Therapeutic indications
LYSOPAINE SORE THROAT AMBROXOL CITRON 20 mg SUGAR-FREE lozenge sweetened with sorbitol and sucralose has a local anaesthetic effect, which relieves pain in case of acute sore throat.
LYSOPAINE SORE THROAT LEMON 20 mg SUGAR-FREE lozenge sweetened with sorbitol and sucralose is intended for the relief of acute sore throat.
2. WHAT DO YOU NEED TO KNOW BEFORE TAKING LYSOPAINE SORE THROAT AMBROXOL CITRON 20 mg SUGAR-FREE, pastille sweetened with sorbitol and sucralose?
List of information needed before taking the medicine
Not applicable.
Contraindications
Do not take LYSOPAINE HEALTH SICKNESS LEMON 20 mg SWEET lozenge sweetened with sorbitol and sucralose in the following cases:
- - if you are hypersensitive (allergic) to ambroxol or to any of the other ingredients contained in LYSOPAINE EARTH AID LEMON 20 MG SUGAR-FREE 20 mg lozenge (see section 6),
- - in case of intolerance to fructose due to the presence of sorbitol.
Precautions for use; special warnings
Be careful with LYSOPAINE HEALTH AILMENTS LEMON 20 mg SUGAR-FREE lozenge sweetened with sorbitol and sucralose:
For adults and children over 12 years of age only.
You should not use LYSOPAINE HEALTH AIL 20 mg SUGAR-FREE lozenge sweetened with sorbitol and sucralose for more than 3 days. If your symptoms persist after 3 days or if you have a high fever, please consult your doctor.
If your doctor has told you that you have an intolerance to certain types of sugars, please contact your doctor before taking this medicine. See also "Important information about some of the ingredients of LYSOPAINE HEALTH AID LEMON 20 mg SUGAR-FREE lozenge sweetened with sorbitol and sucralose ".
If you have liver or kidney problems, ask your doctor before using LYSOPAINE HEALTH AID LEMON 20 mg SUGAR-FREE lozenge sweetened with sorbitol and sucralose.
LYSOPAINE TEARSETTLE 20 mg SUGAR-FREE CITRON AMBROXOL lozenge sweetened with sorbitol and sucralose is not intended to treat painful lesions of the oral cavity (e.g. ulcers or sores). If you have mouth ulcers, please consult a doctor.
May be observed:
- - Difficulty breathing (dyspnoea) related to an underlying disease (e.g. swelling of the throat).
- - A feeling of tightness in the throat due to the local anaesthetic effect of LYSOPAINE HEALTHY LIME 20 mg SUGAR-FREE lozenge sweetened with sorbitol and sucralose.
- - Finally, an allergic reaction resulting in swelling of the mouth and throat.
Your throat and mouth may be less sensitive than usual (numbness).
If extensive skin or mucous membrane lesions occur, as a precautionary measure, treatment with LYSOPAINE HEALTHY LIME 20 mg SUGAR-FREE lozenge sweetened with sorbitol and sucralose should be discontinued and a doctor should be consulted immediately. Severe skin lesions (with a possible diagnosis of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis (TEN)) have been reported very rarely in chronological association with the administration of expectorants, e.g. ambroxol. Ambroxol is also the active ingredient in LYSOPAINE HEALTH AID LEMON 20 mg SUGAR-FREE lozenge sweetened with sorbitol and sucralose. In most cases, these skin lesions may be explained by the severity of the patient's underlying disease (various infections), or by medications used to treat these conditions or other intercurrent conditions or pre-existing severe skin lesions which may begin with non-specific prodromal symptoms similar to those of influenza.
Interactions with other drugs
Use of other drugs:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medication, even if it is obtained without a prescription.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy
Ambroxol passes into the body of the unborn child. It is not recommended during pregnancy, especially during the first 3 months.
Breastfeeding
Ambroxol passes into breast milk. You should not take LYSOPAINE HEALTH AIL 20 mg SUGAR-FREE lozenge sweetened with sorbitol and sucralose if you are breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Sportsmen
Not applicable.
Effects on ability to drive and use machines
Driving and use of machines :
Not applicable.
List of excipients with a known effect
Important information about some of the ingredients of LYSOPAINE HEALTH AID LEMON 20 mg SUGAR-FREE lozenge sweetened with sorbitol and sucralose:
List of excipients with notorious effect: Sorbitol, sucrose (contained in the flavouring).
One lozenge 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 recommended daily dose) which is a source of fructose (a type of sugar). If you have fructose intolerance, you should not take this medicine.
If your doctor has told you that you have an intolerance to certain types of sugars, please contact your doctor before taking this medicine.
3. HOW TO TAKE LYSOPAINE HEALTH AIL 20 mg SUGAR-FREE, lozenge sweetened with sorbitol and sucralose?
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Always take LYSOPAINE HEADSET LEMON 20 mg SUGAR-FREE lozenge sweetened with sorbitol and sucralose exactly as instructed below:
In adults and children over 12 years of age, one lozenge should be sucked to relieve pain. You should not take more than 6 lozenges per day.
You should not use LYSOPAINE HEALTH AIL 20 mg SUGAR-FREE lozenge sweetened with sorbitol and sucralose for more than 3 days.
If your symptoms persist after three days or if you develop a high fever, consult a doctor.
Clinical data has shown a rapid onset of action (within 20 minutes). This effect will last at least three hours.
Symptoms and instructions in case of overdose
If you have taken more LYSOPAINE HEALTH AID 20 mg SWEET LETTER sweetened with sorbitol and sucralose than you should have:
If you have taken too many lozenges (more than 6 per day), consult your doctor or pharmacist in case of abnormal symptoms.
Instructions in case of missed dose(s)
If you forget to take LYSOPAINE HEALTH AID LEMON 20 mg SUGAR-FREE lozenge sweetened with sorbitol and sucralose:
Do not take a double dose to make up for the single dose you forgot to take.
Risk of withdrawal syndrome
Not applicable.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist for more information.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, LYSOPAINE HEALTH AID LEMON 20 mg SUGAR-FREE lozenge sweetened with sorbitol and sucralose is likely to have side effects, although not everyone is likely to have them.
If you experience any of the following side effects, discontinue use of If you experience any of the following side effects, discontinue use of LYSOPAINE HEALTH AID LEMON 20 mg SUGAR-FREE lozenge sweetened with sorbitol and sucralose and contact your doctor immediately:
- - allergic reaction with localised swelling of the face, lips, mouth, tongue and/or throat (angioedema). This may include a feeling of a tight throat or difficulty swallowing or breathing.
- - rapid onset of allergic reactions affecting the whole body (anaphylactic reactions including anaphylactic shock).
The severity of allergic reactions may increase if you take the product again, or if you take another product containing the same substance (see section 2 "What you should know before taking LYSOPAINE HEALTHY LIQUOR AMBROXOL 20 mg SUGAR-FREE lozenge sweetened with sorbitol and sucralose")
Other adverse reactions may occur:
Common (in less than 1 in 10 treated patients, but in more than 1 in 100 treated patients):
- - Heartache (nausea)
- - numbness of the mouth, tongue and throat (oral and pharyngeal hypoesthesia)
- - Altered taste (dysgeusia)
Uncommon (in less than 1 in 100 treated patients, but in more than 1 in 1000 treated patients):
- - diarrhea
- - indigestion (dyspepsia)
- - stomach ache (pain in the upper abdomen)
The frequency of the following adverse reactions cannot be estimated from the available data:
- - itching (urticaria, pruritus)
- - skin rash
- - allergic reactions (other hypersensitivity reactions)
- - vomiting
Reporting side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly to the National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres - website: www.ansm.sante.fr. By reporting adverse reactions, you contribute to providing more information on the safety of the drug.
5. HOW TO USE LYSOPAINE HEALTH AIL 20 mg SUGAR-FREE, pastille sweetened with sorbitol and sucralose?
Keep out of the reach and sight of children.
Expiry date
Do not use LYSOPAINE HEALTH AID LEMON 20 mg SUGAR-FREE lozenge sweetened with sorbitol and sucralose after the expiry date shown on the box and on the blister. The expiry date refers to the last day of the month.
Storage conditions
Store at a temperature not exceeding 30°C.
If necessary, warnings against certain visible signs of deterioration
Do not dispose of medicines down the drain or in the household waste. Ask your pharmacist what to do with unused medicines. This will help protect the environment.
6. ADDITIONAL INFORMATION
Complete list of active ingredients and excipients
What does LYSOPAINE HEALTH AID LEMON 20 mg SUGAR-FREE lozenge sweetened with sorbitol and sucralose contain?
The active substance is :
Ambroxol hydrochloride ..................................................................................................................... 20 mg
For one lozenge.
The other components are:
Lemon flavour (containing sucrose), Frescofort flavour, sorbitol (E420), sucralose, macrogol 6000, talc.
Pharmaceutical form and content
What is LYSOPAINE HEALTH AID LEMON 20 mg SUGAR-FREE lozenge, sweetened with sorbitol and sucralose, and what does it contain?
This medicine comes in the form of a round, white lozenge with bevelled edges and two flat sides.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
BOEHRINGER INGELHEIM FRANCE
14, RUE JEAN ANTOINE DE BAÏF
75013 PARIS
Français
English
