Cholagogic herbs – product information

OUTER LABELLING

CARDBOARD BOX.

Cholagogic herbs

Species cholagogae

Sachet composition:

Dandelion root (Taraxaci radix) – 0.616 g

Peppermint leaf (Menthae piperitae folium) – 0.660 g

Sandy everlasting inflorescence (Helichrysi inflorescentia) – 0.440 g

Yarrow herb (Millefolii herba) – 0.440 g

Frangula bark (Frangulae cortex) – 0.044 g

Herbs for brewing in sachets.

30 sachets, 2.2 g each                EAN UCC: 5909990021970

Indications for use:

Digestive symptoms (e.g. flatulence and belching) caused by bile secretion disorders.

Method of administration: Oral.

Posology: Adults and adolescents over 12 years: 1 sachet, pour a glass of boiling water and brew for 15 minutes. Drink a glass of freshly prepared infusion for digestive symptoms. For emergency treatment.

Contraindications:

Hypersensitivity to any of the ingredients, biliary atresia, cholelithiasis, empyema of the gallbladder, bowel obstruction, abdominal pain of unknown origin. Do not use in children under 12 years.

Warnings and precautions:

Not recommended for use longer than 7-10 days doctor's advice.

U osób ze skłonnością do nadkwaśności mogą występować dolegliwości żołądkowe związane z zawartością substancji gorzkich.

Interactions:

None observed.

Pregnancy and lactation:

Do not use 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:

None observed.

Dose omission:

Do not use double doses to supplement omitted doses.

Storage:

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

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: IL-5782/LN

Batch number:

Expiry date:

Do not use after expiry date.

Non-prescription medicinal product – OTC

Date of information approval: 2016.08.25