Mucoangin Mint 20 mg Lozenges Ambroxol Hydrochloride
What Is Mucoangin Mint, And What Is It Used For?
Mucoangin Mint contains the active substance ambroxol hydrochloride. The active substance is part of the lozenge that has an effect.
Mucoangin Mint has a local anaesthetic effect that relieves the pain in the throat in case of a sore throat. The largest clinical study showed a positive effect within 20 minutes in 73% of patients. The effect lasts at least 3 hours. Mucoangin mint treats mild to moderate signs of a severe sore throat.
What you need to know before using Mucoangin Mint
Do not use Mucoangin Mint
- If you are allergic to ambroxol hydrochloride or any of the other ingredients of this medicine (listed in section 6).
Warnings And Cautions:
Talk to your doctor or pharmacist before using Mucoangin Mint.
- You should not use Mucoangin Mint for more than 3 days. If you still have symptoms after 3 days or a high fever, consult a doctor.
- If your doctor has told you that you are intolerant to some sugars, contact your doctor before taking this medicine. See also “Mucoangin Mint contains sorbitol and lactose”.
- If you have liver or kidney problems, consult your doctor before using Mucoangin Mint.
- Mucoangin Mint is unsuitable for treating painful mouth conditions (e.g. irritating/sore spots or sores). If you have sores in your mouth, consult a doctor.
- Shortness of breath ( dyspnoea ) may occur due to other concomitant illnesses (e.g. swelling of the throat/throat). Other reasons may be a feeling of pressure in the throat due to the local anaesthetic effect of Mucoangin Mint. An additional reason may be an allergic reaction that can cause mouth and throat swelling.
- If your throat and mouth feel less sensitive than usual (numbness)
- Severe skin reactions have been reported with the use of ambroxol hydrochloride. If you get a rash (including ulcers in the mucous membranes of, e.g. mouth, throat, nose, eyes, and genitals), stop using Mucoangin Mint and contact a doctor immediately.
Children:
If you are under 12, do not use Mucoangin Mint.
Other Drugs And Mucoangin Mint:
Tell your doctor or pharmacist if you are taking, have recently taken, or might take other medicines.
Pregnancy, Breastfeeding And Fertility:
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Ambroxol passes to the fetus. You should not take Mucoangin Mint if you are pregnant, especially not during the first three months. Ambroxol passes into breast milk. If you are breastfeeding, do not use Mucoangin Mint.
Driving And Using Machines:
No effects on the ability to drive and use machines are known. You are responsible for assessing whether you can drive a motor vehicle or perform work that requires sharpened vigilance.
One of the factors that can affect your ability in these respects is the use of drugs due to their effects and side effects. Descriptions of these effects and side effects can be found in other sections.
Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Mucoangin Mint Contains Sorbitol, Lactose And Sodium:
A lozenge contains 1.37 g of sorbitol.
Sorbitol is a source of fructose. If you (or your child) cannot tolerate certain sugars, or if you (or your child) have been diagnosed with hereditary fructose intolerance, a rare, inherited disease that prevents fructose from being broken down, consult a doctor before you (or your child) use this medicine. Sorbitol may cause gastrointestinal discomfort and have a mild laxative effect.
A lozenge contains less than 1 mg of lactose monohydrate (a sugar). If your doctor has told you that you are intolerant to some sugars, contact your doctor before taking this medicine.
Mucoangin Mint is largely sugar-free. This medicine contains less than 1 mmol (23 mg) sodium per lozenge, i.e. it is essentially ‘sodium-free’.
Mucoangin How To Use?
- Always use this medicine as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
- The recommended dose is:
- For adults and children over 12 years, let a 1 lozenge melt in your mouth when you need pain relief. You should not use more than 6 lozenges per day.
- You should not use Mucoangin Mint for more than 3 days. If you still have symptoms after 3 days or a high fever, consult a doctor.
If You Use More Mucoangin Mint Than You Should
No symptoms specific to overdose have been reported. If you take too many lozenges (more than 6 per day), consult a doctor or pharmacist if you notice any symptoms. If you have any further questions about using this product, ask your doctor or pharmacist.
Possible Ambroxol Hydrochloride Side Effects:
This medicine can cause side effects like all medicines, although not everybody gets them.
If any of the following side effects occur, stop taking Mucoangin Mint and contact your doctor immediately:
- Allergic reaction with local swelling of the face, lips, mouth, tongue and throat ( angioedema ). This can cause pressure over the throat and difficulty swallowing or breathing.
- Rapid onset of allergic reactions affecting the whole body (anaphylactic reactions including anaphylactic shock )
Additional side effects that may occur:
Common: may affect up to 1 in 10 users
- Nausea
- Numbness in the mouth, tongue and throat ( oral and pharyngeal hypoesthesia )
- Altered taste experience ( dysgeusia )
Uncommon: may affect up to 1 in 100 people
- Diarrhoea
- Stomach upset ( dyspepsia )
- Stomach pain (pain in the upper part of the gastrointestinal tract)
- Dry mouth
Rare: may affect up to 1 in 1,000 users
- Hypersensitivity reaction er
- Skin rash
- Hives
- Dryness in the throat
Has been reported (occurs in an unknown number of users):
(No exact calculation can be made as the side effects did not occur during clinical trials with 1226 patients. These side effects are likely to occur less often than ‘less common, but may occur less frequently):
- Anaphylactic reactions, including anaphylactic shock, angioedema
- Rapidly increasing swelling in and under the skin and in and under the mucous membranes
- Itching
- Severe skin reactions (including erythema multiforme, Stevens-Johnson syndrome / toxic epidermal necrolysis and acute generalized exanthematous pustulosis )
- Vomiting
How To Store Mucoangin Mint?
- Keep this medicine out of sight and reach of children.
- Do not use this medicine after the expiry date stated on the carton and aluminium foil. The expiration date (Exp. Date 🙂 is the last day of the specified month.
- Store Mucoangin Mint at a maximum of 30 ° C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.
Contents Of The Pack And Other Information
Content Declaration
- The active substance is ambroxol hydrochloride. A lozenge contains 20 mg of ambroxol hydrochloride.
- The other ingredients are
- Peppermint flavour (contains gum arabic, Chinese peppermint oil, maltodextrin, lactose monohydrate )
- Sorbitol
- Saccharin sodium
- Macrogol 6000
- Talc
What The Medicine Looks Like And The Contents Of The Pack?
- Mucoangin Mint 20 mg lozenges are round white tablets with bevelled edges. Both sides are flat. Mucoangin Mint 20 mg lozenges are supplied in plastic/aluminium blister cards.
- Pack sizes:
- 8, 10, 16, 18, 20, 24, 27, 30, 32, 36, 40, 45, 48 and 50 tablets.
- Not all pack sizes may be marketed.
Marketing Authorization Holder And Manufacturer
Opella Healthcare France SAS
82 Avenue Raspail, 94250
Gentilly, France
Manufacturer:
Delpharm Reims
10 rue Colonel Charbonneaux
51100 Reims
France
Local Representative
STADA Nordic ApS
Marielundvej 46 A
2730 Herlev
Denmark
This medicinal product is authorized under the European Economic Area under the names:
Belgium: Bisolangin®
Denmark: Netherlands, Sweden: Mucoangin ® Mint
Ireland: Lysopadol® Mint