Šalis: Švedija
kalba: švedų
Šaltinis: Läkemedelsverket (Medical Products Agency)
glykopyrroniumbromid
Dr. August Wolff GmbH & Co Arzneimittel
D11AA01
glycopyrronium
2,2 mg/pumpning
Kräm
glykopyrroniumbromid 2,7 mg Aktiv substans; propylenglykol Hjälpämne; cetostearylalkohol Hjälpämne; bensylalkohol Hjälpämne
Receptbelagt
Förpacknings: Pumpflaska, 124 pumpningar (50 g)
Godkänd
2022-04-22
PACKAGE LEAFLET 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 Perskaitykite visą dokumentą
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_ Axhidrox can be used at the recommended dose in patients with mild or moderate renal impairment. In patients with severe renal impairment or end-stage renal disease requiring dialysis Axhidrox s Perskaitykite visą dokumentą