Angi sept dr. theiss

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ANGI SEPT DR. TAYSS

Composition:

Active ingredients: 2,4-dichlorobenzyl alcohol, menthol, anethole, peppermint oil;

One lozenge contains 1.2 mg of 2,4-dichlorobenzyl alcohol, 5.4 mg of menthol, 2.4 mg of anethole, 0.6 mg of peppermint oil;

Excipients:

Cherry-flavored lozenges: sucrose, glucose syrup (dry matter), purified water, anhydrous citric acid, cherry flavoring containing propylene glycol, natural cherry flavoring containing ethanol, beetroot powder, hibiscus flower extract;

Sea buckthorn-flavored lozenges: sucrose, glucose syrup (dry matter), purified water, anhydrous citric acid, sea buckthorn flavoring, gardenia extract containing propylene glycol, beetroot juice;

Sage-flavored lozenges: sucrose, glucose syrup (dry matter), purified water, anhydrous citric acid, ammonia sulfite caramel (E 150d), sage oil, eucalyptus oil;

Honey-flavored lozenges: sucrose, glucose syrup (dry matter), honey, purified water, linden flower flavoring containing propylene glycol, ammonia sulfite caramel (E 150d), gardenia extract containing propylene glycol;

Lemon-flavored lozenges: sucrose, glucose syrup (dry matter), purified water, anhydrous citric acid, lemon oil, lemon flavoring, lime flavoring containing butylhydroxyanisole ether, red orange flavoring, beta-carotene 1% (E 160a).

Pharmaceutical form. Lozenges.

Main physicochemical properties: cherry-flavored lozenges – round, flat, slightly concave, red in color, with characteristic odor and taste; sea buckthorn-flavored lozenges – round, flat, slightly concave, red-orange in color, with characteristic odor and taste; sage-flavored lozenges – round, flat, slightly concave, dark brown in color, with characteristic odor and taste; honey-flavored lozenges – round, flat, slightly concave, brown in color, with characteristic odor and taste; lemon-flavored lozenges – round, flat, slightly concave, yellow in color, with characteristic odor and taste.

Pharmacotherapeutic group. Preparations used in throat disorders. Antiseptics. ATC code RO2A A20.

Pharmacological properties.

Pharmacodynamics.

A combined antiseptic preparation used in infectious and inflammatory diseases of the oral cavity and pharynx. The main active component, 2,4-dichlorobenzyl alcohol, exerts an antiseptic effect. Peppermint oil, menthol, and anethole contained in the medicinal product reduce pain and exert antibacterial and anti-inflammatory effects.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

For local treatment of infectious-inflammatory diseases of the oral cavity and pharynx with symptoms such as sore throat, hoarseness, and difficulty swallowing.

Contraindications.

Hypersensitivity to the active substances, or to plants of the Apiaceae family containing anethole (fennel, cumin, celery, coriander, and dill), or to any of the excipients.

Do not use in children under 6 years of age.

Interaction with other medicinal products and other forms of interaction.

Unknown.

If simultaneous use with any other medicinal products is necessary, consult a physician.

Special precautions for use.

If symptoms worsen or persist for longer than 3–4 days of treatment, or if new symptoms appear (fever, sweating, weight loss), consult a physician.

In patients suffering from heartburn or hiatal hernia, the symptom may occasionally worsen after taking peppermint oil. In such cases, the use of the product should be discontinued.

Peppermint oil should be used with caution in inflammatory and ulcerative conditions of the gastrointestinal tract.

Diabetic patients should take into account that the product contains sucrose and glucose syrup.

Not recommended for patients with hereditary fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency.

If you have known sugar intolerances, consult your doctor before taking this medicinal product.

May be harmful to teeth.

Use during pregnancy or breastfeeding.

As there are no study data on use during pregnancy or breastfeeding, the product is not recommended during pregnancy or breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

Unknown.

Method of Administration and Dosage.

For adults and children aged 6 years and older: slowly dissolve 1 lozenge in the mouth every 2–3 hours, but no more than 6 lozenges per day. The duration of treatment is determined individually by a physician, but usually lasts 2–3 days. The medicinal product should not be used for longer than 2 weeks.

Children.

Do not use in children under 6 years of age.

Overdose.

In case of overdose, gastrointestinal disturbances may occur (feeling of stomach fullness, heartburn, epigastric pain, nausea, vomiting), diarrhea, rectal ulcer, epileptic seizures, loss of consciousness, apnea, cardiac arrhythmias, ataxia, and other reactions of the central nervous system, possibly due to the presence of menthol.

In case of overdose, gastric lavage is recommended. The patient should be monitored and symptomatic treatment administered if necessary.

Side effects.

Skin hypersensitivity reactions may occur, including rash, urticaria, swelling, or respiratory tract reactions, lip, tongue or throat swelling. Frequency is unknown.

Cases of contact allergy to menthol and peppermint oil have been reported in patients with intraoral symptoms associated with burning mouth syndrome, recurrent oral ulcers, or lichenoid reactions. Frequency is unknown.

Allergic reactions to menthol have been reported, including headache, bradycardia, muscle tremor, ataxia, anaphylactic shock, and erythematous skin rash. Frequency is unknown.

If any adverse reactions occur, discontinue use of the medicinal product immediately and consult a physician without delay.

Shelf life. 3 years.

Storage conditions. Store in the original packaging, out of reach of children, at a temperature not exceeding 25 °C.

Packaging. 12 lozenges with cherry/sea buckthorn/sage/honey/lemon flavor in a blister. 1 or 2 blisters per cardboard box.

Supply classification. Over-the-counter.

Manufacturer/Applicant.

Dr. Theiss Naturwaren GmbH.

Manufacturer's address and place of business.

Michelinstrasse 10, 66424 Homburg, Germany.