SPIRIVA 18 micrograms powder for inhalation

2. What you need to know before starting to use Spiriva 18 micrograms

Do not use Spiriva 18 micrograms

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

-if you are allergic (hypersensitive) to atropine or its derivatives, such as 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, coughing, wheezing, or shortness of breath immediately after inhalation. If this happens, please consult your doctor immediately.
• Be careful that the inhalation powder does not enter your eyes, as this can cause or worsen narrow-angle glaucoma, which is an eye disease. Eye pain or discomfort, blurred vision, halos, or colored images associated with eye redness may be signs of an acute narrow-angle glaucoma attack. 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 you experience signs and symptoms of narrow-angle glaucoma.

• Dry mouth, which has been observed during treatment with anticholinergics, may be associated with dental caries in the long term. Therefore, remember to take care of your oral hygiene.
• If you have had a heart attack in the last 6 months or unstable irregular heartbeats, or life-threatening heart failure in the past year, inform your doctor. This is important to decide if Spiriva is the right medication for you.
• Do 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 of age.

Other medications and Spiriva 18 micrograms

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

No specific adverse reactions have been reported when Spiriva 18 micrograms has been used in combination with other medications commonly used for the treatment of COPD, such as rescue inhalers, e.g., salbutamol, methylxanthines, such as theophylline, and/or oral and inhaled steroids, such as prednisolone.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication. You should not use this medication unless your doctor has specifically recommended it.

Driving and using machines

The occurrence of dizziness, blurred vision, or headache may affect your ability to drive and use machines.

Spiriva 18 micrograms contains lactose monohydrate

If administered according to the recommended dose, one capsule per day, each dose provides up to 5.5 mg of lactose monohydrate. If your doctor has told 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 them before taking this medication.

3. How to use Spiriva 18 micrograms

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. If in 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 only and not for oral ingestion.

Do not swallow the capsules.

The HandiHaler device, into 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 can use it correctly. Read the instructions on how to use the HandiHaler device, which can be found at the end of this leaflet.

Make sure you do not blow into the HandiHaler.

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

You should clean your HandiHaler once a month. The instructions for cleaning the HandiHaler can be found at the end of this leaflet, see "Instructions on how to use the HandiHaler device".

When using Spiriva 18 micrograms, be careful and do not let the powder get into your eyes. If powder gets into your eyes, it could cause blurred vision, pain, and/or eye redness. You should rinse 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 of age.

If you use more Spiriva 18 micrograms than you should

If you inhale more than 1 capsule of Spiriva 18 micrograms in a day, you should talk to your doctor immediately. You may have a higher risk of experiencing a side effect such as dry mouth, constipation, difficulty urinating, increased heart rate, or blurred vision.

If you forget to use Spiriva 18 micrograms

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

If you stop treatment with Spiriva 18 micrograms

Before stopping treatment with Spiriva 18 micrograms, you should talk to your doctor or pharmacist.

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

The side effects described below have been experienced by people who have taken this medication and are listed according to their frequency as frequent, uncommon, rare, or unknown.

Frequent (may affect up to 1 in 10 patients):

• Dry mouth: this is usually mild

Uncommon (may affect up to 1 in 100 patients):

• dizziness
• headache
• alterations in taste
• blurred vision
• irregular heart rhythm (atrial fibrillation)
• throat inflammation (pharyngitis)
• hoarseness (dysphonia)
• cough
• heartburn (gastroesophageal reflux)
• constipation
• fungal infection in the mouth or throat (oropharyngeal candidiasis)
• rash
• difficulty urinating (urinary retention)
• pain when urinating (dysuria)

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

• difficulty sleeping (insomnia)
• visual halos or colored images associated with eye redness (glaucoma)
• increased eye pressure
• irregular heart rhythm (supraventricular tachycardia)
• increased heart rate (tachycardia)
• feeling your heartbeats (palpitations)
• chest pressure associated with cough, wheezing, or shortness of breath immediately after inhalation (bronchospasm)
• nasal bleeding (epistaxis)
• inflammation of the larynx (laryngitis)
• inflammation of the paranasal sinuses (sinusitis)
• intestinal blockage or absence of bowel movement (intestinal obstruction, including paralytic ileus)
• inflammation of the gums (gingivitis)
• inflammation of the tongue (glossitis)
• difficulty swallowing (dysphagia)
• inflammation of the mouth (stomatitis)
• feeling of nausea (nausea)
• hypersensitivity, including immediate reactions
• severe allergic reaction causing swelling of the face and throat (angioedema)
• hives
• itching (pruritus)
• urinary tract infection

Unknown (cannot be estimated from available data):

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

After administration of Spiriva 18 micrograms, individual or severe allergic reactions (anaphylactic reaction) may occur, including allergic reactions that cause swelling of the face and throat (angioedema) or other hypersensitivity reactions (such as sudden drop in blood pressure or dizziness). Additionally, as with all inhaled medications, some patients may experience unexpected chest pressure, coughing, wheezing, or shortness of breath immediately after inhalation (bronchospasm). If you experience any of these reactions, consult your doctor immediately.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines Agency's online system: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Spiriva 18 micrograms

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the packaging and blister.

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

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

Discard the HandiHaler device 12 months after the first use.

Do not store above 25°C.

Do not freeze.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Container Contents and Additional Information

Composition of Spiriva 18 micrograms

The active ingredient is tiotropium. Each capsule contains 18 micrograms of active ingredient tiotropium (as monohydrate bromide). 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 Container Contents

Spiriva 18 micrograms, powder for inhalation, is a hard capsule of light green color that contains 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 of 30 capsules and a HandiHaler device

Clinical package: box with 5 packages of 60 capsules

In addition, a package with a HandiHaler device is available.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

The marketing authorization holder 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 medication is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of the Last Revision of this Prospectus: March 2023

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

Instructions on How to Use the HandiHaler Device

The HandiHaler is an inhalation device that allows you to inhale the medication contained in the Spiriva capsule prescribed by your doctor 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 repeated use.

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

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

The HandiHaler

1 Cap

2 Mouthpiece

3 Base

4 Piercing button

5 Central chamber

1. To open the cap, press the piercing button all the way down and release.

1. Open the cap completely by lifting it up and back.

Then open the mouthpiece by lifting it up and back.

1. Remove a Spiriva capsule from the blister pack (only immediately before use, see blister handling) and place it in the central chamber (5), as indicated in the figure. The position of the capsule inside the chamber does not matter.

1. Close the mouthpiece firmly, until you hear a click, leaving the cap open.

1. Hold the HandiHaler device with the mouthpiece up, press the piercing button all the way down once, and release. This action pierces the capsule and allows the medication to be released when inhaled.

1. Exhale completely. Important: never breathe into the mouthpiece.

1. Bring the HandiHaler to your mouth and close your lips tightly around the mouthpiece. Keep your head straight and take a slow and deep breath, until you can hear or feel the capsule vibrate. 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 completely empty the capsule.

1. Open the mouthpiece again. Remove the used capsule and throw it away. Close the mouthpiece and cap to store the HandiHaler device.

Cleaning the HandiHaler

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

Blister Handling

• 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 air, it should not be used.

• Remove the capsule.

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