Calcipotriol/Betamethasone Rowex 50 microgram/g + 0.5 mg/g Ointment

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Calcipotriol; Betamethasone

Available from:

Rowex Ltd

ATC code:

D05AX; D05AX52

INN (International Name):

Calcipotriol; Betamethasone

Dosage:

50microg/g + 0.5 milligram(s)/gram

Pharmaceutical form:

Ointment

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Other antipsoriatics for topical use; calcipotriol, combinations

Authorization status:

Marketed

Authorization date:

2016-01-29

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CALCIPOTRIOL/BETAMETHASONE ROWEX 50 MICROGRAM/G + 0.5 MG/G OINTMENT
calcipotriol/betamethasone
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 Calcipotriol/Betamethasone Rowex is and what it is used for
2. What you need to know before you use Calcipotriol/Betamethasone
Rowex
3. How to use Calcipotriol/Betamethasone Rowex
4. Possible side effects
5. How to store Calcipotriol/Betamethasone Rowex
6. Contents of the pack and other information
1.
WHAT CALCIPOTRIOL/BETAMETHASONE ROWEX IS AND WHAT IS USED FOR
Calcipotriol/Betamethasone Rowex ointment is used on the skin to treat
plaque psoriasis
(psoriasis vulgaris) in adults. Psoriasis is caused by your skin cells
being produced too
quickly. This causes redness, scaling and thickness of your skin.
Calcipotriol/Betamethasone Rowex ointment contains calcipotriol and
betamethasone.
Calcipotriol helps to bring the rate of skin cell growth back to
normal and betamethasone
acts to reduce inflammation.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE CALCIPOTRIOL/BETAMETHASONE ROWEX
DO NOT USE CALCIPOTRIOL/BETAMETHASONE ROWEX
• If you are allergic to calcipotriol, betamethasone or any of the
other ingredients of this
medicine (listed in section 6)
• If you have problems with calcium levels in the body (ask your
doctor)
• If you have certain types of psoriasis: these are erythrodermic,
exfoliative and pustular
(ask your doctor).
As Calcipotriol/Betamethasone Rowex contains a strong steroid do NOT
use on skin
affected by
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Summary of Product characteristics

Health Products Regulatory Authority
28 August 2023
CRN00DMCK
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Calcipotriol/Betamethasone Rowex 50 microgram/g + 0.5 mg/g Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of ointment contains 50 micrograms of calcipotriol (as
monohydrate) and 0.5 mg of betamethasone (as
dipropionate).
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Ointment.
Off white.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Topical treatment of stable plaque psoriasis vulgaris amenable to
topical therapy in adults
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Calcipotriol/Betamethasone Rowex ointment should be applied to the
affected area once daily.
The recommended treatment period is 4 weeks. There is experience with
repeated courses of Calcipotriol/Betamethasone
Rowex up to 52 weeks. If it is necessary to continue or restart
treatment after 4 weeks, treatment should be continued after
medical review and under regular medical supervision.
When using calcipotriol containing medicinal products, the maximum
daily dose should not exceed 15 g. The body surface
area treated with calcipotriol containing medicinal products should
not exceed 30 % (see section 4.4).
Special populations
_Renal and hepatic impairment_
The safety and efficacy of Calcipotriol/Betamethasone Rowex ointment
in patients with severe renal insufficiency or severe
hepatic disorders have not been evaluated.
_Paediatric population_
The safety and efficacy of Calcipotriol/Betamethasone Rowex ointment
in children below 18 years have not been established.
Currently available data in children aged 12 to 17 years are described
in sections 4.8, 5.1 and 5.2 but no recommendation on a
posology can be made.
_Method of administration_
Calcipotriol/Betamethasone Rowex ointment should be applied to the
affected area. In order to achieve optimal effect, it is not
recommended to take a shower or bath immediately after application of
Calcipotriol/Betamethasone Rowex oint