Ortofleks® 2% 30g ointment tube for external use

The instruction for medical use


of ORTOFLEKS® medicine

the Trade name
of Ortofleks®

the International unlicensed



name Diclofenac Dosage Form Ointment for external use of 20 mg/g

Structure
of 1 g of ointment contains
active agent - sodium diclofenac of 20 mg,
excipients: benzyl benzoate, carbomer, polysorbate 80, sodium hydroxide, the imidazolidinyl urea, water purified.

Description
Ointment of white or almost white color.

Pharmacotherapeutic group
Non-steroidal anti-inflammatory drugs for external use.
The code of automatic telephone exchange M02AA15

the Pharmacological

Pharmacokinetics Diclofenac properties of sodium is well soaked up through skin. Ointment is soaked up, on average, within 5 minutes, the analgetic effect occurs within 30-60 minutes after putting ointment, the maximum action is reached in 1-2 hours and remains within 2.5 - 5 hours. Linking with proteins of plasma - up to 99%. The conjugated metabolites are allocated, generally through kidneys, in a smaller measure, with a stake. Diclofenac is soaked up in synovial fluid where its concentration remains invariable for 7 hours.
A pharmacodynamics
sodium Diclofenac - non-steroidal anti-inflammatory drug which, inhibiting activity of enzymes of cyclooxygenase and a lipoxygenase, slows down synthesis of prostaglandins, thromboxanes and leukotrienes. The pain and hypostases caused by inflammation decrease.

Indications
- myalgias
- a bursitis
- a fibrositis
- a tendinitis, a tendovaginitis
- an epicondylitis
- arthralgias
- sports injuries (stretchings, dislocations, bruises)
- the osteoarthritis of peripheral joints and a backbone, a periartropatiya


apply the Route of administration and doses of 2-4 g of ointment with a thin layer on a painful part of the body 3-4 times a day. The maximum resolved daily dose - 8 g of ointment. Duration of a course of treatment individual (1-14 days). When assigning a dose it is necessary to consider that about 0.5 g of ointment are spent for the site of skin of 1 sq.dm in size, 2-3 tubas of ointment are spent for a course of treatment on average.

Side effects
- local skin allergic reactions (burning, reddening, an itching)
At prolonged use of ointment and/or use of ointment in large numbers can arise the systemic side effects inherent to non-steroidal anti-inflammatory drugs:
- to pain in epigastric area, nausea, an abdominal distension and loss of appetite
- a headache, dizziness, drowsiness
- increase in arterial blood pressure
- ulcerogenic action

of the Contraindication
- hypersensitivity to diclofenac, acetylsalicylic
acid and other
non-steroidal anti-inflammatory drugs
- the bronchial asthma, a small tortoiseshell or rhinitis provoked
by use of acetylsalicylic acid (salicylates) or
other NPVP
- pregnancy (III trimester)
- the breastfeeding period
- disturbance of integrity of integuments

Medicinal interactions
were not noted.

The special
instructions Avoid Ointment Hit on mucous membranes, in eyes or on the injured skin.
Use in pediatrics
the Data on use at children's age are absent.
Pregnancy and the period of breastfeeding
B 1 and P trimester of pregnancy drug use perhaps after careful assessment of potential risk and the expected advantage of treatment
of Feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Drug does not affect ability to drive transport and to work with technical devices.

Overdose
Symptoms: at misuse or accidental overdose of ointment there can be systemic side effects:
- pains in epigastric area, nausea, an abdominal distension and loss of appetite
- a headache, dizziness, drowsiness
symptomatic treatment.

A form of release and packing
of 30 g or 50 g of ointment in the aluminum tuba placed in a pack from cardboard with the enclosed instruction.


To Store storage conditions at a temperature not above 25 °C.
Not to freeze!
To store out of children's reach!


2 years
not to apply a period of storage after an expiration date!


Prescription status
Releases without prescription.


JSC Tallinnsky producer pharmaceutical plant.
Tondi 33, 11316 Tallinn, Estonia


Owner of the registration certificate
of JSC Grindex.
Krustpils St., 53, Riga, LV-1057, Latvia