APPLICATION INSTRUCTION
DICLOFENAC NEO 1% 25G GEL

Drug form: Gel.
Pharmacological group: Nonsteroidal anti-inflammatory mean.
International non-patent name: Diclofenac.
Composition for 25g:
Active substance: Diclofenac Sodium – 0.25 g;
Excipients: Diethylamine hydrochloride, dimethyl sulfoxide, alcohol 95%, methylparaben, carbopol, water, sodium hydroxide, peppermint oil.
Pharmacological operation:
Pharmacodynamics: Diclofenac is a nonsteroidal anti-inflammatory mean with painkilling and antipyretic action.
Inhibition of biosynthesis Prostaglandins plays an important role in the mechanism of drug operation, which is related to the activity suppression of enzyme Cyclooxygenase -1 and Cyclooxygenase -2.
The preparation reduces pain, edema in the inflammatory nidus and improves microcirculation.
Pharmacokinetics: Partially absorbed through the skin when applied topically. Amount of Diclofenac in the skin is proportional at time of contact and application area. Bioavailability is – 6%, plasma protein binding – 99.7% excreted by kidneys.
Indications:it is used in complex therapy, as an aid mean: Inflammatory and degenerative diseases of musculoskeletal system: rheumatology arthritis, psoriatic, chronic arthritis, ankylosing spondylitis, gout and other metabolic arthritis, spine and joints osteoarthritis.
Rheumatoid injuries of soft tissue;
Traumatic lesions of joints, muscles, tendons, ligaments.
Post-traumatic inflammation of soft tissues and joints: in case of tension, stress and damage.
Side effects: Allergic reactions in case of hypersensitivity toward preparation.
Local reactions: Eczema, photosensitization, contact dermatitis (hyperaemia, flaking, itch).
In case of long term use or application on the great area of the body there may be detect systematic side effects as a result of resorptive action of Diclofenac: dizziness, headache, pain in the epigastric area. In case of detecting side effects, the patient must interrupt usage of preparation and address to the doctor.
Using rule and dosage: Adults and children over the age of 12 gel is applied on the damaged area in thin layer, gently infriction 3-4 times in a day. Considering that in case of external application only 6% of Diclofenac is absorbed. In children from 6 to 12 age the gel is applied not more than 2 times in a day according to doctor’s recommendation.
Duration of treatment depends on the indication and treatment efficiency (with the purpose of strengthening effect the gel is used with other forms of Diclofenac). Application of gel shouldn’t exceed 2 weeks without doctor’s consultation.
Dosage omission: In case of dose omission the following dose should be applied as soon as possible or according to the initial scheme.
Contra-indication:
• Additional sensitivity toward the nonsteroidal anti-inflammatory mean;
• The preparation isn’t used during lactation and pregnancy period;
• Usage of preparation in children under the age of 12 isn’t recommended without doctor’s recommendation;
• Disorder of skin integrity.
Overdose:
In case of external use of the preparation, in terms of low systemic absorption of Diclofenac, overdose is practically impossible.
In case of overdose there may detect local allergic reactions, itch and burning.
Treatment is symptomatic.
Pregnancy and lactation period: Usage of preparation isn’t recommended during lactation and pregnancy.
Influence on ability of driving cars and mechanisms: Taking the preparation doesn’t effect on ability of driving cars and mechanisms.
Interaction with other preparations: Preparation strengthens operation of photosensitization disturbances. Clinically significant interactions with other medical preparations isn’t given
Caution: After application of the preparation, in case of expressed itch and burning wash the skin with warm water.
Production form: Primary package: 25g gel in aluminum tube.
Secondary package: The tube is put in the cartoon box with application instruction.
Shelf Life: 2 years.
After the expiry date or in case of defect, revealed after the visual check usage of preparation is forbidden.
Storage conditions: It is kept not more than 15-25⁰ temperature, in a protected from light place, keep away from children.
Order of issue from pharmacy: Pharmaceutical product group III, issued without prescription.
Manufacturer: “Neopharmi” LTD
12th km of Alley David Agmashenebeli. Tbilisi. Georgia.
Tel/fax: +995(32) 259-64-46; 259 57-90.