LEVOVENT 12 MIKROGRAMÓW Proszek do inhalacji, twarda kapsułka

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1. Levovent 12 mcg powder for inhalation, hard capsules
   1. What is Levovent and what is it used for
   2. What you need to know before using Levovent
   3. How to use Levovent
   4. Possible side effects
   5. How to store Levovent
   6. Contents of the pack and other information

Levovent 12 mcg powder for inhalation, hard capsules

formoterol (formoterol fumarate)

Read this leaflet carefully before you start to use this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Levovent and what is it used for

Levovent contains the active ingredient formoterol. Formoterol belongs to a class of substances called
bronchodilators, which facilitate breathing by relaxing the muscles of the airways. This makes it easier for air to
enter and leave the lungs.
Levovent is used to prevent and treat breathing difficulties (bronchospasms):

• in patients with bronchial asthma with or without emphysema (a disease that affects the alveoli of the lung with a gradual worsening of breathing and oxygen supply)
• in patients with chronic bronchitis, with or without emphysema
• caused by substances that trigger allergies or by exertion or cold.

2. What you need to know before using Levovent

DO NOT use Levovent

• if you are allergic to formoterol fumarate, or to any of the other ingredients of this medicine (listed in section 6)
• if the patient is a child under 6 years of age, as adequate experience is not available in this age group
• if you are pregnant or breastfeeding. Warnings and precautionsIn the treatment of asthma, Levovent must be used in association with other inhaled medicines (corticosteroids).
• The doctor will prescribe you to start treatment with Levovent together with inhaled corticosteroids only if your condition is not adequately controlled by these medicines or if your condition is very severe.
• Continue corticosteroid therapy after starting therapy with Levovent, even if you notice an improvement in symptoms.

Do not use Levovent:

• as initial treatment for asthma.
• if you are having an acute asthma attack. In this case, you should use the emergency medicines prescribed by your doctor (short-acting bronchodilators)

Consult your doctor before using Levovent:

• if you have a disease due to excessive functioning of the thyroid (thyrotoxicosis)
• if you have a tumor of the adrenal glands (pheochromocytoma)
• if you suffer from high blood pressure
• if you have heart problems
• if you have a dilation of an artery, known as an aneurysm
• if you have diabetes
• if your electrocardiogram is altered (e.g. prolongation of the QT interval)
• if you have prostate problems (prostatic hypertrophy)
• if you have increased pressure in the eye (glaucoma).

During treatment with Levovent,

• strictly adhere to the dosage recommended by your doctor and do not exceed the maximum recommended daily dose (see section 3 “How to use Levovent”)
• do not start treatment with Levovent or increase the dose during an asthma exacerbation (acute and significant worsening of asthma)
• the use of Levovent can cause a decrease in blood potassium levels, which can be severe. A decrease in blood potassium levels can lead to an alteration of the heart rhythm. The doctor will advise you, based on your situation, to monitor potassium levels.
• if symptoms do not improve or worsen or if the number of doses needed to control symptoms increases, consult your doctor to re-evaluate your therapy.

Stop treatment with Levovent and immediately inform your doctorif shortly after taking the
medicine you feel:

• chest tightness
• cough
• wheezing or shortness of breath, as this may be a sign of a condition called bronchospasm.

Children and adolescents
Children aged between 0 and 6 years should not use Levovent.
Children aged between 6 and 12 years should use the fixed combination of an inhaled corticosteroid and a long-acting bronchodilator, except in cases where their separate administration is required.
Children aged between 6 and 12 years may experience an increase in asthma attacks during treatment with Levovent.

Other medicines and Levovent
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
In particular, tell your doctor if you are taking:

• medicines for breathing problems that are similar to Levovent (long-acting bronchodilators);
• medicines called beta-blockers, used for high blood pressure, heart problems or an eye disease called glaucoma, including eye drops;
• medicines against heart rhythm disturbances (antiarrhythmics) e.g. quinidine, disopyramide and procainamide;
• psychotropic drugs (phenothiazines);
• medicines against allergies (antihistamines) e.g. terfenadine, astemizole and mizolastine;
• medicines against depression (monoamine oxidase inhibitors, tricyclic antidepressants);
• antibiotics (macrolides);
• medicines that can cause changes in the electrocardiogram (prolongation of the QT);
• medicines used for the treatment of asthma (ephedrine, xanthine medicines);
• steroids (hormone-like medicines);
• medicines that increase urine production and reduce pressure (diuretics);
• if you are to undergo anesthesia with halogenated hydrocarbons;
• medicines that act on the central and peripheral nervous system (anticholinergics).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding with breast milk
ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Do not use Levovent during pregnancy.
The medicine may block labor due to the relaxing effect on the muscles of the uterus.
Breastfeeding
Do not use Levovent during breastfeeding.
Fertility
There is no information available on the use of Levovent and its effects on fertility.

Driving and operating machinery
Levovent does not impair the ability to drive vehicles or operate machinery.

For athletes
The use of the drug without therapeutic necessity constitutes doping and may still result in a positive anti-doping test.

3. How to use Levovent

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts
consult your doctor or pharmacist.

Maintenance and prevention therapy
Use in adults
Your doctor will prescribe Levovent only as an addition to inhaled corticosteroids.

• The recommended doseis 1 capsule (12 micrograms) by inhalation twice a day (morning and evening).
• The maximum daily doserecommended for maintenance is 4 capsules (48 micrograms) per day.
• If necessary to obtain relief from symptoms, your doctor may increase the dose, in addition to the one prescribed for normal maintenance therapy, up to two additional capsules per day, considering that the maximum recommended dose of 4 capsules per day must not be exceeded. In any case, if the need for additional doses is more than occasional (e.g. more than two days a week), further medical advice should be sought to review the therapy, as this may mean that the underlying disease is worsening.
• Do not use Levovent to relieve the symptoms of an acute asthma attack. In such cases, use the emergency medicines prescribed by your doctor (short-acting β2-agonists).

Use in children over 6 years of age
Your doctor will prescribe Levovent only as an addition to inhaled corticosteroids.

• The recommended doseis 1 capsule (12 micrograms) by inhalation twice a day (morning and evening).
• For children between 6 and 12 years of age, treatment with a fixed combination of an inhaled corticosteroid and a long-acting bronchodilator is recommended, except in cases where separate administration of an inhaled corticosteroid and a

long-acting bronchodilator is required.

• The maximum daily doseshould not exceed 2 capsules (24 micrograms).
• Do not use Levovent if the child is having an acute asthma attack. In such cases, use the emergency medicines prescribed by your doctor (short-acting β2-agonists).

Prevention of exercise-induced bronchospasm or before exposure to substances known to cause
allergy
In patients with persistent asthma, the use of Levovent may be indicated for the prevention of exercise-induced
bronchospasm or before unavoidable exposure to substances known to cause allergy, but asthma treatment
should also include an inhaled corticosteroid.

Use in adults

• The recommended doseis 1 capsule for inhalation (12 micrograms) at least 15 minutes in advance.
• You may use a dose of 2 capsules (24 micrograms) for prevention if you suffer from severe bronchospasm.

Use in children over 6 years of age

• The recommended doseis 1 capsule for inhalation (12 micrograms) at least 15 minutes in advance.

HOW TO USE LEVOVENT:

• Do not swallow the capsules. The powder contained in the capsules must be inhaled.
• Use Levovent powder for inhalation hard capsules only with the inhaler present inside the box containing Levovent.

Instructions for use of the inhaler

1	I	i l a Remove the cap. t
2	n z i a	Hold the base of the mouthpiece firmly and rotate the mouthpiece in the direction of the arrow to open.
3	A g e	Insert the capsule into the appropriate compartment in the mouthpiece. It is important that the capsule is removed from the bottle only immediately before administration.

4		o c a Turn the mouthpiece to the closed position. m
5		Press the red buttons firmly once, holding the mouthpiece in a vertical position. Then release the buttons. a Note: when the capsule breaks, small fragments of gelatin may go into your mouth or throat. Since this is gelatin for food F use, it is not dangerous. The tendency of the capsule to fragment is minimal if you do not press the buttons more than once, if you follow the storage instructions and put the capsule into the inhaler only l immediately before use (see point no. 3).
6		e d Exhale completely. a
7		n Place the mouthpiece in your mouth and tilt your head back slightly. a Close your lips around the mouthpiece and inhale rapidly, but steadily, as deeply as possible. You should feel a buzz in the chamber due to the rotation of the capsule in the compartment when the powder disperses; if you have not felt any buzz, the capsule may be stuck in the compartment. If this happens, open the inhaler and unlock the capsule from the compartment. Do not try to unlock the capsule by pressing the buttons repeatedly.
8	I If you have felt the buzz, HOLD YOUR BREATH for as long as possible while removing the mouthpiece and exhaling. a Open the inhaler to see if there is still powder in the capsule. If so, repeat the operations indicated at points 6-8.
9	After use, open the inhaler, remove the empty capsule, close the mouthpiece and replace the cap.

If you use more Levovent than you should
In case of accidental ingestion of an excessive dose of Levovent, immediately inform your doctor or
go to the nearest hospital.
After ingestion or use of an excessive dose of Levovent, you may experience:

• tremors
• headache
• palpitations
• fast heartbeat
• high blood sugar
• low levels of potassium in the blood
• alteration of the electrical conduction of the heart detected by electrocardiogram (prolongation of the QTc interval)
• heart rhythm disturbance
• high blood pressure
• nausea
• vomiting

If you forget to use Levovent
Do not use a double dose to make up for a missed dose.
Take the medicine as soon as possible unless it is already time to take the next dose. Then return to
the normal dosing schedule.

If you stop taking Levovent
Take the medicine as prescribed by your doctor and continue until your doctor tells you to
stop.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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

• irregular heartbeat (palpitations)
• headache
• tremors
• cough
• worsening of severe asthma in children aged 6-12 years

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

• muscle cramps
• muscle pain
• fast heartbeat
• dizziness
• agitation
• anxiety
• restlessness
• sleep disturbances
• asthmatic reaction (bronchospasm), including paradoxical bronchospasm (severe and exaggerated narrowing of the airways following inhalation of a substance that normally dilates them)
• sore throat
• dry mouth

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

• heart rhythm disorders: such as atrial fibrillation or supraventricular tachycardia or extrasystoles
• allergic reactions with: o decreased blood pressure o swelling of the face, eyelids, lips o bronchospasm o hives o itching o rash with pustules, blisters and bubbles (exanthem)
• nausea
• low levels of potassium in the blood

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

• fluid retention in the limbs
• chest pain (angina pectoris)
• alteration of the heart's electrical conduction detected by electrocardiogram (prolongation of the QTc interval)
• altered taste
• elevated blood sugar (glucose) levels
• changes in blood pressure

Side effects with unknown frequency (frequency cannot be estimated from available data)

• increased blood pressure
• skin rash

In addition, the following have been reported:

• worsening of asthma
• difficulty breathing (dyspnea)
• cough
• fatigue
• conjunctivitis (irritation of the conjunctiva)
• swelling of the eyelids

Treatments with medicines similar to Levovent (ß2 agonists) can cause:

• increased levels of insulin in the blood (hormone that regulates blood sugar)
• increased free fatty acids
• increased glycerol
• increased ketone bodies.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Levovent

Store Levovent at a temperature not exceeding 25°C.
Do not use this medicine after the expiry date which is reported on the package after Expires. The expiry date
refers to the last day of that month.
Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
Do not dispose of any medicine in the drain or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Levovent contains

• The active ingredient is formoterol fumarate. Each Levovent capsule contains 12 micrograms of formoterol fumarate.
• The other component is lactose.

Description of the appearance of Levovent and contents of the pack
Each pack of Levovent contains a bottle of 60 or 100 capsules and a device.

Marketing Authorisation Holder
Genetic S.p.A.
Via G. Della Monica, 26
84083 Castel San Giorgio (SA)
Italy

Manufacturer
SMB Technology S.A.
39, rue du Parc Industriel
6900 Marche en Famenne
Belgium
Genetic S.p.A.
Contrada Canfora
84084 Fisciano (SA)
Italy