NOTICE
ANSM - Updated on : 18/11/2020
Product name
SPASMAG, capsule
Magnesium, Saccharomyces cerevisiae yeast
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Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as instructed in this leaflet or by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for advice and information.
- If you experience any of the side effects, please tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
You should contact your doctor if you do not feel any improvement or if you feel less well.
What does this leaflet contain?
1. What is SPASMAG, capsule and what is it used for?
2. What do I need to know before taking SPASMAG, capsule?
3. How is SPASMAG capsule taken?
4. What are the possible side effects?
5. How should SPASMAG capsule be stored?
6. Package contents and other information.
1. WHAT IS SPASMAG, capsule AND WHAT IS IT USED FOR?
Pharmacotherapeutic class Mineral supplement ATC code: A12CC02
Indicated for adults and children aged 12 and over.
It contains magnesium and Saccharomyces cerevisiae yeast.
The combination of a number of the following symptoms may suggest magnesium deficiency:
- nervousness, irritability, mild anxiety, transient fatigue, minor sleep disturbances,
- manifestations of anxiety such as digestive spasms or palpitations (healthy heart),
- muscle cramps, tingling.
Magnesium intake can improve these symptoms.
You should consult your doctor if you do not feel any improvement or if you feel less well after 1 month's treatment.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING SPASMAG, capsule?
Never take SPASMAG, capsule :
- if you are allergic or hypersensitive to the active substances or to any of the other ingredients of this medicine, as listed in section 6.
- in case of severe renal insufficiency (impaired kidney function)
- in children under 12 years of age
- in case of phenylketonuria (hereditary disease detected at birth), due to the presence of aspartam.
- In case of allergy to soy or larachide.
Warnings and precautions
Talk to your doctor or pharmacist before taking SPASMAG, capsule.
Other medicines and SPASMAG, capsule
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
SPASMAG, capsule with food, drink and alcohol
Not applicable.
Pregnancy, breast-feeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
This medicine should only be used during pregnancy on the advice of your doctor.
If you discover that you are pregnant during treatment, consult your doctor, as only he/she can judge whether it is necessary to continue treatment.
Ask your doctor or pharmacist for advice before taking any medication.
Breast-feeding
Do not use this product if you are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Not applicable.
SPASMAG, capsule contains laspartam and soy protein.
This medicine contains 8 mg daspartam per capsule.
Laspartam contains a source of phenylalanine. May be dangerous for people with phenylketonuria (PKU), a rare genetic disorder characterized by an accumulation of phenylalanine that cannot be properly eliminated.
If you are allergic to soy or larachide, do not use this product.
3. HOW DO I TAKE SPASMAG, capsule?
Always take this medicine exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
The recommended dose is :
- Children aged 12 to 15: 2 to 6 capsules per day.
- Adults: 6 capsules per day.
Method of administration
Take by mouth.
Capsules should be swallowed with a little water. If necessary, they can be opened and the contents mixed with a liquid.
Frequency of administration
The daily dose should preferably be divided into several doses taken before or during a meal.
Duration of treatment
The usual duration of treatment is 1 month.
If symptoms do not improve after one month of treatment, there is no point in continuing treatment.
Use in children and adolescents
For adults and children aged 12 and over.
If you have taken more SPASMAG, capsule than you should have :
Consult your doctor or pharmacist immediately.
If you forget to take SPASMAG, capsule :
Do not take a double dose to make up for the one you forgot to take.
If you stop taking SPASMAG, capsule :
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this product may cause undesirable effects, but they do not occur systematically in everyone.
- Diarrhoea,
- Abdominal pain
Reporting side effects
If you experience any side effects, please tell your doctor or pharmacist. This also applies to any side effect not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance.
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW DO I USE SPASMAG, capsule?
Keep out of sight and reach of children.
No special storage precautions are required.
Do not use this medicine after the expiration date indicated on the packaging after EXP. The expiration date refers to the last day of that month.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What SPASMAG capsules contain
- The active ingredients are :
Magnesium sulfate trihydrate ........................................................................................ 423.5 mg
Quantity corresponding to magnesium element..................................................................... 59.0 mg
Saccharomyces cerevisiae yeast ...................................................................................... 50.0 mg
For one capsule.
- Other components are :
Magnesium stearate, aspartam, orange* flavoring.
Capsule shell composition : gelatin, titanium dioxide (E171), indigotine (E132).
*Composition of orange flavor : maltodextrin, soya protein, gum arabic, concentrated orange juice, orange essential oil, lemon essential oil, citral, aldehyde acetic, linalin.hyde, linalool, ethyl butyrate, alpha terpineol, octanal, ethyl acetate, geranyl acetate.
What SPASMAG capsules are and what they contain
This medicine comes in capsule form. Box of 60.
Marketing authorization holder
LABORATOIRES GRIMBERG SA
44 AVENUE GEORGES POMPIDOU
92300 LEVALLOIS-PERRET
FRANCE
Marketing authorization holder
LABORATOIRES GRIMBERG SA
ZA DES BOUTRIES, RUE VERMONT
78704 CONFLANS SAINTE HONORINE CEDEX
FRANCE
Manufacturer
LABORATOIRES GRIMBERG SA
ZA DES BOUTRIES, RUE VERMONT
78704 CONFLANS SAINTE HONORINE CEDEX
FRANCE
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder].
Other
Detailed information on this drug is available on the ANSM (France) website.