Calendula ungventum (Ointment) Instructions for Use

ATC Code

D11A (Other dermatological preparations)

Active Substance

Calendulae flos (DAB German Pharmacopoeia)

Clinical-Pharmacological Group

Herbal preparation with anti-inflammatory and tissue regeneration improving action for external use

Pharmacotherapeutic Group

Antiseptic and anti-inflammatory agent of plant origin

Pharmacological Action

A herbal preparation. It exerts an antiseptic and local anti-inflammatory action.

It contains triterpene saponins – glycosides A-F; triterpene alcohols – monools, diols, triols; flavonoids, including isorhamnetin and quercetin glycosides; hydroxycoumarins, including scopoletin, umbelliferone, esculetin; carotenoids – lutein, zeaxanthin; essential oils – alpha-cadinol, T-cadinol, fatty acids; water-soluble polysaccharides – rhamnoarabinogalactans, arabinogalactans. It has an anti-inflammatory effect and reduces capillary permeability. Due to the presence of terpene alkaloids, lactone, and flavones, it exhibits antimicrobial activity.

Indications

• Minor skin injuries such as small cuts, scrapes, and abrasions.
• Superficial burns, including those caused by sun exposure.
• Insect bites for symptomatic relief of local skin irritation.

ICD codes

Dosage Regimen

Apply the ointment 2 to 3 times daily directly onto the affected skin areas. Use a thin layer and gently rub it in.

Ensure the skin is clean and dry before each application. This product is for external use only. Do not use on large areas of the body or under occlusive dressings unless directed by a physician.

Adverse Reactions

Local allergic skin reactions are possible, including redness, swelling, rash, itching, and urticaria. Contact dermatitis at the site of application may occur rarely.

Discontinue use immediately and consult a physician if any signs of a hypersensitivity reaction develop, such as severe itching, spreading rash, or angioedema.

Drug Interactions

No specific drug interactions are currently known for topical application. The potential for interaction with other topically applied medicinal products exists.

Avoid concurrent use with other topical preparations on the same area of skin to prevent incompatibility. Inform your physician about all medications you are using.

Contraindications

• Hypersensitivity to Calendula officinalis or any of the excipients in the ointment base.
• Known allergy to plants of the Asteraceae/Compositae family (e.g., arnica, chamomile, ragweed, tansy, wormwood, aster, chrysanthemum).
• Application to deep or infected wounds and severe burns requiring medical attention.

Overdose

Overdose from topical application is unlikely due to minimal systemic absorption. Excessive application may increase the risk of local adverse reactions.

In case of accidental ingestion, seek medical attention. Symptoms may include gastrointestinal discomfort. Treatment should be symptomatic and supportive.

Use in Pregnancy and Lactation

If use during pregnancy and breastfeeding is necessary, the expected benefit for the mother and the potential risk to the fetus or child should be considered.

Use in Hepatic Impairment

Use with caution for oral administration in liver diseases.

Pediatric Use

Oral administration is contraindicated in children and adolescents under 12 years of age.

Geriatric Use

The drug is approved for use in elderly patients.

Special Precautions

Avoid contact of this product with the eyes.

If a secondary infection occurs during treatment, antibacterial or antifungal therapy as prescribed by a doctor may be required.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

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.