Diclofenacol (Cream) Instructions for Use

Marketing Authorization Holder

Hyperion, S.A. (Romania)

ATC Code

M02AA15 (Diclofenac)

Active Substance

Diclofenac (Rec.INN registered by WHO)

Dosage Form

Diclofenacol

Cream for external use 1%: tube 20 g

Dosage Form, Packaging, and Composition

Cream for external use in the form of a homogeneous mass from white to white with a yellowish tint, with a smell of menthol.

Excipients : menthol (levomenthol), cetearyl alcohol (Lanette N, emulsifier), 2-octyldodecanol (Eutanol G), glycerol, ethanol, liquid paraffin, methylparahydroxybenzoate (nipagin), propylparahydroxybenzoate (nipazol), purified water.

20 g – aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

NSAIDs for external use

Pharmacotherapeutic Group

NSAID

Pharmacological Action

NSAID for external use. It has a local anti-inflammatory and analgesic effect.

Diclofenac non-selectively inhibits COX-1 and COX-2, disrupts the metabolism of arachidonic acid and the synthesis of prostaglandins, which are the main link in the development of inflammation.

Diclofenac is effective for relieving pain, reducing swelling and hyperemia associated with the inflammatory process.

The menthol included in the preparation has a local “cooling” effect. When applied externally, it causes a weakening or disappearance of pain at the site of application, including joint pain at rest and during movement, reduces morning stiffness and swelling of the joints. It helps to increase the range of motion.

Pharmacokinetics

With the recommended method of application of the drug, no more than 6% of diclofenac is absorbed.

Indications

• Rheumatoid arthritis;
• Psoriatic arthritis;
• Ankylosing spondylitis;
• Osteoarthritis of peripheral joints and spine;
• Rheumatic lesions of soft tissues;
• Inflammatory edema of soft tissues;
• Traumatic injuries of soft tissues without violating the integrity of the skin (including bruises and sprains of ligaments, muscles and tendons);
• Muscle and joint pain of rheumatic and non-rheumatic origin (including those caused by heavy physical exertion).

ICD codes

Dosage Regimen

Adults and children over 12 years of age apply a small amount of cream 2-4 g (4-8 cm) in a thin layer to the skin over the inflammation site and rub in lightly until completely absorbed 2-3 times/day. The amount of the drug required for application to the skin depends on the size of the painful area.

Children aged 6 to 12 years it is recommended to apply up to 2 g of the drug to the skin no more than 2 times/day.

The duration of the course of treatment should not exceed 14 days without consulting a doctor.

Adverse Reactions

Side effects depend on individual sensitivity, the magnitude of the applied dose and the duration of treatment.

Allergic reactions skin rash (including vesicular, papular), itching, burning, redness, contact dermatitis, eczema, photosensitivity, swelling of the skin area treated with the drug, peeling; with prolonged use or use in high doses – bronchospasm, anaphylactic reactions (including shock), generalized skin rash, urticaria, angioedema, photosensitivity.

If side effects occur, it is necessary to stop using Diclofenacol cream and consult a doctor.

Contraindications

• Bronchial asthma in combination with polyposis of the nasal mucosa;
• Peptic ulcer of the stomach and duodenum in the acute phase;
• Violation of the integrity of the skin;
• III trimester of pregnancy;
• Lactation period (breastfeeding);
• Children under 6 years of age;
• Hypersensitivity to diclofenac and other components of the drug;
• Hypersensitivity to acetylsalicylic acid or other NSAIDs.

With caution the drug should be used for hepatic porphyria (exacerbation phase), erosive and ulcerative lesions of the gastrointestinal tract, severe impairment of liver and/or kidney function, chronic heart failure, bronchial asthma, bleeding disorders, in the I and II trimesters of pregnancy, in pediatric patients under 12 years of age, in elderly patients.

Use in Pregnancy and Lactation

The use of the drug is contraindicated in the III trimester of pregnancy. The use of Diclofenacol in the I and II trimesters of pregnancy is possible only after consultation with a doctor.

There is no experience with the use of the drug during breastfeeding.

Use in Hepatic Impairment

The drug should be used with caution in hepatic porphyria (exacerbation phase), severe liver dysfunction.

Use in Renal Impairment

The drug should be used with caution in severe renal impairment.

Special Precautions

Diclofenac should be applied only to intact skin, avoiding contact of the drug on open wounds. After applying the cream, it is not recommended to apply an occlusive dressing.

Avoid contact of the drug with the eyes and mucous membranes.

Before using Diclofenacol, the patient should consult a doctor if the following diseases are present: peptic ulcer of the stomach and duodenum, impaired liver and/or kidney function, severe hematopoietic system disorders, bronchial asthma, rhinitis, polyps of the nasal mucosa, allergic reactions in history.

With prolonged use and/or use of the drug in high doses, systemic side effects may occur.

Use in pediatrics

Diclofenacol should not be used in children under 12 years of age without consulting a doctor.

Overdose

Low systemic absorption of the active components of the drug with external use makes overdose almost impossible. The possibility of overdose with accidental ingestion of high doses of the drug is not excluded.

Symptoms headache, dizziness, increased excitability, hyperventilation phenomena with increased convulsive readiness (in children – myoclonic convulsions), abdominal pain, nausea, vomiting, gastrointestinal bleeding, impaired liver and/or kidney function.

Treatment symptomatic.

Drug Interactions

Patients receiving NSAIDs or under clinical observation for any disease should consult a doctor before using Diclofenacol.

Diclofenac may enhance the effect of drugs that cause photosensitivity.

Clinically significant interaction with other drugs has not been described.

Storage Conditions

The drug should be stored out of the reach of children, in a dry, light-protected place at a temperature from 15°C (59°F) to 25°C (77°F); do not freeze.

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.