NOTICE
ANSM - Updated on : 09/11/2021
Product name
SINUPHYL, film-coated tablet
Dried extract of gentian root, primrose flowers, sorrel, elderflower and verbena.
Sidebar
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as instructed 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 7 to 14 days.
What does this leaflet contain?
1. What is SINUPHYL, film-coated tablet and what is it used for?
2. What do I need to know before taking SINUPHYL, film-coated tablet?
3. How do I take SINUPHYL, film-coated tablet?
4. What are the possible side effects?
5. How do I keep SINUPHYL, film-coated tablet?
6. Package contents and other information.
1. WHAT IS SINUPHYL, film-coated tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: other cold preparations, ATC code: R05X
Herbal medicine used to treat acute, uncomplicated inflammation of the paranasal sinuses in adults.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING SINUPHYL, film-coated tablet?
Never take SINUPHYL:
- if you are allergic (hypersensitive) to the active substance or to any of the other ingredients of this medicine (listed in section 6), or
- if you have, or have had, a peptic ulcer.
Warnings and precautions
Consult your doctor if symptoms persist for more than 7 to 14 days, worsen or recur periodically and/or if you experiencefever, nosebleeds, severe pain, purulent nasal discharge, blurred vision, asymmetric numbness of the mid-face, eyes or face.
With known gastritis and in patients with a sensitive stomach, special care is required when taking this medicine. Sinuphyl is best taken after meals, with a glass of water.
Children and adolescents
Use in children and adolescents under 18 years of age is not recommended due to lack of sufficient data.
Other drugs and SINUPHYL
No interaction studies have been performed.
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
Pregnancy and breast-feeding
For safety reasons, Sinuphyl should not be taken during pregnancy.
It is not known whether the active ingredients in Sinuphyl are excreted in breast milk. Sinuphyl should not be used during breast-feeding.
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.
Driving and using machines
Sinuphyl may have a minor influence on the ability to drive vehicles and operate machinery in patients with the possible side effect "dizziness" (see section 4).
Sinuphyl contains glucose and sucrose.
If your doctor has informed you that you have an intolerance to certain sugars, contact your doctor before taking Sinuphyl.
Information for diabetics :
One film-coated tablet contains an average of 0.3 g of digestible carbohydrates.
3. HOW DO I TAKE SINUPHYL, film-coated tablet?
Always take 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.
The recommended dose is :
Adults: 1 film-coated tablet 3 times a day (maximum 3 film-coated tablets a day).
There is insufficient evidence for specific dosage recommendations in cases of renal/hepatic impairment.
Method of administration
Sinuphyl should be swallowed 3 times a day (morning, noon and evening) with a little liquid (e.g. a glass of water), without chewing. If you have a sensitive stomach, it's best to take Sinuphyl after a meal.
Duration of treatment
Unless otherwise indicated, Sinuphyl should be taken for 7 to 14 days. If no improvement is noted, or if symptoms persist beyond this period, please consult a doctor.
If you have taken more Sinuphyl than you should have
If you have taken more Sinuphyl than you should have, please inform your doctor. He/she will decide what action to take. The side effects listed below (e.g. nausea, stomach ache, diarrhoea) may be more severe.
If you forget to take SINUPHYL
If you accidentally take too little Sinuphyl or forget to take it, do not take a double dose next time to make up for the one you forgot to take, but continue to take Sinuphyl as prescribed by your doctor or as indicated in this leaflet.
If you stop taking SINUPHYL
Stopping Sinuphyl is generally safe.
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 automatically in everyone.
Common side effects (up to 1 in 10 people)
Digestive disorders such as abdominal pain, nausea, diarrhea, bloating, vomiting.
Uncommon adverse reactions (up to 1 in 100 people)
Local hypersensitivity reactions such as skin rashes, skin redness, itching of the skin or eyes, and severe allergic reactions such as swelling of the face and neck.swelling of the lips, tongue, throat and/or larynx, with narrowing of the airways, shortness of breath, facial swelling, dizziness.
If the first signs of a hypersensitivity reaction appear, Sinuphyl should be discontinued.
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 STORE SINUPHYL, film-coated tablet?
Do not store above 30°C.
Keep out of sight and reach of children.
Do not use this medicine after the expiration date shown on the pack and blister. The expiration date refers to the last day of that month.
6. CONTENTS AND OTHER INFORMATION
What SINUPHYL contains
- The active substance is a native dry extract (3-6:1) of gentian root(Gentiana lutea L.), primrose flowers(Primula veris L.), curled sorrel(Rumex crispus L.), elderflower(Sambucus nigra L.), verbena(Verbena officinalis L.) (1:3:3:3:3).
1st extracting agent: ethanol 51% (w/w)*5. Each film-coated tablet contains 160.00 mg native dry extract.
- Other components are : sucrose, talc, calcium carbonate (E170), microcrystalline cellulose, maltodextrin, cellulose powder, hypromellose, dextrin, spray-dried acacia, colloidal hydrophobic silica, anhydrous hydrophobic silica, titanium dioxide (E 171), liquid glucose, vegetable magnesium stearate.vegetable magnesium arate, stearic acid, chlorophyll powder 25% (contains copper-chlorophyllin E141), dindigotin aluminium lake (contains indigotin E132 and aluminium hydroxide), carnauba wax, riboflavin (E101).
What SINUPHYL is and what it contains
Sinuphyl film-coated tablets are green, round, biconvex with a smooth surface.
Presentation of 20 film-coated tablets, 2 blisters each containing 10 film-coated tablets
40 film-coated tablets, 4 blisters each containing 10 film-coated tablets
Not all presentations may be marketed.
Marketing authorization holder
BIONORICA SE
Kerschensteinerstrasse 11-15
92318 Neumarkt
Germany
Marketing authorization holder
BOIRON
2 AVENUE DE LOUEST LYONNAIS
69510 MESSIMY
Manufacturer
BIONORICA SE
Kerschensteinerstrasse 11-15
92318 Neumarkt
Germany
Product names in member states of the European Economic Area
This medicinal product is authorized in the member states of the European Economic Area under the following names: In accordance with current regulations.
[To be completed subsequently by the holder].
The last date on which this leaflet was revised was :
[to be completed later by the holder]
{month YYYY}.
Other
Detailed information on this drug is available on the ANSM (France) website.