1 ml of nasal spray, solution contains 1 mg xylometazoline hydrochloride.
Each puff (of approx. 0.09 ml of solution) contains 0.09 mg xylometazoline hydrochloride.
Excipients/Inactive Ingredients: Potassium dihydrogen phosphate, sea water, purified water.
Pharmacotherapeutic group: Rhinologics. ATC code: R01AA07.
Pharmacology: Pharmacodynamics: Xylometazoline, an imidazole derivative, is an alpha-adrenergic sympathomimetic drug. Its vasoconstrictor action produces mucosal decongestion. Onset of action is usually within 5-10 minutes, facilitating nasal breathing by mucosal decongestion and improving drainage of secretions.
Pharmacokinetics: The effect of xylometazoline sets in within a few minutes and remains for several hours (on the average 6-8 h).
The amount of drug absorbed following intranasal application may occasionally be large enough to produce systemic effects, e.g. on the central nervous and cardiovascular systems.
No data from pharmacokinetic studies in humans are available.
For detumescing the nasal mucosa in the event of colds and attacks of runny colds (vasomotor rhinitis), allergic rhinitis.
For facilitating the flow of secretion in inflammation of the paranasal sinuses as well as in catarrh of the tubal middle ear associated with colds.
SNUP STADA 0.1% spray is intended for adults and school-age children.
SNUP STADA 0.1% spray is intended for nasal use.
SNUP STADA 0.1% spray: Unless otherwise prescribed, adults and school-age children from 6 years of age when necessary should put 1 puff of nasal spray into each nostril up to three times daily.
The recommended single dose of SNUP STADA should not be given more than three times a day. Do not use more than the recommended dosage.
The dosage will depend on the individual sensitivity and clinical response.
SNUP STADA should not be used for longer than 7 days except on the advice of a doctor. Wait several days before re-using these medicinal products.
A doctor should always be consulted about the duration of therapy in children.
Chronic cold sufferers may use these medicinal products only with medical monitoring because of the risk of atrophy of the nasal mucosa.
Symptoms of intoxication: The clinical picture of intoxication with imidazole derivatives may be confusing, because phases of stimulation may alternate with phases of suppression of the central nervous system and of the cardiovascular system.
Symptoms of central nervous system stimulation are anxiety, agitation, hallucinations and convulsions.
Symptoms following inhibition of the central nervous system are lowering of body temperature, lethargy, somnolence and coma.
The following symptoms may also occur: Miosis, mydriasis, perspiration, fever, paleness, cyanosis, nausea and vomiting, tachycardia, bradycardia, cardiac arrhythmias, cardiac arrest, palpitation, hypertension, shock-like hypotension, pulmonary edema, respiratory depression and apnea, psychogenic disorders.
Following overdosing dominating central nervous effects with seizures and coma, bradycardia, apnea as well as hypertension replaced by hypotension are common especially in children.
Therapy of intoxication: After severe overdosing intensive care treatment in a hospital is indicated. Administration of activated charcoal (absorbent), sodium sulfate (laxative) or gastric lavage (after large amounts) should be initiated immediately, because absorption of xylometazoline may be quick. For blood pressure reduction a non-selective alpha blocker may be given.
Vasopressors are contraindicated. Antipyretic, anticonvulsant therapy and oxygen if necessary.
Hypersensitivity to the active substance or to any of the excipients of this medicine.
'Dry' inflammation of the nasal mucosa (rhinitis sicca).
Condition after transsphenoidal hypophysectomy or other surgical interventions, which expose the dura mater.
Toddlers and children under 6 years of age.
There are isolated reports on severe side effects (especially apnea) after use of therapeutic dosages. Overdosing must be avoided by all means.
SNUP STADA may only be used after a careful benefit/risk assessment in: Patients treated with monoamine oxidase inhibitors (MAOIs) or with other potentially blood pressure-increasing drugs; Increased intraocular pressure, especially narrow-angle glaucoma; Severe cardiovascular diseases (e.g. coronary heart disease, hypertension); Pheochromocytoma; Metabolic disorders (e.g. hyperthyroidism, diabetes mellitus); Porphyria; Prostatic hypertrophy.
Especially after prolonged use and overdosing the effect of decongestants may lessen. As a result of this abuse of decongestants the following may occur: Reactive hyperemia of the nasal mucosa (rhinitis medicamentosa); Atrophy of the nasal mucosa.
To at least sustain nasal breathing to some extent, the sympathomimetic drug should be used first in one nostril and then switched to the other nostril once the complaints have cleared up.
Other precautions: SNUP STADA 0.1% spray is suitable for school children from 6 years of age and adults. It must not be used in children in the age group of less than 6 years of age.
Effects on ability to drive and use machines: When used as directed SNUP STADA has no influence on the ability to drive and use machines.
Pregnancy: Data on a limited number of exposed pregnancies during the first trimester are insufficient to draw a conclusion on the adverse effects of xylometazoline on pregnancy or on the health of the fetus/newborn infant. To date no other appropriate epidemiological data are available. Animal studies showed reproduction toxicity above therapeutic dosing levels. SNUP STADA should only be used in pregnancy after a careful benefit/risk assessment. Because overdosing may impair the blood supply to the unborn child, during pregnancy the recommended dosage must not be exceeded.
Lactation: It is unknown whether xylometazoline passes into human breast milk. During lactation SNUP STADA should therefore be used only after a careful benefit/risk assessment. Because overdosing might reduce the milk production, during lactation the recommended dosage must not be exceeded.
In this section frequencies of undesirable effects are defined as follows: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known.
Rare: Palpitation, tachycardia.
Very rare: Arrhythmias.
Nervous system disorders:
Very rare: Headache, convulsions (especially in children).
Respiratory, thoracic and mediastinal disorders:
Common: Burning and dryness of the nasal mucosa, sneezing.
Uncommon: Rebound congestion as the decongestant action wears off, nosebleeds.
Very rare: Apnea (reported with use of xylometazoline in young infants and newborn babies).
General disorders and administration site conditions:
Very rare: Fatigue (somnolence, sedation).
Immune system disorders:
Uncommon: Hypersensitivity reactions (angioedema, skin eruptions, pruritus).
Very rare: Restlessness, insomnia, hallucinations (mainly in children).
The combined use of xylometazoline and: Tricyclic antidepressants, Tranylcypromine-type monoamine oxidase inhibitors, Blood pressure increasing medicines may lead to hypertension. The combined use should, therefore, be avoided.
Do not store above 25°C.
Shelf-life: 5 years.
Once opened, this medicament should not be used for longer than 3 months.
R01AA07 - xylometazoline ; Belongs to the class of topical sympathomimetic agents used as nasal decongestants.
Nasal Spray 0.1% (clear, colorless solution) x 15 mL.