340 micrograms / 12 micrograms inhaled powder 
aclidinium / formoterol fumarate dihydrate

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

What Brimica Genuair is

This medicine contains two active substances called aclidinium and formoterol fumarate dihydrate. Both belong to a group of drugs called bronchodilators. Bronchodilators make the muscles in the airways relax, which makes the airways open more and you can breathe easier. The Genuair inhaler delivers the active substances directly to your lungs as you inhale.

What Brimica Genuair is used for

Brimica Genuair is used for adult patients who have difficulty breathing due to a lung disease called chronic obstructive pulmonary disease (COPD), in which the airways and alveoli of the lungs have been damaged or blocked. By opening the airways, the drug relieves symptoms such as shortness of breath. Regular use of Brimica Genuair reduces the effects of COPD in your daily life.

2. What you need to know before using Brimica Genuair

Do not use Brimica Genuair

  • if you are allergic to aclidinium, formoterol fumarate dihydrate 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 Brimica Genuair if you have any of the following conditions / symptoms:

  • If you have asthma . This medicine should not be used to treat asthma .
  • If you have heart problems.
  • If you have epilepsy .
  • If you have thyroid problems ( thyrotoxicosis ).
  • If you have a tumor in any of the adrenal glands ( pheochromocytoma ).
  • If you have difficulty urinating or have problems due to an enlarged prostate .
  • If you have an eye condition called narrow-angle glaucoma, which results in high pressure in the eye.

Stop taking Brimica Genuair and seek medical attention immediately  if you experience any of the following :

  • If you suddenly have pressure over your chest, cough, wheeze or become short of breath right after taking the medicine. See section 4.

Brimica Genuair is used for (long-term) maintenance treatment of COPD. It should not be used to treat a sudden onset of shortness of breath or wheezing.

If your common COPD symptoms (shortness of breath, wheezing and coughing) do not get better or worse while you are using Brimica Genuair, you should continue to use the medicine but contact your doctor as soon as possible as you may need another medicine.

If you see halos around lights or color images, have eye pain or discomfort or suffer from temporary blurred vision, contact and consult your doctor as soon as possible.

Dry mouth has been observed with drugs like Brimica Genuair. In the long run, dry mouth can lead to cavities in the teeth, so it is important that you are careful with oral hygiene.

Children and young people

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

Other medicines and Brimica Genuair

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. If you use Brimica Genuair with certain other medicines, the effect of Brimica Genuair or the other medicines may change.

Tell your doctor or pharmacist if you are taking:

  • medicines similar to Brimica Genuair used to treat breathing difficulties,
  • drugs that lower the amount of potassium in the blood. These include:
    • Corticosteroids are those that you take by mouth (eg prednisolone ),
    • diuretics (eg furosemide or hydrochlorothiazide ),
    • certain medicines used to treat respiratory conditions (eg theophylline),
  • drugs called beta-blockers that can be used to treat high blood pressure or other heart problems (eg atenolol or propranolol) or to treat glaucoma (eg timolol ),
  • drugs that can cause a type of change in the electrical activity of the heart, called prolongation of the QT interval (observed with ECG ). These include drugs for the treatment of:
    • depression (eg monoamine oxidase inhibitors or tricyclic antidepressants ),
    • bacterial infections (eg erythromycin, clarithromycin, and telithromycin),
    • allergic reactions ( antihistamines ).

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, nurse, or pharmacist for advice before taking this medicine. You should not use Brimica Genuair if you are pregnant or breast-feeding unless your doctor tells you to.

Driving and using machines

It is unlikely that Brimica Genuair will affect your ability to drive and use machines. In some patients, this medicine may cause blurred vision or dizziness. If you experience any of these side effects, do not drive or use machines until the dizziness has disappeared and you have regained normal eyesight.

Brimica Genuair 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. How to use Brimica 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 in the morning and one inhalation in the evening.
  • You can use Brimica Genuair at any time before or after eating or drinking.
  • The effects of Brimica Genuair last for 12 hours and therefore you should try to use Brimica Genuair at the same time every morning and evening. This ensures that there are always enough medicines in your body to help you breathe easier throughout the day and night. It also helps you to remember to use the medicine if you take it at regular intervals.
  • The recommended dose can be used in elderly patients and in patients with renal or hepatic impairment. No dose adjustments are needed for these patients.
  • Brimica Genuair is intended for inhalation .
  • Instructions for use: See the Instructions for Use at the end of this leaflet for instructions on how to use the Genuair inhaler. Contact your doctor or pharmacist if you are not sure how to use Brimica Genuair.

COPD is a long-term disease and therefore Brimica Genuair is intended for long-term use. The drug should be used every day, twice daily, and not just when you experience breathing problems or other symptoms of COPD.

If you use more Brimica Genuair than you should  

If you think you have used too much Brimica Genuair you will probably experience some of the side effects, e.g. blurred vision, dry mouth, nausea, tremors / tremor, headache, palpitations, or high blood pressure, and therefore you must contact a doctor immediately or go to the nearest emergency department. Show the packaging with Brimica Genuair. Medical treatment may be required.

If you forget to use Brimica Genuair

If you miss a dose of Brimica Genuair, take one dose as soon as possible and take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop using Brimica 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.

Stop taking the medicine and contact a doctor immediately if you:

  • get swelling of the face, neck, lips, or tongue (with or without difficulty breathing or swallowing), severely itchy raised rash on the skin ( hives ), as it may be a sign of an allergic reaction . The frequency of this reaction can not be calculated from the available data.
  • get pressure over the chest, cough, wheezing, or shortness of breath immediately after using the drug. This may be a sign of a condition called ‘paradoxical bronchospasm’, which is a large and prolonged contraction of the airway muscles immediately after treatment with bronchodilators. This reaction is rare (may affect up to 1 in 1,000 people).

Some side effects can be serious: if you get any of these side effects, talk to your doctor immediately.

Uncommon (may affect up to 1 in 100 people)

  • Muscle weakness, jerky and/or abnormal heart rhythm, may be signs of a decrease in the amount of potassium in your blood
  • Fatigue increased thirst and/or the need to urinate more often than usual, as these may be signs of an increase in the amount of sugar in your blood
  • Palpitations may be a sign of an unusually fast heartbeat or an abnormal heart rhythm

Rare(may affect up to 1 in 1,000 people)

  • Sudden breathing or swallowing difficulties, swollen tongue, throat, lips or face, rash and/or itching – these may be signs of an allergic reaction

Other side effects that may occur when using Brimica Genuair:

Common(may affect up to 1 in 10 people)

  • Combination of sore throat and runny nose – these may be signs of a common cold ( nasopharyngitis )
  • Headache
  • Painful and/or frequent urination – these may be signs of a urinary tract infection
  • Cough
  • Diarrhea
  • A blocked, runny, or stuffy nose and/or pain or a feeling of pressure in the cheeks or the forehead – these may be signs of sinusitis ( sinusitis )
  • Dizziness
  • Muscle cramps
  • Nausea
  • Difficulty sleeping
  • Dry mouth
  • Muscle pain
  • An abscess ( infection ) in the gums
  • Elevated levels in the blood of a protein found in muscles called creatine phosphokinase
  • Shaking/tremor
  • Concern

Uncommon (may affect up to 1 in 100 people)

  • Rapid heartbeat ( tachycardia )
  • Chest pain or pressure over the chest ( angina pectoris )
  • Dimsyn
  • Altered voice ( dysphonia )
  • Difficulty urinating or a feeling that the bladder is not completely emptied ( urinary retention )
  • An abnormal heart curve (prolongation of QT interval) could potentially lead to an abnormal heart rhythm
  • Distorted taste experience ( dysgeusia )
  • Throat irritation
  • Inflammation of the mouth ( stomatitis )
  • High blood pressure
  • Concern
  • 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 Brimica 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, carton, and inhaler bag after Exp. The expiration date is the last day of the specified month.

No special storage instructions.

Keep the Genuair inhaler protected inside the sealed bag until the start of the treatment period.

Use within 60 days after opening the bag.

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

After taking the last dose, the inhaler should be discarded. Medicines should not be disposed of via 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 substances are aclidinium and formoterol fumarate dihydrate. Each delivered dose ( dose one leaving the nozzle) contains 396 micrograms of aclidinium bromide corresponding to 340 micrograms of aclidinium and 11.8 micrograms of formoterol fumarate dihydrate.
  • The other ingredient is lactose monohydrate (see the end of section 2 under “Brimica Genuair contains lactose” for more information).

What the medicine looks like and the contents of the pack

Brimica Genuair is a white or almost white inhalation powder.

The Genuair inhaler is white with an integrated dose indicator and an orange dose button. The nozzle is covered with a removable orange protective cap. The inhaler is delivered sealed in a protective aluminum bag that contains a desiccant. After removing the inhaler from the bag, discard the bag and desiccant.

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

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Muhammad Nadeem

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