Tiotropium Glenmark

Patient Information Leaflet: Information for the user

Tiotropio Glenmark 18 micrograms inhalation powder, hard capsule

tiotropio
equivalent medicine
Please read all of this leaflet carefully before you start using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If any adverse effects occur, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Tiotropio Glenmark is and what it is used for

Tiotropio Glenmark 18 micrograms inhalation powder, hard capsule contains the active substance tiotropium and belongs to a group of medicines for obstructive airway diseases, the inhaled anticholinergic drugs.
Tiotropio Glenmark 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 conditions such as chronic bronchitis and emphysema. Since COPD is a chronic disease, Tiotropio Glenmark must be used every day, not only when breathing difficulties or other COPD symptoms occur.
Tiotropio Glenmark is a long-acting bronchodilator that helps to widen the airways and makes it easier for air to move in and out of the lungs. Regular use of Tiotropio Glenmark may also help when breathlessness related to the disease develops, and will help minimize the impact of the disease on your daily life. It also helps you stay active for longer. Daily use of Tiotropio Glenmark helps prevent sudden short-term worsening of COPD symptoms, which may last for several days. The effect of this medicine lasts for 24 hours, therefore you need to take it only once a day. For the correct dosage of Tiotropio Glenmark, please refer to section 3, “How to use Tiotropio Glenmark” and the instructions for use provided on the back of the leaflet.

2. What you need to know before using Tiotropio Glenmark

Do not use Tiotropio Glenmark:

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

Warnings and precautions
Talk to your doctor or pharmacist before using Tiotropio Glenmark

• Talk to your doctor if you have narrow-angle glaucoma, prostate problems, or difficulty urinating.
• If you have kidney problems, consult your doctor.
• Tiotropio Glenmark is indicated for maintenance treatment of chronic obstructive pulmonary disease (COPD); it must not be used to treat sudden attacks of shortness of breath or wheezing.
• Immediate allergic reactions such as rash, swelling, itching, wheezing or shortness of breath may occur after administration of Tiotropio Glenmark. If this happens, contact your doctor immediately.
• Medicines taken by inhalation, such as Tiotropio Glenmark, may cause chest tightness, cough, wheezing or shortness of breath immediately after inhalation. If this occurs, contact your doctor immediately.
• Avoid carefully that the inhaled powder comes into contact with the eyes, as this may cause the onset or worsening of narrow-angle glaucoma, an eye disease. Pain or discomfort in the eyes, blurred vision, seeing halos around lights or colored images associated with red eyes may be signs of an acute attack of narrow-angle glaucoma. Ocular symptoms may be accompanied by headache, nausea or vomiting. You must stop taking tiotropium bromide and must contact your doctor immediately, preferably an ophthalmologist, if signs or symptoms of narrow-angle glaucoma occur.
• Dry mouth, which has been observed during treatment with anticholinergics, may over time be associated with dental caries. Therefore, good dental hygiene is recommended.
• If you have had a myocardial infarction within the last 6 months, or any form of unstable or life-threatening irregular heartbeat, or severe heart failure in the past year, inform your doctor. This information is important to determine whether Tiotropio Glenmark is the appropriate medicine for you.
• Do not use Tiotropio Glenmark more frequently than once daily.

Children and adolescents
Tiotropio Glenmark is not recommended for children and adolescents under 18 years of age.
Other medicines and Tiotropio Glenmark
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor or pharmacist if you are using or have recently used similar medicines for your lung condition, such as ipratropium or oxitropium.
No specific adverse effects have been reported when Tiotropio Glenmark has been used in combination with other medicines used to treat COPD, such as inhaled symptom-relieving medicines like salbutamol, methylxanthines such as theophylline and/or steroids administered orally or by inhalation such as prednisolone.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not use this medicine unless specifically recommended by your doctor.
Driving and using machines
Dizziness, blurred vision or headache may affect your ability to drive vehicles or operate machinery.
Tiotropio Glenmark contains lactose
Each capsule provides up to 5.2 mg of lactose when taken according to the recommended dosage of one capsule once daily. If your doctor has diagnosed you with an intolerance to certain sugars or an allergy to milk proteins (which may be present in small amounts in the lactose monohydrate component), contact your doctor before taking this medicine.

3. How to use Tiotropium Glenmark

Use this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose is inhaling the contents of one capsule (18 micrograms of tiotropium) once daily. You must inhale twice from the same capsule (see section "Instructions for handling and use" at the end of this leaflet). Do not use a higher dose than recommended.
Tiotropium Glenmark is not recommended for children and adolescents under 18 years of age.
Try to use the capsule at the same time every day. This is important because Tiotropium Glenmark is effective for 24 hours.
The capsules are for inhalation only and must not be taken orally. Do not swallow the capsules.
The Vertical-Haler device, into which the Tiotropium Glenmark capsule must be placed, pierces the capsule and allows the powder to be inhaled.
Make sure you have a Vertical-Haler and know how to use it correctly. Instructions for using the Vertical-Haler are provided on the reverse of this leaflet.
Ensure that you do not blow into the Vertical-Haler.
If you have difficulty using the Vertical-Haler, ask your doctor, nurse, or pharmacist to demonstrate its use.
You must clean your Vertical-Haler once a month. Cleaning instructions for the Vertical-Haler are provided on the reverse of this leaflet.
When using Tiotropium Glenmark, take care to avoid the powder entering your eyes. If the powder does get into your eyes, blurred vision, eye pain and/or redness may occur. In this case, immediately rinse your eyes with lukewarm water and then contact your doctor immediately for further advice.
If you notice that your breathing worsens, inform your doctor as soon as possible.

If you use more Tiotropium Glenmark than you should
If you inhale the contents of more than one Tiotropium Glenmark capsule in one day, contact your doctor immediately. You may be at increased risk of experiencing side effects such as dry mouth, constipation, difficulty urinating, increased heart rate, or blurred vision.

If you forget to use Tiotropium Glenmark
If you forget to take a dose, take it as soon as you remember, but do not take a double dose at the same time or on the same day. Then take your next dose as usual.

If you stop using Tiotropium Glenmark
Before stopping treatment with Tiotropium Glenmark, you must speak to your doctor or pharmacist. If you stop treatment with Tiotropium Glenmark, your COPD symptoms may worsen.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The side effects described below have been reported by people who have used this medicine and are listed by frequency, categorised as common, uncommon, rare, or 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
• altered taste
• blurred vision
• irregular heartbeat (atrial fibrillation)
• sore throat (pharyngitis)
• hoarseness (dysphonia)
• cough
• heartburn (gastroesophageal reflux disease)
• constipation
• fungal infections of the mouth and throat (oropharyngeal candidiasis)
• skin rash
• difficulty urinating (urinary retention)
• pain when urinating (dysuria)

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

• difficulty sleeping (insomnia)
• visual halos around lights or coloured images associated with red eyes (glaucoma)
• increased pressure in the eye (intraocular pressure)
• irregular heartbeat (supraventricular tachycardia)
• fast heartbeat (tachycardia)
• awareness of heartbeat (palpitations)
• chest tightness, associated with cough, wheezing or shortness of breath immediately after inhalation (bronchospasm)
• nosebleeds (epistaxis)
• inflammation of the larynx (laryngitis)
• inflammation of the paranasal sinuses (sinusitis)
• intestinal blockage or absence of bowel movements (intestinal obstruction including paralytic ileus)
• inflammation of the gums (gingivitis)
• inflammation of the tongue (glossitis)
• difficulty swallowing (dysphagia)
• inflammation of the mouth (stomatitis)
• feeling unwell (nausea)
• allergic reactions (hypersensitivity), including immediate reactions
• severe allergic reaction causing swelling of the face or throat (angioedema)
• hives (urticaria)
• itching (pruritus)
• urinary tract infections

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

• loss of body fluids (dehydration)
• dental caries
• severe allergic reaction (anaphylactic reaction)
• skin infections or ulcerations
• dry skin
• joint swelling

Serious side effects may occur after administration of Tiotropio Glenmark, including allergic reactions causing swelling of the face or throat (angioedema) or other hypersensitivity reactions (such as sudden drop in blood pressure or dizziness), occurring either individually or as part of a severe allergic reaction (anaphylactic reaction). In addition, as with other inhaled medicines, some patients may experience unexpected chest tightness, cough, wheezing, or shortness of breath immediately after inhalation (bronchospasm). If any of these effects occur, consult your doctor immediately.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tiotropio Glenmark

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and the blister pack.
The expiry date refers to the last day of that month.
Dispose of the Vertical-Haler device 90 days after first use.
The capsule must be used immediately after opening the blister.
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tiotropio Glenmark contains
The active substance is tiotropium. Each capsule contains 22.5 micrograms of tiotropium bromide
monohydrate, equivalent to 18 micrograms of tiotropium.
During inhalation, 10 micrograms of tiotropium are released from the mouthpiece of the Vertical-Haler.
The other component is lactose monohydrate (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 FD&C Blue No. 1 / Brilliant Blue FCF (E133).

Description of the appearance of Tiotropio Glenmark and contents of the pack
Tiotropio Glenmark 18 microgram powder for inhalation, hard capsule, is an opaque green hard gelatin capsule containing white powder.
Blister packs made of PA/Aluminum/PVC/Aluminum containing 10 capsules.
The Vertical-Haler is a single-dose inhalation device with an orange cap and white body. It is made of acrylonitrile-butadiene-styrene (ABS) plastic and stainless steel. The materials coming into direct contact with the product during inhalation are: stainless steel 304 (capsule-piercing needles), acrylonitrile-butadiene-styrene (ABS) (forming the mouthpiece through which the medicine flows and the capsule chamber).

The product is available in the following pack sizes:

• Cardboard box containing 30 capsules (3 blisters) with one dry powder inhaler
• Cardboard box containing 60 capsules (6 blisters) with one dry powder inhaler
• Cardboard box containing 90 capsules (9 blisters) with one dry powder inhaler
• Cardboard box containing 30 capsules (3 blisters)
• Cardboard box containing 60 capsules (6 blisters)

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Glenmark Arzneimittel GmbH
Industriestr. 31
82194 Gröbenzell
Germany

Manufacturer
Pharmadox Healthcare Limited
KW20 Kordin Industrial Park Paola,
PLA 3000, Malta
Glenmark Pharmaceuticals s.r.o,
Fibichova 143, 566 17 Vysoké Mýto
Czech Republic

This medicinal product is authorized in the European Economic Area Member States under the following names:
Czech Republic: Gartior
Poland: Gartior
Austria: Tiotropium Glenmark 18 Mikrogramm Hartkapseln mit Pulver zur Inhalation
Italy: Tiotropio Glenmark
Slovak Republic: Tiotropium Glenmark

Medical Device: Dry powder inhaler – DPI
Hands must be clean and dry when using the inhaler.
Firmly hold the base of the inhaler and
remove the cap by pulling from the side upwards as shown below (Fig.1).

To open the inhaler, firmly hold it by the base. Press the area marked with “ ” upwards with the fingertip (Fig.2).
Parts of the device:
Commercial name: Vertical-Haler ®
Indication for use:
The inhaler has been designed to assist in the inhalation of inhalable medicines in the form of dry powder contained in capsules; this device is activated by oral inhalation (breath-actuated dry powder inhaler - DPI). The capsules containing the medicine are stored separately from the inhaler. Remove the protective film to extract the capsule from the blister pack (Fig.3).
Each capsule, containing a single dose, must be inserted into the inhaler chamber only at the time of use.
Once placed in the inhaler chamber and pierced by the press button just before inhalation, the medicine can be inhaled by the patient.

The inhaler must be marketed only together with the medicine.
Keep the inhaler open in an upright position. Insert the capsule into the chamber (Fig.4).
Fig. 4

Contraindications:
Patients who are unable to independently control their breathing.
The capsule must be inside the compartment (Fig.5)

Hold the inhaler away from the mouth and exhale slowly and deeply (Fig.9). Hold your breath.
DO NOT blow into the inhaler. Moisture inside the inhaler may reduce the inhaled dose.
6) Close the Vertical-Haler device
Hold the Vertical-Haler device upright and flip the mouthpiece backwards. A "click" confirms that the Vertical-Haler is properly closed (Fig.6)

9) Inhalation
Place the mouthpiece between your teeth and seal your lips firmly around it. Inhale as slowly and deeply as possible (Fig.11).
7) Pierce the capsule
The sound of vibration confirms correct treatment.
Hold the inhaler upright (Fig.7) and press the side button firmly all the way down. Slight resistance confirms that the capsule has been successfully pierced (Fig.8).
DO NOT block the air intake valve located directly below the mouthpiece. Otherwise, optimal release of the medicine is not ensured.
If step 5 needs to be repeated, open the capsule compartment (Fig. 2) to ensure the capsule is correctly positioned in the chamber (Fig. 5).
The sound of rotation ensures correct inhalation.
DO NOT press the side button during inhalation, as it blocks the release of the medicine. The sound of rotation ensures correct inhalation.
Fig. 11 Fig. 12

10) Hold your breath
Hold your breath for at least 10 seconds. Remove the inhaler from your mouth, then breathe normally (Fig.9). This ensures proper deposition of the medicine in the lungs.

Repeat steps 8 to 10 once again to ensure complete inhalation of the medicine.
11) Check that the capsule is empty
Open the Vertical-Haler device and check the capsule for any remaining medicinal powder. If powder remains in the capsule, repeat steps 8–11.
DO NOT open the capsule and avoid contact with the formulation.
DO NOT insert more than one capsule into the inhaler chamber or mix two different medicines.
A noisy environment may make it difficult to hear. It is recommended to use the device in a quiet room.
For further information on inhaler use, please consult your doctor or pharmacist.
DO NOT disassemble the inhaler.

In case of problems that may render the inhaler unsuitable for further use, the customer must return it to the Marketing Authorization Holder in packaging that ensures its physical integrity.

Any serious incident related to the device must be reported to the Marketing Authorization Holder and to the competent authority of the Member State where the user and/or patient is located.

13) Cleaning the Vertical-Haler device
The Vertical-Haler device should be cleaned once a week. Clean the inhaler nozzle and capsule chamber with a dry, clean cloth. Alternatively, a soft, clean brush may be used to remove any residue remaining inside the inhaler. Close the Vertical-Haler device.
Replace the cap on the mouthpiece; this will ensure the device remains clean and safe.
DO NOT use water or other aggressive cleaning agents to clean the device.

14) Rinse mouth
Rinse the mouth with water without swallowing.

15) Disposal
The Vertical-Haler device is designed to be used exclusively with the supplied medicine and no longer. If you receive a new pack with a new Vertical-Haler device, ensure proper disposal of the old inhaler.
Additional warnings:
DO NOT share the Vertical-Haler device with other people. There is a serious risk of cross-infection.
Dispose of in household waste.
Use the inhaler only with the specific medicine as indicated.