Xymelin drops nasal

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

xylometazoline (xylometazoline hydrochloride)

Available from:

Takeda GmbH

ATC code:

R01AA07

INN (International Name):

xylometazoline (xylometazoline hydrochloride)

Dosage:

1mg/ml

Pharmaceutical form:

drops nasal

Units in package:

10ml vial-dropper

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2016-09-15

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
FOR
X
YMELIN, NASAL DROPS, SOLUTION
1.
NAME OF THE MEDICINAL PRODUCT
Xymelin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Xylometazoline hydrochloride 0.5 mg/ml and 1 mg/ml
Excipients, see point 6.1.
3.
PHARMACEUTICAL FORM
Nasal drops, solution
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Acute respiratory diseases with signs of rhinitis, acute allergic
rhinitis, pollinosis, sinusitis,
eustachitis, middle otitis (in order to reduce the nasopharyngeal
mucosal oedema).
Patient’s preparation for diagnostic manipulations in the nasal
passages.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Intranasal.
_0.05% drops for children from 2 to 6 years of age_: Apply 1-2 drops
into each nostril 1-2
times daily. Do not use more than 3 times in 24 hours.
_0.1% drops for adults and children over 6 years of age_: apply 2-3
drops into each nostril
(repeat if necessary). Do not use more than 3 times in 24 hours. Use
medication for not more
than 10 days.
Use the product in children only under adult’s supervision. Use the
product only for such
indications, method of administration and doses, specified in the
patient information leaflet.
4.3
CONTRAINDICATIONS
High sensitivity to drug components, arterial hypertension,
tachycardia, atherosclerosis,
glaucoma,
atrophic
rhinitis,
thyrotoxicosis,
surgeries
on
meninx
(history
of),
condition
following transsphenoidal surgery, pregnancy, children below 2 years
of age (for Xymelin
0.05%); children below 6 years of age (for Xymelin 0.1%). Do not use
the product in case of
inhibitor of monoamine oxidase (IMO) or tricyclic antidepressant
therapy, including 14 days
after dechallenge.
2 WITH CAUTION
Diabetes mellitus, cardiovascular diseases, including CHD,
stenocardia, LONG QT INTERVAL
SYNDROME; porphyria, breastfeeding period, prostatic hyperplasia, in
case of hypersensitivity
to adrenergic agents accompanied with insomnia, dizziness, arrhythmia,
tremor, elevated
blood pressure. PATIENTS WITH LONG QT INTERVAL SYNDROME USING XYLOMETAZOLINE MAY BE
EXPOSED