Package Insert: Information for the Patient

Axhidrox 2,2 mg/ Pulse Cream

Glicopirronio

Read this entire package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Axhidrox and how is it used

2. What you need to know before starting to use Axhidrox

3. How to use Axhidrox

4. Possible adverse effects

5. Storage of Axhidrox

6. Contents of the package and additional information

Axhidrox contains the active ingredient glicopirronio and belongs to a group of medications known as antihidrotics, which are sweat reducers.

This medication 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 exercise, hard physical work, hot weather, certain diseases, or medications. A characteristic of primary axillary hyperhidrosis is that it also occurs normally during the day, but not during sleep.

The use of this medication in the armpits leads to a reduction in sweat production in sweat glands.

Do not use Axhidrox

• If you are allergic to glycopyrrolate or any of the other components of this medication (listed in section 6)
• If you have a eye disease where the pressure in your eye is high (glaucoma)
• If you have or have had an acute hemorrhage due to a heart or blood circulation disorder
• If you have a chronic inflammatory disease of the large intestine (severe ulcerative colitis)
• If you have or have had a chronic inflammation of the large intestine complicated by a severe extension of the colon (toxic megacolon complication of ulcerative colitis)
• If you have or have had an intestinal obstruction as a result of paralysis of the intestinal muscles (paralytic ileus)
• If you have an autoimmune disease that affects the muscles (myasthenia gravis) or the salivary or lacrimal glands (Sjögren's syndrome)

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medication

• If you have or have had problems with the prostate or bladder, or difficulty urinating.

Stop using this medication and consult your doctor if you notice symptoms of urinary retention such as weak or dribbling urination, increased need to urinate, feeling of a full or insufficiently emptied bladder

• If you have severe kidney problems, including dialysis-dependent renal insufficiency.
• If you have blood-brain barrier dysfunction, such as after a traumatic brain injury in the last year, chemotherapy, radiation therapy of the head, skull and brain surgery, or due to intravenous drug abuse
• If you have a heart disease, heart failure, irregular heartbeat, or high blood pressure
• If you have inflamed or injured armpit skin, as this may increase the risk of local side effects. Use this medication only after complete remission of the skin disease or after wound healing

Do not apply the cream to any other part of the body other than the armpits and avoid any contact of the cream with the eyes, nose, or mouth or with other people.

Apply this medication only with the dispenser cap, not with your fingers. If the cream enters the eyes, it may cause pupil dilation and blurred vision. If the cream enters the mouth or nose, it may reduce saliva or nasal secretion production. If the eyes, nose, or mouth come into contact with the cream, these areas must be rinsed immediately with plenty of water to reduce the risk of local side effects.

Cover the treated armpits with clothing during sexual intercourse because the risk of side effects cannot be ruled out if other people come into contact with the cream.

If you notice dry mouth, clean your teeth carefully. Attend your dentist regularly, as this may increase the risk of tooth decay.

Children

Do not use this medication in children and adolescents under 18 years of age because it has not been studied in this age group.

Other medications and Axhidrox

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Some medications may affect or be affected by this medication

These medications include:

• topiramate, used to treat epilepsy and migraines
• 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, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

Driving and operating machinery

After administration of this medication, blurred vision, drowsiness, fatigue, and dizziness (see section 4, "Possible side effects") may occur. In particular, blurred vision may occur if this medication enters the eyes. Do not drive, operate machinery, or perform hazardous work until these effects have disappeared.

Axhidrox contains benzyl alcohol, propylene glycol, and cetearyl alcohol

This medication contains 2.7 mg of benzyl alcohol per pump stroke. Benzyl alcohol may cause allergic reactions and moderate local irritation.

This medication contains 8.1 mg of propylene glycol per pump stroke.

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Apply this medication only on the skin of the armpits and only with the nozzle of the pump, not with your fingers. See section 2 "Warnings and precautions".

The recommended dose is two pulses per axilla.

During the first 4 weeks of treatment, apply this medication to each axilla evenly, once a day, preferably at night.

From the 5th week onwards, you can reduce the application frequency to two times a week, depending on the reduction of sweat production.

Preparation of the pump before first use

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

• Remove the nozzle from the pump.
• Place a sheet of paper on the table. Hold the pump at an angle (see illustration), press the pump down repeatedly until the cream comes out of the opening.
• Press the pump slowly all the way down another 10 times and place the dispensed cream on the paper. Dispose of only the paper with the dispensed cream in the trash.
• The pump is already prepared for use.Noneed to repeat the pump preparation for subsequent uses.

Application of the cream with the nozzle of the pump

• Remove the nozzle from the pump.
• Hold the pump in your hand with the opening of the pump towards the removed nozzle.
• Press the pump all the way down twice to apply the recommended amount of cream on the top of the nozzle (see illustration).
• Distribute the cream evenly with the nozzle on one axilla.
• Repeat this process on the second axilla.
• Then, you must wash the nozzle of the pump, and for safety, you must also wash your hands completely and immediately 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 on the packaging label (see section 6). One treatment corresponds to 4 pump pulses, i.e., 2 pump pulses per axilla.

If you use more Axhidrox than you should

It is unlikely to occur an overdose if you use this medication only on the armpits as described.

However, if you apply this medication too frequently or in excess, the possible side effects may increase (see section 4). Therefore, this medication should not be used on other areas (palms of the hands, feet, face) or on large areas of the body with increased sweating. Excessive sweating could cause body overheating and a possible heatstroke that puts life at risk.

Stop using this medication and seek immediate medical attention if you notice an increase in heat sensation or body temperature.

If you forgot to use Axhidrox

Do not use a double dose to compensate for the missed doses.

If you interrupt treatment with Axhidrox

If you or your doctor decide to stop this medication, excessive sweating will reappear.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

• Swelling, mainly of the face, lips, or throat, which makes it difficult to swallow or breathe, itching, and skin rashes. This could be a sign of a severe allergic reaction or angioedema (frequency unknown, cannot be estimated from available data), which may require urgent medical treatment.
• Blurred vision (frequent side effect). (See section 2, "Driving and operating machines").

The following additional side effects were observed

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

• Dry mouth

Frequent(may affect up to 1 in 10 people)

• At the treated armpit: irritation, pain, itching, eczema, skin inflammation, skin rash, skin redness, nodules
• Dry nose
• Dry eyes
• Dry skin
• Headache
• Constipation

Less frequent(may affect up to 1 in 100 people)

• At the treated armpit: dryness, acne, bumps, swelling, skin hardening, scarring, small blisters, wounds, pustules, inflamed hair follicles
• Skin inflammation
• Eczema
• Itching, itching all over the body
• Skin rash
• Skin redness
• Long-term skin eczema (atopic dermatitis)
• Skin irritation

Plaque (elevated, firm, and superficial skin changes over 1 cm in size)

• Acne
• Urticaria
• Abnormal body odor
• Dermatitis similar to psoriasis (parapsoriasis)
• Dry lips, hands, mucous membranes, throat
• Saliva absence
• Blocked nose
• Eye itching, redness, or irritation
• Differently sized pupils
• Dilated pupils
• Visual problems
• Abdominal distension
• Hard stools
• Indigestion
• Nausea
• Pain in the mouth and throat
• Throat constriction
• Drowsiness
• Fatigue
• Attention disorders
• Anxiety
• Restlessness
• Sleep disorders, poor-quality sleep
• Dizziness
• Headaches
• Urination disorders
• Excessive sweating
• Observed reduction in platelet count in blood analysis
• Increased heart rate
• Alteration of heart rhythm (called "prolonged QT interval", observed in ECG, heart electrical activity)
• Increased liver enzymes, bilirubin, and red blood cell volume observed in blood analysis
• Decreased hemoglobin concentration in red blood cells observed in blood analysis

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label and on the packaging after CAD.:. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

After the first pump activation, the medication can be used for a maximum of 12 months.

Medications should not be disposed of through drains or in the trash.Deposit the containers and medications you no longer need at the Pharmacy Take-Back Point.In case of doubt,ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Axhidrox

• The active principle is glycopyrronium (as bromide of glycopyrronium).

1 g of cream contains bromide of glycopyrronium, equivalent to 8 mg of glycopyrronium. A pump stroke supplies 270 mg of cream, which contains bromide of glycopyrronium, corresponding to 2.2 mg of glycopyrronium.

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

Appearance of the product and contents of the packaging

Axhidrox is a bright white cream, available in a multidose container with a pump and a cap. The multidose container contains 50 g of cream. After preparing the pump, it will provide 124 strokes, which are sufficient for 31 treatments for both axillae.

Mark the number of treatments in the case table. After 31 treatments, do not continue to use the pump, even if it is not completely empty.

Holder of the marketing authorization

Industrial Farmacéutica Cantabria, S.A.

Ctra. Cazoña-Adarzo, s/n

39011 Santander

Spain

Responsible for manufacturing

Dr. August Wolff GmbH & Co. KG Arzneimittel

Sudbrackstrasse 56

33611 Bielefeld

Germany

Last review date of this leaflet:February 2024

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es