Bilobil forte

Package leaflet: Information for the user

Bilobil Forte, 80 mg, hard capsules
Ginkgonis extractum siccum raffinatum et quantificatum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient information leaflet or as directed by the physician or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or if the patient feels worse after 12 weeks, they should contact their doctor.

Contents of the leaflet:

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

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

Bilobil Forte contains a dried, purified, and quantified extract from the leaves of Ginkgo biloba (Ginkgo biloba L.).
Bilobil Forte is a herbal medicinal product used to improve cognitive function (age-related) and to enhance quality of life in mild dementia.

2. Important information before using Bilobil Forte

When not to use Bilobil Forte

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

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

Bilobil Forte with other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
When Bilobil Forte 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 in case of dose adjustment, change of product, or when starting or stopping treatment with Bilobil Forte.
Taking Bilobil Forte concomitantly with dabigatran, a medicine used to prevent blood clotting, may enhance its effect. Consult your doctor before starting treatment.
When Bilobil Forte is used 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 a case, contact your doctor.
Concomitant use of Bilobil Forte with efavirenz (a medicine used to treat HIV infection) is not recommended, as the efficacy of efavirenz may be reduced.

Bilobil Forte with food and drink
Bilobil Forte can 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.
Bilobil Forte is contraindicated during pregnancy due to insufficient data and the risk of increased bleeding tendency (see section 2 “When not to use Bilobil Forte”).
Due to insufficient data on safety, use of Bilobil Forte is not recommended during breastfeeding.

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

Bilobil Forte contains monohydrate lactose, glucose, and azorubine
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
Azorubine (E122) may cause allergic reactions.
One capsule contains 132 mg monohydrate lactose, 4 mg glucose, and 0.03 mg azorubine. If the patient takes the medicine as recommended, each dose provides 132 mg monohydrate lactose, 4 mg glucose, and 0.03 mg azorubine.

3. How to use Bilobil Forte

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose for adults and elderly patients is 1 capsule (80 mg) 2 to 3 times daily.
Do not exceed the maximum daily dose of 3 capsules (corresponding to 240 mg).
Swallow the capsules with water.
Duration of treatment:
Treatment should last 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 continuing treatment is justified.
Children and adolescents
Bilobil Forte should not be used in children and adolescents.
Taking more Bilobil Forte than recommended
If you take more than the recommended dose, consult your doctor or pharmacist. There have been no reports to date of adverse effects associated with overdose of Ginkgo biloba extract.
Missed dose of Bilobil Forte
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.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.

Very common (more than 1 in 10 people):

• headache.

Common (1 to 10 in 100 people):

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

Frequency unknown (cannot be estimated from the available data):

• allergic skin reactions (swelling, redness, itching and rash);
• allergic reactions (anaphylactic shock);
• bleeding from individual organs (eyes, nose, cerebral haemorrhage, gastrointestinal bleeding).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. 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 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Bilobil Forte

Keep this medicine out of sight and reach of children.
Store below 25°C.
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 the sewage system or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Bilobil Forte contains
The active substance in Bilobil Forte is a dry, purified and quantified extract from the leaves of Ginkgo biloba ( Ginkgonis extractum siccum raffinatum et quantificatum ).

• One hard capsule contains 80 mg of extract (in the form of a dry, purified and quantified extract) from Ginkgo biloba L., folium (leaf of Ginkgo biloba), (35-67:1), corresponding to:
• 17.6–21.6 mg flavonoids expressed as flavonoid glycosides,
• 2.24–2.72 mg ginkgolides A, B and C,
• 2.08–2.56 mg bilobalide.
  Extraction solvent: acetone 60% (m/m).
• Other components of the medicinal product: monohydrate lactose, maize starch, talc, colloidal anhydrous silica, magnesium stearate; Capsule shell: black iron oxide (E172), red iron oxide (E172), titanium dioxide (E171), azorubine (E122), gelatin. See section 2 "Bilobil Forte contains lactose, glucose and azorubine".
• Excipient added to the extract: dried spray-dried glucose syrup.

What Bilobil Forte looks like and contents of the pack
Pink-colored capsules containing brown powder (ranging from light to darker) with visible darker small particles and granules.
Available pack sizes: 20, 60, 90 hard capsules in blister packs.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
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.
ul. Równoległa 5
02-235 Warszawa
telephone: +48 22 573 75 00