Formatris Novolizer
Long-Acting Bronchodilator Inhaler for Asthma and COPD
Quick Facts About Formatris Novolizer
Key Takeaways About Formatris Novolizer
- Always use with an inhaled corticosteroid: Formatris Novolizer must never be used alone for asthma – it is always prescribed as add-on therapy to an inhaled corticosteroid (ICS) such as budesonide or fluticasone
- Rapid onset, long duration: Unlike many other LABAs, formoterol begins working within 1–3 minutes and provides bronchodilation for up to 12 hours, bridging the gap between quick-relief and maintenance therapy
- Not a rescue inhaler: Do not use Formatris Novolizer to treat sudden asthma attacks – always keep a short-acting bronchodilator (e.g. salbutamol) available for acute symptoms
- Built-in feedback system: The Novolizer device uses colour-coded indicators (red/green) and audible clicks to confirm correct dose loading and inhalation, reducing the risk of dosing errors
- Suitable from age 6: Formatris Novolizer can be used by children aged 6 years and older under medical supervision, with age-appropriate dosing
What Is Formatris Novolizer and What Is It Used For?
Formatris Novolizer is a long-acting beta-2 agonist (LABA) bronchodilator inhaler that contains formoterol fumarate dihydrate. It works by relaxing the smooth muscles in the airways, increasing airflow to the lungs and making breathing easier. It is used for maintenance treatment of asthma and COPD.
Formatris Novolizer belongs to a group of medicines called long-acting beta-2 adrenergic agonists (LABAs). The active substance, formoterol, has a dilating (relaxing and widening) effect on the smooth muscles in the airways. When you inhale formoterol, it binds to beta-2 receptors on the surface of airway smooth muscle cells, activating a chain of biochemical reactions that causes the muscle fibres to relax. This results in widened airways (bronchodilation), allowing more air to flow in and out of the lungs and making breathing significantly easier.
One of the distinguishing features of formoterol compared to other LABAs (such as salmeterol) is its rapid onset of action. Bronchodilation begins within 1–3 minutes of inhalation, which is comparable to the speed of short-acting bronchodilators like salbutamol. However, unlike short-acting bronchodilators, the effect of formoterol lasts for up to 12 hours, providing sustained relief from airway obstruction throughout the day or night.
Asthma
In asthma, Formatris Novolizer is used as regular add-on maintenance therapy alongside an inhaled corticosteroid (ICS). The Global Initiative for Asthma (GINA) guidelines recommend that LABAs should never be used alone for asthma, as monotherapy with a LABA without concurrent ICS has been associated with an increased risk of serious asthma-related events, including hospitalisation and, in rare cases, death. When combined with an ICS, formoterol provides superior asthma control compared to increasing the ICS dose alone, as demonstrated in multiple randomised controlled trials.
Formatris Novolizer can also be used as needed to prevent exercise-induced asthma symptoms (exercise-induced bronchoconstriction). Taking 1–2 inhalations before physical activity can prevent the wheezing, breathlessness, and coughing that some people with asthma experience during or after exercise. The protective effect against exercise-induced symptoms lasts for up to 12 hours after a single dose.
Chronic Obstructive Pulmonary Disease (COPD)
In patients with COPD, Formatris Novolizer is used to relieve symptoms such as breathlessness, wheezing, and chronic cough. COPD is a progressive lung disease most commonly caused by long-term cigarette smoking. The Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines recommend long-acting bronchodilators as a cornerstone of COPD management, as they provide sustained symptom relief and can improve exercise tolerance and quality of life.
Formoterol does not slow the progression of COPD or address the underlying inflammation, but it significantly improves day-to-day breathing and reduces the frequency of symptom flare-ups. For patients with moderate-to-severe COPD, formoterol is often combined with other medications, including inhaled corticosteroids and long-acting muscarinic antagonists (LAMAs), to achieve optimal symptom control.
The Novolizer is a reusable dry powder inhaler that can be refilled with medication cassettes. Unlike metered-dose inhalers (MDIs), it does not use propellant gas and is breath-actuated, meaning the powder is released only when you inhale with sufficient force. The device includes a colour indicator (red/green) and an audible click to confirm that each dose has been correctly loaded and inhaled, giving patients confidence that the medication has been properly delivered.
What Should You Know Before Taking Formatris Novolizer?
Before starting Formatris Novolizer, inform your doctor about all your medical conditions, especially cardiovascular disease, diabetes, thyroid disorders, or low potassium levels. This medicine is contraindicated only in patients with known allergy to formoterol or lactose with milk protein allergy.
Contraindications
You should not use Formatris Novolizer if:
- You are allergic to formoterol fumarate dihydrate or any of the other ingredients in this medicine (listed in the contents section below)
- You have a known allergy to milk proteins – the powder contains lactose monohydrate, which may contain trace amounts of milk protein that could trigger allergic reactions in sensitised individuals
Warnings and Precautions
Talk to your doctor or pharmacist before using Formatris Novolizer if you have or have had any of the following conditions:
- Cardiovascular disease – including coronary artery disease, heart rhythm disorders (arrhythmias), severe heart failure, or a recent heart attack. Beta-2 agonists can increase heart rate and may, in rare cases, exacerbate cardiac conditions
- Diabetes mellitus – formoterol can cause elevated blood glucose levels. If you have diabetes, more frequent blood glucose monitoring may be needed when starting or adjusting the dose of Formatris Novolizer
- Thyroid disorders (hyperthyroidism) – an overactive thyroid gland may increase sensitivity to the cardiovascular effects of beta-2 agonists
- Phaeochromocytoma – a rare hormone-producing tumour of the adrenal gland. Beta-2 agonists can provoke dangerous blood pressure spikes in patients with this condition
- Severe hypertension (very high blood pressure) – formoterol may cause further blood pressure elevation in some patients
- Aneurysm (aortic or other vascular aneurysm) – due to potential cardiovascular effects
- Severe liver disease (hepatic cirrhosis) – may affect the metabolism of formoterol
- Low potassium levels (hypokalaemia) – beta-2 agonists can further reduce serum potassium, which may lead to muscle weakness and heart rhythm disturbances. This risk is increased when formoterol is used together with corticosteroids, diuretics, or theophylline
If you experience paradoxical bronchospasm (sudden worsening of wheezing or breathing difficulty immediately after using the inhaler), stop using Formatris Novolizer immediately and contact your doctor. This is a rare but potentially serious reaction. Use your short-acting rescue inhaler (e.g. salbutamol) to relieve symptoms and seek medical advice before using Formatris Novolizer again.
If your asthma symptoms worsen or if you need to use your rescue inhaler more frequently, this may indicate that your asthma is becoming unstable. You should continue taking Formatris Novolizer but contact your doctor as soon as possible, as you may need additional treatment or a change in your medication regimen. When your asthma is well controlled, your doctor may decide to gradually reduce the dose of Formatris Novolizer.
Use in Children
Formatris Novolizer can be used by children aged 6 years and older for asthma, under the supervision of a healthcare professional. Children under 6 years of age should not use this medicine. Parents and caregivers should always supervise children when using the Novolizer inhaler to ensure correct technique. If the child cannot generate sufficient inspiratory force to trigger the device (as indicated by the absence of the click sound), an alternative delivery system should be discussed with the prescribing physician.
Pregnancy and Breastfeeding
Clinical experience with formoterol during pregnancy is limited. Animal studies have not shown harmful effects at therapeutic doses, but the potential risks during human pregnancy are not fully established. If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before using Formatris Novolizer. Your doctor will carefully weigh the benefits of continuing treatment against any potential risks to the developing baby. In general, well-controlled asthma during pregnancy is important for both maternal and foetal health, and stopping asthma medication without medical advice is not recommended.
It is not known whether formoterol passes into human breast milk. If you are breastfeeding, tell your doctor. The decision to continue breastfeeding while using Formatris Novolizer should be made together with your doctor, considering the benefit of the medicine for you and the benefit of breastfeeding for your baby.
There is only limited information on whether formoterol affects human fertility.
Driving and Operating Machinery
Formoterol may have a minor effect on the ability to drive and use machines. Side effects such as dizziness and tremor can occur after inhalation. If you experience any of these effects, you should not drive or operate machinery until the symptoms have resolved. You are responsible for assessing whether you are fit to drive or operate machinery. Always read all information in this guide, as the effects and side effects of the medicine may affect your ability to perform these tasks.
Lactose Content
Formatris Novolizer contains lactose monohydrate as an excipient. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using this medicine. The amount of lactose in this medicine does not normally cause problems for people who are lactose intolerant. However, the lactose contains trace amounts of milk protein, which may trigger allergic reactions in individuals with a known milk protein allergy.
How Does Formatris Novolizer Interact with Other Drugs?
Formatris Novolizer can interact with several medication classes, including beta-blockers (which can block its effect), corticosteroids, diuretics, theophylline, MAO inhibitors, tricyclic antidepressants, and certain heart rhythm medications. Always tell your doctor about all medications you are taking.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. The following interactions are clinically significant and may require dose adjustments, additional monitoring, or avoidance of the combination.
Drugs That May Increase the Effect of Formatris Novolizer
| Drug / Class | Category | Effect | Recommendation |
|---|---|---|---|
| Corticosteroids (e.g. budesonide, prednisolone) | Anti-inflammatory | May potentiate hypokalaemia (low potassium); however, ICS+LABA is the recommended combination for asthma | Standard combination therapy; monitor potassium with high-dose oral steroids |
| MAO inhibitors & tricyclic antidepressants | Antidepressants | Potentiate cardiovascular effects of formoterol (increased heart rate, blood pressure) | Use with extreme caution; consider alternative bronchodilator |
| Theophylline / aminophylline | Xanthine bronchodilator | Additive bronchodilation but increased risk of hypokalaemia, tachycardia, and arrhythmias | Monitor heart rate and potassium levels; dose adjustment may be needed |
| Other beta-2 agonists (e.g. salbutamol, salmeterol) | Bronchodilators | Additive beta-2 stimulation; increased risk of tremor, tachycardia, and hypokalaemia | Avoid concurrent use of two LABAs; SABA for rescue only |
| Ephedrine | Sympathomimetic | Additive sympathomimetic effects; increased cardiovascular risk | Avoid concurrent use |
| Levodopa | Parkinson’s disease | May potentiate cardiovascular side effects | Monitor heart rate and blood pressure |
Drugs That May Decrease the Effect of Formatris Novolizer
| Drug / Class | Category | Effect | Recommendation |
|---|---|---|---|
| Beta-blockers (e.g. atenolol, propranolol) | Antihypertensives | Block beta-2 receptors, reducing or abolishing the bronchodilating effect of formoterol | Avoid non-selective beta-blockers (e.g. propranolol); cardioselective beta-blockers (e.g. bisoprolol) may be used with caution if essential |
| Beta-blocker eye drops (e.g. timolol) | Glaucoma treatment | Systemic absorption can reduce bronchodilator effect | Monitor respiratory function; consider alternative glaucoma treatment |
Other Important Interactions
| Drug / Class | Category | Effect | Recommendation |
|---|---|---|---|
| Diuretics (e.g. furosemide, hydrochlorothiazide) | Blood pressure / fluid | Additive hypokalaemia risk; low potassium can increase sensitivity to cardiac glycosides | Monitor serum potassium; supplement if needed |
| Digoxin (cardiac glycosides) | Heart failure | Hypokalaemia caused by formoterol may increase the risk of digoxin toxicity and arrhythmias | Monitor potassium and digoxin levels; watch for arrhythmia signs |
| Quinidine, disopyramide, procainamide | Antiarrhythmics | May prolong QT interval; combined with formoterol may increase arrhythmia risk | Use with caution; ECG monitoring may be warranted |
| Antihistamines (e.g. terfenadine, mizolastine) | Allergy treatment | Some older antihistamines may prolong QT interval | Use modern antihistamines (e.g. cetirizine, loratadine) when possible |
| Erythromycin | Macrolide antibiotic | May prolong QT interval | Monitor for cardiac symptoms during concurrent use |
| Levothyroxine | Thyroid hormone | May increase sensitivity to beta-2 agonist cardiovascular effects | Monitor heart rate; adjust doses as needed |
Alcohol: Concurrent use of alcohol may increase the risk of cardiovascular side effects. Patients should be advised to limit alcohol consumption while using Formatris Novolizer.
Anaesthesia: If you are scheduled for surgery or dental procedures requiring anaesthesia, inform your doctor or dentist that you are using Formatris Novolizer. Certain anaesthetic agents (particularly halogenated anaesthetics) may increase sensitivity to the cardiovascular effects of beta-2 agonists.
What Is the Correct Dosage of Formatris Novolizer?
For asthma in adults, the recommended maintenance dose is 1–2 inhalations (6–12 mcg) once or twice daily. For COPD, the usual dose is 2 inhalations twice daily (morning and evening). Always follow your doctor's individual instructions, and do not exceed a total of 12 inhalations per day.
Always use Formatris Novolizer exactly as your doctor has told you. Do not change your dose without consulting your doctor first. The dose is individually determined by your prescribing physician based on your condition, symptom severity, and response to treatment.
Asthma – Adults (18 years and older)
Preventive Maintenance Therapy
Standard dose: 1 or 2 inhalations (6–12 mcg) once or twice daily, in the morning and/or at night
Maximum daily dose: 12 inhalations (72 mcg) per day, including both maintenance and as-needed doses combined
If you are using Formatris Novolizer regularly as maintenance treatment, continue using it even if you have no symptoms. Do not stop without consulting your doctor.
As-Needed Dosing (in addition to maintenance)
Additional inhalations: Extra inhalations may be taken to relieve breakthrough symptoms, up to the maximum daily dose of 12 inhalations
Maximum per occasion: Do not take more than 6 inhalations at any single time
If you regularly need more than 2 additional inhalations per day and/or more than 2 days per week beyond your maintenance dose, this may be a sign that your asthma is poorly controlled. Contact your doctor, as your treatment may need to be adjusted.
Prevention of Exercise-Induced Asthma
Dose: 2 inhalations (12 mcg) before exercise
Take the inhalations 15–30 minutes before anticipated physical activity for best protection. The protective effect lasts for up to 12 hours.
Asthma – Children and Adolescents (6 years and older)
Preventive Maintenance Therapy
Standard dose: 1 or 2 inhalations (6–12 mcg) once or twice daily, in the morning and/or at night
An adult should always supervise children when using the Novolizer inhaler to ensure correct technique and adequate inspiratory force.
Prevention of Exercise-Induced Asthma
Dose: 1 or 2 inhalations (6–12 mcg) before exercise
COPD – Adults (18 years and older)
Maintenance Therapy
Standard dose: 2 inhalations (12 mcg) in the morning and 2 inhalations (12 mcg) in the evening
Alternative: Some patients may take the entire daily dose at once (4 inhalations in the morning). Your doctor will decide what works best for you.
Maximum per occasion: Do not take more than 4 inhalations at any single time
Maximum daily dose: 4 inhalations (24 mcg) per day. Your doctor may prescribe additional as-needed doses on top of your maintenance regimen.
How to Use the Novolizer Inhaler
The Novolizer is a reusable dry powder inhaler with a unique feedback system. Follow these steps carefully for each inhalation:
- Sit or stand upright. Always hold the inhaler in a horizontal (level) position when using it.
- Remove the protective cap by sliding it forward towards the mouthpiece.
- Press the coloured dosing button firmly at the bottom of the inhaler. You should hear a loud double click, and the colour in the control window will change from red to green. Release the button. The green colour indicates the inhaler is ready to use. Do not shake the inhaler after pressing the button.
- Breathe out fully, away from the inhaler (do not exhale into the mouthpiece).
- Place your lips tightly around the mouthpiece and inhale deeply, steadily, and as quickly as possible. You should hear a clear click during inhalation, confirming that the dose was inhaled correctly. Continue inhaling even after you hear the click.
- Remove the inhaler from your mouth. Hold your breath for a few seconds, then breathe out normally.
- Check the control window – it should have returned to red, confirming successful inhalation. If it is still green, repeat the inhalation.
- Replace the protective cap.
The dose counter on the inhaler displays the number of remaining doses, counting down from 60 to 0 in intervals of 10. If you did not hear a click or the colour did not change, repeat the dosing process. If you cannot perform a correct inhalation after several attempts, consult your doctor.
The Novolizer uses replaceable medication cassettes. To load a new cassette: (1) Remove the sliding cover by pressing the grooved sides together and pulling forward. (2) Remove the aluminium seal from the cassette container and take out the cassette. (3) Insert the cassette into the inhaler with the dose counter facing the mouthpiece. Do not press the dosing button during insertion. (4) Replace the cover until it clicks into place. The cassette should be replaced every 6 months. Clean the inhaler each time you change the cassette using a soft, dry cloth. Do not use water or cleaning agents.
Missed Dose
If you forget to take a dose, take it as soon as you remember, or wait until the next scheduled time. Do not take a double dose to make up for the forgotten dose. If you frequently miss doses, consider setting a daily alarm or associating your inhalation with a routine activity such as brushing your teeth.
Overdose
If you inhale too many doses or if a child accidentally uses the inhaler, the most common symptoms include tremor (shaking), headache, and palpitations (rapid or forceful heartbeat). In more serious cases, an overdose may cause tachycardia (fast heart rate), nausea, elevated blood sugar, and low potassium levels, which can lead to muscle weakness or heart rhythm disturbances. Seek immediate medical attention if you suspect an overdose. Contact your local emergency services or poison control centre.
Stopping Treatment
Do not stop using Formatris Novolizer or change your dose without talking to your doctor first. Abruptly stopping maintenance therapy may lead to worsening of your asthma or COPD symptoms. If your doctor decides to discontinue treatment, they will provide guidance on how to do so safely, which may involve gradually reducing the dose.
What Are the Side Effects of Formatris Novolizer?
The most common side effects of Formatris Novolizer are headache, tremor, and palpitations. These are typical beta-2 agonist effects that are usually mild and tend to diminish with continued use. Serious side effects are rare but can include cardiac arrhythmias and paradoxical bronchospasm.
Like all medicines, Formatris Novolizer can cause side effects, although not everybody gets them. Most side effects are related to the pharmacological activity of beta-2 agonists and are dose-dependent, meaning they are more likely at higher doses. Many of these effects are mild and transient, often resolving within the first few days of treatment as the body adjusts.
- Sudden worsening of breathing difficulty or wheezing immediately after using the inhaler (paradoxical bronchospasm)
- Swelling of the face, lips, tongue, or throat (angioedema)
- Severe skin rash, hives (urticaria), or widespread itching
- Chest pain (angina) or irregular heartbeat
- Severe dizziness or fainting
Common
May affect up to 1 in 10 people
- Headache
- Tremor (involuntary shaking, usually of the hands)
- Palpitations (awareness of your heartbeat, which may feel fast or forceful)
Uncommon
May affect up to 1 in 100 people
- Agitation, restlessness, and anxiety
- Sleep disturbances (insomnia)
- Muscle cramps
- Increased heart rate (tachycardia)
- Irritation of the mouth or throat
Rare
May affect up to 1 in 1,000 people
- Heart rhythm changes (cardiac arrhythmias)
- Hypersensitivity reactions including bronchospasm (muscle spasm in the airways), skin rash, hives (urticaria), and itching
- Angioedema (swelling of the skin, mucous membranes, often affecting the face, eyes, or lips)
- Nausea
- Decreased or elevated serum potassium levels (hypokalaemia/hyperkalaemia)
Very Rare
May affect up to 1 in 10,000 people
- Blood pressure changes (both increases and decreases)
- Taste disturbances
- Dizziness
- Angina pectoris (chest pain due to reduced blood flow to the heart)
- Elevated blood sugar (hyperglycaemia)
- Prolonged QTc interval (a change in heart rhythm measurable on an ECG)
- Elevated levels of insulin, free fatty acids, glycerol, and ketone bodies in the blood
If you experience any side effects not mentioned here, or if any side effect becomes severe or persistent, contact your doctor or pharmacist. Reporting suspected side effects contributes to ongoing monitoring of the benefit-risk balance of medicines.
How Should You Store Formatris Novolizer?
Store Formatris Novolizer in its original carton to protect from moisture. Keep out of the reach and sight of children. Do not use after the expiry date printed on the packaging. Replace the cassette every 6 months.
Keep this medicine out of the sight and reach of children at all times. The inhaler should be stored in the original carton because formoterol powder is sensitive to moisture. Once the packaging is opened, no special storage conditions are required for the inhaler itself.
Do not use this medicine after the expiry date which is stated on the cassette label and on the outer carton after "EXP". The expiry date refers to the last day of that month. The medication cassette should be replaced every 6 months, even if doses remain, to ensure the powder quality and consistency.
Do not flush unused medication down the toilet or put it in household waste. Return any unused or expired medication to your pharmacy for safe disposal. These measures help protect the environment from pharmaceutical contamination.
What Does Formatris Novolizer Contain?
Each metered dose of Formatris Novolizer contains 6 micrograms of formoterol fumarate dihydrate as the active ingredient, delivering approximately 5.1 micrograms at the mouthpiece. The only other ingredient is lactose monohydrate, which may contain trace amounts of milk protein.
Active Ingredient
The active substance is formoterol fumarate dihydrate. Each metered dose contains 6 micrograms of formoterol fumarate dihydrate. Each delivered dose (the amount that leaves the mouthpiece and reaches the patient) is approximately 5.1 micrograms of formoterol fumarate dihydrate. The difference between the metered dose and the delivered dose accounts for the small amount of powder retained within the device during inhalation.
Inactive Ingredient (Excipient)
The only other ingredient is lactose monohydrate. Lactose serves as a carrier for the fine formoterol particles, improving the flow properties of the powder and ensuring consistent dose delivery through the inhaler. The lactose may contain small amounts of milk protein, which could cause allergic reactions in individuals with a known allergy to milk protein (this is separate from lactose intolerance).
Inhaler and Packaging
Formatris Novolizer is available as:
- 1 powder inhaler and 1 cassette containing at least 60 doses
- 1 powder inhaler and 3 cassettes containing at least 60 doses each
- Refill packs of 1, 2, or 3 cassettes containing at least 60 doses each
- Hospital packs: 10 × (1 powder inhaler and 1 cassette with at least 60 doses)
Not all pack sizes may be available in every country. The Novolizer inhaler is designed to be reused for up to one year, with the cassettes replaced as needed. Each cassette can only be used in the original Novolizer device it was dispensed with.
How Does Formatris Novolizer Work in the Body?
Formoterol is a potent, selective long-acting beta-2 adrenergic receptor agonist. It relaxes airway smooth muscle by activating beta-2 receptors, leading to increased cAMP levels and muscle relaxation. Its unique pharmacology provides both rapid onset (1–3 minutes) and long duration of action (up to 12 hours).
The airways in healthy lungs are surrounded by thin bands of smooth muscle that regulate the diameter of the air passages. In conditions such as asthma and COPD, these muscles become excessively contracted (bronchoconstriction), narrowing the airways and making it difficult for air to pass through. Additionally, the airways may become inflamed and swollen, and excess mucus production further obstructs airflow.
Formoterol works by binding to beta-2 adrenergic receptors on the surface of airway smooth muscle cells. These receptors are part of the sympathetic nervous system and, when activated, trigger a cascade of intracellular events: the enzyme adenylyl cyclase is stimulated, increasing the production of cyclic adenosine monophosphate (cAMP). Elevated cAMP levels activate protein kinase A, which phosphorylates several target proteins, ultimately leading to relaxation of the smooth muscle fibres and widening of the airways.
What makes formoterol unique among LABAs is its combination of rapid onset and long duration of action. Most LABAs, such as salmeterol, take 15–30 minutes to begin working but last for 12 hours. Most short-acting beta-2 agonists (SABAs), such as salbutamol, work within minutes but last only 4–6 hours. Formoterol bridges this gap – it begins working within 1–3 minutes (similar to salbutamol) yet maintains its effect for up to 12 hours (like salmeterol). This dual property is attributed to its moderate lipophilicity and high intrinsic efficacy at the beta-2 receptor.
Pharmacokinetic Profile
After inhalation, approximately 20–30% of the delivered dose reaches the lower respiratory tract, where it exerts its therapeutic effect. The remainder is swallowed and absorbed from the gastrointestinal tract but undergoes extensive first-pass metabolism in the liver, resulting in low systemic bioavailability (approximately 40–60% of the orally ingested fraction). Formoterol is metabolised primarily by direct glucuronidation and O-demethylation followed by glucuronidation. The metabolites are inactive and are excreted primarily via the kidneys (approximately 60–70%) and in the faeces (approximately 30–40%). The terminal elimination half-life after inhalation is approximately 2–3 hours.
Beyond bronchodilation, formoterol also has several additional effects on the airways, including inhibition of inflammatory mediator release from mast cells, increased mucociliary clearance (helping to move mucus out of the airways), and reduced microvascular leak (which decreases airway oedema). These secondary effects contribute to its clinical effectiveness, although it is important to note that formoterol is not an anti-inflammatory drug and does not replace the need for inhaled corticosteroids in asthma management.
Frequently Asked Questions About Formatris Novolizer
Formatris Novolizer is a long-acting bronchodilator inhaler used as add-on maintenance therapy for asthma (always together with an inhaled corticosteroid) and for relieving symptoms of chronic obstructive pulmonary disease (COPD). It can also be used to prevent exercise-induced asthma symptoms. The active ingredient, formoterol, relaxes the muscles in the airways, increasing airflow within 1–3 minutes with effects lasting up to 12 hours.
Formatris Novolizer has a rapid onset of action, with bronchodilation beginning within 1 to 3 minutes of inhalation. This is faster than many other long-acting bronchodilators like salmeterol (which takes 15–30 minutes). The peak effect occurs at approximately 2 hours, and the bronchodilating effect lasts for up to 12 hours, allowing twice-daily dosing.
No. According to international asthma guidelines (GINA), Formatris Novolizer must never be used as the sole treatment for asthma. It must always be prescribed alongside an inhaled corticosteroid (ICS), such as budesonide or fluticasone. Using a LABA without an ICS has been associated with an increased risk of serious asthma-related events. Your doctor will prescribe an appropriate ICS alongside Formatris Novolizer.
The most common side effects include headache, tremor (shaking, especially of the hands), and palpitations (awareness of heartbeat). These are typical effects of beta-2 agonist stimulation and are usually mild and temporary, often subsiding within the first few days of regular use. If side effects persist or are troublesome, speak with your doctor.
The Novolizer inhaler has built-in feedback to confirm correct use. When you press the dosing button, the control window changes from red to green, indicating the dose is loaded. When you inhale correctly with sufficient force, you will hear a clear click sound, and the window changes back to red. If you do not hear the click or the colour does not change back, the inhalation was not performed correctly and you should try again.
Yes, Formatris Novolizer can be used by children aged 6 years and older for asthma, under medical supervision. The recommended dose for children is 1–2 inhalations once or twice daily for maintenance therapy, and 1–2 inhalations before exercise for prevention. Children under 6 should not use this medicine. An adult should always help children with the inhaler to ensure correct technique.
References
This article is based on the following international medical guidelines and peer-reviewed sources. All medical claims have evidence level 1A, the highest quality of evidence based on systematic reviews of randomised controlled trials.
- Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention. Updated 2024. Available at: ginasthma.org
- Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management, and Prevention of COPD. 2024 Report.
- National Institute for Health and Care Excellence (NICE). Asthma: diagnosis, monitoring and chronic asthma management. NICE guideline [NG80]. Updated 2024.
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd list. Geneva: WHO; 2023.
- European Medicines Agency (EMA). Formoterol fumarate – Summary of Product Characteristics. EMA product information database. Accessed December 2025.
- Cazzola M, Page CP, Calzetta L, Matera MG. Pharmacology and therapeutics of bronchodilators. Pharmacological Reviews. 2012;64(3):450–504. doi:10.1124/pr.111.004580
- Bateman ED, Reddel HK, Eriksson G, et al. Overall asthma control: the relationship between current control and future risk. Journal of Allergy and Clinical Immunology. 2010;125(3):600–608.
- British National Formulary (BNF). Formoterol fumarate. NICE BNF monograph. Accessed December 2025.
Editorial Team
This article has been written and reviewed by the iMedic Medical Editorial Team, a group of licensed specialist physicians with expertise in pulmonology, respiratory medicine, and clinical pharmacology.
Medical Writers
Board-certified physicians specialising in respiratory medicine and clinical pharmacology with documented academic and clinical experience.
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