Adjunct symptomatic treatment of chronic cognitive and neurosensory pathological deficit in the elderly (excluding Alzheimer’s disease and other dementias).
Supportive treatment of Raynaud’s syndrome.

ANSM ALERT of 09/24/2013:

In agreement with the National Agency for the Safety of Medicines and Health Products (ANSM) and the European Medicines Agency (EMA), we inform you that drugs containing Dihydroergocryptine-caffeine should no longer be used in the indications following:

Adjunct symptomatic treatment of chronic cognitive and neurosensory pathological deficit in the elderly (excluding Alzheimer’s disease and other dementias).
Supportive treatment of Raynaud’s syndrome.
These drugs will soon be subject to a suspension of marketing authorization and a recall of the batches on the market.

Vasobral Dosage

1/2 to 1 tablet, 2 times a day.

THIS MEDICINE WAS PERSONALLY DELIVERED OR PRESCRIBED TO YOU IN A SPECIFIC SITUATION:

·IT CANNOT BE SUITABLE FOR ANOTHER CASE.
·DO NOT ADVISE IT TO ANOTHER PERSON.

Vasobral Contraindications

Never take VASOBRAL, scored tablet in the following cases:

in the event of a history of allergy to one of the constituents of the specialty,
if you are to take VASOBRAL for a long time and develop or have had in the past a fibrotic reaction (scar tissue) affecting your heart.

how does Vasobral work?

After oral administration, the absorption of dihydroergocryptine in the presence of caffeine is rapid (T _max : 0.5 hour).
The maximum concentration is low (C _max : 227 pg / ml) after ingestion of 8 mg of dihydroergocryptine and the plasma half-life is less than 2 hours.

How To Take Vasobral ?

Method and route of administration

Oral route.
Swallow the half-tablet without chewing it, with a little water.

How often and when the drug should be administered

To be distributed throughout the day, preferably just before meals.

How To Store Vasobral ?

Keep out of the reach and sight of children.

Expiration date

Do not use VASOBRAL, scored tablet after the expiry date stated on the box.
The expiration date refers to the last day of the month.

Storage conditions

No special storage conditions.

If necessary, warnings against certain visible signs of deterioration

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with any unused medicine. These measures will help protect the environment.

Vasobral Side Effects

Like all medicines, VASOBRAL, scored tablet can cause side effects, although not everybody gets them:

Very rare side effects (affecting less than 1 in 10,000 people): valve disorders and associated disorders eg. inflammation (pericarditis) or fluid effusion into the pericardium (pericardial effusion).
The first symptoms may be one or more of the following: difficulty breathing, shortness of breath, chest or back pain, and swollen legs. If you experience any of these symptoms, please tell your doctor immediately.
Possibility of nausea, especially if taken on an empty stomach.
If you notice any side effects not listed in this leaflet, or if any side effects get serious, please tell your doctor or pharmacist.

Vasobral Interactions

Interactions with other drugs

Taking or using other medicines:

IN ORDER TO AVOID POSSIBLE INTERACTIONS BETWEEN SEVERAL MEDICINES, ANY OTHER TREATMENT IN PROGRESS MUST BE SENIORLY REPORTED TO YOUR DOCTOR OR YOUR PHARMACIST.

Interactions with food and drink

Not applicable.
Not applicable.
Not applicable.

Interactions with phytotherapy products or alternative therapies

Not applicable.
Not applicable.
Not applicable.

Effects on ability to Drive and use machines

Not applicable.
Not applicable.
Not applicable.

Warnings and Precautions

Take special care with VASOBRAL, scored tablet:

Special warnings

If you develop or have in the past had a fibrotic reaction (scar tissue) affecting your heart, lungs or abdomen. If you are being treated with VASOBRAL for a long time, your doctor will check before you start treatment that your heart, lungs and kidneys are in good condition. They will also have an echocardiogram (ultrasound examination of the heart) done before starting treatment.
During treatment, your doctor will pay special attention to any signs that may be related to a fibrotic reaction. If necessary, he will have an echocardiogram performed. In the event of a fibrotic reaction, treatment should be stopped.

Precautions for use

Taking this medication away from meals is not recommended ( see section 4. POSSIBLE SIDE EFFECTS? ).
IN CASE OF DOUBT, DO NOT HESITATE TO ASK FOR THE ADVICE OF YOUR DOCTOR OR YOUR PHARMACIST.

PREGNANCY & BREAST-FEEDING & Sportsmen

Pregnancy and breast feeding

GENERALLY, DURING PREGNANCY AND BREASTFEEDING, IT IS APPROPRIATE TO ASK YOUR DOCTOR OR PHARMACIST BEFORE TAKING ANY MEDICINAL PRODUCT.

Sportsmen

Warning: this specialty contains an active principle that can induce a positive reaction to the tests carried out during doping controls.

What happens if I overdose from Vasobral ?

Not applicable.
Not applicable.
Not applicable.

What should I do if I miss a dose?

If you forget to take VASOBRAL, scored tablet:

Take the next dose at the usual time; do not double the dose.

What happens if you stop taking Vasobral ?

Not applicable.
Not applicable.
Not applicable.

What is Forms and Composition ?

Complete list of active substances and excipients

What does VASOBRAL contain, scored tablet?

The active substance is :

Dihydroergocryptine A mesilate ………… 4.0 mg
Caffeine …. 40.0 mg

For a scored tablet.

The other ingredients are:

Lactose monohydrate, microcrystalline cellulose, magnesium stearate, colloidal anhydrous silica.

Pharmaceutical form and content

What is VASOBRAL, scored tablet and contents of the outer packaging?

This drug is in the form of scored tablets.
Box of 10, 30, 60 or 100 tablets.

NOT’s

Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:

general information:

Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles

Additional information:

General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.

Special warnings:

For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

It treats possible side effects and drug interactions that require attention and its effect on continuous use.
The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.

Caffeine Dihydroergocryptine