Package leaflet: Information for the user

Bilobil Intense, 120 mg, hard capsules
Ginkgonis extractum siccum raffinatum et quantificatum
Please read the entire leaflet carefully before using 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
physician or pharmacist.

Keep this leaflet so that it can be consulted again if necessary.
If advice or additional information is needed, please contact a pharmacist.
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform a physician or pharmacist. See section 4.
If there is no improvement after 12 weeks, or if the patient feels worse, consult a physician.

Table of contents of the leaflet:

What Bilobil Intense is and what it is used for
Important information before taking Bilobil Intense
How to take Bilobil Intense
Possible side effects
How to store Bilobil Intense
Contents of the pack and other information

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

Bilobil Intense contains a dried, purified, and quantified extract of leaves of Ginkgo biloba (Ginkgo leaf).
Bilobil Intense is a herbal medicinal product used to improve cognitive function (age-related) in elderly individuals and to improve quality of life in mild dementia.

2. Important information before using Bilobil Intense

When not to use Bilobil Intense

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

Warnings and precautions
Before starting to use Bilobil Intense, discuss this with your doctor or pharmacist.
If the patient has an increased tendency to bleed (bleeding tendency) or is taking anticoagulant medicines, they should contact their doctor before using this medicine.
Before undergoing surgery, inform your doctor about using Bilobil Intense. It is recommended to discontinue use of Bilobil Intense at least 3–4 days prior to a planned surgical procedure.
Patients with epilepsy should consult their doctor before starting treatment with Bilobil Intense, as products containing Ginkgo biloba extract may provoke further seizures.
Concomitant use of Bilobil Intense and efavirenz-containing medicines is not recommended (see section "Bilobil Intense with other medicines").

Children and adolescents
There are no indications for use of Bilobil Intense in children and adolescents. Do not use Bilobil Intense in this age group.

Bilobil Intense with other medicines
Inform your doctor or pharmacist about any medicines you are currently taking, have recently taken, or plan to take.
When Bilobil Intense is taken concomitantly with medicines that prevent blood clotting (such as antiplatelet coumarin derivatives, 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 when changing the dose or product, or when starting or stopping treatment with Bilobil Intense.
When Bilobil Intense is taken with dabigatran, a medicine used to prevent blood clotting, its effect may be increased. Consult your doctor before starting treatment.
When Bilobil Intense is taken concomitantly with nifedipine, a medicine used to treat certain heart conditions and hypertension, its effect may be increased, possibly leading to dizziness or increased frequency of hot flushes. In such cases, contact your doctor.
Concomitant use of Bilobil Intense with efavirenz (a medicine used to treat HIV infection) is not recommended, as the efficacy of efavirenz may be reduced.

Taking Bilobil Intense with food and drink
Bilobil Intense may be taken independently of meals.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using 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 use Bilobil Intense").
Due to insufficient data on safety during breastfeeding, use of this medicine is not recommended during lactation.

Driving and operating machinery
There are no data available regarding the influence on the ability to drive or operate machinery.

Bilobil Intense contains monohydrate lactose and glucose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
One hard capsule contains 198 mg of monohydrate lactose and 6 mg of glucose. If the patient takes the medicine as recommended, they will ingest 198 mg of monohydrate lactose 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 information leaflet or as directed by a doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose for adults and elderly patients is 1 capsule (120 mg) twice daily.
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 there is no improvement in symptoms after 3 months of treatment, or if symptoms worsen, consult your doctor to determine whether continued treatment is justified.
Use in children and adolescents
This medicine should not be used in children and adolescents.
Taking more Bilobil Intense than recommended
If you take more capsules than recommended, consult your doctor or pharmacist. There have been no reported cases of overdose symptoms with Ginkgo biloba extract to date.
Missing a dose of Bilobil Intense
Do not take a double dose to make up for a missed dose.
Take the missed dose as soon as possible, unless it is almost time for the next dose. In that case, skip the missed dose and take the next dose at the usual time.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.
Stopping Bilobil Intense
Inform your doctor or pharmacist if you intend to stop taking this medicine.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
Very common (more than 1 in 10 people):

headache.

Common (1 to 10 in 100 people):

dizziness,
diarrhoea, abdominal pain, nausea, vomiting.

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

allergic skin reactions (swelling, redness, itching and rash),
hypersensitivity reactions (anaphylactic shock),
bleeding from various organs (eyes, nose, gastrointestinal tract and cerebral vessels).

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Bilobil Intense

Keep this medicine out of sight and reach of children.
Store at 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 stated month.
Medicines must 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. Contents of the pack and other information

What Bilobil Intense contains

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

What Bilobil Intense looks like and contents of the pack
Brown-colored capsules containing a brown powder (ranging from light to darker) with visible darker small particles and granules.
Available pack sizes: 20 and 60 hard capsules in blister packs.
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
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
Równoległa Street 5
02-235 Warsaw, Poland
Telephone: +48 22 573 75 00