Bilobil Intense

Leaflet attached to the packaging: information for the user

Bilobil intense, 120 mg, hard capsules

Ginkgo biloba extract, dry, purified and quantified

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 12 weeks there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

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

1. What is Bilobil intense and what is it used for

Bilobil intense contains a dry, purified and quantified extract of Ginkgo biloba leaves.
Bilobil intense is a herbal medicine used to improve cognitive function (related to age) in elderly people and to improve the quality of life in mild dementia.

2. Important information before taking Bilobil intense

When not to take Bilobil intense

• if the patient is allergic to Ginkgo biloba extract or any of the other ingredients of this medicine (listed in section 6);
• if the patient is pregnant.

Warnings and precautions

Before starting treatment with Bilobil intense, the patient should discuss it with their doctor or pharmacist.
If the patient has an increased tendency to bleeding (haemorrhagic diathesis) or is taking anticoagulant medicines, they should contact their doctor before taking this medicine.
Before surgery, the patient should inform their doctor about taking Bilobil intense. It is recommended to stop taking Bilobil intense at least 3-4 days before the planned surgical procedure.
Patient with epilepsy should consult their doctor before starting treatment with Bilobil intense, as taking products containing Ginkgo biloba extract may cause further seizures.
It is not recommended to take Bilobil intense with efavirenz (a medicine used to treat HIV infection), as the effect of efavirenz may be reduced.

Children and adolescents

There are no indications for the use of Bilobil intense in children and adolescents. This medicine should not be used in this age group.

Bilobil intense and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
If Bilobil intense is taken with medicines that prevent blood clotting (such as antiplatelet agents, coumarin, clopidogrel, acetylsalicylic acid and other non-steroidal anti-inflammatory drugs), it may affect their action.
If the patient is taking warfarin, a medicine used to prevent blood clotting, the doctor may recommend monitoring the patient during treatment, especially in case of dose changes or product changes, as well as when starting or stopping Bilobil intense.
Taking Bilobil intense with dabigatran, a medicine used to prevent blood clotting, may increase its effect. The patient should consult their doctor before starting treatment.
When taking Bilobil intense with nifedipine, a medicine used to treat certain heart disorders and hypertension, its effect may be increased, which may lead to dizziness or increased heart rate. In such cases, the patient should contact their doctor.
It is not recommended to take Bilobil intense with efavirenz (a medicine used to treat HIV infection), as the effect of efavirenz may be reduced.

Taking Bilobil intense with food and drink

Bilobil intense can be taken with or without food.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Data on the safety of use during pregnancy are insufficient, and there may be an increased risk of bleeding. Therefore, this medicine is contraindicated in pregnant women (see section 2 "When not to take Bilobil intense").
Due to the lack of sufficient data on safety, this medicine is not recommended during breastfeeding.

Driving and using machines

There are no data on the effect on the ability to drive and use machines.

Bilobil intense contains lactose monohydrate and glucose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.
One hard capsule contains 198 mg of lactose monohydrate and 6 mg of glucose. If the patient takes the medicine as recommended, they will take 198 mg of lactose monohydrate and 6 mg of glucose each time.

3. How to take Bilobil intense

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
The recommended dose for adults and the elderly is 1 capsule (120 mg) twice a day.
Do not exceed the maximum daily dose of 240 mg, i.e. 2 capsules.
The capsule should be swallowed with water.
Duration of treatment
Bilobil intense should be taken for at least 8 weeks.
If after 3 months of treatment there is no improvement or the symptoms have worsened, the patient should consult their doctor to determine whether continuation of treatment is justified.

Use in children and adolescents

This medicine should not be used in children and adolescents.

Overdose of Bilobil intense

In case of overdose, the patient should consult their doctor or pharmacist. There are no reports of symptoms of overdose of Ginkgo biloba extract.

Missed dose of Bilobil intense

The patient should not take a double dose to make up for a missed dose.
The patient should take the missed dose as soon as possible, unless it is almost time for the next dose. In this case, the patient should not take the missed dose.
In case of further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

Stopping treatment with Bilobil intense

The patient should inform their doctor or pharmacist about stopping treatment with Bilobil intense.
In case of further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Bilobil intense can cause side effects, although not everybody gets them.
Very common (more than 1 in 10 people):

• headache.

Common (between 1 and 10 people in 100):

• dizziness,
• diarrhoea, abdominal pain, nausea, vomiting.

Frequency not known (cannot be estimated from the available data):

• allergic skin reactions (oedema, erythema, pruritus and rash),
• allergic reactions (anaphylactic shock),
• bleeding from individual organs (eyes, nose, gastrointestinal tract and cerebral vessels).

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Bilobil intense

The medicine should be stored out of sight and reach of children.
Store in a temperature not exceeding 25°C in the original packaging to protect from moisture.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Bilobil intense contains

• The active substance is a dry, purified and quantified extract of Ginkgo biloba leaves. One hard capsule contains 120 mg of extract (in the form of dry, purified and quantified extract) from Ginkgo bilobaL., folium (Ginkgo biloba leaf) (35-67:1), which corresponds to: 26.4 to 32.4 mg of flavonoids calculated as flavonoid glycosides, 3.36 to 4.08 mg of ginkgolides A, B and C, 3.12 to 3.84 mg of bilobalide.
• Extractant: 60% (m/m) acetone.
• Other ingredients of the medicine are: lactose monohydrate, maize starch, talc, colloidal anhydrous silica, magnesium stearate in the capsule core and iron oxide black (E172), iron oxide red (E172), iron oxide yellow (E172), titanium dioxide (E171) and gelatin in the capsule shell, spray-dried glucose liquid as an auxiliary substance added to the extract.

What Bilobil intense looks like and contents of the packaging

Brown capsules containing brown powder (from light to darker) with visible darker small particles and lumps.
Available pack sizes: 20 and 60 hard capsules in blisters.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer/importer:

KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
To obtain more detailed information on this medicine, the patient should contact the local representative of the marketing authorisation holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
phone: +48 22 573 75 00
Date of last revision of the leaflet:20.09.2024