Amidil combo amihaler

Package leaflet: Information for the user

AMIDIL COMBO AmiHaler, 85 micrograms + 43 micrograms, inhalation powder
in hard capsules
Indacaterol + 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 others, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, please inform your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

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

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

What AMIDIL COMBO AmiHaler is
This medicine contains two active substances called indacaterol and glycopyrronium. They belong to a group of medicines known as bronchodilators.

What AMIDIL COMBO AmiHaler is used for
This medicine is used to help make breathing easier in adult patients who have breathing difficulties caused by a lung disease called chronic obstructive pulmonary disease (COPD). In COPD, the muscles around the airways tighten, making it difficult to breathe. This medicine relaxes these muscles in the lungs, allowing air to flow in and out of the lungs more easily.

If taken once daily, this medicine can help reduce the impact of COPD on the patient's daily life.

2. Important information before using AMIDIL COMBO AmiHaler

When not to use AMIDIL COMBO AmiHaler

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

Warnings and precautions
Before starting treatment with AMIDIL COMBO AmiHaler, discuss with your doctor,
pharmacist, or nurse if any of the following apply to the patient:

• if the patient has been diagnosed with asthma – this medicine should not be used for the treatment of asthma,
• if the patient has heart problems,
• if the patient has had seizures (epilepsy),
• if the patient has thyroid disorders (thyrotoxicosis),
• if the patient has diabetes,
• if the patient is taking medicines for lung diseases that contain active substances similar (belonging to the same therapeutic classes) to those contained in AMIDIL COMBO AmiHaler (see section "AMIDIL COMBO AmiHaler and other medicines"),
• if the patient has kidney disease,
• if the patient has severe liver disease,
• if the patient has a condition of the eye called narrow-angle glaucoma,
• if the patient has difficulty passing urine. If any of the above apply to the patient (or the patient is unsure), the patient should talk to a doctor, pharmacist, or nurse before using this medicine.

While being treated with AMIDIL COMBO AmiHaler

• the patient must stop using this medicine and seek immediate medical help if any of the following symptoms occur:
• eye pain or discomfort, temporary blurred vision, seeing colored halos around lights or colored images, accompanied by redness of the eyes. These may be symptoms of an acute attack of narrow-angle glaucoma.
• difficulty breathing or swallowing, swelling of the tongue, lips or face, skin rash, itching, or hives (signs of an allergic reaction),
• chest tightness, cough, wheezing, or shortness of breath immediately after using this medicine – these may be symptoms of paradoxical bronchospasm.
• the patient should contact their doctor immediately if symptoms of COPD, such as breathlessness, wheezing, or coughing, do not improve or worsen.

AMIDIL COMBO AmiHaler is used for ongoing 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. This is because studies have not been conducted in this age group.
AMIDIL COMBO AmiHaler and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including medicines the patient plans to use.
In particular, inform the doctor or pharmacist if the patient is taking:

• any medicines that may be similar to AMIDIL COMBO AmiHaler (containing similar active substances).
• medicines called beta-blockers, used to treat high blood pressure or heart conditions (such as propranolol) or an eye condition called glaucoma (e.g. timolol).
• medicines that reduce potassium levels in the blood, such as:
• corticosteroids (e.g. prednisolone),
• diuretics (water tablets) used to treat high blood pressure, such as hydrochlorothiazide,
• medicines used for breathing problems, such as theophylline.

Pregnancy and breastfeeding
There is no data available 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. Indacaterol, one of the active substances in AMIDIL COMBO AmiHaler, may inhibit uterine contractions due to its effect on the uterus.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine. AMIDIL COMBO AmiHaler should not be used unless otherwise directed by a doctor.
Driving and operating machinery
It is unlikely that this medicine affects the ability to drive or operate machinery. However, this medicine may cause dizziness (see section 4). If the patient experiences dizziness while using this medicine, they should not drive or operate machinery.
AMIDIL COMBO AmiHaler contains lactose
This medicine contains lactose (23.5 mg per capsule). If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.
Before using any medicine, patients should seek advice from a doctor or pharmacist.

3. How to use AMIDIL COMBO AmiHaler

This medicine should always be used exactly as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.

What dose of AMIDIL COMBO 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 use a higher dose than that prescribed by your doctor.

Elderly patients (aged 75 years and above)

If a patient is aged 75 years or older, they may use this medicine at the same dose as other adult patients.

When to inhale AMIDIL COMBO AmiHaler

This medicine should be taken at the same time each day, which will help with remembering to take it.
The patient may take AMIDIL COMBO AmiHaler at any time of day, either before or after food or drink.

How to inhale AMIDIL COMBO AmiHaler

• AMIDIL COMBO AmiHaler is intended for inhalation use only.
• The pack contains a device (inhaler) and capsules (in blisters) containing the medicine as a powder for inhalation. The capsules must only be used with the inhaler provided in the pack (AMIDIL COMBO AmiHaler inhaler). The capsules should be kept in the blisters until ready for use.
• To open the blister, peel off the foil – do not push the capsule through the foil.
• If the patient is starting a new pack, they should use the new AMIDIL COMBO AmiHaler inhaler provided in the pack.
• The inhaler supplied with each pack should be discarded after all capsules from that pack have been used.
• Do not swallow the capsules.
• For further information on how to use the inhaler, refer to the instructions provided at the end of this leaflet.

Use of more than the recommended dose of AMIDIL COMBO AmiHaler

If the patient has inhaled too much of this medicine, or if someone else accidentally takes the patient's capsules, inform a doctor immediately or go to the nearest hospital emergency department. Show the doctor the AMIDIL COMBO AmiHaler medicine pack.
The patient may require medical assistance. Symptoms may include rapid heartbeat, headache, drowsiness, nausea, vomiting, visual disturbances, constipation, or difficulty passing urine.

Missed dose of AMIDIL COMBO AmiHaler

If the patient forgets to inhale a dose at the usual time, they should inhale the dose as soon as possible on the same day. The next dose should be taken at the usual time the following day. Do not inhale more than one dose on the same day.

Stopping AMIDIL COMBO AmiHaler

• AMIDIL COMBO AmiHaler should be used for as long as prescribed by the doctor.
• COPD is a chronic condition and AMIDIL COMBO AmiHaler should be used daily, not only when breathing difficulties or other COPD symptoms occur. For any questions regarding the duration of treatment with this medicine, consult a doctor or pharmacist.

If there are any further doubts concerning the use of this medicine, consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects may be serious:
Common (occur in less than 1 in 10 people)

• difficulty breathing or swallowing, swelling of the tongue, lips or face, hives, skin rash – these may be symptoms of an allergic reaction.
• feeling tired or very thirsty, increased appetite without weight gain, and passing urine more often than usual – these may be symptoms of high blood sugar (hyperglycaemia).

Uncommon (occur in less than 1 in 100 people)

• crushing chest pain with increased sweating – this may be a sign of a serious heart condition (ischaemic heart disease),
• swelling, mainly of the tongue, lips, face or throat (may be symptoms of angioedema),
• difficulty breathing with wheezing or cough,
• eye pain or discomfort, temporary blurred vision, seeing coloured halos around lights or coloured images, accompanied by redness of the eyes – these may be symptoms of glaucoma,
• irregular heartbeat.

If any of these serious side effects occur in the patient, seek medical help immediately.
Other side effects may include:
Very common (occur in more than 1 in 10 people)

• blocked nose, sneezing, cough, headache with or without fever – these may be symptoms of an upper respiratory tract infection.

Common (occur in less than 1 in 10 people)

• sore throat with runny nose – these may be symptoms of pharyngitis,
• painful and frequent urination – these may be symptoms of a urinary tract infection called cystitis,
• feeling of pressure or pain in the cheeks and forehead – these may be symptoms of a sinus infection called sinusitis,
• runny or blocked nose,
• dizziness,
• headache,
• cough,
• sore throat,
• stomach upset, indigestion,
• dental caries,
• difficulty and pain during urination – these may be symptoms of problems emptying the bladder or urinary retention,
• fever,
• chest pain.

Uncommon (occur in less than 1 in 100 people)

• difficulty sleeping,
• rapid heartbeat,
• palpitations – symptoms of irregular heartbeat,
• change in voice (hoarseness),
• nosebleeds,
• diarrhoea or stomach pain,
• dryness of the mouth,
• itching or rash,
• muscle, ligament, tendon, joint and bone pain,
• muscle cramps,
• muscle pain or tenderness,
• pain in hands or feet,
• swelling of hands, ankles and feet,
• fatigue.

Rare (occur in less than 1 in 1000 people)

• tingling or numbness.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of 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
Side effects can also be reported directly to the marketing authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store AMIDIL COMBO AmiHaler

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following EXP.
The expiry date refers to the last day of the stated month.
The marking on the packaging following EXP indicates the expiry date, and following Lot/LOT indicates the batch number.
There are no special requirements regarding storage temperature. The capsules should be stored in the original blister pack to protect them from moisture and 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 any signs of tampering.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the package and other information

What AMIDIL COMBO AmiHaler contains

• The active substances are indacaterol (as maleate) and glycopyrronium bromide. Each hard capsule contains 143 micrograms of indacaterol maleate, equivalent to 110 micrograms of indacaterol, and 63 micrograms of glycopyrronium bromide, equivalent to 50 micrograms of glycopyrronium. The delivered dose (the amount released from the mouthpiece of the inhaler) contains 110 micrograms of indacaterol maleate, equivalent to 85 micrograms of indacaterol, and 54 micrograms of glycopyrronium bromide, equivalent to 43 micrograms of glycopyrronium.
• The other components of the inhalation powder are lactose monohydrate and magnesium stearate. Capsule cap: indigo carmine (E132), yellow iron oxide (E172), carrageenan (E407), potassium chloride, hypromellose, purified water; Capsule body: carrageenan (E407), potassium chloride, hypromellose, purified water.

What AMIDIL COMBO AmiHaler looks like and contents of the pack
AMIDIL COMBO AmiHaler is a hard capsule with a green cap and a transparent, colourless body, made of HPMC (hypromellose), size 3, filled with a white or almost white powder.
The pack contains a device called a powder inhaler for administering one dose of the medicine, and perforated blisters divided into single doses. Each blister contains 10 hard capsules.
Pack sizes available: packs containing 30x1, 60x1 or 90x1 hard capsules and 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 use of the AMIDIL COMBO AmiHaler inhaler
Please read the Instructions for Use of the Inhaler before using AMIDIL COMBO AmiHaler.

Insert the capsule Pierce the capsule Inhale the medicine Check if the capsule
by turning the base deeply is empty

Step 1a: Remove the cap Step 1b: Open the inhaler Step 1c:	Step 2a: Puncture the capsule once. Hold the inhaler upright. Puncture the capsule by rotating the base of the inhaler by 180°. A clicking sound should be heard indicating the capsule has been punctured. Puncture the capsule only once.	Step 3a: Breathe out fully. Before starting inhalation, the patient should breathe out calmly, slowly, and as deeply as possible away from the inhaler. Do not blow into the inhaler.	Check if 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 3c. Remaining powder     Empty capsule
Remove the capsule Detach one blister from the sheet. Open the blister and remove the capsule. Do not push the capsule through the foil. Do not swallow the capsule.		Step 3b: Inhale the medicine deeply. Hold the inhaler as shown in the image. Place the mouthpiece in the mouth and seal lips tightly around it. Breathe in quickly and as deeply as possible. A whistling sound should be audible during inhalation. A taste of the medicine 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 breathe out calmly away from the inhaler.	Remove the empty capsule. Dispose of the empty capsule in 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 COMBO AmiHaler capsules must always be stored in the blister and should only be removed immediately before use. Do not push the capsule out through the foil when removing it from the blister. Do not swallow the capsule. Do not use AMIDIL
Step 1e: Close the inhaler			COMBO AmiHaler with another inhaler. Do not use the AMIDIL COMBO AmiHaler inhaler to administer 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. The device contains sharp needles. To avoid injury, never insert fingers into the capsule chamber while rotating the base of the inhaler. Do not handle capsules with wet hands. Never wash the inhaler with water.

AMIDIL COMBO Pack AmiHaler contains: AMIDIL COMBO AmiHaler inhaler Blisters containing 10 capsules of the medicine AMIDIL COMBO AmiHaler for use with the inhaler	Frequently Asked Questions Why doesn't the inhaler 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 medicine again, repeating steps from 3a to 3c. What should I do if there is still powder left in the capsule? This means the patient did not receive a sufficient amount of medicine. Close the inhaler and repeat the steps from 3a to 3c. What does coughing after inhalation mean? Coughing may occur. If the capsule is empty, the patient has received an adequate dose of the medicine. What if the patient feels small pieces of the capsule on the tongue? This may happen. It is not harmful. The likelihood of the capsule breaking into small pieces increases if it has been pierced more than once.	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.
		Disposal of the inhaler after use Each inhaler should be discarded after all capsules have been used. Ask your pharmacist how to dispose of unused medicines and inhalers.