Xylofact drops nasal

Country: Armenia

Bahasa: Inggeris

Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Bahan aktif:

xylometazoline (xylometazoline hydrochloride)

Boleh didapati daripada:

Biodeal Pharmaceuticals Pvt. Ltd.

Kod ATC:

R01AA07

INN (Nama Antarabangsa):

xylometazoline (xylometazoline hydrochloride)

Dos:

0,5mg/ml

Borang farmaseutikal:

drops nasal

Unit dalam pakej:

20ml plastic bottle-dropper

Jenis preskripsi:

OTC

Status kebenaran:

Registered

Tarikh kebenaran:

2023-11-25

Risalah maklumat

XYLOFACT
NASAL DROP
s
XYLOMETAZOLINEHYDROCHLORIDE
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This medicine is available without a prescription. However, you still
need to use Xylofact
carefully to get the best results from it.
– Keep this leaflet. You may need to read it again.
– Ask your pharmacist if you need more information or advice.
– You must contact a doctor if the symptoms worsen or do not improve
after 5 days.
– If any of the side effects gets serious, or if you notice any side
effect not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.What
Xylofact is and what it is used for
2. Before you use Xylofact
3. How to use Xylofact
4. Possible side effects
5. How to store Xylofact
6. Further information
1.
WHAT XYLOFACT IS AND WHAT IT IS USED FOR
Xylofact is for application in the nose to give relief from:
• Nasal congestion (blocked nose, including colds)
• Perennial and allergic rhinitis (recurring inflammation of the
nasal mucous membranes,
including hay fever)
• Sinusitis.
Xylofact contains the active ingredient xylometazoline hydrochloride
which helps to open up
and clear the nasal passages by reducing the excessive nasal
secretions and returning the
swollen blood vessels to their normal size.
2.
BEFORE YOU USE XYLOFACT
DO NOT use the drops if your child:
• Is under 6 years old.
•
Is
allergic to xylometazoline hydrochloride or any of the other
ingredients in the drops.
• Has an inflamed nasal
p
assage.
•
Is
allergic to other decongestants.
• Has had recent neurosurgery or nasal surgery.
• Has heart or circulatory disease or hypertension
• Has diabetes
• Has hyperthyroidism (overactive thyroid gland)
• Has closed angle glaucoma
• Has an enlarged prostate gland
• Has phaeochromocytoma (a tumour of the nerves
associated with the hormone glands)
• Is taking monoamine oxidase inhibitors (MAOIs) or has
stopped taking them in the last 14 days
• Is taking betablockers
• Has chronic nasal inflamma

Ciri produk

MODULE I : ADMINISTRATIVE INFORMATION
1.3
LABELLING AND PACKAGING
1.3.1
SUMMARY OF PRODUCT CHARACTERISTICS (SMPC)
1.
NAME OF THE MEDICINAL PRODUCT
XYLOFACT
2.
QUALITATIVE AND QUANTITATIVECOMPOSITION
Composition:
Each ml contains:
Xylometazoline Hydrochloride ……..0.5 mg
Excipients………………………………..q.s.
For full list of excipients, see section 6.1.
3.
PHARMACEUTICALS FORM
Nasal Drops
Colorless to almost colorless clear solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATION
For the relief of nasal congestion associated with the common cold,
perennial and
allergic rhinitis (including hay fever), sinusitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Adults and elderly:_ Not applicable.
Xylofact are contra-indicated in children under 6 years of age.
Children between 6 and 12 years under adult supervision (all
indications): 1 or 2
drops, in each nostril up to 2 times a day.
Not to be used for more than 5 days without the advice of a doctor.
(see warnings and
precautions)
Parents or carers should seek medical attention if the child's
condition deteriorates
during treatment.
Not more than 2 doses should be given in any 24 hours.
_Route of administration:_ Nasal use, Do not exceed the stated dose
Keep out of the reach and sight of children
4.3
CONTRAINDICATION

Known hypersensitivity to Xylofact or any of the excipients

Concomitant use of other sympathomimetic decongestants

Cardiovascular disease including hypertension

Diabetes mellitus

Phaeochromocytoma
MODULE I : ADMINISTRATIVE INFORMATION
1.3
LABELLING AND PACKAGING

Prostatic hypertrophy

Hyperthyroidism

Closed angle glaucoma

Monoamine oxidase inhibitors (MAOIs, or within 14 days of stopping
treatment, see
section 4.5)

Beta-blockers – (see section 4.5)

Inflammation of the skin and/or mucosa of the nasal vestibule

Trans-sphenoidalhypophysectomy or nasal surgery exposing the dura
mater

Not to be used in children under the age of 6 years

Rhinitis sicca or atrophic rhinitis
4.4
SPECIAL WAR