Package Insert:Information for the User

Spiriva 18 micrograms, Inhalation Powder

tiotropio

Read this package insert carefully before starting to use this medication,because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Spiriva 18 micrograms helps people with chronic obstructive pulmonary disease (COPD) to breathe more easily. Chronic obstructive pulmonary disease (COPD) is a chronic lung disease that causes difficulty breathing and coughing. The term COPD is associated with chronic bronchitis and emphysema. Since COPD is a chronic disease, you must use Spiriva 18 micrograms every day and not just when you have respiratory problems or other COPD symptoms.

Spiriva 18 micrograms is a long-acting bronchodilator that helps to open the airways and facilitates the intake and expulsion of air from the lungs. Regular use of Spiriva 18 micrograms can also help you when you have persistent difficulty breathing due to your disease and will help you to minimize the effects of the disease on your daily life. It will also help you to be active for a longer time. Daily use of Spiriva 18 micrograms will also help you to prevent sudden and short-term symptoms of COPD exacerbation, which can last for several days.

The effect of this medication lasts 24 hours, so you only need to use it once a day. For proper dosing of Spiriva 18 micrograms, see section 3. How to use Spiriva 18 micrograms and the instructions on how to use the HandiHaler device, which are located at the end of this leaflet.

Do not use Spiriva 18 micrograms

-if you are allergic (hypersensitive) to tiotropium, its active ingredient, or to any other component of this medication (including those listed in section 6).

-if you are allergic (hypersensitive) to atropine or its derivatives, for example ipratropium or oxitropium.

Warnings and precautions

Consult your doctor or pharmacist before using Spiriva 18 micrograms

• Consult your doctor if you have narrow-angle glaucoma, prostate problems or difficulty urinating.
• If you have kidney problems, please consult your doctor.
• Spiriva 18 micrograms is indicated for the maintenance treatment of your chronic obstructive pulmonary disease, it should not be used to treat a sudden episode of shortness of breath or wheezing.
• After administration of Spiriva 18 micrograms, immediate allergic reactions such as rash, swelling, itching, wheezing or shortness of breath may occur. If this happens, please consult your doctor immediately.
• Inhaled medications like Spiriva 18 micrograms may cause chest tightness, cough, wheezing or shortness of breath immediately after inhalation. If this happens, please consult your doctor immediately.
• Be careful that the inhalation powder does not get into your eyes, as this may cause or worsen narrow-angle glaucoma, a disease of the eyes. Eye pain or discomfort, blurred vision, halos around lights or colored images associated with eye redness may be signs of an acute episode of narrow-angle glaucoma. Eye symptoms may be accompanied by headache, nausea or vomiting. You should stop using tiotropium bromide and consult your doctor immediately, preferably an ophthalmologist, when signs and symptoms of narrow-angle glaucoma appear.

-Dry mouth, which has been observed during treatment with anticholinergics, may be associated with long-term dental caries. Therefore, remember to take care of your oral hygiene.

-If you have had a heart attack in the last 6 months or irregular heartbeats that are unstable, or that have put your life at risk, or severe heart failure in the past year, inform your doctor. This is important to decide if Spiriva is the right medication for you.

-You should not use Spiriva 18 micrograms more than once a day.

Children and adolescents

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

Other medications and Spiriva 18 micrograms

Tell your doctor or pharmacist if you are using, have used recently or may need to use any other medication, including medications available without a prescription.

Tell your doctor or pharmacist if you are using or have used medications similar to Spiriva for your lung disease, such as ipratropium or oxitropium.

No specific adverse reactions have been reported when Spiriva 18 micrograms has been used with other medications commonly used to treat COPD, such as rescue inhalers, for example salbutamol, methylxanthines, such as theophylline and/or oral and inhaled corticosteroids, such as prednisolone.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication. Do not use this medication unless your doctor specifically recommends it.

Driving and operating machinery

The appearance of dizziness, blurred vision or headache may affect your ability to drive and operate machinery.

Spiriva 18 micrograms contains lactose monohydrate

If administered according to the recommended dose, one capsule once a day, each dose provides up to 5.5 mg of lactose monohydrate. If your doctor has informed you that you have an intolerance to some sugars, or an allergy to milk proteins (which may be present in small amounts in the lactose monohydrate ingredient), contact him before taking this medication.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is the inhalation of the contents of one capsule (18 micrograms of tiotropium) once a day. Do not use more than the recommended dose.

You should try to use the capsule at the same time every day. This is important since Spiriva 18 micrograms is effective for 24 hours.

The capsules are for inhalation exclusively and not for oral ingestion.

Do not ingest the capsules.

The HandiHaler device, in which you must insert the Spiriva capsule, pierces the capsule and allows you to inhale the powder.

Make sure you have a HandiHaler device and that you can use it correctly. Read the instructions on how to use the HandiHaler device that are found at the end of this prospectus.

Make sure you do not blow into the HandiHaler.

If you have any problem using the HandiHaler, ask your doctor, nurse, or pharmacist to teach you how it works.

You must clean your HandiHaler once a month. The instructions for cleaning the HandiHaler are found at the end of this prospectus, see “Instructions on how to use the HandiHaler device”.

When using Spiriva 18 micrograms, be careful and do not let the powder enter your eyes. If powder enters your eyes, it could cause blurry vision, pain, and/or eye redness. You must wash your eyes immediately with warm water. Consult your doctor immediately for more information.

If you notice that your breathing worsens, consult your doctor as soon as possible.

Use in children and adolescents

Spiriva 18 micrograms is not recommended for children and adolescents under 18 years old.

If you use more Spiriva 18 micrograms than you should

If you inhale more than one Spiriva 18 micrograms capsule in a day, you must talk to your doctor immediately. You may have a higher risk of experiencing an adverse reaction such as dry mouth, constipation, difficulty urinating, increased heart rate, or blurry vision.

If you forgot to use Spiriva 18 micrograms

If you have forgotten a dose, administer a dose as soon as you remember, but do not take two doses at once or on the same day. Then use your next dose as usual.

If you interrupt treatment with Spiriva 18 micrograms

Before interrupting treatment with Spiriva 18 micrograms, you must talk to your doctor or pharmacist.

If you interrupt treatment with Spiriva 18 micrograms, the signs and symptoms of your COPD may worsen.

If you have any other doubt about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The side effects listed below have been experienced by people who have taken this medicine and are listed in order of frequency as frequent, infrequent, rare or unknown frequency.

Frequent (may affect up to one in 10 patients):

• Dry mouth: this is usually mild

Infrequent (may affect up to one in 100 patients):

• Dizziness
• Headache
• Alteration of taste
• Blurred vision
• Irregular heart rhythm (atrial fibrillation)
• Throat inflammation (pharyngitis)
• Hoarseness (dysphonia)
• Cough
• Heartburn (gastroesophageal reflux)
• Constipation
• Fungal infection in the oral cavity or throat (oropharyngeal candidiasis)
• Rash
• Difficulty urinating (urinary retention)
• Painful urination (dysuria)

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

• Difficulty sleeping (insomnia)
• Halos or colored images associated with eye redness (glaucoma)
• Increased eye pressure
• Irregular heart rhythm (supraventricular tachycardia)
• Increased heart rate (tachycardia)
• Feeling of heartbeats (palpitations)
• Chest pressure, associated with cough, wheezing or difficulty breathing immediately after inhalation (bronchospasm)
• Nasal bleeding (epistaxis)
• Laryngitis
• Paranasal sinusitis
• Intestinal obstruction or absence of intestinal movement (including paralytic ileus)
• Gingivitis
• Glossitis
• Difficulty swallowing (dysphagia)
• Stomatitis
• Nausea
• Hypersensitivity, including immediate reactions
• Severe allergic reaction causing facial and throat swelling (angioedema)
• Urticaria
• Itching (pruritus)
• Urinary tract infection

Unknown (cannot be estimated from available data):

• Dehydration
• Dental caries
• Severe allergic reaction (anaphylactic reaction)
• Skin infections or ulcers
• Dry skin
• Swelling of the joints

After administration of Spiriva 18 micrograms, severe adverse reactions, including severe allergic reactions (anaphylactic reactions), may occur individually or as part of a severe allergic reaction, which include angioedema or other hypersensitivity reactions (such as sudden decrease in blood pressure or dizziness). Additionally, as occurs with all inhaled medications, some patients may experience unexpected chest pressure, cough, wheezing or difficulty breathing immediately after inhalation (bronchospasm). If you experience any of these reactions, consult your doctor immediately.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and in the blister.

The expiration date is the last day of the month indicated.

Once you have used the first capsule from the blister, continue using the capsules for the next 9 days, one capsule per day, from the same blister.

Dispose of the HandiHaler device 12 months after the first use.

Do not store at a temperature above 25 °C.

Do not freeze.

Medications should not be disposed of through drains or trash. Deposit the packaging and unused medications at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Spiriva 18 micrograms

The active ingredient is tiotropium. Each capsule contains 18 micrograms of active ingredient tiotropium (as bromide monohydrate). During inhalation, 10 micrograms of tiotropium are released from the mouthpiece of the HandiHaler device.

The other component is lactose monohydrate (which may contain small amounts of milk proteins).

Appearance of the product and contents of the package

Spiriva 18 micrograms, inhalation powder, is a hard, light green capsule containing the inhalation powder, with the product code TI 01 and the company logo printed on the capsule.

The product is available in the following packages:

Package with 30 capsules

Package with 60 capsules

Package with 90 capsules

Package with 10 capsules and a HandiHaler device

Package with 30 capsules and a HandiHaler device

Clinical package: box with 5 packages with 30 capsules plus a HandiHaler device

Clinical package: box with 5 packages with 60 capsules

Additionally, a package with a HandiHaler device is available.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

The holder of the marketing authorization for Spiriva 18 micrograms is:

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

The manufacturer of Spiriva 18 micrograms is:

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

Boehringer Ingelheim France

100-104 avenue de France

75013 Paris

France

Local representative:

Boehringer Ingelheim España, S.A.

Prat de la Riba, 50

08174 Sant Cugat del Vallès (Barcelona)

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Last review date of this leaflet: March 2023

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.

Instructions for using the HandiHaler device

The HandiHaler is an inhalation device that allows you to inhale the medicine contained in the Spiriva capsule that your doctor has prescribed for your respiratory problems.

The HandiHaler is specifically designed for Spiriva. Do not use it to take any other medication.

The HandiHaler should only be used by you and is intended for multiple use.

Remember to carefully follow your doctor's instructions for using Spiriva.

After the first use, you can use your HandiHaler for up to a year to take your medication.

The HandiHaler

1Cover

2Mouthpiece

3Base

4Perforating button

5Central chamber

1. To open the cover, press the perforating button all the way down and release.

2. Open the cover completely by lifting it up and back. Then open the mouthpiece by lifting it up and back.

3. Remove a Spiriva capsule from the blister pack (only immediately before use, see handling the blister pack) and place it in the central chamber (5), as indicated in the figure. It does not matter where the capsule is positioned in the chamber.

4. Close the mouthpiece firmly, until you hear a click, leaving the cover open.

5. Hold the HandiHaler with the mouthpiece up, press the perforating button all the way down once and release. This action perforates the capsule and allows the medicine to be released when you inhale.

6. Exhale completely. Important: Never breathe into the mouthpiece.

7. Hold the HandiHaler to your mouth and close your lips tightly around the mouthpiece. Keep your head straight and take a slow, deep breath until you can hear or feel the capsule vibrating. Inhale until your lungs are full; then hold your breath for a moment and, at the same time, remove the HandiHaler from your mouth. Continue breathing normally. Repeat steps 6 and 7 once more; this will empty the capsule completely.

8. Open the mouthpiece again. Remove the used capsule and discard it. Close the mouthpiece and cover to store the HandiHaler.

Cleaning the HandiHaler

Clean the HandiHaler once a month. Open the cover and mouthpiece. Then open the base by lifting the perforating button. Rinse the entire inhaler with warm water to remove the powder. Dry the HandiHaler thoroughly, removing any excess water with a paper towel and allowing it to air dry, leaving the cover, mouthpiece, and base open. Since it takes 24 hours to dry in the air, it should be cleaned immediately after use and will be ready for the next use. If necessary, the exterior of the mouthpiece can be cleaned with a damp paper towel but not wet.

Handling the blister pack

B.Remove the aluminum foil (only immediately before use) by lifting the tab until a capsule is completely visible.

If another capsule is accidentally exposed to the air, do not use it.

C.Remove the capsule.

The amount of powder contained in the Spiriva capsules is small, so the capsule is only partially filled.