Rino-tonSPRAY 0,1%-0,05%

Information leaflet: information for the consumer

RHINO-TON^®, nasal spray 0.5 mg/ml, 1 mg/ml

xylometazoline hydrochloride

Please read this information leaflet carefully before you start taking this medicine because it contains important information for you.

 • Always use the medicine exactly as described in this info8mation leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet. You may need to read it again.

 • If you have any further questions, please ask your doctor or pharmacist.

• If you experience any adverse reactions, contact your doctor. This recommendation applies to any possible adverse reactions, including those not listed in section 4 of the package insert.

• If the condition does not improve or worsens within 7 days after starting the drug, you should consult a doctor.

 Contents of the leaflet

 1. What RHINO-TON^® is and what it is used for

2. What you need to know before using the drug RHINO-TON^®

 3. How to use the drug RHINO-TON^®

 4. Possible adverse reactions

5. Storage of the medicinal product RHINO-TON^®

 6. Contents of the package and other information

1. What RHINO-TON^® is and what it is used for

The drug RHINO-TON^® contains xylometazoline hydrochloride as an active substance, which belongs to the group of sympathomimetic agents that act on alpha-adrenergic receptors of the nasal mucosa. When applied to the nose, it causes constriction of the blood vessels of the nasal mucosa, thus eliminating the swelling of the mucous membrane and nasopharynx. Facilitates nasal breathing.

 The composition of the drug includes sorbitol, which can reduce the symptoms of dryness of the nasal mucosa.

The action comes in a few minutes and lasts for 12 hours. Xylometazoline does not disrupt the function of the ciliated epithelium.

 The drug RHINO-TON^® is used to treat various types of rhinitis, to facilitate the outflow of secretions in case of inflammation of the paranasal sinuses, as an adjuvant therapy for otitis media (to reduce swelling of the nasopharyngeal mucosa), to facilitate rhinoscopy.

If after 7 days after the start of the drug there is no improvement or you feel worse, you should consult a doctor.

2. What you need to know before using the drug RHINO-TON^®

 Do not use RHINO-TON^® in the following cases:

 - in case of hypersensitivity (allergy) to xylometazoline and / or to any of the components of the drug (see section 6);

- with angle-closure glaucoma;

 - with atrophic rhinitis;

 - with dry rhinitis;

- if you have undergone removal of the pituitary gland or other surgical intervention, proceeding with the opening of the dura mater.

 Special instructions and precautions

Talk to your doctor or pharmacist before using RHINO-TON^®.

Consult your doctor before using RHINO-TON^® in the following cases:

 - in diseases of the cardiovascular system [including arterial hypertension, long QT interval syndrome (due to an increased risk of developing serious ventricular arrhythmias)];

- with hyperthyroidism (a disease of the thyroid gland characterized by an excess of thyroid hormones in the body), diabetes mellitus, pheochromocytoma (a tumor of the adrenal glands that secretes excessive amounts of catecholamines, powerful hormones that cause an increase in blood pressure and other symptoms);

 - with prostatic hypertrophy;

- if you are receiving or have received treatment with monoamine oxidase inhibitors within the last 14 days (see section "Other medicines and RHINO-TON^®");

- with increased sensitivity to sympathomimetics, which is manifested by such symptoms as insomnia, dizziness, etc.

 It is not recommended to use the drug RHINO-TON^® continuously for more than 7 days, as well as other vasoconstrictor drugs for topical use, since it is possible to develop drug-induced rhinitis with swelling of the nasal mucosa, the symptoms of which are similar to the common cold.

 For hygiene reasons and to avoid infection, the spray bottle can only be used by one person.

The recommended dose should not be exceeded, especially in children and elderly patients. The drug RHINO-TON^®, nasal spray 0.5 mg / ml should not be used in children under 2 years of age. Children from 2 to 12 years of age are recommended to use the drug under adult supervision. The drug RHINO-TON^®, nasal spray 1 mg / ml should not be used in children under 12 years of age.

Other medicines and RHINO-TON^®

 Tell your doctor or pharmacist if you are taking, have recently taken or may start taking any other medicines.

 Some medicines may interact with RHINO-TON^®. Make sure your healthcare provider knows you are taking the following medicines:

- monoamine oxidase inhibitors (drugs used in psychiatry), xylometazoline can enhance the effect of monoamine oxidase inhibitors and cause a hypertensive crisis;

 tri- or tetracyclic antidepressants (drugs used to treat depression).

Pregnancy and breastfeeding

 If you are pregnant, likely to become pregnant or planning to become pregnant, or if you are breastfeeding, you should consult your doctor before taking this medicine.

 If during the use of the drug you suspect or determine that you are pregnant, consult your doctor about the possibility of continuing treatment with this drug.

RHINO-TON^® should not be used during pregnancy.

 Do not use RHINO-TON^® during breastfeeding unless it has been prescribed to you by your doctor.

 Driving vehicles and working with mechanisms

 It is impossible to exclude the possible systemic effect of xylometazoline on the cardiovascular system with long-term use or when used in high doses.

Excipients

 1 ml of RHINO-TON^® contains 0.2 mg of benzalkonium chloride. Benzalkonium chloride can cause swelling of the nasal mucosa with prolonged use.

1 ml of RHINO-TON^® contains 3.0 mg of benzyl alcohol, which can cause allergic reactions.

3. How to use the drug RHINO-TON^®

 Always use the medicine exactly as directed in this leaflet or as advised by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist for advice.

 Recommended dose

RHINO-TON^®, nasal spray 0.5 mg/ml

 Children under 2 years of age: the use of the drug RHINO-TON^® is contraindicated.

 Children aged 2 to 12 years: use the drug RHINO-TON^® under adult supervision. It is recommended to use 1 injection in each nostril 1-2 times a day. Do not use more than 3 times a day.

 RHINO-TON^®, nasal spray 1 mg/ml

 Intended for adults and children over 12 years old only: 1 spray in each nostril. If necessary, you can repeat, but not more than 3 times a day.

The last application during the day is preferably done at bedtime.

The duration of use of the drug is no more than 7 days, since prolonged use can lead to drug-induced rhinitis.

Mode of application

 Intranasally.

 Before using the nasal spray RHINO-TON^®, it is necessary to thoroughly clean the nose (for example, by blowing the nose).

 When using the spray, the following procedure must be followed:

1. remove the protective cap;

 2. before the very first use, press the spray nozzle several times to activate the microdosing device; the following applications do not need to repeat this action: the microdoser will always be ready for use;

3. hold the sprayer vertically, with the tip up;

 4. keep your head straight, do not tilt;

 5. insert the tip of the spray nozzle into the nostril, press the spray nozzle once with a short sharp movement and at the same time take a shallow breath through the nose for optimal distribution of the drug over the surface of the nasal cavity;

 6. removing the tip from the nostril, unclench the atomizer;

 7. repeat steps #3-#6 on the other nostril;

 8. clean the tip of the spray nozzle after use;

 9. close the tip of the spray nozzle with a protective cap.

For hygiene reasons and to avoid infection, the spray bottle is recommended to be used by only one person.

 If you miss a dose of RHINO-TON^®, do not use a double dose to make up for the missed dose.

 If you have used more RHINO-TON^® than you should

 If you or your child have taken more of RHINO-TON^® than you should have, or if you accidentally swallow the solution, stop taking the drug and contact your doctor or the nearest emergency room/hospital. If possible, take the container of this drug and/or this package leaflet with you.

Symptoms of a possible overdose: depression of the central nervous system (eg, drowsiness, coma), increase or decrease in blood pressure, increase or decrease in heart rate, nausea, vomiting, pallor, excessive sweating, decrease in body temperature, pupillary constriction, respiratory depression, impaired coordination movement, anxiety.

 Treatment: medical supervision with, if necessary, supportive and symptomatic therapy, reducing the degree of absorption of the drug (for example, the use of activated charcoal). There is no specific antidote.

If you have any further questions about the use of the medicine, ask your doctor or pharmacist.

 4. Possible adverse reactions

 Like all medicines, RHINO-TON^® can cause side effects, although not everyone gets them.

 Most serious adverse reactions

Some adverse reactions that occur very rarely (less than 1 in 10,000 people) require immediate medical attention. If you notice any of the following symptoms, stop using the medicine and contact your doctor immediately:

- anaphylactic reactions. Possible manifestations: the rapid appearance of itchy, raised rashes above the skin (urticaria); other types of rash, redness or blanching of the skin; spasm of the bronchi, leading to difficulty breathing; a sharp decrease in blood pressure, a fast and weak pulse; stomach pain, nausea, vomiting, or diarrhea; dizziness, fainting, or lightheadedness.

Other possible adverse reactions

Common adverse reactions (may affect up to 1 in 10 people):

- headache, dryness, discomfort, burning of the nasal mucosa, drug-induced rhinitis, nausea, burning at the site of application.

 Very rare side effects (may affect up to 1 in 10,000 people):

- temporary visual impairment, irregular (arrhythmia) or increased heart rate, increased blood pressure.

Reporting adverse reactions

It is important to report suspected adverse reactions after registration of the medicinal product in order to ensure continuous monitoring of the benefit/risk balance of the medicinal product. In the event of adverse reactions, 5 listed in this leaflet, as well as not mentioned in it, or in case of ineffectiveness of the medicinal product, it is necessary, first of all, to inform the attending physician immediately.

 5. Storage of the medicinal product RHINO-TON^®

 Shelf life 2 years. The expiration date is indicated on the package.

The medicinal product must not be used after the date indicated on the package.

 Store in a place protected from light at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

 6. Contents of the package and other information

The drug RHINO-TON^® contains xylometazoline hydrochloride as an active ingredient.

RHINO-TON^®, 0.5 mg/ml: 1 ml of the solution contains 0.5 mg xylometazoline hydrochloride as an active ingredient.

 RHINO-TON^®, 1 mg/ml: 1 ml of the solution contains 1.0 mg of xylometazoline hydrochloride as an active substance.

 Excipients: benzyl alcohol, benzalkonium chloride, disodium phosphate dodecahydrate, sodium dihydrophosphate dihydrate, sodium chloride, non-crystallizing sorbitol solution, concentrated hydrochloric acid, purified water.

Appearance of the medicinal product RHINO-TON^® and the contents of the package

Spray nasal.

 Clear or slightly opalescent, colorless or yellowish solution.

 10 ml in polyethylene bottles or in polyethylene terephthalate bottles,

sealed with a polypropylene nasal spray nozzle.

 Each vial, together with the leaflet, is placed in a cardboard box.

Marketing Authorization Holder

Giga Pharm LLC, Republic of Armenia, Gyumri, 3101, st. Gogunts 3/5.

 Tel. +37494000264, +79896335759.

E-mail: gig.am@mail.ru.

RHINO-TON is a trademark of Giga Farm LLC.

Manufacturer

 Pharmtechnology LLC, Republic of Belarus, 220024, Minsk, st. Korzhenevsky, 22.