Bilomag

Patient Information Leaflet

Bilomag, 80 mg, hard capsules
Ginkgonis extractum siccum raffinatum et quantificatum
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed
by your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your doctor or pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If symptoms worsen or do not improve after 3 months of treatment, consult your doctor.

Table of Contents

1. What Bilomag is and what it is used for
2. Important information before taking Bilomag
3. How to take Bilomag
4. Possible side effects
5. How to store Bilomag
6. Contents of the pack and other information

1. WHAT BILOMAG IS AND WHAT IT IS USED FOR

Bilomag is a traditional herbal medicinal product. One capsule contains 80 mg of dried, purified and quantified extract of leaves of Ginkgo biloba (Ginkgonis extractum siccum raffinatum et quantificatum).
Indications for Bilomag:

• for mild circulatory disorders in the limbs, manifested by cold hands and feet,
• as an adjunctive treatment in mild age-related decline in cognitive function.

Bilomag is a traditional herbal medicinal product, the indications of which are based solely on long-standing use.

2. IMPORTANT INFORMATION BEFORE USING BILOMAG

When not to use Bilomag:

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
• if the patient is being treated with anticoagulant medicines (preventing blood clotting), such as heparin and its derivatives, coumarins (warfarin, acenocoumarol);
• if the patient has haemophilia. Ginkgo biloba extract may prolong blood clotting time.

Warnings and precautions
Before starting to take Bilomag, discuss it with your doctor or pharmacist.

• Use of Bilomag is not recommended if: the patient has bleeding disorders or coagulation disorders, or if: the patient is taking drugs preventing thrombus formation, such as aspirin, clopidogrel, dipyridamole, ticlopidine. Concurrent use may prolong blood clotting time.
• Bilomag must be discontinued 36 hours before any planned surgical or dental procedure, as it may increase the risk of bleeding.
• Use of Bilomag is not recommended during pregnancy and breastfeeding.
• Bilomag is not recommended for use in children and adolescents over 12 years of age.

Bilomag and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Taking Bilomag together with certain other medicines may lead to interactions. An interaction means that medicines taken at the same time may affect each other's action and/or side effects.
Do not use Bilomag in patients treated with anticoagulant medicines such as heparin and coumarins (warfarin, acenocoumarol).
Use of Bilomag is also not recommended when taking any of the following medicines:

• Antiplatelet drugs, such as clopidogrel, ticlopidine, acetylsalicylic acid (e.g. aspirin, polopiryna), dipyridamole.
• Herbal medicines that may increase the risk of bleeding, containing garlic (Allium sativum L.) or ginseng (Panax ginseng C.A. Meyer).
• Trazodone (an antidepressant).
• Omeprazole and other medicines in this group, so-called proton pump inhibitors (used in hyperacidity and peptic ulcer disease of the stomach and duodenum).
• Nifedipine (a cardiac medicine and antihypertensive agent).
• Diuretics from the thiazide group (e.g. hydrochlorothiazide).
• Tipranavir (a non-peptidic protease inhibitor indicated for combination antiretroviral treatment of HIV-1 infection).

Only a doctor may decide on the use of Bilomag together with any of the listed medicines.
Please remember that the above medicines may be known to the patient under another name, usually a brand name. In this section, only the active substance or therapeutic group of the medicine is provided, without mentioning brand names. Always carefully check the packaging and patient information leaflet to know the active substance or therapeutic group of the medicine currently being used.
If in doubt, consult your doctor or pharmacist.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Do not use Bilomag during pregnancy and breastfeeding.

Driving and operating machinery
Bilomag may cause dizziness. The patient should not drive or operate machinery until he or she knows how Bilomag affects him or her individually.

Important information about some ingredients of Bilomag
This medicine contains monohydrate lactose. One capsule contains 201.5 mg of lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact their doctor before taking this medicine.

3. HOW TO USE THE MEDICINAL PRODUCT BILOMAG

This medicine should always be taken exactly as described in this patient information leaflet, or as directed by a physician.
If in doubt, consult a doctor or pharmacist.
Adults:
Oral use.
One capsule 1 to 2 times daily (80 mg to a maximum of 160 mg per day), during meals.
Children and adolescents above 12 years of age:
The medicinal product Bilomag is not recommended for use in children and adolescents.
Use of a higher than recommended dose of Bilomag
If a patient has taken a dose higher than recommended, medical advice should be sought from a doctor.
Missed dose of Bilomag
Do not take a double dose to make up for a missed dose. Take the next dose at the scheduled time.

4. POSSIBLE ADVERSE REACTIONS

Like any medicine, this medicine can cause adverse reactions, although not everybody gets them.
The frequency of occurrence is defined as follows: rare (≥1/10,000 and <1/1,000), very rare (<1/10,000).
Oral administration of Japanese sophora extract at recommended doses is usually well tolerated.

Bilateral subdural hematomas have been reported in the literature, presumably due to long-term (up to two years) use of Ginkgo biloba extract. This adverse effect may occur more frequently in patients concurrently using antiplatelet agents or anticoagulant drugs, such as acetylsalicylic acid or warfarin.

Seizures may occur after administration of high doses of Ginkgo biloba extract, especially in patients with a history of seizures or those taking other products that lower the seizure threshold.

If any adverse reactions worsen or if any adverse reactions not listed in the leaflet occur, a doctor or pharmacist should be consulted immediately.

Note: Most of the available data refer to acetone-water extracts of Ginkgo biloba leaves, rather than ethanol-water extracts such as the extract contained in this product. However, due to similarities in phytochemical composition, it is considered possible that the same adverse reactions may occur as with acetone-water extracts.

Reporting of adverse reactions

If any adverse reactions occur, including those not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: [email protected]

Adverse reactions can also be reported to the marketing authorization holder.

Reporting adverse reactions enables continuous monitoring of the safety of the medicinal product and helps to gather additional information on its safe use.

5. HOW TO STORE THE MEDICINAL PRODUCT BILOMAG

Keep the medicine out of the reach and sight of children.
Store below 25 ºC.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Bilomag contains
Bilomag is a traditional herbal medicinal product.
Each capsule contains 80 mg of purified, quantified dry extract from leaves of Ginkgo biloba ( Ginkgo biloba L., folium) DER (40-50:1), corresponding to:
17.6–21.6 mg of flavonoids expressed as flavonoid glycosides,
2.2–2.7 mg of ginkgolides A, B and C,
2.1–2.6 mg of bilobalide.
Extraction solvent: ethanol 50% (V/V)
Other ingredients are: monohydrate lactose, microcrystalline cellulose, siliconized (microcrystalline cellulose and colloidal anhydrous silica), magnesium stearate, quinoline yellow (E104), yellow iron oxide (E172), titanium dioxide.

What Bilomag looks like and contents of the pack
Bilomag is available as yellow hard capsules.
Hard capsules are packed in PVC/PVDC/Aluminium blisters, placed in a cardboard box.
Each blister contains 10 capsules.
The cardboard box contains 20, 60, 90 or 120 capsules per package. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
(NP Pharma logo)
Natur Produkt Pharma Sp. z o.o.
ul. Podstoczysko 30
07-300 Ostrów Mazowiecka
Tel. +48 29 644 29 00
Fax. +48 29 745 39 95
For further information, please contact the Marketing Authorisation Holder.