Brimica Genuair 340 mcg / 12 mcg. 60 doses

What Brimica Genuair is and what it is used for

What is Brimica Genuair?

This medicine contains two active ingredients called aclidinium and formoterol fumarate dihydrate. Both belong to a group of drugs called bronchodilators. Bronchodilators relax the muscles in the airways, which opens them wider and helps you breathe more easily. The Genuair inhaler delivers the active ingredients directly into your lungs when inhaled.

What Brimica Genuair is used for

Brimica Genuair is used in adult patients who have difficulty breathing due to a lung disease called chronic obstructive pulmonary disease (COPD), where the airways and alveoli in the lungs become damaged or blocked. By opening the airways, the drug helps relieve symptoms such as shortness of breath. Taking Brimica Genuair regularly will help minimize the effects of COPD in your daily life.

2. What you need to know before you use Brimica Genuair

Do not use Brimica Genuair:

if you are allergic to aclidinium, formoterol fumarate dihydrate or to the other ingredient of this medicine, lactose (see section 2 under "Brimica Genuair contains lactose").

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Brimica Genuair if you have any of the following diseases/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 one of the adrenal glands (phaeochromocytoma).

If you have difficulty urinating or problems due to an enlarged prostate.

If you have an eye disease called narrow-angle glaucoma, which causes higher pressure in the eye.

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

If you have sudden difficulty breathing or swallowing, if you have swelling of your tongue, throat, lips or face, or a skin rash and/or itching. These may be signs of an allergic reaction.

If you experience sudden chest tightness, coughing, wheezing or shortness of breath immediately after using the medicine. These may be signs of a condition called 'paroxysmal bronchospasm', which is an excessive and prolonged contraction of the muscles of the airways immediately after administration of bronchodilator treatment.

Brimica Genuair is used for the maintenance (long-term) treatment of COPD. You should not use this medicine to treat a sudden attack of breathlessness or wheezing.

If your usual COPD symptoms (shortness of breath, wheezing, cough) do not improve or get worse when using Brimica Genuair, you should continue to use it, but consult a doctor as soon as possible, as you may need another medicine.

If you see a halo around a light source or colored images, have pain or discomfort in your eyes, or temporary blurred vision, consult your doctor immediately.

Dry mouth is seen with medicines such as Brimica Genuair. After prolonged use, dry mouth can be associated with tooth damage, so it is important to take care of your oral hygiene.

Children and adolescents

Brimica Genuair should not be used in children and 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 any other medicines, the effect of Brimica Genuair or the other medicines may change.

Tell your doctor or pharmacist if you are taking:

Any medicines that may be similar to Brimica Genuair to treat breathing difficulties.

Medicines that lower the level of potassium in the blood. They include:

corticosteroids that you may take by mouth (such as prednisolone);

diuretics (such as furosemide or hydrochlorothiazide);

certain medicines used to treat breathing-related conditions (such as theophylline).

Medicines called beta blockers, which may be used to treat high blood pressure and other heart problems (such as atenolol and propranolol) or to treat glaucoma (such as timolol).

Medicines that can cause a type of change in the heart's electrical activity known as QT prolongation (seen on an electrocardiogram). These include medicines to treat:

depression (such as monoamine oxidase inhibitors or tricyclic antidepressants);

bacterial infections (such as erythromycin, clarithromycin, telithromycin);

allergic reactions (antihistamines).

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, talk to your doctor, nurse or pharmacist before using this medicine. You should not use Brimica Genuair if you are pregnant or breast-feeding, unless

Driving and using machines

Brimica Genuair is unlikely to affect your ability to drive or use machines. In some patients, this drug may cause blurred vision or dizziness. If you have these side effects, do not drive or operate machinery until the dizziness passes or your vision returns to normal.

Brimica Genuair contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult 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. If you are not sure, ask your doctor or pharmacist.

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

The effect of Brimica Genuair lasts 12 hours; therefore, you should try to use Brimica Genuair at the same time in the morning and in the evening, as this ensures that there is always enough of the medicine in your body, which helps you to breathe more easily during the day and at night. It will also help you remember to use it.

Instructions for use: Read point 7 at the end of the leaflet for instructions on how to use the Genuair inhaler. If you are not sure how to use Brimica Genuair, ask your doctor or pharmacist.

You can use Brimica Genuair anytime before or after food and drink.

COPD is a chronic disease, which is why Brimica Genuair should be used every day, twice a day, not just when you have breathing problems or other COPD symptoms.

The recommended dose can be used in elderly patients and in patients with kidney or liver problems. No dose adjustment is necessary in such patients.

If you have used more Brimica Genuair than you should

If you think you may have used more Brimica Genuair than you should, it is very possible to experience any of the following side effects, such as blurred vision, dry mouth, nausea, shaking/tremor, headache, palpitations or increased blood pressure, due to which you should immediately contact your doctor or visit the nearest emergency department. Show Brimica Genuair packaging. Medical treatment may be required.

If you forget to use Brimica Genuair

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

If you have stopped using Brimica Genuair

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

If you have any further questions on the use of this medicine, ask 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: if you get any of them, tell your doctor straight away.

Uncommon: may affect up to 1 in 100 peopleM

Muscle weakness, muscle twitching and/or abnormal heart rhythm, as these may be signs of low potassium levels in the blood.

Tiredness, increased thirst and/or the need to urinate more often than usual, as these may be signs of increased blood sugar.

Palpitations, as this may be a sign of an abnormally fast heartbeat or abnormal heart rhythm.

Rare: may affect up to 1 in 1,000 people:

Chest tightness, coughing, wheezing, or shortness of breath immediately after using the medicine.

Sudden difficulty breathing or swallowing, swelling of the tongue, throat, lips or face, skin rash and/or itching - these may be signs of an allergic reaction.

Not known (frequency cannot be estimated from the available data):

Swelling of the face, throat, lips or tongue (with or without difficulty breathing or swallowing), very itchy skin rash (hives), as these may be symptoms of an allergic reaction.

While using Brimica Genuair, other side effects may occur:

Common: may affect up to 1 in 10 people:

a combination of sore throat and runny nose - these may be manifestations of nasopharyngitis;

headache;

painful and/or frequent urination - these may be signs of a urinary tract infection;

cough;

diarrhea;

stuffy, runny nose and/or pain or a feeling of pressure in the cheeks or forehead – these may be signs of sinusitis;

dizziness;

muscle cramps;

nausea;

insomnia;

dry mouth;

muscle pain;

swelling of the hands, ankles, or feet;

abscess (infection) of tissues in and/or around the root of a tooth;

increased blood levels of a protein found in muscles called creatine phosphokinase;

shaking / tremor;

anxiety.

Uncommon:

rapid heartbeat (tachycardia);

pain in the chest area

5. How to store Brimica Genuair

Keep out of the 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 corresponds to the last day of the specified month.

This medicinal product does not require special temperature storage conditions.

Keep the Genuair inhaler protected in the sealed pouch until administration begins.

To be used within 60 days of opening the pouch.

Do not use Brimica Genuair if you notice that the package is damaged or appears to have been opened.

After taking the last dose, the inhaler should be thrown away. Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information

What Brimica Genuair contains

The active substances are: aclidinium bromide and formoterol fumarate dihydrate. Each supplied dose contains 396 micrograms of aclidinium bromide, equivalent to 340 micrograms of aclidinium, and 11.8 micrograms of formoterol fumarate dihydrate.

The other ingredient is: lactose monohydrate.

What Brimica Genuair looks like and contents of the pack

Brimica Genuair is a white or off-white powder.

The Genuair inhaler is a white product with a built-in dose indicator and an orange dosing button. The mouthpiece is covered with a removable protective cap in orange color. Supplied in a sealed protective aluminum pouch containing a desiccant sachet.

Offered types of packaging:

Cardboard box containing 1 inhaler with 30 doses.

Cardboard box containing 1 inhaler with 60 doses.

Cardboard box containing 3 inhalers, each with 60 doses.

Not all types of packaging can be put on sale.