Bilobil Forte

Package Leaflet: Information for the User

Bilobil Forte, 80 mg, Hard Capsules

Ginkgo Extract, Dry, Refined, and Quantified

Read the Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

This Medication Should Always be Used Exactly as Described in the Patient Leaflet or as Advised by a Doctor or Pharmacist.

• Keep this Leaflet, You May Need to Read it Again.
• If You Need Advice or Further Information, Consult a Pharmacist.
• If You Experience any Side Effects, Including those not Listed in this Leaflet, Tell Your Doctor or Pharmacist. See Section 4.
• If After 12 Weeks There is no Improvement or the Patient Feels Worse, Consult a Doctor.

Table of Contents of the Leaflet:

• 1. What is Bilobil Forte and What is it Used for
• 2. Important Information Before Using Bilobil Forte
• 3. How to Use Bilobil Forte
• 4. Possible Side Effects
• 5. How to Store Bilobil Forte
• 6. Contents of the Pack and Other Information

1. What is Bilobil Forte and What is it Used for

Bilobil Forte Contains a Refined and Quantified Dry Extract from the Leaves of Ginkgo Biloba.
Bilobil Forte is a Herbal Medicinal Product Used to Improve Cognitive Function (Related to Age) and 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 Extract or any of the Other Ingredients of this Medicinal Product (Listed in Section 6);
• If the Patient is Pregnant.

Warnings and Precautions

Before Starting to Use Bilobil Forte, Discuss it with a Doctor or Pharmacist.
If the Patient has an Increased Risk of Bleeding (Bleeding Disorder) or is Taking Anticoagulant or Antiplatelet Medications (So-called Blood Thinners), They Should Consult a Doctor Before Using this Medicinal Product.
Before Surgery, Inform the Doctor About the Use of Bilobil Forte. It is Recommended to Stop Using Bilobil Forte at Least 3-4 Days Before the Scheduled Surgery.
Patient with Epilepsy Should Consult a Doctor Before Starting to Use Bilobil Forte, as the Use of Ginkgo Biloba Extract may Cause Seizures.
Concomitant Use of Bilobil Forte and Medications Containing Efavirenz (See Section "Bilobil Forte and Other Medications") is not Recommended.

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 and Other Medications

Tell Your Doctor or Pharmacist About all Medications You are Currently Taking or Have Recently Taken, as well as any Medications You Plan to Take.
When Bilobil Forte is Used Concomitantly with Medications that Prevent Blood Clotting (Such as Antiplatelet Compounds, Cumaryl, Clopidogrel, Acetylsalicylic Acid, and Other Non-steroidal Anti-inflammatory Medications), it may Affect their Action.
If the Patient is Taking Warfarin, a Medication 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 the Use of Bilobil Forte.
When Taking Bilobil Forte with Dabigatran, a Medication Used to Prevent Blood Clotting, its Action may be Enhanced. Consult a Doctor Before Starting Treatment.
When Using Bilobil Forte with Nifedipine, a Medication Used to Treat Certain Heart Disorders and Hypertension, its Action may be Enhanced, which may Lead to Dizziness or Increased Heart Rate. In this Case, Consult a Doctor.
Concomitant Use of Bilobil Forte and Efavirenz (a Medication for the Treatment of HIV Infection) is not Recommended, as the Action 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, Breastfeeding, or Thinks She may be Pregnant or is Planning to Have a Child, She Should Consult a Doctor or Pharmacist Before Using this Medicinal Product.
Bilobil Forte is Contraindicated During Pregnancy Due to the Lack of Sufficient Data and the Risk of Increased Bleeding Tendency (See Section 2 "When Not to Use Bilobil Forte").
Due to the Lack of Sufficient Data on the Safety of Use During Breastfeeding, it is not Recommended to Use Bilobil Forte During this Period.

Driving and Using Machines

There are no Data on the Influence on the Ability to Drive and Use Machines.

Bilobil Forte Contains Lactose, Glucose, and Azorubine

If the Patient has Previously been Diagnosed with Intolerance to Some Sugars, the Patient Should Consult a Doctor Before Taking the Medicinal Product.
Azorubine (E122) may Cause Allergic Reactions.
One Capsule Contains 132 mg of Lactose, 4 mg of Glucose, and 0.03 mg of Azorubine. If the Patient Takes the Medicinal Product as Recommended, They Will Take 132 mg of Lactose, 4 mg of Glucose, and 0.03 mg of Azorubine Each Time.

3. How to Use Bilobil Forte

This Medicinal Product Should Always be Used Exactly as Described in the Patient Leaflet or as Advised by a Doctor or Pharmacist. In Case of Doubt, Consult a Doctor or Pharmacist.
The Recommended Dose for Adults and the Elderly is 1 Capsule (80 mg) 2-3 Times a Day.
Do not Exceed the Maximum Daily Dose of 3 Capsules (Equivalent to 240 mg).
Capsules Should be Swallowed with Water.
Duration of Treatment:
Treatment Should Last at Least 8 Weeks.
If After 3 Months of Treatment with Bilobil Forte There is no Improvement or the Symptoms Have Worsened, Consult a Doctor to Determine if Continuing Treatment is Justified.

Children and Adolescents

Do not Use Bilobil Forte in Children and Adolescents.

Overdose of Bilobil Forte

In Case of Overdose, Consult a Doctor or Pharmacist. So far, there are no Reports of Symptoms of 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 this Case, Do not Take the Missed Dose.
In Case of Further Doubts About the Use of this Medicinal Product, Consult a Doctor or Pharmacist.

4. Possible Side Effects

Like all Medicinal Products, Bilobil Forte can Cause Side Effects, Although not Everybody Gets Them.
Very Common(More than 1 in 10):

• Headache.

Common(Between 1 in 10 and 1 in 100):

• Dizziness,
• Diarrhea, Abdominal Pain, Nausea, Vomiting

Frequency Not Known(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 and Gastrointestinal Bleeding).

Reporting Side Effects

If You Experience any Side Effects, Including those not Listed in this Leaflet, Tell Your Doctor or Pharmacist. Side Effects can be Reported Directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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 Authorization Holder.
By Reporting Side Effects, You can Help Provide More Information on the Safety of this Medicinal Product.

5. How to Store Bilobil Forte

Keep this Medicinal Product Out of the Sight and Reach of Children.
Store in a Temperature Below 25°C.
Do not Use this Medicinal Product After the Expiry Date Stated on the Packaging After EXP.
The Expiry Date is the Last Day of the Specified 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. Contents of the Pack and Other Information

What Bilobil Forte Contains

The Active Substance of Bilobil Forte is a Refined and Quantified Dry Extract from the Leaves of Ginkgo Biloba (Ginkgo Extract, Dry, Refined, and Quantified).

• One Hard Capsule Contains 80 mg of Extract (in the Form of Refined and Quantified Dry Extract) from Ginkgo BilobaL., Folium (Ginkgo Leaf) (35-67:1), Which Corresponds to:
• 17.6-21.6 mg of Flavonoids Expressed as Flavonoid Glycosides,
• 2.24-2.72 mg of Ginkgolides A, B, and C,
• 2.08-2.56 mg of Bilobalide. Extractant: Acetone 60% (m/m).
• Other Ingredients of the Medicinal Product: Lactose, Corn Starch, Talc, Colloidal 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: Spray-dried Glucose Liquid

What Bilobil Forte Looks Like and Contents of the Pack

Pink Capsules Containing Brown Powder (from Light to Darker) with Visible Darker Small Particles and Lumps.
Available Pack Sizes: 20, 60, 90 Hard Capsules in Blister Packs.
Not all Pack Sizes may be Marketed.

Marketing Authorization Holder and Manufacturer:

KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
To Obtain More Detailed Information on this Medicinal Product, Contact the Local Representative of the Marketing Authorization 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: