel fruit (Foeniculi amari fructus) 320 mg, coriander fruit (Coriandri fructus) 200 mg, chamomile flowers (Matricariae flos) 200 mg;

Excipients: sorbitol solution 70% (E 420), propylene glycol, sodium saccharin.

*The medicinal product contains 36% v/v of diluted ethanol.

Pharmaceutical form.
Oral drops, solution.

Main physicochemical characteristics:
Clear, dark brown solution.

Pharmacotherapeutic group.
Agents used in functional gastrointestinal disorders.

ATC code A03AX.

Pharmacological properties.

Pharmacodynamics.
Each of the three active herbal components (standardized pharmaceutical-grade herbal extracts) has been shown to exert a moderate carminative effect and promote normalization of gastrointestinal motility.

Foeniculi liquid extract exerts a carminative and spasmolytic effect. Coriandri liquid extract exerts a carminative and secretomotor effect. Chamomillae liquid extract demonstrates carminative and anti-inflammatory effects, as well as antimicrobial and spasmolytic actions.

The preparation does not cause dental caries.

Pharmacokinetics.
Not studied.

Clinical characteristics.

Indications.

For prevention and treatment of flatulence of any origin, and gastrointestinal disorders of various etiologies in children.

Contraindications.

Hypersensitivity to sorbitol (fructose intolerance), hypersensitivity to components of the medicinal product, to plants of the Apiaceae (Umbelliferae) and Asteraceae (Compositae) families.

Special precautions.

The preparation contains 36 % v/v ethanol; therefore, for children under 6 years of age the single dose should be diluted to reduce the concentration by at least 100-fold, and for children aged 6–12 years by at least 10-fold (see "Method of administration and dosage").

Interaction with other medicinal products and other forms of interaction.
Not known.

Use during pregnancy or breastfeeding.
The medicinal product is intended for use in children only.

Ability to influence reaction rate when driving or operating machinery.
The product is intended for use in children only.

Administration and Dosage

The medication is intended for use in children only. It is taken orally. For children under 12 years of age, the medication must necessarily be diluted with tea or water. The medication is administered three times daily.

Age	Dose	Dilution
From 6 months to 1 year	3–6 drops	1 drop in 5 ml of liquid
From 1 to 6 years	6–10 drops
From 6 to 12 years	10–15 drops	1 drop in 1 ml of liquid

Shake the solution before use; when measuring drops, hold the bottle upside down.

Children.
This medication is prescribed for children aged 6 months to 12 years.

Overdose.
Symptoms of overdose have not been observed. Cases of intoxication are unknown.

Side effects.

In isolated cases, allergic reactions may occur, including hyperemia, rash, itching, and skin swelling.

Shelf life.
3 years 6 months. After the first opening of the bottle, the product is suitable for use within 1 year.

Storage conditions.
Store in a light-protected place at a temperature not exceeding 25°C, in tightly closed packaging.

Packaging.
30 ml in a brown glass dropper bottle, in a cardboard box.

Availability.
Over-the-counter (without prescription).

Manufacturer.
«Dentinox Gesellschaft für pharmazeutische Praparate Lenk & Schuppan», Germany.

Manufacturer's address.
Nunsdorfer Ring 19, 12277 Berlin, Germany.