The instruction for medical use
of KSIMELIN® medicine
the Trade name
the International unlicensed
name Xylomethazolinum Dosage Form
of the Drop nasal 0.05%, 0.1%
of 1 ml of solution contains
active agent – xylomethazolinum a hydrochloride – 0.5 mg or 1 mg, excipients: dinatrium edetat, dinatrium phosphate a dihydrate, a benzalkoniya chloride in the form of 10% of solution, sodium dihydrophosphate a dihydrate, sodium chloride, water
the Transparent colourless liquid purified the Description
Nasal drugs. Antikongenstanta and other nasal drugs for topical administration. Sympathomimetics. Xylomethazolinum.
The ATX R01AA07 code
Pharmacokinetics At properties topical administration in the recommended doses drug is practically not absorbed, concentration in plasma are so small that they cannot be determined by modern analytical methods.
Sympathomimetics with alpha and adrenergic activity for topical administration of a nasal mucous membrane. Xylomethazolinum possesses vasoconstrictive action, reducing puffiness of mucous and promoting drainage of a nose and nasal bosoms. There is a light risk of impact on heart and central nervous system. Long-term treatment can cause hypostasis mucous and hypersecretion. The effect begins in a few minutes after use and lasts till 10 – 12 o’clock.
Symptomatic simplification of the congestion of a nose caused by rhinitis and sinusitis:
– acute respiratory diseases with the phenomena of rhinitis (cold),
– acute allergic rhinitis,
– a pollinosis.
The route of administration and doses
Adults and children are more senior than 10 years:
– Èß¿¼Ñ½¿¡® 0.1%: on 2 drops in each nasal pass
Children from 2 to 10 years:
– Èß¿¼Ñ½¿¡® 0.05%: on 1-2 drops in everyone nasal pass
it is not necessary to use Drug more than 3 times a day. Duration of reception should not exceed 10 days.
the Most widespread side reactions are connected with a nasopharynx and mucous. About 3-8% of patients experience adverse reactions stated below.
Frequency of side effects of drug is regarded as follows: frequent (& gt, 1/100, & lt, 1/10), infrequent (& gt, 1/1000, & lt, 1/100), rare (& gt, 1/10,000, & lt, 1/1000), very rare (& lt, 1/10,000).
– burning of a nasopharynx
– irritation and dryness of a mucous nasopharynx
– at frequent or prolonged use vozmozhenen hypostasis of a mucous nasopharynx and as a result disturbance of breath through a nose,
it is rare:
– discomfort of digestive tract,
It is very rare:
– system allergic reactions
– a headache
– the passing disorder of vision
– tachycardia or irregular pulse
of the Contraindication
– hypersensitivity to drug components
– after surgical interventions on a firm meninx (at transsphenoidal hypophysectomy and other transnasal operations)
– closed-angle glaucoma
– children’s age up to 2 years (for Ксимелин® 0.05%)
– children’s age up to 10 years (for Ксимелин® 0.1%)
At a concomitant use about three – and tetracyclic antidepressants it is impossible to exclude system effect of xylomethazolinum and possible strengthening of its sympathomimetic effect.
Xylomethazolinum should be used with care and only after consultation with the doctor to the patients receiving inhibitors of the mono-amino-oxidase (MAO) and other medicines which can lead to increase in arterial blood pressure.
instructions Xylomethazolinum of 0.05% and 0.1% should not be given to children under 2 years, because of risk of overdose which can lead to oppression of the central nervous system.
Duration of treatment should not be more than ten days as long-term treatment by xylomethazolinum can cause swelling of a mucous membrane of a nose and the strengthened secretion caused by hypersensitivity of cells – converse effect.
Xylomethazolinum has to be applied with care at the persons sensitive to adrenergic substances which can give such symptoms as insomnia, dizziness, a tremor, disturbance of a warm rhythm or high arterial blood pressure.
Xylomethazolinum should be used with care and only after consultation with the doctor at patients with: a hyperthyroidism, diabetes, a hypertension, atherosclerosis, aneurysm, coronary heart disease, arrhythmia, tachycardia, feokhromotsitozy, and in the presence of a problem with urination because of the increased prostate.
Pregnancy and the period of a lactation
Ksilometozolin should not be used during pregnancy because of possible systemic vasoconstrictive action.
Xylomethazolinum can be used during feeding by a breast, on condition of soblyudeniye of recommendations of the doctor.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Xylomethazolinum does not affect ability to run vehicles or use of the equipment.
Overdose as a result of accidental ingestion:
Symptoms: oppression of central nervous system with considerable fall of temperature of a body, drowsiness with sweating, a headache, irregular pulse, a potential coma at children, hypotonia, hypertensia.
Treatment: symptomatic and specific if necessary.
A form of release and packing
On 10 ml in bottles polyethylene with the plastic drop device and the screwing-up cover. The bottle together with the instruction for use in the state and Russian languages is placed in a cardboard box.
At a temperature not above 25 °C.
To store out of children’s reach!
not to use a period of storage after expiry date.
of Proizvoditel Takeda GmbH, Zingen, Germany
the Owner of the registration certificate
Takeda of Pharm of A/S, Denmark
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods): Representative office Takeda Osteuropa Holding GmbH (Austria) in Kazakhstan Almaty, Shashkin St. 44 Phone number (727) 2444004 Fax number (727) 2444005 E-mail address of DSO-KZ@takeda.com