AMBROXOLO 15 mg /5 Ml Syrop
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Treść ulotki
Ambroxolo Mylan Generics 15 mg/5 ml syrup
ambroxol hydrochloride
Generic medicine
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 told you to do.
- Keep this leaflet. You may need to read it again.
- If you want more information or advice, ask your pharmacist.
- If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
- See a doctor if you do not feel better or if your symptoms get worse after a few days.
Contents of this leaflet:
- 1. What Ambroxolo Mylan Generics is and what it is used for
- 2. What you need to know before you take Ambroxolo Mylan Generics
- 3. How to take Ambroxolo Mylan Generics
- 4. Possible side effects
- 5. How to store Ambroxolo Mylan Generics
- 6. Contents of the pack and other information
1. What is Ambroxolo Mylan Generics and what it is used for
This medicine contains the active ingredient ambroxol, belonging to a group of medicines called
mucolytics, used to facilitate the removal of mucus from the respiratory tract.
Ambroxolo Mylan Generics is indicated for the treatment of acute and chronic diseases of the bronchi and
lungs accompanied by excessive mucus.
Consult your doctor if you do not feel better or if you feel worse after a few days.
2. What you need to know before taking Ambroxolo Mylan Generics
Do not take Ambroxolo Mylan Generics
- if you are allergic to ambroxol or any of the other ingredients of this medicine (listed in section 6);
- if you have severe problems with your liver or kidneys; Do not use this medicine in children under 2 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking Ambroxolo Mylan Generics if:
- you suffer from a stomach or intestinal problem called peptic ulcer;
- you have mild or moderate impairment of kidney function;
- you suffer from severe liver problems;
- during the first three months of pregnancy or if you are breastfeeding.
Cases of severe skin reactions associated with the administration of ambroxol have been reported.
If you develop a skin rash (including lesions of mucous membranes such as mouth, throat, nose, eyes,
genitals), stop taking Ambroxolo Mylan Generics and consult your doctor immediately.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent change
in its characteristics.
Children
Ambroxolo Mylan Generics should not be given to children under 2 years of age, as
it may obstruct the bronchi and prevent normal breathing.
Other medicines and Ambroxolo Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Take this medicine with caution and inform your doctor if you are taking antibiotics for the treatment of
infections caused by bacteria, such as amoxicillin, cefuroxime and erythromycin.
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Do not take Ambroxolo Mylan Generics during the first three months of pregnancy, or if you are breastfeeding,
without first consulting your doctor.
Driving and operating machinery
Ambroxolo Mylan Generics does not impair the ability to drive and operate machinery.
Ambroxolo Mylan Generics contains sorbitol, parabens and ethanol
This medicine contains 3.5 g of sorbitolper dose. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) are intolerant to certain sugars, or if you have a diagnosis of hereditary fructose intolerance, a rare genetic illness in which patients cannot transform fructose, talk to your doctor before you (or your child) take this medicine. It can cause intestinal problems and have a
mild laxative effect.
Ambroxolo Mylan Generics contains parabenswhich may cause allergic reactions (even
delayed).
This medicine contains 3.875 mg of alcohol (ethanol)in 5ml. The amount in 5 ml of this medicine is
equivalent to less than 0.1 ml of beer or 0.04 ml of wine.
3. How to take Ambroxolo Mylan Generics
Take this medicine following exactly the instructions in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Adults and adolescents
The initial dose is 10 ml of syrup 3 times a day, unless otherwise indicated by your doctor; subsequently 5 ml 3 times a day.
Use in children
Children from 2 to 5 years of age
The recommended dose is 2.5 ml 3 times a day, unless otherwise indicated by your doctor.
Children over 5 years of age
The recommended dose is 5 ml 3 times a day, unless otherwise indicated by your doctor.
Take Ambroxolo Mylan Generics with meals.
At the beginning of treatment, the dose may be increased or even doubled at the doctor's discretion.
Do not exceed the recommended doses.
Use the measuring cup with graduated markings of 10 ml, 5 ml and 2.5 ml, which you can find in the package, to take the correct dose.
5 ml of syrup corresponds to 15 mg of ambroxol hydrochloride.
If you take more Ambroxolo Mylan Generics than you should
In case of accidental ingestion/intake of an excessive dose of Ambroxolo Mylan Generics, the risk of experiencing undesirable effects increases. Immediately inform your doctor or go to the Emergency Room of the nearest hospital.
Bring this leaflet, the bottle and its container to the hospital or doctor so they know which medicine was taken.
If you forget to take Ambroxolo Mylan Generics
Do not take a double dose to make up for a missed dose.
If you have any doubts about using this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Ambroxolo Mylan Generics immediately and contact your doctor if any of the following
conditions occur: itching, skin rashes (urticaria, skin rash), swelling (angioedema) of the face, eyes, lips and/or
throat with difficulty breathing, due to allergy (hypersensitivity).
The following side effects may occur:
Common(may affect up to 1 in 10 people)
- alteration or decrease in taste;
- loss of sensitivity of mouth and pharynx;
- nausea.
Uncommon(may affect up to 1 in 100 people)
- vomiting, diarrhea, digestive difficulties, abdominal pain;
- dry mouth;
- heartburn.
Rare(may affect up to 1 in 1,000 people)
- headache
- hypersensitivity reactions;
- rash, urticaria.
Not known(frequency cannot be estimated from available data)
- anaphylactic reactions, including anaphylactic shock, angioedema (rapid swelling of the skin, subcutaneous tissues, mucosa and submucosal tissues) and itching;
- severe skin adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalized exanthematous pustulosis);
- obstruction of the airways (bronchi);
- dry throat.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly through the national reporting system at
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 Ambroxolo Mylan Generics
Keep this medicine out of the sight and reach of children.
This medicine does not require any particular storage conditions.
Do not use this medicine after the expiry date which is stated on the package and the bottle after “Exp.”.
The expiry date refers to the last day of that month.
After the first opening of the bottle, the medicine must be used within 30 days; after this period
any remaining medicine must be disposed of.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Ambroxolo Mylan Generics contains
- The active ingredient is ambroxol hydrochloride. 5 ml of syrup contains 15 mg of ambroxol hydrochloride.
- The other ingredients are: sorbitol, propyl parahydroxybenzoate, methyl parahydroxybenzoate, glycerol, raspberry essence, ammonium glycyrrhizinate, hydrochloric acid, sodium hydroxide (pH adjuster), purified water.
Description of the appearance of Ambroxolo Mylan Generics and contents of the pack
Pack containing 1 bottle of 200 ml and graduated measuring cup.
Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano
Manufacturer
ABC Farmaceutici S.p.A., via Canton Moretti 29 - 10090 S. Bernardo d’Ivrea (TO)
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- Kraj rejestracji
- Postać farmaceutycznaSyrup, 15 MG/ 5 ML
- Kod ATCR05CB06
- Substancja czynna
- Wymaga receptyNie
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki AMBROXOLO MYLAN JENERIKSPostać farmaceutyczna: Solution for nebulization, 15 MG/2 MLSubstancja czynna: ambroxolProducent: EPIFARMA S.R.LBez receptyPostać farmaceutyczna: Solution for nebulization, 15 MG/2 MLSubstancja czynna: ambroxolProducent: TECNIGEN S.R.L.Bez receptyPostać farmaceutyczna: Coated tablet, 30 MGSubstancja czynna: ambroxolProducent: ABC FARMACEUTICI S.P.A.Wymaga recepty
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AMBROXOLO MYLAN JENERIKS nie wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w AMBROXOLO MYLAN JENERIKS jest ambroxol. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
AMBROXOLO MYLAN JENERIKS jest produkowany przez MYLAN S.P.A.. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie AMBROXOLO MYLAN JENERIKS jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
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Możesz kupić AMBROXOLO MYLAN JENERIKS w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
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Inne leki zawierające tę samą substancję czynną (ambroxol) to m.in. AMBROTUS, AMBROXOL TEKNIJEN, AMBROXOLO ABK. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
