AXHIDROX 2.2 MG Krem

Treść ulotki

1. AXHIDROX 2.2 mg/application cream
   1. What is AXHIDROX and what is it 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. Package contents and other information

AXHIDROX 2.2 mg/application cream

Glycopyrronium

Read this leaflet carefully before you start 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you use 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 is AXHIDROX and what is it used for

AXHIDROX contains the active ingredient glycopyrronium and belongs to a group of medicines that
reduce sweating called antihydrotics.
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 sport, hard physical work, hot weather, some diseases or medications. Another
characteristic of primary axillary hyperhidrosis is that it usually occurs during the day, but not during
sleep.
The external 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 any of the other ingredients of this medicine (listed in section 6)
• you suffer from an eye condition that causes increased pressure inside the eye (glaucoma)
• you have or have had acute bleeding with unstable heart and blood circulation
• you have a chronic inflammatory disease of the large intestine (severe ulcerative colitis)
• you have or have had chronic inflammation of the large intestine complicated by severe colon distension (toxic megacolon complicating ulcerative colitis)
• you have or have had an intestinal blockage following paralysis of the intestinal muscles (paralytic ileus)
• you have a disease affecting the immune response that affects the muscles (myasthenia gravis) or the salivary or tear glands (Sjögren's syndrome)

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

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

Do not apply the cream to any other part of the body besides the armpits and avoid any contact of the
cream with the eyes, nose or mouth or with other people.
Apply AXHIDROX only with the applicator cap, not with your fingers. If the cream comes into
contact with the eyes, it may cause temporary dilation of the pupils and blurred vision.
If the cream comes into contact with the mouth or nose, the production of saliva or nasal secretions
may be reduced. If the eyes, nose or mouth come into contact with the cream, these areas
must be immediately rinsed with plenty of water to reduce the risk of local side effects.
Cover the treated armpits with clothing as it is not possible to exclude side effects if
other people come into contact with the cream.
If you notice dry mouth, carefully clean your teeth. Have regular dental check-ups with your
dentist, as the risk of tooth decay may be increased.

Children
Do not use this medicine in children and adolescents under 18 years of age because 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 intend to take
other medicines.
Some medicines can influence or be influenced 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 illness or anxiety
• opioids, used to treat pain or cough.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you suspect or are planning a pregnancy, ask
your doctor or pharmacist for advice before taking this medicine.
There are no data on the use of AXHIDROX in pregnant women and it is not known whether the active ingredient of
this medicine passes into breast milk. The doctor will discuss with you whether you can use AXHIDROX
during pregnancy. If you are breastfeeding, you and your doctor must decide whether to
stop breastfeeding or stop therapy with AXHIDROX, taking into account the
benefit of breastfeeding for the baby and the benefit of therapy for you. This is because the baby
should not come into contact with the cream or the treated skin.

Driving and operating machinery
Blurred vision, drowsiness, fatigue and dizziness can occur after administration of
AXHIDROX (see section 4, Possible side effects). In particular, blurred vision may occur if AXHIDROX penetrates the eyes. Do not drive, use machines, or engage in dangerous activities or sports until these effects have disappeared.

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

3. How to use AXHIDROX

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your
doctor or pharmacist.
Apply AXHIDROX 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 doses dispensed from the pump 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 onwards, you can reduce the frequency of application to twice a week, a
depending on the reduction in sweat production.

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

• Remove the pump cap.
• Place a piece of paper on the table. Hold the pump tilted (see the illustration), press the pump repeatedly until cream comes out of the opening.
• Slowly push the pump down completely another 10 times and place the dispensed cream on the paper. Dispose of the paper with the dispensed cream only in the waste bin.
• Now the pump is ready for use. Do notrepeat the pump preparation for subsequent use.

Applying the cream with the pump cap

• Remove the pump cap.
• Hold the pump in your hand with the pump opening facing the removed cap.
• Press the pump all the way down twice to apply the recommended amount of cream to the top of the cap (see the illustration).
• Distribute the cream evenly with the cap in one armpit.
• Repeat this process for the second armpit.
• Afterwards, you must immediately and thoroughly wash the pump cap and, for safety, 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”).
• Note the number of treatments on the table on the outer packaging (see section 6). One treatment corresponds to 4 pump actuations, i.e. 2 pump actuations per armpit.

If you use more AXHIDROX than you should
An overdose is unlikely if you use AXHIDROX only in the armpits as
described.
However, if AXHIDROX is applied too frequently or excessively, the possible side
effects may increase (see section 4). Therefore, AXHIDROX should not be used on
other parts (palms of hands, feet, face) or on large areas of the body with increased sweating. Excessively
reduced sweating could lead to overheating of the body and potentially life-threatening heatstroke.
Stop using AXHIDROX and seek immediate medical attention 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 missed dose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop usingAXHIDROX and contact your doctor or the nearest emergency room immediately if you experience any of the following serious side effects:

• Swelling mainly of the face, lips or throat with difficulty swallowing or breathing, itching and skin rashes. This could be a sign of a severe allergic reaction or angioedema (frequency not known, cannot be estimated based on available data), and may require urgent medical treatment.
• Blurred vision (uncommon side effect). (See section 2, “Driving and operating machinery”).

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, inflamed hair follicle
• nasal dryness
• dry eye
• dry skin
• headache
• constipation

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

• in the treated armpit: dryness, rash, eczema, acne, bumps, skin inflammation
• eczema
• itching
• rash
• skin redness
• long-term skin eczema (atopic dermatitis)
• irritation of the skin plaque skin (superficial skin changes larger than 1 cm with raised and compact skin)
• abnormal body odor
• skin condition similar to psoriasis (parapsoriasis)
• dry lips, hands, mucous membranes
• itching, redness or irritation of the eyes
• altered pupil size
• impaired vision
• abdominal tension
• hard stools
• pain in the mouth, throat, chest
• sensation of constriction in the throat
• drowsiness
• fatigue
• sleep disorders, poor sleep quality
• dizziness
• excessive sweating
• decreased number of platelets in the blood
• fast heartbeat
• alteration of the heart rhythm (called “prolonged QT interval”, shown on ECG, an electrical recording of the heart)
• increased liver enzymes found in blood tests

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through 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 which is stated on the label and the package after
EXP/Scad. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
After the first activation of the pump, the medicine can be used for a maximum of 12 months.
Do not dispose of any medicine in 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 ingredient 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, which contains 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 shiny white cream, available in packs containing a multi-dose container
with a pump and a cap. The multi-dose container contains 50 g of cream. After priming
the pump, the pump delivers 124 doses which are sufficient for 31 treatments of both armpits.
Record the number of treatments in the table on the outer packaging. After 31 treatments, you should not
continue to use 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 Member States of the European Economic Area and in the
United Kingdom (Northern Ireland) under the following denominations:
Sweden: Glycopyrronium Cantabria
Portugal: Axhidrox
Spain: Axhidrox
More detailed information on this medicine is available on the website of the Italian Medicines Agency (https://www.aifa.gov.it/)