Spiriva

Package leaflet: Information for the patient

Spiriva
18 micrograms/inhalation dose, inhalation powder in hard capsules
tiotropium
Please read the entire leaflet carefully before using this medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• Consult your doctor or pharmacist if you have any questions.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What Spiriva is and what it is used for

Spiriva 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 is associated with chronic bronchitis and emphysema. COPD is a chronic condition, so Spiriva must be taken every day, not only when breathing problems or other symptoms of COPD occur.
Spiriva 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 Spiriva may also help reduce persistent breathlessness associated with the disease and lessen the impact of the disease on daily life. Daily use of Spiriva 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, Spiriva should be used once daily.
For information on correct dosage and how to use Spiriva, see section 3. How to use Spiriva and the Instructions for use and handling of the HandiHaler inhalation device, located at the end of this leaflet.

2. Important information before using Spiriva

When not to use Spiriva

• If the patient is allergic (hypersensitive) to tiotropium, the active substance of this medicine, or to any of the other ingredients of this medicine (listed in section 6), or to monohydrate lactose, which contains milk protein.
• If the patient is allergic (hypersensitive) to atropine or its derivatives, such as ipratropium or oxitropium.
• If the patient is under 18 years of age.

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

• The patient should contact the doctor if they have increased intraocular pressure (narrow-angle glaucoma), prostate problems, or difficulty urinating.
• The patient should contact the doctor if they have kidney function disorders.
• Spiriva 18 micrograms is indicated for the treatment of chronic obstructive pulmonary disease (COPD). It should not be used to treat sudden episodes of breathlessness or wheezing.
• Immediate hypersensitivity reactions such as rash, swelling, itching, wheezing, and shortness of breath may occur during treatment with Spiriva. In such cases, contact your doctor immediately.
• As with other inhaled medicines, some patients may experience chest tightness, cough, wheezing, or shortness of breath immediately after using Spiriva. In such cases, contact your doctor immediately.
• Do not allow tiotropium bromide to enter 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 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 bromide and contact your doctor immediately, preferably an ophthalmologist.
• Dryness of the oral mucosa occurring during treatment, related 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 cardiac arrhythmia or severe heart failure within the last year, this should be reported to the doctor. The doctor will decide whether Spiriva can be used.
• Spiriva should not be used more than once daily.

Children and adolescents
Spiriva is not recommended for children and adolescents under 18 years of age.
Spiriva and 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 Spiriva 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 and effect on fertility
Before taking any medicine, consult your doctor.
If the patient is pregnant or suspects she is pregnant, or if she is breastfeeding, she should not use this medicine unless specifically advised by a doctor.
Driving and operating machinery
If dizziness, blurred vision, or headache occur, do not drive or operate machinery.
Spiriva contains lactose monohydrate
When used as recommended, i.e., one capsule of the medicine per day, each dose delivers 5.5 mg 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 this ingredient: lactose monohydrate), the patient should contact their doctor before taking the medicine.

3. How to use Spiriva

Spiriva should always be used exactly as directed by your doctor. If you are unsure, contact your doctor or pharmacist.

One capsule (18 micrograms of tiotropium) should be inhaled once daily. Do not exceed the recommended dose.

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

Spiriva capsules are for inhalation only. Do not take orally.

Do not swallow the capsules.

After placing the Spiriva capsule into the HandiHaler inhalation device, the capsule must be punctured by pressing the piercing button, which allows the medication to be inhaled.

Patients should ensure they have the HandiHaler inhalation device and know how to use it correctly.

Please read the instructions for use and handling of the HandiHaler inhalation device, which are located at the end of this leaflet.

Ensure that you do not exhale into the HandiHaler inhalation device.

If you experience any difficulties using the HandiHaler inhalation device, contact your doctor, nurse, or pharmacist.

The inhalation device should be cleaned once a month. Cleaning instructions for the inhalation device are provided at the end of this leaflet—see: "Instructions for use and handling of the HandiHaler inhalation device".

Avoid getting Spiriva in the eyes, as this may cause blurred vision, eye pain, and/or eye redness. If the medication gets into the eye, immediately rinse with warm water and contact your doctor for further advice without delay.

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

Use in children and adolescents

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

Taking more Spiriva than recommended

If you take more Spiriva than recommended (more than one capsule per day), contact your doctor immediately.

The risk of adverse effects such as dry mouth, constipation, difficulty passing urine, rapid heartbeat, or blurred vision may increase.

If you miss a dose of Spiriva

If you miss a dose, take it as soon as possible.

Never take two doses at the same time or on the same day to make up for a missed dose.

In such cases, skip the missed dose and continue treatment as before.

Take the next dose at the usual time.

Stopping Spiriva

Before stopping Spiriva, consult your doctor or pharmacist.

Symptoms of COPD may worsen after stopping treatment with Spiriva.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
The frequency of occurrence has been defined according to the following convention:
Common: occurs in 1 to 10 people out of 100
Uncommon: occurs in 1 to 10 people out of 1,000
Rare: occurs in 1 to 10 people out of 10,000
Frequency not known: frequency cannot be estimated from the available data

The adverse reactions listed below have been reported by patients during treatment with the medicine
Spiriva. The adverse reactions are listed according to their frequency of occurrence: common, uncommon,
rare or frequency not known.

Common:

• Dryness of the oral mucosa (usually mild)

Uncommon:

• Dizziness
• Headache
• Taste disturbances
• Blurred vision
• Irregular heartbeat (atrial fibrillation)
• Sore throat
• Hoarseness (dysphonia)
• Cough
• Gastroesophageal reflux disease, which may include heartburn
• Constipation
• Fungal infections of the mouth and throat (oral and pharyngeal candidiasis)
• Rash
• Difficulty in passing urine (urinary retention)
• Painful or difficult urination

Rare:

• Difficulty falling asleep (insomnia)
• Seeing rainbow-colored halos around light sources or altered colour vision, together with redness of the eyes (glaucoma)
• Increased intraocular pressure
• Irregular heartbeat (supraventricular tachycardia)
• Increased heart rate (tachycardia)
• 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 in swallowing (dysphagia)
• Stomatitis
• Nausea
• Hypersensitivity, including immediate reactions
• Severe allergic reaction which may cause swelling of the face or throat (angioedema)
• Urticaria
• Itching (pruritus)
• Urinary tract infections

Frequency not known:

• 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 Spiriva. Additionally, as with other medicines administered by inhalation, some patients may experience unexpected chest tightness, cough, wheezing or shortness of breath immediately after inhaling the medicine (bronchospasm).
If any of these symptoms occur, contact your doctor immediately.

Reporting of adverse reactions
If you experience any adverse effects, including any possible adverse 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 at 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 authorisation holder or its representative. Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Spiriva

Keep this medicine out of the sight and reach of children.
Store below 25 °C.
Do not freeze.
The shelf life of the medicine after opening the blister: 9 days.
After removing the first capsule from the blister, use the capsules from the same blister within the next 9 days, one capsule per day.
The HandiHaler inhalation device should be discarded after 12 months from first use.
Do not use this medicine after the expiry date (EXP) stated on the cardboard package and blister. The expiry date refers to the last day of the month.
Medicines should 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 Spiriva contains
The active substance is tiotropium. Each capsule contains 18 micrograms of tiotropium (as micronized monohydrate tiotropium bromide) as the active substance.
The delivered dose (released from the mouthpiece of the HandiHaler inhalation device) contains 10 micrograms of tiotropium.
The other ingredients are: micronized lactose monohydrate, lactose monohydrate 200 M.
Capsule shell composition: gelatin, macrogol 3350, titanium dioxide (E171), yellow iron oxide (E 172), indigo carmine (E 132).

What Spiriva looks like and contents of the pack
Spiriva is in the form of hard, light green capsules containing powder for inhalation. Each capsule is printed with the code TI 01 and the company logo.
Spiriva is available in the following pack sizes:

• 30 capsules
• 30 capsules and HandiHaler inhalation device
• 90 capsules

Additionally, an inhalation device HandiHaler is available separately for sale.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Boehringer Ingelheim International GmbH
Binger Strasse 173
55216 Ingelheim/Rhein
Germany

Manufacturers
Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Strasse 173
55216 Ingelheim/Rhein
Germany
Boehringer Ingelheim France
100-104 avenue de France
75013 Paris
France

For further information, please contact the representative of the Marketing Authorisation Holder.
Poland
Boehringer Ingelheim Sp. z o.o.
Tel.: +48 22 699 0 699

Instructions for use and operation of the HandiHaler inhalation device
The HandiHaler is an inhalation device designed to inhale the medicine Spiriva contained in a capsule, which has been prescribed by a doctor due to breathing difficulties. The HandiHaler inhalation device is intended exclusively for use with Spiriva capsules. It must not be used to administer other medicines.
The HandiHaler inhalation device is intended for use by a single patient only and is designed for repeated use.

	Follow your doctor's instructions carefully when using Spiriva. After first use, the HandiHaler inhalation device may be used for a period of one year to deliver the medication.
	HandiHaler 1. Top cover 2. Mouthpiece 3. Housing with viewing window 4. Piercing button 5. Central chamber
	1. To open the top cover, press the piercing button fully and then release it.
	2. Open the top cover of the inhalation device by pulling it upwards. Then lift the mouthpiece upwards.
	3. Immediately before use, remove the Spiriva capsule from the blister pack (see section "Removing the capsule from the blister") and place it into the central chamber (5) as shown in the illustration. It does not matter which end of the capsule is inserted into the chamber.
	4. Close the mouthpiece securely by snapping it shut. Leave the top cover open.
	5. Holding the HandiHaler inhalation device with the mouthpiece pointing upwards, press the piercing button fully down once and then release it. The capsule will be punctured and the medicine will be ready for inhalation.
	6. Breathe out deeply. Warning: Never breathe out through the mouthpiece.
	7. Place the HandiHaler inhalation device to your mouth and close your lips tightly around the mouthpiece. Keeping your head in an upright position, inhale slowly and deeply so that you can hear or feel the capsule vibrating. Breathe in as much air into your lungs as possible. Then hold your breath as long as comfortable, while removing the inhaler from your mouth. Resume normal breathing. Repeat steps 6 and 7 once more; this will ensure complete emptying of the capsule.
	8. Open the mouthpiece again and remove the used capsule. When the inhalation device is not in use, both the mouthpiece and the top cover should be closed.

Cleaning the HandiHaler inhalation device

The HandiHaler inhalation device should be cleaned once a month. Open the top cover and mouthpiece, then lift the piercing button to open the housing with the viewing window. Remove any powder residue by rinsing the entire inhalation device with warm water. Shake off excess water, then leave the inhalation device open to air-dry on a paper towel. Approximately 24 hours are required for complete drying; therefore, it is best to clean the inhalation device immediately after use so that it will be ready for the next dose. If necessary, the outer part of the mouthpiece may be wiped with a damp, but not wet, cloth.

Removing the capsule from the blister

	A. Separate the strips of the Spiriva blister pack by tearing along the perforation.
	B. Peel back the foil (just before use) until one capsule is exposed. If by accident the second capsule in the blister is exposed, it should be discarded.
	C. Remove the capsule.

The Spiriva capsule contains only a small amount of powder for inhalation, therefore it is only partially filled.