Formoterol Viatrıs

Package leaflet: Information for the patient

Formoterol Viatris Novolizer 6 micrograms/dose inhalation powder

Formoterol
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Formoterol Viatris Novolizer 6 micrograms is and what it is used for
2. What you need to know before using Formoterol Viatris Novolizer 6 micrograms
3. How to use Formoterol Viatris Novolizer 6 micrograms
4. Possible side effects
5. How to store Formoterol Viatris Novolizer 6 micrograms
6. Contents of the pack and other information

1. WHAT FORMOTEROLO VIATRIS NOVOLIZER 6 MICROGRAMS IS AND WHAT IT IS USED FOR

WHAT IT IS USED FOR
Formoterolo Viatris Novolizer 6 micrograms is an inhalation powder containing formoterol.
Formoterol belongs to a group of medicines known as long-acting beta-agonists.
These medicines relax certain muscles, for example by opening the airways in your lungs.
Formoterolo Viatris Novolizer 6 micrograms provides long-lasting relief (up to 12 hours) from symptoms such as wheezing, shortness of breath, and cough in patients with asthma who are already receiving inhaled corticosteroids. It makes breathing easier by relaxing the muscles that tighten the air passages into the lungs. Regular use of Formoterolo Viatris Novolizer 6 micrograms in combination with inhaled corticosteroids can help prevent breathing problems.
Formoterolo Viatris Novolizer 6 micrograms is also used to relieve symptoms such as wheezing, shortness of breath, and cough in patients with chronic obstructive pulmonary disease (COPD).

2. WHAT YOU SHOULD KNOW BEFORE USING FORMOTEROL VIATRIS NOVOLIZER 6 MICROGRAMS

DO NOT USE Formoterol Viatris Novolizer 6 micrograms if you are allergic (hypersensitive) to
formoterol or to any of the other components of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Formoterol Viatris Novolizer 6 micrograms.
Formoterol Viatris Novolizer 6 micrograms must not be used (and is not sufficient) as initial treatment
for asthma.
Formoterol Viatris Novolizer 6 micrograms must not be used to treat an acute asthma attack. In this case,
you must use a short-acting bronchodilator (e.g. salbutamol).
If you are an asthma patient, you must also receive treatment with corticosteroids to achieve optimal
treatment of bronchial inflammation.
It is important that you continue your anti-inflammatory therapy (corticosteroids). You must not reduce
the dose of your anti-inflammatory therapy (corticosteroids) after starting treatment with formoterol
without medical advice, even if your symptoms improve.
If you need your medicine to prevent exercise-induced asthma more frequently than usual, this may be
a sign that your asthma is not well controlled. In this case, contact your doctor for a review of your
therapy.
Pay special attention and consult your doctor before using Formoterol Viatris Novolizer 6
micrograms if you have:

• any heart condition,
• blood pressure problems,
• diabetes,
• overactive thyroid, or
• adrenal gland problems.

As with any other inhaled therapy, there is a risk of paradoxical bronchospasm (immediate increase in
wheezing and breathlessness) immediately after inhalation. If this occurs, speak to your doctor
immediately.
If your symptoms persist or worsen, or if the number of formoterol doses you need to control your
symptoms increases, this usually indicates worsening asthma: in such cases, you must contact your
doctor to review your treatment.
For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive
anti-doping test.

Children
The use of this medicine in children under 6 years of age is not recommended.

Other medicines and Formoterol Viatris Novolizer 6 micrograms
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicine.
This particularly applies to:

• other beta-agonists (e.g. salbutamol, salmeterol) or ephedrine
• xanthine derivatives (e.g. theophylline)
• steroids (e.g. prednisolone)
• diuretics (e.g. furosemide)
• digoxin
• antihistamines (e.g. terfenadine, astemizole)
• medicines for rapid or irregular heartbeat (e.g. quinidine)
• phenothiazines (e.g. chlorpromazine) used to treat psychiatric disorders or severe nausea and vomiting
• antibiotics (e.g. erythromycin)
• tricyclic antidepressants (e.g. amitriptyline) or monoamine oxidase inhibitors (e.g. phenelzine)
• hormones (e.g. L-thyroxine, oxytocin)
• beta-blockers for hypertension or angina (taken orally, e.g. atenolol, metoprolol, or as eye drops, e.g. timolol)

Some general anaesthetics, when interacting with formoterol, may cause heart problems or reduced
blood pressure. However, if you are undergoing surgery, inform the hospital staff that you are taking
Formoterol Viatris Novolizer 6 micrograms.
As with other medicines of this type, if formoterol is taken with alcohol or with medicines for Parkinson’s disease or thyroid disorders, you may experience an increased heart rate (palpitations).

Formoterol Viatris Novolizer 6 micrograms with food, drinks and alcohol
You should avoid drinking alcohol, as it may cause an increased heart rate (palpitations).
There are no known effects on the efficacy of Formoterol Viatris Novolizer 6 micrograms when taken
with food or other drinks.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, ask your
doctor or pharmacist for advice before taking this medicine.
Formoterol should be used during pregnancy (particularly during the first three months, at the end of
pregnancy and during labour) only after careful evaluation.
It is not known whether formoterol passes into breast milk. Therefore, if you are breastfeeding,
administration of Formoterol Viatris Novolizer 6 micrograms should be considered only if the expected
benefit to you outweighs any possible risk to the baby.

Driving and using machines
Formoterol Viatris Novolizer 6 micrograms has no effect on the ability to drive vehicles or operate
machinery.

Formoterol Viatris Novolizer 6 micrograms contains lactose (milk sugar).
Normally, the amount of lactose in a single dose does not cause problems in patients with lactose
intolerance. Milk sugar (lactose) may contain small amounts of milk proteins.

3. HOW TO USE FORMOTEROL VIATRIS NOVOLIZER 6 MICROGRAMS

Use this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist. If the patient using this medicine is a child, you must show the child how to correctly use the inhaler, and the child must only use the inhaler with the help of an adult.

Recommended dose:

Asthma

Adults (including elderly) and adolescents over 12 years of age:
The usual dose is 2 inhalations in the morning and 2 inhalations again in the evening. For severe asthma, your doctor may prescribe 4 inhalations twice daily.
The maximum daily dose is 8 inhalations (4 inhalations twice a day).

Use in children aged 6 years and older:
The usual dose is 2 inhalations in the morning and 2 inhalations again in the evening. For severe asthma, your doctor may prescribe 4 inhalations twice daily.
The maximum daily dose is 8 inhalations (4 inhalations twice a day).
The regular daily dose should not exceed 4 inhalations per day; however, occasionally up to a maximum of 8 inhalations within a 24-hour period may be allowed.

Use in children under 6 years of age:
Formoterol Viatris Novolizer is not recommended in children under 6 years of age, as there is insufficient experience in this age group.

COPD (chronic obstructive pulmonary disease)

Adults (including elderly) and adolescents over 12 years of age:
The usual dose is 2 inhalations in the morning and 2 inhalations again in the evening.
The daily dose for regular use must not exceed 4 inhalations.
If needed, additional inhalations beyond the prescribed regular therapy may be taken to relieve symptoms, up to a maximum of 8 inhalations in total per day. No more than 4 inhalations should be taken on any single occasion.

Method of administration
For inhalation use only.
Perform the inhalation as described in the “Instructions for use” provided below in this leaflet.

If you use more Formoterol Viatris Novolizer 6 micrograms than you should
Symptoms of overdose are consistent with the side effects. These include, for example: tremors, headache, palpitations, nausea, and vomiting.
If you experience any of these reactions, you must contact your doctor immediately.

If you forget to use Formoterol Viatris Novolizer 6 micrograms
Take the missed dose as soon as you remember. If it is close to the time of your next dose, skip the missed dose and take only the next dose at the regular time.
Do not take a double dose to make up for a forgotten dose.

If you stop treatment with Formoterol Viatris Novolizer 6 micrograms
Do not stop or reduce the dose of Formoterol Viatris Novolizer 6 micrograms or any other respiratory medication if you feel better, without first talking to your doctor. It is very important that you use these medicines regularly.
If you experience discomfort, tremors, or an unusually rapid heartbeat, your dose of Formoterol Viatris Novolizer 6 micrograms may be too high. Speak to your doctor as soon as possible.
Once your symptoms are under control, your doctor may consider gradually reducing your dose of Formoterol Viatris Novolizer to adjust the treatment to the lowest effective dose.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine may cause adverse reactions, although not everyone experiences them.
The possible adverse reactions are listed below according to their frequency. If you are unsure about any of the adverse reactions listed below, consult your doctor for clarification.
Main adverse reactions
As may occur with all inhalers, you may experience wheezing immediately after inhaling the powder. This is rare (may occur in 1 out of 1,000 people).
Rarely, an allergic reaction may lead to a condition known as angioedema, characterized by swelling of the face, lips, eyes, and throat. If any of these allergic reactions occur, you must stop taking Formoterolo Viatris Novolizer 6 micrograms immediately and contact your doctor.
Very rarely (may affect 1 out of 10,000 people), severe chest pain (angina pectoris) may occur.
List of all other adverse reactions:
Common adverse reactions (may occur in 1 out of 10 patients):
Headache, tremor, and palpitations.
Uncommon adverse reactions (may occur in 1 out of 100 patients):
Agitation, restlessness, sleep disturbances, muscle cramps, and throat irritation.
Rare adverse reactions (may occur in 1 out of 1,000 patients):
Rapid or irregular heartbeat, nausea (feeling unwell), changes in potassium levels which may cause muscle weakness, nervousness, and wheezing. Skin allergic reactions such as rash, urticaria, and pruritus, leading to transient eruptions, scattered swellings, redness, and itching.
Very rare adverse reactions (may occur in 1 out of 10,000 patients):
Prolongation of the QT interval with a possible increased risk of serious heart rhythm disturbances in susceptible patients, hyperglycaemia (increased blood glucose), taste disturbances, dizziness, and changes in blood pressure.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE FORMOTEROL VIATRIS NOVOLIZER 6 MICROGRAMS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the leaflet, the outer packaging, and the
cartridge container. The expiry date refers to the last day of that month.
Storage conditions
Store the cartridge in the original packaging until use.
After opening the cartridge container and inserting it into the Novolizer inhaler, store
Formoterol Viatris Novolizer 6 micrograms in a dry place protected from moisture and at a
temperature below 25°C.
Information on storage during use
Replace the cartridge 6 months after first opening.
Do not use the powder inhaler for more than one year.
Note: The Novolizer device must be replaced after 2000 inhalations. Therefore, a maximum of 33
cartridges containing 60 single doses must be used with this device (within a single year).
The Novolizer must be cleaned regularly, but at least every time the cartridge is
replaced. Cleaning instructions for the device are provided in the “Instructions for Use” section below
in this leaflet.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Formoterol Viatris Novolizer 6 micrograms contains
Formoterol Viatris Novolizer 6 micrograms is an inhalation powder. The active substance is
formoterol.
One inhalation contains 4.18 micrograms of formoterol (as dihydrate fumarate).
The other component is lactose monohydrate (milk sugar). Formoterol Viatris Novolizer 6
micrograms contains 5.744 mg of lactose per inhalation.

Description of the appearance of Formoterol Viatris Novolizer 6 micrograms and contents of the
package
Formoterol Viatris Novolizer 6 micrograms inhalation powder contains a white powder in
a cartridge and is available in the following pack sizes:
Original packs for sale:
1 powder inhaler and 1 cartridge with at least 60 doses
Refills:
1 cartridge with at least 60 doses
2 cartridges with at least 60 doses each
3 cartridges with at least 60 doses each
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer
Viatris Healthcare Limited,
Damastown Industrial Park,
Mulhuddart, Dublin 15,
Dublin, Ireland

Manufacturer
McDermott Laboratories T/A Mylan Dublin
Respiratory
Unit 25 Baldoyle Industrial Estate
Grange Road, Baldoyle
Dublin 13 (Ireland)

This medicinal product is authorised in the European Economic Area Member States under the
following names:
Austria Novolizer Formoterol Meda 6 Mikrogramm Pulver zur Inhalation
Belgium, Luxembourg Novolizer Formoterol 6 microgrammes, poudre pour inhalation
Germany Formoterol Novolizer 6 Mikrogramm, Pulver zur Inhalation
France Asmelor Novolizer 6 microgrammes/dose, poudre pour inhalation
Ireland Novolizer Formoterol 6 micrograms/dose inhalation powder
Italy Formoterolo Viatris Novolizer 6 microgrammi/dose polvere per inalazione
Netherlands Formoterol Novolizer 6 microgram, inhalatiepoeder
Portugal Formoterol Novolizer 6 microgramas/dose, pó para inalação
Spain Formatris Novolizer 6 microgramos/dosis, polvo para inhalación

Lifestyle advice for the asthmatic patient
Asthma can be managed in various ways. Your doctor will work with you to develop a treatment plan best suited to your individual needs, helping you reduce asthma symptoms and the number of asthma attacks.
There are several things you can do to help:

• Try to avoid or reduce contact with substances that may trigger an asthma episode, for example, pet dander, smoke (including second-hand smoke), moulds, pollen, and dust mites.
• If you know that exercise triggers your asthma, make sure you follow your doctor’s instructions before starting any physical activity.
• Be honest with your doctor or nurse about how asthma affects you day to day, and work with them to develop a treatment plan that fits your lifestyle. Remember to take your asthma medication exactly as prescribed by your doctor.
• If you have any concerns about your medication, discuss them with your pharmacist, nurse, or doctor.

I ’
N

1. PREPARATION: The Novolizer dry powder inhaler makes inhalation simple and safe. It is easy to use, allows quick cartridge replacement, and is simple and fast to clean.

Place the Novolizer dry powder inhaler in front of you. Apply gentle pressure simultaneously on the ribbed surfaces on both sides of the cover cap, push the cover cap forward (←), and lift it up (↑).
Remove the protective aluminium foil from the cartridge container and take out a new cartridge.
However, this should only be done immediately before using the cartridge. The colour code on the cartridge must match the colour of the dosing button.
The small red disc at the bottom of the cylindrical cartridge is a desiccant which should be discarded after removing the cartridge.

First refill:
Insert the cartridge into the Novolizer dry powder inhaler with the dose counter facing towards the mouthpiece (↓). Do not press the dosing button while inserting the cartridge.

Refills:
Note: The Novolizer dry powder inhaler must be cleaned each time the cartridge is replaced, after removing the empty cartridge.
If you have already used the Novolizer dry powder inhaler, first remove the empty cartridge and then insert the new one (↓). Do not press the dosing button while inserting the cartridge.
Replace the cover cap into its sliding rails (↓) and push it down towards the coloured dosing button until it clicks into place (→).
The Novolizer is now loaded and ready for use.
The cartridge may remain in the Novolizer dry powder inhaler until it is empty or for up to 6 months after insertion. The cartridge is empty when you see a “0” appear in the centre of the control window. A new cartridge must then be inserted. The cartridge may only be used with the original dry powder inhaler.

2. USE: Whenever possible, sit or stand during inhalation. Always hold Novolizer in a horizontal position. First, remove the protective cover cap (←).

Press the coloured dosing button fully down. You will hear a loud double click and the colour in the control window will change from red to green. Then release the coloured button. The green colour in the control window indicates that the Novolizer is ready for use.
Breathe out (but not into the Novolizer dry powder inhaler). Place your lips tightly around the mouthpiece, inhale the powder steadily, deeply, and as quickly as possible (maximum inhalation), and hold your breath for a few seconds. During this breath, you will hear a loud click indicating correct inhalation. Then resume normal breathing.
Check that the colour in the control window has returned to red—this also indicates correct inhalation. Replace the protective cover cap over the mouthpiece: the inhalation procedure is now complete. The number shown in the upper window indicates the number of inhalations remaining. The numerical scale from 60 to 0 is displayed in increments of 10. If the audible click and colour change do not occur, please repeat the procedure as described above.
Note: The coloured dosing button should only be pressed immediately before inhalation. With Novolizer, accidental overdose is not possible. The audible click and colour change in the control window indicate that the inhalation has been performed correctly. If the colour in the control window does not return to red, the inhalation must be repeated. If inhalation is not completed correctly after several attempts, consult your doctor.

3. CLEANING: The Novolizer dry powder inhaler must be cleaned regularly, but at least every time the cartridge is changed.

Remove the protective cover cap and the mouthpiece
First, remove the protective cover cap. Then grasp the mouthpiece and turn it briefly counterclockwise (↑) until it loosens. Then remove it (←).
Cleaning
Now turn the Novolizer upside down. Grasp the dispenser capsule and move it forward (←) and upward (↑). You can remove residual powder by gently tapping.
Clean the mouthpiece, dispenser capsule, and powder inhaler with a soft, dry cloth.
DO NOT use water or detergent.
Reassembly – Inserting the dose counter cartridge
After cleaning, insert the dose counter cartridge by sliding it down (  ) and pushing it into place (↓).
Return the inhaler to a horizontal position.
Reassembly – Inserting the mouthpiece and protective cover cap
Insert the mouthpiece with its peg into the groove on the left and turn it to the right until it clicks into place. Complete the process by replacing the protective cover cap.

Notes

• The Patient Leaflet describes how the medicine works. Please read it carefully before using the inhaler for the first time.
• Novolizer can be used with different active substances, does not use propellants, and is rechargeable. This makes Novolizer an environmentally friendly product.
• Overdose is not possible with Novolizer. Even if the button is pressed multiple times, no additional powder is available for inhalation. Press the button only when you intend to inhale. If you are unable to inhale correctly after several attempts, consult your doctor.
• Novolizer can be reloaded using new cartridges* containing the active substance and is therefore ideally suited for long-term use (up to 1 year).
• Do not shake Novolizer when it is loaded.
• Please assist children in the correct use of the device.
• Ensure that Novolizer is protected from moisture and heat and keep it clean at all times.

*For information on corresponding medicines, speak with your doctor.
Viatris Healthcare Limited,
Damastown Industrial Park,
Mulhuddart, Dublin 15,
Dublin, Ireland
CE

Patient Information Leaflet

Formoterolo Viatris Novolizer 12 micrograms/dose inhalation powder

Formoterol
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Formoterolo Viatris Novolizer 12 micrograms is and what it is used for
2. What you need to know before using Formoterolo Viatris Novolizer 12 micrograms
3. How to use Formoterolo Viatris Novolizer 12 micrograms
4. Possible side effects
5. How to store Formoterolo Viatris Novolizer 12 micrograms
6. Contents of the pack and other information

1. WHAT FORMOTEROL VIATRIS NOVOLIZER 12 MICROGRAMS IS AND WHAT IT IS USED FOR

USE
Formoterol Viatris Novolizer 12 micrograms is an inhalation powder containing formoterol.
Formoterol belongs to a group of medicines known as long-acting beta-agonists. These medicines relax certain muscles, for example, they open the airways in your lungs.
Formoterol Viatris Novolizer 12 micrograms provides long-lasting relief (up to 12 hours) from symptoms such as wheezing, shortness of breath and cough in patients with asthma who are already receiving inhaled corticosteroids. It makes breathing easier by relaxing the muscle contractions in the air passages of the lungs. Regular use of Formoterol Viatris Novolizer 12 micrograms in combination with inhaled corticosteroids can help prevent breathing problems.
Formoterol Viatris Novolizer 12 micrograms is also used to relieve symptoms such as wheezing, shortness of breath and cough in patients with chronic obstructive pulmonary disease (COPD).

2. WHAT YOU SHOULD KNOW BEFORE USING FORMOTEROL VIATRIS NOVOLIZER 12 MICROGRAMS

MICROGRAMS
Do not use Formoterol Viatris Novolizer 12 micrograms if you are allergic (hypersensitive) to
formoterol or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Formoterol Viatris Novolizer 12 micrograms.
Formoterol Viatris Novolizer 12 micrograms must not be used (and is not sufficient) as first-line
treatment for asthma.
Formoterol Viatris Novolizer 12 micrograms must not be used to treat an acute asthma attack. In this
case, you must use a short-acting bronchodilator (e.g. salbutamol).
If you are an asthma patient, you must also receive treatment with corticosteroids to achieve optimal
treatment of bronchial inflammation.
It is important that you continue your anti-inflammatory therapy (corticosteroids). You must not reduce
the dose of your anti-inflammatory therapy (corticosteroids) after starting treatment with formoterol
without medical advice, even if your symptoms improve.
If you need your medicine to prevent exercise-induced asthma more frequently than usual, this may be
a sign that your asthma control is not good enough. In this case, contact your doctor for a review of your
treatment.
Take particular care and consult your doctor before using Formoterol Viatris Novolizer 12
micrograms if you have:

• any heart condition,
• blood pressure problems,
• diabetes,
• overactive thyroid, or
• adrenal gland problems.

As with any other inhaled therapy, there is a risk of paradoxical bronchospasm (increased wheezing and
shortness of breath) immediately after inhalation. If this occurs, speak to your doctor immediately.
If your symptoms persist or worsen, or if the number of formoterol doses you need to control your
symptoms increases, this indicates worsening asthma: in such cases, you must contact your doctor to
review your treatment.
For athletes: using the medicine without therapeutic need constitutes doping and may lead to a
positive result in anti-doping tests.

Children
The use of this medicine in children under 6 years of age is not recommended.

Other medicines and Formoterol Viatris Novolizer 12 micrograms
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
In particular, this applies to:

• other beta-agonists (e.g. salbutamol, salmeterol) or ephedrine
• xanthine derivatives (e.g. theophylline)
• steroids (e.g. prednisolone)
• diuretics (e.g. furosemide)
• digoxin
• antihistamines (e.g. terfenadine, astemizole)
• medicines for rapid or irregular heartbeat (e.g. quinidine)
• phenothiazines (e.g. chlorpromazine) used to treat psychiatric disorders or severe nausea and vomiting
• antibiotics (e.g. erythromycin)
• tricyclic antidepressants (e.g. amitriptyline) or monoamine oxidase inhibitors (e.g. phenelzine)
• hormones (e.g. L-thyroxine, oxytocin)
• beta-blockers for hypertension or angina (taken orally, e.g. atenolol, metoprolol, or as eye drops, e.g. timolol)

Some general anaesthetics may interact with formoterol and cause heart problems or a drop in blood
pressure. However, if you are undergoing surgery, inform the hospital staff that you are taking
Formoterol Viatris Novolizer 12 micrograms.
As with other medicines of this type, if formoterol is taken together with alcohol or with medicines for
Parkinson’s disease or thyroid disorders, you may experience an increased heart rate (palpitations).

Formoterol Viatris Novolizer 12 micrograms with food, drinks and alcohol
You should avoid drinking alcohol, as it may cause an increased heart rate (palpitations).
No changes in the effectiveness of Formoterol Viatris Novolizer 12 micrograms are known when taken
with food or other beverages.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, ask your
doctor or pharmacist for advice before taking this medicine.
Formoterol should be used during pregnancy (particularly during the first three months, at the end of
pregnancy and during labour) only after careful assessment.
It is not known whether formoterol passes into breast milk. Therefore, if you are breastfeeding,
treatment with Formoterol Viatris Novolizer 12 micrograms should only be considered if the expected
benefit to you outweighs any possible risk to the baby.

Driving and using machines
Formoterol Viatris Novolizer 12 micrograms has no effect on the ability to drive vehicles or operate
machinery.

Formoterol Viatris Novolizer 12 micrograms contains lactose (milk sugar).
Normally, the amount of lactose in a single dose does not cause problems for patients with lactose
intolerance. Milk sugar (lactose) may contain small amounts of milk proteins.

3. HOW TO USE FORMOTEROL VIATRIS NOVOLIZER 12 MICROGRAMS

Use this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist. If the patient using this medicine is a child, you must show the child how to correctly use the inhaler, and the child must only use the inhaler with the help of an adult.

Recommended dose:

Asthma

Adults (including the elderly) and adolescents over 12 years of age:
The usual dose is 1 inhalation in the morning and 1 inhalation again in the evening. For severe forms of asthma, your doctor may prescribe 2 inhalations twice daily.
The maximum daily dose is 4 inhalations (2 inhalations twice a day).

Use in children aged 6 years and older:
The usual dose is 1 inhalation in the morning and 1 inhalation again in the evening. For severe forms of asthma, your doctor may prescribe 2 inhalations twice daily.
The maximum daily dose is 4 inhalations (2 inhalations twice a day).
The regular daily dose must not exceed 2 inhalations; however, occasionally up to a maximum of 4 inhalations within a 24-hour period may be allowed.

Use in children under 6 years of age:
Formoterol Viatris Novolizer is not recommended in children under 6 years of age, as there is insufficient experience in this age group.

COPD (chronic obstructive pulmonary disease)

Adults (including the elderly) and adolescents over 12 years of age:
The usual dose is 1 inhalation in the morning and 1 inhalation again in the evening.
The daily dose for regular use must not exceed 2 inhalations.
If needed, additional inhalations beyond those prescribed for regular therapy may be used to relieve symptoms, up to a maximum of 4 inhalations in total per day. No more than 2 inhalations should be taken on any single occasion.

Method of administration
For inhalation use only.
Perform the inhalation as described in the “Instructions for use” provided below in this leaflet.

If you use more Formoterol Viatris Novolizer 12 micrograms than you should
Symptoms of overdose are consistent with the side effects. These may include: tremors, headache, palpitations, nausea, and vomiting.
If you experience any of these reactions, you must contact your doctor immediately.

If you forget to use Formoterol Viatris Novolizer 12 micrograms
Take the missed dose as soon as you remember. If it is nearly time for your next dose, skip the missed dose and take only the next dose at the usual time.
Do not take a double dose to make up for a forgotten dose.

If you stop using Formoterol Viatris Novolizer 12 micrograms
Do not stop or reduce the dose of Formoterol Viatris Novolizer or of any other breathing medicine if you feel better, without first talking to your doctor. It is very important that you use these medicines regularly.
If you experience discomfort, tremors, or an unusual increase in heart rate, your dose of Formoterol Viatris Novolizer may be too high. Speak to your doctor as soon as possible.
Once your symptoms are under control, your doctor may consider gradually reducing your dose of Formoterol Viatris Novolizer to adjust your treatment to the lowest effective dose.

If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine may cause adverse reactions, although not everyone experiences them.
The possible adverse reactions are listed below according to their frequency. If you are unsure about any of the adverse reactions listed below, consult your doctor for clarification.
Main adverse reactions
As may occur with all inhalers, you may experience wheezing immediately after inhaling the powder. This occurs rarely (may affect 1 in 1,000 people).
Rarely, an allergic reaction may lead to a condition known as angioedema, characterized by swelling of the face, lips, eyes, and throat. If any of these allergic reactions occur, you must stop taking Formoterolo Viatris Novolizer 6 micrograms immediately and contact your doctor.
Very rarely (may affect 1 in 10,000 people), severe chest pain (angina pectoris) may occur.
List of all other adverse reactions:
Common adverse reactions (may affect 1 in 10 patients):
Headache, tremor, and palpitations.
Uncommon adverse reactions (may affect 1 in 100 patients):
Agitation, restlessness, sleep disturbances, muscle cramps, and throat irritation.
Rare adverse reactions (may affect 1 in 1,000 patients):
Rapid or irregular heartbeat, nausea (feeling unwell), changes in potassium levels which may cause muscle weakness, nervousness, and wheezing. Cutaneous allergic reactions such as rash, urticaria, and pruritus leading to transient eruptions, scattered swellings, redness, and itching.
Very rare adverse reactions (may affect 1 in 10,000 patients):
Prolongation of the QT interval with possible increased risk of serious heart rhythm disturbances in susceptible patients, hyperglycaemia (increased blood glucose), taste disturbances, dizziness, and changes in blood pressure.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE FORMOTEROL VIATRIS NOVOLIZER 12 MICROGRAMS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the leaflet, the packaging, and the
cartridge container. The expiry date refers to the last day of that month.
Storage conditions
Store the cartridge in the original packaging until use.
After opening the cartridge container and inserting it into the Novolizer inhaler, store
Formoterol Viatris Novolizer 12 micrograms in a dry place protected from moisture and at a
temperature below 25°C.
Information on storage during use
Replace the cartridge 6 months after first opening.
Do not use the powder inhaler for more than one year.
Note: The Novolizer device must be replaced after 2000 inhalations. Therefore, a maximum of 33
cartridges containing 60 single doses should be used with this device (within a single year).
The Novolizer must be cleaned regularly, but at least every time the cartridge is
replaced. Cleaning instructions for the device are provided in the “Instructions for Use” reported below
in this leaflet.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Formoterol Viatris Novolizer 12 micrograms contains
Formoterol Viatris Novolizer 12 micrograms is an inhalation powder. The active substance is
formoterol.
One inhalation contains 8.36 micrograms of formoterol (as dihydrate fumarate).
The other component is lactose monohydrate (milk sugar). Formoterol Viatris Novolizer 12
micrograms contains 11.488 mg of lactose per inhalation.

Description of the appearance of Formoterol Viatris Novolizer 12 micrograms and contents of the
package
Formoterol Viatris Novolizer 12 micrograms inhalation powder contains white powder in
a cartridge and is available in the following pack sizes:
Original packs for sale:
1 powder inhaler and 1 cartridge with at least 60 doses
Refills:
1 cartridge with at least 60 doses
2 cartridges with at least 60 doses each
3 cartridges with at least 60 doses each
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder
Viatris Healthcare Limited,
Damastown Industrial Park,
Mulhuddart, Dublin 15,
Dublin, Ireland

Manufacturer
McDermott Laboratories T/A Mylan Dublin Respiratory
Unit 25 Baldoyle Industrial Estate
Grange Road, Baldoyle
Dublin 13 (Ireland)

This medicinal product is authorised in the European Economic Area Member States under the
following names:
Austria Novolizer Formoterol Meda 12 Microgram Powder for Inhalation
Belgium, Luxembourg Novolizer Formoterol 12 micrograms, powder for inhalation
Germany Formoterol Novolizer 12 Microgram, powder for inhalation
France Asmelor Novolizer 12 micrograms/dose, powder for inhalation
Ireland Novolizer Formoterol 12 micrograms/dose inhalation powder
Italy Formoterolo Viatris Novolizer 12 microgrammi/dose polvere per inalazione
Netherlands Formoterol Novolizer 12 microgram, inhalation powder
Portugal Formoterol Novolizer 12 microgramas/dose, pó para inalação
Spain Formatris Novolizer 12 microgramos/dosis, polvo para inhalación

Lifestyle advice for the asthmatic patient
Asthma can be managed in different ways. Your doctor will work with you to decide on a treatment
plan best suited to your individual needs and which can help reduce asthma symptoms and the number of asthma attacks.
There are several things you can do to help, such as:

• Try to avoid or reduce contact with substances that may trigger an asthma episode, for example, animal fur, smoke (including passive smoking), moulds, pollen, and house dust mites.
• If you know that exercise triggers your asthma, make sure you follow your doctor's instructions before starting any physical activity.
• Be honest with your doctor or nurse about how asthma affects you day to day, and work with them to develop a treatment plan that fits your lifestyle. Remember to take your asthma medication exactly as prescribed by your doctor.
• If you have any concerns about your medication, talk to your pharmacist, nurse, or doctor.

I ’
N

1. PREPARATION: The Novolizer dry powder inhaler makes inhalation simple and safe. It is easy to use, with quick cartridge replacement and simple, fast cleaning.

Place the Novolizer dry powder inhaler in front of you. Apply gentle pressure simultaneously on the ribbed surfaces on both sides of the cover cap, push the cover cap forward (←) and lift it up (↑).
Remove the protective aluminium foil from the cartridge container and take out a new cartridge.
However, this should only be done immediately before using the cartridge. The colour code on the cartridge must match the colour of the dose button.
The small red disc at the bottom of the cylindrical cartridge is a desiccant which should be discarded after removing the cartridge.

First refill:
Insert the cartridge into the Novolizer dry powder inhaler with the dose counter facing the mouthpiece (↓). Do not press the dose button while inserting the cartridge.

Refills:
Note: The Novolizer dry powder inhaler must be cleaned every time the cartridge is replaced, after removing the empty cartridge.
If you have already used the Novolizer dry powder inhaler, first remove the empty cartridge and then insert the new one (↓). Do not press the dose button while inserting the cartridge.
Reposition the cover cap into its sliding rails (↓) and push it down towards the coloured dose button until it clicks back into place (→).
The Novolizer is now filled and ready for use.
The cartridge may remain in the Novolizer dry powder inhaler until it is empty or for up to 6 months after insertion. The cartridge is empty when a "0" appears in the centre of the viewing window. A new cartridge must then be inserted. The cartridge may only be used with the original dry powder inhaler.

2. USAGE: Whenever possible, sit or stand while inhaling. Always use Novolizer in a horizontal position. First, remove the protective cover cap (←).

Press the coloured dose button fully down. You will hear a loud double click and the colour in the viewing window will change from red to green. Then release the coloured button. The green colour in the viewing window indicates that the Novolizer is ready for use.
Breathe out (but not into the Novolizer dry powder inhaler). Place your lips tightly around the mouthpiece, inhale the powder steadily, deeply, and as quickly as possible (maximum inhalation), and hold your breath for a few seconds. During this breath, you will hear a loud click indicating correct inhalation. Then resume normal breathing.
Check that the colour in the viewing window has returned to red, which also indicates correct inhalation. Replace the protective cover cap over the mouthpiece: the inhalation procedure is now complete. The number shown in the upper window indicates the number of inhalations remaining. The numerical scale from 60 to 0 is displayed in increments of 10. If the audible click and colour change do not occur, please repeat the procedure as described above.
Note: The coloured dose button should only be pressed immediately before inhalation. With Novolizer, accidental overdose is not possible. The audible click and colour change in the viewing window indicate that inhalation has been performed correctly. If the colour in the viewing window does not return to red, the inhalation must be repeated. If inhalation is not completed correctly after several attempts, you must consult your doctor.

3. CLEANING: The Novolizer dry powder inhaler must be cleaned regularly, but at least every time the cartridge is changed.

Remove the protective cover cap and mouthpiece
First, remove the protective cover cap. Then grasp the mouthpiece and turn it briefly anticlockwise (↑) until loose. Then remove it (←).
Cleaning
Now turn the Novolizer upside down. Grasp the dispenser cap and move it forward (←) and upwards (↑). You may remove residual powder by gently tapping.
Clean the mouthpiece, dispenser cap, and powder inhaler with a soft, dry cloth.
DO NOT use water or detergent.
Reassembly – inserting the dose counter cartridge
After cleaning, insert the dose counter cartridge by sliding it down (  ) and pushing it into place (↓).
Return the inhaler to a horizontal position.
Reassembly – inserting the mouthpiece and protective cover cap
Insert the mouthpiece with its peg into the groove on the left and turn it to the right until it clicks back into place. Finish by replacing the protective cover cap.

Notes

• The Package Leaflet describes how the medicine works. Please read it carefully before using the inhaler for the first time.
• Novolizer can be used with different active substances, does not use propellants, and is refillable. This makes Novolizer an environmentally friendly product.
• Overdose is not possible with Novolizer. Even if the button is pressed multiple times, no additional powder is available for inhalation. Press the button only when you intend to inhale. If you are unable to inhale correctly after several attempts, consult your doctor.
• Novolizer can be refilled using new cartridges* containing the active substance and is therefore ideally suited for long-term use (up to 1 year).
• Do not shake Novolizer when loaded.
• Please assist children in the correct use of the device.
• Ensure that Novolizer is protected from moisture and heat and always keep it clean.

*For information on corresponding medicines, speak to your doctor.
Viatris Healthcare Limited,
Damastown Industrial Park,
Mulhuddart, Dublin 15,
Dublin, Ireland
CE