film-coated tablets
Leaf extract from Ginkgo biloba
1. What Bio-Biloba is and what it is used for
Traditional herbal medicine for the treatment of long-term symptoms in the elderly, such as memory problems, difficulty concentrating, dizziness, tinnitus and feeling tired, after a doctor has determined that there is no other serious illness.
The indications for a traditional herbal medicine are based solely on experience with long-term use.
2. What you need to know before using Bio-Biloba
Do not use Bio-Biloba
- if you are allergic (hypersensitive) to Ginkgo biloba or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
- If you are taking medicines that affect the tendency to bleed (eg anticoagulantsand acetylsalicylic acid ), talk to your doctor before using Bio-Biloba.
- You should stop using Bio-Biloba 14 days before your scheduled surgery.
- If you are being treated with antiepileptic drugs , the treatment effect of this medicine may be impaired. Therefore, consult your doctor before using Bio-Biloba.
- If your symptoms worsen, consult your doctor.
Other medicines and Bio-Biloba
If you are being treated with warfarin and starting, stopping or changing treatment with Bio-Biloba, the effect of warfarin should be monitored . Caution is also recommended when combining Bio-Biloba and dabigatran etexilate.
Concomitant administration of Ginkgo biloba and nifedipine should be performed with caution as the combination may cause dizziness and increased discomfort from hot flashes.
It is possible that the effect of birth control pills may decrease with the concomitant use of Ginkgo biloba.
In case of contact with a doctor or other healthcare professional, remember to tell them that you are taking or have recently taken this over-the-counter medicine. It is especially important for you who are taking a medicine where it is important that you have a stable level in the blood.
Pregnancy and breastfeeding
In the absence of adequate data, Bio-Biloba should not be used by pregnant or lactating women.
Driving and using machines
Bio-Biloba has no or negligible effect on the ability to drive and use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and / or side effects . Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or other healthcare professional.
3. How to use Bio-Biloba
Always use this medicine exactly as described in this leaflet. If you are not sure, talk to your doctor or other healthcare professional.
The recommended dose is:
Elderly: 1 tablet 1-2 times daily.
Use for children
Bio-Biloba should not be used by children.
If you forget to take Bio-Biloba
Do not take a double dose to make up for a forgotten dose.
4. Possible side effects
Like all medicines, Bio-Biloba can cause side effects , although not everybody gets them.
Side effects are in the blood and lymphatic system
- Increased bleeding tendency
Side effect is in the heart
- Palpitations and irregular heartbeat
Side effect is in the central nervous system
- Restlessness
- Sleep disorders
- Headache
- Dizziness
Side effect is in the gastrointestinal tract
- Nausea
- Vomiting
- Diarrhea
Side effects are in the skin and underlying tissue .
- Rash
- Itching
- Hives
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Bio-Biloba
Do not store above 30 ° C.
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton after EXP .: and on blisters after EXP .: The expiry date (EXP.) Is the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
The active substance in 1 film-coated tablet is 105 mg extract of Ginkgo biloba L., leaf (ginkgo), equivalent to:
22 – 27 mg flavonoids as flavone glycosides
2.8 – 3.4 mg ginkgolide A, B and C
2.6 – 3.2 mg bilobalid
and contains less than 0.5 micrograms of ginkgo acids.
When manufacturing a tablet, approx. 3 – 4 grams of dried ginkgo leaves.
The other ingredients are: microcrystalline cellulose, talc, hypromellose, titanium dioxide (E171), colloidal anhydrous silica, magnesium stearate.
What the medicine looks like and the contents of the pack
White, film-coated, round, biconvex tablet (12 mm).
Packs of 60 or 150 tablets.
Not all pack sizes may be marketed.
Holder of registration for sale and manufacturer
Pharma Nord ApS
Think 4 – 6
DK-6500 Vojens
Denmark
Local representative:
Pharma Hus AB
Gunnebogatan 28
S-163 53 Spånga