Ontipria

Patient Information Leaflet

Ontipria, 18 micrograms, inhalation powder in hard capsule
Tiotropium
Please read all of this leaflet carefully before taking 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 tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Ontipria is and what it is used for

Ontipria, 18 micrograms, inhalation powder in hard capsule 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 refers to chronic bronchitis and emphysema. COPD is a chronic condition, therefore Ontipria, 18 micrograms, inhalation powder in hard capsule must be taken every day, not only when breathing problems or other symptoms of COPD occur.
Ontipria, 18 micrograms, is a long-acting bronchodilator that helps to open the airways and allows air to move in and out of the lungs more freely. Regular use of Ontipria, 18 micrograms, may also help reduce persistent breathlessness associated with the disease and may improve the impact of the disease on daily life.
The medicine also helps maintain physical activity for longer. Daily use of Ontipria 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 taken only once daily.
For correct dosing of Ontipria, 18 micrograms, see section 3.
Instructions on how to use Ontipria, 18 micrograms, are provided on another page of this leaflet.

2. Important information before using Ontipria

When not to use Ontipria

• 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 oxytropium.

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

• The patient should consult a doctor if they have narrow-angle glaucoma, problems with the prostate gland, or difficulty urinating.
• The patient should consult a doctor if they have kidney function disorders.
• This medicine 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.
• Immediate allergic reactions such as rash, swelling, itching, wheezing, or shortness of breath may occur after administration. In such cases, contact a doctor immediately.
• As with other inhaled medicines, after inhaling Ontipria 18 micrograms, symptoms such as chest tightness, cough, wheezing, or shortness of breath may occur. In such cases, contact a doctor immediately.
• Care must be taken to avoid getting the powder into the 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 altered color vision, together with red 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 bromide and contact a doctor immediately, preferably an ophthalmologist.
• Dryness of the oral mucosa, which may occur during treatment due to the anticholinergic effect of the medicine, 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 arrhythmias or severe heart failure within the last year, this should be reported to the doctor. It is important to make an appropriate decision on whether Ontipria can be used in the patient.
• Ontipria 18 micrograms should not be used more than once daily.

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

Ontipria with other medicines
Tell your doctor or pharmacist about all medicines (including those available without a prescription) that 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 oxytropium.
No adverse effects have been reported when Ontipria 18 micrograms is used together with other medicines commonly used in the treatment of COPD, such as: inhaled rescue medicines (e.g. salbutamol), methylxanthines (e.g. theophylline), and/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 recommended by a doctor.

Driving and operating machinery
If dizziness, blurred vision, or headache occur, the patient should not drive or operate machinery. The patient should not drive if any of these symptoms occur.

Ontipria 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 that may cause allergic symptoms.

3. How to use Ontipria

This medicine should always be used as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
It is recommended to inhale the contents of one capsule (18 micrograms of tiotropium) once daily.
Do not use a higher dose than recommended.
Take the capsule at the same time each day. This is important because Ontipria 18 micrograms
works for 24 hours.
Capsules are for inhalation use only and must not be taken orally.
Do not swallow the capsules.
The dry powder inhaler MRX003-T10 DPI (Dry Powder Inhaler, DPI), referred to as the “inhaler”
in this leaflet, is used to hold the Ontipria capsule. The inhaler pierces the capsule, allowing the
powder inside to be inhaled.
Patients should ensure they have the inhaler and know how to use it correctly. Instructions for
using the inhaler are provided on another page of this leaflet.
Make sure not to exhale into the inhaler.
If you experience any difficulties using the inhaler, contact your doctor, nurse, or pharmacist
for guidance on the correct method of use.
The inhaler should be cleaned once a month. Instructions for cleaning the inhaler are provided
later in this leaflet.
Avoid getting Ontipria 18 micrograms into the eyes. This may cause blurred vision, eye pain,
and/or eye redness. Immediately rinse the eyes with warm water and consult a doctor without delay.
If you feel that breathing difficulties are worsening, contact your doctor immediately.

Taking more Ontipria than recommended
If more than one capsule of the medicine is taken per day, contact your doctor immediately.
The risk of side effects may increase, such as dry mouth, constipation, difficulty passing urine,
rapid heartbeat, or blurred vision.

Missing a dose of Ontipria
If a patient forgets to take a dose, they should take it as soon as they remember.
Never take two doses at the same time or on the same day. Take the next dose at the usual time.

Stopping treatment with Ontipria
Before stopping treatment with Ontipria 18 micrograms, consult your doctor or pharmacist.
After stopping Ontipria, 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 will experience them.
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 occur in up to 1 in 10 people):

• dryness of the oral mucosa (usually mild in severity)

Uncommon (may occur in up to 1 in 100 people):

• dizziness
• headache
• taste disturbances
• blurred vision
• irregular heartbeat (atrial fibrillation)
• sore throat (pharyngitis)
• 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 up to 1 in 1,000 people):

• difficulty falling asleep (insomnia)
• seeing rainbow-colored halos around light sources or altered color vision, together 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 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, 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):

• loss of body fluids (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) following administration of Ontipria, 18 micrograms. Additionally, 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 symptoms occur, contact your doctor immediately.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Ontipria

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after:
"EXP". The expiry date refers to the last day of the stated month.
The inhaler should be discarded no later than 6 months after first use.
The capsule should be used immediately after opening the blister.
After removing the first capsule from the blister, the capsules from the same blister should be used consecutively over the next 9 days, one capsule per day.
Do not store above 30°C.
Medicines should 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 packaging and other information

What the medicine Ontipria contains
The active substance is tiotropium.
Each capsule contains 18 micrograms of tiotropium (as tiotropium bromide). During inhalation via the inhaler mouthpiece, 10 micrograms of tiotropium is delivered.
The other ingredients are monohydrate lactose (capsule content), hypromellose (type 2906, 4.5 mPa), (capsule shell), concentrated ammonium hydroxide, butyl alcohol, anhydrous ethanol, iron oxide, black (E 172), isopropyl alcohol, potassium hydroxide, propylene glycol, shellac, purified water (ink).

What Ontipria looks like and contents of the packaging
Ontipria is a powder for inhalation: colourless, transparent hard capsules, size 3, with the printed mark “T10” on the capsule, containing a white powder.
The medicine is packed in perforated peelable blisters containing 10 capsules each. The cardboard box contains blisters and an inhaler. The inhaler is white with a red button.

Pack sizes:
Cardboard box containing 30 capsules (3 blisters) and one dry powder inhaler MRX003-T10.
Cardboard box containing 60 capsules (6 blisters) and one dry powder inhaler MRX003-T10.
Cardboard box containing 90 capsules (9 blisters) and one dry powder inhaler MRX003-T10.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zentiva, k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic

Manufacturer
Helm Pharmaceuticals GmbH
Nordkanalstrasse 28
20097, Hamburg
Germany

This medicinal product is authorised for sale in the European Economic Area under the following names:
Bulgaria, Portugal, Slovakia: Plubrom
Czech Republic, Romania, Slovenia: Dilochob
Estonia, Latvia, Lithuania, Hungary, Poland: Ontipria
Croatia: Plubir

For further information about this medicine, please contact the representative of the Marketing Authorisation Holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00

Instructions for use and operation of the MRX003-T10 inhalation device
The dry powder inhaler MRX003-T10 allows inhalation of the medicine contained in Ontipria capsules, which your doctor has prescribed for respiratory disorders.
Always follow your doctor’s instructions carefully when using Ontipria. The MRX003-T10 DPI inhaler is designed specifically for Ontipria capsules; patients must not use it to administer other medicines.
Inhalation with capsules must be performed exclusively using the MRX003-T10 DPI inhaler.
Do not use other inhalers to administer Ontipria capsules. Each capsule contains a small amount of powder. Do not open the capsule, as it may no longer be suitable for use.
The MRX003-T10 DPI inhaler must only be used with the accompanying capsules packed in blisters.

Do not swallow Ontipria capsules.
Read the patient information leaflet first, then the user instructions, before using the inhaler and each time you renew your prescription. New information may be available.

Familiarise yourself with the inhaler and Ontipria capsules:
If you are using any inhaler for the first time, you should be properly trained by your doctor before using the inhaler.
Ontipria is supplied in a pack containing blistered capsules and an inhaler.
Always use a new inhaler supplied with the medicine.

The inhaler contains:

1. Top cover
2. Mouthpiece
3. Mouthpiece ridge
4. Housing
5. Central chamber
6. Piercing button
7. Air inlet slits

To deliver the full dose of the medicinal product, perform 4 main steps:

Step 1. Opening the inhaler:

After removing the inhaler from its pouch:
Open the top cover by lifting the front ridge.

Pull the top cover upwards to expose the mouthpiece.
Open the mouthpiece by pulling the ridge upwards so that the capsule chamber becomes visible.

Step 2. Placing the capsule in the inhaler:

Each day, separate only 1 strip from the blister by tearing along the perforation.
Remove the Ontipria capsule from the blister:
Do not cut the blister or use sharp instruments to remove the capsule.
Lift one corner of the blister as indicated by the arrow in the illustration and peel off the aluminium foil layer. Peel off the entire printed foil until the capsule is fully exposed.
If more than one blister has been opened, do not use the additional capsule and discard it.

Place the capsule into the capsule chamber of the inhaler.
Close the mouthpiece firmly until you hear a click. Leave the top cover open.

Step 3. Piercing the capsule
Hold the inhaler with the mouthpiece facing upwards.
Press the piercing button until it stops, then release it.

This pierces the capsule so that the medicine can be inhaled during breathing.
Do not press the piercing button more than once.
Do not shake the inhaler.
Piercing the capsule may break the capsule cap and body into small particles. Some of these particles may pass through the inhaler outlet into the mouth or throat during inhalation. This is a normal occurrence. The small capsule particles are not harmful to the patient.

Step 4. Delivering the full daily dose (2 inhalations from the same capsule):

Exhale fully in one breath, emptying the lungs of air.
Important: Do not exhale through the inhaler.
With the next breath, inhale the medicine:
Hold your head in an upright position

looking straight ahead.
Place the inhaler in your mouth in a horizontal position.
Do not block the air inlet slits.
Seal your lips tightly around the mouthpiece.
Breathe in slowly and deeply until you feel your lungs are full. You will hear and/or feel the capsule vibrating.
Hold your breath for a few seconds, then remove the inhaler from your mouth.
Breathe normally.
To receive the full daily dose, completely empty the air from your lungs

and repeat the above steps once more. Place the inhaler in your mouth before inhaling the powder from the same capsule again.
Important: Do not press the piercing button a second time.
Remember: To receive the full daily dose each day, inhale the powder from one capsule twice. Ensure that you perform a complete exhalation before inhaling from the inhaler.

Cleaning and storage of the inhaler:
After taking the full daily dose, open the mouthpiece and discard the used capsule into a waste bin without touching it.
Remove any capsule fragments or accumulated powder without touching them by turning the inhaler upside down and gently but firmly tapping the housing. Then close the mouthpiece and the top cover.
Do not store the inhaler and Ontipria capsules (blister packs) in a humid place.
Ontipria capsules must always be stored in tightly sealed blisters.

The inhaler should be cleaned once a month.
Open the cap and the mouthpiece.
Open the base by pressing the piercing button upwards.
Check whether the capsule chamber is contaminated with capsule particles or powder. If so, shake them out.
Rinse the inhaler with warm water, pressing the piercing button several times so that the capsule chamber and piercing needle are exposed to running water. Check that all accumulated powder and capsule fragments have been removed.
Dry the inhaler thoroughly by shaking off excess water onto a paper towel. Then air-dry the inhaler, leaving the top cover, mouthpiece, and housing open until completely dry.
Do not use a hairdryer to dry the inhaler.
Do not use the inhaler if it is wet. If necessary, the mouthpiece may be cleaned externally with a clean damp cloth.

Each Ontipria capsule contains only a small amount of powder. This constitutes one full dose, taken in two inhalations.
Do not open the Ontipria capsule, as it may no longer be suitable for use.