NOTICE
ANSM - Updated: 22/01/2013
Name of the drug
BIOMAG CITRUS, chewable tablet
framed
Read this leaflet carefully before using this medicine. It contains important information for your treatment.
If you have further questions, if you are not sure, ask your doctor or pharmacist for more information.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, talk to your pharmacist.
· If symptoms worsen or persist after 4 weeks, seek medical attention.
· If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Summary notice
In this notice :
1. What is BIOMAG CITRUS, chewable tablet and in what cases is it used?
2. What information do you need to know before using BIOMAG CITRUS, chewable tablet ?
3. How to use BIOMAG CITRUS, chewable tablet ?
4. What are the possible side effects?
5. How to store BIOMAG CITRUS, chewable tablet ?
6. Additional information.
1. WHAT IS BIOMAG CITRUS, chewable tablet AND WHAT IT IS USED FOR?
Pharmacotherapeutic class
Not applicable.
Therapeutic indications
BIOMAG CITRUS, chewable tablet is a homeopathic medicine traditionally used in the manifestations of anxiety, stress and in states of temporary tiredness.
2. BEFORE YOU USE BIOMAG CITRUS, chewable tablet?
List of information needed before taking the medication
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Cons-indications
Never use BIOMAG CITRUS, chewable tablet:
· In children under 6 years of age due to the risk of miscarriage related to the pharmaceutical form.
· If you are allergic (hypersensitive) to the active substances or to any of the ingredients in BIOMAG CITRUS, chewable tablet.
Precautions for use; special warnings
Be careful with BIOMAG CITRUS, chewable tablet:
· The use of this drug is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).
· The use of this drug is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase / isomaltase (rare hereditary diseases) deficiency.
Interactions with other drugs
Taking other medicines:
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, tell your doctor or pharmacist.
Interactions with food and drinks
Food and drinks
This medicine is to be taken away from meals.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
In the absence of experimental and clinical data, and as a precaution, the use of this drug is not recommended during pregnancy and lactation.
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
Important information about some of the ingredients of BIOMAG CITRUS , chewable tablet:
This medicine contains lactose and sucrose.
3. HOW TO USE BIOMAG CITRUS, chewable tablet?
Instructions for a good use
Not applicable.
Dosage, Mode and / or Route (s) of Administration, Frequency of Administration and Duration of Treatment
Dosage
Medicine reserved for adults and children over 6 years old.
Attack treatment for 15 days :
- Adults: 2 tablets 3 times a day.
- Children over 6 years old: 1 tablet 2 to 3 times a day.
Maintenance treatment for 1 month :
- Adults: 1 tablet 3 times a day.
- Children over 6 years old: 1 to 2 tablets daily.
Method and route of administration
Chewable tablets and let melt under the tongue, preferably outside meals.
Oral way.
Duration of treatment
Treatment should not be continued beyond 4 weeks without medical advice.
Symptoms and instructions in case of overdose
If you take more BIOMAG CITRUS, chewable tablet than you should:
Consult your doctor or your pharmacist.
Instructions for omitting one or more doses
If you forget to take BIOMAG CITRUS, chewable tablet:
Do not take a double dose to make up for the dose you forgot to take.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of adverse effects
Like all medicines, BIOMAG CITRUS, chewable tablet can have side effects, although not everybody gets them.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE BIOMAG CITRUS, chewable tablet?
Keep out of the reach and sight of children.
Expiration date
Do not use BIOMAG CITRUS, chewable tablet after the expiry date which is stated on the blister or carton.
Storage conditions
No special storage conditions.
If necessary, warn against some visible signs of deterioration
Medications should not be thrown away to the sewer or garbage. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Complete list of active substances and excipients
What does BIOMAG CITRUS, chewable tablet contain ?
The active substances are :
Magnesia muriatica 1 DH .............................................. .................................................. .................... 50 mg
Magnesia bromata 4 DH .............................................. .................................................. ..................... 10 mg
Magnesia phosphorica 1 DH .............................................. .................................................. ............... 50 mg
Plumbum metallicum 8 DH .............................................. .................................................. ................. 10 mg
Kalium phosphoricum 5 DH .............................................. .................................................. ................. 10 mg
Ambra grisea 8 DH .............................................. .................................................. ............................. 10 mg
for a 1 g tablet.
The other components are :
Lactose, magnesium stearate, rice starch, sucrose, natural citrus flavor.
Pharmaceutical form and content
What is BIOMAG CITRUS, chewable tablet and contents of the pack?
BIOMAG CITRUS, tablet is a chewable tablet.
Box of 6 tablets of 15 tablets.
Name and address of the marketing authorization holder and the production authorization holder responsible for batch release, if different
Holder
LEHNING LABORATORIES
3 rue du petit marsh
57640 saint-beard
LA FRANCE
exploiting
LEHNING LABORATORIES
3 rue du petit marsh
57640 saint-beard
F rance
Maker
LEHNING LABORATORIES
3 rue du petit marsh
57640 saint-beard
LA FRANCE
Names of the drug in the member states of the European Economic Area
Not applicable.
Date of approval of the notice
The last date this notice was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet information
Detailed information on this medicine is available on the ANSM website (France).
Information reserved for health professionals
Not applicable.
Other
Not applicable.