Diklo-F 0.1% 5 ml of eye drops

The instruction for medical use




of Diklo-F Torgovoye medicine a name
Diklo-F

Mezhdunarodnoye the unlicensed


name Diclofenac Dosage Form
of the Drop eye 0.1% 5 ml


contains Structure of 1 ml of drug:
active agent: diclofenac of sodium of 1.0 mg,
excipients: a benzalkoniya chloride, dinatrium edetat, boric acid, trometamin, hydroxide, acid chlorohydrogen, water for injections polioksit the 35th castor oil, povidone, sodium.

The description
Transparent solution from colourless till light yellow color

Pharmacotherapeutic group
Drugs for treatment of diseases of eyes.
Non-steroidal anti-inflammatory drugs. Diclofenac.
The ATX S01BC03 code

the Pharmacological

Pharmacokinetics At properties of instillation of eye drops diclofenac is soaked up in a system blood stream. However the concentration of medicinal substance reached in blood is much lower than a limit of detection and has no clinical importance.
The pharmacodynamics
Diklo-F possesses anti-inflammatory, analgetic and febrifugal action. The mechanism of action is caused by not selective inhibition of activity of cyclooxygenase 1 and 2 that leads to suppression of synthesis of prostaglandins in the inflammation center.
When using in the form of 0.1% of solution of eye drops diclofenac reduces the inflammation resulting from an infection, an injury or surgery, reduces a miosis at surgeries, reduces synthesis of prostaglandins in moisture of an anterior chamber.

Indications
- miosis inhibition during operation for a cataract
- treatment and prevention of inflammatory processes after surgical interventions on an eyeball
- prevention of cystous hypostasis of a makula after operations for a cataract
- treatment of non-infectious conjunctivitis
- treatment and prevention of posttraumatic inflammatory process at the getting and not getting eyeball wounds (as addition to local antibacterial therapy)

the Route of administration and doses
Locally. For inhibition of an intraoperative miosis drug is dug in in a conjunctival sac within 2 hours with an interval of 30 minutes (4 times) before operation.
For prevention of cystous hypostasis of a makula drug is dug in on 1 drop by 3 – 4 times a day within 2 weeks after operation.
Other indications: on 1 drop 3 – 4 times a day depending on weight of a state. The course of treatment can proceed from 1 to 2 weeks under observation of the ophthalmologist.

Side effects
- burning of eyes
- illegibility of visual perception (right after burying)
- turbidity of a cornea (cataract)
- an iritis
- an itching of eyes, hyperaemia of the person, fever, a fever, a photosensitization, skin rash (mainly erythematic, a small tortoiseshell), a multiformny exudative erythema, a Quincke's disease of the person
- nausea,

Contraindication vomiting
- hypersensitivity to active ingredient of drug or to other
auxiliary ingredients
- hypersensitivity to acetylsalicylic acid or other NPVP (an aspirinovy triad - a combination of bronchial asthma, the nose recuring a polypose or near-nasal bosoms and intolerance of acetylsalicylic acid)
- pregnancy and the period of a lactation
- children's age up to 8 years

Medicinal interactions
Drug can enhance effect of indirect anticoagulants. Simultaneous use of this drug with diflunizaly is not recommended (as development of bleeding from digestive tract) and other NPVP, including acetylsalicylic acid in high doses (3 g and more in day is possible).
Use together with lithium drugs, digitoxin, indirect anticoagulants leads to strengthening of their effect.
If necessary it is possible to apply along with other eye drops including containing glucocorticosteroids. At the same time the break between appliques has to be not less than 5 minutes for prevention of washing away of active ingredients the subsequent doses.

Special instructions
the Patients using contact lenses have to use drug only in 5 min. after removal of lenses and can put on them in 15 minutes after burying drug.
The bottle needs to be closed after each use. It is not necessary to touch with a pipette tip an eye.
A break between use of various drops of 5 minutes.
With care
the Epithelial herpetic keratitis (including in the anamnesis), the diseases causing fibrillation disturbances (including hemophilia, lengthening of a bleeding time, tendency to bleedings), advanced and children's age.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
to Patients at whom after applique of eye drops the sight clearness is temporarily lost is not recommended to drive or work with a difficult technique, machines or other equipment demanding sight clearness right after burying drug.

Overdose
Symptoms: strengthening of side effect.
Treatment: symptomatic.

Form of release and packing
of the Drop eye 0.1%.
On 5 ml of drug in plastic bottles droppers.
On 1 bottle dropper together with the screw-on cap in which there is a device for opening of a bottle and with the instruction for medical use in the state and Russian languages place in a cardboard pack.


To Store storage conditions in the place protected from light at a temperature not above 30 °C.
Not to freeze.
To store out of children's reach!

A period of storage
2 years
the use Period after opening of a bottle 1 month.
Not to use after the expiry date specified on packing!

Prescription status
According to the prescription


of Proizvoditel SENTISS FARM PVT. LTD.
212/D-1, Greene Park, New Delhi, India
At the plant: Villidzh Khera Nikhla, Tekhsil Nalagarkh, Region of Solan, Himachal Pradesh 174,101, India

Name and country of the owner of the registration certificate
of SENTISS FARMA of PVT. LTD., India
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products: Republic of Kazakhstan, 050000, Almaty, Bogenbay St. of the Batyr 132, office 309 Ph./fax: +7 (7272) 96-45-99Email: sentiss_kz@land.ru