NOTICE
ANSM - Updated: 13/10/2016
Name of the drug
OSCILLOCOCCINUM, granules in single-dose container
framed
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medicine exactly as described in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Talk to your pharmacist for any advice or information.
· If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or if you feel worse after 3 days.
Summary notice
What does this booklet contain :
1. What is OSCILLOCOCCINUM, granules in a single-dose container and in which cases is it used?
2. What information do you need to know before taking OSCILLOCOCCINUM, granules in a single-dose container?
3. How to take OSCILLOCOCCINUM, granules in single-dose container?
4. What are the possible side effects?
5. How to store OSCILLOCOCCINUM, granules in single-dose container?
6. Additional information.
1. WHAT IS OSCILLOCOCCINUM, granules in a single-dose container AND WHAT IT IS USED FOR?
Pharmacotherapeutic class
Not applicable.
Therapeutic indications
OSCILLOCOCCINUM is a homoeopathic medicine traditionally used in the treatment of flu: fever, chills, headache, body aches.
2. BEFORE YOU TAKE OSCILLOCOCCINUM, 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
Never take OSCILLOCOCCINUM, granules in single-dose container:
· if you are allergic (hypersensitive) to the active substance or to any of the other ingredients of this medicine, listed in section 6.
Precautions for use; special warnings
Warnings and precautions for use
OSCILLOCOCCINUM can not replace seasonal influenza vaccination.
This medicine contains sucrose. Its use is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase / isomaltase (rare hereditary diseases) deficiency.
This medicine contains lactose. Its use is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).
Interactions with other drugs
Other medicines and OSCILLOCOCCINUM, granules in single-dose container:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Interactions with food and drinks
OSCILLOCOCCINUM, granules in single dose container with food, drinks and alcohol:
This medicine is to be taken away from meals.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy, lactation and fertility
Given the dilution height, and despite the lack of sufficient experimental and clinical data, OSCILLOCOCCINUM can be taken during pregnancy and lactation.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
OSCILLOCOCCINUM, granules in a single-dose container contains sucrose and lactose.
3. HOW TO TAKE OSCILLOCOCCINUM, 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
As soon as possible, as soon as the first symptoms of the flu condition appear, take 1 dose 3 times a day for 1 to 3 days.
If symptoms persist beyond 3 days, consult your doctor.
Administration mode
Sublingual route.
In adults: melt entire contents of a dose under the tongue or in a little water.
| | |
Remove the single-dose container of its packaging. | Open by removing cap. | Put the whole content in the mouth and let it melt under the tongue. |
In children: before 6 years old, dissolve the granules in a little water because of the risk of false route.
Symptoms and instructions in case of overdose
If you take more OSCILLOCOCCINUM, single dose granules than you should have:
Immediately consult your doctor or pharmacist.
Instructions for omitting one or more doses
If you forget to take OSCILLOCOCCINUM, granules in single-dose container:
Do not take a double dose to make up for the dose you forgot to take.
Risk of withdrawal syndrome
Not applicable.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist for more information.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of adverse effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr
By reporting side effects, you can help provide more information about the safety of the medicine.
5. HOW TO STORE OSCILLOCOCCINUM, granules in single-dose container?
Keep this medicine out of the sight and reach of children.
Expiration date
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of this month.
Storage conditions
This medicine does not require any special storage precautions.
If necessary, warn against some visible signs of deterioration
Do not dispose of any medication at the sewer or with household waste. Ask your pharmacist to eliminate medications that you no longer use. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Complete list of active substances and excipients
What OSCILLOCOCCINUM contains, granules in a single-dose container:
· The active substance is:
Fluid extract peptone liver and heart of Anas Barbariae boosted to 200 K.
· The other components are:
Sucrose, lactose.
Pharmaceutical form and content
Appearance of OSCILLOCOCCINUM, granules in single-dose container and contents of the pack
OSCILLOCOCCINUM is in the form of granules in a single-dose container. They are packaged in a box of 1, 6 or 30 single doses.
Name and address of the marketing authorization holder and the production authorization holder responsible for batch release, if different
Marketing Authorization Holder and Manufacturer
Holder
Boiron
2 AVENUE OF WESTERN LYONNAIS
69510 MESSIMY
LA FRANCE
exploiting
Boiron
2 AVENUE OF WESTERN LYONNAIS
69510 MESSIMY
LA FRANCE
Maker
The head office
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 leaflet was last revised is {date}.
AMM under exceptional circumstances
Not applicable.
Internet information
Detailed information on this medicine is available on the ANSM website (France).
Information reserved for health professionals
Not applicable.
Other
Not applicable.