Axhidrox

Patient Information Leaflet: Information for the User

AXHIDROX 2.2 mg/dose cream

Glycopyrronium
Please read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What AXHIDROX is and what it is used for
2. What you need to know before using 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 medicines
that reduce sweating called antihidrotics.
AXHIDROX is used for the topical treatment of severe primary axillary hyperhidrosis in adults.
Primary axillary hyperhidrosis causes excessive sweating in both armpits without any apparent
reason such as physical exercise, hard physical work, hot climate, certain diseases or medications.
Another characteristic of primary axillary hyperhidrosis is that it usually occurs during the day, but not
during sleep.
Topical use of AXHIDROX on the armpits reduces sweat production in the sweat glands.

2. What you need to know before using AXHIDROX

Do not use AXHIDROX if

• you are allergic to glycopyrronium or to any of the other ingredients of this medicine (listed in section 6)
• you suffer from an eye disorder causing increased internal eye pressure (glaucoma)
• you have or have had acute bleeding with unstable heart and circulatory condition
• you have chronic inflammatory bowel disease of the colon (severe ulcerative colitis)
• you have or have had chronic inflammation of the colon complicated by severe colon distension (toxic megacolon complicating ulcerative colitis)
• you have or have had intestinal obstruction due to paralysis of intestinal muscles (paralytic ileus)
• you have an immune-mediated disease affecting muscles (myasthenia gravis) or salivary or lacrimal glands (Sjögren's syndrome)

Warnings and precautions
Talk to your doctor or pharmacist before using AXHIDROX if

• you have or have had prostate or bladder problems, or difficulties urinating. Stop using this medicine and consult a doctor if you notice symptoms of urinary retention such as weak or dribbling urine flow, increased need to urinate, feeling of a full bladder or incomplete bladder emptying.
• you have severe kidney problems, including dialysis-dependent renal failure.
• you have dysfunctions of the blood-brain barrier, such as after traumatic brain injuries within the past year, chemotherapy, radiotherapy to the head, cranial or brain surgery, or due to intravenous drug abuse.
• you have heart disease, heart failure, irregular heartbeat, or high blood pressure
• you have inflamed or damaged skin in the armpits, as this may increase the risk of local adverse effects. Use AXHIDROX only after complete remission of skin disease or full wound healing.

Do not apply the cream to any other part of the body except the armpits, and avoid any contact of the cream with the eyes, nose, or mouth, or with other people.
Apply AXHIDROX only using the dispenser cap, not with your fingers. If the cream comes into contact with the eyes, it may cause temporary pupil dilation and blurred vision.
If the cream comes into contact with the mouth or nose, saliva production or nasal secretions may be reduced. If the cream contacts the eyes, nose, or mouth, these areas should be immediately rinsed thoroughly with plenty of water to reduce the risk of local adverse effects.
Cover the treated armpits with clothing, as adverse effects cannot be ruled out if other people come into contact with the cream.
If you experience dry mouth, clean your teeth carefully. Have regular dental check-ups, as the risk of tooth decay may be increased.

Children
Do not use this medicine in children and adolescents under 18 years of age, as it has not been studied in this age group.

Other medicines and AXHIDROX
Tell your doctor or pharmacist if you are taking, have recently taken, or plan to take any other medicines.
Some medicines may affect or be affected by AXHIDROX.
These medicines include:

• topiramate, used to treat epilepsy and migraine
• sedating antihistamines, used to treat allergies or sleep disorders
• tricyclic antidepressants, used to treat depression
• monoamine oxidase inhibitors, used to treat depression or Parkinson's disease
• neuroleptics or antipsychotics, used to treat mental illnesses or anxiety
• opioids, used to treat pain or cough.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
There are no data on the use of AXHIDROX in pregnant women, and it is not known whether the active substance of this medicine passes into breast milk. Your doctor will discuss with you whether you can use AXHIDROX during pregnancy. If you are breastfeeding, you and your doctor must decide whether to discontinue breastfeeding or discontinue treatment with AXHIDROX, taking into account the benefit of breastfeeding for the child and the benefit of treatment for you. This is because the infant must not come into contact with the cream or treated skin.

Driving and using machines
Blurred vision, drowsiness, fatigue, and dizziness may occur after administration of AXHIDROX (see section 4, Possible side effects). Blurred vision may particularly occur if AXHIDROX gets into the eyes. Do not drive, operate machinery, or engage in dangerous activities or sports until these effects have subsided.

AXHIDROX contains benzyl alcohol, propylene glycol, and cetostearyl alcohol
This medicine contains 2.7 mg of benzyl alcohol per delivered dose. Benzyl alcohol may cause an allergic reaction and mild local irritation.
This medicine contains 8.1 mg of propylene glycol per delivered dose.
The medicine contains cetostearyl alcohol and stearic alcohol, which may cause local skin reactions (e.g. contact dermatitis).

3. How to use AXHIDROX

Use this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.
Apply AXHIDROX only to the skin of the armpits and only using the pump cap, 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 evenly to each armpit once daily, preferably in the evening.
From week 5 onwards, the frequency of application may be reduced to twice a week, depending on the reduction in sweat production.

Preparing the pump before first use
To obtain the recommended dose, it is necessary to remove air from the pump as follows:

• Remove the pump cap.

• Place a piece of paper on a flat surface. Hold the pump at an angle (see illustration) and press the pump repeatedly until cream appears at the opening.
• Slowly press the pump down completely another 10 times, dispensing the cream onto the paper. Dispose of the paper with the cream only in the waste bin.
• The pump is now ready for use. Do not repeat the priming procedure for subsequent uses.

Applying the cream using the pump cap

• Remove the pump cap.
• Hold the pump with the opening facing towards the removed cap.
• Press the pump fully down twice to dispense the recommended amount

of cream onto the top of the cap (see illustration).

• Spread the cream evenly over one armpit using the cap.
• Repeat this process for the second armpit.
• Afterwards, wash the pump cap and, for safety, your hands immediately and thoroughly with soap and water. This is important to avoid contact of the cream with the nose, eyes, or mouth. (See section 2, "Warnings and precautions").
• Record the number of treatments in the table on the outer packaging (see section 6). One treatment corresponds to 4 pump actuations, i.e., 2 actuations per armpit.

If you use more AXHIDROX than you should
Overdose is unlikely if AXHIDROX is used only on the armpits as described.
However, if AXHIDROX is applied too frequently or excessively, possible side effects may increase (see section 4). Therefore, AXHIDROX must not be used on other areas (palms of hands, feet, face) or over large areas of the body with increased sweating. Excessively reduced sweating could lead to overheating of the body and potentially fatal heat stroke.
Stop using AXHIDROX and contact your doctor immediately if you notice a growing sensation of heat or an increase in body temperature.

If you forget to use AXHIDROX
Do not apply a double dose to make up for a forgotten dose.

If you stop using AXHIDROX
If you or your doctor decide to stop using AXHIDROX, excessive sweating will return.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this one can cause side effects, although not everyone experiences them.
Stop using AXHIDROX and contact your doctor or nearest emergency department immediately if you experience any of the following serious side effects:

• swelling mainly of the face, lips or throat, accompanied by difficulty swallowing or breathing, itching and skin rash. This could be a sign of a severe allergic reaction or angioedema (frequency not known, cannot be estimated based on available data); urgent medical treatment may be required.
• blurred vision (common side effect). (See section 2, “Driving and use of machines”).

The following additional side effects have been observed
Very common side effects (may affect more than 1 in 10 people)

• dry mouth

Common side effects (may affect up to 1 in 10 people)

• in the treated armpit: irritation, pain, itching, eczema, skin inflammation, rash, redness of the skin, nodules
• dry nose
• dry eyes
• dry skin
• headache
• constipation

Uncommon side effects (may affect up to 1 in 100 people)

• in the treated armpit: dryness, acne, swelling, skin hardening, scarring, small blisters, wounds, pustules, inflamed hair follicles
• eczema
• itching, generalized itching
• rash
• redness of the skin
• long-term skin eczema (atopic dermatitis)
• skin plaque irritation (superficial skin lesions larger than 1 cm with raised and compact skin)
• acne
• urticaria
• abnormal body odour
• skin condition similar to psoriasis (parapsoriasis)
• dry lips, hands, mucous membranes, throat
• absence of saliva
• nasal congestion
• itching, redness or irritation of the eyes
• altered pupil size
• dilated pupils
• visual impairment
• abdominal tension
• hard stools
• indigestion
• nausea
• mouth and throat discomfort
• sensation of throat tightness
• drowsiness
• fatigue
• attention disturbances
• anxiety
• restlessness
• sleep disturbances, poor quality sleep
• dizziness
• headache discomfort
• difficulty in bladder emptying
• excessive sweating
• reduced platelet count in the blood
• increased heart rate
• changes in heart rhythm (known as “prolonged QT interval”, seen on ECG, an electrical recording of the heart)
• increased liver enzymes, bilirubin and red blood cell volume detected in blood tests
• decreased haemoglobin concentration in red blood cells observed in blood tests

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store AXHIDROX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and on the carton after EXP/Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
After the first actuation of the pump, the medicine can be used for a maximum of 12 months.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What AXHIDROX contains

• The active substance is glycopyrronium (as glycopyrronium bromide). 1 g of cream contains glycopyrronium bromide, equivalent to 8 mg of glycopyrronium. One pump actuation delivers 270 mg of cream, containing glycopyrronium bromide corresponding to 2.2 mg of glycopyrronium.
• The excipients are benzyl alcohol (E 1519), propylene glycol (E1520) and cetostearyl alcohol (see section 2), citric acid (E330), glycerol monostearate 40-55, macrogol 20 glycerol monostearate, sodium citrate (E331), octyldodecanol and purified water.

Description of the appearance of AXHIDROX and package contents
AXHIDROX is a white, glossy cream, available in packages containing a multidose container with a pump and a cap. The multidose container holds 50 g of cream. After priming the pump, it delivers 124 doses, sufficient for 31 treatments of both underarms.
Record the number of treatments in the table on the outer packaging. After 31 treatments, do not continue using the pump, even if it is not completely empty.

Marketing Authorisation Holder and Manufacturer
Difa Cooper S.p.A.
Via Milano 160
21042 Caronno Pertusella (VA)

Manufacturer
Dr. August Wolff GmbH & Co. KG Arzneimittel
Sudbrackstrasse 56
Schildesche
33611 Bielefeld
Germany

This medicinal product is authorised in the European Economic Area Member States and in the
United Kingdom (Northern Ireland) under the following names:
Sweden: Glycopyrronium Cantabria
Portugal: Axhidrox
Spain: Axhidrox

More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (Agenzia Italiana del Farmaco) (https://www.aifa.gov.it/)