Metabolism-boosting herbs (anti-acne herbs) – product information

OUTER LABELLING

CARDBOARD BOX

Metabolism-boosting herbs (anti-acne herbs)

Species metabolicae

Sachet composition:

Couch grass rhizome (Graminis rhizoma) – 0.60 g

Wild pansy herb (Violae tricoloris herba) – 0.40 g

Chicory root (Cichorii radix) – 0.40 g

Nettle leaf (Urticae folium) – 0.34 g

Bean pericarp (Phaseoli pericarpium) – 0.20 g

Rhubarb root (Rhei radix) – 0.06 g

Herbs for brewing in sachets, 2 g per sachet

30 sachets, 2.0 g each                 EAN UCC: 5909990728749

Indications for use:

A diuretic used as an aid for adolescent acne.

Method of administration: Oral.

Posology: Adults and adolescents over 12 years:

1 sachet, pour a glass of water and slowly heat up to boiling point, do not boil. Leave covered for 10-15 minutes. Drink fresh decoction 2 times a day.

Contraindications:

Hypersensitivity to any of the ingredients, inflammation of the colon, kidneys, appendicitis.

Warnings and precautions:

Due to rhubarb root content, not recommended to exceed daily dose, use for longer than 7-10 day or use in children under 12 years. If symptoms worsen or persist, consult a doctor.

Interactions:

None observed.

Pregnancy and lactation:

Due to rhubarb root content, not recommended during pregnancy and lactation.

Impact on ability to drive vehicles and operate machinery:

None.

Adverse effects:

None observed.

Reporting adverse effects:

In case of any adverse effect, including those not stated on the packaging, notify a doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Adverse Drug Reaction Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warszawa, tel.: 22 49-21-301,
fax: 22 49-21-309, e-mail: ndl@urpl.gov.pl.

Adverse effects can also be reported to the marketing authorisation holder. Reporting adverse effects allows for more safety information to be gathered on a medicinal product.

Overdose:

May cause a laxative effect.

Dose omission:

Do not use double doses to supplement omitted doses.

Storage:

Przechowywać w zamkniętych opakowaniach, w temperaturze do 30°C. Lek przechowywać w miejscu niewidocznym i niedostępnym dla dzieci.

Marketing authorisation holder:

- Labofarm Sp. z o.o.

ul. Lubichowska 176 b

83-200 Starogard Gdański

tel. 58 561 20 08

e-mail: poczta@labofarm.com.pl

Marketing authorisation number: 15963

Batch number:

Expiry date:

Do not use after expiry date.

Non-prescription medicinal product – OTC

Date of information approval: 2016.08.25