4. Possible side effects

…..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: (see details below). By reporting side effects you can help provide more information on the safety of this medicine. 

Ireland

HPRA Pharmacovigilance

Website: www.hpra.ie

Malta

ADR Reporting Website:

www.medicinesauthority.gov.mt/adrportal

By reporting side effects you can help provide more information on the safety of this medicine. 

6. Contents of the pack and other information

Marketing Authorisation Holder and Manufacturer

…….

Bricanyl Turbohaler is manufactured by AstraZeneca AB, Forskargatan 18, SE-151 36 Södertälje, Sweden.

FURTHER INFORMATION ABOUT ASTHMA

 If you would like further information about asthma and its treatment, please contact:

Asthma Society of Ireland, 26 Mountjoy Square, Dublin 1.

Asthma Information Line: 1850 44 54 64

This leaflet was last revised in October 2023 March 2024.

Bricanyl and Turbohaler are trade marks of the AstraZeneca group of companies.

© AstraZeneca 2023 2024

RSP 23 0019 RSP 23 0020

6.Contents of the pack and other information

.....

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation for Bricanyl Turbohaler is held by AstraZeneca AB, SE-151 85 Södertälje, Sweden.

Bricanyl Turbohaler is manufactured by AstraZeneca AB, SE-151 85 Forskargatan 18, SE-151 36 Södertälje, Sweden.

.......

This leaflet was last revised in January 2023 October 2023.

......

RSP 22 0000RSP 23 0019

6.Contents of the pack and other information

.....

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation for Bricanyl Turbohaler is held by AstraZeneca AB, SE-151 85 Södertälje, Sweden.

Bricanyl Turbohaler is manufactured by AstraZeneca AB, SE-151 85 Forskargatan 18, SE-151 36 Södertälje, Sweden.

.......

This leaflet was last revised in January 2023 October 2023.

......

RSP 22 0000RSP 23 0019

3.      How to use Bricanyl Turbohaler 

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. If Bricanyl Turbohaler is to be used by a child, make sure that they use it correctly.

Bricanyl Turbohaler should be used as required rather than regularly.

Seek medical attention right away if your asthma symptoms (cough, breathlessness, wheezing or tight chest) are getting worse or if you are too breathless to speak, eat or sleep.

You must contact your doctor as soon as possible if you need higher doses of Bricanyl Turbohaler than usual to relieve your breathing problems. Your doctor may want to change your asthma medicine to improve your breathing.

If you use Bricanyl Turbohaler more than twice a week to treat your asthma symptoms, this indicates poorly controlled asthma and may increase the risk of severe asthma attacks (worsening of asthma) that can have serious complications and may be life-threatening or even fatal. You should contact your doctor as soon as possible to review your asthma treatment.

If you use a medicine against inflammation of your lungs daily, e.g., “inhaled corticosteroid”, it is important to continue using it regularly, even if you feel better.

6.      Contents of the pack and other information

[...]

This leaflet was last revised in January 2023 December 2019.

4.4               Special warnings and precautions for use

Patients should be instructed in proper use and their inhalation technique checked regularly.

With each inhalation a fraction of the delivered dose will be deposited in the oral cavity. To minimize unnecessary systemic exposure to terbutaline, the patients should be advised to, when possible, rinse their mouth after each use. For further information see section 4.9.

Patients who are prescribed regular anti-inflammatory therapy should be advised to continue taking their anti-inflammatory medication even when symptoms decrease and they do not require Bricanyl Turbohaler.

If a previously effective dosage regimen no longer gives the same symptomatic relief, the patient should urgently seek further medical advice as soon as possible as this could be a sign of worsening asthma and warrants a reassessment of the asthma therapy. Consideration should be given to the requirements for additional therapy (including increased dosages of anti-inflammatory medication). Severe exacerbations of asthma should be treated as an emergency in the usual manner.

As for all beta₂-agonists caution should be observed in patients with thyrotoxicosis. 

Overuse of short-acting beta-agonists may mask the progression of the underlying disease and contribute to deteriorating asthma control, leading to an increased risk of severe asthma exacerbations and mortality.

Patients who take more than twice a week additional “as needed” terbutaline should be re-evaluated for proper treatment adjustment as these patients are at risk for overuse of terbutaline.

[...]

10.  Date of revision of the text

18^th January 2023 8th June 2020.

Section 2 – qualitative and quantitative composition of product updated

Section 3 – Pharmaceutical form and description of product updated

Section 4.2 – Editorial update to align with QRD template

Section 4.3 – Updated in line with QRD template

Section 4.4 – Information relating to the inclusion of lactose monohydrate added.

Section 4.8 – Updated with information relating to lactose.

Section 5.2 – Pharmacokinetic properties information updated.

Section 6.1 – Lactose monohydrate added as an excipient.

Section 6.5 – number of metered doses updated from 100 to 120 doses.

Section 6.6 – Updated in line with QRD template.

Section 7 – Marketing Authorisation Holder updated.

Section 8 – Marketing Authorisation Number updated.

Section 10 – Date of revision updated.

Section 2 update to spelling of ‘sulfate’

Section 5.1 update to spelling of ‘sulfate’

Section 10 update to date of revision

Section 4.4- addition of cross reference to 4.9

Section Section 4.9- information on accumulation of dry powder in the mouthpiece

Section 10 – Update to "Date of Revision"

Section 4.4

Paragraph inserted after paragraph 1.

With each inhalation a fraction of the delivered dose will be deposited in the oral cavity. To minimize unnecessary systemic exposure to terbutaline, the patients should be advised to, when possible, rinse their mouth after each use.

Section 10

Date of revision changed to 5^th April 2012

Section 4.5

Additional paragraph added at end of section, reads as,

” There are some data which indicate that there is a risk of interaction between monoamine oxidase inhibitors, tricyclic antidepressants and terbuatline.”

Section 10

13th August 2010