Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Glycopyrronium bromide may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for
What Seebri Breezhaler is This medicine contains an active substance called glycopyrronium bromide. This belongs to a group of medicines called bronchodilators. What Seebri Breezhaler is used for This medicine is used to make breathing easier for adult patients who 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 blocks the tightening of these muscles in the lungs, making it easier for air to get in and out of the lungs. If you use this medicine once a day, it will help to reduce the effects of COPD on your everyday life. 2.
e Seebri Breezhaler
Do not use Seebri Breezhaler
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During treatment with Seebri Breezhaler, stop taking this medicine and tell your doctor immediately: if you experience tightness of the chest, coughing, wheezing or breathlessness immediately after using Seebri Breezhaler (signs of bronchospasm). if you experience difficulties in breathing or swallowing, swelling of the tongue, lips or face, skin rash, itching and hives (signs of allergic reaction). if you experience eye pain or discomfort, temporary blurring of vision, visual halos or coloured images in association with red eyes. These may be signs of an acute attack of narrow-angle glaucoma. Seebri Breezhaler is used as a maintenance treatment for your COPD. Do not use this medicine to treat a sudden attack of breathlessness or wheezing. Children and adolescents Do not give this medicine to children or adolescents below the age of 18 years. Other medicines and Seebri Breezhaler Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines similar to Seebri Breezhaler used for your lung disease, such as ipratropium, oxitropium or tiotropium (so called anticholinergics). No specific side effects have been reported when Seebri Breezhaler has been used together with other medicines used to treat 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 or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. There are no data from the use of this medicine in pregnant women and it is not known whether the active substance of this medicine passes into human milk. Driving and using machines It is unlikely that this medicine will affect your ability to drive and use machines. Seebri Breezhaler contains lactose This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. 3.
Seebri Breezhaler
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. How much Seebri Breezhaler to use The usual dose is to inhale the content of one capsule each day. You only need to inhale once a day because the effect of this medicine lasts for 24 hours. Do not use more than your doctor tells you to use. Elderly people You can use this medicine if you are aged 75 years and over at the same dose as for other adults. When to inhale Seebri Breezhaler Use this medicine at the same time each day. This will also help you to remember to use it.
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You can inhale this medicine any time before or after food or drink. How to inhale Seebri Breezhaler In this pack, you will find an inhaler and capsules (in blisters) that contain the medicine as inhalation powder. Only use the capsules with the inhaler provided in this pack (Seebri Breezhaler inhaler). The capsules should remain in the blister until you need to use them. Do not push the capsule through the foil. When you start a new pack, use the new Seebri Breezhaler inhaler that is supplied in the pack. Dispose of each inhaler after all capsules in that pack have been used. Do not swallow the capsules. Please read the instructions at the end of this leaflet for more information on how to use the inhaler. If you use more Seebri Breezhaler than you should If you have inhaled too much of this medicine or if someone else accidentally uses your capsules, you must immediately either tell your doctor or go to the nearest emergency unit. Show the pack of Seebri Breezhaler. Medical attention may be needed. If you forget to use Seebri Breezhaler If you forget to inhale a dose, take one 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 your treatment with Seebri Breezhaler Keep using this medicine for as long as your doctor tells you. COPD is a long-term disease and you should use this medicine every day and not only when you have breathing problems or other symptoms of COPD. If you have questions about how long to continue your treatment with this medicine, talk to your doctor or pharmacist. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 4.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Some side effects may be serious but are uncommon (may affect up to 1 in 100 people) • Irregular heart beat • High level of blood sugar (hyperglycaemia: typical symptoms include excessive thirst or hunger and frequent urination) • Rash, itching, hives, difficulty breathing or swallowing, dizziness (possible signs of allergic reaction) • Swelling mainly of the tongue, lips, face or throat (possible signs of angioedema) If you get any of these side effects, tell your doctor immediately. Some side effects may be serious, but the frequency of these side effects is not known (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 3
• • •
Runny or stuffy nose, sneezing, sore throat Diarrhoea or stomach ache Musculoskeletal pain
Some side effects are uncommon (may affect up to 1 in 100 people) • Difficulty and pain when passing urine • Painful and frequent urination • Palpitations • Rash • Numbness • Cough with sputum • Dental caries • Feeling of pressure or pain in the cheeks and forehead • Nose bleeds • Pain in arms or legs • Pain in muscles, bones or joints of the chest • Stomach discomfort after meals • Throat irritation • Tiredness • Weakness • Itching • Voice alteration (hoarseness) • Nausea • Vomiting Some elderly patients above 75 years of age experienced headache (frequency common) and urinary tract infection (frequency common). Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. 5.
Seebri Breezhaler
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is 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. Store the capsules in the original blister in order to protect from moisture. Do not remove from the blister until immediately before use. The inhaler in each pack should be disposed of after all capsules in that pack have been used. Do not use this medicine if you notice that the pack is damaged or shows signs of tampering. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
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throw away medicines you no longer use. These measures will help protect the environment. 6.
What Seebri Breezhaler contains The active substance is glycopyrronium bromide. Each capsule contains 63 micrograms of glycopyrronium bromide (equivalent to 50 micrograms glycopyrronium). The delivered dose (the dose that leaves the mouthpiece of the inhaler) is equivalent to 44 micrograms of glycopyrronium. The other ingredients of the inhalation powder are lactose monohydrate and magnesium stearate.
United Kingdom Novartis Pharmaceuticals UK Ltd. Tel: +44 1276 698370 This leaflet was last revised in 06/2026
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Instructions for use of Seebri Breezhaler inhaler Please read the full Instructions for Use before using the Seebri Breezhaler.
Insert
Pierce and release
Inhale deeply
Check capsule is empty
1
2
3
Check
Step 1a: Pull off cap
Step 2a: Pierce capsule once Hold the inhaler upright. Pierce capsule by firmly pressing both side buttons at the same time. You should hear a noise as the capsule is pierced. Only pierce the capsule once.
Step 1b: Open inhaler
Step 3a: Breathe out fully Do not blow into the inhaler.
If there is powder left in the capsule:
Step 3b: Inhale medicine deeply Hold the inhaler as shown in the picture. Place the mouthpiece in your mouth and close your lips firmly around it. Do not press the side buttons.
Step 2b: Release side buttons
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Check capsule is empty Open the inhaler to see if any powder is left in the capsule.
Powder remaining
Empty
Breathe in quickly and as deeply as you can. During inhalation you will hear a whirring noise. You may taste the medicine as you inhale.
Remove empty capsule Put the empty capsule in your household waste. Close the inhaler and replace the cap.
Step 1c: Remove capsule Separate one of the blisters from the blister card. Peel open the blister and remove the capsule. Do not push the capsule through the foil. Do not swallow the capsule.
Step 3c: Hold breath Hold your breath for up to 5 seconds. Important Information
Step 1d: Insert capsule Never place a capsule directly into the mouthpiece.
Step 1e: Close inhaler
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Frequently Asked Questions
Your Seebri Breezhaler Inhaler pack contains:
Capsule chamber
Why didn't the inhaler make a noise when I inhaled? The capsule may be stuck in the capsule chamber. If this happens, carefully loosen the capsule by tapping the base of the inhaler. Inhale the medicine again by repeating steps 3a to 3c.
Mouthpiece
Screen
Base Inhaler
Side buttons
Blister Inhaler base
Blister Card
What should I do if there is powder left inside the capsule? You have not received enough of your medicine. Close the inhaler and repeat steps 3a to 3c. I coughed after inhaling
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Cleaning the inhaler Wipe the mouthpiece inside and outside with a clean, dry, lint-free cloth to remove any powder residue. Keep the inhaler dry. Never wash your inhaler with water.
Disposing of the inhaler after use Each inhaler should be disposed of after all capsules have been used. Ask your pharmacist how to dispose of medicines and inhalers that are no longer required.
Seebri Breezhaler 44 micrograms inhalation powder (hard capsules) comes as capsule containing 44mcg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Seebri Breezhaler 44 micrograms inhalation powder (hard capsules) is glycopyrronium bromide.
This leaflet reproduces the patient information leaflet approved for Seebri Breezhaler 44 micrograms inhalation powder (hard capsules), as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Seebri Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Posology
The recommended dose is the inhalation of the content of one capsule once daily using the Seebri Breezhaler inhaler.
Seebri Breezhaler is recommended to be administered, at the same time of the day each day. If a dose is missed, the next dose should be taken as soon as possible. Patients should be instructed not to take more than one dose in a day.
Special populations
Elderly population
Seebri Breezhaler can be used at the recommended dose in elderly patients (75 years of age and older) (see section 4.8).
Renal impairment
Seebri Breezhaler can be used at the recommended dose in patients with mild to moderate renal impairment. In patients with severe renal impairment or end-stage renal disease requiring dialysis Seebri Breezhaler should be used only if the expected benefit outweighs the potential risk since the systemic exposure to glycopyrronium may be increased in this population (see sections 4.4 and 5.2).
Hepatic impairment
No studies have been conducted in patients with hepatic impairment. Glycopyrronium is predominantly cleared by renal excretion and therefore no major increase in exposure is expected in patients with hepatic impairment. No dose adjustment is required in patients with hepatic impairment.
Paediatric population
There is no relevant use of Seebri Breezhaler in the paediatric population (under 18 years) in the indication COPD.
Method of administration
For inhalation use only.
The capsules must be administered only using the Seebri Breezhaler inhaler (see section 6.6).
The capsules must only be removed from the blister immediately before use.
The capsules must not be swallowed.
Patients should be instructed on how to administer the medicinal product correctly. Patients who do not experience improvement in breathing should be asked if they are swallowing the medicinal product rather than inhaling it.
For instructions on use of the medicinal product before administration, see section 6.6.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Not for acute use
Seebri Breezhaler is a once-daily, long-term maintenance treatment and is not indicated for the initial treatment of acute episodes of bronchospasm, i.e. as a rescue therapy.
Hypersensitivity
Immediate hypersensitivity reactions have been reported after administration of Seebri Breezhaler. If signs suggesting allergic reactions occur, in particular, angioedema (including difficulties in breathing or swallowing, swelling of the tongue, lips, and face), urticaria or skin rash, treatment should be discontinued immediately and alternative therapy instituted.
Paradoxical bronchospasm
In clinical studies with Seebri Breezhaler, paradoxical bronchospasm was not observed. However, paradoxical bronchospasm has been observed with other inhalation therapy and can be life-threatening. If this occurs, treatment should be discontinued immediately and alternative therapy instituted.
Anticholinergic effect
Seebri Breezhaler should be used with caution in patients with narrow-angle glaucoma or urinary retention.
Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using Seebri Breezhaler and to contact their doctor immediately should any of these signs or symptoms develop.
Patients with severe renal impairment
A moderate mean increase in total systemic exposure (AUClast) of up to 1.4-fold was seen in subjects with mild and moderate renal impairment and up to 2.2-fold in subjects with severe renal impairment and end-stage renal disease. In patients with severe renal impairment (estimated glomerular filtration rate below 30 ml/min/1.73 m2), including those with end-stage renal disease requiring dialysis, Seebri Breezhaler should be used only if the expected benefit outweighs the potential risk (see section 5.2). These patients should be monitored closely for potential adverse reactions.
Patients with a history of cardiovascular disease
Patients with unstable ischaemic heart disease, left ventricular failure, history of myocardial infarction, arrhythmia (excluding chronic stable atrial fibrillation), a history of long QT syndrome or whose QTc (Fridericia method) was prolonged (>450 ms for males or >470 ms for females) were excluded from the clinical trials, and therefore the experience in these patient groups is limited. Seebri Breezhaler should be used with caution in these patient groups.
Excipients
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
The co-administration of Seebri Breezhaler with other anticholinergic-containing medicinal products has not been studied and is therefore not recommended.
Although no formal drug interaction studies have been performed, Seebri Breezhaler has been used concomitantly with other medicinal products commonly used in the treatment of COPD without clinical evidence of drug interactions. These include sympathomimetic bronchodilators, methylxanthines, and oral and inhaled steroids.
In a clinical study in healthy volunteers, cimetidine, an inhibitor of organic cation transport which is thought to contribute to the renal excretion of glycopyrronium, increased total exposure (AUC) to glycopyrronium by 22% and decreased renal clearance by 23%. Based on the magnitude of these changes, no clinically relevant drug interaction is expected when glycopyrronium is co-administered with cimetidine or other inhibitors of organic cation transport.
Concomitant administration of glycopyrronium and orally inhaled indacaterol, a beta2-adrenergic agonist, under steady-state conditions of both active substances did not affect the pharmacokinetics of either medicinal product.
Pregnancy
There are no data from the use of Seebri Breezhaler in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). Glycopyrronium should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the foetus.
Breast-feeding
It is unknown whether glycopyrronium bromide is excreted in human milk. However, glycopyrronium bromide (including its metabolites) was excreted in the milk of lactating rats (see section 5.3). The use of glycopyrronium by breast-feeding women should only be considered if the expected benefit to the woman is greater than any possible risk to the infant (see section 5.3).
Fertility
Reproduction studies and other data in animals do not indicate a concern regarding fertility in either males or females (see section 5.3).
Glycopyrronium has no or negligible influence on the ability to drive and use machines.
Summary of the safety profile
The most common anticholinergic adverse reaction was dry mouth (2.4%). The majority of the reports of dry mouth were suspected to be related to the medicinal product and were mild, with none being severe.
The safety profile is further characterised by other symptoms related to the anticholinergic effects, including signs of urinary retention, which were uncommon. Gastrointestinal effects including gastroenteritis and dyspepsia were also observed. Adverse reactions related to local tolerability included throat irritation, nasopharyngitis, rhinitis and sinusitis.
Tabulated summary of adverse reactions
Adverse reactions reported during the first six months of two pooled pivotal Phase III trials of 6 and 12 months duration are listed by MedDRA system organ class (Table 1). Within each system organ class, the adverse reactions are ranked by frequency, with the most frequent reactions first. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category for each adverse reaction is based on the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Table 1 Adverse reactions
Adverse reactions
Frequency category
Infections and infestations
Nasopharyngitis1)
Common
Rhinitis
Uncommon
Cystitis
Uncommon
Immune system disorders
Hypersensitivity
Uncommon
Angioedema2)
Uncommon
Metabolism and nutrition disorders
Hyperglycaemia
Uncommon
Psychiatric disorders
Insomnia
Common
Nervous system disorders
Headache3)
Common
Hypoaesthesia
Uncommon
Cardiac disorders
Atrial fibrillation
Uncommon
Palpitations
Uncommon
Respiratory, thoracic and mediastinal disorders
Sinus congestion
Uncommon
Productive cough
Uncommon
Throat irritation
Uncommon
Epistaxis
Uncommon
Dysphonia2)
Uncommon
Paradoxical bronchospasm2)
Not known
Gastrointestinal disorders
Dry mouth
Common
Gastroenteritis
Common
Nausea2)
Uncommon
Vomiting1) 2)
Uncommon
Dyspepsia
Uncommon
Dental caries
Uncommon
Skin and subcutaneous tissue disorders
Rash
Uncommon
Pruritus2)
Uncommon
Musculoskeletal and connective tissue disorders
Musculoskeletal pain1) 2)
Common
Pain in extremity
Uncommon
Musculoskeletal chest pain
Uncommon
Renal and urinary disorders
Urinary tract infection3)
Common
Dysuria
Uncommon
Urinary retention
Uncommon
General disorders and administration site conditions
Fatigue
Uncommon
Asthenia
Uncommon
1) More frequent for glycopyrronium than placebo in the 12 months database only.
2) Reports have been received from post-approval marketing experience in association with the use of Seebri Breezhaler. These were reported voluntarily from a population of uncertain size, and it is therefore not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure. Therefore the frequency was calculated from clinical trial experience.
3) Seen more frequently for glycopyrronium than placebo in elderly >75 years only.
Description of selected adverse reactions
In the pooled 6-month database the frequency of dry mouth was 2.2% versus 1.1%, of insomnia 1.0% versus 0.8%, and of gastroenteritis 1.4% versus 0.9%, for Seebri Breezhaler and placebo respectively.
Dry mouth was reported mainly during the first 4 weeks of treatment with a median duration of four weeks in the majority of patients. However in 40% of cases symptoms continued for the entire 6-month period. No new cases of dry mouth were reported in months 7-12.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
High doses of glycopyrronium may lead to anticholinergic signs and symptoms for which symptomatic treatment may be indicated.
Acute intoxication by inadvertent oral ingestion of Seebri Breezhaler capsules is unlikely due to the low oral bioavailability (about 5%).
Peak plasma levels and total systemic exposure following intravenous administration of 150 micrograms glycopyrronium bromide (equivalent to 120 micrograms glycopyrronium) in healthy volunteers were respectively about 50-fold and 6-fold higher than the peak and total exposure at steady-state achieved with the recommended dose (44 micrograms once daily) of Seebri Breezhaler and were well tolerated.
Medicines sold in Poland with the same active substance: W Polsce znany jako
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
Ask anything about Seebri Breezhaler 44 micrograms inhalation powder (hard capsules). The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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