AMBROMUCIL 100 mg Гранулы Для Приготовления Раствора Для Приема Внутрь
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Инструкция по применению AMBROMUKIL
Содержание инструкции
- AMBROMUCIL 100 mg granules for oral solution, 100 mg capsules
- AMBROMUCIL should not be administered simultaneously with other medicines of the
AMBROMUCIL 100 mg granules for oral solution, 100 mg capsules
AMBROMUCIL 10 mg/ml syrup
ambroxol acefyllinate
Read this leaflet carefully before you start 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 may be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What AMBROMUCIL is and what it is used for
- 2. What you need to know before you take AMBROMUCIL
- 3. How to take AMBROMUCIL
- 4. Possible side effects
- 5. How to store AMBROMUCIL
- 6. Contents of the pack and other information
1. WHAT AMBROMUCIL IS AND WHAT IT IS USED FOR
AMBROMUCIL is a medicine based on ambroxol acefyllinate, a substance capable of releasing the
active ingredients acephylline (which works by dilating the bronchi, facilitating air entry into the lungs) and
ambroxol (which regulates mucus secretion), and is indicated for 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)
2. WHAT YOU NEED TO KNOW BEFORE TAKING AMBROMUCIL
Do not take AMBROMUCIL
- If you are allergic to the active ingredient (ambroxol acefyllinate), to other derivatives of the same class (xanthines), or to any of the other components of this medicine (listed in section 6);
- in case of hypotension (low blood pressure);
- in case of acute myocardial infarction (death of a part of the heart muscle due to lack of blood supply for a certain period of time);
- if you have severe liver (hepatic) and/or kidney (renal) impairment (see “Warnings and precautions”);
- if you are breastfeeding (see “Pregnancy and breastfeeding”).
Warnings and precautions
Consult your doctor or pharmacist before taking AMBROMUCIL.
AMBROMUCIL should not be administered simultaneously with other medicines of the
same class (xanthines) (see “Other medicines and AMBROMUCIL”).
Numerous factors can determine blood levels of ambroxol acephyllinate higher than
average, with a consequent risk of developing toxic effects.
It may therefore be necessary to reduce the doses of AMBROMUCIL:
- in elderly patients;
- if you suffer from alcoholism;
- if you have had congestive heart failure (the heart's inability to provide adequate blood supply to the body's needs);
- if you suffer from chronic obstructive lung diseases (long-lasting);
- if you have concomitant infections;
- if you suffer from hepatic and/or renal dysfunction;
- if you are taking drugs such as erythromycin, TAO, lincomycin, clindamycin and cimetidine (see “Other medicines and AMBROMUCIL”).
Cigarette smoking reduces the function of AMBROMUCIL, therefore if you are a smoker it may
be necessary to increase the doses of this medicine.
Take AMBROMUCIL with caution:
- if you are elderly;
- if you have heart disease (heart conditions);
- if you suffer from high blood pressure;
- if you have severe hypoxemia (abnormal decrease in oxygen content in the blood);
- if you suffer from hyperthyroidism (excessive thyroid function);
- in case of chronic cor pulmonale (enlargement of a region of the heart caused by some lung disease, leading to an alteration of normal cardiac function);
- in case of congestive heart failure;
- if you have a peptic ulcer (lesion of the inner lining of the stomach or intestine);
- if you have severe liver or kidney diseases.
Cases of severe skin reactions associated with the administration of drugs
containing ambroxol, such as AMBROMUCIL, have been reported. If you develop a skin rash (including lesions of
mucous membranes such as mouth, throat, nose, eyes, genitals), stop taking AMBROMUCIL and
seek immediate medical attention.
Cases of habituation and dependence following the use of
AMBROMUCIL have not been reported.
Children and adolescents
AMBROMUCIL should be administered with caution in young children.
Other medicines and AMBROMUCIL
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Do not take AMBROMUCIL simultaneously with other xanthine preparations (see “Warnings
and precautions”).
Use caution when taking drugs such as erythromycin, lincomycin and
clindamycin (antibiotics), TAO (drugs that reduce blood coagulation) and cimetidine
(anti-ulcer) as these drugs may induce an increase in the levels of theophylline in the blood
(see “Warnings and precautions”).
Theophylline (bronchodilator) should not be administered simultaneously with other
xanthine preparations.
The association between AMBROMUCIL and ephedrine or other sympathomimetic bronchodilators should
be evaluated with caution (see “Warnings and precautions”).
Also note that the simultaneous administration of AMBROMUCIL with:
- furosemide (diuretic medicine) may cause an increase in diuresis (urine elimination);
- reserpine (medicine used to lower blood pressure or for mental disorders) may cause tachycardia (increased heart rate).
Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Avoid taking AMBROMUCIL in the first months of pregnancy. The use of AMBROMUCIL in
pregnancy should be limited only to cases where asthma poses a serious danger to the
mother.
Breastfeeding
The use of AMBROMUCIL is contraindicated during breastfeeding (see “Do not take
AMBROMUCIL”).
Driving and using machines
AMBROMUCIL does not impair the ability to drive vehicles or operate machinery.
AMBROMUCILcontainssucrose,lactose,methylp-hydroxybenzoate,propylp-
hydroxybenzoate and sodium
AMBROMUCIL 100 mg granules for oral solution and AMBROMUCIL 10 mg/ml syrup
contain sucrose.If your doctor has diagnosed you with intolerance to certain sugars, contact
him/her before taking these medicines.
AMBROMUCIL 100 mg capsules contains lactose.If your doctor has diagnosed you with intolerance
to certain sugars, contact him/her before taking this medicine.
AMBROMUCIL 10 mg/ml syrup contains methylp-hydroxybenzoateandpropylp-
hydroxybenzoatewhich may cause allergic reactions (including delayed reactions).
AMBROMUCIL 100 mg granules for oral solution contains less than 1 mmol (23 mg) of sodium
per sachet, i.e. it is essentially “sodium-free”
3. HOW TO TAKE AMBROMUCIL
Take this medicine following exactly the instructions of your doctor or pharmacist.
It will be the doctor who establishes the dose that will be most suitable for you and explains how to take it. In any
case, and at any time, if you have doubts, consult your doctor or pharmacist.
Keep in mind that a 10 ml measuring spoon of syrup contains 100 mg of active ingredient
(ambroxol acefyllinate).
Adults
The recommended dose is 1 sachet of 100 mg or 1 capsule of 100 mg or 10 ml of
syrup, to be taken twice a day.
Children aged between 1 and 6 years
The recommended dose is 2.5 ml of syrup, to be taken twice a day.
Children aged between 6 and 12 years
The recommended dose is 5 ml of syrup, to be taken twice a day.
Method of administration:
Dissolve the contents of the sachet in water.
If you take more AMBROMUCIL than you should
In case of overdose, generalized tonic-clonic seizures and
serious ventricular arrhythmias (alterations of the heart rhythm) may occur. These manifestations may constitute the
first signs of intoxication.
If the aforementioned symptoms occur, consult your doctor who will prescribe the
most appropriate treatment.
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 everybody gets them.
Rare side effects (may affect up to 1 in 1,000 people)
- hypersensitivity reactions (allergy);
- rash, urticaria (skin eruption characterized by the appearance of lesions generally accompanied by itching).
Side effects with unknown frequency (frequency cannot be estimated based on available data)
- anaphylactic reactions, including anaphylactic shock (severe allergic reaction with rapid onset), angioedema (rapid swelling of the skin, subcutaneous tissues, mucosa and submucosal tissues) and itching;
- serious skin adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalized exanthematous pustulosis) (see “Warnings and precautions”);
- in case of excessively high doses, nausea, vomiting, epigastric pain (pain in the upper part of the abdomen), hematemesis (vomiting blood), diarrhea, headache, irritability, insomnia, tachycardia (increased heart rate), extrasystole (premature heartbeat), hypotension, tachypnea (significant increase in breathing rate), albuminuria (high concentration of albumin in the urine) and hyperglycemia (high blood sugar concentration) may occur;
- in case of overdose, generalized tonic-clonic seizures and severe ventricular arrhythmias (heart rhythm disturbances) may occur; these manifestations may constitute the first signs of intoxication (see “If you take more AMBROMUCIL than you should”).
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.
However, ambroxol acefyllinate, at adequate doses, is usually well tolerated.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. 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 AMBROMUCIL
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
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 AMBROMUCIL contains
AMBROMUCIL 100 mg granules for oral solution
One 100 mg sachet contains:
Active ingredient: ambroxol hydrochlorides 100 mg
Other ingredients: sodium carboxymethylcellulose, sodium saccharin, raspberry aroma, sucrose.
AMBROMUCIL 100 mg capsules
One 100 mg capsule contains:
Active ingredient: ambroxol hydrochlorides 100 mg
Other ingredients: lactose, starch, polyvinylpyrrolidone, magnesium stearate.
Capsule components:yellow iron oxide (E172), erythrosine (E127), titanium dioxide (E171),
gelatin.
AMBROMUCIL 10 mg/ml syrup
100 ml of syrup contain:
Active ingredient: ambroxol hydrochlorides 1,000 mg
Other ingredients: sucrose, glycerol, raspberry aroma, methyl p-hydroxybenzoate, propyl p-
hydroxybenzoate, purified water.
Description of the appearance of AMBROMUCIL and contents of the pack
AMBROMUCIL 100 mg granules for oral solution
30 heat-sealed sachets in paper/aluminium/polyethylene containing 100 mg of granules for oral solution.
AMBROMUCIL 100 mg capsules
30 capsules of 100 mg contained in aluminium/PVC blisters.
AMBROMUCIL 10 mg/ml syrup
Dark glass bottle containing 200 ml of syrup.
Marketing Authorisation Holder
Malesci Istituto Farmacobiologico S.p.A., Via Lungo l’Ema, 7 - Bagno a Ripoli (FI)
Manufacturer
AMBROMUCIL 100 mg granules for oral solution
Doppel Farmaceutici srl, Via Volturno, 48 – Quinto de’ Stampi, Rozzano, 20089, Italy
AMBROMUCIL 100 mg capsules
Doppel Farmaceutici srl, Via Volturno, 48 – Quinto de’ Stampi, Rozzano, 20089, Italy
AMBROMUCIL 10 mg/ml syrup
Doppel Farmaceutici srl, Via Martiri delle Foibe, 1 – Cortemaggiore (PC)
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- Страна регистрации
- Форма выпускаGranules for oral solution, 100 MG
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги AMBROMUKILФорма выпуска: Injectable solution, 240 MG/10 MLДействующее вещество: aminophyllineПроизводитель: MONICO S.P.A.Отпускается по рецептуФорма выпуска: Injectable solution, 240 MG/10 MLДействующее вещество: aminophyllineПроизводитель: S.A.L.F. SPA LABORATORIO FARMACOLOGICOОтпускается по рецептуФорма выпуска: Coated tablet, 400 MGДействующее вещество: доксофиллинаПроизводитель: ABC FARMACEUTICI S.P.A.Отпускается по рецепту
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AMBROMUKIL производится компанией MALESCI ISTITUTO FARMACOBIOLOGICO S.P.A.. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
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