- Approval Id
- a22440ae298ceb3d
- Drug Approval Emc Name
- Axhidrox pump-pack 2.2 mg/pump actuation cream 2.2 mg/270 mg Cream POM
- Drug Name
- Axhidrox pump-pack 2.2 mg/pump actuation cream 2.2 mg/270 mg Cream POM
- Company Address
- Van-der-Smissen-Strasse 1, Hamburg, 22767, Germany
- Company Website
- https://axunio.eu/
- Company Telephone
- + 49 (0)40 - 38 02 32 14
- Company Fax
- + 49 (0)40 - 38 02 32 09
- Company Medical Info Direct Line
- + 49 (0)40 - 38 02 32 14
- Company Medical Info Email
- [email protected]
- Company Customer Care Direct Line
- + 49 (0)40 - 38 02 32 14
- Company Stock Availability
- [email protected]
- Atc Code
- D11AA01
- Legal Category
- Prescription only medicine
- Authorisation Holder
- 7. Marketing authorisation holder axunio Pharma GmbH Van-der-Smissen-Strasse 1 22767 HamburgGermany Email: [email protected]
- Authorisation Number
- 8. Marketing authorisation number(s) PL 47848/0056
- Authorisation Date
- 9. Date of first authorisation/renewal of the authorisation 09/06/2025
- Instruction Authorisation Holder
- 7. Marketing authorisation holder axunio Pharma GmbH Van-der-Smissen-Strasse 1 22767 HamburgGermany Email: [email protected]
- Instruction Authorisation Number
- 8. Marketing authorisation number(s) PL 47848/0056
- Instruction Authorisation Date
- 9. Date of first authorisation/renewal of the authorisation 09/06/2025
- Instruction Composition
- 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.
- Instruction Dosage Form
- 3. Pharmaceutical form Cream White glossy cream
- Instruction Clinical Particulars
- 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 should be used only if the expected benefit outweighs the potential risk since the systemic exposure to glycopyrronium may be increased in this population (see section 4.4). Hepatic impairment No studies have been conducted in patients with hepatic impairment. Glycopyrronium is predominantly cleared by renal excretion and therefore no major increase in exposure to the active substance is to be expected in patients with hepatic impairment. No dose adjustment is required in patients with hepatic impairment. Method of administration Preparation of the pump before the first use The multidose container requires priming before it is used for the first time. To get a full initial dose, the air trapped in the pump must be removed as follows: – Hold the pump at an angle (see illustration) and repeatedly press the pump down until cream comes out of the opening onto a piece of paper. – Slowly push the pump down fully another 10 times and put the pumped cream onto the paper. Dispose the paper with the dispensed cream via waste bin only. – The pump is now ready for use. Repeated preparation of the pump is not necessary for subsequent use. Regular application of the cream After priming, the application of the cream is done using the cap as further detailed: – Hold the pump in one hand with the opening of the pump towards the removed cap of the pump (see illustration). – Fully press the pump twice to apply the recommended amount of cream to the top of the cap. – Using the cap, evenly distribute the cream in one armpit. – Repeat this process for the second armpit. – Afterwards, for safety, wash the cap and your hands immediately and thoroughly with soap and water. This is important to avoid contact of the cream with nose, eyes or mouth as well as with other persons (see section 4.4). – Tick off the number of treatments in the table on the outer carton (see section 6). 4.3 Contraindications – Hypersensitivity to the active substance, or to any of the excipients listed in section 6.1. – Medical conditions that can be exacerbated by the anticholinergic effect of Axhidrox (e.g. glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis, Sjögren syndrome). 4.4 Special warnings and precautions for use Axhidrox should be used with caution in patients with severe prostatic hyperplasia, bladder-neck obstruction or a history or presence of urinary retention. In these patients, doctors and patients should be alert for signs and symptoms of urinary retention (e.g., difficulty passing urine, distended bladder) and patients must be instructed to immediately discontinue the use of Axhidrox and to consult a doctor if any of these signs or symptoms develop. In patients with severe renal impairment (estimated glomerular filtration rate below 30 ml/min/1.73 m2), including those with end-stage renal disease requiring dialysis, Axhidrox should be used only if the expected benefit outweighs the potential risk. These patients should be monitored closely for potential adverse reactions. Because an increased heart rate is a known effect of anticholinergics, Axhidrox should be used with caution in patients with coronary artery disease, congestive heart failure, cardiac arrhythmias and hypertension. No studies have been performed in patients with dysfunctions of the blood-brain barrier (e.g. traumatic brain injuries within the past year, chemotherapy, radiation therapy of the head, surgery to the skull and brain, intravenous drug addicts). Axhidrox should only be used by these patients if other treatment options are not sufficiently effective. The application of Axhidrox under the armpits should be done only with the cap of the multidose container and not with the fingers. In particular, Axhidrox must not get into the eyes (see section 4.2) since glycopyrronium can cause temporary dilation of the pupils and blurred vision. In case of contact with the mouth or nose, a reduction in the production of saliva or nasal secretions cannot be ruled out. If the eyes, nose or mouth come in contact with the cream, these areas should be rinsed immediately with plenty of water to reduce the risk of local side effects. In order to exclude side effects, skin to skin contact of the treated skin area with other areas including skin of others should be avoided i.e. by covering the treated area with clothes (e.g. during intercourse). If the skin of the armpits is visibly inflamed or injured this may increase the risk of local adverse reactions with Axhidrox. Therefore, Axhidrox should only be used after clinical recovery or remission of symptoms of the skin. Since the use of Axhidrox can cause dry mouth (see section 4.8), increased risk of caries due to the reduced salivation cannot be ruled out. Careful dental hygiene and regular dental health checks are therefore recommended. Benzyl alcohol may cause allergic reactions and mild local irritations. Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis). 4.5 Interaction with other medicinal products and other forms of interaction No interaction studies have been performed. Co-administration of Axhidrox with other anticholinergic-acting medicinal products has not been studied. It cannot be ruled out that the concomitant use of these products may result in an increase in anticholinergic effects. This applies, for example, for the use of topiramate, sedative antihistamines, tricyclic antidepressants, monoamine oxidase inhibitors, neuroleptics, antipsychotics and opioids. 4.6 Fertility, pregnancy and lactation Pregnancy There are no or limited amount of data from the use of glycopyrronium bromide in pregnant women. Studies in animals have shown reproductive toxicity (see section
- Instruction Pharmacology
- 5. Pharmacological properties 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Other dermatological preparations, antihidrotics, ATC code: D11AA01 Mechanism of action Glycopyrronium is a competitive antagonist of the muscarinic acetylcholine receptors. Pharmacodynamic effects Glycopyrronium inhibits acetylcholine-driven effects on smooth muscle and heart muscle cells and on various glands, including the sweat glands. In the sweat glands, this results in a reduction in perspiration. Clinical efficacy and safety The safety and efficacy of Axhidrox in patients with primary axillary hyperhidrosis was evaluated in a Phase 3 Study, consisting of a 4-week double-blind and placebo-controlled treatment period (Phase 3a Part), followed by an open-label extension of treatment up to 72 weeks (Phase 3b Part). In total, 171 patients (18-65 years) were included in the 4-week, multicentre, randomized, double-blind, placebo-controlled Phase 3a Part of the pivotal study. Across the treatment groups, the mean age was 36 years, 51% were men. Almost all were of white ethnic origin. The disease severity was severe primary axillary hyperhidrosis (HDSS score of 3 or 4) with at least 50 mg of sweat production in each axilla measured gravimetrically at room temperature and at a humidity consistent with the normal climate in that area over a period of 5 minutes. The primary endpoint was defined as the absolute change in sweat production with the GPB 1% cream vs. placebo from baseline to Day 29, as assessed by gravimetry. Key secondary endpoints were the comparison between GPB 1% cream and placebo regarding absolute change in Hyperhidrosis Quality of Life Index (HidroQoL) score from baseline to Day 29 and the percentage of responders based on HDSS score at Day 29 (improvement of ≥ 2 points). After 4 weeks of treatment in the placebo-controlled Phase 3a Part, the group treated with Axhidrox showed a larger, approximately 2-fold, sweat reduction from baseline than the placebo group. The absolute reduction in sweat production from baseline to Day 29 was statistically significantly higher in the Axhidrox group compared with the placebo group (Table 2). The analysis assessing the key secondary endpoints showed an improvement of 2 or more points in the HDSS score to treatment with Axhidrox than to treatment with placebo (p = 0.0542). In the analysis assessing absolute changes in the HidroQoL score, the median improvement was significantly larger in the group treated with Axhidrox than with placebo group (p < 0.0001). Table 2. Data from the Phase 3a Part Placebo (n = 84) GPB 1% (n = 87) GPB 1% vs. placebo p-values Primary endpoint Absolute change in sweat production from Baseline to Day 29 Baseline [mg] (mean ± SD) 284.64 (212.47) 30
- Instruction Pharmaceutical Particulars
- 6. Pharmaceutical particulars 6.1 List of excipients Benzyl alcohol (E1519) Propylene glycol (E1520) Cetostearyl alcohol Citric acid (E330) Glycerol monostearate 40–55 Macrogol 20 glycerol monostearate Sodium citrate (E331) Octyldodecanol Water, purified 6.2 Incompatibilities In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. 6.3 Shelf life 3 years After first actuation, the medicinal product may be used for a maximum of 12 months. 6.4 Special precautions for storage This medicinal product does not require any special storage conditions. 6.5 Nature and contents of container Multidose container consisting of a container part (pouch laminate of LDPE, PET and aluminium encased in white rigid polypropylene bottle) and a pump part and its cap (both of white polypropylene). Pack size: One container containing 50 g cream corresponding to 124 actuations or 31 treatments in both armpits. In order not to exceed the number of treatments per container, the user is invited to mark the number in the table on the outer carton. 6.6 Special precautions for disposal and other handling Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
- Instruction Content
- ## Composition
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.
## Pharmaceutical Form
3. Pharmaceutical form Cream White glossy cream
## Clinical Particulars
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 should be used only if the expected benefit outweighs the potential risk since the systemic exposure to glycopyrronium may be increased in this population (see section 4.4). Hepatic impairment No studies have been conducted in patients with hepatic impairment. Glycopyrronium is predominantly cleared by renal excretion and therefore no major increase in exposure to the active substance is to be expected in patients with hepatic impairment. No dose adjustment is required in patients with hepatic impairment. Method of administration Preparation of the pump before the first use The multidose container requires priming before it is used for the first time. To get a full initial dose, the air trapped in the pump must be removed as follows: – Hold the pump at an angle (see illustration) and repeatedly press the pump down until cream comes out of the opening onto a piece of paper. – Slowly push the pump down fully another 10 times and put the pumped cream onto the paper. Dispose the paper with the dispensed cream via waste bin only. – The pump is now ready for use. Repeated preparation of the pump is not necessary for subsequent use. Regular application of the cream After priming, the application of the cream is done using the cap as further detailed: – Hold the pump in one hand with the opening of the pump towards the removed cap of the pump (see illustration). – Fully press the pump twice to apply the recommended amount of cream to the top of the cap. – Using the cap, evenly distribute the cream in one armpit. – Repeat this process for the second armpit. – Afterwards, for safety, wash the cap and your hands immediately and thoroughly with soap and water. This is important to avoid contact of the cream with nose, eyes or mouth as well as with other persons (see section 4.4). – Tick off the number of treatments in the table on the outer carton (see section 6). 4.3 Contraindications – Hypersensitivity to the active substance, or to any of the excipients listed in section 6.1. – Medical conditions that can be exacerbated by the anticholinergic effect of Axhidrox (e.g. glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis, Sjögren syndrome). 4.4 Special warnings and precautions for use Axhidrox should be used with caution in patients with severe prostatic hyperplasia, bladder-neck obstruction or a history or presence of urinary retention. In these patients, doctors and patients should be alert for signs and symptoms of urinary retention (e.g., difficulty passing urine, distended bladder) and patients must be instructed to immediately discontinue the use of Axhidrox and to consult a doctor if any of these signs or symptoms develop. In patients with severe renal impairment (estimated glomerular filtration rate below 30 ml/min/1.73 m2), including those with end-stage renal disease requiring dialysis, Axhidrox should be used only if the expected benefit outweighs the potential risk. These patients should be monitored closely for potential adverse reactions. Because an increased heart rate is a known effect of anticholinergics, Axhidrox should be used with caution in patients with coronary artery disease, congestive heart failure, cardiac arrhythmias and hypertension. No studies have been performed in patients with dysfunctions of the blood-brain barrier (e.g. traumatic brain injuries within the past year, chemotherapy, radiation therapy of the head, surgery to the skull and brain, intravenous drug addicts). Axhidrox should only be used by these patients if other treatment options are not sufficiently effective. The application of Axhidrox under the armpits should be done only with the cap of the multidose container and not with the fingers. In particular, Axhidrox must not get into the eyes (see section 4.2) since glycopyrronium can cause temporary dilation of the pupils and blurred vision. In case of contact with the mouth or nose, a reduction in the production of saliva or nasal secretions cannot be ruled out. If the eyes, nose or mouth come in contact with the cream, these areas should be rinsed immediately with plenty of water to reduce the risk of local side effects. In order to exclude side effects, skin to skin contact of the treated skin area with other areas including skin of others should be avoided i.e. by covering the treated area with clothes (e.g. during intercourse). If the skin of the armpits is visibly inflamed or injured this may increase the risk of local adverse reactions with Axhidrox. Therefore, Axhidrox should only be used after clinical recovery or remission of symptoms of the skin. Since the use of Axhidrox can cause dry mouth (see section 4.8), increased risk of caries due to the reduced salivation cannot be ruled out. Careful dental hygiene and regular dental health checks are therefore recommended. Benzyl alcohol may cause allergic reactions and mild local irritations. Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis). 4.5 Interaction with other medicinal products and other forms of interaction No interaction studies have been performed. Co-administration of Axhidrox with other anticholinergic-acting medicinal products has not been studied. It cannot be ruled out that the concomitant use of these products may result in an increase in anticholinergic effects. This applies, for example, for the use of topiramate, sedative antihistamines, tricyclic antidepressants, monoamine oxidase inhibitors, neuroleptics, antipsychotics and opioids. 4.6 Fertility, pregnancy and lactation Pregnancy There are no or limited amount of data from the use of glycopyrronium bromide in pregnant women. Studies in animals have shown reproductive toxicity (see section
## Pharmacological Properties
5. Pharmacological properties 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Other dermatological preparations, antihidrotics, ATC code: D11AA01 Mechanism of action Glycopyrronium is a competitive antagonist of the muscarinic acetylcholine receptors. Pharmacodynamic effects Glycopyrronium inhibits acetylcholine-driven effects on smooth muscle and heart muscle cells and on various glands, including the sweat glands. In the sweat glands, this results in a reduction in perspiration. Clinical efficacy and safety The safety and efficacy of Axhidrox in patients with primary axillary hyperhidrosis was evaluated in a Phase 3 Study, consisting of a 4-week double-blind and placebo-controlled treatment period (Phase 3a Part), followed by an open-label extension of treatment up to 72 weeks (Phase 3b Part). In total, 171 patients (18-65 years) were included in the 4-week, multicentre, randomized, double-blind, placebo-controlled Phase 3a Part of the pivotal study. Across the treatment groups, the mean age was 36 years, 51% were men. Almost all were of white ethnic origin. The disease severity was severe primary axillary hyperhidrosis (HDSS score of 3 or 4) with at least 50 mg of sweat production in each axilla measured gravimetrically at room temperature and at a humidity consistent with the normal climate in that area over a period of 5 minutes. The primary endpoint was defined as the absolute change in sweat production with the GPB 1% cream vs. placebo from baseline to Day 29, as assessed by gravimetry. Key secondary endpoints were the comparison between GPB 1% cream and placebo regarding absolute change in Hyperhidrosis Quality of Life Index (HidroQoL) score from baseline to Day 29 and the percentage of responders based on HDSS score at Day 29 (improvement of ≥ 2 points). After 4 weeks of treatment in the placebo-controlled Phase 3a Part, the group treated with Axhidrox showed a larger, approximately 2-fold, sweat reduction from baseline than the placebo group. The absolute reduction in sweat production from baseline to Day 29 was statistically significantly higher in the Axhidrox group compared with the placebo group (Table 2). The analysis assessing the key secondary endpoints showed an improvement of 2 or more points in the HDSS score to treatment with Axhidrox than to treatment with placebo (p = 0.0542). In the analysis assessing absolute changes in the HidroQoL score, the median improvement was significantly larger in the group treated with Axhidrox than with placebo group (p < 0.0001). Table 2. Data from the Phase 3a Part Placebo (n = 84) GPB 1% (n = 87) GPB 1% vs. placebo p-values Primary endpoint Absolute change in sweat production from Baseline to Day 29 Baseline [mg] (mean ± SD) 284.64 (212.47) 30
## Pharmaceutical Particulars
6. Pharmaceutical particulars 6.1 List of excipients Benzyl alcohol (E1519) Propylene glycol (E1520) Cetostearyl alcohol Citric acid (E330) Glycerol monostearate 40–55 Macrogol 20 glycerol monostearate Sodium citrate (E331) Octyldodecanol Water, purified 6.2 Incompatibilities In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. 6.3 Shelf life 3 years After first actuation, the medicinal product may be used for a maximum of 12 months. 6.4 Special precautions for storage This medicinal product does not require any special storage conditions. 6.5 Nature and contents of container Multidose container consisting of a container part (pouch laminate of LDPE, PET and aluminium encased in white rigid polypropylene bottle) and a pump part and its cap (both of white polypropylene). Pack size: One container containing 50 g cream corresponding to 124 actuations or 31 treatments in both armpits. In order not to exceed the number of treatments per container, the user is invited to mark the number in the table on the outer carton. 6.6 Special precautions for disposal and other handling Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
- Company Detail Path
- /organization/axunio-pharma-gmbh
