Alimemazin Evolan 40 mg/ml Orala droppar, lösning

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

alimemazinhemitartrat

Tillgänglig från:

Evolan Pharma AB

ATC-kod:

R06AD01

INN (International namn):

alimemazinhemitartrat

Dos:

40 mg/ml

Läkemedelsform:

Orala droppar, lösning

Sammansättning:

natriummetabisulfit Hjälpämne; glycerol Hjälpämne; alimemazinhemitartrat 50,05 mg Aktiv substans; sackaros Hjälpämne; makrogolglycerolhydroxistearat Hjälpämne

Receptbelagda typ:

Receptbelagt

Produktsammanfattning:

Förpacknings: Flaska, 50 ml

Bemyndigande status:

Godkänd

Tillstånd datum:

2018-08-08

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE USER
ALIMEMAZIN EVOLAN 40 MG/ML, ORAL DROPS, SOLUTION
alimemazine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Alimemazin Evolan is what it is used for
2.
What you need to know before you take Alimemazin Evolan
3.
How to take Alimemazin Evolan
4.
Possible side effects
5.
How to store Alimemazin Evolan
6.
Contents of the pack and other information
1.
WHAT ALIMEMAZIN EVOLAN IS WHAT IT IS USED FOR
Alimemazin Evolan contains alimemazine which has calming properties.
Alimemazin Evolan relieves
allergies and also has anti-itching properties.
Alimemazine Evolan is used in adults and children from 3 years of age:
-
as a tranquilizer before anaesthesia.
-
for short-term treatment of itching and allergies.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALIMEMAZIN EVOLAN
DO NOT TAKE ALIMEMAZIN EVOLAN
-
if you are allergic to alimemazine or any of the other ingredients of
this medicine (listed in
section 6).
-
if you have leucopenia or have previously suffered from
agranulocytosis (blood changes).
-
If you suffer from myastenia gravis (a disease causing muscle
weakness).
Alimemazin Evolan should not be given to children below 3 years due to
the risk of pronounced
tiredness.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Alimemazin Evolan if
you have:
-
Liver or kidney damage.
-
Diseases with seizures (e.g. epilepsy)
-
Parkinson's disease.
-
Pronounced slow heart rhythm (bradycardia), cardiovascular diseases or
a hereditary form of ECG
changes (prolo

Produktens egenskaper

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Alimemazin Evolan 40 mg/ml, oral drops, solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml oral drops 40 mg/ml contains:
Alimemazine tartrate corresponding to alimemazine 40 mg.
Excipients with known effect:
Sodium metabisulphite (E 223) 8 mg/ml
Sackarose 160 mg/ml
Makrogolglycerol hydroxystearate 15 mg/ml
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral drops, solution
Clear, colourless to slightly yellow solution
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Adults and children from 3 years:
-
Premedication.
-
Short term treatment of pruritus and allergies.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose should be decided individually.
Alimemazine should be used at the lowest effective dose and for the
shortest possible treatment time.
The recommended dose should not be exceeded (see also section 4.4)
_Premedication:_
2-4 mg per kg body weight, however maximum 50 mg at least 2 hours
before
examination or anaesthesia. A smaller dose of alimemazine could
preferably be given the evening
before. Atropine or equivalent medicinal product should be given, in
the usual way, to reduce the
bronchial secretion.
_Pruritus and allergies:_
Adults: 5 mg 2-4 times daily. Children: 3-5- years: 2.5-10 mg, 5-12
years: 2.5-
15 mg daily. The daily dose should be divided into a morning, noon and
evening dose, with a larger
dose given in the evening.
Alimemazin Evolan oral drops can be diluted with a suitable beverage,
e.g. juice, lemonade, coffee,
but not milk, before ingestion.
2
A dosing aid (glass pipette or plastic syringe) for dosing Alimemazin
Evolan oral drops is included in
the pack. The glass pipette is graduated 0.25 ml, 0.5 ml, 0.75 ml and
1 ml. The plastic syringe is
graduated every 0.1 ml up to 1 ml.
_One drop corresponds to about 1 mg of alimemazine._
Volume
Corresponding amount of alimemazine
0,25 ml
10 mg
0,5 ml
20 mg
0,75 ml
30 mg
1 ml
40 mg
4.3
CONTRAINDICATIONS
Hypersensitivity to the active