Ginkgo Arkopharma hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

GINKGO ARKOPHARMA hard capsules

Ginkgo biloba L

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

Always follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.

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

Contents of the leaflet:

1. What GINKGO ARKOPHARMA is and what it is used for
2. What you need to know before taking GINKGO ARKOPHARMA
3. How to take GINKGO ARKOPHARMA
4. Possible adverse effects
5. How to store GINKGO ARKOPHARMA
6. Contents of the pack and other information

1. What GINKGO ARKOPHARMA is and what it is used for

A traditional herbal medicinal product used for the symptomatic relief of mild disorders resulting from cerebral circulation disturbances (such as dizziness and vertigo) or disturbances in the lower limbs (such as cramps and cold sensation in the legs), based solely on its traditional use.

2. What you need to know before starting to take GINKGO ARKOPHARMA

Do not take GINKGO ARKOPHARMA

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

Warnings and precautions

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

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

Taking GINKGO ARKOPHARMA with other medicines

It may enhance the effect of antiplatelet agents.

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Taking GINKGO ARKOPHARMA with food and drink

Food and drink do not affect the action of this medicine.

Pregnancy and breastfeeding

There are no adequate and well-controlled studies in pregnant or breastfeeding women; therefore, administration is not recommended.

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

Driving and using machines

No effects on the ability to drive or operate machinery have been reported.

3. How to take GINKGO ARKOPHARMA

Follow exactly the instructions for use provided in this leaflet or those given by your pharmacist or doctor. In case of doubt, consult your pharmacist or doctor.

The recommended dose is:

Adults: Take 2 capsules at breakfast, lunch, and dinner with a glass of water.

This medicine is for oral use.

To achieve an optimal effect, a treatment duration of 6–8 weeks is recommended.

Use in children and adolescents

Do not use in individuals under 18 years of age without consulting your pharmacist or doctor.

If you take more GINKGO ARKOPHARMA than you should

Cases of overdose with GINKGO ARKOPHARMA have not been reported.

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

If you forget to take GINKGO ARKOPHARMA

If you miss a dose, take the medicine as soon as possible and continue the treatment as prescribed. However, if the next dose is approaching, it is better not to take the missed dose and wait for the next scheduled dose. Under no circumstances should you take a double dose to make up for missed doses.

4. Possible adverse effects

Like all medicines, this medicine can produce adverse effects, although not everyone will experience them.

These adverse effects are generally mild and transient; in some cases, allergic reactions or skin hypersensitivity, headache, and gastrointestinal disorders (nausea, vomiting, diarrhoea) may occur. Cases of bleeding have been reported, especially in patients taking medicines containing Ginkgo extracts together with anticoagulant medicines or non-steroidal anti-inflammatory drugs.

Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of GINKGO ARKOPHARMA

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

Do not store above 30 °C.

Do not use this medicine after the expiry date stated on the packaging, following the abbreviation "EXP". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the Punto Sigre collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the container and other information

Composition of GINKGO ARKOPHARMA

Each capsule contains as the active substance: 180 mg of cryo-ground leaves of Ginkgo biloba L (Ginkgo).

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

Appearance of the product and contents of the container

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Arkopharma LABORATORIOS, S.A.U.

C/ Amaltea, 9

28045 MADRID

Manufacturer

ARKOPHARMA

LABORATOIRES PHARMACEUTIQUES

BP 28 – 06511 CARROS Cedex – France

Date of the most recent review of this summary: November 2016

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/