NOTICE
ANSM - Updated on: 03/03/2006
Name of the medicinal product
SPASMINE, coated tablet
framed
Read this leaflet carefully before you start taking this medicine. It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, ask your pharmacist.
· If symptoms worsen or persist, consult your doctor.
· If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.
Review summary
In this notice :
1. WHAT IS SPASMINE, coated tablet AND WHAT CASES IS IT USED FOR?
2. BEFORE YOU TAKE SPASMINE, coated tablet?
3. HOW TO TAKE SPASMINE, coated tablet?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE SPASMINE, coated tablet?
6. ADDITIONAL INFORMATION
1. WHAT IS SPASMINE, coated tablet AND WHAT CASES IS IT USED FOR?
Pharmacotherapeutic group
MEDICAMENT OF PHYTOTHERAPY with sedative aim
(N: central nervous system)
Therapeutic indications
Traditionally used to reduce the nervousness of adults and children, especially in the case of sleep disorders.
2. BEFORE YOU TAKE SPASMINE, coated tablet?
List of information needed before taking the medication
Not applicable.
Cons-indications
Do not take SPASMINE, a coated tablet if you have a history of allergy to any of the ingredients .
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Precautions for use; special warnings
Take special care with SPASMINE, coated tablet:
Special warnings
Due to the presence of lactose and sucrose, this medication should not be used in cases of congenital galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency (rare congenital diseases).
Precautions for use
Medications are not the only response to stress. A better hygiene of life, a decrease in the consumption of stimulants (including alcoholic beverages) also make it possible to fight effectively against the excess of nervousness. |
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
Interaction with other medicines
Taking or using other medicines
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
It is best not to use this medication during pregnancy;
If you discover that you are pregnant during treatment, consult your doctor as he alone can judge the need to continue.
The use of this medication should be avoided during breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
List of excipients with a known effect: sucrose, lactose.
3. HOW TO TAKE SPASMINE, coated tablet?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
RESERVED FOR ADULTS AND CHILDREN OVER 6 YEARS.
Nervousness:
· Adult: 1 or 2 tablets, one to three times daily.
· Child: 1 tablet, one to three times daily.
Sleeping troubles:
· Adult: 2 to 4 tablets, in the evening.
· Child: 1 or 2 tablets, in the evening.
Swallow the tablets with a little water.
Administration mode
Oral use.
Symptoms and Instructions for Overdose
Not applicable.
Instructions for omission of one or more doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, SPASMINE, a coated tablet, is likely to have side effects, although not everybody gets it.
If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.
5. HOW TO STORE SPASMINE, coated tablet?
Keep out of the reach and sight of children.
Expiration date
Do not use SPASMINE, coated tablet after the expiry date which is stated on the carton.
Storage conditions
Store at a temperature below 25 ° C.
If necessary, warnings against visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What does SPASMINE contain as a coated tablet?
The active substances are:
Valerian (dry hydroalcoholic root extract) .......................................... 120 mg
Hawthorn (flowering head powder) ........................................... .................................................. ... 100 mg
For a coated tablet.
The other components are:
Sodium lactose monohydrate, povidone, microcrystalline cellulose, sodium carboxymethyl starch, hydrated colloidal silica, crospovidone, magnesium stearate, shellac, talc, sucrose, gum arabic, gelatin, Sepisperse AS 5902 brown, Opagloss 6000.
Pharmaceutical form and content
What is SPASMINE, coated tablet and contents of the pack?
This medication is in the form of tablets. Box of 30 or 60.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
Laboratories JOLLY JATEL
28, avenue Carnot
78951 Saint Germain en Laye Cedex
exploiting
Laboratories JOLLY JATEL
28, avenue Carnot
781000 SAINT GERMAIN EN LAYE
Maker
PROPHARM'AIX
56 ZI - avenue Victoire
13106 ROUSSET
or
BIOPHELIA
Route of Montbazon
37260 MONTS
or
LABORATOIRES GALENIQUES VERNIN SA
20, rue Louis-Charles Vernin
77190 DAMMARIE-LES-LYS
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the Afssaps website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.