Axhidrox 2.2 mg/puff cream

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Axhidrox 2.2 mg/pump cream

Glycopyrronium

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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 sweat-reducing medicines called antihidrotics.

This medicine 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 weather, certain illnesses, or medications. A characteristic of primary axillary hyperhidrosis is that it typically occurs during the day but not during sleep.

The use of this medicine on the armpits leads to a reduction in sweat production by 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)
• if you have an eye condition in which the pressure in your eye is high (glaucoma)
• if you currently have or have had acute bleeding due to a heart or blood circulation disorder
• if you have chronic inflammatory bowel disease of the large intestine (severe ulcerative colitis)
• if you currently have or have had chronic inflammation of the large intestine complicated by severe enlargement of the colon (toxic megacolon as a complication of ulcerative colitis)
• if you currently have or have had intestinal obstruction due to paralysis of the intestinal muscles (paralytic ileus)
• if you have an immune-mediated disorder affecting the muscles (myasthenia gravis) or the salivary or tear glands (Sjögren's syndrome)

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medicine

• if you have or have had prostate or bladder problems, or difficulty urinating.

Stop using this medicine and consult your doctor if you experience symptoms of urinary retention such as weak or dribbling urine flow, increased need to urinate, or a sensation of a full or incompletely emptied bladder.

• if you have severe kidney disorders, including dialysis-dependent renal failure.
• if you have impairments of the blood-brain barrier, for example after traumatic brain injury within the past year, chemotherapy, radiotherapy to the head, brain or skull surgery, or due to intravenous drug abuse.
• if you have heart disease, heart failure, irregular heartbeat, or high blood pressure.
• if the skin under your arms is inflamed or damaged, as this may increase the risk of local side effects. Use this medicine only after complete remission of the skin condition or after 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, mouth, or other people.

Apply this medicine only using the dispenser cap, not with your fingers. If the cream gets into the eyes, it may cause pupil dilation and blurred vision. If the cream enters the mouth or nose, it may reduce saliva production or nasal secretions. If the cream comes into contact with the eyes, nose, or mouth, rinse the affected areas immediately with plenty of water to reduce the risk of local side effects.

Cover the treated armpits with clothing during sexual activity, as side effects in other individuals cannot be ruled out if they come into contact with the cream.

If you experience dry mouth, clean your teeth carefully. Visit your dentist regularly, as the risk of dental caries may increase.

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

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Some medicines may interact with or be affected by this medicine.

These 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 or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

There are no data on the use of this medicine in pregnant women, and it is unknown whether the active ingredient passes into breast milk. Your doctor will advise you whether you may use this medicine during pregnancy. If you are breastfeeding, you and your doctor must decide whether to discontinue breastfeeding or stop treatment with this medicine, taking into account the benefits of breastfeeding for your child and the benefits of treatment for you. This is because your baby should not come into contact with the cream or the treated skin.

Driving and using machines

Blurred vision, drowsiness, fatigue, and dizziness may occur after administration of this medicine (see section 4, "Possible side effects"). In particular, blurred vision may occur if this medicine comes into contact with the eyes. Do not drive, operate machinery, or perform dangerous work 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 pump actuation. Benzyl alcohol may cause allergic reactions and moderate local irritation.

This medicine contains 8.1 mg of propylene glycol per pump actuation.

This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetostearyl alcohol.

3. How to use Axhidrox

Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Apply this medicine only to the skin of the armpits and only with the pump cap, not with your fingers. See section 2 "Warnings and precautions".

The recommended dose is two pumps per armpit.

During the first 4 weeks of treatment, apply this medicine evenly to each armpit once daily, preferably at night.

From week 5 onwards, you may reduce the frequency of application to twice a week, depending on the reduction in sweat production.

Preparing the pump before first use

To obtain the recommended dose, you must remove the air trapped in the pump, as follows:

• Remove the pump cap.
• Place a piece of paper on the table. Hold the pump at an angle (see illustration), and press down repeatedly until cream emerges from the opening.
• Slowly press the pump fully down another 10 times, dispensing the cream onto the paper. Dispose of the paper with the dispensed cream in the trash only.
• The pump is now ready for use. Do not repeat the pump preparation for subsequent uses.

Applying the cream using the pump cap

• Remove the pump cap.
• Hold the pump in your hand with the pump opening facing the removed cap.
• Press the pump fully down twice to dispense the recommended amount of cream onto the top of the cap (see illustration).
• Evenly spread the cream from the cap over one armpit.
• Repeat this process for the second armpit.
• Then, wash the pump cap, and for safety, immediately and thoroughly wash your hands with water and soap. This is important to avoid contact of the cream with the nose, eyes, or mouth. (See section 2 "Warnings and precautions").
• Mark the number of treatments in the table on the packaging (see section 6). One treatment corresponds to 4 pump presses, i.e., 2 pump presses per armpit.

If you use more Axhidrox than you should

It is unlikely that an overdose will occur if you use this medicine only on the armpits as described.

However, if this medicine is applied too frequently or in excess, possible side effects may increase (see section 4). Therefore, this medicine must not be used on other areas (palms of hands, feet, face) or over large areas of the body with increased sweating. Excessive reduction of sweating could lead to overheating of the body and potentially life-threatening heat stroke.

Stop using this medicine and seek immediate medical attention if you notice an increased sensation of heat or elevated body temperature.

If you forget to use Axhidrox

Do not use a double dose to make up for missed doses.

If you stop using Axhidrox

If you or your doctor decide to stop using this medicine, excessive sweating will return.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Stop using this medicine and contact your doctor or nearest emergency service immediately if you experience any of the following serious side effects:

• swelling, mainly of the face, lips or throat, making swallowing or breathing difficult, together with itching and skin rash. This could be a sign of a severe allergic reaction or angioedema (frequency not known, cannot be estimated from available data), which may require urgent medical treatment.
• blurred vision (frequent side effect). (See section 2, "Driving and use of machines").

The following additional side effects were observed

Very common (may affect more than 1 in 10 people)

• dry mouth

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• in the treated armpit: dryness, acne, lumps, swelling, skin hardening, scar, small blisters, wound, pustules, inflamed hair follicles
• skin inflammation
• eczema
• itching, generalized itching
• skin rash
• redness of the skin
• long-lasting skin condition (atopic dermatitis)
• skin irritation
• plaque (elevated, firm, superficial skin lesions larger than 1 cm)
• acne
• urticaria
• abnormal body odor
• skin condition resembling psoriasis (parapsoriasis)
• dryness of lips, hands, mucous membranes, throat
• absence of saliva
• nasal congestion
• itching, redness or irritation of the eyes
• pupils of different sizes
• dilated pupils
• vision problems
• abdominal distension
• hard stools
• indigestion
• nausea
• pain in mouth and throat
• tightness in the throat
• somnolence
• fatigue
• attention disorders
• anxiety
• restlessness
• sleep disturbances, poor quality of sleep
• dizziness
• discomfort in the head
• bladder emptying disorders
• excessive sweating
• reduced platelet count observed in a blood test
• increased heart rate
• heart rhythm disturbance (called "prolonged QT interval", observed on ECG, electrical activity of the heart)
• increased liver enzymes, bilirubin and red blood cell volume observed in a blood test
• decreased hemoglobin concentration in red blood cells observed in a blood test

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 packaging after EXP:. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

After the first pump activation, the medicine can be used for up to 12 months.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the Sigre Point in your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Axhidrox

• 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 other components are benzyl alcohol (E1519), propylene glycol (E1520) and cetyl stearyl alcohol (see section 2), citric acid (E330), glycerol monostearate 40-55, macrogol 20 glycerol monostearate, sodium citrate (E331), octyldodecanol and purified water.

Nature of the product and contents of the pack

Axhidrox is a white, shiny cream, available in a multidose container with a pump and a cap. The multidose container holds 50 g of cream. After priming the pump, it will deliver 124 actuations, sufficient for 31 treatments for both axillae.

Mark the number of treatments on the table provided in the carton. After 31 treatments, the pump must no longer be used, even if it is not completely empty.

Marketing Authorization Holder

Industrial Farmacéutica Cantabria, S.A.

Barrio Solía 30

La Concha de Villaescuida

39690 Cantabria (Spain)

Manufacturer

Dr. August Wolff GmbH & Co. KG Arzneimittel

Sudbrackstrasse 56

33611 Bielefeld

Germany

Date of the most recent revision of this leaflet: February 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es