GREGAL 10 MICROGRAMS/RELEASED DOSE INHALATION POWDER (HARD CAPSULE)

2. What you need to know before taking Gregal

Do not use Gregal:

• if you are allergic to tiotropium or any of the other components of this medicine (listed in section 6).
• if you are allergic to atropine or similar medicines 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 medicines 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, unstable or life-threatening irregular heartbeats, or severe heart failure in the last 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. If this happens, please consult your doctor immediately.

Inhaled medicines like Gregal may cause chest tightness, coughing, wheezing, or shortness of breath immediately after inhalation. If this happens, use a rapid-acting inhaler (rescue) immediately, such as salbutamol. If these symptoms occur, stop using Gregal and consult your doctor immediately.

Be careful that the inhalation powder does not enter your eyes, as this can cause watery eyes or could 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 episode. Eye symptoms may be accompanied by headache, nausea, or vomiting. You should stop using this medicine and consult your doctor immediately, preferably an ophthalmologist, when these signs and symptoms of narrow-angle glaucoma appear.

Inhaled medicines may decrease normal saliva secretion in your mouth and produce dry mouth. This may be associated with dental caries in the long term. 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, unstable or life-threatening irregular heartbeats, or severe heart failure in the last year, inform your doctor. This is important to decide if Gregal is the right medicine for you.

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

Children and adolescents

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

Using Gregal withother medicines

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine, including any other inhaler and medicines obtained without a prescription.

Tell 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 with other medicines 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 medicine. You should not use this medicine 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.

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 medicine. It may cause allergic reactions in patients with cow's milk protein allergy.

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

3. How to use Gregal

Follow the instructions for administration of this medicine 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 onecapsule once a daywith the Zonda inhaler. One capsule provides the necessary daily dose of tiotropium (released dose of 10 micrograms of tiotropium). Do not use more than the recommended dose.

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

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

Do not swallow 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 instructions for use of the inhaler are located behind this leaflet. Remember to follow these instructions carefully. Additionally, images are provided on the correct placement of the capsule in the inhaler on the inside of the package cap. To avoid the risk of asphyxiation, NEVERplace a capsule directly into the mouthpiece.If you have any problems using the Zonda inhaler, ask your doctor, nurse, or pharmacist to show you how it works.

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

Make sure you do not blow into the Zonda inhaler. When using Gregal, be careful and do not let the powder enter your eyes. If powder enters your eyes, it could cause blurred vision, pain, and/or eye redness. You should rinse your eyes immediatelywith warm water. Consult your doctor immediatelyfor 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 of age.

If you use more Gregal than you should

If you inhale more than 1 Gregal capsule 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 Gregal

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

If you stop treatment with Gregal

Before stopping treatment with Gregal, you should talk to your doctor or pharmacist. If you stop using this medicine, the signs and symptoms of COPD may worsen.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

After using this medicine, 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 a sudden drop in blood pressure or dizziness), or increased wheezing and shortness of breath. Additionally, as with all inhaled medicines, some patients may experience unexpected chest tightness, coughing, wheezing, or shortness of breath immediately after inhalation (bronchospasm).

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

Do not use Gregal again until you see or at least talk to your doctor. If you have wheezing and shortness of breath, use your rapid-acting inhaler (rescue) immediately.

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

Common: may affect up to 1 in 10 people

• Dry mouth: this is usually mild

Uncommon: may affect up to 1 in 100 people

• dizziness
• headache
• alterations in taste
• blurred vision
• irregular heartbeat (atrial fibrillation)
• throat inflammation (pharyngitis)
• hoarseness (dysphonia)
• coughing
• heartburn (gastroesophageal reflux)
• constipation
• fungal infection in the mouth 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)
• halos or colored images associated with eye redness (glaucoma)
• increased eye pressure
• irregular heartbeat (supraventricular tachycardia)
• increased heart rate (tachycardia)
• palpitations
• chest tightness associated with coughing, wheezing, or shortness of breath immediately after inhalation (bronchospasm)
• nasal bleeding (epistaxis)
• larynx inflammation (laryngitis)
• sinus inflammation (sinusitis)
• intestinal blockage or absence of bowel movement (intestinal obstruction including paralytic ileus)
• gum inflammation (gingivitis)
• tongue inflammation (glossitis)
• difficulty swallowing (dysphagia)
• mouth inflammation (stomatitis)
• feeling of dizziness (nausea)
• hypersensitivity, including immediate reactions
• severe allergic reaction that causes swelling of the face and throat (angioedema)
• hives
• itching (pruritus)
• urinary tract infection

Not known: cannot be estimated from the available data

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

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Gregal

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

Do not use this medicine after the expiration date that appears on the box and label of the bottle after CAD or EXP. The expiration date is the last day of the month indicated.

Do not refrigerate or freeze.

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

Use this medicine within 30 days (15-capsule bottle) or 60 days (30-capsule bottle) after opening the bottle.

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

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

The inhaler device should be disposed of according to local requirements.

6. Container contents and additional information

Composition of Gregal 10 micrograms/dosereleasedpowder for inhalation

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

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

Appearance of the product and container contents

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

This medication is presented in bottles with a screw cap. The bottle is presented in a box with the Zonda inhaler. The Zonda inhaler has a green body and cap with a white actuator.

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

Only certain package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

C/Anabel Segura, 11 Edificio Albatros B, 1ª Planta

Alcobendas, 28108 Madrid (Spain)

Manufacturer

Laboratorios LICONSA S.A.

Avda. Miralcampo, No 7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares, Guadalajara

Spain

or

Actavis Ltd

BLB015, BLB016, Bulebel Industrial Estate,

Zejtun, ZTN3000,

Malta

Local representative:

Laboratorios BIAL, S.A.

C/ Alcalá 265, Edificio 2, Planta 2

28027 Madrid Spain

This medication is authorized in the Member States of the European Economic Area under the following names:

Spain: Gregal 10 micrograms/dose released powder for inhalation

Portugal: Gregal

Date of the last revision of thisleaflet: February 2021

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

<-----------------------------------------------------------------------------------------------------------------?

Zonda inhaler instructions for use

Dear patient,

The Zonda inhaler allows you to inhale the medication contained in the Gregal capsule prescribed by your doctor for your respiratory problems.

Remember to carefully follow your doctor's instructions for using Gregal. The Zonda inhaler is specifically designed for Gregal capsules, so it should not be used for any other medication.

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 bottle of capsules. 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

1. Hold the base of the inhaler firmly. Then, open the mouthpiece by lifting it upwards, in the direction of the arrow.

1. Remove 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 not store the capsule in the Zonda inhaler.

1. To avoid the risk of choking, NEVER place a capsule directly into the mouthpiece.

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

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

1. Exhale deeply. Important: never exhale into the mouthpiece.

1. Bring the inhaler to your mouth and keep your head in an upright position. Close your lips tightly around the mouthpiece and inhale slowly and deeply, but sufficiently to hear or feel the capsule vibrating inside the central chamber. Hold your breath for as long as you feel comfortable while removing the inhaler from your mouth. Continue breathing normally. Repeat steps 7 and 8 once more; this will completely empty the capsule.

1. 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.

Poligono Industrial Miralcampo

Avda. Miralcampo, 7

19200 Azuqueca de Henares – Guadalajara, Spain

0051