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Description

The instruction for medical use

of ARUTIMOL medicine

the Trade name
Arutimol

Mezhdunarodnoye the unlicensed

name Timololum Dosage Form
of the Drop eye 0.25%, 0.5%, 5 ml

Structure
of 1 ml of drug contains
active agent – Timololum a maleate of 3.42 mg and 6.83 mg (in terms of Timololum of 2.5 mg and 5.0 mg)
excipients: a benzalkoniya chloride of 50% solution, K 30 povidone, dinatrium edetat, phosphate dinatrium dodecahydrate, dihydrophosphate sodium a dihydrate, water for injections.

Description
Transparent colourless or slightly yellowish color flavourless liquid.

Pharmacotherapeutic group
Drugs for treatment of diseases of eyes. Protivoglaukomny drugs and miotik. Beta blockers. Timololum.
The ATX S01EDO1 code

the Pharmacological

Pharmacokinetics At properties topical administration of Timololum a maleate quickly gets through a cornea. After instillation of eye drops the maximum concentration
of Timololum in watery moisture of an anterior chamber of an eye is reached in 1-2 hours.
In insignificant quantity gets to a system blood stream by absorption through vessels of a conjunctiva, mucous a nose and a plaintive path.
Removal of metabolites of Timololum is carried out mainly by kidneys.
At newborns and small children the concentration of active agent significantly exceeds it Smakh in plasma of adults.
The pharmacodynamics
Timololum is a non-selective blocker of beta adrenoceptors. Has no internal symptomatic and membrane stabilizing activity.
At topical administration in the form of eye drops Arutimol reduces both the normal, and increased intraocular pressure due to reduction of intraocular liquid. Does not influence the size of a pupil and accommodation.
Effect of drug is shown in 20 minutes after instillation in a conjunctival cavity. The maximum decrease in intraocular pressure occurs in 1-2 hours and remains within 24 hours.

Indications
– the increased intraocular pressure (eye hypertensia)
– glaucoma (chronic open angle glaucoma)
– afakichesky glaucoma and other types of secondary glaucoma
– as an additional tool for decrease in intraocular
pressure in closed-angle glaucoma (in a combination from miotika)
– congenital glaucoma (at insufficiency of other therapeutic measures).

The route of administration and doses
at the beginning of therapy dig in on 1 drop of the drug Arutimol 0.25% and 0.5%
2 times a day.
If intraocular pressure at regular use is normalized, it is necessary to limit a dosage to 1st once a day on the 1st drop of drug. Treatment by Arutimol is carried out, as a rule, for an appreciable length of time. The break or change of a dosage is carried out only according to the instruction of the attending physician.

Side effects
– the irritation and hyperaemia of a conjunctiva, an eyelid skin, burning and an itching of eyes, dacryagogue, a photophobia, hypostasis of an epithelium of a cornea, a dot superficial keratopathy, a cornea giposteziya, a diplopia, a ptosis, xerophthalmus
– when carrying out fistuliziruyushchy antiglaukomny operations is possible development of amotio of a choroid in the postoperative period
– heart failure, bradycardia, bradyarrhythmia, a lowering of arterial pressure, collapse, atrioventricular block, cardiac arrest, passing disturbances of cerebral circulation
– an asthma, a bronchospasm, pulmonary insufficiency
– topical administration at newborns can lead to an apnoea
– a headache, dizziness, weakness, a depression, paresthesias, fatigue
– nausea, diarrhea
– urticaria, eczema
– rhinitis, disturbance of sexual functions,

the Contraindication alopecia
– the increased individual sensitivity to Timololum
– bronchial asthma or other heavy chronic obstructive
respiratory diseases
– sinus bradycardia (the slowed-down heartbeat)
– atrioventricular block of II, III degrees
– the profound heart failure
– cardiogenic shock
– allergic reactions with generalized skin rashes
– heavy atrophic rhinitis
– cornea dystrophy
– the children’s and teenage age up to 18 years

Medicinal interactions
Sharing of Arutimol with the eye drops containing adrenaline can cause mydriasis.
Specific effect of drug – decrease in intraocular pressure amplifies at simultaneous use of eye drops, containing –
shchy adrenaline and pilocarpine. It is not necessary to dig in two beta blockers in eyes. At co-administration with Arutimol of the drugs breaking deposition of catecholamines (reserpine) development of arterial hypotension (including orthostatic), bradycardia and dizziness is possible.
The lowering of arterial pressure and delay of a warm rhythm can be exponentiated at combined use of drug with antagonists of calcium, reserpine and beta blockers.
Simultaneous use with insulin or oral protivodiabeti-
chesky means can lead to a hypoglycemia.
The following drugs are not recommended to be administered along with Arutimol: Amiodaronum, the halogenated flying anesthetics, antiarrhytmic drugs (propafenon and agents of the class Ia), Baclofenum, a clonidine and lidocaine.
CYP2D6 inhibitors, such as quinidine and Cimetidinum, can increase concentration of Timololum in blood plasma.
Timololum strengthens action of muscle relaxants therefore
drug withdrawal in 48 hours prior to the planned surgical intervention using the general anesthesia is necessary.
These data can belong also to medicines which were applied shortly before it.

Special instructions
Arutimol can hide hypoglycemia symptoms at patients with diabetes or symptoms of hyperfunction of a thyroid gland.
At transfer of patients to treatment with Timololum
the refraction tion after the effects caused by the miotika applied earlier can be necessary korrek-.
Arutimol it is necessary to apply with care at patients with pulmonary insufficiency, heavy cerebrovascular insufficiency, hroni-
chesky heart failure in compensation stage, diabetes, a hypoglycemia, a thyrotoxicosis, a myasthenia, Reynaud’s syndrome, a pheochromocytoma, atrophic rhinitis and also at co-administration of other beta blockers and psychoactive medicines which strengthen epinephrine discharge.
Some patients receiving beta blockers tested long heavy hypotension during anesthesia. In case of the forthcoming surgery using the general anesthesia, it is necessary to cancel drug in 48 hours.
If the patient carries soft contact lenses, then he should not apply eye drops Arutimol of 0.25% and 0.5% as preservative can be laid on soft contact lenses and make an adverse effect on eye tissues. Before use of drug it is necessary to remove contact lenses and again to establish them not earlier than in 15 minutes after instillation. Short-term misting of sight can be observed after instillation of drops Arutimol of 0.25% and 0.5%. In a bigger degree it takes place in interaction of drug with alcohol.
The period of pregnancy and a lactation
it is not necessary to apply during pregnancy and during feeding by a breast as Timololum is excreted in breast milk. Arutimol’s use 0.25% and 0.5% for treatment of pregnant women and nursing mothers is admissible only if the expected advantage exceeds risk of development of possible side effects.
Features of influence of medicine on ability to run the vehicle or potentially dangerous by mechanisms
Right after burying drug perhaps temporary decrease in clearness of sight and delay of mental reactions that can reduce ability to active participation in traffic, service of cars or to performance of work without reliable support.

Overdose
Symptoms: development of the all-resorptive effects characteristic of beta blockers (dizziness, a headache, arrhythmia, bradycardia, a bronchospasm, nausea, vomiting) is possible.
Treatment: to immediately wash eyes with water or normal saline solution, symptomatic therapy.

A release form
On 5 ml of drug in a bottle dropper of Botlpak from polyethylene of high density with the screw-on cap.
On 1 bottle together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.

To Store storage conditions in the place protected from light, at a temperature not above 25C.
To store out of children’s reach!

A period of storage
3 years
the Expiration date after opening of a bottle no more than 6 weeks.
Not to use after expiry date.

Prescription status
According to the prescription

the Producer Chauvin ankerfarm GmbH
Brunsbyutteler Damm 163-175,
Berlin, Germany

the Owner of the registration certificate
of OOO “Valeant”, Russia

the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products Representative office of OOO “Valeant” to RKKazahstan, 050059, Almaty, Al-Farabi Avenue, 17, Business center “Nurly-Tau” Block 4B, office 1104 Phone number + 7 727 3 111 516, fax +7 727 3 111 517 E-mail:

To Develop Îffice.KZ@valeant.com

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