Package Insert: Information for the Patient

Tavulus 18 micrograms Powder for Inhalation (Hard Capsule)

Tiotropio

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, 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.

This medicine contains the active ingredient tiotropio. This medicine 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 this medicine every day and not just when you have respiratory problems or other COPD symptoms.

This medicine is a long-acting bronchodilator that helps to open up the airways and facilitates the intake and expulsion of air from the lungs. The regular use of this medicine can also help you when you have continuous 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. The daily use of this medicine will also help you to prevent sudden and short-term symptoms of worsening of your COPD, which can last for several days. The effect of this medicine lasts 24 hours, so you only need to use it once a day. For correct dosing of this medicine, see section 3. How to use Tavulus 18 micrograms and the usage instructions at the end of this leaflet.

Do not use Tavulus 18 micrograms

• If you are allergic (hypersensitive) to tiotropium, or to any of the other components of this medication (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 starting to use this medication:

• Consult your doctor if you have narrow-angle glaucoma, prostate problems or difficulty urinating.
• If you have kidney problems, please consult your doctor.
• This medication 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 this medication, 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 this one may cause chest tightness, cough, wheezing or immediate shortness of breath after inhalation. If this happens, please consult your doctor immediately.
• Be careful not to let the inhalation powder 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 anticholinergic treatment, may be associated with dental caries at a long-term. Therefore, please take care of your oral hygiene.
• If you have had a myocardial infarction in the last 6 months or unstable irregular heartbeats that have endangered your life, or severe heart failure in the past year, inform your doctor. This is important to decide if this medication is the right one for you.
• You should not use this medication more than once a day.

Children and adolescents

This medication is not recommended for children and adolescents under 18 years old.

Other medications and Tavulus 18 micrograms

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medication.

Inform 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 this medication 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 steroids, for example prednisolone.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or 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.

Tavulus 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 a certain sugar intolerance, consult with 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.

This medication is not recommended for children and adolescents under 18 years old.

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

The capsules are for inhalation only and not for oral ingestion. Do not ingest the capsules.

The dry powder inhaler (MRX003-T10), in which you must insert the capsule of this medication, pierces the capsule and allows you to inhale the powder.

Make sure you have a dry powder inhaler and that you are able to use it correctly. The instructions for using the dry powder inhaler are located at the end of this prospectus.

Make sure you do not blow into the dry powder inhaler.

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

You must clean your dry powder inhaler once a month. The instructions for cleaning the dry powder inhaler are located at the end of this prospectus.

When using this medication, 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 eyesimmediatelywith warm water. Consult your doctorimmediatelyfor more information.

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

If you use more Tavulus 18 micrograms than you should

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

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone: 91 562 04 20, consult with your doctor or pharmacist.

If you forgot to use Tavulus 18 micrograms

If you have forgotten a dose, administer a dose as soon as you remember, butdo nottake two doses at once or on the same day. Then administer your next dose as usual. Do not administer a double dose to compensate for the missed doses.

If you interrupt treatment with Tavulus 18 micrograms

Before interrupting treatment with this medication, you must talk to your doctor or pharmacist. If you interrupt treatment with this medication, the symptoms and signs 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 described below have been experienced by people who have taken this medicine.

After taking this medicine, you may experience severe side effects, either individually or as part of a severe allergic reaction (anaphylactic reaction), including severe allergic reactions that cause swelling of the face or throat (angioedema) or other hypersensitivity reactions (such as a sudden drop in blood pressure or dizziness). Additionally, as with all inhaled medicines, some patients may experience unexpected chest pressure, cough, wheezing, or difficulty breathing immediately after inhalation (bronchospasm). If you experience any of these side effects, consult your doctor immediately.

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

• Dry mouth: this is usually mild

Infrequent (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 disease)
• Constipation
• Fungal infection in the oral cavity or throat (oropharyngeal candidiasis)
• Rash
• Difficulty urinating (urinary retention)
• Painful urination (dysuria)

Rare (may affect up to 1 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)
• Throat inflammation (laryngitis)
• Paranasal sinus inflammation (sinusitis)
• Intestinal blockage or absence of intestinal movement (intestinal obstruction including paralytic ileus)
• Gum inflammation (gingivitis)
• Tongue inflammation (glossitis)
• Difficulty swallowing (dysphagia)
• Mouth inflammation (stomatitis)
• Feeling of dizziness (nausea)
• Allergic reactions (hypersensitivity), including immediate reactions
• Severe allergic reaction that causes facial and throat swelling (angioedema)
• Rash (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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:http://www.notificaram.es.By reporting side 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 on the blister. The expiration date is the last day of the month indicated.

Use the capsule directly, within 30 minutes after opening the blister. Each dry powder inhaler should be replaced every 6 months, which corresponds to the administration of a maximum of 180 capsules.

Do not store at a temperature above 30°C.

Store the medication in the original packaging to protect it from moisture.

Do not dispose of medications 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 packaging and medications that you no longer need. This will help protect the environment.

Composition of Tavulus 18 micrograms

• The active ingredient is tiotropium. Each capsule contains 18 micrograms of active ingredient tiotropium (as bromide). During inhalation, 10 micrograms of tiotropium are released from the mouthpiece of the dry powder inhaler.
• The other component is lactose monohydrate (which may contain small amounts of milk proteins).

Appearance of the product and contents of the package

Tavulus 18 micrograms capsules, which release 10 micrograms of inhalation powder per dose, are hard, colorless, and transparent capsules containing white powder and marked with "T10" printed on the capsules.

This medication is presented in blisters. The packages contain the blisters and the dry powder inhaler. The dry powder inhaler has a white body with a red button.

Package formats:

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

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing Authorization Holder

Zentiva k.s.

U Kabelovny 130

Dolní Mecholupy

102 37 Prague 10

Czech Republic

Responsible Manufacturer:

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Germany

For more information about this medication, please contact the local representative of the marketing authorization holder:
Zentiva Spain S.L.U.

Avenida de Europa, 19, Edificio 3, Planta 1.

28224 Pozuelo de Alarcón, Madrid

Spain

This medication is authorized in the EEA member states under the following names:

Last review date of this leaflet:March 2024

For detailed information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.

Instructions for use of the dry powder inhaler (MRX003R-T10)

Dear patient,

The dry powder inhaler (MRX003-T10) allows you to inhale the medication contained in the Tavulus capsule prescribed by your doctor for your respiratory problems.

To ensure correct administration of the medication, you must be trained by your doctor or any other healthcare professional on how to use the inhaler.

The dry powder inhaler is specifically designed for Tavulus capsules, so do not use it for any other medication.

Your medication is supplied with Tavulus capsules in blisters.

Use the new dry powder inhaler provided with your medication when necessary. Each dry powder inhaler must be replaced after 6 months, which corresponds to a maximum of 180 capsules.Do not usethe device if you notice any deterioration or if the capsule remains in the device.