NOTICE
ANSM - Updated: 24/06/2014
Name of the drug
COCCULINE, orodispersible tablet
framed
Read this leaflet carefully before taking 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 24 hours after travel, see a doctor.
· 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 COCCULINE, orodispersible tablet AND WHAT IT IS USED FOR?
2. BEFORE YOU TAKE COCCULINE, orodispersible tablet?
3. HOW TO TAKE COCCULINE, orodispersible tablet?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE COCCULINE, orodispersible tablet?
6. ADDITIONAL INFORMATION
1. WHAT IS COCCULINE, orodispersible tablet AND WHAT IT IS USED FOR?
Pharmacotherapeutic class
Not applicable
Therapeutic indications
COCCULINE, orodispersible tablet is a homeopathic medicine traditionally used in motion sickness.
2. BEFORE YOU TAKE COCCULINE, orodispersible 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
Not applicable.
Precautions for use; special warnings
Be careful with COCCULINE, orodispersible 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).
Interactions with other drugs
Not applicable
Interactions with food and drinks
Food and drinks
This medication is best taken away from meals.
Interactions with herbal products or alternative therapies
Not applicable
Use during pregnancy and lactation
Pregnancy
Ask your doctor or pharmacist for advice before taking any medicine.
feeding
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 COCCULINE, orodispersible tablet
This medicine contains lactose.
3. HOW TO TAKE COCCULINE, orodispersible 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 18 months.
· In adults:
2 tablets to be sucked 3 times a day the day before and the day of the trip.
2 tablets to suck at the onset of symptoms. Renew the plug if necessary.
· In children:
1 tablet to suck 3 times a day the day before and the day of the trip.
1 tablet to suck at the onset of symptoms. Renew the plug if necessary.
Stop taking as soon as symptoms disappear
Administration mode
Sublingual route
In children 18 months to 6 years old, dissolve the tablet in a little water before taking it because of the risk of a miscarriage.
Symptoms and instructions in case of overdose
Not applicable
Instructions for omitting one or more doses
Not applicable
Risk of withdrawal syndrome
Not applicable
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of adverse effects
Like all medicines, COCCULINE, orodispersible tablet can cause 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 COCCULINE, orodispersible tablet?
Keep out of the reach and sight of children.
Expiration date
Do not use COCCULINE, orodispersible tablet after the expiry date which is stated on the carton.
Storage conditions
Keep at a temperature not exceeding 30 ° C.
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 COCCULINE, orodispersible tablet contain?
The active substances are:
Cocculus indicus 4CH ............................................... .................................................. ................... 0.625 mg
Nux vomica 4CH ............................................... .................................................. ........................... 0.625 mg
Tabacum 4CH ................................................ .................................................. ............................. 0.625 mg
Petroleum 4CH ................................................ .................................................. ............................ 0.625 mg
For an orodispersible tablet of 250 mg.
The other components are:
Lactose, croscarmellose sodium, magnesium stearate.
Pharmaceutical form and content
What is COCCULINE, orodispersible tablet and contents of the pack?
This medicine comes in the form of a box of 40 orodispersible tablets.
Name and address of the marketing authorization holder and the production authorization holder responsible for batch release, if different
Holder
Boiron
2 AVENUE OF WESTERN LYONNAIS
69510 MESSIMY
exploiting
Boiron
2 AVENUE OF WESTERN LYONNAIS
69510 MESSIMY
Maker
Boiron
2 AVENUE OF WESTERN LYONNAIS
69510 MESSIMY
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 Afssaps (France) website.
Information reserved for health professionals
Not applicable
Other
Not applicable