NOTICE
ANSM - Updated: 24/06/2014
Name of the drug
CREAM WITH CALENDULA, cream
Calendula officinalis mother tincture
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 1 week, 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 CALENDULA CREAM, CREAM AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU USE CALENDULA CREAM, cream?
3. HOW TO USE CALENDULA CREAM, cream?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE CALENDULA CREAM, cream?
6. ADDITIONAL INFORMATION
1. WHAT CALENDULA CREAM, CREAM AND WHAT IT IS USED FOR
Pharmacotherapeutic class
Not applicable.
Therapeutic indications
CALENDULA CREAM, cream is a homeopathic medicine traditionally used in the adjunctive treatment of irritated skin.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE CALENDULA CREAM, cream?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never use CALENDULA CREAM, cream:
· Hypersensitivity to Calendula or any of the excipients.
Precautions for use; special warnings
Not applicable.
Interactions with other drugs
Not applicable.
Interactions with food and drinks
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast 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
Not applicable.
3. HOW TO USE CALENDULA CREAM, cream?
Instructions for a good use
Not applicable.
Dosage, Mode and / or Route (s) of Administration, Frequency of Administration and Duration of Treatment
Dosage
Apply the cream once or twice a day, on a carefully cleaned skin. Massage lightly to penetrate.
Administration mode
Dermal.
Duration of treatment
The treatment should not exceed 1 week.
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, CALENDULA CREAM cream can cause side effects, although not everybody gets them.
Risk of skin reactions in people sensitive to Calendula.
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 CALENDULA CREAM, cream?
Keep out of the reach and sight of children.
Expiration date
Do not use CALENDULA CREAM, cream after the expiry date which is stated on the carton.
Storage conditions
No special storage conditions.
Do not store beyond 6 months after opening.
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 CREME AU CALENDULA contain, cream?
The active substance is:
Calendula officinalis tincture .............................................. .................................................. ....... 0.880g
For a 20g jar of cream.
The other components are:
Glycerin, stearic acid, 30% sodium hydroxide solution, perhydrosqualene, purified water, perfume (Astral Venus essence).
Pharmaceutical form and content
What CALENDULA CREAM, cream and contents of the pack?
This medicine comes in the form of a cream. Pot (PP / PE) of 20 g.
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 de l'Ouest 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.