MUCOARICODIL 30 mg /10 Ml Сироп
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Инструкция по применению MUKOARIKODIL
Содержание инструкции
MUCOARICODIL 30 mg/10 ml syrup
ambroxol hydrochloride
Read this leaflet carefully before taking this medicine as 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 side effects occur, including those 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 worsen after a short period of time.
Contents of this leaflet:
- 1. What MUCOARICODIL is and what it is used for
- 2. What you need to know before you take MUCOARICODIL
- 3. How to take MUCOARICODIL
- 4. Possible side effects
- 5. How to store MUCOARICODIL
- 6. Contents of the pack and other information
1. WHAT IS MUCOARICODIL AND WHAT IS IT USED FOR
MUCOARICODIL contains the active ingredient ambroxol hydrochloride belonging to the category of
mucolytics (medicines that facilitate the dissolution of mucus present in the respiratory tract, facilitating its
elimination).
MUCOARICODIL is indicated for the treatment of altered mucus secretion in acute and chronic
bronchopulmonary diseases (diseases of the bronchi and lungs).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MUCOARICODIL
Do not take MUCOARICODIL
- if you are allergic to ambroxol hydrochloride, or to any of the other ingredients of this medicine (listed in section 6);
- if you have severe liver (hepatic) and/or kidney disorders;
- in case of rare hereditary diseases that may be incompatible with one of the excipients (see section 2 “MUCOARICODIL contains sorbitol, benzoic acid and glycerol”).
MUCOARICODIL is contraindicated in children under 2 years of age (see “Children and adolescents”).
Warnings and precautions
Talk to your doctor or pharmacist before taking MUCOARICODIL:
- if you have a peptic ulcer (lesion of the stomach mucosa);
- if you have mild or moderate kidney impairment;
- during the first three months of pregnancy or if you are breastfeeding.
Cases of severe skin reactions associated with the administration of ambroxol hydrochloride have been reported.
If you develop a skin rash (including lesions of mucous membranes such as mouth, throat, nose, eyes,
genitals), stop taking MUCOARICODIL and consult your doctor immediately.
These reactions may be symptoms of serious skin conditions characterized by skin peeling and severe toxic skin reaction, including Stevens-Johnson syndrome and toxic epidermal necrolysis (TEN). The initial symptoms of these conditions may resemble the flu: fever, muscle and throat pain, nasal inflammation (rhinitis), cough.
If you notice the appearance of lesions on the skin or mucous membranes, stop taking MUCOARICODIL and consult
your doctor immediately.
Children and adolescents
The use of MUCOARICODIL is contraindicated in children under 2 years of age (see “Do not take
MUCOARICODIL”).
Due to the physiological characteristics of the respiratory tract, the ability to drain bronchial mucus
(elimination of mucus at the level of the bronchi) is reduced in children under 2 years of age; therefore, mucolytics
(such as MUCOARICODIL) can cause bronchial obstruction in children in this age group (see “Do not take
MUCOARICODIL”).
Other medicines and MUCOARICODIL
Tell your doctor or pharmacist if you/your child are taking, have recently taken or might
take any other medicines.
In particular, avoid the concomitant use of ambroxol and antibiotics (medicines to treat infections)
such as amoxicillin, cefuroxime, erythromycin, as the concentrations of these latter may be
increased in the secretions at the level of the lungs and bronchi.
MUCOARICODIL does not appear to interact with other medicines, in particular with cardiac glycosides
(medicines that increase the contractility of the heart), corticosteroids (anti-inflammatory drugs), bronchodilators
(medicines that increase the caliber of the bronchi), diuretics (medicines that increase the production of
urine) commonly used in the treatment of bronchopneumonia.
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Taking MUCOARICODIL is not recommended during the first three months of pregnancy; in the further
period this medicine should only be taken if absolutely necessary and under the direct control
of the doctor.
Breastfeeding
MUCOARICODIL is excreted in breast milk. The use of MUCOARICODIL is not recommended during
breastfeeding. Therefore, it is necessary to decide whether to stop breastfeeding or treatment with the
medicine, taking into account the importance of the medicine for the mother.
Driving and operating machinery
No studies have been conducted on the effects of MUCOARICODIL on the ability to drive vehicles or operate
machinery.
MUCOARICODIL contains sorbitol, benzoic acid and glycerol
MUCOARICODILcontains 1.75 mg of sorbitolper unit dose (5 ml) equivalent to 0.35 mg/ml
MUCOARICODILcontains 5.75 mg of benzoic acidper unit dose (5 ml) equivalent to 1.15 mg/ml
MUCOARICODILcontains glycerolwhich can cause headache, stomach upset and diarrhea.
3. HOW TO TAKE MUCOARICODIL
Take this medicine following exactly the instructions in this leaflet or as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults
The recommended initial dose is 10 ml to be taken 3 times a day; subsequently the dose may be reduced to 5 ml to be taken 3 times a day.
It is advisable to take the syrup during or after main meals.
Children and adolescents
Each ml of syrup equates to 3 mg of ambroxol hydrochloride. A 5 ml measuring spoon with markings corresponding to ½ (2.5 ml) and ¼ (1.25 ml) is attached to the syrup package.
It is advisable to take the medicine during or after main meals.
If you take more MUCOARICODIL than you should
No cases of overdose with MUCOARICODIL are known.
In case of accidental ingestion/intake of an excessive dose of MUCOARICODIL, immediately inform your doctor or go to the nearest hospital.
If you forget to take MUCOARICODIL
Do not take a double dose to make up for a 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 everybody gets them.
Common side effects (may affect up to 1 in 10 people)
- alteration or decrease in the sense of taste (dysgeusia), decreased sensitivity of the mouth (oral hypoesthesia) and pharynx (pharyngeal hypoesthesia), nausea;
Uncommon side effects (may affect up to 1 in 100 people)
- vomiting, diarrhea and abdominal pain, indigestion (dyspepsia), dry mouth;
Rare side effects (may affect up to 1 in 1,000 people)
- hypersensitivity reactions;
- rash, urticaria;
- headache, gastrointestinal disorders, especially heartburn (burning sensation in the stomach);
Side effects with unknown frequency (frequency cannot be estimated based on available data)
- anaphylactic reactions, including anaphylactic shock, 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);
| AGE | RECOMMENDED DOSE |
| From 2 to 5 years | 2.5 ml of syrup 3 times a day |
| Over 5 years | 5 ml of syrup 3 times a day |
bronchial obstruction (see “Children and adolescents”).
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 MUCOARICODIL
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.
The period of validity after opening the bottle is 6 months.
Do not dispose of any medicine in waste water 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 MUCOARICODIL contains
100 ml of syrup contains:
The active ingredient is: ambroxol hydrochloride 300 mg.
The other ingredientsare: benzoic acid, glycerol 85%, sorbitol solution 70%, hydroxyethylcellulose,
raspberry aroma, purified water.
Description of the appearance of MUCOARICODIL and package contents
Syrup, colorless solution. Glass bottle containing 150 or 200 ml of solution with a screw cap in
polypropylene and a tamper-evident ring in polyethylene. The package contains a measuring spoon.
Marketing Authorisation Holder
- A. Menarini Industrie Farmaceutiche Riunite s.r.l., Via Sette Santi, 3 – Florence.
Manufacturer
Berlin Chemie A.G. – Glienicker Weg 125 – 12489 - Berlin (Germany).
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- Страна регистрации
- Форма выпускаSyrup, 30 MG/10 ML
- Код АТХR05CB06
- Действующее вещество
- Отпускается по рецептуНет
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги MUKOARIKODILФорма выпуска: Solution for nebulization, 15 MG/2 MLДействующее вещество: АмброксолПроизводитель: EPIFARMA S.R.LОтпускается без рецептаФорма выпуска: Solution for nebulization, 15 MG/2 MLДействующее вещество: АмброксолПроизводитель: TECNIGEN S.R.L.Отпускается без рецептаФорма выпуска: Coated tablet, 30 MGДействующее вещество: АмброксолПроизводитель: ABC FARMACEUTICI S.P.A.Отпускается по рецепту
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Действующее вещество MUKOARIKODIL — Амброксол. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
MUKOARIKODIL производится компанией A. MENARINI INDUSTRIE FARMACEUTICHE RIUNITE S.R.L.. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения MUKOARIKODIL с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
Польша имеет хорошо развитую систему здравоохранения в крупных городах, таких как Варшава, Краков, Вроцлав и Гданьск. Аптеки широко доступны и работают в соответствии с действующим законодательством, обеспечивая доступ к рецептурным препаратам.
Вы можете купить MUKOARIKODIL в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
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Другие лекарства с тем же действующим веществом (Амброксол) включают AMBROTUS, AMBROXOL TEKNIJEN, AMBROXOLO ABK. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
