INGALIPT-ZDOROVYA FORTE WITH CHAMOMILE

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT INGALIPT-ZDOROVYEFORTE WITH CAMOMILE (INGALIPT-ZDOROVYEFORTEWITHCAMOMILE)

Composition:

Active substances: 1 can (30 ml) contains 0.75 g of soluble sulfanilamide, 0.54 g of sodium sulfathiazole calculated as anhydrous sodium sulfathiazole, 0.015 g of thymol, 0.015 g of eucalyptus oil, 0.015 g of peppermint oil, 1.26 g of liquid extract of Salvia officinalis leaves (1:10) (extraction agent – 70% ethanol), 1.26 g of liquid extract of chamomile (6:10) (extraction agent – 50% ethanol);

1 bottle (50 ml) contains 1.25 g of soluble sulfanilamide, 0.9 g of sodium sulfathiazole calculated as anhydrous sodium sulfathiazole, 0.025 g of thymol, 0.025 g of eucalyptus oil, 0.025 g of peppermint oil, 2.1 g of liquid extract of Salvia officinalis leaves (1:10) (extraction agent – 70% ethanol), 2.1 g of liquid extract of chamomile (6:10) (extraction agent – 50% ethanol);

Excipients: ethanol 96%, refined sugar, glycerin, polysorbate, purified water.

Pharmaceutical form. Oral spray.

Main physicochemical properties: clear yellow to brown liquid with a characteristic odor.

Pharmacotherapeutic group. Agents acting on the respiratory system. Preparations used in throat diseases. Antiseptics. ATC code R02A A20.

Pharmacological properties.

Pharmacodynamics. The pharmacological effects of the drug are due to 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 a strong antimicrobial effect, which is enhanced by eucalyptus oil. Peppermint oil, when applied to mucous membranes, produces a moderate local anesthetic effect. Chamomile extract, in addition to anti-inflammatory and antimicrobial effects, stimulates tissue regeneration.

The combination of these components provides comprehensive pathogenetic therapy of inflammatory diseases of the mucous membrane 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 infectious and inflammatory diseases of the ear, nose and throat organs and the oral mucosa (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 forms of interaction. 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 (procaine, anestezin, dicaine).

Special precautions for use

Before using the medication, especially if you have a tendency towards 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.

It is strictly prohibited for the medication to get into the eyes.

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, avoid eating for 15–30 minutes.

When using the medication in children, note that a single dose sprayed for 1–2 seconds contains 0.0076–0.0152 ml of ethanol (96%), which corresponds to the following per single dose: for children aged 3–5 years (body weight 15–21 kg) – 0.0004–0.0013 ml/kg; for children aged 6–12 years (body weight 21–38 kg) – 0.0002–0.0007 ml/kg.

The medication contains sugar, which should be taken into account for patients with diabetes mellitus and those with hereditary fructose intolerance or glucose-galactose malabsorption syndrome.

Use during pregnancy or breastfeeding. The use of the medication during pregnancy or breastfeeding is possible only under medical supervision, with careful consideration of the benefit-risk ratio and strict adherence to the recommended dosing regimen.

Ability to affect reaction speed when driving or operating machinery. The medication does not affect the ability to drive or operate machinery. However, drivers should be aware that it may interfere with alcohol testing results.

Method of Administration and Dosage

For local application to the oral and oropharyngeal mucous membranes by spraying, in adults and children aged 3 years and older. To administer, spray the preparation 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 individually determined by a physician and depend on the severity of the condition!

Instructions for Using the Canister/Bottle

1. Remove the protective cap from the canister/bottle.
2. Attach the provided oral nozzle (sprayer) to the valve stem of the canister, ensuring beforehand that it is clean.
3. 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 is observed, the procedure may be repeated.
4. Insert the free end of the sprayer into the oral cavity and, while holding the canister vertically, press down on the sprayer head. The spraying duration should be 1–2 seconds.
5. After completing the spraying, remove the sprayer from the valve stem and cover the canister with the protective cap to prevent contamination.
6. The sprayer should be kept clean and washed daily under a stream of warm water, then dried thoroughly in a warm place.

Children. The product is contraindicated 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 carried out under medical supervision.

Overdose. Cases of overdose have not been reported. Overuse may lead to an increase in the frequency or severity of adverse effects.

Treatment: discontinue the drug, rinse the oral cavity with warm boiled water. Symptomatic therapy.

Side effects.

In individual cases, the following may occur:

Immune system: allergic reactions, including angioedema, bronchospasm.

Skin: rashes, itching, urticaria, swelling at the site of contact.

Gastrointestinal tract: 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 can 30 ml with spray nozzle and protective cap in a box; 1 bottle 50 ml with oral spray device and protective cap in a box.

Availability. Over-the-counter.

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVYA".

Manufacturer's address and place of business. Ukraine, 61013, Kharkiv region, city of Kharkiv, Shevchenko Street, 22.