NOTICE
ANSM - Updated: 24/06/2014
Name of the drug
COCCULINE, granules in single-dose container
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, granules in a single-dose container AND WHAT IT IS USED FOR?
2. BEFORE YOU TAKE COCCULINE, granules in a single-dose container
3. HOW TO TAKE COCCULINE, granules in single-dose container?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE COCCULINE, granules in single-dose container?
6. ADDITIONAL INFORMATION
1. WHAT IS COCCULINE, granules in a single-dose container AND WHAT IT IS USED FOR?
Pharmacotherapeutic class
Not applicable
Therapeutic indications
COCCULINE, granules in single-dose container is a homeopathic medicine traditionally used in motion sickness.
2. BEFORE YOU TAKE COCCULINE, granules in a single-dose container
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
Take care with COCCULINE, granules in single-dose container:
· The use of this drug is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase / isomaltase (rare hereditary diseases) deficiency.
· 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, granules in single-dose container:
This medicine contains lactose and sucrose.
3. HOW TO TAKE COCCULINE, granules in single-dose container?
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.
1 dose of granules the day before and 1 dose just before departure.
1 dose of granules at the onset of symptoms.
Renew the plug if necessary. Stop taking as soon as symptoms disappear
Administration mode
Sublingual route. Melt the granules under the tongue.
In children 18 months to 6 years old, dissolve the granules in a little water before taking because of the risk of a false route.
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 granules in single-dose containers may 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 COCCULINE, granules in single-dose container?
Keep out of the reach and sight of children.
Expiration date
Do not use COCCULINE, granules in a single-dose container after the expiry date which is stated on the carton.
Storage conditions
No special precautions of conservation.
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 contain, granules in a single-dose container?
The active substances are:
Cocculus indicus 4CH ............................................... .................................................. .................. 0,0025 ml
Nux vomica 4CH ............................................... .................................................. .......................... 0,0025 ml
Tabacum 4CH ................................................ .................................................. ............................ 0.0025 ml
Petroleum 4CH ................................................ .................................................. ........................... 0,0025 ml
For a tube of granules in a single-dose container of 1 g.
The other components are:
Lactose, sucrose.
Pharmaceutical form and content
What is COCCULINE, granules in single-dose container and contents of the pack?
This medicine is in the form of granules in a single-dose container.
Box of 3 or 6 tubes.
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
20 RELEASE STREET
69110 SAINTE FOY LES LYON
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.