Tavulus 18 micrograms powder for inhalation (hard capsule)

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Tavulus 18 micrograms inhalation powder (hard capsule)

Tiotropium

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

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

Leaflet contents:

1. What Tavulus 18 micrograms is and what it is used for
2. What you need to know before using Tavulus 18 micrograms
3. How to use Tavulus 18 micrograms
4. Possible side effects
5. How to store Tavulus 18 micrograms
6. Contents of the pack and other information

1. What Tavulus 18 micrograms is and what it is used for

This medicine contains the active substance tiotropium. 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, not only when you have breathing problems or other COPD symptoms.

This medicine is a long-acting bronchodilator that helps open the airways and makes it easier to inhale and exhale air from the lungs. Regular use of this medicine can also help when you have ongoing breathing difficulties due to your disease, and will help minimize the impact of the disease on your daily life. It also helps you stay active for longer. Daily use of this medicine will also help prevent sudden, short-term worsening of your COPD symptoms, which may last several days. The effect of this medicine lasts 24 hours; therefore, you only need to take it once a day. For correct dosing of this medicine, see section 3. How to use Tavulus 18 micrograms and the instructions for use at the end of this leaflet.

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

Do not use Tavulus 18 micrograms

• If you are allergic (hypersensitive) to tiotropium or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic (hypersensitive) to atropine or its derivatives, such as ipratropium or oxitropium.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use this medicine:

• Consult your doctor if you have narrow-angle glaucoma, prostate problems, or difficulty urinating.
• If you have kidney problems, please consult your doctor.
• This medicine is indicated for the maintenance treatment of your chronic obstructive pulmonary disease (COPD); it should not be used to treat a sudden episode of breathlessness or wheezing.
• Immediately after administration, immediate allergic reactions such as rash, swelling, itching, wheezing, or shortness of breath may occur. If this happens, please consult your doctor immediately.
• Inhaled medicines such as this one may cause chest tightness, cough, wheezing, or shortness of breath immediately after inhalation. If this occurs, please consult your doctor immediately.
• Be careful not to get the inhaled powder into your eyes, as this may cause or worsen narrow-angle glaucoma, an eye condition. Eye pain or discomfort, blurred vision, halos around lights, or colored images associated with eye redness may be signs of an acute attack of narrow-angle glaucoma. Eye symptoms may be accompanied by headache, nausea, or vomiting. You must stop using tiotropium bromide and consult your doctor immediately, preferably an ophthalmologist, if signs or symptoms of narrow-angle glaucoma appear.
• Dry mouth, which has been observed during treatment with anticholinergics, may be associated over time with dental caries. Therefore, remember to maintain good oral hygiene.
• If you have had a myocardial infarction within the last 6 months, unstable or life-threatening cardiac arrhythmias, or severe heart failure within the past year, inform your doctor. This is important to determine whether this medicine is appropriate for you.
• You should not use this medicine more than once a day.

Children and adolescents

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

Other medicines and Tavulus 18 micrograms

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

No specific adverse reactions have been reported when this medicine has been used together with other medicines commonly used to treat COPD, such as rescue inhalers (e.g., salbutamol), methylxanthines (such as theophylline), and/or oral or inhaled corticosteroids (such as prednisolone).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. You should not use this medicine unless specifically recommended by your doctor.

Driving and using machines

Dizziness, blurred vision, or headache may affect your ability to drive or operate machinery.

Tavulus 18 micrograms contains lactose monohydrate

When administered at the recommended dose—one capsule once daily—each dose provides up to 5.5 mg of lactose monohydrate. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to use Tavulus 18 micrograms

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is inhalation of the contents of one capsule (18 micrograms of tiotropium) once daily. Do not exceed the recommended dose.

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

You should try to use the capsule at the same time each day. This is important because this medicine is effective for 24 hours.

The capsules are for inhalation only and must not be taken orally. Do not swallow the capsules.

The dry powder inhaler (MRX003-T10), into which you must place the capsule of this medicine, 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. Instructions for using the dry powder inhaler are provided at the end of this leaflet.

Ensure that you do not blow into the dry powder inhaler.

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

You must clean your dry powder inhaler once a month. Instructions for cleaning the dry powder inhaler are provided at the end of this leaflet.

When using this medicine, take care not to let the powder enter your eyes. If powder gets into your eyes, it may cause blurred vision, eye pain and/or redness. You must wash your eyes immediately with lukewarm water. Consult your doctor immediately for further advice.

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 1 capsule of this medicine in one day, you must speak to your doctor immediately. You may be at increased risk of experiencing an adverse reaction such as dry mouth, constipation, difficulty urinating, increased heart rate, or blurred vision.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91 562 04 20, or consult your doctor or pharmacist.

If you forget to use Tavulus 18 micrograms

If you have missed a dose, take it as soon as you remember, but do not take two doses at the same time or on the same day. Then take your next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop using Tavulus 18 micrograms

Before stopping treatment with this medicine, you must speak to your doctor or pharmacist. If you stop treatment with this medicine, your COPD symptoms may worsen.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. The adverse effects listed below have been reported by people who have taken this medicine.

After administration of this medicine, serious adverse reactions may occur individually or as part of a severe allergic reaction (anaphylactic reaction), including allergic reactions causing 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 chest tightness, cough, wheezing, or difficulty breathing immediately after inhalation (bronchospasm). If you experience any of these adverse reactions, consult your doctor immediately.

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
• taste disturbances
• blurred vision
• irregular heart rhythm (atrial fibrillation)
• throat inflammation (pharyngitis)
• hoarseness (dysphonia)
• cough
• heartburn (gastroesophageal reflux disease)
• 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 redness of the eyes (glaucoma)
• increased intraocular pressure
• irregular heart rhythm (supraventricular tachycardia)
• increased heart rate (tachycardia)
• awareness of your heartbeat (palpitations)
• chest tightness associated with cough, wheezing, or difficulty breathing immediately after inhalation (bronchospasm)
• nosebleed (epistaxis)
• inflammation of the larynx (laryngitis)
• inflammation of the sinuses (sinusitis)
• intestinal blockage or absence of intestinal 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 dizzy (nausea)
• allergic reactions (hypersensitivity), including immediate reactions
• severe allergic reaction causing swelling of the face and throat (angioedema)
• skin rash (urticaria)
• itching (pruritus)
• urinary tract infection

Not known (frequency cannot be estimated from available data):

• loss of body water (dehydration)
• dental caries
• severe allergic reaction (anaphylactic reaction)
• skin infections or ulcerations
• dry skin
• swelling of the joints

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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tavulus 18 micrograms

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

Do not use this medicine after the expiry date stated on the packaging and on the blister. The expiry date refers to the last day of the month indicated.

Always use the capsule immediately within 30 minutes of opening the blister. Each dry powder inhaler should be replaced after 6 months, which corresponds to the administration of up to 180 capsules.

Do not store above 30°C.

Keep the medicine in the original packaging to protect it from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tavulus 18 micrograms

• The active substance is tiotropium. Each capsule contains 18 micrograms of the active substance 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 pack

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

This medicine is supplied in blisters. The packs contain the blisters and a dry powder inhaler. The dry powder inhaler has a white body with a red button.

Pack sizes:

• 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 pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Zentiva k.s.

U Kabelovny 130

Dolní Mecholupy

102 37 Prague 10

Czech Republic

Manufacturer:

Helm Pharmaceuticals GmbH
Nordkanalstrasse 28
20097 Hamburg
Germany

More information about this medicine can be requested by contacting 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 medicine is authorized in the EEA Member States under the following names:

Date of last revision of this leaflet: March 2024

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (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 medicine, you must be trained by your doctor or another healthcare professional on how to use the inhaler.

The dry powder inhaler is specifically designed for Tavulus capsules and therefore should not be used with any other medication.

Your medicine comes packaged with Tavulus capsules in blisters.

Use, as appropriate, the new dry powder inhaler provided with your medicine. Each dry powder inhaler should be replaced after 6 months, which corresponds to a maximum of 180 capsules. Do not use the device if you notice any damage or if the capsule remains in the device.