ACOPAIR 18 mcg Powder

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Acopair
3. 18 micrograms, powder for inhalation in a hard capsule
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
4. What is Acopair and what is it used for
5. Important information before using Acopair
   1. When not to use Acopair:
   2. Warnings and precautions
   3. Before starting to use Acopair, discuss it with your doctor or pharmacist
   4. Children and adolescents
   5. Acopair and other medicines
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Acopair contains lactose
6. How to use Acopair
   1. Using a higher dose of Acopair than recommended
   2. Missing a dose of Acopair
   3. Stopping the use of Acopair
7. Possible side effects
   1. Common (may affect up to 1 in 10 people):
   2. Uncommon (may affect up to 1 in 100 people):
   3. Rare (may affect up to 1 in 1,000 people):
   4. Frequency not known (cannot be estimated from the available data):
   5. Reporting side effects
8. How to store Acopair
9. Contents of the pack and other information
   1. What Acopair contains
   2. What Acopair looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder:
   5. Manufacturer:
   6. Mylan Healthcare Sp. z o.o.
   7. Date of last revision of the leaflet:
   8. Instructions for use and handling of the NeumoHaler inhaler
   9. Cleaning the NeumoHaler inhaler:
   10. Removing the capsule from the blister pack:
   11. Manufacturer of the NeumoHaler inhaler (medical device):

Package Leaflet: Information for the Patient

Acopair

18 micrograms, powder for inhalation in a hard capsule

Tiotropium

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

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

Table of Contents of the Leaflet

• 1. What is Acopair and what is it 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 is Acopair and what is it used for

Acopair makes it easier for people with chronic obstructive pulmonary disease (COPD) to breathe.
COPD is a chronic lung disease that causes shortness of breath and coughing. The name COPD is associated
with chronic bronchitis and emphysema. COPD is a chronic disease, so the Acopair medicine should be taken daily, and not just when breathing problems or other COPD symptoms occur.
Acopair is a long-acting bronchodilator that helps to widen the airways and make it easier for air to get in and out of the lungs. Regular use of Acopair may also help reduce persistent shortness of breath associated with the disease and help reduce the impact of the disease on daily life. The medicine helps to maintain activity for longer. Daily use of Acopair will also help prevent sudden, short-term worsening of COPD symptoms, which can last for several days. The effect of the medicine lasts for 24 hours, so it should only be taken once a day.
For information on the correct dosage and method of using Acopair, see section 3.

• 3. How to use Acopair and the Instructions for Use and Handling of the NeumoHaler inhaler, which can be found later in the leaflet.

2. Important information before using Acopair

When not to use Acopair:

oxitropium.

Warnings and precautions

Before starting to use Acopair, discuss it with your doctor or pharmacist

• The patient should contact their doctor if they have increased intraocular pressure (narrow-angle glaucoma), prostate problems, or difficulty urinating.
• The patient should contact their doctor if they have kidney problems.
• Acopair is indicated for the treatment of chronic obstructive pulmonary disease. It should not be used to treat sudden attacks of shortness of breath or wheezing.
• During the use of Acopair, immediate hypersensitivity reactions, such as rash, swelling, itching, wheezing, or shortness of breath, may occur. In such cases, the doctor should be contacted immediately.
• As with other inhaled medicines, after using Acopair, some patients may experience a feeling of chest tightness, coughing, wheezing, or shortness of breath. In such cases, the doctor should be contacted immediately.
• It is not allowed for the powder to get into the eyes during inhalation, as it may cause the occurrence or worsening of symptoms of narrow-angle glaucoma, which is an eye disease. Eye pain or discomfort, blurred vision, seeing a rainbow-colored halo around a light source, or changed color vision, along with eye redness, may be a sign of acute narrow-angle glaucoma. Eye disorders may be accompanied by: headache, nausea, and vomiting. If symptoms of narrow-angle glaucoma occur, the use of tiotropium bromide should be discontinued and the doctor should be contacted immediately, preferably an ophthalmologist.
• Dryness of the oral mucosa occurring during the use of the medicine, related to its anticholinergic effect, may cause tooth decay after a longer period, so it is necessary to remember to maintain oral hygiene.
• If the patient has had a heart attack, arrhythmia, or life-threatening irregular heartbeat, or severe heart failure in the last year, they should inform their doctor. The doctor will decide whether Acopair is a suitable medicine for the patient.
• Acopair should not be used more than once a day.

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 you are taking now or have recently taken, as well as any medicines you plan to take, including those available without a prescription.
In particular, inform your doctor or pharmacist about other medicines used to treat lung disease, such as ipratropium or oxitropium.
No specific interactions have been reported when taking Acopair with other medicines used to treat COPD, such as: inhaled medicines used as needed, e.g., salbutamol, methylxanthines (e.g., theophylline), and/or oral and inhaled steroids, e.g., prednisolone.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine. Do not take this medicine unless your doctor has told you to.

Driving and using machines

Dizziness, blurred vision, or headache may affect your ability to drive or use machines.

Acopair contains lactose

When using the medicine as recommended, i.e., one capsule once a day, each dose of the medicine provides up to 5.5 mg of lactose. If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to use Acopair

This medicine should always be used as directed by your doctor. If you are unsure, ask your doctor or pharmacist.
It is recommended to inhale the contents of one capsule (18 micrograms of tiotropium) once a day. Do not take more than the recommended dose.
Acopair is not recommended for children and adolescents under 18 years of age.
Take the capsule at the same time each day. This is important because Acopair works for 24 hours.
The capsules should only be used for inhalation. Do not swallow them.
The NeumoHaler inhaler, into which the Acopair capsule should be inserted, pierces the capsule and allows the powder to be inhaled. Make sure you have a NeumoHaler inhaler and use it correctly. The instructions for using the NeumoHaler inhaler can be found later in the leaflet.
Make sure that air is not exhaled into the NeumoHaler inhaler.
If you have any difficulties with using the NeumoHaler inhaler, ask your doctor, nurse, or pharmacist for help.
The NeumoHaler inhaler should be cleaned once a month. The cleaning instructions can be found later in the leaflet.
Do not allow the Acopair medicine to get into your eyes, as it may cause: blurred vision, eye pain, and/or eye redness. If the medicine gets into your eye, rinse it immediately with warm water and contact your doctor.

Using a higher dose of Acopair than recommended

If you inhale the contents of more than one Acopair capsule per day, contact your doctor immediately. You may be at increased risk of side effects, such as: dry mouth, constipation, difficulty urinating, rapid heartbeat, or blurred vision.

Missing a dose of Acopair

If you miss a dose, 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 the use of Acopair

Before stopping the use of Acopair, consult your doctor or pharmacist. After stopping the use of Acopair, COPD symptoms may worsen.
If you have any further questions about using 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.
The following side effects have occurred in patients using Acopair. Side effects are listed according to their frequency: common, uncommon, rare, or frequency not known.

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

• dry mouth: usually mild

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

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

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

• difficulty sleeping (insomnia)
• seeing a rainbow-colored halo around a light source or changed color vision with eye redness (glaucoma)
• increased eye pressure
• irregular heartbeat (supraventricular tachycardia)
• rapid heartbeat (tachycardia)
• palpitations
• chest tightness associated with coughing, wheezing, or shortness of breath occurring immediately after inhalation of the medicine (bronchospasm)
• nasal bleeding
• laryngitis
• sinusitis
• intestinal obstruction (including paralytic ileus)
• gingivitis
• glossitis
• difficulty swallowing (dysphagia)
• stomatitis
• nausea
• hypersensitivity, including immediate reactions
• severe allergic reactions, which can cause swelling in the face or throat (angioedema)
• hives
• itching (pruritus)
• urinary tract infections

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

• dehydration
• tooth decay
• severe allergic reactions (anaphylactic reactions)
• skin infections or ulcers
• dry skin
• joint swelling

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

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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
Side effects can also be reported to the marketing authorization holder or its representative. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Acopair

Keep the medicine out of the 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 month stated.
The NeumoHaler inhaler can be used until all the capsules from the packaging have been used (but no longer than 3 months from the first use).
The batch number is stated on the packaging after: Lot.
Do not store above 30°C.
Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Acopair contains

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

What Acopair looks like and contents of the pack

Powder for inhalation in a hard capsule.
The capsules are white or almost white, marked with black ink "T18" on the cap, containing a white or almost white powder.
Aluminum/Aluminum blister pack in a cardboard box.
NeumoHaler is a single-dose inhaler with a green casing and cap, 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 authorization holder and manufacturer

Marketing authorization 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
To obtain more detailed information on the medicine and its names in the Member States of the European Economic Area, contact the marketing authorization holder:

Mylan Healthcare Sp. z o.o.

Tel: + 48 22 546 64 00

Date of last revision of the leaflet:

Instructions for use and handling of the NeumoHaler inhaler

NeumoHaler allows for the inhalation of the medicine contained in the Acopair capsule, as prescribed by your doctor for breathing problems.
Follow your doctor's instructions carefully when using Acopair. The NeumoHaler inhaler is specially designed for Acopair capsules. Do not use it to administer other medicines. The NeumoHaler inhaler can be used until all the capsules from the packaging have been used (but no longer than 3 months from the first use). NeumoHaler consists of an upper cover (curved upper cover), mouthpiece (located under the upper cover), casing, capsule-piercing button (on the side of NeumoHaler), and central chamber (located under the mouthpiece).

• 1. Upper cover
• 2. Mouthpiece
• 3. Casing
• 4. Capsule-piercing button
• 5. Central chamber

• 1. Remove the upper cover. Make sure that no object is in the mouthpiece.

• 2. Open the mouthpiece by pulling it upwards while pressing the notches.

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

• 4. Close the mouthpiece tightly until a click is heard.

• 5. Holding the NeumoHaler inhaler with the mouthpiece facing upwards, press the capsule-piercing button once to the end, then release it. The capsule will be pierced, allowing the medicine to be released during inhalation.

• 6. Exhale deeply. Important: Avoid exhaling into the mouthpiece.

• 7. Put the NeumoHaler inhaler to your mouth, seal your lips tightly around the mouthpiece. With your head in an upright position, take a slow and deep breath in so that you can hear or feel the vibration of the capsule. Take a breath in until your lungs are full. Then, hold your breath for as long as is comfortable and remove the NeumoHaler inhaler from your mouth.

Repeat steps 6 and 7 again to completely empty the capsule.

• 8. Open the mouthpiece again. Remove and discard the used capsule. Close the mouthpiece and put the upper cover back on. Make sure that the upper cover is properly closed.

Cleaning the NeumoHaler inhaler:

The NeumoHaler inhaler should be cleaned once a month.

• 1. Open the upper cover and mouthpiece. Then, open the casing by pressing your thumb on the triangle below the capsule-piercing button, as shown in the picture.

• 2. Rinse the entire inhaler with warm water to remove any powder residue. Dry the NeumoHaler inhaler thoroughly by shaking off excess water onto a paper towel, then, without reassembling the parts, leave it to air dry. It takes about 24 hours to dry completely, so clean it immediately after use so that it is ready for the next dose. If necessary, the outer part of the mouthpiece can be wiped with a damp, but not wet, cloth.

Removing the capsule from the blister pack:

• 1. Separate a single blister by breaking along the perforation.

• 2. Peel the foil from the single blister to expose the capsule.

Do not push the capsule through the foil.

• 3. The capsules should only be stored in the blister pack and removed immediately before use. Remove the capsule from the blister pack with dry hands.

Do not swallow the capsule.
The Acopair capsule contains only a small amount of inhalation powder, so it is only partially filled.

Manufacturer of the NeumoHaler inhaler (medical device):

Ferrer International S.A.
Joan Buscalla 1-9
Sant Cugat del Valles
08173 Barcelona
Spain