NOTICE
ANSM - Updated on : 30/07/2024
IN THIS APPENDIX, THE TERMS "MARKETING AUTHORIZATION" AND "AUTHORIZATION" SHALL BE UNDERSTOOD AS "TRADITIONAL HERBAL MEDICINE REGISTRATION" AND "REGISTRATION" RESPECTIVELY.
Product name
SINUFIX, soft capsule
Lemon essential oil, thyme essential oil, peppermint essential oil.
Sidebar
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as it is prescribed by your doctor, pharmacist or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for any advice or information you may need.
- 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 SINUFIX, soft capsule and what is it used for?
2. What do I need to know before taking SINUFIX, softgel?
3. How do I take SINUFIX softgel?
4. What are the possible side effects?
5. How should SINUFIX softgels be stored?
6. Package contents and other information.
1. WHAT IS SINUFIX, soft capsule AND WHAT IS IT USED FOR?
SINUFIX, soft capsule is a traditional herbal medicine used in the symptomatic treatment of the common cold in adults.
Its use is reserved for the indication specified, based exclusively on the length of time it has been used.
You should consult your doctor if you do not feel better or feel worse after 5 days.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING SINUFIX, soft capsule?
Never take SINUFIX, soft capsule:
- If you are allergic to the active substances (terpene derivatives), or to any of the other ingredients of this medicine, as listed in section 6.
- If you are allergic to extracts of the following botanical species: Citrus, Thymus, Mentha.
- If you have liver disease, cholangitis, achlorhydria, gallstones or any other biliary disorder.
- If you have a history of epilepsy or convulsive seizures (contraindicated due to the presence of terpene derivatives).
Warnings and precautions
Talk to your doctor or pharmacist before taking SINUFIX, soft capsule.
Follow the recommended dosage and duration of treatment.
In the event of fever, breathing difficulties, purulent phlegm or worsening of symptoms while taking this medicine, consult a doctor.
Patients suffering from heartburn or hiatal hernia may experience an exacerbation of these symptoms after taking mint essential oil. Ask your doctor or pharmacist for advice before taking this medicine if you suffer from :
- heartburn,
- hiatal hernia,
- inflammation or ulceration of the gastrointestinal tract.
This speciality contains terpene derivatives which, in excessive doses, may lead to :
- convulsions in infants and children,
- respiratory pauses and collapse in infants.
Children and adolescents
In the absence of sufficient data in this population, the use of this drug is not recommended in children and adolescents under 18 years of age.
Other medicinal products and SINUFIX, soft capsule.
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
SINUFIX, softgel with food, drink and alcohol
Not applicable.
Pregnancy, breast-feeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Safety during pregnancy and lactation has not been established. This medicine is not recommended during pregnancy and lactation.
Driving and use of machinery
Not applicable.
SINUFIX, soft capsule contains
Not applicable.
3. HOW DO I TAKE SINUFIX, softgel capsule?
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
Adults: the recommended dose is 1 softgel 3 times a day.
Children and adolescents
Use in children and adolescents under 18 is not recommended.
Method of administration
Take by mouth.
Swallow capsule whole, without chewing, with a large glass of water.
Duration of treatment
5 days.
If symptoms persist beyond 5 days, consult a doctor or pharmacist.
If you have taken more SINUFIX softgels than you should have
Ask your doctor or pharmacist for advice.
If you forget to take SINUFIX, soft capsule
Do not take a double dose to make up for the one you forgot to take.
If you stop taking SINUFIX, soft capsule
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 product may cause undesirable effects, but these do not occur systematically in everyone.
Due to the presence of essential oils:
- Risk of allergic reactions,
- Possibility of digestive disorders, particularly gastralgia,
- Risk of convulsions in children.
The frequency of this type of reaction is unknown. If you experience any side effects not mentioned above, please consult a doctor or a qualified healthcare professional.
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 Centres Régionaux de Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr/.
By reporting adverse reactions, you contribute to providing more information on drug safety.
5. HOW TO USE SINUFIX, soft capsule?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the packaging. The expiration date refers to the last day of that month.
Store at a temperature not exceeding 30°C.
Do not take this medicine if you notice any damaged capsules.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to dispose of any medicines you no longer use. This will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What SINUFIX soft capsule contains
- The active ingredients are :
Lemon(Citrus limon (L.) Burman fil.) (essential oil of lemon pericarp).............................. 11.4 mg
Thyme(Thymus vulgaris L. or Thymus zygis L.) (essential oil of the aerial parts of) 11.4 mg
Peppermint(Mentha x piperita L.) (essential oil of the fresh aerial parts of)... 11.4 mg
For one softgel capsule.
- Other ingredients include
Medium-chain triglyceride (RSPO: roundtable on sustainable palm oil).
Capsule shell : bovine gelatin, glycerol, water.
What is SINUFIX softgel and what does it contain?
Cardboard box of 15 soft capsules in blister packs (PVC/PVDC/Aluminium).
Marketing authorization holder
SYLVEOS SAS
12 AVENUE DE LA GRANDE ARMEE
75017 PARIS
Marketing authorization holder
UPSA SAS
3 RUE JOSEPH MONIER
92500 RUEIL MALMAISON
Manufacturer
NextPharma Ploërmel
Z.I. de Camagnon
56800 Ploërmel
Drug names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder]
{month YYYY}.
Other
Detailed information on this drug is available on the ANSM (France) website.