Tiotropium elpen

Package leaflet: Information for the user

Tiotropium Elpen, 10 micrograms/inhalation dose, inhalation powder, divided
Tiotropium
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. 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 inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Tiotropium Elpen is and what it is 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 pack and other information

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

Tiotropium Elpen helps people with chronic obstructive pulmonary disease (COPD) to breathe better. COPD is a chronic lung disease that causes breathlessness and cough. The term COPD refers to chronic bronchitis and emphysema. COPD is a long-term condition, so Tiotropium Elpen must be taken every day, not only when breathing problems or other symptoms of COPD occur.
Tiotropium Elpen is a long-acting bronchodilator that helps open the airways and allows air to move in and out of the lungs more easily. Regular use of Tiotropium Elpen may also help reduce persistent breathlessness caused by the disease and improve daily symptoms. The medicine also helps maintain physical activity for longer.
Daily use of Tiotropium Elpen can 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, it should be used only once daily. The correct dosage of Tiotropium Elpen is described in section 3. Instructions for proper use of Tiotropium Elpen are provided 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 to 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 treatment with Tiotropium Elpen, discuss this 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 function disorders.
• Tiotropium Elpen is indicated for maintenance therapy in patients with chronic obstructive pulmonary disease (COPD). It should not be used to treat sudden episodes of breathlessness or wheezing.
• Immediately after administration of Tiotropium Elpen, immediate hypersensitivity reactions such as rash, swelling, itching, wheezing, or shortness of breath may occur. In such a case, consult your doctor immediately.
• As with other inhaled medicines, immediately after using Tiotropium Elpen, chest tightness, cough, wheezing, or shortness of breath may occur. In such a case, consult your doctor immediately.
• Care must be taken to avoid getting the powder into the eyes during inhalation, as this may cause the onset or worsening of narrow-angle glaucoma, an eye condition. Eye pain or discomfort, blurred vision, seeing halos around lights, or changes in color vision, together with red eyes, may be signs of 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 a doctor immediately, preferably an ophthalmologist.
• Dryness of the oral mucosa observed during anticholinergic treatment may lead to dental caries over time; therefore, good oral hygiene should be maintained.
• If the patient has had a myocardial infarction within the last 6 months, or has experienced unstable or life-threatening cardiac arrhythmia or severe heart failure within the last year, this should be reported to the doctor. The doctor will decide whether Tiotropium Elpen can be used.
• Tiotropium Elpen should not be used more than once daily.

Children and adolescents
The use of Tiotropium Elpen is not recommended in children and adolescents under 18 years of age.

Tiotropium Elpen and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including medicines you plan to use.
Inform your doctor or pharmacist about other medications used for lung disease, such as ipratropium or oxitropium.
No adverse effects have been reported when Tiotropium Elpen is used together with other medicines commonly used in the treatment of COPD, such as inhaled short-acting bronchodilators (e.g., salbutamol), methylxanthines (e.g., theophylline), or oral and inhaled corticosteroids (e.g., prednisolone).

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

Driving and operating machinery
If dizziness, blurred vision, or headache occur, do not drive or operate machinery.

Tiotropium Elpen contains lactose monohydrate
Each strip containing a dose of the medicine contains 11.86 mg of lactose (in the form of lactose monohydrate). If the patient has previously been diagnosed with intolerance to certain sugars or allergy to milk proteins (which may be present in small amounts in lactose monohydrate), the patient should consult their doctor before taking this medicine.

3. How to use Tiotropium Elpen

This medicine should always be used as directed by the physician or pharmacist.
If in doubt, consult your doctor or pharmacist.
The recommended dose is one inhalation of the contents of one capsule once daily. Each capsule containing the dose of medicine contains 16 micrograms of tiotropium bromide monohydrate, corresponding to 13 micrograms of tiotropium, and the dose delivered from the mouthpiece of the Elpenhaler device is 10 micrograms of tiotropium. Do not exceed the recommended dose.
Tiotropium Elpen is not recommended for use in children and adolescents under 18 years of age.
The capsule containing the dose of medicine should be used at the same time each day. This is important because Tiotropium Elpen works for 24 hours.
The capsules are intended for inhalation only and not for oral ingestion.
Do not swallow the contents of the capsule.
The Elpenhaler device, which must be used with Tiotropium Elpen capsules, enables inhalation of the powder.
The patient should ensure they have the Elpenhaler device and that they are using it correctly. Instructions for using the Elpenhaler device are provided at the end of this leaflet.
The medicine should be stored in its aluminium pouch to protect it from moisture and removed only immediately before first use.
Ensure that air is not exhaled into the mouthpiece of the Elpenhaler device.
If any difficulties arise with using the Elpenhaler device, ask your doctor, nurse, or pharmacist to demonstrate its correct use.
The Elpenhaler device should be cleaned after each use. Instructions for cleaning the Elpenhaler device are provided at the end of this leaflet.
Avoid allowing Tiotropium Elpen to enter the eyes. This may cause blurred vision, eye pain, or eye redness. Immediately rinse the eyes with warm water and consult a doctor without delay.
If breathing difficulties worsen, contact your doctor as quickly as possible.
Use of a higher than recommended dose of Tiotropium Elpen
If more than one capsule per day is inhaled, contact your doctor immediately. The risk of adverse effects such as dry mouth, constipation, difficulty in urination, increased heart rate, or blurred vision may increase.
Missing a dose of Tiotropium Elpen
If a dose is missed, it should be taken as soon as remembered. 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 treatment with Tiotropium Elpen, consult your doctor or pharmacist. After discontinuation of Tiotropium Elpen, symptoms of COPD may worsen.
If further doubts arise regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
The adverse reactions listed below have been reported by patients during treatment with this medicine. The adverse reactions 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)

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 pharyngeal candidiasis)
• Rash
• Difficulty in urination (urinary retention)
• Painful urination

Rare (may affect up to 1 in 1000 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)
• Awareness of heartbeat (palpitations)
• Chest tightness associated with cough, wheezing, or shortness of breath occurring immediately after inhaling the medicine (bronchospasm)
• Nosebleeds
• Laryngitis
• Sinusitis
• Bowel obstruction or absence of intestinal peristalsis (intestinal obstruction, including paralytic ileus)
• Gingivitis
• Glossitis
• Swallowing difficulties (dysphagia)
• Stomatitis
• Nausea
• Hypersensitivity, including immediate reactions
• Severe allergic reaction causing swelling of the face or throat (angioedema)
• Urticaria
• Itching
• Urinary tract infection

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

• Loss of body water (dehydration)
• Dental caries
• Severe allergic reactions (anaphylactic reactions)
• Skin infections or ulceration
• Dry skin
• Joint swelling

Severe adverse reactions 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) following administration of Tiotropium Elpen.
Additionally, as with other inhaled medicines, some patients may experience unexpected chest tightness, cough, wheezing, or shortness of breath immediately after inhaling the product (bronchospasm). If any of these symptoms occur, contact a doctor immediately.

Reporting of adverse reactions
If any adverse reactions occur in patients, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions 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
PL-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 authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Tiotropium Elpen

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, aluminium sachet, label, and blisters containing the dose of medicine, following the abbreviation "EXP". The expiry date refers to the last day of the stated month.
There are no special requirements regarding storage temperature.
Store in the original packaging to protect from moisture. After first opening the aluminium sachet, the product should be used within 60 days and stored at a temperature below 25°C.
The label attached to the sachet should be filled in with the date of first opening of the sachet. This label should be affixed to the bottom of the device. The aluminium sachet and the moisture-absorbing packet should be discarded.
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 Tiotropium Elpen contains
The active substance is tiotropium. Each dose-containing blister contains
16 micrograms of monohydrated tiotropium bromide, equivalent to 13 micrograms
of tiotropium. During inhalation, 10 micrograms of tiotropium is delivered through the mouthpiece of the
Elpenhaler inhaler.
The other ingredient is monohydrated lactose (which may contain small amounts of milk proteins).

What Tiotropium Elpen looks like and contents of the pack
1 white plastic inhalation device Elpenhaler, containing 30 dose strips, packed in an aluminium sachet with a desiccant pouch. The aluminium sachet is enclosed in a cardboard box with the patient information leaflet. Pack containing 30 doses.
2 white plastic inhalation devices Elpenhaler, each containing 30 dose strips, individually packed in aluminium sachets with a desiccant pouch. The 2 aluminium sachets are enclosed in a cardboard box with the patient information leaflet. Pack containing 60 doses.
3 white plastic inhalation devices Elpenhaler, each containing 30 dose strips, individually packed in aluminium sachets with a desiccant pouch. The 3 aluminium sachets are enclosed in a cardboard box with the patient information leaflet. Pack containing 90 doses.
Not all pack sizes may be marketed.
After opening the aluminium sachet, discard both the sachet and the desiccant pouch – do not ingest or inhale them.
The dose strips contained in blisters inside the Elpenhaler inhaler must be used exclusively with this specific device and before the expiry date indicated on the label.

Marketing Authorisation Holder and Manufacturer
ELPEN Pharmaceutical Co. Inc.
95 Marathonos Ave., 19009, Pikermi, Attica,
Greece

This medicinal product is authorised for marketing in the European Economic Area countries under the following names:
Netherlands: Adcopium 10 microgram inhalation powder, pre-dispensed

INSTRUCTIONS FOR USE OF THE ELPENHALER DEVICE:
Elpenhaler is a device for administering a metered dose of inhalation powder.
Each dose is stored in a blister within a specially designed dose strip.
The Elpenhaler device consists of 3 parts:

• Mouthpiece and its cover (1).
• Surface (2) for placing the dose strip (carrier surface).
• Compartment (3) for storing dose strips.
  The above three parts are connected but can be opened separately. The carrier surface consists of:
• Attachment point (2A) for positioning the blister.

• Recess (2B) for placing the dose strip.
• Two guide strips (2C) that ensure the dose strip is correctly positioned on the carrier surface.

The dose strip contains:

• Two aluminium foils (4).
• Blister (5) containing the medicine.
• Hole (6).

USING THE ELPENHALER DEVICE
Α. Preparing the device

• Open the compartment by pressing as shown in the illustration, remove the strip and close the compartment again.
• Fully uncover the mouthpiece by gently pressing the area with the strips.
• Unlock and push the mouthpiece backward to expose the carrier surface.
• Hold the dose strip with the shiny side facing upwards so that the blue line, indicated by the arrow in the illustration, is visible. The labelled side of the strip should face downwards.

• Place the hole of the strip onto the attachment point on the carrier surface. Press gently to ensure the strip is securely attached to the attachment point.
• The dose strip will fit into the recesses on the carrier surface, and the guide strips will keep it in the correct position.

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

B. Inhaling the dose
Hold the device away from the mouth. Take a full breath in. Be careful not to exhale into the mouthpiece of the device. Place the Elpenhaler inhalation device into the mouth and seal the lips tightly around the mouthpiece.

• Inhale slowly and deeply through the mouth (not through the nose) until the lungs are full.
• Hold the breath for about 5 seconds, or as long as possible, while removing the device from the mouth.
• Exhale and continue breathing normally.
• Open the mouthpiece.

• It will be visible that all the powder has been used and the blister of the strip is empty.
• Remove the empty strip, discard it, and proceed to step C.

C. Cleaning the inhaler
After each use, wipe the mouthpiece and carrier surface with a dry cloth or dry paper tissue. Do not use water to clean the device.
Close the mouthpiece and place its protective cover over it.