Etrilect 0,5 mg/ml + 1 mg/ml Oral lösning

Страна: Швеция

Язык: шведский

Источник: Läkemedelsverket (Medical Products Agency)

Активный ингредиент:

bromhexinhydroklorid; efedrinhydroklorid

Доступна с:

Teva Sweden AB

код АТС:

R05CB10

ИНН (Международная Имя):

bromhexine hydrochloride; ephedrine hydrochloride

дозировка:

0,5 mg/ml + 1 mg/ml

Фармацевтическая форма:

Oral lösning

состав:

efedrinhydroklorid 1 mg Aktiv substans; bromhexinhydroklorid 0,533 mg Aktiv substans; etanol, vattenfri Hjälpämne; glycerol Hjälpämne

Тип рецепта:

Receptbelagt

Обзор продуктов:

Förpacknings: Flaska, 300 ml; Flaska, 500 ml

Статус Авторизация:

Godkänd

Дата Авторизация:

2017-08-11

тонкая брошюра

Bromhexine/ephedrine, SE/H/1624/001, 15.06.20
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ETRILECT 0.5 MG/ML + 1 MG/ML ORAL SOLUTION
bromhexine hydrochloride + ephedrine hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See Section 4.
WHAT IS IN THIS LEAFLET
1.
What Etrilect is and what it is used for
2.
What you need to know before you take Etrilect
3.
How to take Etrilect
4.
Possible side effects
5.
How to store Etrilect
6.
Contents of the pack and other information
1.
WHAT ETRILECT IS AND WHAT IT IS USED FOR
Etrilect contains bromhexine and ephedrine. Bromhexine is thought to
thin the mucus in the airways.
This may facilitate the expectoration of mucus. Ephedrine dilates the
airways and acts to reduce
mucous membrane swelling.
Etrilect is used to treat cough with viscous mucus when there is a
simultaneous need for a
bronchodilator.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ETRILECT
DO NOT TAKE ETRILECT
-
if you are allergic to bromhexine, ephedrine or any of the other
ingredients of this medicine
(listed in Section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Etrilect.
In particular, tell your doctor before starting this medicine:
-
if you have a history of heart disease, irregular heart rhythm 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 sputum.
Etrilect may cause a dry mouth. Good oral hygiene (e.g. brushing with
fluoride toothpas

Характеристики продукта

Bromhexine/ephedrine, SE/H/1624/001, 15.06.20
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Etrilect 0.5 mg/ml + 1 mg/ml oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of oral solution contains:
0.533 mg bromhexine hydrochloride
1.0 mg ephedrine hydrochloride
Excipient with known effect:
1 ml of oral solution contains 30.26 mg ethanol. See section 4.4.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution
Clear, colourless to light-yellow solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cough with viscous mucus with a concurrent need for bronchodilator
effect.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and children 15 years and over:_
15 ml, 3 to 4 times daily
_Children 11 to 14 years:_
10–15 ml, 3 times daily
_Children 6 to 10 years:_
10 ml, 3 times daily
_Children 2 to 5 years:_
5 ml, 3 times daily
_Children over 6 months:_
2.5 ml, 3 times daily
4.3.
CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Caution is advised when treating patients with cardiovascular
diseases, hypertension, hyperthyroidism,
prostatic hypertrophy, closure glaucoma, angle, diabetes mellitus.
Cardiovascular effects may be seen with sympathomimetic drugs,
including ephedrine. There is some
evidence from post-marketing data and published literature of rare
occurrences of myocardial
ischaemia associated with beta agonists. Patients with underlying
severe heart disease (e.g. ischaemic
heart disease, arrhythmia or severe heart failure) who are receiving
Etrilect should be warned to seek
Bromhexine/ephedrine, SE/H/1624/001, 15.06.20
medical advice if they experience chest pain or other symptoms of
worsening heart disease. Attention
should be paid to assessment of symptoms such as dyspnoea and chest
pain, as they may be of either
respiratory or cardiac origin.
Caution is advised when treating patients with gastric ulcers.
Caution is advis