Rinostop Spray Double Help: instructions for use

Composition per 1 ml

Description : transparent colorless or yellowish solution. Pharmacotherapeutic group : anticongestive agent (alpha-adrenergic agonist). ATX code : R01AA05.

What Rinostop contains

The main active component of the drug is xylometazoline hydrochloride. This substance belongs to alpha-adrenergic agonists; when applied topically, it causes a reflex vasoconstriction.

Rinostop is produced in the form of:

• nasal spray: in bottles with a dispenser spray with a capacity of 10–30 ml, with a concentration of 0.1 and 0.05% of the active substance;
• nasal drops: similar volume and concentration in bottles with a drip dispenser.

Among the auxiliary components of the product: distilled water and stabilizing additives.

Pharmacological properties. Pharmacodynamics

The cold medicine Rinostop ® Extra (oxymetazoline) has a vasoconstrictor effect. When applied topically to the inflamed mucous membrane of the nasal cavity, it reduces swelling, nasal congestion, and nasal discharge, eliminating the symptoms of rhinitis. Restores nasal breathing. Elimination of swelling of the nasal mucosa helps restore aeration of the paranasal sinuses and middle ear cavity, which prevents the development of bacterial complications (sinusitis, sinusitis, otitis media). When used locally intramuscularly in therapeutic concentrations, it does not irritate or cause hyperemia of the nasal mucosa.

The drug begins to act quickly (within a few minutes). The duration of action of Rinostop ® Extra is up to 12 hours.

What does Rinostop help with?

Xylometazoline, getting on the mucous membrane, narrows capillary vessels, stimulates the outflow of fluid, eliminates swelling, freeing the nasal passages and relieving congestion. This is a symptomatic drug, its compounds act locally, a small amount of the drug is absorbed into the bloodstream, which is unable to cause systemic effects for the body.

The mechanism of operation of Rinostop is based on the reaction of adrenoline receptors. The narrowing of the nasal capillaries and the reduction of swelling as a result of its use helps prevent further complicated course of the respiratory disease, prevent inflammation of the middle ear or the development of acute sinusitis.

The effect occurs 2–4 minutes after applying the solution to the mucous membranes and lasts up to 6–8 hours.

Correct use of the medicine does not lead to disruption of the functions of the ciliated epithelium and the synthesis of protective mucous secretion. The drug does not affect the general course of the disease and infectious pathogens. It reduces symptoms and restores physical comfort by restoring nasal breathing.

Contraindications for use

• atrophic rhinitis;
• hypersensitivity to the components of the drug;
• angle-closure glaucoma;
• condition after transsphenoidal hypophysectomy;
• surgical interventions on the dura mater (history);
• children under 1 year of age – for drops 0.025%;
• children under 6 years of age - for drops of 0.05%.

You should adhere to the recommended concentrations of the drug intended for different age categories (see methods of use).

Rinostop price

Rinostop price in Moscow:

• Rinostop nasal drops 0.1% and 0.05% 10 ml - 21 - 25 rubles;
• nasal spray 0.1% And 0.05% 15 ml - 56 - 65 rubles.

Rinostop tablets, produced by the pharmaceutical company Bosnalek (Bosnia and Herzegovina) are not synonymous with Rinostop drops and spray, as they have a different composition.

• Online pharmacies in RussiaRussia

ZdravCity

• Rinostop Aqua Baby for children 0+ for runny nose, nasal spray, 100% sea water 125 mlLaboratory De La Mer
  329 RUR order
• Rinostop 0.05% 15 mlPharmstandard-Leksredstva OJSC

  86 rub. order

• Rhinostop nasal drops. 0.1% 10ml ZAO LEKKO/Pharmstandard

  36 RUR order

• Rinostop Aqua Soft for runny nose from 6 months, nasal spray, 100% sea water 125 mlLaboratory De La Mer

  RUB 328 order

• Rinostop Aqua Norm for runny nose 3+, nasal spray, 100% sea water 125 mlLaboratory De La Mer

  RUB 329 order

Carefully

In patients taking monoamine oxidase inhibitors (MAO) and other drugs that increase blood pressure (including for up to 14 days after their discontinuation); in patients with concomitant severe forms of cardiovascular diseases (arterial hypertension, coronary heart disease, chronic heart failure, tachycardia, arrhythmias); with hyperthyroidism, diabetes mellitus, pheochromocytoma, prostatic hyperplasia with clinical manifestations (urinary retention), severe atherosclerosis, porphyria, during pregnancy and during

breastfeeding, with increased intraocular pressure, chronic renal failure, in patients taking tricyclic antidepressants and bromocriptine, as well as other drugs that increase blood pressure. If you have one or more of the diseases and conditions listed above, you should consult your doctor before starting to take the drug.

Contraindications

Like other xylometazoline-based products, Rinostop is prohibited from use:

• when treating children under 2 years of age;
• for severe forms of hypertension;
• glaucoma;
• increased intracranial pressure;
• consequences of traumatic brain injuries;
• some forms of cardiac arrhythmia;
• with individual high sensitivity to any of the components.

Pregnant women are also prohibited from using Rinostop due to the high risk of developing gestosis.

The remedy for nasal congestion requires special care in case of existing chronic heart diseases, atherosclerosis and other vascular pathologies, including complications of diabetes mellitus and hyperthyroidism. In such cases, drops and spray should be used as rarely as possible, only in case of significant problems with breathing. During their use, it is important to monitor vital signs.

Directions for use and doses

Intranasally. Adults and children over 6 years of age: - apply 1 - 2 drops of 0.05% solution in each nasal passage 2 - 3 times a day. Children from 1 year to 6 years: apply 1-2 drops of 0.025% solution in each nasal passage 2-3 times a day. Children under one year: children under 4 weeks of age - 1 drop of 0.01% solution in each nasal passage 2 - 3 times a day. From the 5th week of life to 1 year - 1-2 drops in each nasal passage 2-3 times a day. Use the recommended dose for no more than 5-7 days without consulting a doctor. If symptoms worsen or improvement does not occur within 3 days, you should consult your doctor.

Pharmacological effect

Xylometazoline belongs to alpha-adrenergic agonists - substances that stimulate the activity of specific receptors in the vascular walls that are sensitive to adrenaline and nonadrenaline. The result of its action is a rapid narrowing of the lumen and a decrease in capillary permeability upon contact with mucous membranes. Thanks to this, swelling at the site of inflammation is significantly reduced, the intensity of mucous discharge during rhinitis is reduced, and it becomes possible to breathe normally.

The vasoconstrictor effect of xylometazoline is not accompanied by disturbances in the condition of the mucosa or changes in its functions. The ciliated epithelium, which traps particles of dust and other contaminants penetrating into the nasal cavity, does not reduce activity during the use of Rinostop.

The use of the drug also does not have a systemic effect. Xylometazoline is absorbed into the general bloodstream in small quantities, narrowing only the capillaries of the mucous membrane. Rinostop does not affect the duration of diseases and the intensity of their course. Its task is to eliminate negative symptoms of congestion and restore normal well-being during illness.

The effect of using the solution occurs within 2–5 minutes. after applying it to the mucous membranes: the swelling resolves, the lumen of the nasal passages increases, opening up access to air. The effect of the drug lasts up to 5–7 hours.

Side effects

Burning or dryness of the mucous membranes of the nasal cavity, dryness of the mucous membranes of the mouth and throat; sneezing; an increase in the volume of secretions released from the nose; nose bleed; after the effect of the drug wears off, a feeling of nasal congestion (reactive hyperemia). Side effects caused by the systemic effect of the drug (if the solution is accidentally taken orally): increased blood pressure, headache, dizziness, palpitations, tachycardia, restlessness, anxiety, fatigue, drowsiness, sedation, irritability, sleep disturbance (in children), nausea , insomnia, exanthema, hallucinations, Quincke's edema, itching, convulsions, respiratory arrest (in

babies). Visual impairment (if in contact with eyes). Long-term continuous use of vasoconstrictor drugs can lead to tachyphylaxis, atrophy of the nasal mucosa and recurrent swelling of the nasal mucosa (rhinitis medicamentosa). If any of the side effects indicated in the instructions or other side effects not listed in the instructions occur, consult your doctor.

When should you use Rinostop?

Indications for using the nasal solution include:

• acute rhinitis with nasal congestion;
• vasomotor, allergic and other types of runny nose, accompanied by swelling of the mucous membranes and impaired nasal breathing;
• for sinusitis, sinusitis and other sinusitis with congestion and swelling of the nasal sinuses;
• with inflammation and swelling of the auditory tube;
• in preparation for diagnostic procedures before treatment with an otolaryngologist.

Rinostop is not a long-acting drug. It must be used once or in short courses over several days. Otherwise, the risk of side effects and complications increases.

Overdose

If the drug is accidentally ingested or overdose, the following symptoms may appear: anxiety, restlessness, hallucinations, convulsions, decreased body temperature, lethargy, drowsiness, coma, constriction or dilation of the pupils, fever, sweating, pallor, cyanosis, palpitations, bradycardia, arrhythmia, cardiac arrest, increased blood pressure, decreased blood pressure, nausea, vomiting, respiratory depression, respiratory arrest. Treatment: gastric lavage, taking activated carbon; symptomatic.

special instructions

Long-term use and overdose of the drug should be avoided, especially in children. Avoid contact of the drug with the eyes. To avoid the spread of infection, it is necessary to use the drug individually.

Impact on the ability to drive vehicles and machinery . After long-term use of cold remedies containing oxymetazoline, and in doses higher than recommended, a general effect on the cardiovascular system cannot be excluded.

system and the central nervous system. In these cases, it is recommended to be careful when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Rinostop Spray Double Help: instructions for use

Read these instructions carefully before you start using this medicine because they contain information that is important to you. Save the instructions, you may need them again. If you have any questions, consult your doctor. The medicine you are using is intended for you personally and should not be given to others as it may cause harm to them even if they have the same symptoms as you.

Registration number: LP-005808

Trade name: Rinostop® Double Help

International nonproprietary name: Xylometazoline + [Dexpanthenol]

Dosage form: dosed nasal spray

Composition for 1 dose:

Active ingredients: xylometazoline hydrochloride – 0.1 mg, dexpanthenol – 5 mg. Excipients: sodium citrate dihydrate - 0.509 mg, sodium chloride - 0.250 mg, hypromellose - 0.100 mg, benzalkonium chloride - 0.015 mg, citric acid monohydrate - 0.350 mg, purified water up to 100 µl.

Description:

Transparent colorless solution.

Pharmacotherapeutic group: anticongestive agent

ATX code: R01AB06

Pharmacological properties

Pharmacodynamics

Xylometazoline - belongs to the group of local vasoconstrictors (decongestants) with alpha-adrenomimetic activity, causes constriction of the blood vessels of the nasal mucosa, reduces hyperemia and swelling of the mucous membrane, restores the patency of the nasal passages, facilitates nasal breathing and thereby reduces the symptoms of rhinitis. The effect of the drug usually occurs within a few minutes after its use and lasts up to 10 hours.

Dexpanthenol is a B vitamin and is a derivative of pantothenic acid. Dexpanthenol is converted in the body into pantothenic acid, which is an integral part of coenzyme A, and is involved in the processes of acetylation, carbohydrate and fat metabolism, in the synthesis of acetylcholine, corticosteroids, porphyrins; stimulates the regeneration of skin and mucous membranes, normalizes cellular metabolism, accelerates mitosis and increases the strength of collagen fibers. It has a regenerating, metabolic and mild anti-inflammatory effect.

Pharmacokinetics

Xylometazoline hydrochloride is practically not absorbed when applied topically; plasma concentrations are so low that they cannot be determined by modern analytical methods.

When applied topically, dexpanthenol is quickly absorbed by the skin and converted into pantothenic acid and binds to plasma proteins (mainly beta-globulin and albumin). Its concentration in the blood is 0.5-1 mg/l, in the blood serum - 100 μg/l. Pantothenic acid is not metabolized in the body (except for inclusion in Co-A) and is excreted unchanged.

Indications for use

• acute respiratory diseases with symptoms of rhinitis;
• acute allergic rhinitis;
• vasomotor rhinitis;
• sinusitis;
• otitis media (as part of combination therapy to reduce swelling of the nasopharyngeal mucosa);
• to facilitate rhinoscopy;
• to restore impaired nasal breathing after surgical interventions in the nasal cavity.

Contraindications

Hypersensitivity to the components of the drug, arterial hypertension, tachycardia, severe atherosclerosis, hyperthyroidism, glaucoma, atrophic rhinitis, dry rhinitis, porphyria, prostatic hyperplasia, surgical interventions on the meninges (history), simultaneous use with monoamine oxidase inhibitors (MAO) and tricyclics antidepressants, pregnancy, breastfeeding, children under 6 years of age.

Carefully

Diabetes mellitus, pheochromocytoma, diseases of the cardiovascular system (including coronary heart disease), increased sensitivity to the action of adrenergic drugs, accompanied by insomnia, dizziness, arrhythmia, tremor, increased blood pressure.

If you have one or more of the diseases and conditions listed above, you should consult your doctor before starting use.

Use during pregnancy and breastfeeding

The drug should not be used during pregnancy. The drug is contraindicated during breastfeeding.

Before use, if you are pregnant, think you might be pregnant, or are planning a pregnancy, you should consult your doctor.

Directions for use and doses

Intranasally.

For adults and children over 6 years old.

When using the nasal spray, the bottle must be kept in an upright position. Before use, it is necessary to clean the nasal passages.

During injection, you need to inhale lightly through your nose. One spray into each nasal passage up to 3-4 times a day.

Duration of therapy is 5-7 days.

Should not be used for more than 7 days. The duration of use of the drug in children is determined after consultation with a doctor.

Repeated use is possible only after a break of several days.

If after 5 days of treatment there is no improvement or the symptoms worsen or new symptoms appear, you should consult your doctor. Use the drug only according to the indications, method of administration and in the doses indicated in the instructions.

Side effect

The adverse events presented below are listed depending on the anatomical and physiological classification and frequency of occurrence. The frequency of occurrence is determined as follows: very often (with a frequency of more than 1/10), often (with a frequency of at least 1/100, but less than 1/10), infrequently (with a frequency of at least 1/1000, but less than 1/100) , rare (with a frequency of at least 1/10,000, but less than 1/1000), very rare (with a frequency of less than 1/10,000), not known (the frequency is unknown based on available data).

Nervous system disorders:

Very rare: anxiety, insomnia, headache, fatigue (drowsiness), hallucinations (mainly in children).

Cardiovascular system disorders:

Rarely: palpitations, tachycardia, increased blood pressure.

Very rare: arrhythmia.

Respiratory system disorders:

Very rare: swelling of the nasal mucosa, hypersecretion, nosebleeds.

Frequency unknown: burning and dryness of the nasal mucosa, sneezing.

Disorders of the musculoskeletal system:

Very rare: convulsions (especially in children).

Immune system disorders:

Very rare: allergic reactions (angioedema, skin rash, itching).

If any of the side effects indicated in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Overdose

In cases of overdose or accidental oral use, the following symptoms may occur: mydriasis, nausea, vomiting, cyanosis, fever, convulsions, tachycardia, cardiac arrhythmias, vascular insufficiency, cardiac arrest, hypertension, pulmonary edema, respiratory dysfunction, hallucinations.

Patients may also experience symptoms of central nervous system depression, including drowsiness, decreased body temperature, bradycardia, shock, respiratory arrest, and coma.

Treatment

The use of activated carbon, gastric lavage, oxygen ventilation. To lower blood pressure, 5 mg of phentolamine in 0.9% sodium chloride solution is prescribed by slow intravenous administration or 100 mg of phentolamine orally. Vasoconstrictor drugs are contraindicated. If necessary, antipyretic and anticonvulsant drugs are used.

In case of overdose, consult a doctor.

Interaction with other drugs

With the simultaneous use of MAO inhibitors and tricyclic antidepressants, the systemic effect may be enhanced.

If you are using any other medications (including over-the-counter medications) at the same time, consult your doctor before use.

special instructions

Before use, it is necessary to clean the nasal passages. Avoid getting the drug into your eyes.

To avoid the spread of infection, it is necessary to use the drug individually. The duration of use of the drug in children is determined after consultation with a doctor.

Patients with long QT syndrome using xylometazoline may be at increased risk of developing serious ventricular arrhythmias.

Do not exceed the maximum duration and recommended doses when using the drug independently. If there is no improvement or if the symptoms of the disease worsen, you should consult a doctor.

Impact on the ability to drive vehicles and machinery

When using the drug in accordance with these instructions for use, the drug does not affect the ability to drive vehicles or machines, however, if adverse events occur, you should refrain from performing these types of activities.

Release form

Dosed nasal spray, 0.1 mg + 5 mg/dose. 60 doses (10 ml) or 100 doses (15 ml) in polymer bottles (high density polyethylene). The bottles are rolled with dosing pumps complete with a sprayer and a protective cap. A self-adhesive label is placed on the bottle.

Each bottle, along with a sprayer, a protective cap and instructions for use, is placed in a cardboard pack.

Storage conditions

At a temperature not higher than 25°C. Keep out of the reach of children.

Best before date

25 months. Do not use after the expiration date stated on the package.

Vacation conditions

Available without a prescription.

Marketing Authorization Holder/Complaint Receiving Entity

OTCPharm JSC, Russia, 123112, Moscow, st. Testovskaya, 10, floor 12, room II, room. 29, Tel. Fax www.otcpharm.ru

, Russia, 305022, Kursk, st. 2nd Aggregatnaya, 1a/18, tel./fax www.pharmstd.ru