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BIO-BILOBA FILM-COATED TABLETS

Active substance(s): GINKGO BILOBA EXTRACT

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Bio-Biloba 100 mg film-coated tablets
Extract from Ginkgo biloba
Read all of this leaflet carefully before you start taking
this medicine because it contains important information for you.
• This medicine is available without prescription. However,
in order to get the best results you should take Bio-Biloba
exactly as described in this leaflet or as your doctor, qualified
healthcare practitioner or pharmacist has told you.
• Keep this leaflet. You may need to read it again.
• Ask your doctor, qualified healthcare practitioner or pharmacist if you need more information or advice.
• You must talk to a doctor or qualified healthcare practitioner
if your symptoms worsen, or do not improve after 2 weeks.
• If any of the side effects listed become serious, or you notice
any side effects not stated in this leaflet, please tell your
doctor, qualified healthcare practitioner or pharmacist.
What is in this leaflet
1. What Bio-Biloba is and what it is used for
2. What you need to know before you take Bio-Biloba
3. How to take Bio-Biloba
4. Possible side effects
5. How to store Bio-Biloba
6. Contents of the pack and other information
1. What Bio-Biloba is and what it is used for

Bio-Biloba is a traditional herbal medicinal product containing
an extract obtained from leaves of the Ginkgo biloba tree. It is
used to relieve symptoms of Raynaud’s syndrome and tinnitus.
This use is based on traditional use only.
What is Raynaud’s syndrome?
Raynaud’s syndrome has symptoms such as cold hands and
feet, and pain, tingling and numbness of the fingers and toes
which may turn white for short periods. These symptoms are
caused by interruptions in the blood supply to these areas,
commonly in response to a change in temperature or emotional stress.
What is Tinnitus?
Tinnitus is noise in the ears (hissing, ringing) which is not due
to an external sound source. Tinnitus has several causes,
some of which are unknown.
2. What you need to know before you take Bio-Biloba

Do not take Bio-Biloba if:
• You are allergic (hypersensitive) to Ginkgo biloba or any of
the other ingredients in this medicine (see section 6).
• You are under 18 years of age.
• You are pregnant or breast feeding.
• You have epilepsy or are taking medicines for epilepsy.
• You are taking efavirenz a medicine used in the treatment
of HIV.
Tell your doctor, qualified healthcare practitioner or
pharmacist before
taking this medicine if:
• You have been told by your doctor that you have a bleeding
disorder. This means you may bleed for longer than is normal.
• You are due to have an operation in the next 2 weeks since
preparations containing Ginkgo may increase bleeding.

If you take other medicines
Do not take this medicine before talking to your doctor,
qualified healthcare practitioner or pharmacist if you
are taking:
• Anticoagulant or antiplatelet medicines – used to thin your
blood and reduce the risk of getting a blood clot e.g. –
warfarin, acenocoumarol, phenindione, apixaban, edoxaban,
dabigatran, rivaroxban, dalteparin, enoxaparin, tinzaparin,
heparin or clopidogrel.
• Acetylsalicylic acid (aspirin) or other non steroidal antiinflammatory drugs (NSAIDs), used for pain relief.
• Nifedipine - used to treat high blood pressure, Raynaud’s
syndrome and prevent angina chest pain.
Tell your doctor, or pharmacist if you are taking, or have recently
taken, any other medicines. This includes medicines bought
without a prescription. This is because Bio-Biloba may affect
the way some medicines work.
Bio-Biloba and food
Bio-Biloba can be taken with food (see section 3).
Driving and using machines
This medicine may cause dizziness which may affect your
ability to drive or use machines. If you are affected, do not
drive or use machines.
3. How to take Bio-Biloba

Always take this medicine exactly as described in this leaflet
or as your doctor, or pharmacist has told you. Check with
your doctor, qualified healthcare practitioner or pharmacist
if you are not sure.
• Adults & elderly: 1 tablet twice daily after food. Do not take
more than the stated dose or the dose recommended by
your doctor, qualified healthcare practitioner or pharmacist.
• Tablets should be swallowed whole with a glass of water.
• For oral use only.
If you take more Bio-Biloba than you should
If you accidentally take too much of this medicine and feel
ill, talk to your doctor, qualified healthcare practitioner or
pharmacist. Have this leaflet at hand.
If you forget to take Bio-Biloba
Do not take a double dose to make up for a missed dose.
Take the next dose at the usual time. It does not matter if you
have missed a dose.
If you feel Bio-Biloba is not working
If your symptoms worsen, or have not improved after taking
this medicine for 2 weeks you should talk to your doctor or
qualified healthcare practitioner.
If you have any further questions about taking this medicine talk
to your doctor, qualified healthcare practitioner or pharmacist.

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Like all medicines, this medicine can cause side effects,
although not everybody gets them. The following side effects
can occur when using this product. The frequency of them
occurring is not known.
Serious side effects
If you experience sudden difficult breathing or swallowing,
swelling of your lips, tongue, throat, skin or body, or you feel
faint, stop taking this medicine and contact your doctor or
emergency services immediately. These could be symptoms
of a severe allergic reaction.
Other side effects
• Bleeding disorders (you bleed longer than normal).
• Digestive symptoms (such as feeling or being sick or diarrhoea).
• Headache, dizziness.
• Skin reactions (such as itching or rash). These are often
short-lived and should get better on their own. However if they
persist talk to your doctor, qualified healthcare practitioner
or pharmacist.
If you are concerned about any side effect or if you notice any
side effects not listed in this leaflet, tell your doctor, qualified
healthcare practitioner or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor, qualified healthcare practitioner or pharmacist. This includes any possible
side effects not listed in the package leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Bio-Biloba

• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated
on the packaging. The expiry date refers to the last day of
that month.
• Do not store above 25 °C. Keep the blisters in the outer
carton to protect from light.
• Do not use this medicine if you notice a change in colour of
the tablets. Tablets should be white in colour.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines
you no longer need. These measures will help protect the
environment.

6. Contents of the pack and other information

What Bio-Biloba contains
• The active ingredient in each tablet is 100 mg of extract
(as dry extract) from Ginkgo biloba L. leaf (DER 35-67:1).
Extraction solvent: acetone 60% w/w.
• Other ingredients in the tablet core are microcrystalline
cellulose, silica colloidal anhydrous, talc and magnesium
stearate. The film coating contains hypromellose, talc and
titanium dioxide (E171).
What Bio-Biloba looks like and contents of the pack
• Bio-Biloba is a round, biconvex, white, film-coated tablet.
• Bio-Biloba comes in blister packs of 60 or 150 film-coated
tablets. Not all pack sizes may be marketed.
Traditional Herbal Registration Holder and Manufacturer
Pharma Nord ApS
Tinglykke 4-6
DK-6500 Vojens
Denmark
Importer and Distributor
Pharma Nord (UK) Ltd
Telford Court
Morpeth
Northumberland
NE61 2DB
United Kingdom
THR no. 20243/0002
Certification Mark

4. Possible side effects

Sight or reading problems?
For a large print or audio version of this leaflet please contact
Pharma Nord (UK) Ltd, Telford Court, Morpeth, Northumberland, NE61 2DB, United Kingdom.
This leaflet was last revised 15/06/2017

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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