OUTER LABELLING
CARDBOARD BOX
Fennel fruit
Foeniculi fructus
Sachet composition:
Foeniculi fructus (fennel fruit) – 2.0 g
Herbs for brewing in sachets, 2.0 g per sachet
30 sachets, 2.0 g each EAN UCC: 5909990022175
Method of administration: Oral.
Indications for use:
Traditional medicine used in mild spasmodic digestive symptoms, such as flatulence and passing wind.
Posology: 1 sachet, pour a glass of boiling water and brew while covered for 15 minutes. Adults and adolescents over 12 years: drink 1 glass of fresh infusion 3 times a day. Children from 4 to 12 years: half a glass of fresh infusion 3 times a day, only for mild, temporary symptoms.
Contraindications:
Hypersensitivity to fennel fruit or other plants (aniseed, caraway, celery, coriander, dill) from the umbelliferous family (Apiaceae/Umbelliferae) or to anethole.
Warnings and precautions:
Not recommended for children under 4 years, due to lack of data.
Interactions:
None observed.
Pregnancy and lactation:
No available data on fennel fruit use during pregnancy. It is unknown whether fennel fruit components are absorbed into breast milk. Due to insufficient data, the product is not recommended for use during pregnancy and lactation.
Impact on ability to drive vehicles and operate machinery:
None.
Adverse effects:
Fennel can cause rare allergic reactions affecting skin and respiratory system (≥1/10 000 to <1/1000).
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-6305/LN
Batch number:
Expiry date:
Do not use after expiry date.
Non-prescription medicinal product – OTC
Date of information approval: 24.11.2016
PL