Gripostadon balm

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT GRIPOCITRON BALSAM (GRIPOCITRON BALSAM)

Composition:

Active substances: 100 g of the preparation contains: Pine essential oil (Pini sylvestris aetheroleum) 3 g, Eucalyptus essential oil (Eucalypti aetheroleum) 10 g;

Excipients: cetostearyl alcohol, glycerol monostearate, polyethylene glycol stearate, cetostearyl ether of polyethylene glycol, tromethamine, anhydrous citric acid, purified water.

Pharmaceutical form. Topical emulsion.

Main physicochemical characteristics: white-colored emulsion with a refreshing aroma and a characteristic odor.

Pharmacotherapeutic group. Antitussives in combination with expectorants.

ATC code R05F B02.

Pharmacological Properties.

Pharmacodynamics.

The main active component of the medicinal product is eucalyptus oil containing not less than 80 % of 1,8-cineole, which has spasmolytic activity. Its action is combined with that of common pine oil, which contains 30–40 % alpha-pinene, improving blood supply. The pharmacological effects of these essential oils (thinning and dissolving bronchial secretions, enhanced elimination by the ciliated epithelium, reduction of catarrhal manifestations in the respiratory tract, anti-inflammatory action) are widely used in therapeutic practice. Due to their lipophilic properties, the active substances are well distributed over the skin and are absorbed. After absorption, they are partially excreted through the lungs, thus reaching directly to the site of action via the bloodstream. Therefore, the initial effect occurring during inhalation is enhanced when taking a warm bath.

Clinical characteristics.

Indications.

For relief of symptoms of respiratory tract colds associated with excessive mucus production.

Contraindications.

Hypersensitivity to any component of the medicinal product. Bronchial asthma, pertussis, pseudocroup, tendency to seizures. Damaged skin, for example in burns or impaired skin integrity. Marked respiratory hypersensitivity, such as impaired vocal cord function.

Interaction with other medicinal products and other forms of interaction.

No interactions with other substances have been observed to date.

Special precautions for use.

Do not apply near the eyes or on mucous membranes. After application, hands should be thoroughly wiped to prevent contact with the face (especially the eyes). Care should be taken to ensure that children do not touch with their hands the areas of skin to which the product has been applied. Cetostearyl alcohol may cause local skin irritation (e.g. contact dermatitis).

Baths should not be taken by patients with cardiovascular diseases in the decompensated stage (severe arterial hypertension, arrhythmia, angina pectoris), or when body temperature is elevated above 38°C.

Use during pregnancy or breastfeeding.

As adequate studies on the safety of using the medicinal product during pregnancy have not been conducted, it should not be used during pregnancy.

During breastfeeding, do not apply on the breasts.

Ability to influence reaction rate when driving or operating machinery.

No effect.

Method of Administration and Dosage

The product is used for rubbing, steam inhalation, or as a component of therapeutic baths.

Rubbing.

For rubbing, the product is applied undiluted.

Apply a strip of emulsion 3–5 cm long onto the skin of the chest several times a day and rub thoroughly.

Steam Inhalation.

Steam inhalation is recommended 3 times daily for several days until symptoms resolve. Dissolve a strip of emulsion 3–5 cm long (1 teaspoon) in 1–2 liters of hot water and inhale the vapors under a towel placed over the head, or via an inhaler.

When using an inhaler, mix the emulsion strip with hot water in the lower chamber of the inhaler (for children aged 3 to 4 years, use a 1–2 cm strip; for children aged 4 to 12 years, use a 2–3 cm strip; for children aged 12 years and older, and adults, use a 3–5 cm strip).

Bathing.

Baths are primarily used for children aged 3 to 6 years.

Dissolve the product in water (36–37 °C) as follows: 2 strips of emulsion 10 cm long (2 tablespoons) per 40 liters of water. Bathe for 10 minutes daily until symptoms resolve. Additionally, if necessary, rub the chest and back with the product 2–3 times a day.

If symptoms do not improve within 4–5 days or worsen, or if dyspnea, fever, or purulent or bloody sputum occur, consult a physician.

Children.

Inhalations for children from age 3 should be performed only under adult supervision. For inhalations, use water no hotter than 70 °C. In the absence of a special inhaler, the distance between the water surface and the face should be at least 20 cm.

Overdose.

When used correctly at recommended doses, intoxication is practically excluded. Accidental ingestion of the undiluted product may cause gastrointestinal complications such as nausea, vomiting, possible diarrhea, and seizures. Systemic absorption should only be considered in extreme cases.

In mild cases, discontinuation of the medicinal product is sufficient. In other cases, symptomatic treatment should be administered. In the event of seizures, administer 5–10 mg diazepam intravenously or a short-acting barbiturate; in cases of ingestion, perform gastric lavage and administer 30 g of sodium sulfate in 250 ml of water.

Side effects.

Allergic reactions, including skin rashes, itching, contact dermatitis, contact eczema, skin and mucous membrane irritation, bronchospasm.

If adverse reactions occur, discontinue treatment and consult a physician.

Shelf life. 2 years.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

40 g of the drug in an aluminum or laminated tube, in a carton.

Availability classification. Over-the-counter.

Manufacturer.

LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVYA".

Manufacturer's address and place of business.

22, Shevchenka Street, Kharkiv, Kharkiv region, 61013, Ukraine.