Vaniqa 11.5% cream

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Eflornithine monohydrate chloride

זמין מ:

Almirall Ltd

קוד ATC:

P01CX03

INN (שם בינלאומי):

Eflornithine monohydrate chloride

כמות:

115mg/1gram

טופס פרצבטיות:

Cream

מסלול נתינה (של תרופות):

Cutaneous

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 13090000; GTIN: 4042762054392

עלון מידע

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
VANIQA 11.5% CREAM
Eflornithine
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 symptoms 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 Vaniqa is and what it is used for
2.
What you need to know before you use Vaniqa
3.
How to use Vaniqa
4.
Possible side effects
5.
How to store Vaniqa
6.
Contents of the pack and other information
1.
WHAT VANIQA IS AND WHAT IT IS USED FOR
Vaniqa contains the active substance eflornithine. Eflornithine slows
down the growth of hair through
its effect on a specific enzyme (a protein in the body involved in the
production of hair).
Vaniqa is used to reduce the growth of excessive hair (Hirsutism) on
the face of women older than
18 years of age. 2.
WHAT YOU NEED TO KNOW BEFORE YOU USE VANIQA
DO NOT USE VANIQA:
•
if you are allergic to eflornithine or any of the other ingredients of
this medicine listed in
section 6.
WARNINGS AND PRECAUTIONS
Talk to your doctor of pharmacist before using Vaniqa
•
tell your doctor of any other medical problems you may be experiencing
(especially related to
your kidneys or liver).
•
if you are unsure whether or not to use this medicine contact your
doctor or pharmacist for
advice.
Excessive growth of hair may be a result of underlying diseases. Talk
to your doctor if you suffer from
polycystic ovary syndrome (PCOS) or specific hormone producing
tumours, or if you take medicines
that can induce hair growth, e.g. cyclosporine (following organ
transplants), glucocorticoids (e.g.
against rheumatic or allergic diseases), minoxidil
(against high blood press

מאפייני מוצר

OBJECT 1
VANIQA 11.5% CREAM
Summary of Product Characteristics Updated 10-Aug-2017 | Almirall
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 Fertility, 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
Vaniqa 11.5% cream
2. Qualitative and quantitative composition
Each gram of cream contains 115 mg of eflornithine (as hydrochloride
monohydrate).
Excipients with known effect:
Each gram of cream contains 47.2 mg of cetostearyl alcohol, 14.2 mg of
stearyl alcohol, 0.8 mg of methyl
parahydroxybenzoate and 0.32mg of propyl parahydroxybenzoate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Cream.
White to off white cream
4. Clinical particulars
4.1 Therapeutic indications
Treatment of facial hirsutism in women.
4.2 Posology and method of administration
Posology
Vaniqa cream should be applied to the affected area twice daily, at
least eight hours apart. Efficacy has
only been demonstrated for affected areas of the face and under the
chin. Application should be limited to
these areas. Maximal applied do