Leaflet: information for the user

GINKGO ARKOPHARMA hard capsules

Ginkgo bilobaL

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if you get worse or do not improve after 4 weeks.

1. What isGINKGO ARKOPHARMAand what it is used for

2.What you need to know before starting to takeGINKGO ARKOPHARMA

3. How to takeGINKGO ARKOPHARMA

4. Possible side effects

5. Storage ofGINKGO ARKOPHARMA

6. Contents of the pack and additional information

Traditional medication based on plants used for symptomatic relief of mild disorders resulting from cerebral circulatory alterations (such as dizziness and vertigo) or lower extremities (such as cramps and cold sensation in the legs), based exclusively on its traditional use.

Do not take GINKGO ARKOPHARMA

If you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).

Warnings and precautions

If you are to undergo surgery, this medication should be discontinued at least 2 weeks before.

Consult your doctor or pharmacist before starting to take GINKGO ARKOPHARMA.

Taking GINKGO ARKOPHARMA with other medications

It may potentiate the effect of antiplatelet agents.

Inform your doctor or pharmacist if you are taking, have taken recently, or may have to take any other medication.

Taking GINKGO ARKOPHARMA with food and beverages

Foods and beverages have no influence on the effect of the medication.

Pregnancy and Breastfeeding

There are no adequate and well-controlled studies in pregnant women, or in lactation, so its administration is not recommended.

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your pharmacist or doctor before using this medication.

Driving and operating machines

No effects have been registered on the ability to drive and operate machines.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your pharmacist or doctor. If in doubt, ask your pharmacist or doctor.

The recommended dose is:

Adults: take 2 capsules in the morning, lunch, and dinner with a glass of water.

This medication is used orally.

To achieve an optimal effect, it is recommended to have a treatment of 6-8 weeks.

Use in children and adolescents

Do not use in individuals under 18 years old, without consulting your pharmacist or doctor.

If you take more GINKGO ARKOPHARMA than you should

No cases of overdosing with GINKGO ARKOPHARMA have been described.

In case of overdose or accidental ingestion, consult your pharmacist or doctor immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the product and the amount ingested.

If you forgot to take GINKGO ARKOPHARMA

In case of forgotten dose, take the medication as soon as possible continuing the treatment as prescribed. However, if the next dose is near, it is better not to take the forgotten dose and wait for the next one. Never take a double dose to compensate for the forgotten doses.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

These adverse effects are generally mild and transient; in some cases, they may include allergies or skin hypersensitivity, headaches, and gastrointestinal disturbances (nausea, vomiting, diarrhea). Cases of bleeding have been reported, especially in patients taking medications containing Ginkgo extracts along with anticoagulant or nonsteroidal anti-inflammatory medications.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not store at a temperature above 30 °C.

Do not use this medication after the expiration date that appears on the packaging, after the abbreviation “CAD”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the Pharmacy Take-Back Point. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of GINKGO ARKOPHARMA

Each capsule contains as active ingredient: 180 mg of cryomilled leaves of Ginkgo biloba L (Ginkgo).

The other components are the excipients: gelatin (capsule coating).

Appearance of the product and content of the packaging

There are 3 presentations in bottles containing 50, 100 and 200 capsules.

Holder of the marketing authorization and responsible for manufacturing

Holder

Arkopharma LABORATORIES, S.A.U.

C/ Amaltea, 9

28045 MADRID

Responsible for manufacturing

ARKOPHARMA

Laboratoires Pharmaceutiques

BP 28 – 06511 CARROS Cedex – France

Date of the last review of this leaflet: November 2016

The detailed and updated information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/