Bilomag

1. WHAT IS BILOMAG AND WHAT IS IT USED FOR

Bilomag is a traditional herbal medicine. One capsule contains 80 mg of dry refined and quantified extract of Ginkgo biloba leaves (Ginkgo extractum siccum raffinatum et quantificatum).

Indications for use of Bilomag:

• mild circulatory disorders in the limbs, manifested by a feeling of cold hands and feet,
• auxiliary in minor cognitive impairment associated with age.

Bilomag is a traditional herbal medicinal product, whose indications are based solely on long-term use.

2. IMPORTANT INFORMATION BEFORE TAKING BILOMAG

When not to take 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 medications (preventing blood clotting), such as heparin and its derivatives, coumarins (warfarin, acenocoumarol);
• if the patient has hemophilia. Ginkgo biloba extract may prolong blood clotting time.

Warnings and precautions

Before starting to take Bilomag, consult a doctor or pharmacist.

• It is not recommended to take Bilomag if: the patient has bleeding or blood clotting disorders, or if the patient is taking medications that prevent the formation of blood clots, such as aspirin, clopidogrel, dipyridamole, ticlopidine. Concurrent use may prolong blood clotting time.
• 36 hours before a planned surgical or dental procedure, it is necessary to discontinue Bilomag, as it may increase the risk of bleeding.
• It is not recommended to take Bilomag 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 and some other medicines may cause interactions. Interaction means that medicines taken at the same time may affect each other's action and/or side effects. Do not take Bilomag if you are being treated with anticoagulant medications, such as heparin and coumarins (warfarin, acenocoumarol). It is also not recommended to take Bilomag if you are taking any of the following medicines:

• Antiplatelet agents, such as clopidogrel, ticlopidine, acetylsalicylic acid (e.g. aspirin, polopirin), 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, known as proton pump inhibitors (used for hyperacidity and stomach and duodenal ulcers).
• Nifedipine (a heart and blood pressure lowering medicine).
• 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 can decide on the use of Bilomag with any of the above medicines. Remember that the above medicines may be known to the patient under a different name, usually a trade name. In this section, only the active substance or therapeutic group of the medicine is given, without the trade name. Always carefully check the packaging and information leaflet to know what the active substance or therapeutic group of the medicine is. In case of doubt, consult a doctor or pharmacist.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or plan to have a child, consult a doctor or pharmacist before taking this medicine. Do not take Bilomag during pregnancy and breastfeeding.

Driving and using machines

Bilomag may cause dizziness. The patient should not drive or operate machines until they know how Bilomag affects them.

Important information about some ingredients of Bilomag.

This medicine contains lactose monohydrate. One capsule contains 201.5 mg of lactose. If you have been diagnosed with intolerance to some sugars, consult your doctor before taking this medicine.

3. HOW TO TAKE BILOMAG

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor. In case of doubt, consult a doctor or pharmacist. Adults: Oral use. One capsule 1 to 2 times a day (from 80 mg to a maximum of 160 mg per day), during meals. Children and adolescents over 12 years of age: The medicine is not recommended for use in children and adolescents.

Taking a higher dose of Bilomag than recommended

If you have taken a dose of Bilomag higher than recommended, consult a doctor.

Missing a dose of Bilomag

Do not take a double dose to make up for a missed dose. Take the next dose at the right time.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Bilomag can cause side effects, although not everybody gets them. The frequency of side effects is defined as: rare (≥1/10,000 and <1>

There have been reports of cases of bilateral subdural hematoma, which was probably caused by long-term (up to two years) administration of Ginkgo biloba extract. This side effect may occur more frequently in patients who are taking antiplatelet or anticoagulant medications, such as acetylsalicylic acid or warfarin. Seizures may occur after administration of large doses of Ginkgo biloba extract, especially in patients with a history of seizures or taking other products that lower the seizure threshold. If any of the side effects worsen or any side effects not listed in the leaflet occur, inform your doctor or pharmacist. Note:Most of the available data concerns acetone-water extracts of Ginkgo biloba leaves, not ethanol-water extracts, like the extract in this product. However, due to the similarity in phytochemical composition, it is assumed that the same side effects may occur as with acetone-water extracts.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, inform your doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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: ndl@urpl.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE BILOMAG

Keep out of the sight and reach of children. Store in a temperature 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 given month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What Bilomag contains

Bilomag is a traditional herbal medicine. One capsule contains 80 mg of dry refined and quantified extract of Ginkgo biloba leaves (Ginkgo bilobaL., folium) DER (40-50:1), which corresponds to: 17.6-21.6 mg of flavonoids calculated 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 of the medicine are: lactose monohydrate, microcrystalline cellulose, silicified (microcrystalline cellulose and anhydrous colloidal silica), magnesium stearate, gelatin, quinoline yellow (E104), iron oxide yellow (E172), titanium dioxide.

What Bilomag looks like and what the pack contains

Bilomag is available in the form of yellow hard capsules. The hard capsules are packaged in PVC/PVDC/Aluminum blisters, in a cardboard box. The blisters contain 10 capsules. The cardboard box contains 20, 60, 90, or 120 capsules in the package. Not all pack sizes may be marketed.

Marketing authorization 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
To obtain more detailed information, contact the marketing authorization holder.

Date of last revision of the leaflet: