Calcipotriol zalf 0,05 mg/g, zalf

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

CALCIPOTRIOL

Beschikbaar vanaf:

Sandoz B.V.

ATC-code:

D05AX02

INN (Algemene Internationale Benaming):

CALCIPOTRIOL

farmaceutische vorm:

Zalf

Samenstelling:

DINATRIUMEDETAAT 2-WATER ; DINATRIUMWATERSTOFFOSFAAT 2-WATER (E 339) ; MACROGOLSTEARYLETHER ; PARAFFINE, DUNVLOEIBAAR ; PARAFFINE, ZACHT (E 905) ; PROPYLEENGLYCOL (E 1520) ; TOCOFEROL, DL-ALFA ACETAAT ; WATER, GEZUIVERD,

Toedieningsweg:

Cutaan gebruik

Therapeutisch gebied:

Calcipotriol

Product samenvatting:

Hulpstoffen: DINATRIUMEDETAAT 2-WATER; DINATRIUMWATERSTOFFOSFAAT 2-WATER (E 339); MACROGOLSTEARYLETHER; PARAFFINE, DUNVLOEIBAAR; PARAFFINE, ZACHT (E 905); PROPYLEENGLYCOL (E 1520); TOCOFEROL, DL-ALFA ACETAAT; WATER, GEZUIVERD;

Autorisatie datum:

2007-05-01

Bijsluiter

Sandoz B.V.
Page 1/7
Calcipotriol zalf 0,05 mg/g, zalf RVG 33408
1313-V6
1.3.1.3 Package Leaflet
juli 2018
PACKAGE LEAFLET: INFORMATION FOR THE USER
CALCIPOTRIOL ZALF 0,05 MG/G, ZALF
Calcipotriol
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 [NATIONALLY COMPLETED NAME]
is and what it is used for
2.
What you need to know before you use [NATIONALLY COMPLETED NAME]
3.
How to use [NATIONALLY COMPLETED NAME]
4.
Possible side effects
5.
How to store [NATIONALLY COMPLETED NAME]
6.
Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[NATIONALLY COMPLETED NAME] is used on the skin for local treatment of
mild to
moderately severe psoriasis (psoriasis vulgaris).
Psoriasis is when your skin cells are being produced too quickly. This
causes scaling and
redness. This ointment helps bring the rate at which your skin cells
are produced back to
normal.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE [NATIONALLY COMPLETED NAME]
DO NOT USE [NATIONALLY COMPLETED NAME]:

if you are allergic to calcipotriol or to any of the other ingredients
of this medicine (listed
in Section 6).

if you have severe liver or kidney impairment

if you have a problem with your calcium metabolism or if the level of
calcium in
your body is too high. This ointment can increase calcium levels in
the blood.
Sandoz B.V.
Page 2/7
Calcipotriol zalf 0,05 mg/g, zalf RVG 33408
1313-V6
1.3.1.3 Package Leaflet
juli 2018

if you concomitantly use treatment with other medicinal prod

Productkenmerken

Sandoz B.V.
Page 1/8
Calcipotriol zalf 0,05 mg/g, zalf RVG 33408
1311-v5
1.3.1.1 Summary of the Product Characteristics
juli 2018
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Calcipotriol zalf 0,05 mg/g, zalf
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of ointment contains 0.05 mg (is equal to 50 micrograms) of
calcipotriol.
Excipient with known effect: Propylene glycol _10mg/g_
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Ointment
White to off-white ointment.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[Nationally completed name] is indicated for the topical treatment of
mild to moderately
severe psoriasis (psoriasis vulgaris).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults: _
As monotherapy
[
Nationally completed name] should be applied to the affected skin on
limbs or trunk once or
twice daily. At the beginning of treatment, twice daily (morning and
evening) application is
recommended. For maintenance therapy, the frequency of application may
be decreased to
once daily, depending on the response.
Ointment has to be applied as a thin layer to affected skin with
gentle rubbing to cover the
affected area until most of the ointment disappears.
Sandoz B.V.
Page 2/8
Calcipotriol zalf 0,05 mg/g, zalf RVG 33408
1311-v5
1.3.1.1 Summary of the Product Characteristics
juli 2018
The maximum amount of ointment applied should not exceed 100 grams per
week. If it is
used together with cream or solution containing calcipotriol, the
total weekly dose of
calcipotriol should not exceed 5 mg (for example 40 ml scalp solution
plus 60 g of cream or
ointment).
The duration of therapy depends on the clinical appearance. A
pronounced therapeutic effect
is generally seen after a maximum of 4-8 weeks. Therapy can be
repeated.
As combination therapy
Once daily application in combination with topical corticosteroids
(e.g. administration of
[
Nationally completed name] in the morning and steroid in the evening)
is effective and well
tolerated.
_ _
_Renal/hepati