BRONCOMNES 100 mg Granulki
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Treść ulotki
BRONCOMNES
100 mg granules for oral suspension
1% syrup
Ambroxol acefyllinate
Read this leaflet carefully before taking this medicine as it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
- If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What BRONCOMNES is and what it is used for
- 2. What you need to know before you take BRONCOMNES
- 3. How to take BRONCOMNES
- 4. Possible side effects
- 5. How to store BRONCOMNES
- 6. Contents of the pack and other information
1. What is BRONCOMNES and what is it for
BRONCOMNES contains the active ingredient ambroxol theophylline which belongs to the class of mucoregulatory drugs with antibronchospastic activity (drugs that regulate mucus secretion and dilate the bronchi, favoring the entry of air into the lungs).
BRONCOMNES is a bronchodilator used in the treatment of symptoms derived from diseases of the bronchi and lungs with contraction of the respiratory muscles of the small bronchi (spastic bronchial component) acting on the various factors that lead to bronchial obstruction.
2. What you need to know before taking BRONCOMNES
Do not take BRONCOMNES
- if you are allergic to ambroxol acefyllinate, to other xanthine derivatives or to any of the other ingredients of this medicine (listed in section 6).
- in case of acute myocardial infarction.
- in case of low blood pressure (hypotensive states).
- in case of severe liver and/or kidney damage.
- if you are breastfeeding
Warnings and precautions
Consult your doctor or pharmacist before taking BRONCOMNES.
Numerous factors can influence the functioning of BRONCOMNES, including age, alcoholism, reduced heart function (congestive heart failure), chronic obstructive pulmonary diseases, which cause narrowing of the bronchi, such as asthma and obstructive bronchitis, concomitant infections, alterations of liver and/or kidney function, the simultaneous administration of lincomycin, clindamycin and erythromycin (antibiotics), oral anticoagulant therapy (TAO), and cimetidine (antihistamine). Cigarette smoking reduces the functioning of BRONCOMNES, therefore if you smoke you may require higher doses of the medicine.
Take the medicine with caution if:
- you are elderly
- you have heart disease
- you suffer from hypertension
- you suffer from severe hypoxemia, i.e. a decrease in the concentration of oxygen in the blood
- you suffer from hyperthyroidism, i.e. an increase in thyroid function
- you suffer from an increase in volume of the right side of the heart (chronic cor pulmonale)
- you suffer from congestive heart failure, i.e. poor heart function
- you suffer from peptic ulcer (ulcer of the stomach and duodenum)
- you suffer from liver and/or kidney diseases
Cases of severe skin reactions associated with the administration of ambroxol acefyllinate have been reported. If you develop a skin rash (including lesions of mucous membranes such as mouth, throat, nose, eyes, genitals), stop taking Broncomnes and consult your doctor immediately.
Children
The administration of the medicine must be carried out with caution in young children.
Other medicines and BRONCOMNES
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, tell your doctor if you are taking:
- Furosemide, a diuretic, which, when taken together with BRONCOMNES, increases the flow and amount of urine.
- Reserpine, an antihypertensive and antipsychotic which, when taken together with BRONCOMNES, can cause tachycardia, i.e. an increase in heart rate. Theophylline, a bronchodilator, should not be administered simultaneously with other xanthine preparations. The association between theophylline and ephedrine or other sympathomimetic bronchodilator medicines requires caution.
BRONCOMNES with alcohol
Drinking alcohol can interact with the functioning of BRONCOMNES
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Avoid taking BRONCOMNES in the first months of pregnancy while in the further period take it only if the doctor considers that failure to control asthma constitutes a real risk to you.
Driving and using machines
No effects of BRONCOMNES on the ability to drive vehicles and operate machinery have been observed.
BRONCOMNES syrup also contains methyl p-hydroxybenzoate, propyl p-hydroxybenzoate.
May cause allergic reactions (even delayed).
BRONCOMNES syrup and BRONCOMNES granules also contain sucrose:If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine
3. How to take BRONCOMNES
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Children from 1 to 6 years
The recommended dose is 2.5 ml of syrup twice a day.
Children from 6 to 12 years
The recommended dose is 5 ml of syrup twice a day.
Adults
The recommended dose is 1 sachet of 100 mg or 10 ml of syrup twice a day.
One 10 ml measuring spoon of syrup contains 100 mg of ambroxol theophylline.
The contents of the sachet should be dissolved in water.
If you take more BRONCOMNES than you should
In case of overdose, seizures may occur, characterized by muscle spasms (tonic seizures) or by cyclical phases of muscle contraction-relaxation (clonic seizures) and severe alterations of heart rhythm (severe ventricular arrhythmias). These manifestations may constitute the first signs of intoxication.
If you forget to take BRONCOMNES
Do not take a double dose to make up for a missed dose.
If you stop taking BRONCOMNES
If you have any doubts about the use of 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.
The following side effects may occur:
Rare: may affect up to 1 in 1,000 people:
- Hypersensitivity reactions
- Rash, urticaria
Not known: frequency cannot be estimated based on available data
- Anaphylactic reactions, including anaphylactic shock, angioedema (rapid swelling of the skin, subcutaneous tissues, mucous membranes and submucosal tissues) and pruritus.
- Severe skin adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalized exanthematous pustulosis)
In analogy with what has been reported with other xanthine derivatives, in case of excessively high doses of the product,
the following may occur:
- nausea
- vomiting
- pain under the sternum, between the ribs (epigastric pain)
- emission of blood from the mouth (hematemesis)
- diarrhea
- headache (cephalalgia)
- irritability
- insomnia
- tachycardia (increased heart rate)
- extrasystole (alteration of normal heart rhythm)
- lowering of blood pressure (hypotension)
- increased breathing rate (tachypnea)
- occasionally presence of albumin in the urine (albuminuria)
- occasionally increased blood sugar concentration (hyperglycemia) The appearance of side effects may require discontinuation of treatment, which may be resumed, if necessary, at lower doses after the disappearance of all signs and symptoms of toxicity.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist or nurse. You can also report side effects directly through
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 BRONCOMNES
No special storage conditions.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label after Expiry. The expiry
date refers to the last day of that month.
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 BRONCOMNES contains
100 mg granules for oral suspension:
- The active ingredient is ambroxol acefyllinate. One sachet contains 100 mg of ambroxol acefyllinate.
- The other ingredients are: sodium carboxymethylcellulose, sodium saccharin, raspberry aroma, sucrose. 1% syrup:
- The active ingredient is ambroxol acefyllinate. 100 ml of syrup contain 1 g of ambroxol acefyllinate.
- The other ingredients are: sucrose, glycerol, raspberry aroma, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, purified water.
Description of the appearance of BRONCOMNES and contents of the pack
100 mg granules for oral solution: 30 sachets
1% syrup: 200 ml bottle
Marketing Authorisation Holder
SUBSTIPHARM 24 rue Erlanger, 75016 Paris - France
Distributor
SUBSTIPHARM S.r.l. Via Felice Casati, 20 – 20124 Milano
Manufacturer
For the syrup:
DOPPEL FARMACEUTICI S.r.l. - Via Martiri Delle Foibe, 1 -Cortemaggiore (PC)
For the sachets:
DOPPEL FARMACEUTICI S.r.l. - Via Volturno, 48 - Quinto de' Stampi -Rozzano (MI)
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- Kraj rejestracji
- Postać farmaceutycznaGranules, 100 MG
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki BRONKOMNESPostać farmaceutyczna: Injectable solution, 240 MG/10 MLSubstancja czynna: aminophyllineProducent: MONICO S.P.A.Wymaga receptyPostać farmaceutyczna: Injectable solution, 240 MG/10 MLSubstancja czynna: aminophyllineProducent: S.A.L.F. SPA LABORATORIO FARMACOLOGICOWymaga receptyPostać farmaceutyczna: Coated tablet, 400 MGSubstancja czynna: doxofyllineProducent: ABC FARMACEUTICI S.P.A.Wymaga recepty
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BRONKOMNES jest produkowany przez SUBSTIPHARM. 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 BRONKOMNES 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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