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30 January 2024

Respiratory system – information

Sage leaf – product information

Summary of product characteristics

1. NAME OF MEDICINAL PRODUCT

Sage leaf, 1.5 g per sachet

Herbs for brewing in sachets.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each sachet contains 1.5 g of Salviae officinalis L., folium (sage leaf)

3. PHARMACEUTICAL FORM

Herbs for brewing in sachets.

4. CLINICAL PARTICULARS

Traditional herbal medicinal product with stated indications, derived solely from long-term use.

4.1. Indications for use

Traditionally for oral use:

for symptomatic treatment of mild digestive problems, such as heartburn and flatulence
for relieving excessive perspiration.

Traditionally for topical use:

for symptomatic treatment of inflammation of the oral and pharyngeal mucosa
for relieving mild inflammation of the skin.

4.2. Posology and method of administration

Infusion for oral use:

For digestive disorders: Adults – 1 sachet, pour a glass of boiling water (approx. 200 ml) and brew covered for 15 minutes. Drink fresh infusion 3 times a day.

For excessive perspiration: Adults – 1 sachet, pour half a glass of boiling water (approx. 100 ml) and brew covered for 15 minutes. Drink fresh infusion once a day.

Do not exceed recommended doses. Sage leaf products should not be used for longer than 2 weeks.

Infusion for topical use:

For excessive perspiration: Adults – 2 sachets, pour half a glass of boiling water (approx. 100 ml) and brew covered for 15 minutes.

For mouth and throat gargling: use a couple of times a day. Sage leaf products should not be used for longer than 1 week.

For poultices: use sterile gauzes soaked in infusion, apply to skin 2-4 times a day. Average duration of use is 2 weeks.

Method of administration:

Oral.

To oral mucosa.

To skin.

4.3. Contraindications:

Hypersensitivity to the active substance.

4.4. Special warnings and precautions for use

If symptoms do not subside, consult a doctor.

Children and adolescents:

Due to insufficient data, not recommended for children and adolescents under 18 years. Such use requires doctor's advice.

4.5 Drug interactions and other interactions

None observed.

Sage leaf product may affect the activity of GABAergic drugs (e.g. barbiturates, benzodiazepines), even in case of lack of clinical signs. Therefore, concomitant use is not recommended.

4.6. Impact on fertility, pregnancy and lactation

Safety of use during pregnancy and lactation has not been determined. Due to lack of data, such use is not recommended.

4.7. Impact on ability to drive vehicles and operate machinery

May affect the ability to drive vehicles and operate machinery. Not recommended up to 2 hours before driving vehicles during night hours or in case of fatigue.

4.8. Adverse effects

Unknown.

Reporting suspected adverse effects

After a medicinal product receives marketing authorisation, it is important to report suspected adverse effects. It allows for continuous monitoring of the medicinal product's risk-benefit ratio. Medical professionals should report all suspected adverse effects to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warszawa,
tel.: + 48 22 49-21-301, fax: +48 22 49-21-309, e-mail: ndl@urpl.gov.pl.

Adverse effects can also be reported to the marketing authorisation holder.

4.9. Overdose

A dose exceeding 15 g of sage leaf caused a warm sensation, tachycardia, dizziness and epileptic seizures.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamics

No pharmacodynamic studies have been conducted. Recommended for stated indications based on traditional use. Pharmacodynamic studies are not required for traditional herbal medicinal products.

5.2. Pharmacokinetics

No pharmacokinetic studies have been conducted. Pharmacokinetic studies are not required for traditional herbal medicinal products.

5.3. Preclinical safety data

Thujone is considered a neurotoxin, and low-thujone chemotypes of sage are preferred. Allowed daily dose of thujone is 5.0 mg per person, no longer than 2 weeks.

No reproductive toxicity, genotoxicity or carcinogenicity studies have been conducted.

6. PHARMACEUTICAL PARTICULARS

6.1. List of excipients

None.

6.2. Incompatibilities

No data.

6.3. Expiry date

1 year

6.4. Special precautions for storage

Store closed in max. 25° C, keep away from children.

6.5. Box type and contents

30 sachets, heat-sealed blotting paper, 1.5 g of herbs each, packaged in a cardboard box.