ABUFENE 400 mg is a drug used in hot flashes of menopause
For warnings, precautions for use and contraindications, please consult the instructions for use of ABUFENE 400 mg.
Abufene 400mg is a non-estrogenic inhibitor (and therefore does not contain hormones) of hot flashes , composed of the active principle amino acid: Beta-alanine .
ABUFENE 400 mg is a drug used in hot flashes during menopause.
Hot flash, the most common symptom of menopause
Characterized by a feeling of intense heat which suddenly invades the cleavage, the neck, and then rises to the face, hot flashes are possibly accompanied by redness and sweating. They last between 30 seconds and a few minutes, and are often followed by cold sweats. These episodes, sometimes repeating up to 15 to 20 times a day, can inconvenience some women to the point of preventing them from working.
The usual dosage is 1 to 2 tablets per day. The tablets should preferably be taken before meals.
In some cases, this dosage may be increased to 3 tablets per day. The duration of treatment is 5 to 10 days.
The drug will be administered for periods of 5 to 10 days until the hot flashes are inhibited. When these reappear, a new drug treatment becomes necessary again for the same period.
No habituation being observed, the treatment can be prolonged during all the period of the vasomotor disorders (flushes, redness) clinical, without limitation of duration.
The active substance is : Beta-alanine: 400 mg
For one tablet.
The other components are :
Magnesium stearate, glycerol palmitostearate (Precirol), hydrated silica (Levilite), wheat starch.
List of excipients with known effect: Wheat starch (gluten).
Box of 60 tablets
Attention, the drug Abufene 400mg is not a product like the others. Read the package leaflet carefully before ordering. Keep medicines out of the reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.
Menopause in a few figures:
Menopause is a normal physiological stage in women characterized by a decrease in the production of estrogen and progesterone due to the gradual cessation of the functioning of the ovaries, the loss of reproductive function and the cessation of menstruation.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Updated on: 02/07/2015
Beta-alanine
Keep this leaflet. You might need to read it again.
Contact your pharmacist for advice or information.
If you experience any of the side effects, talk to your pharmacist or doctor. This also applies to any side effects not mentioned in this leaflet (see section 4).
You should contact your doctor if you experience no improvement or feel less well after a few days of treatment.
1. What is ABUFENE 400 mg, tablet and in which cases is it used?
2. What information should I take before taking ABUFENE 400 mg tablet ?
3. How to take ABUFENE 400 mg tablet ?
4. What are the possible side effects?
5. How to store ABUFENE 400 mg tablets ?
6. Package contents and other information
1. WHAT ABUFENE 400 mg is AND WHAT IT IS USED FOR?
Beta-alanine is an amino acid non-hormonal inhibitor of menopausal hot flashes.
This medication is used in hot flashes of menopause.
2. BEFORE YOU TAKE ABUFENE 400 mg tablet?
List of information needed before taking the medication
Do not take ABUFENE 400 mg tablets:
· if you are allergic (hypersensitive) to the active substance or to any of the other ingredients of this medication mentioned in section 6.
· in case of intolerance or gluten allergy due to the presence of wheat starch (gluten).
Precautions for use; special warnings
Take special care with ABUFENE 400 mg tablet:
· Special warnings
The persistence of the symptoms, the aggravation or the appearance of new disorders, require to take a medical opinion.
If side effects occur (rash, pruritus), treatment should be discontinued.
Treatment with this medication does not preclude any specific treatment.
IN CASE OF DOUBT DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST
Interaction with other medicines
Other medications and ABUFENE 400 mg tablet
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
Interactions with food and beverages
ABUFENE 400 mg, tablet with food, beverages and alcohol
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Use during pregnancy and lactation
If you are pregnant or breastfeeding, if you think you are pregnant or plan to become pregnant, ask your doctor or pharmacist> before taking this medicine.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
ABUFENE 400 mg, tablet contains wheat starch (gluten).
3. HOW TO TAKE ABUFENE 400 mg tablet?
Administration mode
Oral use.
Duration of treatment
It is advisable to take the medication for periods of 5 to 10 days until cessation of hot flushes. In the event of a recurrence of hot flushes, a new medicinal cure for the same duration can be envisaged. An addiction to this medication is not expected.
If persistent or worsening of hot flashes, consult your doctor
Symptoms and Instructions for Overdose
Instructions for omission of one or more doses
If you have any further questions on the use of this medication, ask your doctor or pharmacist.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, this medicine may cause side effects, although not everybody gets them.
o Tingling passengers most often at the extremities of the upper or lower limbs.
o Exceptional rashes on the skin or itching.
Declaration of side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE abufene 400 mg tablet?
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the package.
No special storage conditions.
If necessary, warnings against visible signs of deterioration
Full list of active substances and excipients
What ABUFENE 400 mg contains: tablet
· The active substance is beta-alanine
· The other components are: Magnesium stearate, glycerol palmitostearate (precirol), hydrated silica (Levilite), wheat starch.
Pharmaceutical form and content
Aspect of ABUFENE 400 mg, tablet and contents of the pack
This medication is in the form of tablets. Box of 12, 30 or 60 tablets.
Not all pack sizes may be marketed.
BUILDING THE WILSON
70, AVENUE DU GENERAL DE GAULLE
92800 PUTEAUX
BOUCHARA RECORDATI LABORATORIES
BUILDING THE WILSON
70, AVENUE DU GENERAL DE GAULLE
92800 PUTEAUX
EUROPEAN PHARMACOTECHNIE-EUROPHARTEC
1, HENRI MATISSE STREET
63370 LEMPDES
or
BOUCHARA RECORDATI LABORATORIES
MECATRONIC PARK
03410 SAINT VICTOR
Names of the medicinal product in the Member States of the European Economic Area
Date of approval of the notice
The last date on which this notice was revised is <{MM / YYYY}> <{month YYYY}.>
AMM under exceptional circumstances
Detailed information on this medicine is available on the ANSM website (France).
Information for health professionals only
Health Education Council:
Menopause :
In women, menopause is a period marked by the decrease in the production of sex hormones (estrogens) by the ovaries. Monthly bleeding (menstrual bleeding) becomes irregular and gradually decreases until amenorrhea (no rule). A woman is considered postmenopausal after a year of no menstruation. For the majority of women, menopause is observed around the age of 50 years. In some cases, it may occur naturally between 40 and 55 years of age.
In the majority of women, menopause is accompanied by multiple so-called "climacteric" disorders such as hot flushes or vaginal dryness. These disorders are related to the decline in estrogen production and may vary in intensity according to women. Hot flushes last for 30 seconds to 2 minutes and can occur at the onset of menopause. They can be spontaneous or triggered by external factors. At night, they can be accompanied by a strong perspiration (night sweats) and disrupt the sleep. Hot flushes generally last a few months at the onset of menopause and then decrease, but this varies from one woman to another.
Menopause Treatments:
In postmenopausal women with climacteric disorders that are sufficiently troublesome to impair quality of life, hormone replacement therapy may be initiated if desired. The minimum effective dose and the shortest possible duration are recommended, in compliance with precautions for use and contraindications.
There are non-hormonal treatments that are meant to relieve some symptoms of menopause. The advantages and disadvantages of each drug must be taken into account before starting treatment.
Amino acid
beta-alanine
. Presentations . Composition . Indications . Contraindications . Warning . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
ABUFENE: tablet (white); box of 30.
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ABUFENE: tablet (white); box of 60.
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Laboratory Bouchara-Recordati
| p cp | |
| Beta-alanine | 400 mg |
| Wheat starch (gluten) | + |
Usual dosage:
1 or 2 tablets per day. If necessary, the dosage may be increased to 3 tablets per day.
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