Systral Cream

Krajina: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktívna zložka:

CHLORPHENOXAMINE HYDROCHLORIDE

Dostupné z:

MEDA Pharma GmbH & Co KG Benzstrasse 1, 61352 Bad Homburg, Germany

ATC kód:

D04AA34

INN (Medzinárodný Name):

CHLORPHENOXAMINE HYDROCHLORIDE 15 mg/g

Forma lieku:

CREAM

Zloženie:

CHLORPHENOXAMINE HYDROCHLORIDE 15 mg/g

Typ predpisu:

OTC

Terapeutické oblasti:

ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.

Stav Autorizácia:

Withdrawn

Dátum Autorizácia:

2005-08-19

Príbalový leták

_Désignation:_
SYSTRAL CRÈME MALTE
_Code :_
40891-3
_Format à plat :_
160X200 MM
_Format plié :_
_Impression R°:_
NOIR
_Impression V°:_
NOIR
_Papier:_
50 G
_Edition :_
3
LAETUS N°327
160 MM
200 MM
Sens de lecture
Sens de lecture
50 MM
50 MM
SYSTRAL_40891-3_ps.indd 1
19/02/16 11:37
160 MM
200 MM
Sens de lecture
Sens de lecture
50 MM
50 MM
SYSTRAL_40891-3_ps.indd 2
19/02/16 11:37

Súhrn charakteristických

1.
NAME OF THE MEDICINAL PRODUCT
Systral Cream
Chlorphenoxamine hydrochloride 15 mg/g
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of Systral Cream contains 15 mg of chlorphenoxamine hydrochloride.
Excipient(s) with known effect [mg/1g cream]
_:_
Cetyl stearyl alcohol (Ph.Eur.) 50 mg,
Methylhydroxybenzoate (Ph.Eur.) 1.8 mg, Propylhydroxybenzoate
(Ph.Eur.) 0.2 mg,
Bergamot oil (component of perfume oil)
_ _
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Cream.
Systral Cream is a white, slightly perfumed cream.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For local treatment of allergic and itching skin disorders such as
insect stings, jellyfish stings,
urticaria and eczema as well as sunburn, minor burns and frost-bites.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Unless otherwise prescribed, Systral Cream shall be applied to the
affected and itching skin
areas several times a day.
METHOD OF ADMINISTRATION
For application to the skin. When using a dressing, it shall be made
sure that it is permeable
to air.
DURATION OF TREATMENT
Inter-individually, until symptoms have disappeared.
4.3
CONTRAINDICATIONS
•
Systral Cream is contraindicated in case of hypersensitivity to the
active substance,
Methylhydroxybenzoate, Propylhydroxybenzoate or to any of the
excipients listed in
section 6.1.
•
Moreover, Systral Cream contains cetyl stearyl alcohol. Patients with
a known
hypersensitivity to this substance should not be treated with this
product.
Systral Cream must not be used on large skin areas (e.g. to treat
burns or scalds) in babies or
young children. These injuries require immediate medical attention.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Page 1 of 8
Cetyl stearyl alcohol may cause local skin reactions (e.g. contact
dermatitis).
Bergamot oil may increase sensitivity to UV light (natural and
artificial sunlight).
2
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
To date, no interactions with other products have been reported.
4.6
FERTILIT