Patient leaflet - BIO-BILOBA FILM-COATED TABLETS
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 emo-tional 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 anti-inflammatory 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. Bio-Biloba 100 mg film-coated tablets
Extract from Ginkgo biloba
PACKAGE LEAFLET: INFORMATION FOR THE USER
4. Possible side effects
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 emergency ser-vices immediately. These could be symptoms of a severe allergic reaction.
Other side effects
- Bleeding such as bleeding in the eye, nose, brain or stomach has also been reported. If this occurs, consult your doctor immediately.
- Digestive symptoms (such as feeling or being sick, stomach ache, vomiting or diarrhoea).
- Headache, dizziness.
- Allergic skin reactions (such as red bumps on the skin, swelling of the skin, 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 health-care 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 informa-tion 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 house-hold 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
6500 Vojens
Denmark
Importer and Distributor
Pharma Nord (UK) Ltd
Telford Court
Morpeth
Northumberland
NE61 2DB
United Kingdom
THR no. 20243/0002
Sight or reading problems?
For a large print or audio version of this leaflet please contact Pharma Nord (UK) Ltd, Telford Court, Morpeth, Northumber-land, NE61 2DB, United Kingdom.
This leaflet was last revised 30/08/2024
I-6706-6