Trimbow Inhalers

Trimbow is a breathing aid medication that contains three active ingredients: beclomethasone dipropionate, formoterol fumarate dihydrate, and glycopyrronium. Regular treatment with these three active substances helps to alleviate and prevent symptoms such as shortness of breath, wheezing, and cough in adult patients with chronic obstructive pulmonary disease (COPD). Trimbow may reduce exacerbations (worsening) of COPD symptoms. COPD is a serious, long-term disease in which the airways become blocked and the air sacs inside the lungs become damaged, causing difficulty in breathing.

Trimbow contains beclomethasone dipropionate, formoterol, and glycopyrronium in a solution formulation that generates an aerosol with extra-fine particles with an average median aerodynamic mass diameter (DAMM) of approximately 1.1 microns and co-deposition of all three components. Trimbow's aerosol particles are on average much smaller than those supplied with non-extra-fine formulations. For beclomethasone dipropionate, this results in a more potent effect than for formulations with a non-extra-fine particle size distribution (100 micrograms of superfine beclomethasone dipropionate in Trimbow equals 250 micrograms of beclomethasone dipropionate in a formulation not superfine).

Beclomethasone dipropionate

Beclomethasone dipropionate administered by inhalation in the recommended doses has a glucocorticoid anti-inflammatory action in the lungs. Glucocorticoids are commonly used for suppression of inflammation in chronic inflammatory airway diseases such as COPD. Its action is mediated by the binding to glucocorticoid receptors in the cytoplasm, which causes an increase in the transcription of genes that encode anti-inflammatory proteins.

Formoterol

Formoterol is a selective beta2 adrenergic agonist that produces relaxation of the bronchial smooth muscle in patients with reversible airway obstruction. The bronchodilator effect is established rapidly, within 1-3 minutes after inhalation, and lasts for 12 hours after a single dose.

Trimbow Inhalers uses include being indicated in the treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately controlled with a combination of an inhaled corticosteroid and a long-acting beta2-agonist or a combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist (for effects on symptom control and prevention of exacerbations.

Always use this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist again.

Adults

The recommended dose is two doses in the morning and two doses in the evening.

If you think the medicine is not working very well, see your doctor.

If you have been using another inhaler containing beclomethasone dipropionate before, consult your doctor as the effective dose of trimbow beclomethasone dipropionate for the treatment of COPD may be lower than that of other inhalers.

Trimbow is for inhalation use only.

You must inhale the medicine through your mouth, which brings the medicine directly to the lungs.

This medicine is in a pressurized container inside a plastic inhaler with a mouth applicator.

Trimbow is available in three package sizes:

• a container that provides 60 doses
• a container that provides 120 doses
• a container that provides 180 doses

Stand up or sit upright to inhale. IMPORTANT: Do not perform steps 2 to 5 too quickly.

1. Remove the protective cap from the oral applicator and check that the applicator is clean, that is, that there are no traces of dust or dirt.
2. Exhale as slowly and deeply as possible to empty your lungs.
3. Hold the inhaler straight with the mouthpiece down and place the mouthpiece between your teeth without biting it. Then place your lips around the mouthpiece, with your tongue flat under it.
4. Breathe in slowly and deeply through your mouth to fill your lungs with air (this should take about 4-5 seconds). Right after you start to inhale, firmly squeeze the top of the pressure pack to release a dose.
5. Hold your breath as long as you can and finally remove the inhaler from your mouth and breathe out slowly. Do not expel air through the inhaler.
6. Check that the dose counter (60/120 doses) has subtracted one unit or that the dose indicator (180 doses) has rotated slightly.

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

There is a risk of worsening shortness of breath and wheezing immediately after using Trimbow, known as paradoxical bronchospasm (may affect up to 1 in 1,000 people). If this occurs, you should discontinue treatment with Trimbow and use your quick-acting “rescue” inhaler without delay to treat shortness of breath and wheezing. You should contact your doctor immediately.

Tell your doctor immediately

if you experience allergic reactions such as skin allergies, hives, itchy skin, rash (may affect up to 1 in 100 people), redness of the skin, swelling of the skin or mucous membranes, especially of the eyes, face, lips, and throat (may affect up to 1 in 1,000 people).

if you experience eye pain or discomfort, transient blurred vision, visual halos, or colored images associated with red eyes. These may be signs of an acute narrow-angle glaucoma crisis (may affect up to 1 in 10,000 people).

Tell your doctor if you notice any of the following symptoms while using Trimbow, as they may be due to lung infection (may affect up to 1 in 10 people):

• fever or chills
• increased mucus production, change in mucus colour
• increased cough or shortness of breath

Possible side effects are listed below according to their frequency.

Common Trimbow Inhalers side effects(may affect up to 1 in 10 people):

• sore throat
• runny or stuffy nose and sneezing
• fungal infections of the mouth. Rinsing your mouth or gargling with water and brushing your teeth immediately after inhalation can help prevent these side effects.
• hoarseness
• headache
• urinary tract infection

Uncommon Trimbow Inhalers side effects (may affect up to 1 in 100 people):

• flu
• inflammation of the paranasal sinuses
• itchy, runny or stuffy nose
• fungal infections of the throat or alimentary canal (esophagus)
• yeast infections of the vagina
• agitation
• tremor
• dizziness
• abnormalities or reduced sense of taste
• numbness
• inflammation of the ear
• irregular heartbeat
• changes in the electrocardiogram (cardiac tracing)
• unusually fast heartbeat and heart rhythm disturbances
• palpitations (feeling of abnormal heartbeat)
• redness of the face
• increased blood flow to somebody tissues
• cough and productive cough
• throat irritation
• nosebleed
• dry mouth
• diarrhea
• swallowing difficulties
• sickness
• upset stomach
• stomach upset after meals
• burning sensation on the lips
• cavities
• skin rash, hives, itchy skin
• inflammation of the lining of the mouth with or without ulcers
• increased sweating
• muscle cramps and muscle pain
• pain in arms or legs
• pain in the chest muscles, bones, or joints
• fatigue
• Increased blood pressure
• decreased levels of some components of the blood: of certain white blood cells called granulocytes, potassium or cortisol
• increased levels of some components of the blood: glucose, C-reactive protein, number of platelets, insulin, free fatty acids or ketones

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

• yeast infections in the chest
• decreased appetite
• sleep disorders (sleeping too little or too much)
• oppressive chest pain
• A feeling of missing a heartbeat, unusually slow heartbeat
• A spill of blood from a blood vessel to the tissues around it
• Decreased blood pressure
• weakness
• pain in the back of the mouth and throat
• inflammation and redness of the pharynx
• throat dryness
• frequent and painful urination
• difficulty and pain when urinating
• inflammation of the kidneys

Very rare (may affect up to 1 in 10,000 people):

• low level of the number of certain blood cells called platelets
• choking sensation or shortness of breath
• swelling of the hands and feet
• growth retardation in children and adolescents

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