NOTICE
ANSM - Updated: 07/09/2015
Name of the drug
SINUSPAX chewable tablet
framed
Read all of this leaflet carefully before you start using 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.
Summary notice
What does this booklet contain :
1. What is SINUSPAX chewable tablet and what is it used for?
2. What information do you need to know before using SINUSPAX Chewable Tablet ?
3. How to use SINUSPAX chewable tablet ?
4. What are the possible side effects?
5. How to store SINUSPAX chewable tablets ?
6. Additional information.
1. WHAT IS SINUSPAX chewable tablet AND WHAT IT IS USED FOR
Pharmacotherapeutic class
Not applicable.
Therapeutic indications
SINUSPAX chewable tablet is a homeopathic medicine traditionally used in the adjunctive treatment of sinusitis and in the treatment of rhinitis.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE SINUSPAX chewable tablets
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 use SINUSPAX Chewable Tablet:
· if you are allergic (hypersensitive) to the active substances or to any of the other ingredients of this medicine, listed in section 6.;
· in children under 6 years old.
Precautions for use; special warnings
Warnings and precautions for use
Talk to your doctor or pharmacist before using SINUSPAX Chewable Tablet .
The use of this drug is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).
The use of this drug is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase / isomaltase (rare hereditary diseases) deficiency.
Given the presence of the Silicea strain in the formula, this drug should not be used in cases of otitis or sinusitis without medical advice.
Given the presence of the Hepar sulfur strain in the formula, this drug should not be used in cases of otitis or sinusitis without medical advice.
Interactions with other drugs
Other medicines and SINUSPAX chewable tablet:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Interactions with food and drinks
SINUSPAX chewable tablet with food, drinks and alcohol:
This medication is best taken away from meals.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
· In the absence of experimental and clinical data and as a precaution, the use of this drug should be avoided during pregnancy and lactation.
· Ask your doctor or pharmacist for advice before taking any medicine.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
SINUSPAX Chewable Tablet contains lactose, sucrose and mannitol.
3. HOW TO USE SINUSPAX chewable tablet?
Instructions for a good use
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if in doubt.
Dosage, Mode and / or Route (s) of Administration, Frequency of Administration and Duration of Treatment
Dosage
Reserved for adults and children over 6 years old.
Adults: 2 chewable tablets 2 to 3 times a day.
Children over 6 years old: 1 chewable tablet 2 to 3 times a day.
Melt under the tongue, preferably away from meals.
Administration mode
Sublingual route.
Frequency of administration
Space the catches as soon as possible and stop the catches as soon as the symptoms disappear.
Duration of treatment
The duration of treatment should not exceed 10 days.
Symptoms and instructions in case of overdose
If you take more SINUSPAX chewable tablets than you should:
Immediately consult your doctor or pharmacist.
Instructions for omitting one or more doses
If you forget to take SINUSPAX Chewable Tablet:
Do not take a double dose to make up for the tablet you forgot to take.
Risk of withdrawal syndrome
Not applicable.
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 SINUSPAX chewable tablet?
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
No special storage conditions.
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 SINUSPAX contains chewable tablets:
· The active substances are:
Belladonna 3DH ................................................ .................................................. ................. 20.0 mg
Calcarea carbonica ostrearum 3DH .............................................. .......................................... 20.0 mg
Calcarea fluorica 3DH ............................................... .................................................. .......... 20.0 mg
Cinnabaris 8DH ................................................ .................................................. .................. 20.0 mg
Hepar sulfuris calcareum 5DH .............................................. .................................................. 20.0 mg
Hydrastis canadensis 3DH ............................................... .................................................. ... 20.0 mg
Kalium bichromicum 5DH ............................................... .................................................. ..... 20.0 mg
Kalium sulfuricum 4DH ............................................... .................................................. ......... 20.0 mg
Manganum sulfuricum 3DH ............................................... .................................................. ... 20.0 mg
Sabadilla 3DH ................................................ .................................................. .................... 20.0 mg
Silicea 5DH ................................................ .................................................. ........................ 20.0 mg
Thuya occidentalis 2DH ............................................... .................................................. ....... 20.0 mg
For a 500 mg tablet
· The other components are:
Lactose, sucrose, mannitol (E421), magnesium stearate.
Pharmaceutical form and content
Aspect of SINUSPAX chewable tablet and package contents
This medicine comes in the form of chewable tablets in blister packs.
Box of 3 platelets of 20 chewable tablets.
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
LEHNING LABORATORIES
3 RUE DU PETIT MARAIS
57640 SAINTE BARBE
LA FRANCE
exploiting
LEHNING LABORATORIES
3 RUE DU PETIT MARAIS
57640 SAINTE BARBE
LA FRANCE
Maker
LEHNING LABORATORIES
3 RUE DU PETIT MARAIS
57640 SAINTE BARBE
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.