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Maximum allowed state defined price ( from ZVA webpage) Euro: | | Recheck |
Reģ. Nr.: 00-0264
Vendor, principal: Pharma Nord. No prescription needed/Patient care products, dressings, gloves, medical devices,...
* This table was compiled fully automatically, independently from any advertisers, transparently and without any modification relaying the open offers available on the mentioned dates. . BIO-BILOBA 100MG N60
Package leaflet: Information for the userBIO-BILOBA 100 mg film-coated tablets
Refined and quantified dry extract of maidenhair tree
Read all of this leaflet carefully before use because it contains important information for you
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist 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 or pharmacist. 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 3 months.
What is in this leaflet
1. What Bio-Biloba is and what it is used for
2. What you need to know before you use Bio-Biloba
3. How to use 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 indicated for treating functional brain activity disorders in elderly patients. As a supplementary medicine in case of arterial blood supply disorders of the limbs.
2. What you need to know before you use Bio-Biloba Do not use Bio-Biloba:
- if you are allergic to any of the other ingredients of this medicine (listed in section 6);
- if you are pregnant.
Warnings and precautions
Before starting treatment with Bio-Biloba, ensure that the symptoms are not caused by an earlier disease that would necessitate specific treatment.
Before a surgery, tell your doctor if you are using Bio-Biloba tablets.
If you have a predilection for bleeding or if you use medicines inhibiting the coagulation of blood (anticoagulants) or thrombocyte aggregation (acetylsalicylic acid or other non-steroidal anti-inflammatory drugs), only use Bio-Biloba tablets after talking to your doctor.
Do not take larger than recommended doses.
Children
Not recommended for use in children under the age of 12 due to insufficient data.
Other medicines and Bio-Biloba
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Bio-Biloba can increase the activity of anticoagulants (medicines reducing blood coagulation).
Using Bio-Biloba tablets is not recommended if you regularly take medicines that inhibit the coagulation of blood (anticoagulants) or thrombocyte aggregation (acetylsalicylic acid or other non-steroidal anti-inflammatory drugs).
Concomitant use of these medicines can increase the risk of bleeding.
Talk to your doctor before starting treatment with Bio-Biloba tablets if you are taking antiepileptics, efavirens (an antiviral agent), cyclosporine, dabigatrane, nifedipine, talinolol, atorvastatin, omeprasol, tolbutamide.
Talk to your doctor before using Bio-Biloba if you are taking any other medicines.
Pregnancy and breast-feeding
Using this medicine during pregnancy is contraindicated.
Using this medicine during breast-feeding is not recommended due to insufficient data.
Talk to your doctor or pharmacist before using any medicines.
Driving and using machines
Bio-Biloba has no influence on the ability to drive and use machines.
3. How to use Bio-Biloba
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is 1-2 tablets (100-200 mg) per day during or after a meal, taken with a sufficient quantity of liquids. The tablets should be swallowed whole.
The treatment must last for at least 8 weeks.
If the symptoms have not disappeared after 3 months or if the symptoms are exacerbated, your doctor must evaluate whether the continuation of the treatment is justified.
Use in children
Bio-Biloba is not recommended for use in children under the age of 12 without first talking to a doctor.
If you take more Bio-Biloba than you should
If you have taken more Bio-Biloba 100 mg tablets than you should have and are feeling nauseous as a result, talk to your doctor or pharmacist or go to a hospital. Be sure to bring the package of the medicine.
If you forget to use Bio-Biloba
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of the possible side effects listed below is classified as follows:
very common (occurs in more than 1 person in 10)
common (occurs in 1 to 10 persons in 100)
uncommon (occurs in 1 to 10 persons in 1,000)
rare (occurs in 1 to 10 persons in 10,000)
very rare (occurs in less than 1 person in 10,000)
unknown (incidence cannot be estimated from available data)
Very common side effects: - Headache
Common side effects:
- Stomach pain, nausea, vomiting, diarrhoea, dry mouth -_ Dizziness
Uncommon side effects:
- Restlessness, sleep problems
Rare side effects
- Increased risk of bleeding
Very rare side effects
- Tachycardia, heart rhythm disorder
- Hives
- Weakness
Unknown (incidence cannot be estimated from available data)
- There have been reports of ocular, nasal, cerebral and gastrointestinal bleeding.
- Hypersensitivity reactions (allergic shock) may occur.
- Allergic skin reactions (redness, swelling, itchiness and rash).
Reporting of side effects
If you get any side effects, talk to a doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee . By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Bio-Biloba
Do not store at a temperature higher than 30 °C.
Do not use this medicine after the expiry date which is stated on the blister and external package. The expiry date refers to the last day of that month.
Keep this medicine out of the sight and reach of children.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information What Bio-Biloba 100 mg contains
Active substance: One film-coated tablet (433 mg) contains 100 mg of refined and quantified dry extract of maidenhead tree, corresponding to:
22-27 mg of flavonoids in the form of flavonglycosides 2.8-3.4 mg of gincolides A, B, and C 2.6-3.2 mg of bilobalides.
Extraction medium: 60-65% acetone (m/m).
Other ingredients: microcrystalline cellulose (E460), talc (E553b), anhydrous colloidal silica (E551), magnesium stearate (E470b), hypromellose (E464), titanium dioxide (E171).
What Bio-Biloba 100 mg tablets look like
Bio-Biloba 100 mg tablets are round white biconvex coated tablets. Pack size: 30 or 60 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Pharma Nord ApS Tinglykke 4-6 DK-6500 Vojens Denmark
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Pharma Nord Eesti OÜ Uus-Sadama 21 Tallinn 10120 Phone: +372 646 10 30 E-mail: [email protected]
This leaflet was last revised in September 2017
Instruction, annotation source for medicine: State Agency of Medicines, Estonia • Medicaments images are for illustrative purposes only and may differ from the actual product.
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DDD. Information source: WHO Collaborating Centre for Drug Statistics Methodology. Norwegian Institute of Public Health
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