In this manual :
1. WHAT IS COCCULINE, granules in a single-dose container AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE TAKING COCCULINE, granules in a single-dose container
3. HOW DO I TAKE COCCULINE, granules in a single-dose container?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE COCCULINE, granules in a single-dose container?
6. ADDITIONAL INFORMATION
1. WHAT IS COCCULINE, granules in a single-dose container AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
Not applicable
COCCULINE, granules in a single-dose container is a homeopathic medicine traditionally used for motion sickness.
2. WHAT YOU SHOULD KNOW BEFORE TAKING COCCULINE, granules in a single-dose container
List of information needed before taking the medicine
- If your doctor has informed you of an intolerance to certain sugars, contact him or her before taking this medicine.
Not applicable.
Precautions and special warnings
Take care with COCCULINE, granules in a single-dose container:
- The use of this medicine is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase/isomaltase deficiency (rare hereditary diseases).
- The use of this medicine is not recommended 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 significant effect
Important information about some of the ingredients of COCCULINE, granules in single-dose containers:
This medicine contains lactose and sucrose.
3. HOW TO TAKE COCCULINE, granules in a single-dose container
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.
1 dose of granules the day before and 1 dose just before departure.
1 dose of granules as soon as symptoms appear.
Repeat if necessary. Stop taking as soon as symptoms disappear
Method of administration
Sublingual route. Let the granules melt under the tongue.
In children between 18 months and 6 years of age, dissolve the granules in a little water before taking them 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, granules in unidose container is likely to have side effects, although not everyone is subject to 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 STORE COCCULINE, granules in single-dose containers
Keep out of the reach and sight of children.
Do not use COCCULINE, granules in a single-dose container after the expiry date stated on the box.
No special storage precautions.
If necessary, warnings against certain visible signs of deterioration
Do not dispose of the medicine in the sewage system or in your 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 granules in a single-dose container contain?
The active ingredients are:
Cocculus indicus 4CH ................................................................................................................... 0,0025 ml
Nux vomica 4CH ........................................................................................................................... 0,0025 ml
Tabacum 4CH .............................................................................................................................. 0,0025 ml
Petroleum 4CH ............................................................................................................................. 0.0025 ml
For one tube of granules in a single-dose container of 1 g.
Other components are:
Lactose, sucrose.
Pharmaceutical form and contents
What is COCCULINE, granules in a single-dose container and what does it contain?
This medicine is presented as granules in a single-dose container.
Box of 3 or 6 tubes.
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
20 RUE DE LA LIBERATION
69110 SAINTE FOY LES LYON
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.
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