DICLORAN PLUS GEL 30G

Dosage Form: gel for external use

Composition on 1 g of gel

Active substances:
Diclofenac Diethylamine............................................ 11.61 mg
equivalent to diclofenac sodium......................... 10.0 mg
Flax seed oil...................................... 30.0 mg
Levomenthol................................................................. 50.0 mg
Methyl salicylate.......................................................... 100.0 mg
Excipients:
Butylhydroxyanisole....................................................... 0.20 mg
Butylhydroxytoluene.................................................... 2.0 mg
Benzyl alcohol................................................................ 10.0 mcl
Disodium edetat........................................................... 1.0 mg
Diethylamine.................................................................. 7.1 mcl
Carbomer 980.............................................................. 10.8 mg
Citric acid monohydrate...................................... 1.0 mg
Macrogol glyceryl hydroxystearate
(Cremophor RH-40)......................................................... 35.0 mg
Propylene glycol.......................................................... 100.0 mg
Water............................................................................ Sk. required up to 1.0 gr

Pharmacotherapeutic group

Nonsteroidal anti-inflammatory drug (NSAIDs).

Pharmacological properties

Nonsteroidal anti-inflammatory drug (NSAIDs) for external use. When used according to the instructions, DIKLORAN&№174; PLUS has a local analgesic, anti-inflammatory and anti-exudative effect. Diclofenac sodium and methyl salicylate - NSAIDs, the mechanism of action of which is due to the suppression of the synthesis of prostaglandins. When applied topically, they reduce pain and inflammation in the joints, morning stiffness and swelling of the joints, increase the range of motion. The main component of flaxseed oil is α-linolenic acid, which also has anti-inflammatory action. Levomenthol causes irritation of nerve endings, has a local distracting and mild analgesic effect, causes a feeling of coolness at the site of application of the drug.

Pharmacokinetics

When applied topically according to instructions, diclofenac sodium, methyl salicylate and linseed oil are absorbed and penetrate into the subcutaneous tissue, muscle tissue and articular capsule.

Indications for use

- diseases of the musculoskeletal system (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, osteoarthritis of the peripheral joints and the spine, osteochondrosis with radicular syndrome, sciatica);
- rheumatic lesions of soft tissues (tendovaginitis, bursitis);
- muscle pain of rheumatic and non-rheumatic origin (caused, including excessive physical exertion);
- post-traumatic inflammation of soft tissues and joints (due to sprains, overstresses and bruises).

Contraindications for use

Hypersensitivity to diclofenac, methyl salicylate, or other components of the drug, a complete or incomplete combination of bronchial asthma, recurrent polyposis of the nasal mucosa and paranasal sinuses, and intolerance to Acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (including anamnesis or intolerance to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (including anamnesis or intolerance to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (including anamnesis in the anamnesis or intolerance to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (including anamnesis) (III trimester), lactation period (breastfeeding), children's age (up to 6 years), violation of the integrity of the skin.

Dosing regimen and method of administration

Outwardly. Adults and children over 12 years old apply the gel to the skin 3-4 times a day and lightly rub it. The required amount of the drug depends on the size of the painful area. A single dose of the drug DIKLORAN PLUS - 2-4 g (4-8 cm with a fully open mouth of the tube). Children from 6 to 12 years old should not use more than 2 times a day, a single dose of the drug up to 2 g. The duration of treatment without consulting a doctor should not exceed 10 days. The question of the possibility of a more prolonged use of the drug the doctor decides individually and gives the patient further instructions.

Precautions for use

For external use only.
According to the instructions, DIKLORAN&№174; PLUS should be applied only to intact skin, avoiding contact with open wounds. After applying the gel should not apply an occlusive dressing. With prolonged application to open surfaces, systemic side effects may develop due to resorptive action. Do not allow the drug to enter the eyes and mucous membranes. Carefully the drug should be prescribed for severe violations of the liver and kidneys, bronchial asthma, in the first and second trimester of pregnancy, in elderly patients.

special instructions

If the drug has fallen into disrepair or the expiration date has expired - do not throw it into sewage or on the street! Put the medicine in the bag and put it in the trash.These measures will help protect the environment!

Symptoms of overdose, measures to assist overdose

When applied externally at doses recommended by the instructions for DIKLORAN&№174; PLUS, the extremely low systemic absorption of the active ingredients of the drug makes overdosing almost impossible. In case of accidental ingestion, systemic side effects may develop. Treatment with ingestion: gastric lavage, induction of vomiting, taking Activated carbon, forced diuresis, symptomatic therapy. Dialysis is ineffective due to the high degree of binding of diclofenac to plasma proteins (about 99%).

Possible side effects when using the drug

Local reactions: eczema, photosensitivity, contact dermatitis (itching, redness, swelling of the treated skin area, papules, vesicles, peeling). Systemic reactions: generalized skin rash, allergic reactions (urticaria, angioedema, bronchospastic reactions).

Interaction with other drugs

Diclofenac may enhance the effects of drugs that cause photosensitization. Clinically significant interactions with other drugs are not described.

Indication of the possibilities and features of the medical use of the drug by pregnant women and women during breastfeeding
The drug is contraindicated in the III trimester of pregnancy. The question of the use of the drug in the I and II trimesters of pregnancy is solved individually. Due to the lack of experience with DICLORAN&№174; PLUS during lactation, the use of the drug in this period is not recommended.

Information on the possible effect of a medicinal product for medical use on the ability to drive vehicles, machinery
When used according to the instructions, DIKLORAN&№174; PLUS does not affect the ability to drive and maintain moving mechanical equipment.

Expiration date and indication of the prohibition of the use of the drug after the expiration date
3 years.
Do not use beyond the expiration date printed on the package.

Storage conditions
At a temperature not higher than 30 ° C. Do not freeze.