NOTICE
ANSM - Updated on: 20/04/2017
Description of the Medicine
LYSOPAÃ NE THROAT AMBROXOL LEMON 20 mg without sugar, sweetened sorbitol and sucralose tablet
Ambroxol hydrochloride
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Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medication by strictly following the information provided in this leaflet or by your doctor or pharmacist.
AT· Keep this leaflet. You might need to read it again.
AT· Contact your pharmacist for advice or information.
AT· If you experience any of the side effects, talk to your doctor or pharmacist. This also applies to any undesirable effects not mentioned in this leaflet. See section 4.
AT· You should contact your doctor if you experience no improvement or feel less well after 3 days.
What is in this leaflet?
1. What is LYSOPAĆ NE THROAT AMBROXOL LEMON 20 mg SUGAR-free, sorbitol and sucralose-sweetened tablet and in which cases is it used?
2. What information should I take before taking LYSOPAĆ NE THROAT AMBROXOL LEMON 20 Mg WITHOUT SUGAR, sorbitol and sucralose sweetened tablet ?
3. How to take LYSOPAÃ NE THROAT AMBROXOL LEMON 20 mg WITHOUT SUGAR, sorbitol and sucralose sweetened tablet ?
4. What are the possible undesirable effects?
5. How to store LYSOPAĆ NE THROAT AMBROXOL LEMON 20 mg SUGAR-free, sorbitol and sucralose-sweetened tablet ?
6. Contents of the package and other information .
1. WHAT LYSOPAÑA NEEDS THROAT AMBROXOL LEMON 20 mg SUGAR-FREE, sweetened sorbitol and sucralose tablet AND IN WHAT CASES IS IT USED?
Local throat treatment / local preparation (local anesthetics).
LYSOPAĆ NE THROAT AMBROXOL LEMON 20 mg SUGAR-FREE, sorbitol-sweetened sorbitol and sucralose has a local anesthetic effect, which relieves pain in cases of acute sore throat.
LYSOPAÃ NE THROAT AMBROXOL LEMON 20 mg SUGAR-FREE, sorbitol and sucralose-sweetened tablet is intended for the relief of acute sore throat.
2. BEFORE YOU TAKE LYSOPAE NEAR THROAT AMBROXOL LEMON 20 mg SUGAR-FREE, sorbitol and sucralose-sweetened tablet?
Never take LYSOPAÃ NE THROAT AMBROXOL LEMON 20 mg WITHOUT SUGAR, sorbitol and sucralose sweetened tablet:
AT· if you are allergic (hypersensitive) to ambroxol or to any of the other ingredients of this medication mentioned in section 6,
AT· in case of fructose intolerance due to the presence of sorbitol.
Warnings and Precautions
Talk to your doctor or pharmacist before taking LYSOPAÃ NE THROAT AMBROXOL LEMON 20 Mg WITHOUT SUGAR, sorbitol and sucralose sweetened tablet:
You should not use LYSOPAÃ NE THROAT AMBROXOL LEMON 20 mg WITHOUT SUGAR, sorbitol and sucralose sweetened tablet for more than 3 days. If your symptoms persist after 3 days or if you have a high fever, consult your doctor.
If your doctor has told you that you are intolerant of certain types of sugars, please contact your doctor before taking this medication. See also "Important information about some of the ingredients of LYSOPAÃ NE BROMBON MILK AMBROXOL LEMON 20 mg SUGAR-FREE, sorbitol and sucralose-sweetened tablet" .
If you have any problems with the medicine, consult your physician's opinion before using it. LYSOPAÃ NE BROMINO AMBROXOL LEMON 20 Mg WITHOUT SUGAR, sorbitol sweetened with sucralose.
LYSOPAĆ NE THROAT AMBROXOL LEMON 20 mg SUGAR-FREE, sorbitol-sweetened sucralose tablet is not intended to treat painful lesions of the oral cavity (eg ulcers or sores ). If you have oral ulcers, consult a physician.
Can be observed:
AT· Respiratory difficulties (dyspnea) related to underlying disease (eg, swelling of the throat).
AT· A tight throat sensation related to the local anesthetic effect of LYSOPAÃ NE THROAT AMBROXOL LEMON 20 mg WITHOUT SUGAR, sweetened sorbitol and sucralose tablet.
AT· Finally, an allergic reaction leads to swelling of the mouth and throat.
Your throat and mouth may be less sensitive than usual (numbness).
Severe skin reactions have been reported in the administration of ambroxol. If a rash appears on your skin (including mucosal lesions, such as in the mouth, throat, nose, eyes, organs), stop using LYSOPAÃ NE THROAT AMBROXOL LEMON 20 mg WITHOUT SUGAR, sweetened sorbitol and sucralose tablet and contact your doctor immediately.
children
This medication should not be used in children under 12 years of age.
Other medicines and LYSOPAÃ NE THROAT AMBROXOL CASSIS 20 mg SUGAR-FREE, sorbitol and sucralose-sweetened tablet
Inform your doctor or pharmacist if you are taking, have recently taken or may be taking any other medicines.
LYSOPAÃ NE THROAT AMBROXOL CASSIS 20 mg SUGAR-FREE, sweetened sorbitol and sucralose tablets with food, drink and alcohol
Not applicable.
Pregnancy, breast-feeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor or pharmacist for advice before taking this medication.
Pregnancy
Ambroxol passes into the organism of the child to be born. Taking this medication is not recommended during pregnancy, especially during the first 3 months.
feeding
Ambroxol passes into breast milk. You should not take LYSOPAÃ NE BRONG THROATS AMBROXOL LEMON 20 mg SUGAR-FREE, sorbitol-sweetened tablet and sucralose if you are breast-feeding.
Driving and using machines
Not applicable.
LYSOPAÃ NE THROAT AMBROXOL LEMON 20 mg SUGAR-FREE, sorbitol-sweetened sucralose tablet contains sorbitol and sucrose (contained in the arsenic)
One pellet contains 1.37 g of sorbitol (equivalent to 8.2 g of sorbitol per maximum recommended daily dose) and 6.3 mg of sucrose (equivalent to 37.8 mg of sucrose per maximum daily dose recommended), which are a source of fructose (a certain type of sugar). If you suffer from fructose intolerance, you should not take this medication.
If your doctor has told you that you are intolerant of certain types of sugars, please contact your doctor before taking this medication.
3. HOW TO TAKE LYSOPAĆ NE THROAT AMBROXOL LEMON 20 mg SUGAR-FREE, sweetened sorbitol and sucralose tablet?
Always take this medication exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if you are unsure.
The recommended dose is:
In adults and children over 12 years of age, a tablet should be sucked to relieve pain. You should not take more than 6 pills a day.
You should not use LYSOPAÃ NE THROAT AMBROXOL LEMON 20 mg SUGAR-free, sorbitol-sweetened tablet and sucralose for more than three days.
If your symptoms persist after three days or if you are experiencing a major fever, please consult a physician.
The clinical data showed a rapid action (within 20 minutes maximum). This effect will last at least three hours.
If you take more LYSOPAÃ NE THROAT AMBROXOL LEMON 20 Mg WITHOUT SUGAR, sorbitol and sucralose sweetened tablet that you should not have "
If you have taken too many tablets (more than 6 per day), consult your doctor or pharmacist if you have abnormal symptoms.
If you forget to take LYSOPAÃ NE THROAT AMBROXOL LEMON 20 Mg WITHOUT SUGAR, sorbitol and sucralose sweetened tablet
Do not take a double dose to make up for the missed dose.
If you stop LYSOPAÃ NE THROAT AMBROXOL CASSIS 20 mg SUGAR-FREE, sorbitol and sucralose-sweetened tablet
Not applicable.
If you have any further questions about the use of this medication, ask your doctor or pharmacist.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medication can cause side effects, although not everybody gets them.
If you experience any of the following side effects, discontinue LYSOPAINE NEARLY THERAPEUTIC AMBROXOL LEMON 20 mg WITHOUT SUGAR, sorbitol and sucralose sweetened tablet and contact your doctor immediately ately:
AT· allergic reaction with localized swelling of the face, lips, mouth, tongue and / or throat (Angioedema). This can result in a tight throat sensation or difficulty in swallowing or breathing.
AT· allergic reactions occurring rapidly and affecting the body as a whole (anaphylactic reactions including anaphylactic shock).
The severity of allergic reactions may increase if you take the product again, or if you are taking another product containing the same substance ( see section 2 "What should be known before taking LYSOPAÃ NE THROAT AMBROXOL LEMON 20 mg WITHOUT SUGAR, sorbitol and sucralose sweetener " ).
Other undesirable effects may include:
Frequent: can occur in a maximum of 1 in 10 people
AT· sickness (nausea)
AT· numbness of the mouth, tongue and throat (oral hypoesthesia and pharyngeal)
AT· impairment of taste (dysgeusia)
Uncommon: may occur in a maximum of 1 in 100
AT· Diarrha © e
AT· indigestion (dyspepsia)
AT· stomach pain (pain in the upper abdomen)
AT· dry mouth
Rare: can occur in maximum in 1 in 1,000 people
AT· hypersensitivity reactions
AT· Skin rash, urticaria
AT· dry throat
Undetermined Frequency: Can not be estimated on the basis of available data
(A precise estimate of the frequency is not possible because the undesirable effect did not occur in a clinical trial database of 1226 patients. Is not superior to Low Frequency (3/1226), but may be lower.)
AT· anaphylactic reactions, including anaphylactic shock, angioedema (rapid swelling of the skin, subcutaneous tissue, mucosa or submucosal tissue) and pruritus
AT· severe cutaneous reactions (including polymorphic rhythm, Stevens-Johnson Syndrome / Lyell Syndrome, and acute generalized acute exanthematosis)
AT· vomiting
Declaration of side effects
If you experience any side effects, talk to your doctor, pharmacist or nurse. This also applies to any undesirable effects not mentioned in this leaflet. You can also report undesirable effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (NSAH) and network of Pharmacovigilance Regional Centers - Website: www.ansm.sante.fr
By reporting adverse effects, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE LYSOPAĆ NE THROAT AMBROXOL LEMON 20 mg SUGAR-FREE, sorbitol and sucralose-sweetened tablet?
Keep this medication out of the reach and sight of children.
Do not use this medication after the expiration date on the carton and on the label. The redemption date refers to the last day of the month.
Keep at a temperature not exceeding 30 ° C.
Do not throw any medicines into the sewer or with the household garbage. Ask your pharmacist to discontinue the medications you are no longer using. These measures will protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What LYSOPAÃ NE NEXT THICKEN AMBROXOL LEMON 20 Mg WITHOUT SUGAR, sorbitol and sucralose sweetened tablet
AT· The active substance is:
Ambroxol hydrochloride .............................................. .................................................. 20 mg
AT· The other components are: Lemon (containing sucrose), Frescofort, sorbitol (E420), sucralose, macrogol 6000, talc.
What is LYSOPAÃ NE THROAT AMBROXOL LEMON 20 mg WITHOUT SUGAR, sorbitol and sucralose sweetened tablet and contents of the outer packaging
This medication is in the form of a round, white patch with beveled edges and two flat faces.
Box of 12, 18, 24, 30, 36, 42, 48 pads under brackets (Aluminum / Aluminum).
Not all presentations may be marketed.
Holder of the marketing authorization
SANOFI-AVENTIS FRANCE
82 AVENUE RASPAIL
94250 GENTILLY
Operator of the marketing authorization
SANOFI-AVENTIS FRANCE
82 AVENUE RASPAIL
94250 GENTILLY
Maker
DELPHARM REIMS
10 RUE COLONEL CHARBONNEAUX
51100 REIMS
Names of medicines in the 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:
The last date on which this notice was revised is as follows:
[To be subsequently completed by the Contractor]
<{MM / YYYY}> <{YYYY month}.>
Other
Detailed information on this medicinal product is available on the website of the ANSM (France).