NOTICE
ANSM - Updated on: 05/11/2020
IN THIS ANNEX, THE TERMS "MARKETING AUTHORIZATION" SHALL BE MEAN AS "TRADITIONAL PLANT-BASED MEDICINAL PRODUCT REGISTRATION" AND THE TERM "AUTHORIZATION" AS "REGISTRATION"
Name of the drug
BELIVAIR RUM PELARGONIUM, film-coated tablet
Dry extract of Pelargonium root
Box
Read all of this leaflet carefully before taking this medicine as it contains important information for you.
You should always take this medication by carefully following the information provided in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you get any side effects, talk to your doctor or pharmacist. This also applies to any side 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 7 days.
What does this booklet contain ?
1. What is BELIVAIR RHUME PELARGONIUM, film-coated tablet and in which cases it is used?
2. What you need to know before you take BELIVAIR RHUME PELARGONIUM, film-coated tablet?
3. How to take BELIVAIR RHUME PELARGONIUM, film-coated tablet?
4. What are the possible side effects?
5. How to store BELIVAIR RHUME PELARGONIUM, film-coated tablet?
6. Contents of the pack and other information.
1. WHAT BELIVAIR RHUME PELARGONIUM, film-coated tablet IS AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: Traditional herbal medicine
BELIVAIR COLD PELARGONIUM, film-coated tablet is a traditional herbal medicine used for the symptomatic treatment of colds.
Its use is reserved for the indication specified on the sole basis of long-standing use.
BELIVAIR RHUME PELARGONIUM, film-coated tablet is indicated for adults, adolescents and children over 6 years of age.
You should talk to your doctor or pharmacist if you do not feel better or if you feel worse after 7 days.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BELIVAIR PELARGONIUM RUM, film-coated tablet?
Do not take BELIVAIR RHUME PELARGONIUM, film-coated tablet
· if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
· if you have severe liver or kidney disease.
Warnings and precautions
Talk to your doctor or pharmacist before taking BELIVAIR RHUME PELARGONIUM, film-coated tablet .
While using the medication, if symptoms worsen, talk to your doctor.
In the event of signs of hepatic toxicity (such as nausea, loss of appetite, epigastric pain, fatigue, yellow discoloration of the skin ...), immediately stop the administration of the drug and consult a doctor.
Due to the chemical structure of the active substance, special precautions must be taken in patients on anticoagulant therapy (see section '' other medicines and BELIVAIR RHUME PELARGONIUM).
Children
The use of the drug is not recommended in children under 6 years of age due to the lack of data.
Other medicines and BELIVAIR COLD PELARGONIUM, film-coated tablet
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
This product can influence the coagulation parameters and can increase the effect of anticoagulants (such as warfarin). Under these circumstances, if bleeding occurs while using BELIVAIR RHUME PELARGONIUM, stop taking the treatment and consult your doctor or pharmacist
BELIVAIR RUM PELARGONIUM, film-coated tablet with food and drink
Not applicable.
Pregnancy and breast feeding
Due to the lack of sufficient data, the use of this drug is not recommended during pregnancy and lactation.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine .
Driving and using machines
Not applicable.
BELIVAIR RHUME PELARGONIUM, film-coated tablet contains
Not applicable.
3. HOW TO TAKE BELIVAIR RHUME PELARGONIUM, film-coated tablet?
Always take this medication exactly as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Swallow the tablet without chewing it with a sufficient quantity of liquid.
Dosage
The recommended dose is:
Adults and adolescents over 12 years of age:
One tablet 3 times a day (morning, noon and evening)
Use in children:
Children 6 to 12 years old:
One tablet twice a day (morning and evening).
Children under 6:
The use of this medication is not recommended in children under 6 years of age due to the lack of data.
Administration mode :
Oral use.
Duration of treatment
If symptoms persist beyond 7 days while using the medication, consult your doctor.
Do not exceed the recommended dose.
If you take more BELIVAIR RHUME PELARGONIUM film-coated tablet than you should
No case of overdose has been reported. If you take more BELIVAIR RHUME PELARGONIUM than you should, consult your doctor or pharmacist who will take the necessary measures.
If you forget to take BELIVAIR RHUME PELARGONIUM, film-coated tablet
Do not take a double dose to make up for the dose you forgot to take, but continue treatment with the usual dose at the usual time.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist for more information.
If you stop taking BELIVAIR RHUME PELARGONIUM, film-coated tablet
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects observed are:
Very rare (may affect up to 1 in 10,000 people):
Moderate gastrointestinal disturbances (diarrhea, epigastric discomfort, nausea or vomiting, dysphagia), slight bleeding from the gums and nose as well as allergic reactions have been reported.
Frequency not known (cannot be estimated from the available data):
Hepatotoxicity has been reported
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to any side 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 network of Regional Pharmacovigilance Centers - Website: www.signalement-sante.gouv.fr
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE BELIVAIR RHUME PELARGONIUM, film-coated tablet?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package after {"EXP"}. The expiration date refers to the last day of this month.
This medication does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist to dispose of the medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION
What BELIVAIR RHUME PELARGONIUM contains, film-coated tablet
· The active substance is:
Pelargonium ( Pelargonium sidoides DC or mixture P.sidoides DC with P.reniforme Curt .) (Dry root extract of) ......................... .................................................. .................................................. .......... 20 mg
Extraction solvent: ethanol 14% V / V.
Drug / Extract Ratio 4-7: 1.
For one tablet
· The other excipient components are:
Core : anhydrous colloidal silica, microcrystalline cellulose, magnesium stearate.
Coating : hypromellose, talc, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), macrogol 6000.
Adjuvants of the extract : powdered cellulose, anhydrous colloidal silica.
What BELIVAIR RHUME PELARGONIUM, film-coated tablet looks like and contents of the pack
Box of 15, 20 or 30 film-coated tablets in blister packs (PVC / PVDC / Aluminum.
Not all presentations may be marketed.
Marketing authorization holder
THERABEL LUCIEN PHARMA
19 RUE ALPHONSE DE NEUVILLE
75017 PARIS
Marketing authorization operator
THERABEL LUCIEN PHARMA
19 RUE ALPHONSE DE NEUVILLE
75017 PARIS
Maker
WIEWELHOVE GMBH
DÔRNEBRINK 19
49479 IBBENBÜREN
GERMANY
Names of the drug in the member states of the European Economic Area
This medicine is authorized in the member states of the European Economic Area under the following names: In accordance with the regulations in force.
[To be completed later by the holder]
The last date on which this leaflet was revised is:
[To be completed later by the holder]
Other
Detailed information on this medicine is available on the ANSM website (France).