Gartior

Package leaflet: Information for the patient

Gartior, 18 micrograms/dose delivered, inhalation powder in hard capsule
Tiotropium
Please read carefully the entire leaflet before using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist immediately. See section 4.

Table of contents

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

1. What Gartior is and what it is used for

Gartior, 18 micrograms/dose delivered, inhalation powder in hard capsule contains the active substance tiotropium and belongs to a group of medicines used in the treatment of obstructive respiratory diseases, inhaled medications, anticholinergic drugs.
Gartior 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 Gartior should be taken every day, not only when breathing problems or other COPD symptoms occur.
Gartior is a long-acting bronchodilator that helps widen the airways and allows air to flow more easily into and out of the lungs. Regular use of Gartior may also help reduce persistent breathlessness associated with the disease and may improve the impact of the disease on daily life. Daily use of Gartior 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, Gartior should be taken only once daily.
Information on the correct dosage of Gartior is provided later in this leaflet under section 3. How to use Gartior and Instructions for use.

2. Important information before using Gartior
When not to use Gartior

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

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

• Consult your doctor if you have narrow-angle glaucoma, prostate gland (prostate) problems, or difficulty passing urine.
• If you have kidney function disorders, consult your doctor.
• Gartior is indicated for maintenance therapy in patients with chronic obstructive pulmonary disease. It should not be used to treat sudden attacks of breathlessness or wheezing.
• Immediately after using Gartior, immediate allergic reactions such as rash, swelling, itching, wheezing, or difficulty breathing may occur. In such a case, contact your doctor immediately.
• Shortly after inhaling medicines such as Gartior, you may experience chest tightness, cough, wheezing, or breathlessness. In such a case, contact your doctor immediately.
• Be careful not to get the powder into your 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 and contact your doctor immediately, preferably an ophthalmologist.
• Dryness of the oral mucosa, which may occur during treatment with Gartior due to its anticholinergic effect, may lead to dental caries over time; therefore, maintaining good oral hygiene is important.
• If you have had a myocardial infarction in the last 6 months, or if you have had unstable or life-threatening cardiac arrhythmia or severe heart failure in the last year, inform your doctor. It is important to make the appropriate decision on whether Gartior can be used in your case.
• Gartior should not be used more than once daily.

Children and adolescents
Gartior is not recommended for children and adolescents under 18 years of age.
Gartior with other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Inform your doctor or pharmacist about other medicines used for lung disease, such as ipratropium or oxitropium.
No adverse effects have been reported when Gartior 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 and inhaled steroids, e.g. prednisolone.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine. Do not use this medicine unless advised by your doctor.
Driving and operating machinery
Dizziness, blurred vision, or headache may occur, which could affect your ability to drive or operate machinery.
Gartior contains lactose
If you have previously been diagnosed with intolerance to certain sugars or allergy to milk proteins (which may be present in small amounts in the ingredient monohydrate lactose), you should consult your doctor before taking this medicine.

3. How to use Gartior

This medicine should always be used as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
The recommended dose is inhalation of the contents of one capsule (18 micrograms of tiotropium) once daily.
Two inhalations should be taken from the same capsule (see section "Instructions for use" at the end of this leaflet).
Do not use a higher dose than recommended.
Gartior 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 Gartior works for 24 hours.
The capsules are for inhalation use only and must not be taken orally. Do not swallow the capsules.
The Vertical-Haler inhaler, into which the Gartior capsule is inserted, pierces the capsule, allowing the powder inside to be inhaled.
The patient should ensure they have the inhaler and are using it correctly. Instructions for using the inhaler are provided later in this leaflet.
Make sure not to exhale into the Vertical-Haler inhaler.
If you experience any difficulties using the Vertical-Haler inhaler, contact your doctor, nurse, or pharmacist for guidance on proper use.
The Vertical-Haler inhaler should be cleaned once a week. Cleaning instructions are provided later in this leaflet.
When using Gartior, care should be taken to avoid getting the powder into the eyes. This may cause blurred vision, eye pain, and/or eye redness. Immediately rinse the eyes with warm water and contact your doctor without delay.
If you feel that breathing difficulties worsen, contact your doctor immediately.
Overdose of Gartior
If more than one Gartior capsule is used per 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 Gartior
If a dose of Gartior is missed, take it as soon as remembered.
Never take two doses at the same time or on the same day. Take the next dose at the usual time.
Stopping Gartior treatment
Before stopping treatment with Gartior, consult your doctor or pharmacist.
After stopping Gartior, 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 everybody will experience them.
The adverse reactions listed below have been reported by patients during the use of this
medicine. The adverse reactions are listed according to their frequency of occurrence: common, uncommon,
rare or frequency not known.

Common (may occur in not more than 1 in 10 people):

• dryness of the oral mucosa: usually mild in severity

Uncommon (may occur in not more than 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

Rare (may occur in not more than 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 breathlessness occurring immediately after inhalation of 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 reactions, including immediate reactions
• severe allergic reaction which may cause swelling of the face or throat (angioedema)
• urticaria
• itching
• urinary tract infection

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

• decreased body water (dehydration)
• dental caries
• severe allergic reactions (anaphylactic reactions)
• skin infections or skin ulceration
• dry skin
• joint swelling

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 alone or as part of a severe allergic reaction (anaphylactic reaction) after administration of Gartior. Additionally, as with other inhaled medicines, some patients may experience unexpected chest tightness, cough, wheezing or breathlessness immediately after inhalation (bronchospasm). If any of these symptoms occur, contact a doctor immediately.

Reporting of adverse reactions
If any adverse reactions occur, including any undesirable effects 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.: + 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 enables further information on the safety of the medicine to be collected.

5. How to store Gartior

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box or on the blister after: EXP. The expiry date refers to the last day of the stated month.
The Vertical-Haler inhaler must be discarded 90 days after first use.
The capsule should be used immediately after opening the blister.
Do not store above 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Gartior 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 during inhalation, from the mouthpiece of the Vertical-Haler inhaler, contains 10 micrograms of tiotropium.
The other ingredients are lactose monohydrate (which may contain small amounts of milk proteins).
The capsule shell contains gelatin, purified water, macrogol 4000, titanium dioxide (E 171), yellow iron oxide (E 172), and brilliant blue FCF (E 133).

What Gartior looks like and contents of the pack
Gartior 18 micrograms per measured dose, powder for inhalation in a hard capsule, is an opaque green hard gelatin capsule containing a white powder.
The pack consists of a PA/Aluminium/PVC/Aluminium foil blister containing 10 capsules.
The Vertical-Haler is a single-dose inhaler with an orange mouthpiece and a white body. It is made of acrylonitrile-butadiene-styrene (ABS) polymer plastic and stainless steel.
Materials that come into direct contact with the medicine during inhalation are: stainless steel 304 (piercing needles), and acrylonitrile-butadiene-styrene-ABS (components of the mouthpiece through which the medicine is released and the capsule chamber).

Pack sizes available:

• A cardboard box containing 30 capsules (3 blisters) and a dry powder inhaler
• A cardboard box containing 60 capsules (6 blisters) and a dry powder inhal combustor
• A cardboard box containing 90 capsules (9 blisters) and a dry powder inhaler
• A cardboard box containing 30 capsules (3 blisters)
• A cardboard box containing 60 capsules (6 blisters)

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b
140 78 Prague 4
Czech Republic

Manufacturer/Importer
Pharmadox Healthcare Limited
Kw20a Kordin Industrial Park
Paola, PLA 3000
Malta
Glenmark Pharmaceuticals s.r.o.
Fibichova 143
566 17 Vysoké Mýto
Czech Republic

This medicinal product is authorised in the countries of the European Economic Area under the following names:

For more detailed information about the medicine, please contact the
local representative of the marketing authorisation holder:
Glenmark Pharmaceuticals Sp. z o.o.
Dziekonskiego 3 Street
00-728 Warsaw
Tel: +48 22 35 12 500
Email: [email protected]
Medical device: Dry powder inhaler 1) Cap image

• (Eng. DPI - Dry Powder Inhaler) Hands must be clean and dry when using the inhaler. Hold the base of the inhaler firmly and remove the cap from the side as shown below (Fig. 1).
  Trade name: Vertical-Haler
  Parts of the inhaler:
  A) Cap
  D) Side button
  B) Mouthpiece
  E) Open space
  C) Chamber
  F) Capsule chamber

2) Opening the Vertical-Haler inhaler
To open the inhaler, hold it firmly by the base. Press upwards with the fingertip on the area marked “ ” (Fig. 2).
Before use:
The inhaler has been designed to assist in the inhalation of inhaled medicines in the form of dry powder contained in capsules; such a device is breath-actuated (breath-actuated dry powder inhaler - DPI). The drug-containing capsules are stored separately from the inhaler.
Each capsule containing a single dose should be placed in the inhaler chamber only at the time of use.
3) Removing the capsule
Remove the protective foil to take out the capsule from the blister (Fig. 3).
After placing it in the inhaler chamber and piercing it via the button, just before inhalation, the patient may begin inhalation of the medicine.
The inhaler should only be sold together with the medicine.

4) Placing the capsule
Contraindications:
Patients who are unable to control their breathing independently.
Hold the open inhaler vertically. Place the capsule into the chamber (Fig. 4).

5) Checking correct capsule placement
The capsule should be positioned in the recess of the chamber (Fig. 5).
8) Performing a deep exhalation
Keep the inhaler away from the mouth and perform a calm, deep exhalation (Fig. 9).
Hold your breath.

DO NOT blow air into the inhaler. Moist air blown into the inhaler may reduce the inhaled dose.

6) Closing the Vertical-Haler inhaler
Hold the Vertical-Haler inhaler vertically and close the mouthpiece. A "click" sound confirms that the Vertical-Haler inhaler has been properly closed (Fig. 6).

9) Performing inhalation
Place the mouthpiece between the teeth and seal the lips tightly around it.
Inhale slowly and as deeply as possible (Fig. 11).
A vibrating sound confirms correct performance.
7) Piercing the capsule
DO NOT cover the air inlets located directly beneath the mouthpiece. Otherwise, optimal release of the medicine will not be ensured.
Hold the inhaler vertically (Fig. 7) and press the side button firmly until resistance is felt. Slight resistance confirms correct piercing of the capsule (Fig. 8).
If necessary, repeat the procedure from point 5. Open the capsule chamber (Fig. 2) to ensure that the capsule is correctly positioned in the recess (Fig. 5).
DO NOT press the side button during inhalation, as this will block the release of the medicine. The vibrating sound confirms correct inhalation.

10) Holding breath
Hold your breath for at least 10 seconds. Remove the inhaler from the mouth and then breathe normally (Fig. 9).
This ensures deposition of the medicine in the lungs.
Repeat steps 8 to 10 to ensure that the entire dose of medicine has been delivered.

11) Checking the emptied capsule
Additional precautions:
Open the Vertical-Inhaler and check whether any medicinal powder remains in the capsule. If powder is still present, repeat steps 8–11.
DO NOT share the Vertical-Haler inhaler with other people. There is a serious risk of cross-infection.
The inhaler may be disposed of with household waste.

12) Emptying the Vertical-Haler inhaler
Remove the empty capsule (Fig. 13). The capsule may have cracked into small fragments that could have entered the oral cavity or throat. This is not a cause for concern, as the capsule component is edible and harmless.
DO NOT place more than one capsule in the inhaler chamber, nor place two different medicines.

Noise in the room may make it difficult to hear whether the device is operating properly. It is recommended to use the device in a quiet environment.
13) Cleaning the Vertical-Haler inhaler
The Vertical-Haler inhaler should be cleaned once a week. Wipe the inhaler mouthpiece and capsule chamber with a clean, dry cloth. Alternatively, use a soft, clean brush to remove any residue that may remain inside the inhaler. Close the Vertical-Haler inhaler.
Replace the cap onto the mouthpiece to protect the device from contamination.
DO NOT use water or other aggressive detergents to clean the device.
To obtain additional information regarding the use of the inhaler, please contact your doctor or pharmacist.
DO NOT disassemble the inhaler.
If any problems occur with the use of the medical device, the patient should return it to the marketing authorisation holder or its representative in packaging ensuring physical integrity.
All serious incidents occurring after use of the medical device should be reported to the marketing authorisation holder and the relevant national competent authority.

14) Rinsing the mouth
Rinse the mouth with water, but do not swallow the water.
15) Disposal of the device
The Vertical-Inhaler is intended for use only with the accompanying medicine and no other. If the patient receives a new pack with a new Vertical-Haler inhaler, remember to dispose of the old inhaler.