Naklofen - instructions for use, dose, side effects, contraindications

Excipients: carbomer, macrogol, diethanolamine, isopropyl alcohol, propylene glycol, sodium sulfite, anhydrous, cetomacrogol, decyloleate, vaseline oil, purified water.

Description:Homogeneous gel of white color.

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

ATX: & nbsp

S.01.B.C.03 Diclofenac

M.01.A.B.05 Diclofenac

Pharmacodynamics:

Naklofen gel is a non-steroidal anti-inflammatory drug (NSAID) for topical application, with pronounced analgesic and anti-inflammatory properties. Indiscriminately inhibiting cyclooxygenase type 1 and 2, disrupts the metabolism of arachidonic acid, reduces the number of prostaglandins, including in the inflammatory focus. Naklofen gel is used to eliminate pain syndrome and reduce puffiness associated with the inflammatory process.

With the recommended method of using the drug, no more than 6-7% of diclofenac is absorbed into the systemic circulation. It is excreted by the kidneys. Diclofenac quickly absorbed, with the concentration in the synovial fluid higher than in the plasma.

Pharmacokinetics:

Indications:

The drug is used to relieve pain and inflammation according to the following indications:

- Rheumatoid arthritis, osteoarthrosis, rheumatic soft tissue damage (tendovaginitis, bursitis);

- bruises, damage to ligaments, muscles and tendons;

- inflammatory edema of soft tissues, tenderness of muscles and joints, including those caused by heavy physical exertion.

Contraindications:

- Do not apply Naklofen gel in case of hypersensitivity to diclofenac or auxiliary components of the drug or to other non-steroidal anti-inflammatory drugs (complete or incomplete acetylsalicylic acid intolerance syndrome-sinusitis, urticaria, nasal polyps, bronchial asthma).

- Children under the age of 6 years.

- Violation of the integrity of the skin.

- Pregnancy (III trimester) ..

Carefully:Hepatic porphyria (exacerbation), erosive-ulcerative lesions of the gastrointestinal tract,severe violations of liver and kidney function, chronic heart failure, bronchial asthma, bleeding disorders (including hemophilia, lengthening bleeding time, a tendency to bleeding), elderly age, pregnancy I-II trimester and lactation.

Pregnancy and lactation:The drug in the III trimester of pregnancy is not recommended. In the first trimester of pregnancy and during lactation, Naklofen gel is used in small amounts and for a short period of time. The lactating woman should not apply the drug to the mammary gland.

Dosing and Administration:Outwardly. For adults and adolescents over 12 years, a strip of gel 5-10 cm long is applied to the affected area and gently rubbed into the skin 2-3 times a day. Children aged 6 to 12 years are treated with a strip no more than 3 cm not more often than 2 times a day. When using the drug for more than 10 days should consult with your doctor.

Side effects:

Gel Naklofen rarely causes side effects.

From the skin: redness, photosensitivity, contact dermatitis (itching, hyperemia, swelling of the treated area of the skin, papular-vesicular rashes, peeling), burning sensation, erythematous skin rash, hives, eczema.

Systemic reactions: urticaria, bronchial asthma, angioedema, systemic anaphylactic reactions (including shock).

Overdose:

Extremely low systemic absorption of diclofenac with external application makes an overdose virtually impossible. In case of accidental ingestion of a large amount of the drug, nausea, vomiting and systemic side effects of NSAIDs are possible.

Symptoms: nausea and vomiting.

Treatment: gastric lavage, Activated carbon, forced diuresis, symptomatic therapy. Hemodialysis is ineffective.

Interaction:

Care should be taken when taking oral forms of other non-steroidal anti-inflammatory drugs. Diclofenac The gel may enhance the effect of drugs that cause photosensitivity. Clinically significant interaction with other drugs is not described.

Special instructions:

Gel Naklofen should be applied only to undamaged skin. Avoid contact with eyes, mucous membranes or open wounds. Gel Naklofen should not be used under airtight (occlusive) bandages.Care should be taken when applying a large amount of gel to large surfaces of sensitive skin for an extended period of time. When used with other dosage forms of diclofenac, the total maximum daily dose should be taken into account.

During the period of application of the Naklofen gel, prolonged exposure to sunlight should be avoided.

After applying the gel on the skin, you should wash your hands thoroughly. The drug is intended for external use only.

Effect on the ability to drive transp. cf. and fur:The drug does not affect the ability to drive and other mechanical means.

Form release / dosage:

Gel for external use 1%.

Packaging:

60 g of gel in an aluminum tube. 1 tube in a cardboard box together with instructions for use.

Storage conditions:

Store at a temperature not exceeding 30 ° C. Keep out of the reach of children.

Shelf life:

4 years.

Do not use the drug after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:П N013166 / 01

Date of registration:25.12.2007

The owner of the registration certificate:KRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO

Manufacturer: & nbsp

KRKA, d.d. Slovenia

Representation: & nbspKRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO

Information update date: & nbsp09.03.2016

Illustrated instructions

Instructions

Naklofen (Naklofen)