OUTER LABELLING
CARDBOARD BOX
Bearberry leaf
Uvae ursi folium
Sachet composition:
Bearberry leaf (Uvae ursi folium) – 2.5 g
Herbs for brewing in sachets
30 sachets, 2.5 g each EAN UCC: 5909990022182
Indications for use:
For mild urinary infections as an antiseptic.
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. Drink fresh decoction once a day.
Contraindications:
Hypersensitivity to bearberry leaf. Not recommended in case of kidney disease, irritable bowel syndrome nor for children under 12 years. Do not exceed the recommended daily dose of 1 sachet.
Warnings and precautions:
If symptoms worsen or do not subside, consult a doctor.
Interactions:
Bearberry leaf products should not be used concomitantly with urinary acidifying agents.
Pregnancy and lactation:
Do not use during pregnancy and lactation.
Impact on ability to drive vehicles and operate machinery:
None.
Adverse effects:
Patients with sensitive stomaches and children may experience nausea and vomiting.
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. 30 °C keep away from children. Protect from light, moisture and foreign odors. 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-6306/LN
Batch number:
Expiry date:
Do not use after expiry date.
Non-prescription medicinal product – OTC
Date of information approval: 2016.08.25
PL