0.5 mg / ml + 1 mg / ml oral solution
Bromhexine hydrochloride and ephedrine hydrochloride
What Mollisupradine is and what it is used for
Mollisupradine contains bromhexine and ephedrine. Bromhexine is considered to make the mucus in the airways thinner. It can facilitate the expectoration of mucus. Ephedrine dilates the trachea and has a decongestant effect on the mucous membranes.
Mollisupradine is used for coughs with viscous mucus and at the same time needs a bronchodilator effect.
Bromhexine and ephedrine contained in Mollisupradine may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before you use Mollisupradine
Do not use Mollisupradine:
– if you are allergic to bromhexine, ephedrine, or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor or pharmacist before taking Mollisupradine.
You must talk to a doctor before using this medicine:
- if you have a history of heart disease, irregular heartbeat or angina
- if you have heart disease, high blood pressure , high levels of thyroid hormone in the blood ( hyperthyroidism ), enlarged prostate , glaucoma , diabetes or stomach ulcers
- if you have bloody cough
Mollisupradine may cause dry mouth. Careful oral hygiene (brushing with fluoride toothpaste twice a day) while using Mollisupradine is therefore important.
Severe skin reactions have been reported with the use of bromhexine. If you get a rash (including ulcers in the mucous membranes of eg mouth, throat, nose, eyes, genitals), stop using Mollisupradine and contact a doctor immediately.
At high doses and long-term use, there is a certain risk of developing an addiction.
Other medicines and Mollisupradine
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may affect or be affected by treatment with Mollisupradine, for example:
- MAO inhibitors and tricylic antidepressants (antidepressants)
- medicines for high blood pressure
- dexamethasone (cortisone preparation)
- cardiac glycosides (for the treatment of heart problems)
- quinidine (for the treatment of heart rhythm problems)
- ergot alkaloids (for the treatment of migraines )
- oxycytocin (to initiate labor)
- anesthetics (narcotics) such as cyclopropane or halothane
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
No adverse effects in the fetus have been shown, but normal caution applies especially during the first 3 months of pregnancy.
Breast-feeding
Bromhexine is likely to pass into breast milk and should therefore be avoided during breastfeeding. Therefore, you should not use Mollisupradine while you are breastfeeding.
Driving and using machines
During treatment with Mollisupradine, dizziness may occur. This should be taken into account when sharpened attention is required, for example when driving a car.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or 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.
Mollisupradine contains alcohol
This medicine contains 450 mg ethanol (alcohol), per 15 ml medicine (maximum dose). The amount in 15 ml of this medicine corresponds to 11.4 ml of beer or 4.8 ml of wine.
The amount of alcohol in this medicine is unlikely to have any effects on adults and adolescents and its effect in children is probably not noticeable. It can have some effect in younger children, e.g. somnolence.
The alcohol in this medicine may affect the effectiveness of other medicines. Tell 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 are or have been addicted to alcohol, consult your doctor or pharmacist before using this medicine.
How to use Mollisupradine
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is:
Adults and children over 15 years: 15 ml, 3-4 times a day
Children 11-14 years: 10-15 ml, 3 times a day
Children 6-10 years: 10 ml, 3 times a day
Children 2-5 years: 5 ml, 3 times a day
Children from 6 months: 2.5 ml, 3 times a day
If you use more Mollisupradine than you should
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following serious side effects, stop using the medicine immediately and contact a doctor:
Rare (may affect up to 1 in 1,000 people):
- Spasm of the musculoskeletal system, which may cause difficulty breathing ( bronchospasm ).
Has been reported (occurs in an unknown number of users):
- Severe allergic reactions including anaphylactic shock and angioedema with symptoms such as rapidly increasing swelling of the face, tongue and throat; difficulty swallowing; hives and itching , dizziness and difficulty breathing.
- Severe skin reactions with symptoms such as:
- circular, irregular, red spots on the skin of the hands and arms (erythema multiforme),
- skin rash, usually in the form of blisters or sores in the oral cavity and eyes and other mucous membranes such as e.g. in the genitals ( Stevens-Johnson syndrome ),
- severe, extensive skin damage with separation of the skin from superficial mucous membranes ( toxic epidermal necrolysis ),
- skin rash with blisters and fever ( acute generalized exanthematous pustulosis ).
Other side effects that may occur are:
Common (may affect up to 1 in 10 people):
- Dizziness
- Headache
- Palpitation
- Tremors
- Concern
- Rash
- Hives
- Difficulty urinating
Uncommon (may affect up to 1 in 100 people):
- Nausea
- Diarrhea
- Vomiting
- Insomnia
Rare (may affect up to 1 in 1,000 people):
- Hallucinations
- Confusion
- Aggressiveness
- Transient increase in certain liver values
- Dry mouth
- Hypersensitivity reaction
Has been reported (occurs in an unknown number of users):
– Decreased appetite
How to store Mollisupradine
Keep this medicine out of the sight and reach of children. Do not store above 30 ° C.
Do not use this medicine after the expiry date which is stated on the bottle label after EXP: The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.seed contents of the package and other information
Content declaration
- The active substances are bromohexine hydrochloride and ephedrine hydrochloride.
- 1 ml Mollisupradine contains 0.533 mg bromhexine hydrochloride and 1.0 mg ephedrine hydrochloride.
- The other ingredients are glycerol , polysorbate 20, citric acid monohydrate, ethanol , levomenthol, blood orange aroma, sodium hydroxide (E524), water.
What the medicine looks like and contents of the pack
Mollisupradine is a clear, colorless to the light yellow solution that tastes like menthol.
Mollisupradine is supplied in yellow-brown glass bottles with a drip-free plastic cap (polypropylene). A plastic dosing cup is attached to the bottle.
Pack sizes:
200 ml, 300 ml, 500 ml oral solution.
Not all pack sizes may be marketed
Marketing Authorization Holder and Manufacturer
Unimedic Pharma AB
Box 6216
102 34 Stockholm