Gregal 10 micrograms/dose powder for inhalation (hard capsule)
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Gregal 10 micrograms/dose delivered as powder for inhalation (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, consult your doctor, pharmacist or nurse.
- 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, pharmacist or nurse, even if these effects are not listed in this leaflet. See section 4.
Contents of the leaflet
- What Gregal is and what it is used for
- What you need to know before using Gregal
- How to use Gregal
- Possible side effects
- How to store Gregal
- Contents of the pack and other information
1. What Gregal is and what it is used for
Gregal contains the active substance tiotropium. Tiotropium 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.
Gregal is a long-acting bronchodilator that helps open the airways and makes it easier to breathe in and out. Regular use of this medicine can also help when you have ongoing difficulty breathing due to your disease, helping you minimize the impact of the disease on your daily life. It also helps you stay active for longer. Daily use of this medicine helps prevent sudden, short-term worsening symptoms of your COPD, which may last several days. The effect of this medicine lasts 24 hours; therefore, you only need to use it once a day.
This medicine must not be used as a rescue therapy to treat sudden chest tightness, cough, wheezing, or shortness of breath. Please use a fast-acting (rescue) inhaler such as salbutamol. Always carry your rescue inhaler with you.
2. What you need to know before using Gregal
Do not use Gregal:
- if you are allergic to tiotropium or to 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
Talk to your doctor, pharmacist, or nurse before starting to use Gregal:
- if you are taking other medicines containing 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 myocardial infarction (heart attack) within the last 6 months, unstable or life-threatening irregular heartbeats, or severe heart failure in the past year.
Gregal is indicated for the maintenance treatment of your chronic obstructive pulmonary disease (COPD). It should not be used to treat a sudden episode of breathing difficulty or wheezing (wheezing).
Immediately after administration, immediate allergic reactions such as rash, swelling, itching, wheezing, or difficulty breathing may occur. If this happens, please consult your doctor immediately.
Inhaled medicines like Gregal may cause chest tightness, cough, wheezing, or shortness of breath immediately after inhalation. If this occurs, use a fast-acting (rescue) inhaler immediately, such as salbutamol. If these symptoms occur, stop using Gregal and consult your doctor immediately.
Be careful that the inhaled powder does not enter your eyes, as this may cause watery eyes or could trigger 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 episode of narrow-angle glaucoma. Ocular symptoms may be accompanied by headache, nausea, or vomiting. You must stop using this medicine and consult your doctor immediately, preferably an ophthalmologist, if signs or symptoms of narrow-angle glaucoma appear.
Inhaled medicines may reduce normal saliva production in your mouth, causing dry mouth. Long-term dry mouth may be associated with dental caries. Therefore, remember to maintain good oral hygiene, rinse your mouth, and brush your teeth regularly.
If you have had a myocardial infarction (heart attack) within the last 6 months, unstable or life-threatening irregular heartbeats, or severe heart failure in the past year, inform your doctor. This is important in deciding whether Gregal is the appropriate medicine for you.
Do 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.
Use of Gregal with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including other inhalers and medicines obtained without a prescription.
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 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. Do not use this medicine unless specifically advised by your doctor.
Driving and using machines
Dizziness, blurred vision, or headache may affect your ability to drive or operate machinery.
Gregal contains lactose
Lactose is a type of sugar found in cow's milk. If your doctor has diagnosed you with an intolerance to certain sugars, consult with him before using this medicine. It may cause allergic reactions in patients allergic to cow's milk protein.
When administered at the recommended dose—one capsule once daily—each dose delivers up to 18 mg of monohydrate lactose.
3. How to use Gregal
Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.
The recommended dose is the inhalation of the contents of one capsule once daily using the Zonda inhaler. One capsule provides the daily required 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 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 Zonda inhaler, into which you must place the Gregal capsule, pierces the capsule and allows you to inhale the powder. The capsules must only be inhaled using the Zonda inhaler. Do not use other inhalers to administer Gregal capsules.
Make sure you know how to use the Zonda inhaler correctly. Instructions for using the inhaler are provided on the back of this leaflet. Remember to carefully follow these instructions. Additional images showing the correct placement of the capsule in the inhaler are also provided inside the lid of the package. To avoid the risk of choking, NEVER place a capsule directly into the mouthpiece. If you have any difficulty using the Zonda inhaler, ask your doctor, nurse, or pharmacist to show you how it works.
If necessary, you may clean the mouthpiece of your Zonda inhaler after use with a dry paper tissue.
Make sure you do not blow into the Zonda inhaler. When using Gregal, be careful 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 should rinse 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.
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 capsule of Gregal 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.
If you forget to use Gregal
If you forget to take 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 as usual. Do not take a double dose to make up for a missed dose.
If you stop using Gregal
Before stopping treatment with Gregal, you should speak to your doctor or pharmacist. If you stop using this medicine, the signs and symptoms of COPD may worsen.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
After using 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 and throat (angioedema) or other hypersensitivity reactions (such as 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, cough, wheezing, or difficulty breathing immediately after inhalation (bronchospasm).
If you experience any of these reactions, consult your doctor immediately.
Do not use Gregal again until you have seen or at least spoken with your doctor. If you develop wheezing and shortness of breath, use your fast-acting (rescue) inhaler immediately.
Other adverse effects have been reported by people who have used this medicine and are listed below according to their frequency:
Frequent: 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
- taste disturbances
- 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 people
- 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)
- palpitations
- chest tightness, associated with cough, wheezing, or difficulty breathing immediately after inhalation (bronchospasm)
- nosebleeds (epistaxis)
- inflammation of the larynx (laryngitis)
- inflammation of the sinuses (sinusitis)
- intestinal blockage or absence of intestinal movement (intestinal obstruction including paralytic ileus)
- gum inflammation (gingivitis)
- inflammation of the tongue (glossitis)
- difficulty swallowing (dysphagia)
- inflammation of the mouth (stomatitis)
- sensation of dizziness (nausea)
- hypersensitivity, including immediate reactions
- severe allergic reaction causing swelling of the face and throat (angioedema)
- hives (urticaria)
- itching (pruritus)
- urinary tract infection
Not known: cannot be estimated from available data
- loss of body water (dehydration)
- dental caries
- skin infections or ulcerations
- dry skin
- swelling of the joints
Reporting of adverse effects
If you experience any adverse effect, consult your doctor, pharmacist, or nurse, 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: https://www.notificaram.es. By reporting adverse 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 expiry date stated on the carton and on the label of the bottle after CAD or EXP. The expiry date refers to 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 must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
The inhalation device must be discarded according to local requirements.
6. Contents of the pack and other information
Composition of Gregal 10 micrograms/dose released, powder for inhalation
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The active substance is tiotropium. Each capsule contains 13 micrograms of the active substance tiotropium (as tiotropium bromide). During inhalation, 10 micrograms of tiotropium are released per capsule from the mouthpiece of the Zonda inhaler and inhaled into the lungs.
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The other ingredients are lactose monohydrate (capsule content) and hypromellose (capsule shell).
Appearance of the product and contents of the pack
Gregal 10 micrograms/dose released, powder for inhalation, is a colourless and transparent hard capsule containing white powder.
This medicine is supplied in bottles with a screw cap. The bottle is provided in a carton together with the Zonda inhaler. The Zonda inhaler has a green body and cap with a white button.
Gregal is available in packs containing 15 capsules or 30 capsules, each with one Zonda inhaler.
Only certain pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 medicinal product is authorised 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 most recent review of this leaflet: February 2021
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/
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Instructions for use of Zonda
Dear Patient,
The Zonda inhaler allows you to inhale the medication contained in the Gregal capsule prescribed by your doctor for your respiratory problems.
Please remember to follow your doctor's instructions carefully when using Gregal. The Zonda inhaler is specifically designed for use with Gregal capsules and must not be used with any other medication.
The capsules must only be inhaled using the Zonda inhaler. Do not use other inhalers to administer Gregal capsules. Each capsule contains only a small amount of powder. Do not open the capsule, as it may not work properly.
The Zonda inhaler should be used only with the bottle of capsules provided. Do not reuse the inhaler with any other bottle of capsules. Dispose of the Zonda device once all the provided capsules have been used.
Zonda
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Protective cap
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Mouthpiece
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Base
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Piercing button
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Central chamber
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Pull the protective cap upwards.
- Hold the base of the inhaler firmly. Open the mouthpiece by lifting it upwards, in the direction of the arrow.
- Remove one Gregal capsule from the bottle immediately before use and close the bottle tightly. Place one capsule into the central chamber in the base of the inhaler. Do not store the capsule in the Zonda inhaler.
- To avoid the risk of choking, NEVER place a capsule directly into the mouthpiece.
- Close the mouthpiece firmly until you hear a click, leaving the protective cap open.
- Hold the inhaler with the mouthpiece facing upwards. Press the piercing button fully down once and release it. This action pierces the capsule and allows the medicine to be released when you inhale.
- Breathe out fully. Important: Never breathe out into the mouthpiece.
- Bring the inhaler to your mouth and keep your head upright. Close your lips tightly around the mouthpiece and inhale slowly and deeply enough to hear or feel the capsule vibrating in the central chamber. Hold your breath for as long as comfortable while removing the inhaler from your mouth. Then continue breathing normally. Repeat steps 7 and 8 once more; this will completely empty the capsule.
- After use, open the mouthpiece again and discard the empty capsule. Close the mouthpiece and the 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