FORMOTEROLO 12 MICROGRAMS Inhalation powder, hard capsule

Содержание инструкции

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

FORMOTEROLO EG 12 micrograms powder for inhalation, hard capsules

Generic medicine

Read this leaflet carefully before you start using 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 could 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 FORMOTEROLO EG is and what it is used for
• 2. What you need to know before you use FORMOTEROLO EG
• 3. How to use FORMOTEROLO EG
• 4. Possible side effects
• 5. How to store FORMOTEROLO EG
• 6. Contents of the pack and other information

1. What is FORMOTEROLO EG and what it is used for

FORMOTEROLO EG contains the active ingredient formoterol. Formoterol belongs to a class of
substances called bronchodilators, which make breathing easier by relaxing the muscles of the airways.
This makes it easier for air to enter and leave the lungs.
FORMOTEROLO EG 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 cause allergies or by exertion or cold.

2. What you need to know before using FORMOTEROLO EG

Do not use FORMOTEROLO EG

• if you are allergic to formoterol fumarate or any of the other ingredients of this medicine (listed in section 6).
• if the patient is a child up to 6 years of age, as adequate experience is not available in this age group;
• if you are pregnant or breastfeeding.

Warnings and precautions
In the treatment of asthma, FORMOTEROLO EG must be used in association with other inhaled medicines
(corticosteroids).

• Your doctor will prescribe you to start treatment with FORMOTEROLO EG 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 FORMOTEROLO EG, even if you notice an improvement in symptoms.

Do not use FORMOTEROLO EG:

• 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 FORMOTEROLO EG.

• have had an ischemia or heart attack,
• if you have a disease due to excessive functioning of the thyroid gland (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 diabetes,
• if you have a dilation of an artery, known as an aneurysm,
• if your electrocardiogram is altered (e.g. prolongation of the QT interval),
• if you have prostate problems (prostatic hypertrophy),
• if you have increased eye pressure (glaucoma).

During treatment with FORMOTEROLO EG

• strictly adhere to the dosage recommended by your doctor and do not exceed the maximum recommended daily dose (see section 3 “How to use FORMOTEROLO EG”),
• do not start treatment with FORMOTEROLO EG or increase the dose during an asthma exacerbation (acute and significant worsening of asthma),
• the use of FORMOTEROLO EG may cause a decrease in blood potassium levels which may be severe. A decrease in blood potassium levels can lead to a heart rhythm disturbance. Your 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 FORMOTEROLO EG 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 FORMOTEROLO EG.
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 FORMOTEROLO
EG.

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

• medicines for breathing problems that are similar to FORMOTEROLO EG (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 (QT prolongation);
• 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 are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Do not use FORMOTEROLO EG during pregnancy.
The medicine may block labor due to the relaxing effect on the muscles of the uterus.
Breastfeeding
Do not use FORMOTEROLO EG during breastfeeding.
Fertility
No information is available on the use of FORMOTEROLO EG and its effects on fertility.

Driving and using machines
FORMOTEROLO EG does not impair the ability to drive vehicles or operate machinery.

FORMOTEROLO EG contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this
medicine.

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

3. How to use FORMOTEROLO EG

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

Maintenance and prevention therapy
Use in adults
Your doctor will prescribe FORMOTEROLO EG only as an add-on therapy to inhaled corticosteroids.
The recommended dose is 1 capsule (12 micrograms) via inhalation 2 times a day (morning and evening).
The recommended maximum daily maintenance dose is 4 capsules (48 micrograms) per
day.
If necessary to obtain relief from symptoms, your doctor may increase the dose, in addition to that 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 a
worsening of the underlying disease is occurring.
Do not use FORMOTEROLO EG to relieve the symptoms of an acute asthma attack. In this case, use the
emergency medicines prescribed by your doctor (short-acting β2-agonists).

Use in children over 6 years of age
Your doctor will prescribe FORMOTEROLO EG only as an add-on therapy to inhaled corticosteroids.
The recommended dose is 1 capsule (12 micrograms) via 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 dose should not exceed 2 capsules (24 micrograms).
Do not use FORMOTEROLO EG if the child has an acute asthma attack. In this case, use the medicines
prescribed by your doctor (short-acting β2-agonists).

Prevention of exercise-induced bronchospasm or before exposure to known substances that can cause

allergy.
In patients with persistent asthma, the use of FORMOTEROLO EG 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 dose is1 capsule for inhalation (12 micrograms) at least 15 minutes in advance.
You can use a dose of 2 capsules (24 micrograms) as a preventive measure 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 administer

1		n a i Remove the cap. l
2	a	t Hold the base of the inhaler firmly and rotate the mouthpiece in the direction of the arrow to open.
3	e n z i	Place the capsule in the appropriate compartment in the inhaler. It is important that the capsule is removed from the blister pack only immediately before administration.
4	A g	Turn the mouthpiece to the closed position.

5		Press the red buttons firmly once, holding the inhaler in a vertical position. Then release the buttons. o Note: When the capsule breaks, small fragments of gelatin may go into your mouth or throat. Since this is gelatin for food use, c 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 immediately before use (see point no. 3).
6		a m Exhale completely. r
7		F Place the mouthpiece in your mouth and tilt your head back slightly. Close your lips around the mouthpiece and inhale rapidly, but l 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 is dispersed; if you did not feel and no buzzing, the capsule may be stuck in the compartment. If this happens, open the inhaler and unblock the capsule from the compartment. Do not try to unblock the capsule by pressing the buttons repeatedly.
8	d If you felt the buzzing, HOLD YOUR BREATH for as long as possible while removing the inhaler then exhale. a Open the inhaler to see if there is still powder in the capsule. If so, repeat the operations indicated in points 6-8.
9	n After use, open the inhaler, remove the empty capsule, close the mouthpiece and replace the cap.
a Cleaning the inhaler: To remove any powder residue, clean the mouthpiece and the capsule compartment with a dry cloth. Alternatively, you can use a soft toothbrush.

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

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

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

If you stop taking FORMOTEROLO EG
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 between 6-12 years

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

• fast heartbeat (tachycardia)
• muscle cramps, muscle pain
• 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: or atrial fibrillation or supraventricular tachycardia or extrasystoles
• allergic reactions with: or decreased blood pressure or swelling of the face, eyelids, lips or bronchospasm or hives or itching or 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 through an electrocardiogram (prolongation of the QTc interval)
• elevated blood sugar (glucose) levels
• altered taste
• changes in blood pressure

Side effects with unknown frequency: frequency cannot be estimated based on available data:

• increased blood pressure
• skin rash Furthermore, the following have been reported:
• worsening of asthma
• difficulty breathing (dyspnea)
• cough
• fatigue
• conjunctivitis
• swelling of the eyelids Treatments with medicines similar to FORMOTEROLO EG (ß2 agonists) may 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. This includes any possible side effects not listed in this leaflet. 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 FORMOTEROLO EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after Exp. The expiry date refers to the last day of that month.
Protect from heat and humidity.
Do not store at a temperature above 25°C.
Do not dispose of any medicine in waste water 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 pack and other information

What FORMOTEROLO EG contains

• The active ingredient is formoterol (as formoterol fumarate). Each capsule contains 12 micrograms of formoterol.
• The other ingredients are anhydrous lactose and lactose monohydrate.

Description of the appearance of FORMOTEROLO EG and contents of the pack
Transparent gelatin capsules containing a yellowish powder.
FORMOTEROLO EG is available in packs containing 1 bottle of 60 or 100 capsules and a
device.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
EG S.p.A., Via Pavia 6, 20136 Milan

Manufacturer
SMB TECHNOLOGY S.A. – 39, rue du Parc Industriel, 6900 Marche en Famenne – Belgium