EXTRACT SAGE WITH VITAMIN C DR. THEISS

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT EXTRAKT SHAVLIYI Z VITAMINOM C Dr. TAYSS

Composition:

Active substances: sage leaf extract, dry (Salvia officinalis) (3.4-4.6:1), sage oil, ascorbic acid (vitamin C);

1 tablet for sucking contains: dry sage leaf extract (Salvia officinalis) (3.4-4.6:1) – 50 mg, sage oil – 6 mg, ascorbic acid (vitamin C) – 20 mg;

Excipients: stabilizing additive (ascorbic acid), anhydrous citric acid, glucose syrup, sucrose, purified water.

Pharmaceutical form. Tablets for sucking.

Main physicochemical characteristics: round, light brown tablets with characteristic odour.

Pharmacotherapeutic group. Preparations used for throat disorders.

ATC code R02A A20.

Pharmacological properties.

Pharmacodynamics.

The main active ingredients – sage extract and sage oil – have pronounced anti-inflammatory, disinfectant, astringent, and expectorant effects.

Vitamin C helps boost immunity, which is important in cold-related illnesses.

Dr. Theiss Sage Extract with Vitamin C disinfects the oral cavity and nasopharynx, promotes expectoration, and supports rapid recovery in colds and infectious diseases of the upper respiratory tract accompanied by cough.

Clinical characteristics.

Indications.

As part of complex therapy for infectious and inflammatory diseases of the upper respiratory tract accompanied by cough; diseases of the mucous membranes of the oral cavity and pharynx: stomatitis, gingivitis, pharyngitis.

Contraindications.

Hypersensitivity to the components of the drug.

Interaction with other medicinal products and other forms of interaction.

Administration of sage preparations may affect the action of drugs acting via GABA receptors (barbiturates, benzodiazepines); therefore, concomitant use with such medicinal products is not recommended.

Absorption of ascorbic acid is reduced when used simultaneously with oral contraceptives, fruit or vegetable juices, and alkaline drinks.

Ascorbic acid, when administered orally, enhances the absorption of penicillin, tetracyclines, and iron; it increases the risk of developing crystalluria during salicylate treatment.

Special precautions for use.

The medicinal product contains sucrose and glucose syrup; therefore, it should not be used in patients with rare hereditary disorders such as fructose intolerance or sucrase-isomaltase deficiency. If you have been diagnosed with intolerance to certain sugars, consult your doctor before taking this medicinal product. The product may be harmful to teeth.

Advice for diabetic patients: 1 tablet contains 2.34 g of carbohydrates.

Since the product contains ascorbic acid, although in a small amount, it should be used with caution in patients with glucose-6-phosphate dehydrogenase deficiency, predisposition to thrombosis, thrombophlebitis, diabetes mellitus, or severe kidney disorders.

Due to the known neurotoxic effect of thujone present in sage, its daily intake should not exceed 5 mg. The thujone content in 1 tablet for oral administration ranges between 0.62–0.82 mg.

If symptoms worsen or persist during treatment for more than 7 days, or if new symptoms of unknown etiology occur (fever, sweating, weight loss), a doctor must be consulted immediately.

Use during pregnancy or breastfeeding.

There are insufficient studies on the use of this medicinal product during pregnancy or breastfeeding; therefore, the product is not recommended for use during these periods.

Ability to influence the speed of reactions while driving or operating machinery.

No effect on the ability to drive a vehicle or operate machinery is expected.

Dosage and Administration.

For adults and children aged 12 years and older: take 1 tablet 3–4 times daily, slowly dissolving it in the mouth.

The duration of treatment is determined by a physician depending on the nature and course of the disease. Sage preparations should not be used for longer than 2 weeks.

Children.

The medication is not recommended for children under 12 years of age.

Overdose.

There have been no reports of overdose. However, excessive use of sage-containing preparations may cause gastrointestinal disturbances.

Side effects.

Allergic reactions are possible, including skin rash, itching, urticaria, angioneurotic edema, and in some cases anaphylactic shock if sensitization is present.

Shelf life. 3 years.

Storage conditions. Store at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging. 12 effervescent tablets per blister; 1 or 2 blisters per cardboard box.

Availability. Over-the-counter.

Manufacturer/Marketing authorization holder.

Dr. Theiss Naturwaren GmbH.

Manufacturer's address and place of business.

Michelinstrasse 10, 66424 Homburg, Germany.