TIOTROPIUM 10 mcg/inhalation dose Powder

Contents of the leaflet

1. PATIENT INFORMATION LEAFLET
2. Leaflet attached to the packaging: Information for the user
3. Tiotropium Elpen, 10 micrograms/dose, inhalation powder, divided
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is Tiotropium Elpen and what is it used for
5. Important information before using Tiotropium Elpen
   1. When not to use Tiotropium Elpen
   2. Warnings and precautions
   3. Before starting to take Tiotropium Elpen, discuss it with your doctor or pharmacist
   4. Children and adolescents
   5. Tiotropium Elpen and other medicines
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Tiotropium Elpen contains lactose monohydrate
6. How to use Tiotropium Elpen
   1. Using a higher dose of Tiotropium Elpen than recommended
   2. Missing a dose of Tiotropium Elpen
   3. Stopping Tiotropium Elpen
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 1000 people):
   4. Unknown frequency (frequency cannot be estimated from available data):
   5. Reporting side effects
8. How to store Tiotropium Elpen
9. Contents of the packaging and other information
   1. What Tiotropium Elpen contains
   2. What Tiotropium Elpen looks like and contents of the packaging
   3. Marketing authorization holder and manufacturer
   4. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   5. Date of last revision of the leaflet:
   6. INSTRUCTIONS FOR USE OF THE ELPENHALER DEVICE:
   7. B. Inhaling the dose
   8. C. Cleaning the inhalator

PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: Information for the user

Tiotropium Elpen, 10 micrograms/dose, inhalation powder, divided

Tiotropium

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Tiotropium Elpen and what is it used for

Tiotropium Elpen 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 Tiotropium Elpen should be taken daily, not just when breathing problems or other COPD symptoms occur.
Tiotropium Elpen 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 Tiotropium Elpen can also help reduce persistent shortness of breath associated with the disease and help reduce the impact of the disease on daily life. The medicine also helps to maintain activity for longer.
Taking Tiotropium Elpen once a day 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. The correct dosage of Tiotropium Elpen is described in section 3. The instructions for using Tiotropium Elpen and the user manual are at the end of this leaflet.

2. Important information before using Tiotropium Elpen

When not to use Tiotropium Elpen

• 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 oxytropium

Warnings and precautions

Before starting to take Tiotropium Elpen, discuss it with your doctor or pharmacist

• The patient should contact their doctor if they have narrow-angle glaucoma, prostate problems, or difficulty urinating.
• The patient should contact their doctor if they have kidney problems.
• Tiotropium Elpen is indicated for maintenance therapy in patients with chronic obstructive pulmonary disease. It should not be used to treat sudden attacks of shortness of breath or wheezing.
• After taking Tiotropium Elpen, immediate hypersensitivity reactions, such as rash, swelling, itching, wheezing, or shortness of breath, may occur. In such a situation, the patient should consult their doctor immediately.
• Similar to other inhaled medicines, after taking Tiotropium Elpen, a feeling of chest tightness, coughing, wheezing, or shortness of breath may occur. In such a situation, the patient should consult their doctor immediately.
• Do not allow the powder to get into the eyes, as it may cause or worsen glaucoma, which is an eye disease. Eye pain or discomfort, blurred vision, seeing a rainbow-colored ring around a light source, or changes in color vision, along with eye redness, may be signs of acute glaucoma. Eye problems may be accompanied by: headache, nausea, and vomiting. If symptoms of glaucoma occur, the patient should stop taking Tiotropium Elpen and consult their doctor, preferably an ophthalmologist, immediately.
• Dryness of the oral mucosa observed during anticholinergic treatment may cause tooth decay after a longer period, so it is essential to maintain oral hygiene.
• If the patient has had a heart attack in the last 6 months or has had unstable or life-threatening heart rhythm disorders in the last year, they should inform their doctor. The doctor will decide whether Tiotropium Elpen can be taken.
• Tiotropium Elpen should not be taken more than once a day.

Children and adolescents

Tiotropium Elpen should not be used in children and adolescents under 18 years of age.

Tiotropium Elpen and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, including those they plan to take.
The patient should inform their doctor or pharmacist about other medicines used to treat lung disease, such as ipratropium or oxytropium.
No interactions have been reported when taking Tiotropium Elpen with other medicines used to treat COPD, such as inhaled rescue medicines, e.g., salbutamol, methylxanthines, e.g., theophylline, or oral and inhaled steroids, e.g., prednisolone.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. The medicine should not be taken unless prescribed by a doctor.

Driving and using machines

If dizziness, blurred vision, or headache occurs, the patient should not drive or operate machinery.

Tiotropium Elpen contains lactose monohydrate

Each dose-containing strip contains 11.86 mg of lactose (in the form of lactose monohydrate). If the patient has previously been diagnosed with intolerance to some sugars or milk protein allergy (which may be present in small amounts in the lactose monohydrate ingredient), they should consult their doctor before taking the medicine.

3. How to use Tiotropium Elpen

This medicine should always be used as directed by the doctor or pharmacist. If in doubt, consult the doctor or pharmacist.
The recommended dose is to inhale the contents of 1 dose strip once a day. Each dose strip contains 16 micrograms of tiotropium bromide monohydrate, which corresponds to 13 micrograms of tiotropium, and the delivered dose from the Elpenhaler inhaler is 10 micrograms of tiotropium. Do not exceed the recommended dose.
Tiotropium Elpen should not be used in children and adolescents under 18 years of age.
The dose strip should be taken at the same time every day. This is important because Tiotropium Elpen works for 24 hours.
The strips are for inhalation only and should not be swallowed.
Do not ingest the contents of the strip.
The Elpenhaler device, which should be used with the Tiotropium Elpen strips, allows the powder to be inhaled.
The patient should ensure they have the Elpenhaler device and use it correctly. The instructions for using the Elpenhaler device are at the end of this leaflet.
The medicine should be stored in the aluminum pouch to protect it from moisture and only removed just before first use.
Make sure that air is not exhaled into the Elpenhaler mouthpiece.
If there are any difficulties with using the Elpenhaler device, the patient should ask their doctor, nurse, or pharmacist to show them how it works.
The Elpenhaler device should be cleaned after each use. The instructions for cleaning the Elpenhaler device are at the end of this leaflet.
Do not allow Tiotropium Elpen to get into the eyes. This may cause blurred vision, eye pain, or eye redness. The eyes should be rinsed immediately with warm water, and the doctor should be consulted.

Using a higher dose of Tiotropium Elpen than recommended

If a higher dose of Tiotropium Elpen than 1 strip per day is inhaled, the doctor should be consulted immediately. The patient may be at increased risk of side effects, such as dryness of the oral mucosa, constipation, difficulty urinating, rapid heartbeat, or blurred vision.

Missing a dose of Tiotropium Elpen

If the patient forgets to take a dose, they should take it as soon as they remember. Do not take two doses at the same time or on the same day.
The next dose should be taken at the usual time.

Stopping Tiotropium Elpen

Before stopping Tiotropium Elpen, the doctor or pharmacist should be consulted. After stopping Tiotropium Elpen, COPD symptoms may worsen.
If there are any further doubts about using this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Tiotropium Elpen can cause side effects, although not everybody gets them.
The following side effects have been reported by patients taking Tiotropium Elpen. Side effects are listed by frequency: common, uncommon, rare, or unknown.

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

• Dryness of the oral mucosa (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
• Heartburn (gastroesophageal reflux disease)
• Constipation
• Fungal infections of the mouth and throat (oral thrush)
• Rash
• Difficulty urinating (urinary retention)
• Painful urination

Rare (may affect up to 1 in 1000 people):

• Difficulty sleeping (insomnia)
• Seeing a rainbow-colored ring around a light source or changes in color vision, along with eye redness (glaucoma)
• Increased eye pressure
• Irregular heartbeat (supraventricular tachycardia)
• Rapid heartbeat (tachycardia)
• Feeling of heartbeat (palpitations)
• Chest tightness associated with coughing, wheezing, or shortness of breath occurring immediately after inhalation of the product (bronchospasm)
• Nosebleeds
• Laryngitis
• Sinusitis
• Intestinal obstruction (including paralytic ileus)
• Gingivitis
• Glossitis
• Swallowing difficulties (dysphagia)
• Stomatitis
• Nausea
• Hypersensitivity, including immediate reactions
• Severe allergic reaction with swelling of the face or throat (angioedema)
• Hives
• Itching
• Urinary tract infections

Unknown frequency (frequency cannot be estimated from available data):

• Dehydration
• Tooth decay
• Severe allergic reactions (anaphylactic reactions)
• Infections or ulcers of the skin
• 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 sudden low blood pressure or dizziness) may occur alone or as part of a severe allergic reaction (anaphylactic reaction) after taking Tiotropium Elpen.
Additionally, as with other inhaled medicines, some patients may experience unexpected chest tightness, coughing, wheezing, or shortness of breath immediately after inhaling the product (bronchospasm). If any of these symptoms occur, the doctor should be consulted immediately.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Tiotropium Elpen

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, aluminum pouch, label, and blisters containing the dose after the "EXP" abbreviation. The expiry date refers to the last day of the month.
There are no special storage temperature requirements for the medicine.
Store in the original packaging to protect from moisture. After opening the aluminum pouch, use within 60 days and store the product below 25°C.
On the sticker attached to the pouch, write the date of first opening of the pouch. The sticker should be attached to the bottom of the device. The aluminum pouch and the desiccant pouch should be discarded.
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 packaging and other information

What Tiotropium Elpen contains

The active substance of the medicine is tiotropium. Each blister contains 16 micrograms of tiotropium bromide monohydrate, which corresponds to 13 micrograms of tiotropium. When inhaled, 10 micrograms of tiotropium are delivered through the Elpenhaler inhaler.
The other ingredient is lactose monohydrate (which may contain small amounts of milk proteins).

What Tiotropium Elpen looks like and contents of the packaging

1 white plastic inhalation device Elpenhaler, which contains 30 dose strips, is packed in an aluminum pouch with a desiccant pouch. The aluminum pouch is packed in a cardboard box with a patient information leaflet. Packaging containing 30 doses.
2 white plastic inhalation devices Elpenhaler, each containing 30 dose strips, are packed in separate aluminum pouches with a desiccant pouch. 2 aluminum pouches are packed in a cardboard box with a patient information leaflet. Packaging containing 60 doses.
3 white plastic inhalation devices Elpenhaler, each containing 30 dose strips, are packed in separate aluminum pouches with a desiccant pouch. 3 aluminum pouches are packed in a cardboard box with a patient information leaflet. Packaging containing 90 doses.
Not all pack sizes may be marketed.
After opening the aluminum pouch, the pouch and the desiccant pouch should be discarded - do not eat or inhale them.
The dose strips with blisters in the Elpenhaler inhaler should only be used with this specific device, before the expiry date stated on the label.

Marketing authorization holder and manufacturer

ELPEN Pharmaceutical Co. Inc.
95 Marathonos Ave., 19009, Pikermi, Attica,
Greece

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Netherlands:
Adcopium 10 microgram inhalation powder, pre-dispensed

Date of last revision of the leaflet:

INSTRUCTIONS FOR USE OF THE ELPENHALER DEVICE:

Elpenhaler is a device for taking inhalation powder in doses.
Each dose is stored in a blister that is part of a specially designed strip with blisters containing the dose.

• Open the compartment, press as shown in the illustration, remove the strip, and close the compartment again.
• Exposure of the mouthpiece by gently pressing on the area with the strips.
• Unlock and push the mouthpiece back to expose the base.
• Hold the strip with the blister with the shiny surface facing up, so that the blue line is visible, as indicated by the arrow in the illustration. The surface of the strip with the label should face down.

• Place the hole of the strip on the base of the device. Gently press to ensure the strip is securely attached to the base.
• The strip with blisters will fit into the recesses on the base, and the guide strips will keep the strip in the correct position.

• Close the mouthpiece, pull the protruding end of the strip horizontally to detach and discard it.
• The dose is ready for inhalation.

B. Inhaling the dose

Hold the device away from the mouth. Take a full breath. Be careful not to exhale onto the mouthpiece of the device. Put the Elpenhaler inhaler in the mouth and close the lips tightly around the mouthpiece.

• Slowly take a deep breath in through the mouth (not the nose) until the lungs are full.
• Hold the breath for about 5 seconds or as long as possible and remove the device from the mouth.
• Exhale and continue breathing normally.
• Open the mouthpiece.
• It will be visible that all the powder has been used up and the blister of the strip

is empty.

• Remove the empty strip, discard it, and proceed to step C.

C. Cleaning the inhalator

After each use, wipe the mouthpiece of the device and the base with a dry cloth or dry paper tissue. Do not use water to clean the device.
Close the mouthpiece and put its protective cover back on.