OUTER LABELLING
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Equisetum stem
Equiseti herba
Herbs for brewing in sachets, 2.0 g per sachet
30 sachets, 2.0 g each
Effect:
Increases urine output.
Indications for use:
As an aid in mild urinary symptoms to increase urine output and to flush the urinary tract.
Contraindications:
Hypersensitivity to equisetum stem. Diseases requiring a reduction of fluid intake (e.g. severe heart or kidney disease).
Precautions for use:
Due to insufficient data, not recommended for children under 12 years.
If symptoms persist longer than 1 week of use, worsen or are accompanied by fecer, painful urination or bloody urine, consult a doctor.
Drug interactions and other interactions:
None observed.
Special precautions:
Pregnancy and lactation:
Due to insufficient data, not recommended during pregnancy and lactation.
Impact on ability to drive vehicles and operate machinery:
None observed.
Posology and method of administration:
1 sachet, pour a glass of boiling water. Brew while covered for 15 minutes.
Adolescents over 12 years, adults: drink fresh infusion 3 times a day.
Use for 2-4 weeks.
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:
Possible mild gastrointestinal symptoms and allergic reactions, e.g. rash. Frequency of occurrence is unknown.
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:
Equisetum stem (Equiseti herba) – 2.0 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-6308/LN
EAN UCC 5909990022199