OUTER LABELLING
(box)
Elder flower
Sambuci flos
Herbs for brewing in sachets
30 sachets, 2.5 g each
Effect:
Diaphoretic.
Indications for use:
Used to relieve early symptoms of the common cold.
Contraindications:
Hypersensitivity to elder flower.
Precautions for use:
Due to lack of relevant data, not recommended for use in children under 12 years. If symptoms persist, worsen during use or there occur shortness of breath, fever or purulent sputum, consult a doctor.
Drug interactions and other interactions:
None observed.
Special precautions:
Pregnancy and lactation:
Due to insufficient data, not recommended for use during pregnancy and lactation.
Impact on ability to drive vehicles and operate machinery:
No data.
Posology and method of administration:
1-2 sachets, pour a glass of water and slowly heat up to boiling point, do not boil. Leave covered for 10-15 minutes.
Adolescents over 12 years, adults, elderly patients: drink fresh decoction 3 times a day.
Do not use for longer than 1 week.
Overdose:
No data.
Dose omission:
Do not use double doses to supplement omitted doses.
For details regarding use, consult a doctor or pharmacist.
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.
Storage:
Store closed in max. 30° C, keep away from children.
Do not use after expiry date.
Composition:
Elder flower (Sambuci flos) – 2.5 g per sachet
Marketing authorisation holder:
- Labofarm Sp. z o.o.
ul. Lubichowska 176 b
83-200 Starogard Gd.
tel. 58 561 20 08
e-mail: poczta@labofarm.com.pl
Date of labelling approval: 26.04.2016
Non-prescription medicinal product – OTC
Marketing authorisation number: IL-6304/LN
EAN UCC 5909990022168
PL