322 micrograms inhaled powder 
aclidinium (aclidinium bromide)

1. What Bretaris Genuair is and what it is used for

What Bretaris Genuair is

The active substance in Bretaris Genuair is aclidinium bromide, which belongs to a group of medicines called bronchodilators. Bronchodilators help relax the airways and help keep the bronchioles open. Bretaris Genuair is a dry powder inhaler that uses your breathing to deliver the medicine directly to your lungs. This makes it easier for patients with chronic obstructive pulmonary disease (COPD) to breathe.

What Bretaris Genuair is used for

Bretaris Genuair is used to help open the airways and relieve the symptoms of COPD, a serious and long-lasting lung disease characterized by difficulty breathing. Regular use of Bretaris Genuair can help you when you have ongoing shortness of breath associated with your illness. Bretaris Genuair helps you minimize the impact of the disease on your daily life and reduce the number of worsening periods (worsening of your COPD symptoms for several days).

2. What you need to know before using Bretaris Genuair

Do not use Bretaris Genuair

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

Warnings and cautions

Talk to your doctor, pharmacist or nurse before using Bretaris Genuair.

  • if you have recently had heart problems
  • if you see a halo around lights or color images ( glaucoma )
  • if you have an enlarged prostate , problems urinating or a blockage in the bladder.

Bretaris Genuair is used for maintenance treatment and should not be used to treat a sudden onset of shortness of breath or wheezing. If your COPD symptoms (shortness of breath, wheezing, coughing) do not get better or worse, you should contact and consult your doctor as soon as possible.

Dry mouth , which has been observed with medicines similar to Bretaris Genuair, can be associated with caries if you use the medicine for a long time . Therefore, be careful with oral hygiene.

Stop taking Bretaris Genuair and seek medical attention immediately:

  • if you get pressure over your chest, cough, have wheezing or become short of breath right after taking the medicine. This may be a sign of a condition called bronchospasm .

Children and young people

Bretaris Genuair must not be used by children or adolescents under 18 years of age.

Other medicines and Bretaris Genuair

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Tell your doctor if you have taken or are taking similar medicines for breathing problems, e.g. medicines containing tiotropium or ipratropium. Ask your doctor or pharmacist if you are unsure. The use of Bretaris Genuair with these medicines is not recommended.

Pregnancy and breastfeeding

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. You should not use Bretaris Genuair if you are pregnant or breast-feeding unless your doctor tells you to.

Driving and using machines

Bretaris Genuair may have some effect on the ability to drive and use machines. This medicine may cause headache, dizziness or blurred vision. Do not drive and do not use machines until the headache has disappeared, the feeling of dizziness has passed and vision has returned to normal.

Bretaris Genuair 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. How to use Bretaris Genuair

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose is one inhalation twice daily, in the morning and in the evening.

The effects of Bretaris Genuair last for 12 hours; therefore, you should try to use your Bretaris Genuair‑ inhaler at the same time every morning and evening. This ensures that there is enough medicine in your body to help you breathe easier throughout the day and night. It also helps you remember to use it.

The recommended dose can be used in elderly patients and in patients with renal or hepatic impairment. No dose adjustments are needed.

COPD is a long-term illness and therefore it is recommended that Bretaris Genuair be used every day, twice daily, and not only when you experience breathing problems or other symptoms of COPD.

How to use the medicine

This medicine is intended for inhalation.

See the Instructions for Use for instructions on using the Genuair inhaler. If you are not sure how to use Bretaris Genuair, contact your doctor or pharmacist.

You can use Bretaris Genuair at any time before or after food or drink.

If you take more Bretaris Genuair than you should

If you happen to take a larger dose of Bretaris Genuair than you were told to, contact your doctor or pharmacist.

If you forget to use Bretaris Genuair

If you miss a dose of Bretaris Genuair, inhale one dose as soon as you remember. However, if it is almost time for your next dose , skip the missed dose .

Do not take a double dose to make up for a forgotten dose .

If you stop using Bretaris Genuair

This medicine is intended for long-term use. If you want to stop treatment, talk to your doctor first, as your symptoms may get worse.

If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Allergic reactions are rare but may occur (may affect up to 1 in 1,000 people). Stop using the medicine and contact your doctor immediately if you get swelling of the face, throat, lips, or tongue (with or without difficulty breathing or swallowing), dizziness or fainting, faster pulse, or if you get a severe itchy rash on the skin ( hives ) because this may be a symptom of an allergic reaction.

The following side effects may occur when using Bretaris Genuair:

Common: affects 1 in 10 people

  • Headache
  • Sinusitis ( sinusitis )
  • Common cold ( nasopharyngitis )
  • Cough
  • Diarrhea
  • Nausea

Uncommon : affects 1 in 100 people

  • Dizziness
  • Dry mouth
  • Oral inflammation ( stomatitis )
  • Hoarseness ( dysphonia )
  • Faster heartbeat ( tachycardia )
  • Palpitation
  • Difficulty emptying the bladder ( urine retention )
  • Dimsyn
  • Rash
  • Skin itching

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Bretaris Genuair

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 inhaler label and carton after “EXP”. The expiration date is the last day of the specified month.

Store the inhaler inside the bag until the period of use begins.

Use within 90 days after opening the bag.

Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.

After taking the last dose , the inhaler should be discarded. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is aclidinium bromide. Each delivered dose contains 375 micrograms of aclidinium bromide corresponding to 322 micrograms of aclidinium.
  • The other ingredients are lactose monohydrate (see section 2 “Bretaris Genuair contains lactose”)

What the medicine looks like and the contents of the pack

Bretaris Genuair is a white or almost white powder.

Genuair  inhaler device is white with a built-in dose indicator and a green dosage button. The nozzle is covered with a removable, green lid. It is delivered in a plastic bag.

Pack sizes available:

Carton containing 1 inhaler with 30 doses .

Carton containing 1 inhaler with 60 doses .

Carton containing 3 inhalers with 60 doses each .

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Manufacturer

Pharmaceutical Industries Almirall, SA

Ctra. Nacional II, Km. 593

08740 Sant Andreu de la Barca, Barcelona

Spain

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Muhammad Nadeem

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