Ginkofar Intense

Package Leaflet: Information for the Patient

GINKOFAR INTENSE

120 mg, coated tablets

Dried, refined, and quantified Ginkgo biloba extract

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

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

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 3 months or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet:

• 1. What is Ginkofar Intense and what is it used for
• 2. Important information before using Ginkofar Intense
• 3. How to use Ginkofar Intense
• 4. Possible side effects
• 5. How to store Ginkofar Intense
• 6. Package contents and other information

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

Ginkofar Intense contains a quantified extract of Ginkgo biloba leaves, which improves blood flow in the brain, dilates blood vessels, and prevents platelet aggregation. The active substances in the extract are considered to be flavonoid glycosides, ginkgolides, and bilobalide.

Indications for Use

Ginkofar Intense is used:

• to improve cognitive abilities in older adults (memory impairment and mental performance disorders related to age),
• to improve the quality of life in mild dementia. The medicine is intended for adults.

If there is no improvement after 90 days or the patient feels worse, they should contact their doctor.

2. Important Information Before Using Ginkofar Intense

When Not to Use Ginkofar Intense

• if the patient is allergicto Ginkgo biloba leaf extract or any other component of this medicine (listed in section 6),
• if the patient is pregnant (see "Pregnancy and Breastfeeding").

Warnings and Precautions

Before starting to use Ginkofar Intense, the patient should consult a doctor or pharmacist if they have an increased tendency to bleed (bleeding disorder). Patients taking anticoagulant or antiplatelet medicines (so-called blood-thinning medicines) should consult their doctor before using this medicine. Before surgery, the patient should inform their doctor or dentist about using Ginkofar Intense. It is recommended to stop using Ginkofar Intense at least 3-4 days before a planned surgical or dental procedure, such as tooth extraction. Caution should be exercised in patients with epilepsy, as it cannot be ruled out that seizures may occur during treatment with Ginkofar Intense. The patient should not take higher doses than recommended. If symptoms of an allergic reaction occur, the patient should stop using the medicine. If there is no improvement or worsening of symptoms during treatment, the patient should consult their doctor or pharmacist.

Children and Adolescents

Ginkofar Intense should not be used in children and adolescents due to the lack of indications and limited data on the safety of its use in this patient group.

Ginkofar Intense and Other Medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take (including those available without a prescription). In particular, the patient should inform their doctor or pharmacist if they regularly take any of the following medicines:

• anticoagulants (phenprocoumon, warfarin)
• antiplatelet agents (clopidogrel, acetylsalicylic acid, and other nonsteroidal anti-inflammatory drugs)Concomitant use of these medicines and Ginkofar Intense may increase the risk of bleeding.

The patient should also inform their doctor or pharmacist about the use of the following medicines:

• efavirenz(used to treat HIV infection),
• nifedipine(used to treat high blood pressure),
• talinolol(used to treat heart diseases and high blood pressure),
• dabigatran(used to prevent blood clots).

Ginkofar Intense with Food and Drink

Ginkofar Intense should be taken orally, regardless of meals, with a glass of water. It is not recommended to take the medicine with alcohol.

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 using this medicine. Ginkofar Intense is contraindicated during pregnancy due to the lack of sufficient data and the risk of increased bleeding tendency. Due to the lack of sufficient data, Ginkofar Intense is not recommended during breastfeeding.

Driving and Using Machines

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

Ginkofar Intense Contains Lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.

3. How to Use Ginkofar Intense

This medicine should always be used exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist. If there are any doubts, the patient should consult their doctor or pharmacist.

Dosage

The recommended dose of Ginkofar Intense for adults is 1 tablettaken twice a day(preferably in the morning and evening).

Duration of Use

Treatment should last for at least 8 weeks. If the symptoms worsen or there is no improvement after 3 months of using the medicine, the patient should consult their doctor. After three months, the patient should consult their doctor about whether to continue treatment.

Use in Children and Adolescents

Ginkofar Intense should not be used in children and adolescents.

Method of Administration

Ginkofar Intense should be taken orally, regardless of meals, with a glass of water. The score line on the tablet is only to facilitate breaking the tablet to make it easier to swallow.

Using a Higher Dose of Ginkofar Intense Than Recommended

If a higher dose of the medicine is used than recommended, the patient should immediately consult their doctor or pharmacist.

Missing a Dose of Ginkofar Intense

The patient should not take a double dose to make up for a missed dose. If the patient forgets to take a dose, they should do so as soon as they remember, unless it is almost time for the next dose.

Stopping Use of Ginkofar Intense

If the patient has any further doubts about using this medicine, they should consult their doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Ginkofar Intense can cause side effects, although not everybody gets them. The following side effects may occur during treatment with Ginkofar Intense:

Very Common(more than 1 in 10 people):

• headache.

Common(between 1 and 10 people in 100):

• dizziness,
• gastrointestinal disorders (diarrhea, abdominal pain, nausea, vomiting).

Frequency Not Known(cannot be estimated from the available data):

• bleeding from individual organs (eyes, nose, gastrointestinal bleeding, and cerebral vessels). The risk of bleeding increases when taking blood-thinning medicines (anticoagulants and antiplatelet agents, see section 2),
• allergic reactions (anaphylactic shock),
• allergic skin reactions (flushing, swelling, itching, and rash).

Reporting Side Effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring, 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, e-mail: ndl@urpl.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to Store Ginkofar Intense

The Medicine Should Be Stored Out of Sight and Reach of Children.

Store in the original package. Store below 25°C. Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Other Information

What Ginkofar Intense Contains

• The active substance is dried, refined, and quantified Ginkgo biloba leaf extract. Each coated tablet contains 120 mg of quantified dried Ginkgo biloba extract (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. The solvent used for the first extraction: 65% (v/v) acetone.
• Other ingredients are: tablet core:microcrystalline cellulose, crospovidone, lactose monohydrate, talc, magnesium stearate, sodium carboxymethylcellulose, anhydrous colloidal silica; tablet coating:polyvinyl alcohol, titanium dioxide (E171), macrogol 3000, yellow iron oxide (E172), talc.

What Ginkofar Intense Looks Like and What the Package Contains

Ginkofar Intense are beige-yellow, oval, biconvex, coated tablets with a score line on one side. The tablets are packaged in PVC/PVDC-Aluminum blisters, together with the patient information leaflet, in a cardboard box. The package contains 10, 20, 30, 40, 50, 60, 90, or 120 (bulk package containing 2 packages of 60 coated tablets) coated tablets. Not all pack sizes may be marketed.

Prescription Status

OTC - Medicinal product available without a prescription.

Marketing Authorization Holder and Manufacturer

Biofarm Sp. z o.o., ul. Wałbrzyska 13, 60-198 Poznań, tel.: +48 61 66 51 500, fax: +48 61 66 51 505, biofarm@biofarm.pl

Date of the Last Update of the Leaflet:

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