Mucodox
Italy
Table of Contents
Package leaflet: Information for the patient
MUCODOX 0.8 g/100 ml syrup, 100 mg hard capsules
Sobrerol
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.
- Keep this leaflet. You may need to read it again.
- If you need more information or advice, consult your pharmacist.
- If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
- Contact your doctor if you do not notice any improvement or if your symptoms worsen.
Contents of this leaflet:
- What MUCODOX is and what it is used for
- What you need to know before taking MUCODOX
- How to take MUCODOX
- Possible side effects
- How to store MUCODOX
- Contents of the pack and other information
1. What MUCODOX is and what it is used for
MUCODOX contains the active substance sobrerol, which belongs to a group of medicines called mucolytics, that reduce the viscosity of mucus, liquefying it and facilitating its elimination.
MUCODOX is indicated to facilitate the removal of excess mucus in acute and chronic respiratory tract disorders.
2. What you need to know before taking MUCODOX
Do not take MUCODOX
- if you are allergic to sobrerol or to any of the other ingredients of this medicine (listed in section 6).
Do not give this medicine to children under 2 years of age (see “Children”).
Do not give MUCODOX to children with a history of epilepsy or febrile seizures.
Warnings and precautions
Talk to your doctor or pharmacist before taking MUCODOX.
This medicine contains sobrerol which, in excessive doses, may cause neurological disorders such as seizures in newborns and children.
Do not extend treatment beyond 3 days due to the risks associated with the accumulation of terpene derivatives in the body, including the brain, and particularly the risk of neuropsychiatric disorders.
Children
Do not administer this medicine to children under 2 years of age, as it may cause bronchial obstruction. The ability to clear bronchial mucus is limited in this age group due to the characteristics of the respiratory tract.
Other medicines and MUCODOX
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not use MUCODOX if you are also taking other products (medicinal or cosmetic) containing terpene derivatives (e.g. camphor, cineole, niaouli, wild thyme, terpineol, terpin, citral, menthol, and essential oils of pine needles, eucalyptus, and turpentine), regardless of the route of administration (oral, rectal, cutaneous, or pulmonary).
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Take MUCODOX only when strictly necessary and under direct medical supervision.
Driving and using machines
MUCODOX does not impair the ability to drive vehicles or operate machinery.
MUCODOX 0.8 g/100 ml syrup contains sucrose, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, ethanol and sodium
This medicine contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
This medicine contains 6 g of sucrose per 1 measuring spoon (10 ml). This should be taken into account in patients with diabetes mellitus.
This medicine contains methyl p-hydroxybenzoate and propyl p-hydroxybenzoate, which may cause allergic reactions (including delayed reactions).
This medicine contains 986.25 mg of alcohol (ethanol) per maximum daily dose (children over 2 years), i.e. 20 ml of MUCODOX syrup, and up to 1,973 mg of alcohol (ethanol) per maximum daily dose (adults), i.e. 40 ml of MUCODOX syrup.
The amount of alcohol in 20 ml of this medicine is equivalent to 25 ml of beer or 10.4 ml of wine per maximum daily dose (children over 2 years).
The amount of alcohol in 40 ml of this medicine is equivalent to 50 ml of beer or 20.8 ml of wine per maximum daily dose (adults).
The small amount of alcohol in this medicine does not appear to have an effect in adults and adolescents, and its effects in children are not clearly evident. However, some effects may occur in young children, for example drowsiness.
The alcohol in this medicine may alter the effects of other medicines. Talk to your doctor or pharmacist if you are taking other medicines.
If you are pregnant or breastfeeding, talk to your doctor or pharmacist before taking this medicine.
If you have alcohol dependence, consult your doctor or pharmacist before taking this medicine.
This medicine contains 28 mg of sodium (a key component of table salt) per dose (20 ml). This corresponds to 1.4% of the maximum recommended daily dietary intake for an adult.
3. How to take MUCODOX
Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
MUCODOX 0.8 g/100 ml syrup
Adults: the recommended dose is 1–2 measuring cups (10–20 ml) twice daily.
Children over two years of age: the recommended dose is 1 measuring cup (10 ml) twice daily.
MUCODOX 100 mg capsules
Adults: the recommended dose is 2–4 capsules twice daily.
If you take more MUCODOX than you should
No cases of overdose are known.
In case of accidental ingestion/overdose of MUCODOX, contact your doctor immediately or go to the nearest hospital.
If you forget to take MUCODOX
Do not take a double dose to make up for the missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following side effects may occur:
Frequency not known (frequency cannot be estimated from the available data)
- Stomach disturbances and nausea.
- Bronchial obstruction.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store MUCODOX
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
The stated expiry date applies to the product if unopened and stored correctly.
Syrup: no special precautions for storage.
Hard capsules: store at a temperature not exceeding 30°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What MUCODOX contains
MUCODOX 0.8 g/100 ml syrup
The active substance is sobrerol. 100 ml of syrup contain 800 mg of sobrerol.
The other components are: sucrose, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, sodium dihydrogen phosphate, glycerine, caramel (E 150), cardamom flavour, saccharin, sodium hydroxide, ethyl alcohol, purified water.
MUCODOX 100 mg hard capsules
The active substance is sobrerol. Each hard capsule contains 100 mg of sobrerol.
The other components are: maize starch, talc, magnesium stearate.
Capsule constituents
Body: titanium dioxide (E171), gelatin. Cap: iron oxide (E172), indigotine (E 132), gelatin.
Description of the appearance of MUCODOX and contents of the pack
MUCODOX 0.8 g/100 ml syrup
Syrup at 0.8 g/100 ml. Each pack contains one 150 ml bottle.
MUCODOX 100 mg hard capsules
Hard capsules of 100 mg. Each pack contains 20 capsules.
Marketing Authorisation Holder
Meda Pharma s.p.a., via Felice Casati 20, 20124 Milano (MI) - Italy
Manufacturer
Laboratorio Farmacologico Milanese S.r.l. – Via Monterosso, 273 - 21042 Caronno Pertusella (VA)