DR. THEISS'S OINTMENT WITH COMFREY

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT DR. THEISS COMFREY OINTMENT

Composition:

Active ingredients: comfrey tincture (Tinctura Symphyti e radix), tocopherol acetate (vitamin E);

100 g of ointment contains comfrey tincture (Tinctura Symphyti e radix) (1:5) 10 g (extractant: ethanol 65% v/v), tocopherol acetate (vitamin E) 1 g;

Excipients: lard, antioxidant Vitabland ATR-CA 50, corn oil, macrogol-30-dipolyhydroxystearate, pine needle fragrance, coloring agent – copper chlorophyllin complex (E 141).

Pharmaceutical form. Ointment.

Main physicochemical properties: smooth, light green mass with a characteristic odor.

Pharmacotherapeutic group. Topically used agents for joint and muscle pain. ATC code MO2A X10.

Pharmacological properties.

Pharmacodynamics.

The effect of the medicinal product is determined by the components included in its composition. The main active substances of comfrey root are allantoin, mucilage, and tannins. These provide anti-inflammatory and analgesic effects and promote bone callus formation. Allantoin regenerates the epithelium and reduces pain.

Vitamin E enhances the effect of allantoin, improves cellular nutrition, and protects cells from destruction.

Pharmacokinetics.

Pharmacokinetic studies have not been conducted.

Clinical characteristics.

Indications.

Joint, back, and lumbar pain associated with radiculitis, osteochondrosis, and arthritis. Sports- and household-related injuries such as contusions, tendon strains, and closed bone fractures. Dryness and superficial skin cracks.

Contraindications.

Hypersensitivity to the active substances or to any of the excipients of the medicinal product. The use of the drug is contraindicated in children and adolescents under 18 years of age due to lack of data on its application in this population.

Interaction with other medicinal products and other forms of interaction.

Not known.

If simultaneous use with any other medicinal products is required, medical advice should be sought.

Special precautions for use

To avoid the occurrence of adverse effects, a small amount of ointment should be applied to the skin in advance to determine individual sensitivity.

Do not apply to skin exhibiting allergic reactions, mucous membranes (including the nose), or the area around the eyes, or to damaged, irritated skin or open wounds. Do not use the product on the facial area and avoid contact of the ointment with the eyes. Apply exclusively to intact skin.

Macrogol-30-dipolyhydroxystearate may cause allergic reactions.

If symptoms persist or worsen during use of the medicinal product, consult a physician.

Use during pregnancy or breastfeeding

Safety during pregnancy or breastfeeding has not been established. Due to lack of sufficient data, this medicinal product is contraindicated during pregnancy or breastfeeding.

Ability to influence reaction rate when driving or operating machinery

Unknown.

Method of Administration and Dosage

For adults: Apply the ointment thinly 2–3 times daily to the affected painful areas.

The duration of treatment depends on the nature and course of the disease and should not exceed 10 days, and overall, 4–6 weeks per year.

Children

The use of the medicinal product in children and adolescents under 18 years of age is contraindicated.

Overdose

No cases of overdose have been reported.

Side effects.

Allergic reactions to the components of the medicinal product are possible (including itching, swelling, urticaria).

Shelf life. 2 years.

Shelf life after first opening – 6 months.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

20 g, 50 g, or 100 g in a glass jar. 1 jar in a cardboard box.

Availability. Over-the-counter.

Manufacturer/Applicant.

Dr. Theiss Naturwaren GmbH.

Manufacturer's address and location of business activity.

Michelinstrasse 10, 66424 Homburg, Germany.