Pharmacotherapeutic group: 2.13.1 – Central Nervous System. Other medicines acting in the nervous system. Medicines used in the symptomatic treatment of changes in the cognitive functions.

Abolibe Forte is indicated for the treatment of mild to moderate dementia.

Do not take Abolibe Forte:

– if you are allergic to ginkgo biloba or to any of the other ingredients of this medicine

(listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Abolibe Forte.

– If you have high blood pressure, Abolibe Forte alone does not control the blood pressure.

– If you are addicted to alcohol, talk to your doctor or pharmacist before taking this medicine.

Other medicines and Abolibe Forte

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.Ginkgo biloba interacts with anticoagulants, anticonvulsants, antiplatelet medicines, buspirone, diltiazem, insulin, low molecular weight heparins, inhibitors of the monoamine oxidase, nicardinpine, nifedipine, non-steroidal anti-inflammatory drugs, papaverine, selective

serotonin reuptake inhibitors, hypericum (Saint John’s wort), thiazide diuretics, thrombolytic agents and trazodone.

The alcohol in this medicine may alter the effects of other medicines. Talk to your doctor or pharmacist if you are taking other medicines.

Abolibe Forte with food and drink

Abolibe Forte must be ingested with water.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

The safety of Abolibe Forte during pregnancy has not yet been determined.

Driving and using machines

The amount of alcohol in this medicine is not likely to have an effect in adults and adolescents, and its effects in children are not likely to be noticeable. It may have some effects in younger children, for example feeling sleepy.

Abolibe Forte contains ethanol (alcohol)

This medicine contains 481.25 mg of alcohol (ethanol) in each mL which is equivalent to 6.88 mg/kg. 1 mL of this medicine is equivalent to 12.03 mL of beer or 4.81 mL of wine.

Abolibe Forte contains sodium saccharin.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The usual dose is of 1 ml  3 times a day or 3 ml twice a day, diluted in half a glass of water.

1 ml is equivalent to 40 mg of pure ginkgo biloba extract, and correspondsto 30 drops.

Abolibe Forte must be taken preferably with meals.

Method and route of administration:

Oral use.

Dilute the drops in half a glass of water.

In order to count the drops turn the bottle upside down and keep it in a vertical position.

If you take more Abolibe Forte than you should

There are no cases described regarding intoxication with the product.

If you forget to take Abolibe Forte

Do not take a double dose to make up for a forgotten dose.

When such situation happens you must re-start treatment as soon as you remember and tell your doctor about what happened.

If you stop taking Abolibe Forte

Not applicable.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Abolibe Forte is usually well tolerated. However, gastrointestinal complaints may occur (nausea). Changes in skin (cutaneous changes) and headaches may also occur although very rarely.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the contacts listed below. By reporting side affects you can help provide more information on the safety of this medicine.

Website: http://www.infarmed.pt/web/infarmed/submissaoram

(preferably)

or through the following contacts:
Direção de Gestão do Risco de Medicamentos
Parque da Saúde de Lisboa, Av. Brasil 53

1749-004 Lisboa

Tel: +351 21 798 73 73

Linha do Medicamento: 800222444 (free) e-mail: farmacovigilancia@infarmed.pt

Do not store above 25ºC.

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

Do not use Abolibe Forte after the expiry date which is stated on the carton and label of the bottle after VAL.:. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Abolibe Forte contains

The active substance is Gingko biloba, extract. Each ml of oral solution contains 40 mg of Ginkgo biloba, extract.

The other ingredients are:

Lemon essence,

Orange essence, Ethanol 96%,

Sodium saccharin,

Purified water.

What Abolibe Forte looks like and contents of the pack

Abolibe Forte is an oral solution packed into a brown glass dropper container, with a dropper applicator and white inviolable cap.

Abolibe Forte pack-size: one dropper container of 50 ml, oral solution.

Marketing Authorisation Holder and Manufacturer

SIDEFARMA – Sociedade Industrial de Expansão Farmacêutica, S.A.

Rua da Guiné, 26

2689-514 Prior Velho

Portugal

Medicinal product subject to medical prescription.

This leaflet was last revised in October 2022