LYSOPAINE Ambroksol MOUTHWASH SPRAY 20ML in our pharmacy Bio is a drug indicated for the relief of acute sore throat.
Lysopain oral spray solution is a medication indicated for the relief of acute sore throats. Ask your pharmacist about the benefits of Lysopain mouth spray.
Syrups and elixirs.
Lysopaïne mouthwash solution is now available in French pharmacies.
Lysopaine Sore Throat Mouth Spray is indicated for the relief of acute sore throats in adults and children over 12.
1 to 3 sprays a day
Ambroxol is an effective molecule for relieving acute sore throats. Ambroxol has :
Rare: dysgeusia, hypoesthesia of the mouth and pharynx, nausea may occur in some people.
20 ml bottle
If you're suffering from a mild sore throat, you can buy your own treatment and successfully treat yourself.
All you need to do is take what has worked for you in the past from your medicine cabinet, as many people don't necessarily want to run to the doctor at the first sign of symptoms, either for lack of time or to save money.
The pharmacist will be able to advise you effectively.
But if you notice that there's no improvement after 48 hours, and your condition seems to be getting worse: run to the doctor.
Similarly, if you have a sore throat accompanied by a fever, you should consult your doctor immediately: angina that is not properly treated can have serious repercussions.
Only he can prescribe the right treatment and, above all, determine whether the problem is viral or not.
Self-medication should therefore be used with moderation, and is not recommended for pregnant women, young children, people undergoing heavy medical treatment, or the elderly.
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Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Last updated: 20/04/2017
Ambroxol hydrochloride
You should always take this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any of the 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 experience no improvement or feel less well after 3 days.
1. What is LYSOPAINE THERMAL AMBROXOL MENT 17.86 mg / ml SUGAR-FREE, oral solution sweetened with sucralose and in which cases is it used?
2. What should be known before taking LYSOPAINE THROAT AMBROXOL MENTHE 17.86 mg / ml SUGAR-FREE, mouth-spraying solution sweetened with sucralose?
3. How to take LYSOPAINE THROAT AMBROXOL MENTHE 17.86 mg / ml SUGAR-FREE, oral solution sweetened with sucralose?
4. What are the possible side effects?
5. How to store LYSOPAINE THROAT AMBROXOL MENTHE 17.86 mg / ml SUGAR-FREE, oral solution sweetened with sucralose?
6. Package contents and other information
Pharmacotherapeutic group: local throat treatment / local preparation (local anesthetics).
This drug contains ambroxol hydrochloride which produces the therapeutic effect you need.
LYSOPAINE THROAT AMBROXOL MINT 17.86 mg / ml SUGAR-FREE, oral solution sweetened with sucralose exerts a local anesthetic effect, which relieves pain in cases of acute sore throat.
LYSOPAINE THROAT AMBROXOL MINT 17.86 mg / ml SUGAR-FREE, oral solution sweetened with sucralose is intended for the relief of acute sore throat in adults and children from 12 years.
You should contact your doctor if you experience no improvement or feel less well after 3 days.
· if you are allergic (hypersensitive) to ambroxol hydrochloride or to any of the other ingredients of this medication mentioned in section 6.
Warnings and Precautions
Talk to your doctor or pharmacist before taking LYSOPAINE THROAT AMBROXOL MENTHE 17.86 mg / ml SUGAR-FREE, oral solution sweetened with sucralose
· You should not use LYSOPAINE THROAT AMBROXOL MENTHE 17.86 mg / ml SUGAR-FREE, oral spray solution sweetened with sucralose for more than 3 days. If your symptoms persist after 3 days or if you have a high fever, consult your doctor.
· If you have liver or kidney problems, seek the advice of your doctor before using LYSOPAINE THROAT AMBROXOL MENTHE 17.86 mg / ml SUGAR-FREE, oral solution sweetened with sucralose.
· LYSOPAINE THROAT AMBROXOL MENTHE 17.86 mg / ml SUGAR-FREE, oral solution sweetened with sucralose is not intended to treat painful sores in the oral cavity (eg ulcers or sores). If you have mouth ulcers, see a doctor.
Respiratory difficulties (dyspnea) can be observed:
· linked to an underlying disease (eg, swelling of the throat),
· or a tight throat related to the local anesthetic effect of LYSOPAINE THROAT AMBROXOL MENTHE 17.86 mg / ml SUGAR-FREE,
· or an allergic reaction causing swelling of the mouth and throat.
· Your throat and mouth may be less sensitive than usual (numbness).
· Severe skin reactions associated with administration of ambroxol have been reported. If you develop a rash (including mucosal lesions in the mouth, throat, nose, eyes, genitals), stop using LYSOPAINE THROAT AMBROXIN MENTHE 17.86 mg / ml SUGAR-FREE, solution for oral spraying sweetened with sucralose and contact your doctor immediately.
children
This medication should not be used in children under 12 years of age.
Other drugs and LYSOPAINE THROAT AMBROXOL MENTHE 17.86 mg / ml SUGAR-FREE, oral solution sweetened with sucralose
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
LYSOPAINE THROAT AMBROXOL MENTHE 17.86 mg / ml SUGAR-FREE, oral spray solution sweetened with sucralose 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 medicine.
Pregnancy
Ambroxol passes into the organism of the unborn child. You should not take LYSOPAINE THERAPEUTIC SKIN AMBROXOL MENTHE 17.86 mg / ml SUGAR-FREE, oral solution sweetened with sucralose during pregnancy, especially during the first 3 months.
feeding
Ambroxol passes into breast milk. You should not take LYSOPAINE THROAT AMBROXOL MENTHE 17.86 mg / ml SUGAR-FREE, oral solution sweetened with sucralose if you are breast-feeding.
Driving and using machines
Not applicable.
LYSOPAINE THROAT AMBROXOL MINT 17.86 mg / ml SUGAR-FREE, sweetened oral spray solution contains ethanol and propylene glycol
This medicine contains small amounts of ethanol (alcohol) of less than 100 mg per dose (4 sprays).
This medicine contains propylene glycol which may cause irritation of the oral mucosa.
The recommended dose is:
In adults and children over 12 years of age, one dose (4 sprays) should be administered to the back of the throat to relieve pain. You should not take more than 6 doses a day.
Clinical studies have shown a rapid delay of action (with a first effect observed after 15 minutes), the effect will last at least three hours.
You should not use LYSOPAINE THROAT AMBROXOL MENTHE 17.86 mg / ml SUGAR-FREE, mouth spray solution sweetened with sucralose for more than three days. If your symptoms persist after three days or if you have a high fever, consult a doctor.
If you take more LYSOPAINE THROAT AMBROXOL MENTHE 17.86 mg / ml SUGAR-FREE, oral solution sweetened with sucralose you should not have
Immediately consult your doctor or pharmacist.
If you forget to take LYSOPAINE THROAT AMBROXOL MENTHE 17.86 mg / ml SUGAR-FREE, oral solution sweetened with sucralose
Do not take a double dose to make up for a missed dose.
If you stop taking LYSOPAINE THROAT AMBROXIN MENTHE 17.86 mg / ml SUGAR-FREE, oral solution sweetened with sucralose
Not applicable.
If you have any further questions on the use of this medication, ask your doctor or pharmacist.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
If you experience any of the following side effects, discontinue treatment with LYSOPAINE THROAT AMBROXIN MENTHE 17.86 mg / ml SUGAR-FREE, oral solution sweetened with sucralose and contact your doctor immediately :
· allergic reaction with localized swelling of the face, lips, mouth, tongue and / or throat (angioedema). This can result in a tight throat or difficulty swallowing or breathing.
· 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 to know before taking LYSOPAINE THROAT AMBROXIN MENTHE 17.86 mg / ml SUGAR-FREE, oral solution sweetened with sucralose ").
Other side effects may include:
Common: may occur in a maximum of 1 in 10 people
· Sickness of heart (nausea)
· Numbness of the mouth, tongue and throat (oral and pharyngeal hypoaesthesia)
· Altered taste (dysgeusia)
Uncommon: may occur in a maximum of 1 in 100
· Indigestion (dyspepsia)
· Stomach ache (pain in the upper abdomen)
· Dry mouth
Rare: can occur in maximum in 1 in 1,000 people
· Hypersensitivity reactions
· Rash, hives
· Diarrhea
· Dry throat
The following undesirable effects can not be estimated from the available data:
· Anaphylactic reactions, including anaphylactic shock, angioedema (rapid swelling of the skin, subcutaneous tissue, mucosa or submucosal tissue) and pruritus
· Severe skin reactions (including erythema multiforme, Stevens-Johnson syndrome / Lyell syndrome, and acute generalized acute exanthematous pustulosis)
· vomiting
Declaration of side effects
If you experience any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton and vial. The expiry date refers to the last day of that month.
Store at a temperature not exceeding 30 ° C.
After first opening, the medication should be stored for up to 6 months.
Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
· The active substance is:
Ambroxol hydrochloride.
1 spray contains 2.5 mg of ambroxol hydrochloride.
1 ml of spray contains 17.86 mg of ambroxol hydrochloride.
· The other components are: citric acid monohydrate, disodium phosphate dihydrate, polysorbate 20, sucralose, refreshing aroma (contains propylene glycol) menthol-eucalyptus flavoring (contains propylene glycol), ethanol and purified water.
This medication is in the form of a clear, almost colorless solution.
The spray is available in a glass bottle with a pump and an oral adapter.
Bottle of 20 ml or 30 ml.
Not all pack sizes may be marketed.
Marketing Authorization Holder
82 AVENUE RASPAIL
94250 GENTILLY
Marketing Authorization Operator
SANOFI-AVENTIS FRANCE
82 AVENUE RASPAIL
94250 GENTILLY
IM WIRRIGEN 25
45731 WALTROP
GERMANY
Names of the medicinal product 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: In accordance with the regulations in force.
The last date on which this leaflet was revised is:
[to be completed later by the holder]
<{MM / YYYY}> <{YYYY month}.>
Detailed information on this medicine is available on the ANSM website (France).
Oral preparation for analgesic purposes
ambroxol
. Presentations . Composition . Indications . Attention . Pregnancy and breastfeeding . Instructions for use and dosage . Side effects . Lexicon
LYSOPAINE AMBROXOL THROAT: solution for oral spray (mint flavor); bottle of 20 ml.
Not refunded - Free price -
Sanofi-Aventis Laboratory France
| p pulv | |
| Ambroxol hydrochloride | 2.5 mg |
| Alcohol | + |
| Propylene glycol | + |
Usual dosage:
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