Diklak Lipogel - instructions for use, dose, side effects, contraindications

Excipients: d-alpha-tocopherol 10.0 mg, carbomer 15.0 mg, decyloleate 5.0 mg, octyl dodecanol 5.0 mg, lecithin * 20.0 mg, ammonia aqueous 10% 26.0 mg, disodium edetate dihydrate 0.4 mg, "Vert de Creme" aromatic oil 0.2 mg, isopropanol 201.7 mg, water 706.7 ml. .

* It is used as a 26.7 mg mixture of phospholipon 80 / isopropanol in a ratio of 75: 25.

Description:Slightly yellowish emulsion homogeneous gel with a characteristic smell of isopropyl alcohol.

Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug (NSAID).

ATX: & nbsp

S.01.B.C.03 Diclofenac

M.01.A.B.05 Diclofenac

Pharmacodynamics:Active component diclofenac a derivative of phenylacetic acid, a non-steroidal anti-inflammatory drug with pronounced analgesic and anti-inflammatory properties. Indiscriminately inhibiting cyclooxygenase type 1 and 2, disrupts the metabolism of arachidonic acid and the synthesis of prostaglandins, which are the main link in the development of inflammation. Diclofenac is used to eliminate pain syndrome and reduce puffiness associated with with the inflammatory process.

Pharmacokinetics:

With the recommended method of applying the drug, no more than 6% of diclofenac is absorbed. When applied to the area of the affected joint concentration in the synovial fluid is higher than in the blood plasma. It is mainly excreted by the kidneys.

Indications:

- back pain with inflammatory and degenerative diseases of the spine (radiculitis, osteoarthrosis, lumbago, sciatica);

- pain in the joints (joints of the fingers, knees, etc.) with rheumatoid arthritis, osteoarthritis;

- pain in muscles (due to stretching, overstrain, bruises, injuries);

- inflammation and swelling of soft tissues and joints due to injuries and rheumatic diseases (tendovaginitis, bursitis, lesions of periarticular tissues).

Contraindications:

Hypersensitivity to diclofenac, acetylsalicylic acid or other NSAIDs, a complete or incomplete combination

bronchial asthma, recurrent polyposis of the nasal mucosa and paranasal sinuses and intolerance to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (including history), pregnancy (III trimester), lactation period, children's age (up to 12 years), violation of the integrity of the skin at the intended site of application.

Carefully:

hepatic porphyria (exacerbation), erosive and ulcerative lesions of the gastrointestinal tract, severe liver and kidney disease, chronic heart failure, bronchial asthma, advanced age, pregnancy I and II trimester.

Pregnancy and lactation:The drug should not be used in the III trimester of pregnancy. Experience with diclofenac during lactation is not available. Use in I and II trimesters is possible only after consultation with a doctor.

Dosing and Administration:

Outwardly. Adults and children over 12 years of age, the drug is applied to the skin 3-4 times a day and lightly rubbed. The required amount of the drug depends on the size of the painful area. A single dose of the drug - 2-4 g (which by volume corresponds to the size of cherries to walnuts). The duration of treatment depends on the indications and the effect observed. It is not recommended to use the drug for more than 14 days without consulting a doctor. For elderly patients, patients with renal or hepatic impairment a change in dosage is not required.

Side effects:

According to the World Health Organization (WHO), unwanted the effects are classified according to their frequency of development as follows: very often (> 1/10), often (>1/100, <1/10), infrequently (>1/1000, <1/100), rarely (>1/10000, <1/1000), very rarely (<1/10000).

Local

From the skin and subcutaneous tissue:

often - skin rashes, eczema, erythema, dermatitis (including contact dermatitis), skin itching;

infrequently - dandruff, dry skin, swelling;

rarely bullous dermatitis;

very rarely - the reaction of photosensitization, pustular eruptions.

System

From the immune system:

very rarely - hypersensitivity reactions, angioedema.

From the gastrointestinal tract:

very rarely - violations of the gastrointestinal tract.

From the respiratory system:

very rarely - bronchial asthma.

Overdose:

Extremely low systemic absorption of active components of the drug with external application makes an overdose almost impossible. However, with the occasional ingestion of 50 g of gel equivalent to 500 mg of diclofenac, undesirable reactions may occur, similar to adverse reactions. First aid is to wash the stomach,

reception of activated carbon.

Interaction:

Diclofenac can enhance the effect of drugs that cause photosensitivity.Since systemic absorption is minimal, the interaction of diclofenac with other drugs is unlikely.

Special instructions:Diclac® Lipogel should only be applied to intact skin, avoiding exposure to open wounds. After applying, do not apply an occlusive dressing. Do not allow the product to get into the eyes and mucous membranes.

Effect on the ability to drive transp. cf. and fur:Not applicable.

Form release / dosage:Gel for external use 1%.

Packaging:For 50 g or 100 g in aluminum tubes. The neck of the tube is sealed with a protective aluminum membrane and closed by a screwed plastic cover with a recessed pin. 1 tube is placed in a cardboard box together with instructions for medical use.

Storage conditions:

Store at a temperature not exceeding 25 ° C. Keep medicinal product out of the reach of children.

Shelf life:

3 years. Do not use the medicinal product after the expiration date indicated on the package.

After opening the tube it is recommended to use it no longer than 9 months.

Terms of leave from pharmacies:On prescription

Registration number:LP-001225

Date of registration:16.11.2011

Date of cancellation:2016-11-16

The owner of the registration certificate:Sandoz d.Sandoz d. Slovenia

Manufacturer: & nbsp

SALUTAS PHARMA, GmbH Germany

Representation: & nbspSANDOZ SANDOZ Switzerland

Information update date: & nbsp10.02.2016

Illustrated instructions

Instructions

Diclac® Lipogel (Diclac® Lipogel)