Xymelin extra spray nasal 10ml

Dosage form

spray

Composition

1 ml of nasal spray contains: Ipratropium bromide monohydrate 0.6 mg, Xylometazoline hydrochloride 0.5 mg

Excipients: Disodium edetate dihydrate, glycerol (85%), concentrated hydrochloric acid (up to pH 4.5), sodium hydroxide (up to pH 4.5), purified water

In a plastic bottle equipped with a pump dispenser with a tip and with a protective cap made of polyethylene 10 ml of the drug. In the package 1 bottle.

Mechanism of action

Xymelin Extra - Xylometazoline belongs to the group of local vasoconstrictor agents (decongestants) with alpha-adrenomimetic action, causes constriction of the blood vessels of the nasal mucosa, thus eliminating the swelling and hyperemia of the mucous membrane of the nasopharynx. Relieves nasal breathing in rhinitis.

Ipratropium bromide has an anticholinergic effect.

With intranasal administration, it reduces the secretion of the glands of the nasal mucosa.

In therapeutic concentrations does not irritate the mucous, does not cause hyperemia.

The effect of the drug occurs after 5 - 10 minutes and lasts for 6-8 hours.

Indications and usage

- Symptomatic treatment of edema and hyperemia of the nasal cavity.
- Acute respiratory infections with symptoms of rhinitis (rhinitis).
- Acute allergic rhinitis.
- Pollinosis.
- Sinusitis.

Contraindications

- Hypersensitivity to the drug.
- Arterial hypertension.
- Tachycardia.
- Pronounced atherosclerosis.
- Glaucoma.
- Atrophic rhinitis.
- Thyrotoxicosis.
- Surgical interventions on the meninges (in history).
- Pregnancy (I trimester).
- Age up to 18 years.

- Diabetes.
- Angina III - IV functional class.
- Bladder neck obstruction.
- Prostatic hyperplasia.
- In the treatment of patients prone to nosebleeds.
- Paralytic intestinal obstruction.
- Patients with cystic fibrosis.

- Dizziness.
- Tremor of skeletal muscles.
- To sleep disorders.
- Arrhythmia.
- Increased blood pressure.

Pregnancy and Breastfeeding

Contraindicated in pregnancy (I term).

During pregnancy (II - III trimesters) and lactation, the drug should be used only after a careful assessment of the ratio of benefits and risks to the mother and the fetus, it is not allowed to exceed the recommended dosage.

Dosage and administration

Intranasal.

For adults over 18: 1 injection in each nasal passage 3 times a day.

The drug is not applied Bepee 10 days without consulting a doctor.

Xymelin Extra Single Injection contains about 70 mcg xylometazoline hydrochloride and 84 mcg ipratropium bromide.

Adverse reactions

With frequent and / or long-term use: Irritation and / or dryness of the nasal mucosa, burning and tingling in the nose and throat, swelling of the nasal mucosa, sneezing, hypersecretion of the glands of the nasal mucosa, nose bleeds, headache.

Rarely: Systemic allergic reactions, blurred vision, palpitations, tachycardia, arrhythmia, headache, dizziness, high blood pressure, insomnia.

Before use, you must clean the nasal passages.

It should not be used for a long time, for example, in chronic rhinitis.

Patients should be warned about the inadmissibility of the drug Xymelin Extra in the eyes or around the eyes. In case of contact with eyes, rinse with cold water.

If the symptoms of the disease worsen or the patient's condition does not improve within 3 days of taking Xymelin Extra, you should consult with your doctor.

Influence on the ability to drive and use of mechanisms The use of the drug in therapeutic doses does not affect the ability to drive and use mechanisms. Overdose or getting the drug into the eyes can affect the ability to drive and use machinery.

Drug interactions

Simultaneous use with monoamine oxidase inhibitors can lead to an increase in blood pressure.

Simultaneous intake with tri- and tetracyclic antidepressants may enhance the sympathomimetic effect of xylometazoline.

With the concomitant use of other anticholinergic drugs, the anticholinergic effect of ipratropium bromide may be enhanced.

Overdosage

After intranasal administration of Xymelin Extra, acute overdose is unlikely, since drug absorption is extremely low.

Symptoms: in case of overdose, dry mouth, accommodation disturbances, tachycardia, headache, arterial hypertension are characteristic of the clinical picture.
Treatment: symptomatic.

Storage conditions

Store at a temperature not higher than 25 ° С.