NOTICE
ANSM - Updated on : 28/06/2022
Product name
RHINEA, single-dose oral solution
Sidebar
Please read this leaflet carefully before using this medicine, as it contains important information for you.
You must always use this medicine in strict accordance with the information provided in this leaflet or by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for advice and information.
- If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well after 5 days.
What does this leaflet contain?
1. What is RHINEA, single-dose oral solution and what is it used for?
2. What do I need to know before using RHINEA, single-dose oral solution?
3. How do I use RHINEA, Oral Solution in a single-dose container?
4. What are the possible side effects?
5. How do I keep RHINEA, single-dose oral solution?
6. Package contents and other information.
1. WHAT IS RHINEA, single-dose oral solution AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: Homeopathic medicines.
RHINEA, single-dose oral solution is a homeopathic medicine traditionally used for rhinopharyngitis with nasal congestion or mucous discharge.
Indicated for children aged 1 month to 12 years.
2. WHAT DO I HAVE TO KNOW BEFORE USING RHINEA, single-dose oral solution?
Never use RHINEA, single-dose oral solution
- if you are allergic to the active substances or to any of the other components of this medicine, as listed in section 6.
- in children under 1 month of age.
Warnings and precautions
Talk to your doctor or pharmacist before using RHINEA, single-dose oral solution.
DO NOT INSTILL INTO THE EYE, EAR OR NOSE.
DO NOT INJECT.
If symptoms persist or worsen beyond 5 days, or in the event of fever over 38.5°C or purulent sputum, consult a doctor.
Children
This presentation is reserved for children aged 1 month to 12 years.
Other medicines and RHINEA, single-dose oral solution
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
RHINEA, single-dose oral solution with food and drink
Not applicable.
Pregnancy, breast-feeding and fertility
Not applicable.
Driving and use of machinery
Not applicable.
3. HOW TO USE RHINEA, single-dose oral solution?
Always use this medicine exactly as instructed in this leaflet, or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
The recommended dose is 1 single-dose 4 to 6 times a day for 5 days.
Space out doses as soon as the condition improves.
Method of administration
Oral administration.
- Wash hands before use.
- Do not store single-dose containers after opening. Discard single-dose containers after each use.
- Children should be placed in a sitting position before administration.
To ensure that the solution is always sterile, use a new container each time.
1. Open foil pouch.
2. Detach single-dose container from clip.
3. Open the unit-dose container by turning the cap.
4. Pour the contents of the container into the mouth, pressing lightly.
5. Carefully close the sachet containing the other single-dose containers by folding over the open side.
Duration of treatment
Do not exceed 5 days' treatment without medical advice.
If symptoms worsen during treatment, consult your doctor.
If you have used more RHINEA, oral solution in single-dose containers than you should have
Consult your doctor or pharmacist immediately.
If you forget to use RHINEA, single-dose oral solution
Do not take a double dose to make up for the one you forgot to take.
If you stop using RHINEA, single-dose oral solution
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone.
Reporting side effects
If you experience any side effects, please tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Regional Pharmacovigilance Centers.
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO CONSERVE RHINEA, single-dose oral solution?
Before opening the sachet: no special storage precautions.
After opening the sachet: single-dose containers must be used within 12 months.
After opening the single-dose container:
- The product must be used immediately.
- Discard the single-dose container after use.
- Do not store for future use.
Keep out of sight and reach of children.
Do not use after the expiration date indicated on the packaging. The expiration date refers to the last day of that month.
Do not use this medicine if you notice that the container is damaged or has already been opened, as there is a risk of rapid bacterial contamination.
Do not dispose of any medicine in the garbage . Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What RHINEA, single-dose oral solution, contains
- The active ingredients are :
Dulcamara 8 DH......................................................................................................... 333.3 mg
Atropa belladonna 8 DH............................................................................................... 333.3 mg
Sambucus nigra 4 DH ................................................................................................. 333.3 mg
For a 1 mL single-dose container.
- Other ingredients: purified water.
What RHINEA, oral solution in unidose container is and what it contains
This medicine comes in the form of a 1 mL single-dose oral solution.
Boxes of 15, 20 or 30 single-dose containers.
Not all presentations may be marketed.
Marketing authorization holder
LG HOMEO
AVENUE DU GENERAL DE GAULLE
14200 HEROUVILLE SAINT-CLAIR
FRANCE
Marketing authorization holder
LABORATOIRES GILBERT
928 AVENUE DU GENERAL DE GAULLE
14200 HEROUVILLE SAINT-CLAIR
FRANCE
Manufacturer
LABORATOIRES GILBERT
AVENUE DE CAMBRIDGE
14200 HEROUVILLE SAINT-CLAIR
FRANCE
Product names in member states of the European Economic Area
Not applicable.
This leaflet was last revised on :
{month YYYY}.
Other
Detailed information on this drug is available on the ANSM (France) website.