Ingalipht-zdorovya forte
Ukraine
Table of Contents
INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT INGALIPT-ZDOROVYEFORTE (INGALIPT-ZDOROVYEFORTE)
Composition:
Active substances: 1 canister (30 ml) contains soluble sulfadimidine 0.75 g, sodium sulfathiazole calculated as anhydrous sodium sulfathiazole 0.54 g, thymol 0.015 g, eucalyptus oil 0.015 g, peppermint oil 0.015 g, liquid extract of medicinal sage leaves (1:10) (extraction agent — 70% ethanol) 1.26 g;
1 bottle (50 ml) contains soluble sulfadimidine 1.25 g, sodium sulfathiazole calculated as anhydrous sodium sulfathiazole 0.9 g, thymol 0.025 g, eucalyptus oil 0.025 g, peppermint oil 0.025 g, liquid extract of medicinal sage leaves (1:10) (extraction agent — 70% ethanol) 2.1 g;
Excipients: ethanol 96%, refined sugar, glycerin, polysorbate, purified water.
Pharmaceutical form. Oral spray.
Main physicochemical properties: clear liquid ranging from light yellow to dark yellow in color with a characteristic odor.
Pharmacotherapeutic group. Agents acting on the respiratory system. Preparations used in throat diseases. Antiseptics. ATC code R02AA20.
Pharmacological properties.
Pharmacodynamics. The pharmacological effects of the drug are determined by the action of its components. Soluble streptocide and sodium sulfathiazole exert antimicrobial activity against Gram-positive and Gram-negative bacteria causing diseases of the oral cavity and pharynx. Thymol has antiseptic, expectorant, and spasmolytic effects. Eucalyptus oil has anti-inflammatory and antiseptic activity. Sage exerts pronounced antimicrobial action, which is enhanced by eucalyptus oil. Peppermint oil exerts a moderate local anesthetic effect when applied to mucous membranes.
The combination of the drug's components provides comprehensive pathogenetic therapy for inflammatory diseases of the mucous membranes of the oral cavity and upper respiratory tract. The drug exhibits anti-inflammatory, antimicrobial, and antifungal effects; it is active against Gram-positive and Gram-negative bacteria, as well as Candida species.
Clinical characteristics.
Indications. Local treatment of inflammatory and infectious diseases of the ear, nose and throat organs and the mucous membrane of the oral cavity (tonsillitis, pharyngitis, laryngitis, aphthous and ulcerative stomatitis).
Contraindications. Hypersensitivity to the components of the drug, history of severe toxic-allergic reactions to sulfonamides.
Interaction with other medicinal products and other types of interactions. If you are taking any other medicinal products, be sure to consult your doctor regarding the possibility of using this drug!
Possible reduction of the antimicrobial effect of the drug when used simultaneously with derivatives of para-aminobenzoic acid (novocaine, anesthesin, dicaine).
Special precautions for use.
Before using the medication, especially if you are prone to allergies, consult your doctor! Do not use the medication for longer than the recommended period without consulting a physician!
Always inform your doctor about any previous reactions you have had to medications of this group.
Contact of the medication with the eyes must be avoided.
Before application, it is recommended to rinse the mouth with warm boiled water. Using sterile swabs, remove necrotic deposits from affected areas of the oral cavity (ulcers, erosions). After spraying the medication into the oral cavity, refrain from eating for 15–30 minutes.
When using the medication in children, note that a single dose sprayed over 1–2 seconds contains 0.0076–0.0152 ml of ethanol (96%), which corresponds to a single dose of: 0.0004–0.0013 ml/kg for children aged 3–5 years (body weight 15–21 kg) and 0.0002–0.0007 ml/kg for children aged 6–12 years (body weight 21–38 kg).
The medication contains sugar, which should be taken into account in patients with diabetes mellitus and in patients with hereditary fructose intolerance or glucose-galactose malabsorption syndrome.
Use during pregnancy or breastfeeding. The medication may be used during pregnancy or breastfeeding only under medical supervision, with careful consideration of the benefit-risk ratio and strict adherence to the recommended dosing regimen.
Ability to affect reaction rate when driving or operating machinery. The medication does not affect the ability to drive or operate machinery. However, drivers should be aware that the product may interfere with breathalyzer tests for alcohol.
Method of Administration and Dosage
For topical application to the oral and nasopharyngeal mucous membranes by spraying, in adults and children aged 3 years and older. Spray the medication into the oral cavity for 1–2 seconds.
Adults: spray 3–4 times daily.
Children aged 3 years and older: spray 1–2 times daily, unless otherwise directed by a physician.
The duration of treatment depends on the course of the disease and usually lasts 3–10 days.
The frequency and duration of administration should be determined individually by a physician, depending on the severity of the condition!
Instructions for Using the Canister/Bottle
- Remove the protective cap from the canister/bottle.
- Attach the provided oral nozzle (sprayer) to the valve stem of the canister, ensuring it is clean beforehand.
- Shake the canister/bottle for 1 minute and perform no more than 5 actuations of the nozzle until a fine spray appears. If no spray appears, repeat the action once.
- Insert the free end of the sprayer into the oral cavity and, holding the canister vertically, press the sprayer head. The spraying duration should be 1–2 seconds.
- After completing the spray application, remove the sprayer from the valve stem and cover the canister with the protective cap to prevent contamination.
- Keep the sprayer clean by washing it daily under a stream of warm water and then drying it in a warm place.
Children. Do not use the medication in children under 3 years of age.
Use with caution in children aged 3 years and older due to the potential risk of reflex bronchospasm caused by the presence of eucalyptus and peppermint essential oils. Treatment of children should be conducted under medical supervision.
Overdose. Cases of overdose have not been reported. Overdose may lead to an increased risk of adverse effects.
Treatment: discontinue the medication, rinse the oral cavity with warm boiled water. Provide symptomatic therapy.
Side effects.
In individual cases, possible:
Immune system side effects: allergic reactions, including angioneurotic edema, bronchospasm.
Skin side effects: rashes, itching, urticaria, swelling at the site of contact.
Gastrointestinal side effects: nausea, vomiting, local effects (burning sensation in the mouth, lump in the throat or irritation).
Other: general weakness, difficulty breathing.
If any adverse events or unusual reactions occur, consult your doctor regarding further use of the medication.
Shelf life. 1.5 years.
Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.
Packaging. 1 aerosol bottle of 30 ml with spray nozzle and protective cap in a box; 1 bottle of 50 ml with oral spray device and protective cap in a box.
Availability. Over-the-counter (without prescription).
Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVIYA".
Manufacturer's address and place of business. 22, Shevchenka Street, Kharkiv, Kharkiv region, 61013, Ukraine.