Axhidrox 2.2 mg/pump actuation cream

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Glycopyrronium bromide

Inapatikana kutoka:

Dr. August Wolff GmbH & Co. KG Arzneimittel

ATC kanuni:

D11AA

INN (Jina la Kimataifa):

Glycopyrronium bromide

Dawa fomu:

Cream

Eneo la matibabu:

Antihidrotics

Idhini hali ya:

Not marketed

Idhini ya tarehe:

2023-03-03

Taarifa za kipeperushi

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
AXHIDROX 2.2 MG/PUMP ACTUATION CREAM
glycopyrronium
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 Axhidrox is and what it is used for
2.
What you need to know before you use Axhidrox
3.
How to use Axhidrox
4.
Possible side effects
5.
How to store Axhidrox
6.
Contents of the pack and other information
1.
WHAT AXHIDROX IS AND WHAT IT IS USED FOR
Axhidrox contains the active substance glycopyrronium and belongs to a
group of sweat reducing
medicines called antihidrotics.
Axhidrox is used for topical treatment of severe primary axillary
hyperhidrosis in adults.
Primary axillary hyperhidrosis causes excessive sweating in both
armpits without any apparent reason
like sports, hard physical work, hot weather, certain diseases or
medicines. A feature of primary
axillary hyperhidrosis is that it occurs usually during the day but
not during sleep.
External use of Axhidrox in the armpits leads to reduced sweat
production in the sweat glands.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE AXHIDROX
DO NOT USE AXHIDROX IF YOU
–
are allergic to glycopyrronium or any of the other ingredients of this
medicine (listed in section 6).
–
have an eye disease where the pressure is high in your eye (glaucoma).
–
have or have had acute bleeding with unstable heart and blood
circulation status.
–
have a chronic inflammatory disease of the large bowel (severe
ulcerative colitis).
–
have or have had a chronic inflammation of the large bowel complicated
by severe extens

Tabia za bidhaa

Health Products Regulatory Authority
27 November 2023
CRN00DHFX
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Axhidrox 2.2 mg/pump actuation cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Glycopyrronium
1 g cream contains glycopyrronium bromide, equivalent to 8 mg of
glycopyrronium. One actuation of the pump delivers
270 mg cream, which contains glycopyrronium bromide, corresponding to
2.2 mg glycopyrronium.
Excipients with known effect
This medicine contains 21.6 mg cetostearyl alcohol, 2.7 mg benzyl
alcohol and 8.1 mg propylene glycol per pump actuation.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream
White glossy cream
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Axhidrox is indicated for the topical treatment of severe primary
axillary hyperhidrosis in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Cutaneous use
Axhidrox is for topical use in the underarm area only and not for use
in other body areas.
Posology
The recommended dosage of Axhidrox is two pump actuations per armpit
(equivalent to 540 mg of cream or 4.4 mg
glycopyrronium per armpit). After priming, the pump must be pressed
down all the way twice to get the desired dose of
540 mg cream (4.4 mg glycopyrronium).
During the first 4 weeks of treatment, Axhidrox is applied to each
armpit evenly, once a day, preferably in the evening.
From the 5th week on, the frequency of application of Axhidrox may be
reduced to twice a week, depending on the reduction
of axillary sweating.
Continuous treatment of primary axillary hyperhidrosis with Axhidrox
is required to maintain the effect.
_Paediatric population_
The safety and efficacy of Axhidrox in children and adolescents under
18 years has not yet been established.
No data are available.
_ _
_Elderly_
The safety and efficacy of Axhidrox in the elderly population above 65
years has not been established.
_Renal impairment_
Health Products Regulatory Authority
27 November 2023
CRN00DHFX
Page 2 of 9
Axhidrox can be used at the recommended do