Formoterol Eg

Patient Information Leaflet

FORMOTEROLO EG 12 micrograms inhalation powder, hard capsules

Generic medicine
Please read all of 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 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 FORMOTEROLO EG is 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

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

FORMOTEROLO EG contains the active substance formoterol. Formoterol belongs to a class of
substances called bronchodilators, which make breathing easier by relaxing the muscles in the airways.
This allows air to flow in and out of the lungs more easily.
FORMOTEROLO EG is used to prevent and treat breathing difficulties (bronchospasms)

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

2. What you need to know before using FORMOTEROLO EG

Do not use FORMOTEROLO EG

• 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 up to 6 years of age, as there is insufficient experience with this age group;
• if you are pregnant or breastfeeding.

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

• Your doctor will prescribe FORMOTEROLO EG in combination with inhaled corticosteroids only if your condition is not adequately controlled by these medicines or if your condition is very severe.
• Continue your corticosteroid therapy after starting treatment with FORMOTEROLO EG, even if you notice an improvement in symptoms.

Do not use FORMOTEROLO EG:

• as initial treatment for asthma.
• during an acute asthma attack. In such cases, use the emergency medicines prescribed by your doctor (short-acting bronchodilators).

Consult your doctor before using FORMOTEROLO EG if you:

• have had ischemia or a heart attack,
• have a condition caused by overactivity of the thyroid gland (thyrotoxicosis),
• have a tumor of the adrenal glands (pheochromocytoma),
• have high blood pressure,
• have heart problems,
• have diabetes,
• have an arterial dilation known as an aneurysm,
• have an abnormal electrocardiogram (e.g. prolonged QT interval),
• have prostate problems (prostatic hypertrophy),
• have increased eye pressure (glaucoma).

During treatment with FORMOTEROLO EG

• strictly follow the dosage prescribed by your doctor and do not exceed the recommended maximum daily dose (see section 3 “How to use FORMOTEROLO EG”),
• do not start treatment with FORMOTEROLO EG or increase its dose during an asthma exacerbation (acute and significant worsening of asthma),
• use of FORMOTEROLO EG may cause a decrease in potassium levels in the blood, which can be serious. Low potassium levels may lead to heart rhythm disturbances. Your doctor will advise you, based on your condition, whether potassium levels should be monitored.
• if your symptoms do not improve or worsen, or if the number of doses needed to control symptoms increases, consult your doctor to reassess your therapy.

Stop treatment with FORMOTEROLO EG and contact your doctor immediately if, shortly after taking the medicine, you experience:

• chest tightness,
• cough,
• shortness of breath or difficulty breathing, as these may be signs of a condition called bronchospasm.

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

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

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

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Do not use FORMOTEROLO EG during pregnancy.
The medicine may delay labour due to its relaxing effect on the uterine muscles.
Breastfeeding
Do not use FORMOTEROLO EG while breastfeeding.
Fertility
There is no information 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 or operate machinery.

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

For those engaged in sports
Using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

3. How to use FORMOTEROL EG

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Maintenance and preventive therapy

Use in adults
Your doctor will prescribe FORMOTEROL EG only as an add-on therapy to inhaled corticosteroids.
The recommended dose is 1 capsule (12 micrograms) administered by inhalation twice daily (morning and evening).
The maximum recommended daily maintenance dose is 4 capsules (48 micrograms) per day.
If needed to relieve symptoms, your doctor may increase your dose above the usual maintenance dose by up to two additional capsules per day, provided that the maximum recommended dose of 4 capsules per day is not exceeded. However, if additional doses are needed more than occasionally (e.g., more than two days per week), you must seek further medical advice to review your treatment, as this may indicate a worsening of the underlying disease.
Do not use FORMOTEROL EG to relieve symptoms of an acute asthma attack. In such cases, use the emergency medication prescribed by your doctor (short-acting β2-agonists).

Use in children over 6 years of age
Your doctor will prescribe FORMOTEROL EG only as an add-on therapy to inhaled corticosteroids.
The recommended dose is 1 capsule (12 micrograms) administered by inhalation twice daily (morning and evening).
For children aged between 6 and 12 years, 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 must not exceed 2 capsules (24 micrograms).
Do not use FORMOTEROL EG if the child is experiencing an acute asthma attack. In such cases, use the emergency medication prescribed by your doctor (short-acting β2-agonists).

Prevention of exercise-induced bronchospasm or before exposure to known allergens
In patients with persistent asthma, FORMOTEROL EG may be used to prevent exercise-induced bronchospasm or before unavoidable exposure to known allergens. However, asthma treatment must also include an inhaled corticosteroid.

Use in adults
The recommended dose is 1 inhaled capsule (12 micrograms), taken at least 15 minutes beforehand.
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 dose is 1 inhaled capsule (12 micrograms), taken at least 15 minutes beforehand.

Method of administration

1		Remove the cap.
2		Hold the base of the inhaler firmly and rotate the mouthpiece in the direction of the arrow to open.
3		Place the capsule into the designated compartment in the inhaler. It is important to remove the capsule from the container only immediately before administration.
4		Turn the mouthpiece back to the closed position.
5		Firmly press down the red buttons once only, holding the inhaler in an upright position. Then release the buttons. Note: When the capsule breaks, small fragments of gelatin may enter the mouth or throat. Since this is food-grade gelatin, it is not harmful. The tendency of the capsule to fragment is minimal provided the buttons are not pressed more than once, storage instructions are followed, and the capsule is placed in the inhaler only immediately before use (see step 3).
6		Breathe out fully.
7		Put the mouthpiece into your mouth and tilt your head slightly backward. Close your lips around the mouthpiece and inhale quickly, but steadily, as deeply as possible. You should hear a buzzing sound in the chamber caused by the rotation of the capsule as the powder disperses. If you do not hear a buzzing sound, the capsule may be jammed in the compartment. If this occurs, open the inhaler and unblock the capsule from the compartment. Do not attempt to unblock the capsule by repeatedly pressing the buttons.
8	If you heard the buzzing sound, HOLD YOUR BREATH for as long as possible while removing the inhaler, then breathe out. Open the inhaler to check whether any powder remains in the capsule. If so, repeat the steps described in points 6–8.
9	After use, open the inhaler, remove the empty capsule, close the mouthpiece, and replace the cap.
Cleaning the inhaler: To remove any powder residue, clean the mouthpiece and the capsule compartment with a dry cloth. Alternatively, a soft brush may be used.

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

• tremor
• headache
• palpitations
• rapid heartbeat
• high blood sugar
• low potassium levels in the blood
• disturbance in the heart's electrical conduction detected by electrocardiogram (prolongation of the QTc interval)
• heart rhythm disorder
• high blood pressure
• nausea
• vomiting

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

If you stop using FORMOTEROLO EG
Take the medicine exactly as prescribed by your doctor and continue until your doctor tells you to stop.

If you have any doubts about the use of this medicine, consult 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):

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

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

• heart rhythm disorders: such as atrial fibrillation, supraventricular tachycardia, or extrasystoles
• allergic reactions with:
  - decrease in blood pressure
  - swelling of the face, eyelids, lips or bronchospasm
  - hives (urticaria)
  - itching
  - skin rash with pustules, blisters and bullae (exanthema)
• nausea
• low levels of potassium in the blood

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

• fluid accumulation in the limbs
• chest pain (angina pectoris)
• disturbance in the heart's electrical conduction as seen on electrocardiogram (prolongation of QTc interval)
• high levels of blood sugar (glucose)
• taste disturbance
• changes in blood pressure

Side effects with unknown frequency: frequency cannot be estimated from the available data:

• increase in blood pressure
• skin rash

Additionally, the following have been reported:

• worsening of asthma
• difficulty in breathing (dyspnoea)
• cough
• fatigue
• conjunctival irritation
• swelling of the eyelids

Treatment with medicines similar to FORMOTEROL EG (ß2 agonists) may cause:

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the carton after "Exp.". The expiry date refers to the last day of that month.
Protect from heat and moisture.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What FORMOTEROLO EG contains

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

Description of the appearance of FORMOTEROLO EG and the pack contents
Transparent gelatin capsules containing a yellowish powder.
FORMOTEROLO EG is available in packs containing 1 bottle with 60 or 100 capsules and a
nebulizer.
It is possible that not all pack sizes are marketed.

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

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