In this manual :
1. WHAT IS COCCULINE, orodispersible tablet AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE TAKING COCCULINE, orodispersible tablet
3. HOW DO I TAKE COCCULINE, Orodispersible Tablet?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE COCCULINE, orodispersible tablet?
6. ADDITIONAL INFORMATION
1. WHAT IS COCCULINE, orodispersible tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
Not applicable
COCCULINE, orodispersible tablet is a homeopathic medicine traditionally used for motion sickness.
2. WHAT YOU SHOULD KNOW BEFORE TAKING COCCULINE, orodispersible tablet
List of information needed before taking the medicine
- If your doctor has informed you of an intolerance to certain sugars, contact him/her before taking this medicine.
Not applicable.
Precautions and special warnings
Take care with COCCULINE, orodispersible tablet:
- This medicine should not be used in patients with galactose intolerance, Lapp lactase deficiency or glucose/galactose malabsorption syndrome (rare hereditary diseases).
Interactions with other medicines
Not applicable
Interactions with food and drink
Food and drink
This medicine should preferably be taken with meals.
Interactions with herbal products or alternative therapies
Not applicable
Use during pregnancy and breastfeeding
Pregnancy
Ask your doctor or pharmacist for advice before taking any medicine.
Breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Not applicable
Effects on ability to drive and use machines
Not applicable
List of excipients with a known effect
Important information about certain ingredients of COCCULINE, orodispersible tablet
This medicine contains lactose.
3. HOW TO TAKE COCCULINE, orodispersible tablet
Instructions for proper use
Not applicable
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
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 travel.
2 tablets to be sucked as soon as the symptoms appear. Repeat if necessary.
- In children:
1 tablet to be sucked 3 times a day the day before and the day of travel.
1 tablet to be sucked as soon as symptoms appear. Repeat if necessary.
Stop taking as soon as symptoms disappear
Method of administration
Sublingual route
In children aged 18 months to 6 years, dissolve the tablet in a little water before taking it because of the risk of a false start.
Symptoms and instructions in case of overdose
Not applicable
Instructions in case of missed dose(s)
Not applicable
Risk of withdrawal syndrome
Not applicable
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, COCCULINE, orodispersible tablet is likely to have side effects, although not everyone is likely to experience them.
If you notice any side effects not listed in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
5. HOW TO CONSERVE COCCULINE, orodispersible tablet?
Keep out of the reach and sight of children.
Do not use COCCULINE, orodispersible tablet after the expiry date stated on the box.
Store at a temperature not exceeding 30°C.
If necessary, warnings against certain visible signs of deterioration
Do not dispose of the medicine in the sewer or in the household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.
6. ADDITIONAL INFORMATION
Full list of active ingredients and excipients
What does COCCULINE, orodispersible tablet contain?
The active ingredients 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.
Other components are:
Lactose, croscarmellose sodium, magnesium stearate.
Pharmaceutical form and content
What is COCCULINE, orodispersible tablet and what does it contain?
This medicine is presented in a box of 40 orodispersible tablets.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
BOIRON
20 RUE DE LA LIBERATION
69110 SAINTE FOY LES LYON
FRANCE
Operator
BOIRON
20 RUE DE LA LIBERATION
69110 SAINTE FOY LES LYON
FRANCE
Manufacturer
BOIRON
2 AVENUE DE L'OUEST LYONNAIS
69510 MESSIMY
FRANCE
Names of the medicinal product in the Member States of the European Economic Area
Not applicable
Date of approval of the package leaflet
The last date on which this package leaflet was approved was {date}.
MA under exceptional circumstances
Not applicable
Detailed information on this medicinal product is available on the website of Afssaps (France).
Information reserved for health professionals
Not applicable
Not applicable