Prospecto: information for thepatient

Gregal 10 micrograms/dosereleasedpowder for inhalation (hard capsule)

tiotropio

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

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

1. What isGregaland for what it is used

2. What you need to know before starting to useGregal

3. How to useGregal

4. Possible adverse effects

5. Storage ofGregal

6. Contents of the package and additional information

Gregal contains the active ingredient tiotropio. Tiotropio 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 medication every day and not only when you have respiratory problems or other COPD symptoms.

Gregal 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 this medication 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. Daily use of this medication 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.

This medication should not be used as rescue therapy for the treatment of sudden chest tightness, cough, wheezing, or shortness of breath. Please use a rapid-acting inhaler (rescue), such as salbutamol. Carry this rescue inhaler with you at all times.

Do not use Gregal:

• If you are allergic to tiotropium or any of the other components of this medication (listed in section 6).
• If you are allergic to atropine or similar medications such as ipratropium or oxitropium.
• If you are allergic to lactose or other sugars.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Gregal:

• If you are taking other medications that contain ipratropium or oxitropium.
• If you have narrow-angle glaucoma, prostate problems, or difficulty urinating.
• If you have any kidney problems.
• If you have had a heart attack in the last 6 months, irregular heartbeats that are unstable or have put your life at risk, or severe heart failure in the past year.

Gregal 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 Gregal, immediate allergic reactions such as rash, swelling, itching, wheezing, or shortness of breath may occur. Please consult your doctor immediately if this happens.

Inhaled medications like Gregal can cause chest tightness, cough, wheezing, or shortness of breath immediately after inhalation. If this occurs, use an immediate-acting inhaler (rescue) such as salbutamol right away. If these symptoms appear, stop using Gregal and consult your doctor immediately.

Be careful that the inhalation powder does not get into your eyes, as this can cause eye redness, and could provoke or worsen narrow-angle glaucoma, a disease of the eyes. Eye pain or discomfort, blurred vision, halos, 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 this medication and consult your doctor immediately, preferably an ophthalmologist, when signs and symptoms of narrow-angle glaucoma appear.

Inhaled medications can decrease the normal secretion (saliva) in your mouth and cause dry mouth. It may be associated with long-term dental caries. Therefore, remember to take care of your oral hygiene, rinse your mouth, and brush your teeth regularly.

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

You should not use this medication more than once a day (see section 3).

Children and adolescents

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

Use of Gregal with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including any other inhaler and over-the-counter medications.

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 for the treatment of COPD, such as rescue inhalers, e.g. salbutamol, methylxanthines, such as theophylline, and/or oral and inhaled corticosteroids, such as prednisolone.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or 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 specifically recommends it.

Driving and operating machinery

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

Gregal contains lactose

Lactose is a type of sugar found in cow's milk. If your doctor has told you that you have an intolerance to certain sugars, consult with them before using this medication. It may cause allergic reactions in patients with an allergy to cow's milk protein.

If administered according to the recommended dose, one capsule once a day, each dose provides up to 18 mg of lactose monohydrate.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.This medication should be used exactly as directed by your doctor or pharmacist.Consult your doctor or pharmacist again if you are unsure.

The recommended dose is the inhalation of the contents ofonecapsule once a day with the Zonda inhaler. One capsule provides the daily dose of tiotropium (10 micrograms of tiotropium released dose). Do not use more than the recommended dose.

You should try to use this medication 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 Zonda inhaler, in which you must insert the Gregal capsule, pierces the capsule and allows you to inhale the powder. The capsules should only be inhaled using the Zonda inhaler. Do not use other inhalers to administer the Gregal capsules.

Make sure you know how to use the Zonda inhaler correctly. The usage instructions for the inhaler are located behind this prospectus.Remember to carefully follow these usage instructions. Additionally, additional images on the correct placement of the capsule in the inhaler are provided inside the packaging.To avoid the risk of asphyxiation, NEVER place a capsule directly inside the mouthpiece..If you have any problems using the Zonda inhaler, ask your doctor, nurse, or pharmacist to teach you how it works.

If necessary, you can clean the mouthpiece of your Zonda inhaler after use with a dry paper tissue.

Make sure you do not blow into the inhaler Zonda.When using Gregal, 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 should wash your eyesimmediatelywith warm water. Consult your doctorimmediatelyfor more information.

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

Use in children and adolescents

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

If you use more Gregal than you should

If you inhale more than 1 Gregal capsule in a day, you should 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.

If you forget to use Gregal

If you have forgotten to administer a dose, do it 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 Gregal

Before interrupting treatment with Gregal, you should talk to your doctor or pharmacist. If you interrupt the use of this medication, the symptoms and signs of COPD may worsen.

If you have any other questions about the use of thismedication, ask your doctor,pharmacistor nurse.

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

After using this medicine, severe adverse reactions may occur individually or as part of a severe allergic reaction (anaphylactic reaction) that include allergic reactions causing swelling of the face and throat (angioedema) or other hypersensitivity reactions (such as sudden decrease in blood pressure or dizziness), or increased wheezing and shortness of breath. Additionally, as occurs with all inhaled medications, some patients may experience unexpected chest pressure, cough, wheezing, or immediate difficulty breathing after inhalation (bronchospasm).

If you experience any of these reactions, consult your doctor immediately.immediately.

Do not use Gregal again until you see or at least speak with your doctor. If you have wheezing and shortness of breath, use your rescue inhaler immediately.

Other side effects have been experienced by people who have used this medicine and are listed according to their frequency:

Frequent: may affect up to 1 in 10 people

- Dry mouth: this is generally mild

Rare: may affect up to 1 in 100 people

- Dizziness

- Headache

- Taste alterations

- 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 1 in 1,000 people

- 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)

- Palpitations

- Chest pressure, associated with cough, wheezing, or immediate difficulty breathing after inhalation (bronchospasm)

- Nasal bleeding (epistaxis)

- Laryngitis (inflammation of the larynx)

- Sinusitis (inflammation of the paranasal sinuses)

- Intestinal obstruction or absence of intestinal movement (including paralytic ileus)

- Gingivitis (inflammation of the gums)

- Glossitis (inflammation of the tongue)

- Difficulty swallowing (dysphagia)

- Stomatitis (inflammation of the mouth)

- Nausea (dizziness)

- Hypersensitivity, including immediate reactions

- Severe allergic reaction causing swelling of the face and throat (angioedema)

- Urticaria

- Itching (pruritus)

- Urinary tract infection

Unknown: cannot be estimated from available data

- Dehydration

- Tooth decay

- Skin infections or ulcers

- Dry skin

- Joint swelling

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe box and label of the bottleafter CAD or EXP. The expiration date is the last day of the month indicated.

Do not refrigerate or freeze.

Keep the bottle perfectly closed. Store in the original packaging to protect it from moisture.

Use this medication within 30 days (bottle of 15 capsules) or 60 days (bottle of 30 capsules) after opening the bottle.

The Zonda inhaler can only be used with the bottle of capsules provided. Do not reuse the inhaler for another bottle of capsules.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines you no longer need at the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the containers and medicines you no longer need. This way, you will help protect the environment.

The inhaler device should be disposed of in accordance with local requirements.

Composition of Gregal 10 micrograms/dosereleasedpowder for inhalation

• The active ingredient is tiotropium. Each capsule contains 13 micrograms of active ingredient tiotropium (as bromide of tiotropium). During inhalation, 10 micrograms of tiotropium are released from each capsule from the Zonda inhaler mouthpiece and are inhaled into the lungs.

• The other components are lactose monohydrate (capsule content) and hydroxypropylmethylcellulose (capsule coating).

Appearance of the product and contents of the package

Gregal 10 micrograms/dose released powder for inhalation is a hard, colourless and transparent capsule containing white powder.

This medicine is presented in bottles with screw cap closure. The bottle is presented in a box with the Zonda inhaler. The Zonda inhaler has a green body and a white top with a white push button.

Gregal is available in packaging with 15 capsules or 30 capsules and a Zonda inhaler.

Only some packaging sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Teva Pharma, S.L.U.

C/Anabel Segura, 11 Edificio Albatros B, 1st Floor

Alcobendas, 28108 Madrid (Spain)

Manufacturer responsible

Laboratorios LICONSA S.A.

Avda. Miralcampo, No 7,Industrial EstateMiralcampo

19200 Azuqueca de Henares, Guadalajara

Spain

or

Teva Pharma B.V.

Swensweg 5, 2031 GA Haarlem,

Netherlands

or

Actavis Ltd

BLB015, BLB016, Bulebel Industrial Estate,

Zejtun, ZTN3000,

Malta

Local representative:

Laboratorios BIAL, S.A.

C/ Alcalá 265, Edificio 2, 2nd Floor

28027 Madrid Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Spain:Gregal 10 micrograms/dose released powder for inhalation

Italy:Gregal 10 mcg per dose erogated powder for inhalation, hard capsule

Portugal:Gregal

Last review date of thisleaflet: February 2021

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

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Instructions for use of Zonda

Dear patient,

The Zonda inhalerallows you to inhale the medicine contained in the Gregal capsule that your doctor has prescribed for your respiratory problems.

Remember to follow your doctor's instructions carefully to use Gregal. The Zonda inhaler is specifically designed for Gregal capsules, so do not use it for any other medicine.

The capsules should only be inhaled using the Zonda inhaler.Do notuse other inhalers to administer Gregal capsules. Each capsule contains only a small amount of powder.Do notopen the capsule or it may not work.

The Zonda inhaler should be used with the capsule bottle provided. Do not reuse the inhaler for any other capsule bottle. Dispose of the Zonda device after 15 uses (if you have used the 15-capsule bottle) or 30 uses (if you have used the 30-capsule bottle).

Zonda

1. Protective cap

2. Mouthpiece

3. Base

4. Piercing button

5. Central chamber

1. Pull the protective cap upwards

2. Hold the base of the inhaler firmly. After opening the mouthpiece by lifting it upwards in the direction of the arrow, extract a Gregal capsule from the bottle immediately before use and close the bottle perfectly. Place a capsule in the central chamber at the base of the inhaler.Do notstore the capsule in the Zonda inhaler.

3.To avoid the risk of asphyxiation,NEVER place a capsule directly into the mouthpiece.

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

5. Hold the inhaler with the mouthpiece upwards, press the piercing button firmly once and release it. This action pierces the capsule and allows the medicine to be released when you inhale.

6. Breathe out fully. Important: never breathe out into the mouthpiece.

7. Hold the inhaler to your mouth and keep your head in a straight position. Close your lips tightly around the mouthpiece and inhale slowly and deeply but sufficiently to hear or feel the capsule vibrate inside the central chamber. Hold your breath for the time you feel comfortable while removing the inhaler from your mouth. Continue breathing normally. Repeat steps 7 and 8 again; this will empty the capsule completely.

8. After use,open the mouthpiece again and discard the empty capsule. Close the mouthpiece and protective cap to store the Zonda inhaler.

The Zonda inhaler is a Medical Device (CE).

Manufacturer:

Laboratorios Liconsa S.A.

Industrial Estate Miralcampo

Avda. Miralcampo, 7

19200 Azuqueca de Henares – Guadalajara, Spain

0051