Glycopyrronium Doc

Package leaflet: Information for the user

GLYCOPYRRONIUM DOC 44 micrograms inhalation powder, hard capsules

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important
information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet
What GLYCOPYRRONIUM DOC is and what it is used for
What you need to know before taking GLYCOPYRRONIUM DOC
How to take GLYCOPYRRONIUM DOC
Possible side effects
How to store GLYCOPYRRONIUM DOC
Contents of the pack and other information

1. What GLICOPIRRONIO DOC is and what it is used for

This medicinal product contains the active substance glycopyrronium bromide, which belongs to a group of medicines called bronchodilators.
What GLICOPIRRONIO DOC is used for
This medicinal product is used to help adult patients breathe more easily when they have breathing difficulties due to a lung disease called chronic obstructive pulmonary disease (COPD).
In COPD, the muscles around the airways tighten. This makes breathing difficult. This medicine prevents the tightening of these muscles in the lungs, making it easier for air to flow into and out of the lungs.
If you take this medicine once daily, it will help reduce the effects of COPD in your daily activities.

2. What you need to know before taking GLICOPIRRONIO DOC

Do not use GLICOPIRRONIO DOC

• if you are allergic to glycopyrronium bromide or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor before using GLICOPIRRONIO DOC if any of the following apply to you:

• you have kidney problems
• you have a condition affecting the eyes called narrow-angle glaucoma
• you have difficulty urinating

During treatment with GLICOPIRRONIO DOC, stop taking the medicine and contact your doctor
immediately if:

• shortly after using GLICOPIRRONIO DOC you feel chest tightness, coughing, wheezing or shortness of breath (signs of bronchospasm);
• you experience difficulty breathing or swallowing, swelling of the tongue, lips or face, rash, itching or hives (signs of an allergic reaction);
• you develop eye pain or discomfort, temporary blurred vision, seeing halos or colored images around lights, associated with red eyes. These could be signs of an acute attack of
  narrow-angle glaucoma.
  GLICOPIRRONIO DOC is used as maintenance therapy for COPD. Do not use this medicine to treat a sudden attack of breathlessness or shortness of breath.
  Children and adolescents
  Do not give this medicine to children or adolescents under 18 years of age.
  Other medicines and GLICOPIRRONIO DOC
  Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines similar to GLICOPIRRONIO DOC used for lung diseases, such as ipratropium, oxitropium or tiotropium (called anticholinergics).
  No specific adverse effects have been reported when GLICOPIRRONIO DOC has been used together with other medicines used in the treatment of COPD, such as reliever inhalers (e.g. salbutamol), methylxanthines (e.g. theophylline) and/or oral and inhaled steroids (e.g. prednisolone).
  Pregnancy, breastfeeding and fertility
  If you are pregnant, think you might be pregnant or are planning to become pregnant, or if you are breastfeeding, consult your doctor or pharmacist before taking this medicine.
  There are no data on the use of this medicine during pregnancy, and it is not known whether the active substance of this medicine passes into breast milk.
  Driving and using machines
  It is unlikely that this medicine affects the ability to drive or operate machinery.
  GLICOPIRRONIO DOC contains lactose
  This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take GLICOPIRRONIO DOC

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
How much GLICOPIRRONIO DOC to use
The usual dose is inhalation of the contents of one capsule daily.
It is sufficient to inhale once a day, as the effect of this medicine lasts for 24 hours. Do not use more
medicine than recommended by your doctor.
Elderly
If you are aged 75 years or older, you may use this medicine at the same dosage as other adults.
When to inhale GLICOPIRRONIO DOC
Use this medicine every day at the same time. This will help you remember to take it. You may inhale
this medicine at any time before or after eating or drinking.
How to inhale GLICOPIRRONIO DOC

• In this package you will find a dry powder inhaler and capsules (in blisters) containing the medicine as a powder for inhalation. Use the capsules only with the inhaler provided in this package. The capsules must remain in the blister until the moment of use.
• Do not push the capsules through the protective foil.
• When starting a new package, use the inhaler provided in the package or, if reusing, the inhaler must be discarded after 90 uses, counted from the first use of the inhaler.
• Do not swallow the capsules.
• Read the instructions at the end of this leaflet for further information on how to use the inhaler.

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If you use more GLICOPIRRONIO DOC than you should
If you have inhaled too much medicine or if someone else has accidentally used your capsules, inform your
doctor immediately or go to the nearest emergency department. Show the GLICOPIRRONIO DOC packaging.
Medical treatment may be necessary.
If you forget to use GLICOPIRRONIO DOC
If you forget to inhale a dose, take it as soon as possible. However, do not take two doses on the same
day. Then take the next dose as usual.
How long to continue treatment with GLICOPIRRONIO DOC

• Continue using this medicine for as long as your doctor tells you to.
• COPD is a long-term condition and you must take this medicine every day, not only when you have breathing difficulties or other COPD symptoms.

If you have any doubts about how long to continue treatment with this medicine, ask your doctor or pharmacist.
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious but are not common
(may affect up to 1 in 100 people)

• Irregular heartbeat
• High blood sugar level (hyperglycaemia: typical symptoms include excessive thirst or hunger and frequent need to urinate)
• Skin rash, itching, hives, difficulty breathing or swallowing, dizziness (possible signs of an allergic reaction)
• Swelling, especially of the tongue, lips, face or throat (possible signs of angioedema)

If you experience any of these side effects, inform your doctor immediately.
Some side effects can be serious, but their frequency is unknown
(frequency cannot be estimated from the available data)

• Difficulty breathing with wheezing or coughing (signs of paradoxical bronchospasm)

Some side effects are common
(may affect up to 1 in 10 people)

• Dry mouth
• Difficulty sleeping
• Runny or stuffy nose, sneezing, sore throat
• Diarrhoea or stomach pain
• Musculoskeletal pain

Some side effects are not common
(may affect up to 1 in 100 people)

• Difficulty and pain when urinating
• Painful and frequent urination
• Palpitations
• Skin rash
• Numbness
• Cough with sputum
• Dental caries
• Feeling of pressure or pain in the cheeks and forehead

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• Nosebleeds
• Pain in the arms or legs
• Pain in the muscles, bones or joints of the chest
• Stomach discomfort after meals
• Throat irritation
• Tiredness
• Weakness
• Itching
• Voice changes (hoarseness)
• Nausea
• Vomiting
  Some elderly patients over 75 years of age have experienced headache (common frequency) and urinary tract infections (common frequency).

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store GLICOPIRRONIO DOC

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 blister after "EXP". The expiry date refers to the last day of that month.
Do not store above 25°C.
Keep the capsules in the original blister to protect them from moisture. Remove the capsules from the blister only immediately before use.
The inhaler in each pack or a reused inhaler must be disposed of after 90 uses, counted from the first use of the inhaler.
Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What GLICOPIRRONIO DOC contains

• The active substance is glycopyrronium bromide. Each capsule contains 63 micrograms of glycopyrronium bromide (equivalent to 50 micrograms of glycopyrronium). The delivered dose (the dose released from the inhaler mouthpiece) is equivalent to 44 micrograms of glycopyrronium.
• The other components of the inhalation powder are lactose monohydrate and magnesium stearate.

Description of the appearance of GLICOPIRRONIO DOC and contents of the pack
GLICOPIRRONIO DOC 44 micrograms inhalation powder, hard capsules with an orange transparent cap and colourless transparent body containing white or almost white powder.
Each pack may contain a device called an inhaler, together with the capsules in their packaging.
The following pack sizes are available:
Packs containing 10 x 1, 30 x 1, 60 x 1, 90 x 1 hard capsules in peelable single-dose perforated blisters,
together with an inhaler.
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Packs containing 10 x 1, 30 x 1, 60 x 1 hard capsules in peelable single-dose perforated blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
DOC Generici S.r.l. - Via Turati 40 – 20121 Milano - Italy.
Manufacturer
Laboratorios LICONSA S.A. - Avenida Miralcampo 7, Polígono Industrial Miralcampo – 19200 Azuqueca de Henares, Guadalajara - Spain

This medicinal product is authorised in the European Economic Area (EEA) Member States under the following names:
Member State Name
Netherlands Glycopyrronium DOC 44 mcg inhalatiepoeder in harde capsules
Italy GLICOPIRRONIO DOC
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Instructions for handling and use
Read the complete Instructions for Use before using GLICOPIRRONIO DOC.

Insert Pierce and release Inhale deeply Check that the
capsule is empty

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