Dovobet ointment

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Calcipotriol monohydrate; Betamethasone dipropionate

Available from:

DE Pharmaceuticals

ATC code:

D05AX52

INN (International Name):

Calcipotriol monohydrate; Betamethasone dipropionate

Dosage:

50microgram/1gram ; 500microgram/1gram

Pharmaceutical form:

Cutaneous ointment

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13050200

Patient Information leaflet

IIE007-01 - 175 x 280 mm
175 mm
280 mm
Calcipotriene. Conoptal
®
,
Daivonex
®
,
Dovonex
®
, Daivobet
®
, Dovobet
®
Taclonex
®
,
Psorcutan
®
, Token
®
,
Fucidin
®
, Fucidin
®
H, Fucicort
®
,
Fucibet
®
, Fucithalmic
®
, Isathal
®
,
Isathalmic
®
, Verutex
®
, Verutex
®
B
1 column and 2 columns
PackRat approved
Comments:
INS007-00 - 22/09/2017 DVR - Moved details about itemnumber
IIE007-01 - 03/06/2018 - OMA - Updated for CI project (CAPA 173674),
changed reference from INS005 to IIE005-01
Revision info:
Used for:
OMA
11/06/2018
Insert
175 x 280mm
IIE007-01
20/01/2004
PSR
100%
PACKAGE LEAFLET: INFORMATION FOR THE USER
DOVOBET
® 50 MICROGRAMS/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, pharmacist or
nurse.
• 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.
059889-XX
345
345
WHAT IS IN THIS LEAFLET:
1. What Dovobet
®
is and what it is used for
2. What you need to know before you use Dovobet
®
3. How to use Dovobet
®
4. Possible side effects
5. How to store Dovobet
®
6. Contents of the pack and other information
1. WHAT DOVOBET
® IS AND WHAT IT IS USED FOR
Dovobet 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.
Dovobet 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 DOVOBET
®
DO NOT USE DOV

Summary of Product characteristics

OBJECT 1
DOVOBET OINTMENT
Summary of Product Characteristics Updated 14-Aug-2018 | Leo
Laboratories Limited
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Dovobet 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).
Excipient with known effects:
Butylhydroxytoluene (E321) 50 micrograms/g ointment
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Ointment.
Off-white to yellow.
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
Dovobet ointment should be applied to the affected area once daily.
The recommended treatment period is 4 weeks. There is experience with
repeated courses of Dovobet up to
52 weeks. If it is necessary to continue or restart treatment after 4
weeks