Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Glycopyrronium may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
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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.
e Axhidrox
Do not use Axhidrox if you
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Axhidrox
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Apply Axhidrox only on the skin in your armpits and only with the cap of the pump, not with your fingers (see section 2, "Warnings and precautions"). The recommended dose is two pump actuations per armpit. During the first 4 weeks of treatment, apply Axhidrox to each armpit evenly, once a day, preferably in the evening. From the 5th week on, you may reduce the frequency of application to twice a week, depending on the reduction of sweat production. Preparation of the pump before the first use To obtain the recommended dose, you must remove the air trapped in the pump, as follows:
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop using Axhidrox and contact your doctor or nearest emergency department immediately, if you get the following serious side effect:
The following further side effects were observed: Very common side effect (may affect more than 1 in 10 people)
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or apple App Store.By reporting side effects you can help provide more information on the safety of this medicine. 5.
Axhidrox
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the label and on the carton after 'EXP'. The expiry date refers to the last day of that month. This medicine does not require any special storage conditions. After first pump actuation, the medicine may be used for a maximum of 12 months. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6.
What Axhidrox contains
actuation of the pump delivers 270 mg cream which contains glycopyrronium bromide, corresponding to 2.2 mg glycopyrronium.
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Axhidrox pump-pack 2.2 mg/pump actuation cream 2.2 mg/270 mg Cream POM comes as cream containing 2.2mg / 2.2mg / 270mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Axhidrox pump-pack 2.2 mg/pump actuation cream 2.2 mg/270 mg Cream POM is glycopyrronium.
This leaflet reproduces the patient information leaflet approved for Axhidrox pump-pack 2.2 mg/pump actuation cream 2.2 mg/270 mg Cream POM, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Axhidrox is indicated for the topical treatment of severe primary axillary hyperhidrosis in adults.
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).
– 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).
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).
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.
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 5.3). Based on the low systemic exposure following dermal application of Axhidrox, these findings are not considered relevant for human dermal use at the approved dosing. The use of Axhidrox may be considered during pregnancy, if necessary.
Breast-feeding
Studies in lactating rats have shown that glycopyrronium and its metabolites distribute into and is enriched in milk following intravenous and oral application (for details see section 5.3).
The contact of the suckling child with the cream or Axhidrox-treated skin should be avoided, therefore a decision must be made whether to discontinue breast-feeding or to discontinue Axhidrox therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Fertility
There are no data on the effect of glycopyrronium on human fertility. Animal studies have shown impaired female fertility at exposures considered in excess of the maximum human exposure, indicating low clinical relevance (see section 5.3).
Axhidrox has moderate influence on the ability to drive and use machines. Blurred vision, fatigue, and dizziness may occur following administration of Axhidrox (see section 4.8). Blurred vision in particular may occur if Axhidrox gets into the eyes (see section 4.4).
Summary of the safety profile
The most common adverse events (> 1%) were application site reactions (15.3%), dry mouth (12.3%), dry eye (3.3%), headache (1.3%), dry skin (1.3%), nasal dryness (1.5%), constipation (1.3%) and blurred vision (1.1%). While dry mouth tended to decrease with longer use, the type and frequency of all other adverse events were similar when using Axhidrox for 4 weeks as well as for 28, 52 or 72 weeks. There was no evidence that adverse events tended to get worse in severity over a longer treatment duration.
Tabulated list of adverse reactions
Adverse reactions in patients using Axhidrox up to 72 weeks are listed by MedDRA system organ class (Table 1). The table also includes data from a 14-day study with 0.5%, 1% and 2% glycopyrronium bromide (GPB) cream respectively.
Within the individual system organ classes, the adverse reactions are ranked by frequency. Within the individual frequency groups, the undesirable effects are indicated in order of decreasing severity. The frequency of adverse effects is defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Table 1: Adverse reactions
System organ class
Very common
(≥ 1/10)
Common
(≥ 1/100 to < 1/10)
Uncommon
(≥ 1/1,000 to < 1/100)
Not known
Gastrointestinal disorders
Dry mouth
Constipation
Lip dry, Abdominal distension, Hard stool, Aptyalisam, Dyspepsia, Nausea
Eye disorders
Dry eye, Vision blurred
Eye pruritus, Ocular hyperaemia, Pupils unequal, Visual impairment, Eye irritation, Mydriasis
Respiratory, thoracic and mediastinal disorders
Nasal dryness
Oropharyngeal pain, Throat tightness, Dry throat, Nasal congestion
Nervous system disorders
Headache
Dizziness, Somnolence, Poor quality sleep, Disturbance in attention, Head discomfort
Psychiatric disorders
Sleep disorder, Anxiety, Restlessness
Ear and labyrinth disorders
Vertigo
Skin and subcutaneous tissue disorders
Dry skin
Hyperhidrosis, Pruritus, Pruritus generalized, Rash, Skin odour abnormal, Erythema, Parapsoriasis, Skin irritation, Dry hands, Dermatitis atopic, Eczema, Skin plaque, Acne, Urticaria
General disorders and administration site conditions
Application site dermatitis, eczema, rash, papules, erythema, irritation, pain, or pruritus
Application site acne, swelling, dryness, vesicles, induration, scar or wound, Mucosal dryness, Tiredness
Infections and infestations
Application site folliculitis, pustules
Blood and lymphatic system disorders
Thrombocytopenia
Cardiac disorders
Tachycardia
Immune system disorders
Hypersensitivity, Angioedema
Renal and urinary disorders
Micturition disorder
Investigations
Electrocardiogram QT prolongation, Hepatic enzymes increased, Blood bilirubin increased and Mean cell volume increased, Mean cell haemoglobin concentration decreased
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Overdosage with Axhidrox is considered unlikely with topical administration to the armpits only.
If Axhidrox is misused on other parts (palms, feet, face) or large areas of the body with increased sweating an increased risk of side effects or an overdose cannot be ruled out. Signs of overdose observed especially with systemic oral administration of glycopyrronium included redness of the skin with a sensation of heat, overheating of the body, life-threatening heatstroke, dryness of the skin and mucous membranes, mydriasis with loss of accommodation, changes in mental status and fever, sinus tachycardia, a decrease in intestinal noises, functional ileus, urinary retention, hypertension, tremors and myoclonic twitching.
In case of severe or life-threatening symptoms, the administration of a quaternary ammonium anticholinesterase, such as neostigmine, should be considered.
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
Ask anything about Axhidrox pump-pack 2.2 mg/pump actuation cream 2.2 mg/270 mg Cream POM. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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