Ginkgo-Biloba Pharma Nord film-coated tablets

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

GINKGO BILOBA EXTRACT

Dostępny od:

Pharma Nord ApS

INN (International Nazwa):

GINKGO BILOBA EXTRACT

Dawkowanie:

.

Forma farmaceutyczna:

Film-coated tablet

Typ recepty:

Product not subject to medical prescription

Status autoryzacji:

Authorised

Data autoryzacji:

2018-03-16

Ulotka dla pacjenta

B. PACKAGE LEAFLET
PACKAGE LEAFLET : INFORMATION FOR THE USER
GINKGO-BILOBA PHARMA NORD® FILM-COATED TABLETS
_GINKGO DRY EXTRACT_
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
TRADITIONAL HERBAL MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
Always take this product exactly as described in this leaflet or as
your doctor, pharmacist or nurse
has told you.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
•
You must talk to a doctor if you do not feel better or if you feel
worse after 2 weeks.
WHAT IS IN THIS LEAFLET
1.
What Ginkgo-Biloba Pharma Nord is and what it is used for
2.
What you need to know before you take Ginkgo-Biloba Pharma Nord
3.
How to take Ginkgo-Biloba Pharma Nord
4.
Possible side effects
5.
How to store Ginkgo-Biloba Pharma Nord
6.
Contents of the pack and other information
1.
WHAT GINKGO-BILOBA PHARMA NORD IS AND WHAT IT IS USED FOR
Ginkgo-Biloba Pharma Nord is a traditional herbal medicine containing
an extract obtained from
leaves of the
_Ginkgo biloba_
tree.
It is used to relieve the symptoms of poor blood flow in conditions
such as cold hands and feet. This
is exclusively based on long-standing use. Prior to use, other serious
conditions should have been
ruled out by a medical doctor.
Ginkgo-Biloba Pharma Nord is for use in adults.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE GINKGO-BILOBA PHARMA NORD
DO NOT TAKE GINKGO-BILOBA PHARMA NORD
•
If you are allergic (hypersensitive) to Ginkgo biloba or any of the
other ingredients in this
product (listed in section 6).
•
If you are pregnant, may become pregnant or if you are breastfeeding
WARNINGS AND PRECAUTIONS
Before taking this product
•
Check with your doctor that your symptoms are not caused by any
serious underlying
condition.
•
Talk to your doctor or pharmacist if you have a cond

Charakterystyka produktu

Health Products Regulatory Authority
09 September 2022
CRN00CZQV
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ginkgo-Biloba Pharma Nord film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100 mg of extract (as dry extract, refined) from
_Ginkgo biloba _L., folium (Ginkgo leaf) (35-67:1),
corresponding to:
22.0-27.0 mg of flavonoids expressed as flavone glycosides
2.8-3.4 mg of ginkgolides A, B and C
2.6-3.2 mg of bilobalide.
First extraction solvent: acetone 60 % w/w
For full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Film coated tablet (tablet).
White, round (12 mm diameter), biconvex film coated tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
A traditional herbal medicinal product used to alleviate the symptoms
of poor blood flow in conditions such as cold hands and
feet. This is exclusively based on long-standing use. Prior to use,
other serious conditions should have been ruled out by a
medical doctor.
This product is indicated for use in adults and older people.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults: _One tablet to be taken twice daily, after food. Tablets
should be swallowed whole with a glass of water_. _
_Elderly: _No adjustment of dose is required for the treatment of
elderly patients.
_Children and Adolescents:_ This product is not indicated or
recommended for use in children or adolescents less than 18 years
old (see section 4.4).
Duration of use
If symptoms worsen or persist for more than 2 weeks, a qualified
healthcare professional (e.g. a doctor or a pharmacist) should
be consulted.
Health Products Regulatory Authority
09 September 2022
CRN00CZQV
Page 2 of 5
Method of administration
For oral use only.
4.3 CONTRAINDICATIONS
Hypersensitivity to Ginkgo preparations or to any of the excipients
listed in section 6.1
Pregnancy and Lactation (see section 4.6 ‘Fertility, pregnancy and
lactation’).
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The use in children and adolescents under 18 years