Amidil amihaler

Package leaflet: Information for the user

AMIDIL AmiHaler, 44 micrograms, inhalation powder in hard capsules
Glycopyrronium
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

1. What AMIDIL AmiHaler is and what it is used for
2. Important information before using AMIDIL AmiHaler
3. How to use AMIDIL AmiHaler
4. Possible side effects
5. How to store AMIDIL AmiHaler
6. Contents of the pack and other information
   Instructions for using the AMIDIL AmiHaler inhaler

1. What AMIDIL AmiHaler is and what it is used for

What AMIDIL AmiHaler is
This medicine contains an active substance called glycopyrronium bromide. It belongs to a group of medicines known as bronchodilators.
Why AMIDIL AmiHaler is used
This medicine is used to make breathing easier in adult patients who have difficulty breathing due to a lung disease called chronic obstructive pulmonary disease (COPD).
In COPD, the muscles of the airways tighten, making breathing difficult. This medicine prevents the tightening of these muscles in the lungs, allowing air to flow more easily into and out of the lungs.
Using this medicine once daily will help reduce the impact of COPD on the patient's daily life.

2. Important information before using AMIDIL AmiHaler

When not to use AMIDIL AmiHaler

• if the patient is allergic to glycopyrronium bromide or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with AMIDIL AmiHaler, consult a doctor if any of the following apply to the patient:

• if the patient has kidney disease,
• if the patient has a condition of the eye called narrow-angle glaucoma,
• if the patient has difficulty passing urine.

During treatment with AMIDIL AmiHaler, stop using the medicine immediately and contact a doctor:

• if the patient experiences chest tightness, cough, wheezing or shortness of breath immediately after using AMIDIL AmiHaler (symptoms of bronchospasm),
• if the patient develops difficulty breathing or swallowing, swelling of the tongue, lips or face, skin rash, itching or hives (symptoms of an allergic reaction),
• if the patient experiences eye pain or discomfort, transient disturbances in vision, seeing colored halos around objects or colored images, accompanied by redness of the eyes. These may be symptoms of an acute attack of narrow-angle glaucoma.

AMIDIL AmiHaler is used for the maintenance treatment of COPD. This medicine should not be used to treat sudden attacks of breathlessness or wheezing.
Children and adolescents
This medicine should not be given to children or adolescents under 18 years of age.
AMIDIL AmiHaler and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This includes also medicines similar to AMIDIL AmiHaler used in the treatment of lung disease, such as ipratropium, oxitropium or tiotropium (so-called anticholinergic medicines).
No specific adverse interactions have been reported when AMIDIL AmiHaler was used together with other medicines used in the treatment of COPD, such as short-acting inhaled medicines (e.g. salbutamol), methylxanthines (e.g. theophylline) and (or) oral and inhaled corticosteroids (e.g. prednisolone).
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
There are no data on the use of this medicine in pregnant women, and it is not known whether the active substance in this medicine passes into human milk.
Driving and operating machinery
It is unlikely that this medicine will affect the ability to drive or operate machinery.
AMIDIL AmiHaler contains lactose
This medicine contains lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use AMIDIL AmiHaler

This medicine should always be taken as directed by your doctor or pharmacist. If you have any doubts,
please consult your doctor or pharmacist.
What dose of AMIDIL AmiHaler should be taken
The usual dose is one capsule inhaled daily.
This medicine should be taken only once a day, as its effect lasts for 24 hours.
Do not take a higher dose than prescribed by your doctor.
Elderly patients
If the patient is 75 years of age or older, this medicine may be used at the same dose as in other adult
patients.
When to inhale AMIDIL AmiHaler
This medicine should be taken at the same time each day, which will help you remember to take it.
You may take this medicine at any time, before or after food or drink.
How to inhale AMIDIL AmiHaler

• The package contains an inhaler and capsules (in blisters) containing the medicine as a powder for inhalation. The capsules should only be used with the inhaler provided in the package. The capsules should remain in the blisters until immediately before use.
• Do not push the capsule through the foil.
• If the patient is starting a new package, a new AMIDIL AmiHaler inhaler provided in the package should be used.
• The inhaler supplied with each package should be discarded after all capsules from that package have been used.
• Do not swallow the capsules.
• For further information on how to use the inhaler, please read the instructions provided at the end of this leaflet.

Taking more AMIDIL AmiHaler than recommended
If you have inhaled too much of this medicine, or if someone else has accidentally taken your
capsules, you should immediately inform your doctor or go to the nearest hospital emergency
department. Show the doctor the AMIDIL AmiHaler packaging. Medical assistance may be required.
Missing a dose of AMIDIL AmiHaler
If you forget to inhale a dose, take it as soon as possible.
However, do not take two doses on the same day. Take the next dose at your usual time.
How long to continue treatment with AMIDIL AmiHaler

• This medicine should be used for as long as your doctor recommends.
• COPD is a chronic condition, and this medicine should be taken every day, not only when breathing difficulties or other COPD symptoms occur. If you have any questions about how long to continue treatment, please speak with your doctor or pharmacist.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Some adverse reactions may be serious, but occur infrequently (occurring in
less than 1 in 100 patients):

• irregular heartbeat,
• high blood sugar levels (hyperglycaemia: typical symptoms include excessive thirst or hunger and frequent urination),
• rash, itching, hives, breathing or swallowing difficulties, dizziness (possible signs of an allergic reaction),
• swelling mainly of the tongue, lips, face or throat (possible signs of angioedema). If any of these symptoms occur in a patient, inform the doctor immediately.

Some adverse reactions may be serious, but their frequency is unknown
(cannot be estimated from the available data):

• breathing difficulties with wheezing or coughing (symptoms of paradoxical bronchospasm).

Some adverse reactions are common (occurring in less than 1 in 10 patients):

• dryness of the mouth,
• sleep disturbances,
• runny or stuffy nose, sneezing, sore throat,
• diarrhoea or abdominal pain,
• musculoskeletal pain.

Some adverse reactions are uncommon (occurring in less than 1 in 100
patients):

• difficulty passing urine and pain during urination,
• painful or frequent urination,
• palpitations,
• rash,
• numbness,
• cough with sputum production,
• dental caries,
• feeling of pressure or pain in the cheeks or forehead,
• nosebleeds,
• pain in arms or legs,
• muscle, bone or joint pain in the chest,
• feeling of discomfort in the stomach after meals,
• throat irritation,
• feeling of fatigue,
• weakness,
• itching,
• voice changes (hoarseness),
• nausea,
• vomiting.

In some elderly people (aged over 75 years), headache (common) and urinary tract infection (common) may occur.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store AMIDIL AmiHaler

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister marked EXP.
The expiry date refers to the last day of the stated month.
The marking on the packaging following the abbreviation EXP indicates the expiry date, and following the abbreviation Lot/LOT indicates the batch number.
Do not store above 25°C.
Keep the capsules in the original blister to protect them from moisture. The capsules should be removed immediately before use.
The inhaler provided in each package should be discarded after all capsules from that package have been used.
Do not use this medicine if the packaging is damaged or if there are visible signs of tampering.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What AMIDIL AmiHaler contains

• The active substance is glycopyrronium bromide. Each hard capsule contains 63 micrograms of glycopyrronium bromide (equivalent to 50 micrograms of glycopyrronium). The delivered dose (the dose delivered via the inhaler mouthpiece) corresponds to 44 micrograms (µg) of glycopyrronium.
• Other ingredients: monohydrate lactose and magnesium stearate; Capsule cap: hypromellose, carrageenan (E407), indigo carmine (E132), potassium chloride, purified water; Capsule body: hypromellose, carrageenan (E407), potassium chloride, purified water.

What AMIDIL AmiHaler looks like and contents of the pack
AMIDIL AmiHaler is a hard capsule with a transparent blue cap and a transparent, colourless body, made of hypromellose, size 3, filled with a white or almost white powder.
The pack contains a device called a single-dose powder inhaler for administering the medicinal product, and perforated blisters divided into single doses. Each blister contains 10 hard capsules.
The following pack sizes are available: 30x1, 60x1 or 90x1 hard capsules, together with one inhaler.
A patient information leaflet is included in the pack.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01

Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
Medana Branch in Sieradz
ul. Władysława Łokietka 10, 98-200 Sieradz

Instructions for using the AMIDIL AmiHaler inhaler
Please read the Instructions for using the inhaler before using AMIDIL AmiHaler.

Insert the capsule Pierce the capsule Inhale the medicine
Check whether
with base down deeply
the capsule is empty
2 3 Check

Step 1a: Remove the cap Step 1b: Open the inhaler Step 1c:	Step 2a: Pierce the capsule once Hold the inhaler upright. Pierce the capsule by rotating the base of the inhaler by 180°. A clicking sound should be heard, indicating the capsule has been pierced. Pierce the capsule only once.	Step 3a: Perform a full exhalation Before starting inhalation, the patient should calmly, slowly, and as deeply as possible, exhale away from the inhaler. Do not blow into the inhaler.	Check whether the capsule is empty Open the inhaler to check whether any powder remains in the capsule. If powder remains in the capsule: Close the inhaler. Repeat steps from Step 3a to Step 3c.
Remove the capsule Separate one blister from the strip. Open the blister and remove the capsule. Do not push the capsule through the foil. Do not swallow the capsule.		Step 3b: Inhale the medication deeply Hold the inhaler as shown in the illustration. Place the mouthpiece into the mouth and seal the lips tightly around it. Inhale quickly and as deeply as possible. A whistling sound should be heard during inhalation. A taste of the medication may be noticed during inhalation. Step 3c: Hold breath Immediately after inhalation, the patient should hold their breath for at least 5–10 seconds, then exhale calmly away from the inhaler.	Remaining powder Empty capsule Remove the empty capsule Dispose of the empty capsule into a waste container. Close the inhaler and replace the cap.
Step 1d: Insert the capsule Never place the capsule directly into the mouthpiece.			Important information AMIDIL AmiHaler capsules must always be stored in the blister and should only be removed immediately before use. Do not push the capsule through the foil when removing it from the blister. Do not swallow the capsule. Do not use AMIDIL AmiHaler capsules with another inhaler.
Step 1e: Close the inhaler			Do not use the AMIDIL AmiHaler inhaler for other medications in capsule form. Never place the capsule in the mouth or into the inhaler mouthpiece. Do not rotate the base of the inhaler more than once. Do not blow into the inhaler mouthpiece. Do not rotate the base of the inhaler during inhalation through the mouthpiece. Sharp needles are part of the device components. To avoid injury, never insert fingers into the capsule chamber while rotating the inhaler base. Do not handle capsules with wet hands. Never wash the inhaler with water.
The AMIDIL AmiHaler product package contains: AMIDIL AmiHaler inhaler Blister packs containing 10 AMIDIL AmiHaler capsules for use with the inhaler		Frequently asked questions Why does the inhaler not make a sound during inhalation? The capsule may be stuck in the chamber. In this case, gently loosen the capsule by tapping the base of the inhaler. Then, inhale the medication again by repeating steps from Step 3a to Step 3c.	Cleaning the inhaler Wipe the inner and outer parts of the mouthpiece with a clean, dry, lint-free cloth to remove any powder residue. Keep the inhaler dry. Never wash the inhaler with water.