OUTER LABELLING
Birch leaf
Betulae folium
Herbs for brewing in sachets.
30 sachets, 3.0 g each
Ingredients:
Betulae folium (birch leaf) – 3.0 g
One sachet contains 3.0 g of birch leaf, containing at least 1.5% of flavonoids expressed as hyperoside.
Effect:
Diuretic.
Indications for use:
Mild inflammations of the urinary tract, to increase urine output.
Posology and method of administration:
1 sachet, pour a glass of water and slowly heat up to boiling point, do not boil. Leave while covered for 10-15 minutes. Drink fresh decoction 2-3 times a day.
Contraindications:
Edema caused by limited heart and kidney function. Hypersensitivity to birch and birch pollen.
Special warnings and precautions for use:
Due to lack of safety data, not recommended for use in children. In case symptoms worsen or persist after 2-3 weeks, consult a doctor.
Drug interactions and other interactions:
None observed.
Pregnancy and lactation:
Due to lack of safety data, not recommended during pregnancy and lactation.
Impact on ability to drive vehicles and operate machinery:
Unknown
Adverse effects:
Possible gastrointestinal symptoms (nausea, vomiting, diarrhea) and allergic reactions (itching, hives, rash).
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:
No data.
Storage:
Store closed in original box in max. 30 °C, keep away from children.
Do not use after expiry date.
Non-prescription medicinal product – OTC.
Marketing authorisation holder:
- Labofarm Sp. z o.o.
ul. Lubichowska 176 b
83-200 Starogard Gdański
tel. 058 561-20-08
fax 058 561-20-16
e-mail: poczta@labofarm.com.pl
Information date: 26.04.2016
Batch number:
Expiry date:
Marketing authorisation number: 12357
EAN UCC: 5909990618675
PL