Seebri Breezhaler

Italy
Brand name Seebri Breezhaler
Form powder for inhalation, hard capsule
Active substance / Dosage
GLYCOPYRROLATE BROMIDE
Prescription type Prescription only
ATC code
R03BB06
Registration number 042306
Manufacturer NOVARTIS EUROPHARM LIMITED
Seebri Breezhaler powder for inhalation, hard capsule

Table of Contents

Package leaflet: Information for the user

Seebri Breezhaler 44 micrograms inhalation powder, hard capsules

glycopyrronium
(as glycopyrronium bromide)
Please read all of this leaflet carefully before you start using 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 pass it on to others, even if they have the same symptoms as yours, because it may be harmful.
  • If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What Seebri Breezhaler is and what it is used for

What Seebri Breezhaler is
This medicine contains the active substance glycopyrronium bromide, which belongs to a group of
medicines called bronchodilators.
What Seebri Breezhaler is used for
This medicine is used to help adults 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 move in 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 using Seebri Breezhaler

Do not use Seebri Breezhaler

  • 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 Seebri Breezhaler if any of the following apply to you:

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

During treatment with Seebri Breezhaler, stop taking the medicine and contact your doctor
immediately:

  • if, shortly after using Seebri Breezhaler, you experience chest tightness, cough, wheezing or shortness of breath (signs of bronchospasm);
  • if you experience difficulty breathing or swallowing, swelling of the tongue, lips or face, rash, itching or hives (signs of an allergic reaction);
  • if you develop eye pain or discomfort, temporary blurred vision, halos around lights or colored images associated with red eyes. These could be signs of an acute attack of narrow-angle glaucoma.

Seebri Breezhaler is used as maintenance treatment 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 Seebri Breezhaler
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines similar to Seebri Breezhaler used for lung diseases, such as ipratropium, oxitropium or tiotropium (called anticholinergics).
No specific adverse effects have been reported when Seebri Breezhaler was 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, breast-feeding and fertility
If you are pregnant, think you might be pregnant or are planning to become pregnant, or if you are breast-feeding, 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 will affect your ability to drive or operate machinery.
Seebri Breezhaler contains lactose
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to use Seebri Breezhaler

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

  • This pack contains an inhaler and capsules (in blisters) containing the medicine as a powder for inhalation. Use the capsules only with the inhaler provided in this pack (the Seebri Breezhaler inhaler). The capsules must remain in the blister until you are ready to use them.
  • Do not push the capsules through the protective foil.
  • When starting a new pack, use the new Seebri Breezhaler inhaler provided in the new pack.
  • Dispose of the inhaler from each pack after using all the capsules in the pack.
  • Do not swallow the capsules.
  • Read the instructions at the end of this leaflet for further information on how to use the inhaler.

If you use more Seebri Breezhaler 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 room. Show the Seebri
Breezhaler pack. Medical treatment may be necessary.
If you forget to use Seebri Breezhaler
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 Seebri Breezhaler

  • Continue using this medicine for as long as your doctor tells you to do so.
  • COPD is a long-term condition and you must take this medicine every day, not only when you have difficulty breathing 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 using 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 uncommon
(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)
  • 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 uncommon
(may affect up to 1 in 100 people)

  • Difficulty and pain when urinating
  • Painful and frequent urination
  • Palpitations
  • Rash
  • Numbness
  • Cough with phlegm
  • Dental caries
  • Feeling of pressure or pain in the cheeks and forehead
  • Nosebleed
  • Pain in the arms or legs
  • Pain in the muscles, bones or joints of the chest
  • Stomach discomfort after meals
  • Throat irritation
  • Fatigue
  • Weakness
  • Itching
  • Voice changes (hoarseness)
  • Nausea
  • Vomiting

Some elderly patients over 75 years of age experienced headache (common frequency) and urinary tract infections (common frequency).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Seebri Breezhaler

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"/"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 pack to protect them from moisture. Remove the capsules from the blister pack only immediately before use.
The inhaler contained in each pack must be discarded after all capsules in the pack have been used.
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 no longer required. This will help protect the environment.

6. Package contents and other information

What Seebri Breezhaler 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 monohydrate lactose and magnesium stearate.
  • The ingredients of the capsule shell are: hypromellose, carrageenan, potassium chloride, sunset yellow FCF (E110), and printing ink.
    The ingredients of the printing ink are: shellac (E904), propylene glycol, ammonium hydroxide, potassium hydroxide, and black iron oxide (E172).

Description of the appearance of Seebri Breezhaler and package contents
Seebri Breezhaler 44 microgram inhalation powder capsules are hard, transparent and orange, containing a white powder. They have a black band with the product code “GPL50” printed in black above the band and the company logo ( ) printed in black below the band.
Each package contains a device called an inhaler and blisters with the capsules. Each blister strip contains 6 or 10 capsules.
The following pack sizes are available:
Packs containing 6 x 1, 10 x 1, 12 x 1 or 30 x 1 hard capsules and one inhaler.
Multiple pack containing 90 (3 packs of 30 x 1) hard capsules and 3 inhalers.
Multiple pack containing 96 (4 packs of 24 x 1) hard capsules and 4 inhalers.
Multiple pack containing 150 (15 packs of 10 x 1) hard capsules and 15 inhalers.
Multiple pack containing 150 (25 packs of 6 x 1) hard capsules and 25 inhalers.
Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturer
Novartis Farmacéutica SA
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Novartis Pharma GmbH
Roonstraße 25
D-90429 Nuremberg
Germany
Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Novartis Pharma N.V. SIA Novartis Baltics Lietuvos filialas
Tél/Tel: +32 2 246 16 11 Tel: +370 5 269 16 50

България Luxembourg/Luxemburg
Novartis Bulgaria EOOD Novartis Pharma N.V.
Тел.: +359 2 489 98 28 Tél/Tel: +32 2 246 16 11

Česká republika Magyarország
Novartis s.r.o. Novartis Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 457 65 00

Danmark Malta
Novartis Healthcare A/S Novartis Pharma Services Inc.
Tlf: +45 39 16 84 00 Tel: +356 2122 2872

Deutschland Nederland
Novartis Pharma GmbH Novartis Pharma B.V.
Tel: +49 911 273 0 Tel: +31 88 04 52 111

Eesti Norge
SIA Novartis Baltics Eesti filiaal Novartis Norge AS
Tel: +372 66 30 810 Tlf: +47 23 05 20 00

Ελλάδα Österreich
Novartis (Hellas) A.E.B.E. Novartis Pharma GmbH
Τηλ: +30 210 281 17 12 Tel: +43 1 86 6570

España Polska
Novartis Farmacéutica, S.A. Novartis Poland Sp. z o.o.
Tel: +34 93 306 42 00 Tel.: +48 22 375 4888

France Portugal
Novartis Pharma S.A.S. Novartis Farma - Produtos Farmacêuticos, S.A.
Tél: +33 1 55 47 66 00 Tel: +351 21 000 8600

Hrvatska România
Novartis Hrvatska d.o.o. Novartis Pharma Services Romania SRL
Tel. +385 1 6274 220 Tel: +40 21 31299 01

Ireland Slovenija
Novartis Ireland Limited Novartis Pharma Services Inc.
Tel: +353 1 260 12 55 Tel: +386 1 300 75 50

Ísland Slovenská republika
Vistor hf. Novartis Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 2 5542 5439

Italia Suomi/Finland
Novartis Farma S.p.A. Novartis Finland Oy
Tel: +39 02 96 54 1 Puh/Tel: +358 (0)10 6133 200

Κύπρος Sverige
Novartis Pharma Services Inc. Novartis Sverige AB
Τηλ: +357 22 690 690 Tel: +46 8 732 32 00

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu

Instructions for use of the Seebri Breezhaler inhaler

Read the instructions for use completely before using Seebri Breezhaler.

White medical device with a central orange button and a circular structure with small black side elements on a white background Schematic drawing of a hand inserting a medical device into the mouth with an arrow indicating movement toward the throat A hand opens the white and orange medical device by removing the protective cap to expose the Two hands holding a white cylindrical medical device with black curved arrows indicating horizontal rotational movement

Insert Puncture and release Inhale Check that the
deeply capsule is empty
Check
1 2 3
ca

A hand lifting upward toward the Line drawing of a profile face with arrows indicating downward and forward movement of the jaw and neck Two hands squeezing a white cylindrical medical device with black arrows indicating inward pressure toward the center White medical device with a central orange button and two orange side knobs on a white background with thin black lines Two drawings showing hands rotating and manipulating a white medical device with orange inserts for the A hand holding a circular orange and white medical device to apply it to the body's skin with movement indicated by an arrow Two orange horizontal diagrams with black borders; the first shows a brown granular mass at the bottom, the second is empty with an inner circle Illustration of a blister pack of tablets with a single dose removed and hands opening a single-dose package to extract an orange pill A hand holding a white and orange medical device with a black arrow indicating downward rotational movement Line drawing of a facial profile showing nose, mouth, and ear, highlighting the chin, cheek, and neck area

Discard the empty capsule
in household waste.

Hands removing a white and gray protective cap from a medical device with orange details on a white background A hand lifting and rotating downward the protective cap of a white and orange cylindrical medical device Three technical illustrations of a medical device: a white and orange container, an interlocking mechanism, and a blister pack with pills