Dimetindene-Phenylephrine nasal drops, 15 ml

• Acute rhinitis (including runny nose for colds);

• allergic rhinitis (including hay fever);

• vasomotor rhinitis;

• chronic rhinitis;

• acute and chronic sinusitis;

• acute otitis media (as an auxiliary treatment).

• Preparation for surgical interventions in the nasal area and elimination of edema of the nasal mucosa and paranasal sinuses after surgical interventions in this area.

Intranasally.

Children under 1 year of age: Contraindicated.

Children aged 1 to 6 years (under adult supervision): 1-2 drops in each nasal passage 3-4 times a day.

Children aged 6 to 12 years (under the supervision of adults) 3-4 drops in each nasal passage 3-4 times a day.

For adolescents over the age of 12 and adults: 3-4 drops in each nasal passage 3-4 times a day.

It is recommended to thoroughly clean the nasal passages before use; buried in the nose, head thrown back. This head position is maintained for several minutes.

The drug should not be used continuously for more than 7 days. If symptoms persist, a doctor should be consulted.

Active ingredients: dimethindene maleate - 0.25 mg; phenylephrine hydrochloride (corresponds to 2.5 mg of phenylephrine) - 3.045 mg.

Excipients: sodium hydrogen phosphate anhydrous - 4.4 mg, citric acid monohydrate - 2.6 mg, sorbitol - 35.0 mg, benzalkonium chloride - 0.1 mg, lavender oil - 0.2 mg, purified water - up to 1 ml ...

• Hypersensitivity to phenylephrine, dimethindene maleate or other components of the drug.

• Atrophic rhinitis (including fetid discharge - ozena).

• Taking MAO inhibitors (simultaneously or in the previous 14 days).

• Angle-closure glaucoma.

• Children up to age 1 year.

Carefully

Cardiovascular diseases (arterial hypertension, arrhythmias, generalized atherosclerosis), hyperthyroidism, prostate adenoma, diabetes mellitus, bladder neck obstruction (for example, due to prostatic hypertrophy), epilepsy.

As with the use of any local vasoconstrictor agents, caution should be exercised when prescribing Dimetinden + Phenylephrine to patients with severe reactions to sympathomimetics, manifested in the form of insomnia, dizziness, tremors, cardiac arrhythmias or increased blood pressure.

Trade name

Dimetindene + Phenylephrine

International non-proprietary or group name

Dimetindene + Phenylephrine

Dosage form

Nasal drops

Composition for I ml:

Active ingredients: dimethindene maleate - 0.25 mg; phenylephrine hydrochloride (corresponds to 2.5 mg of phenylephrine) - 3.045 mg.

Excipients: sodium hydrogen phosphate anhydrous - 4.4 mg, citric acid monohydrate - 2.6 mg, sorbitol - 35.0 mg, benzalkonium chloride - 0.1 mg, lavender oil - 0.2 mg, purified water - up to 1 ml ...

Description

Transparent from colorless to slightly yellow solution with a weak specific smell of lavender.

Pharmacotherapeutic group

Combined antiallergic agent (H1-histamine receptor blocker + alpha adrenomimetic).

ATX code:

R01AB01.

Pharmacological properties

Pharmaco dynamics

Dimetindene + Phenylephrine is a combined preparation containing phenylephrine and dimethindene.

Phenylephrine is a sympathomimetic agent that, when applied topically, has a moderate vasoconstrictor effect (by stimulating alpha1-adrenergic receptors located in the venous vessels of the nasal mucosa), eliminates edema of the nasal mucosa and its paranasal sinuses.

Dimetindene is an anti-allergic agent - an antagonist of histamine H1 receptors; does not reduce the activity of the ciliated epithelium of the nasal mucosa.

Pharmacokinetics

Dimetindene + Phenylephrine is intended for topical use, and its activity does not depend on the concentration of active substances in the blood plasma.

Indications for use

• Acute rhinitis (including runny nose for colds);

• allergic rhinitis (including hay fever);

• vasomotor rhinitis;

• chronic rhinitis;

• acute and chronic sinusitis;

• acute otitis media (as an auxiliary treatment).

• Preparation for surgical interventions in the nasal area and elimination of edema of the nasal mucosa and paranasal sinuses after surgical interventions in this area.

Contraindications

• Hypersensitivity to phenylephrine, dimethindene maleate or other components of the drug.

• Atrophic rhinitis (including fetid discharge - ozena).

• Taking MAO inhibitors (simultaneously or in the previous 14 days).

• Angle-closure glaucoma.

• Children up to age 1 year.

Carefully

Cardiovascular diseases (arterial hypertension, arrhythmias, generalized atherosclerosis), hyperthyroidism, prostate adenoma, diabetes mellitus, bladder neck obstruction (for example, due to prostatic hypertrophy), epilepsy.

As with the use of any local vasoconstrictor agents, caution should be exercised when prescribing Dimetinden + Phenylephrine to patients with severe reactions to sympathomimetics, manifested in the form of insomnia, dizziness, tremors, cardiac arrhythmias or increased blood pressure.

Application during pregnancy and during breastfeeding

Given the possible systemic vasoconstrictor effect of phenylephrine, Dimetindene + Phenylephrine is not recommended for use during pregnancy and lactation.

Method of administration and dosage

Intranasally.

Children under 1 year of age: Contraindicated.

Children aged 1 to 6 years (under adult supervision): 1-2 drops in each nasal passage 3-4 times a day.

Children aged 6 to 12 years (under the supervision of adults) 3-4 drops in each nasal passage 3-4 times a day.

For adolescents over the age of 12 and adults: 3-4 drops in each nasal passage 3-4 times a day.

It is recommended to thoroughly clean the nasal passages before use; buried in the nose, head thrown back. This head position is maintained for several minutes.

The drug should not be used continuously for more than 7 days. If symptoms persist, a doctor should be consulted.

Side effect

Classification of the incidence of side effects according to the recommendations of the World Health Organization (WHO):
Very often> 1/10;
Often> 1/100 to <1/10;
Infrequently from> 1/1000 to <1/100;
Rarely> 1/10000 to <1/1000;
Very rarely <1/10000, including isolated reports;

Respiratory system:
Rarely: discomfort in the nose, dry nose, nosebleeds.

Local reactions:
Rare: burning sensation in the area of ??application.

If any of the side effects indicated in the instructions are aggravated, or you notice any other side effects that are not indicated in the instructions, inform your doctor.

Overdose

An overdose of Dimetinden + Phenylephrine can cause sympathomimetic effects, for example, heart palpitations, premature contraction of the ventricles of the heart, headache in the occiput, tremors, fatigue, increased blood pressure, emotional excitement, insomnia, pallor of the skin.

The drug can also cause mild sedation, dizziness, stomach pain, nausea, and vomiting.

Treatment: the use of activated charcoal, laxatives in young children; in adults and children over 6 years old - taking a large amount of liquid. There is no specific antidote.

The high blood pressure caused by phenylephrine can be eliminated with the use of alpha-blockers.

Interaction with other medicinal products

Phenylephrine (like other vasoconstrictor drugs) is contraindicated in patients receiving MAO inhibitors at this time or have received them within the previous 2 weeks.

You should not prescribe the drug at the same time as tri- and tetracyclic antidepressants, beta-blockers.

special instructions

Dimetindene + Phenylephrine should not be used continuously for more than 7 days without consulting a doctor. Long-term or excessive use of the drug can cause tachyphylaxis and the 'rebound' effect associated with the re-development of nasal congestion (rhinitis medicamentosa), leading to the development of systemic vasoconstrictor action.

Do not exceed the recommended doses of Dimetindene + Phenylephrine! Otherwise, the development of manifestations of the systemic action of the drug, especially in children and elderly patients, is possible.

In children under the age of 6, only nasal drops are used.

Dimetindene + Phenylephrine does not have a sedative effect (does not affect the speed of psychomotor reactions).

The effect of the drug on the ability to drive vehicles, mechanisms

Does not affect.

Release form

Nasal drops (0.25 mg + 2.5 mg) / ml.

10, 15, 20, 30, 40 or 50 ml of the drug in a dark glass bottle or in a high-density polyethylene polymer bottle or in a polyethylene terephthalate bottle with a polyethylene dropper and a polypropylene screw cap with / without first opening control or sealed with a stopper - dropper and a plastic screw cap or with a dropper stopper (a dropper in the form of a plastic diffuser), with / without a plastic screw cap and a first opening ring or equipped with a plastic divider, sealed with a plastic lid with / without a first opening ring

A label made of writing paper or a label or self-adhesive label is attached to each bottle.

Each bottle, together with instructions for medical use, is placed in a box made of cardboard box for consumer packaging or from chromium-ersatz cardboard.

Storage conditions

At a temperature not higher than 30 ? C.

Keep out of the reach of children.

Shelf life

3 years.

Do not use after the expiration date.

Vacation conditions

Available without a prescription.