Acopair

Package leaflet: Information for the patient

Acopair
18 micrograms, inhalation powder in a hard capsule
Tiotropium
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 questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

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

1. What Acopair is and what it is used for

Acopair helps people with chronic obstructive pulmonary disease (COPD) to breathe more easily.
COPD is a chronic lung disease that causes breathlessness and cough. The term COPD refers to
chronic bronchitis and emphysema. COPD is a chronic condition, therefore Acopair should be taken every day, not only when breathing difficulties or other COPD symptoms occur.
Acopair is a long-acting bronchodilator that helps open the airways and allows air to flow more freely into and out of the lungs. Regular use of Acopair may also help reduce persistent breathlessness associated with the disease and may improve daily symptoms. The medicine helps maintain physical activity for longer. Daily use of Acopair may also help prevent sudden, short-term worsening of COPD symptoms, which may last for several days. The effect of the medicine lasts for 24 hours; therefore, Acopair should be taken only once daily.
For information on the correct dosage and method of using Acopair, see section 3. How to use Acopair and the Instructions for use and handling of the NeumoHaler inhaler, located later in this leaflet.

2. Important information before using Acopair

When not to use Acopair:

• if the patient is allergic (hypersensitive) to tiotropium or any of the other ingredients of this medicine (listed in section 6),
• if the patient is allergic (hypersensitive) to atropine or its derivatives, such as ipratropium or oxitropium.

Warnings and precautions
Before starting to use Acopair, discuss this with your doctor or pharmacist

• The patient should contact the doctor if they have increased intraocular pressure (narrow-angle glaucoma), prostate problems, or difficulty passing urine.
• The patient should contact the doctor if they have kidney function disorders.
• Acopair is indicated for the treatment of chronic obstructive pulmonary disease (COPD). It should not be used to treat sudden attacks of breathlessness or wheezing.
• Immediate hypersensitivity reactions such as rash, swelling, itching, wheezing, or shortness of breath may occur during treatment with Acopair. In such cases, contact your doctor immediately.
• As with other inhaled medicines, some patients may experience a feeling of chest tightness, cough, wheezing, or shortness of breath immediately after inhaling Acopair. In such cases, contact your doctor immediately.
• Care must be taken to avoid getting the powder into the eyes during inhalation, as this may cause or worsen symptoms of narrow-angle glaucoma, an eye condition. Eye pain or discomfort, blurred vision, seeing halos around lights, or changes in color vision, together with redness of the eyes, may indicate acute narrow-angle glaucoma. These eye symptoms may be accompanied by headache, nausea, and vomiting. If symptoms of narrow-angle glaucoma occur, discontinue tiotropium bromide and contact your doctor immediately, preferably an ophthalmologist.
• Dryness of the oral mucosa occurring during treatment, related to the anticholinergic effect of the drug, may lead to dental caries over time; therefore, maintaining good oral hygiene is important.
• If the patient has had a heart attack, heart rhythm disorders, life-threatening irregular heartbeat, or severe heart failure within the past 6 months (for heart attack and rhythm disorders) or past year (for heart failure), they should inform their doctor. The doctor will decide whether Acopair is suitable for the patient.
• Acopair must not be used more than once daily.

Children and adolescents
Acopair is not recommended for children and adolescents under 18 years of age.

Acopair and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to use, including those obtained without a prescription.
In particular, inform your doctor or pharmacist about other medicines used for lung disease, such as ipratropium or oxitropium.
No specific adverse interactions have been reported when Acopair is used together with other medicines commonly used in the treatment of COPD, such as inhaled rescue medicines (e.g. salbutamol), methylxanthines (e.g. theophylline), and/or oral or inhaled corticosteroids, such as prednisolone.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine. This medicine should not be used unless specifically advised by a doctor.

Driving and operating machinery
Dizziness, blurred vision, or headache may affect the ability to drive or operate machinery.

Acopair contains lactose
When used as directed—one capsule once daily—each dose of the medicine delivers up to 5.5 mg of lactose. If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to use Acopair

This medicine should always be used as prescribed by the doctor. If in doubt, consult
your doctor or pharmacist.
It is recommended to inhale the contents of one capsule (18 micrograms of tiotropium) once daily. Do not
use a higher dose than recommended.
Acopair is not recommended for children and adolescents under 18 years of age.
The capsule should be taken at the same time each day. This is important because Acopair
works for 24 hours.
The capsules must be used by inhalation only. Do not use orally.
Do not swallow the capsules.
The NeumoHaler inhaler, into which the Acopair capsule is inserted, pierces the capsule
and allows the powder to be inhaled. The patient should ensure they have the NeumoHaler
inhaler and know how to use it correctly. Instructions for using the NeumoHaler inhaler are provided
later in this leaflet.
Ensure that air is not exhaled into the NeumoHaler inhaler.
If you experience any difficulties using the NeumoHaler inhaler, seek help from your
doctor, nurse, or pharmacist.
The NeumoHaler inhaler should be cleaned once a month. Cleaning instructions for the inhaler are provided
later in this leaflet.
Avoid getting Acopair into the eyes, as this may cause: blurred vision, eye pain, and (or) eye redness. If the medicine gets into the eye, immediately rinse it with warm water and promptly consult a doctor.
If you feel that breathing difficulties are worsening, contact your doctor as quickly as possible.

Using more than the recommended dose of Acopair
If more than one capsule of Acopair has been inhaled in one day, contact your doctor immediately.
The risk of side effects may increase, such as: dryness of the oral mucosa, constipation, difficulty in urination, increased heart rate, or blurred vision.

Missing a dose of Acopair
If a dose has been missed, take it as soon as possible, but never take two doses at the same time or on the same day.
Take the next dose at the usual time.

Stopping treatment with Acopair
Before stopping treatment with Acopair, consult your doctor or pharmacist. After stopping Acopair, symptoms of COPD may worsen.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
The adverse effects listed below occurred in patients during treatment with this medicine. The adverse
effects are listed according to their frequency of occurrence: common, uncommon, rare, or frequency not known.

Common (may affect up to 1 in 10 people):

• dryness of the oral mucosa: usually mild in severity

Uncommon (may affect up to 1 in 100 people):

• dizziness
• headache
• taste disturbances
• blurred vision
• irregular heartbeat (atrial fibrillation)
• sore throat
• hoarseness (dysphonia)
• cough
• heartburn (gastroesophageal reflux disease)
• constipation
• fungal infections of the mouth and throat (oral and throat candidiasis)
• rash
• difficulty in urination (urinary retention)
• painful or difficult urination

Rare (may affect up to 1 in 1,000 people):

• difficulty sleeping (insomnia)
• seeing rainbow-colored halos around light sources or altered color vision accompanied by redness of the eyes (glaucoma)
• increased intraocular pressure
• irregular heartbeat (supraventricular tachycardia)
• increased heart rate (tachycardia)
• palpitations
• chest tightness associated with cough, wheezing, or shortness of breath occurring immediately after inhaling the medicine (bronchospasm)
• nosebleeds
• laryngitis
• sinusitis
• intestinal blockage or absence of intestinal peristalsis (intestinal obstruction, including paralytic ileus)
• gingivitis
• glossitis
• difficulty swallowing (dysphagia)
• stomatitis
• nausea
• hypersensitivity, including immediate reactions
• severe allergic reaction which may cause swelling of the face or throat (angioedema)
• urticaria
• itching (pruritus)
• urinary tract infections

Frequency not known (cannot be estimated from available data):

• loss of body fluids (dehydration)
• dental caries
• severe allergic reactions (anaphylactic reactions)
• skin infections or skin ulcers
• dry skin
• joint swelling

Severe adverse effects such as allergic reactions, which may cause swelling of the face or throat (angioedema), or other hypersensitivity reactions (such as sudden drop in blood pressure or dizziness) may occur alone or as part of a severe allergic reaction (anaphylactic reaction) after administration of Acopair. Additionally, as with other inhaled medicines, some patients may experience unexpected chest tightness, cough, wheezing, or shortness of breath immediately after inhaling the medicine (bronchospasm). If any of these symptoms occur, contact a doctor immediately.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse effects 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.: 22 49-21-301
website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder or its representative. Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Acopair

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the stated month.
The NeumoHaler inhaler may be used until all capsules from the package are used up
(no longer than 3 months after first use).
The batch number is indicated on the packaging after: Lot.
Do not store above 30 °C.
Keep in the original packaging to protect from moisture.
Medicines must not be disposed of via the sewage system 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 packaging and other information

What Acopair contains

• The active substance is tiotropium. Each capsule contains 18 micrograms of the active substance tiotropium (in the form of anhydrous bromide). During inhalation, each capsule delivers 12 micrograms of tiotropium through the mouthpiece of the NeumoHaler inhaler.
• Other ingredients: lactose, hypromellose, titanium dioxide (E 171), black ink.

What Acopair looks like and contents of the pack
Powder for inhalation in a hard capsule.
White or almost white capsules marked with black ink "T18" on the cap, containing white or almost white powder.
Aluminium/Aluminium blister in a cardboard box.
The NeumoHaler is a single-dose inhalation device with a green housing and cover, and a white button, made of plastic (ABS) and stainless steel.
Pack sizes:

• Cardboard box containing 30 capsules,
• Cardboard box containing 60 capsules,
• Cardboard box containing 90 capsules. The NeumoHaler inhaler is included in each cardboard box.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Viatris Limited
Damastown Industrial Park
Mulhuddart
Dublin 15
DUBLIN
Ireland
Manufacturer:
Ferrer Internacional, S.A.
Joan Buscallà 1-9
Sant Cugat del Vallès
08173 Barcelona
Spain

For further information about this medicinal product and its names in the European Economic Area countries, please contact the Marketing Authorisation Holder:
Mylan Healthcare Sp. z o.o.
Tel: + 48 22 546 64 00

Instructions for use and operation of the NeumoHaler inhaler
The NeumoHaler enables inhalation of the medicine contained in the Acopair capsule, prescribed by your doctor for breathing problems.
You must strictly follow your doctor's instructions when using Acopair. The NeumoHaler inhaler has been specifically designed for Acopair capsules. Do not use it to administer any other medicines. The NeumoHaler inhaler may be used until all capsules from the pack are used up (for up to a maximum of 3 months from first use). The NeumoHaler consists of an upper cover (curved top cover), mouthpiece (located beneath the upper cover), housing, piercing button (located on the side of the NeumoHaler), and central chamber (located beneath the mouthpiece).

NeumoHaler

1. Upper cover

2. Mouthpiece
3. Housing
4. Piercing button
5. Central chamber

1. Remove the upper cover. Ensure that no foreign objects are present in the mouthpiece.

2. Open the mouthpiece by pulling it upwards while pressing the indentations.

3. Remove a capsule from the blister (only immediately before use, see section "Removing the capsule from the blister") and place it into the central chamber of the NeumoHaler as shown in the illustration. It does not matter which end of the capsule is inserted into the chamber. Never place the capsule directly into the mouthpiece.

4. Close the mouthpiece firmly until a click is heard.

5. Holding the NeumoHaler inhaler with the mouthpiece pointing upwards, press the piercing button fully down once, then release it. The capsule will be pierced, allowing the medicine to be released during inhalation.
6. Breathe out deeply. Important: Avoid

exhaling into the mouthpiece.

7. Place the NeumoHaler inhaler into your mouth and seal your lips tightly around the mouthpiece. Keeping your head upright, inhale slowly and deeply so that you hear or feel the capsule vibrating. Continue inhaling until your lungs are full. Then hold your breath for as long as comfortable, and simultaneously remove the NeumoHaler from your mouth.
   Repeat steps 6 and 7 once more to ensure complete emptying of the capsule.

8. Open the mouthpiece again. Remove and dispose of the used capsule. Close the mouthpiece and replace the upper cover. Ensure that the cover is properly closed.

Cleaning the NeumoHaler inhalation device:
The NeumoHaler inhaler should be cleaned once a month.

1. Open the upper cover and mouthpiece. Then open the housing by pressing your thumb on the triangle embossed below the piercing button, as shown in the illustration.

2. Rinse the entire inhaler with warm water to remove any powder residue. Dry the NeumoHaler thoroughly by shaking off excess water onto a paper towel, then leave the parts disassembled to air-dry completely. Approximately 24 hours are required for full drying; therefore, wash the device immediately after use so that it is ready for the next dose. If necessary, the outer part of the mouthpiece may be wiped with a damp, but not wet, cloth.

Removing the capsule from the blister:

1. Detach a single blister by breaking along the perforation.

2. Peel back the foil from the individual blister to expose the capsule.

Do not push the capsule through the foil.

3. Capsules must be stored only in the blister and removed immediately before use. Remove the capsule from the blister with dry hands.

Do not swallow the capsule.
The Acopair capsule contains only a small amount of powder for inhalation and is therefore only partially filled.

Manufacturer of the NeumoHaler (medical device):
Ferrer International S.A.
Joan Buscalla 1-9
Sant Cugat del Valles
08173 Barcelona
Spain