Lungamo

Patient Information Leaflet

Lungamo, 18 micrograms/dose, inhalation powder in hard capsule
Tiotropium
Please read all of this leaflet carefully before using this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• Please contact your doctor or pharmacist if you have any questions.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What Lungamo is and what it is used for

Lungamo contains the active substance tiotropium. Lungamo helps people with chronic obstructive pulmonary disease (COPD) to breathe more easily. COPD is a long-term lung disease that causes breathlessness and cough. The term COPD is associated with chronic bronchitis and emphysema.
COPD is a chronic condition, therefore Lungamo must be taken every day, not only when breathing problems or other symptoms of COPD occur.
Lungamo 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 Lungamo may also help reduce persistent breathlessness caused by the disease and improve symptoms affecting daily life. Daily use of Lungamo may also help prevent sudden, short-term worsening of COPD symptoms, which may last for several days.

2. Important information before using Lungamo

When not to use Lungamo

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

Warnings and precautions
Before starting treatment with Lungamo, discuss this with your doctor or pharmacist.

• The patient should contact a doctor if they have narrow-angle glaucoma, prostate problems, or difficulty urinating.
• The patient should contact a doctor if they have kidney function disorders.
• Lungamo is indicated for the treatment of chronic obstructive pulmonary disease (COPD). It must not be used to treat sudden episodes of breathlessness or wheezing.
• Immediate hypersensitivity reactions such as rash, swelling, itching, wheezing, or shortness of breath may occur during treatment with Lungamo. In such cases, contact a doctor immediately.
• Inhaled medicines, such as Lungamo, may cause a feeling of chest tightness, cough, wheezing, or shortness of breath immediately after administration. In such cases, contact a doctor immediately.
• Care should be taken to avoid getting the inhalation powder into the eye, as this may cause the onset or worsening of 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 red eyes, may indicate acute narrow-angle glaucoma. Eye-related symptoms may be accompanied by headache, nausea, and vomiting. If symptoms of narrow-angle glaucoma occur, discontinue use of Lungamo and contact a doctor immediately, preferably an ophthalmologist.
• Dryness of the mouth, observed during anticholinergic treatment, may lead to dental caries over time. Therefore, maintaining good oral hygiene is important.
• 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, they should inform their doctor. It is important to make an appropriate decision on whether Lungamo can be used in the patient.
• This medicine must not be used more than once daily.

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

Lungamo with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, 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 adverse effects have been reported when Lungamo is used together with other medicines used in the treatment of COPD, such as: inhaled, short-acting medicines (e.g. salbutamol), methylxanthines (e.g. theophylline), and/or oral or inhaled steroids (e.g. prednisolone).

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

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

Lungamo contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking this medicine. Lactose contains small amounts of proteins which may cause allergic reactions.

3. How to use Lungamo

Lungamo should always be used as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

One capsule (18 micrograms of tiotropium) should be inhaled once daily. Two inhalations should be taken from the same capsule (see section "Instructions for use and handling" at the end of this leaflet). Do not use more than the recommended dose.

The capsule should be taken at the same time each day. This is important because Lungamo works for 24 hours.

Use in children and adolescents
Lungamo is not recommended for children and adolescents under 18 years of age.

Method of administration
Capsules are for inhalation only and must not be taken orally. Do not swallow the capsules.

The capsule should be removed from the blister pack immediately before using the inhaler!

The Vertical-Haler inhaler, into which the Lungamo capsule must be inserted, pierces the capsule and enables inhalation of the powder.

Patients should ensure they have the Vertical-Haler inhaler and know how to use it correctly. Instructions for using the Vertical-Haler inhaler are provided at the end of this leaflet.

If you feel that breathing difficulties are worsening, contact your doctor as soon as possible.

Overdose of Lungamo
If more than one capsule of Lungamo is used in a single day, contact your doctor immediately. The risk of adverse effects may increase, such as dry mouth, constipation, difficulty in urination, rapid heartbeat, or blurred vision.

Missed dose of Lungamo
If you miss a dose, take it as soon as possible. However, never take two doses at the same time or on the same day. Take the next dose at the usual time. Do not take a double dose to make up for a missed dose.

Stopping Lungamo
Before stopping Lungamo, consult your doctor or pharmacist.
After discontinuing this medicine, 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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The adverse reactions listed below have been reported by patients during the use of this medicine.
Serious 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 individually or as part of a severe allergic
reaction (anaphylactic reaction) after administration of Lungamo. Additionally, in some patients,
the following may occur: unexpected chest tightness, cough, wheezing or shortness of breath
immediately after inhalation of the medicine (bronchospasm).
If any of these symptoms occur, contact your doctor immediately.
Other adverse reactions
Common (may occur in up to 1 in 10 people)

• dry mouth

Uncommon (may occur in 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 passing urine (urinary retention)
• painful urination (dysuria)

Rare (may occur in up to 1 in 1,000 people)

• difficulty sleeping (insomnia)
• seeing rainbow-colored halos around light sources or altered color vision, along with redness of the eyes (glaucoma)
• increased intraocular pressure
• irregular heartbeat (supraventricular tachycardia)
• increased heart rate (tachycardia)
• sensation of rapid heartbeat (palpitations)
• chest tightness associated with cough, wheezing or shortness of breath occurring immediately after inhaling the medicine (bronchospasm)
• nosebleeds
• laryngitis
• sinusitis
• intestinal obstruction 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 (rash)
• itching (pruritus)
• urinary tract infections

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

• loss of body fluids (dehydration)
• dental caries
• severe allergic reactions (anaphylactic reactions)
• skin infections or skin ulceration
• dry skin
• joint swelling Reporting of adverse reactions If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions 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, fax: 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 Lungamo medicine

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the cardboard packaging
and the blister. The expiry date refers to the last day of the specified month.
Do not store above 30°C.
Dispose of the inhaler after 90 days from first use.
Use the capsule immediately after opening the blister.
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 Lungamo contains
The active substance is tiotropium.
Each capsule contains 22.5 micrograms of tiotropium bromide monohydrate, equivalent to 18
micrograms of tiotropium. The delivered dose (released from the mouthpiece of the Vertical-Haler inhaler) is 10
micrograms of tiotropium.
The product also contains monohydrate lactose (which may contain small amounts of milk proteins).
The capsule shell contains gelatin, purified water, macrogol 4000, titanium dioxide (E171), yellow iron oxide (E172), and brilliant blue (E133).

What Lungamo looks like and contents of the pack
Lungamo is an opaque green capsule measuring 16 mm x 5.8 mm, containing powder for inhalation.
The blisters are made of PA/Aluminium/PVC/Aluminium foil and contain 5 or 10 capsules.
Lungamo is available in the following pack sizes:

• Carton box containing the Vertical-Haler inhaler and 10 capsules
• Carton box containing the Vertical-Haler inhaler and 15 capsules
• Carton box containing the Vertical-Haler inhaler and 30 capsules
• Carton box containing the Vertical-Haler inhaler and 60 capsules
• Carton box containing the Vertical-Haler inhaler and 90 capsules
• Hospital pack: Carton box containing the Vertical-Haler inhaler and 5x30 capsules (multi-pack)
• Carton box containing the Vertical-Haler inhaler and 60 capsules
• Carton box containing three Vertical-Haler inhalers and 90 capsules
• Hospital pack: Carton box containing 5x60 capsules (multi-pack)
• Carton box containing 30 capsules
• Carton box containing 60 capsules
• Carton box containing 90 capsules

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
STADA Arzneimittel AG,
Stadastrasse 2-18,
61118 Bad Vilbel,
Germany

Manufacturer/Importer
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park,
Paola, PLA 3000
Malta
Stada Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

For further information, please contact the Marketing Authorisation Holder.
STADA Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Tel. +48 22 737 79 20

This medicinal product is authorised in the European Economic Area under the following names:
Germany: Tiotropium STADA AG 18 Microgram Hard Capsules for Inhalation Powder

Instructions for use and handling
You must strictly follow your doctor's instructions regarding the use of Lungamo. The Vertical-Haler inhaler has been specifically designed for use with Lungamo. It must not be used for any other medication. The Vertical-Haler inhaler may be used for administering the medicine for up to 90 days.

	Vertical-Haler Inhaler – Explanation of Individual Parts 1 Cap 2 Mouthpiece 3 Housing 4 Button 5 Capsule Chamber
	1. Removing the Cap Hold the Vertical-Haler inhaler and remove the cap from the housing to expose the mouthpiece, as shown in the illustration (Fig. 1).
	2. Opening the Inhaler To open the Vertical-Haler inhaler, hold it by the sides of the housing. Press the area marked "˄" with your fingertip (as shown in the enlarged illustration). Open the inhaler by lifting the mouthpiece upward away from the housing, as shown in the figure (Fig. 2).
	3. Inserting the Capsule Hold the Vertical-Haler inhaler with the opening facing upward. Place the capsule into the capsule chamber (Fig. 3). Note: Remove the capsule from the blister pack only immediately before using the inhaler!
	Ensure that the capsule is correctly inserted (Fig. 4).
	4. Closing the Chamber Firmly press the mouthpiece down onto the housing until a click is heard (Fig. 5).
	5. Piercing the Capsule Hold the Vertical-Haler with the mouthpiece facing upward. Firmly press the button fully down until it is completely recessed (Fig. 6). Release the button again. This will pierce the capsule, allowing the medication to be inhaled during inspiration. Note: If step 5 needs to be repeated, open the capsule chamber (Fig. 2) to ensure that the capsule is correctly positioned (Fig. 4).
	6. Preparation for Use Hold the Vertical-Haler inhaler away from the mouth and exhale fully, emptying the lungs of air (Fig. 7). Do not blow into the Vertical-Haler inhaler.
	7. Inhalation Hold your next breath with your head in an upright position, close your lips tightly around the mouthpiece. Breathe in slowly and as deeply as possible (Fig. 8). The patient will hear a vibrating sound from the capsule rotating inside the capsule chamber, dispersing the medication. Inhale until the lungs are full, then hold your breath for as long as possible, while removing the Vertical-Haler inhaler from the mouth. Then resume normal breathing. Repeat steps 6 and 7 once more. Two inhalations should be taken from the same capsule.
	Caution: When holding the inhaler during inhalation, take care not to block the air vents located on the sides of the mouthpiece. This could restrict airflow within the inhaler, reducing capsule movement and medication dispersion. Do not press tightly on the mouthpiece during inhalation, as this may block capsule movement.
	Cleaning the Vertical-Haler Inhaler After use, open the mouthpiece. Hold the inhaler downward to remove the capsule from the capsule chamber. Wipe the mouthpiece and capsule chamber with a clean, dry cloth. If necessary, use a soft, clean brush to remove any powder residue inside the chamber. Close the mouthpiece and replace the cap. This helps keep the dry powder inhaler clean. If needed, clean the outer part of the mouthpiece with a damp cloth.

Note:
The Lungamo capsule contains only a small amount of inhalation powder; therefore, it is only
partially filled.