Foradil

Patient Information Leaflet

Foradil 12 mcg inhalation powder, hard capsules

formoterol
(formoterol fumarate)
Please read all of this leaflet carefully before you use 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 they have the same symptoms as yours, because it could 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 Foradil is and what it is used for
2. What you need to know before using Foradil
3. How to use Foradil
4. Possible side effects
5. How to store Foradil
6. Contents of the pack and other information

1. What Foradil is and what it is used for

Foradil contains the active substance formoterol. Formoterol belongs to a class of medicines 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.
Foradil 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 temperatures.

2. What you should know before using Foradil

DO NOT use Foradil

• 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 adequate experience in this age group is not available
• if you are pregnant or breastfeeding.

Warnings and precautions
In the treatment of asthma, Foradil must be used in combination with other medicines (corticosteroids) administered by inhalation.

• Your doctor will prescribe starting treatment with Foradil 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 treatment with Foradil, even if you notice an improvement in symptoms.

Do not use Foradil:

• 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 Foradil:

• if you have a disease caused by overactivity of the thyroid gland (thyrotoxicosis)
• if you have a tumour of the adrenal glands (pheochromocytoma)
• if you suffer from high blood pressure
• if you have heart problems
• if you have an arterial dilation, known as an aneurysm
• if you have diabetes
• if your electrocardiogram is abnormal (e.g. QT interval prolongation)
• if you have prostate problems (prostatic hypertrophy)
• if you have increased eye pressure (glaucoma).

During treatment with Foradil,

• strictly follow the dosage recommended by your doctor and do not exceed the maximum recommended daily dose (see section 3 “How to use Foradil”)
• do not start treatment with Foradil or increase its dose during an asthma exacerbation (acute and significant worsening of asthma)
• use of Foradil may cause a decrease in blood potassium levels, which can be serious. Low blood potassium levels may lead to heart rhythm disturbances. Your doctor will advise you, based on your condition, to monitor potassium levels.
• 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 treatment. Stop treatment with Foradil and inform your doctor immediately if, shortly after taking the medicine, you experience:
• chest tightness
• cough
• breathlessness or shortness of breath, as these may be signs of a condition called bronchospasm.

Children and adolescents
Children aged 0 to 6 years must not use Foradil.
Children aged between 6 and 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 between 6 and 12 years may experience an increase in asthma attacks during treatment with Foradil.

Other medicines and Foradil
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 Foradil (long-acting bronchodilators);
• medicines called beta-blockers, used for high blood pressure, heart problems, or an eye disease called glaucoma, including eye drops;
• medicines for heart rhythm disorders (antiarrhythmics), e.g. quinidine, disopyramide, and procainamide;
• psychotropic medicines (phenothiazines);
• medicines for allergies (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 anaesthesia with halogenated hydrocarbons;
• medicines acting on the central and peripheral nervous system (anticholinergics).

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Do not use Foradil during pregnancy.
The medicine may delay labour due to its relaxing effect on uterine muscles.
Breastfeeding
Do not use Foradil during breastfeeding.
Fertility
No information is available on the use of Foradil and its effects on fertility.

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

Foradil contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them 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 Foradil

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

Maintenance therapy and prevention

Use in adults
Your doctor will prescribe Foradil only as an add-on therapy to inhaled corticosteroids.

• The recommended dose is 1 capsule (12 micrograms) for 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 therapy, as this may indicate a worsening of your underlying condition.

• Do not use Foradil 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 Foradil only as an add-on therapy to inhaled corticosteroids.

• The recommended dose is 1 capsule (12 micrograms) for inhalation twice daily (morning and evening).
• For children aged 6 to 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 Foradil 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, Foradil 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 inhalation 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 inhalation capsule (12 micrograms) taken at least 15 minutes beforehand.

HOW TO USE FORADIL:

• Do not swallow the capsules. The powder inside the capsules must be inhaled.
• Remove the capsules from the blister only immediately before use.
• Use Foradil powder for inhalation hard capsules only with the Aerolizer inhaler provided in the Foradil package.

Instructions for using the inhaler
The Aerolizer inhaler consists of the following

parts:

1. A blue cap to protect the mouthpiece of the base
2. A base that enables proper drug release. The base consists of:
3. A mouthpiece
4. A capsule chamber
5. A blue button and pins on each side
6. An air inlet channel

1. Remove the cap.
2. Hold the base firmly and rotate the mouthpiece in the

direction of the arrow.

3. With completely dry fingers, remove the capsule from the blister only immediately before administration and place it into the capsule chamber. IMPORTANT: do not place the capsule in the mouthpiece.

4. Close the chamber by rotating the mouthpiece back to the closed position. You will hear a "click."

5. Press both blue buttons down fully at the same time, only once, while holding the inhaler vertically with the mouthpiece pointing upward. Then release the buttons. Perform this step only once. Note: When the capsule is pierced, small fragments of gelatin may enter the mouth or throat. Since this is food-grade gelatin, it is not harmful.
6. Breathe out fully.

7. Place the mouthpiece in your mouth and tilt your head slightly backward. Close your lips tightly around the mouthpiece and inhale rapidly but steadily as deeply as possible. You should hear a buzzing sound from the chamber caused by the capsule rotating in the chamber. If you do not hear this sound, open the capsule chamber and check whether the capsule is blocked. Then repeat the steps described in point 7. Do not attempt to unblock the capsule by repeatedly pressing the buttons.
8. After inhaling with the Aerolizer, hold your breath as long as possible while removing the inhaler, then breathe out through your nose. Open the capsule chamber to check whether any powder remains in the capsule. If so, repeat the steps described in points 6–8.

9. After inhaling all the powder, open the capsule chamber (see step 2), remove the empty capsule, and clean the capsule chamber with a dry cloth. Alternatively, you may use a soft brush. DO NOT USE WATER TO CLEAN THE AEROLIZER.

10. Close the mouthpiece and replace the cap.

If you use more Foradil than you should
If you accidentally ingest an excessive dose of Foradil, contact your doctor immediately or go to the nearest hospital.
After ingestion or excessive use of Foradil, the following may occur:

• tremors
• 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 disturbances
• high blood pressure
• nausea
• vomiting

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

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone 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
• rapid 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)
• throat irritation
• dry mouth

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

• heart rhythm disorders: either atrial fibrillation, or supraventricular tachycardia, or extrasystoles
• allergic reactions with: either decreased blood pressure, or swelling of the face, eyelids, lips, or bronchospasm, or hives, or itching, or 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)
• alteration of the heart's electrical conduction detected by electrocardiogram (prolongation of the QTc interval)
• taste disturbance
• high levels of sugar (glucose) in the blood
• changes in blood pressure

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

• increased blood pressure
• skin rash

In addition, the following have been reported:

• worsening of asthma
• difficulty breathing (dyspnoea)
• cough
• fatigue
• conjunctival irritation
• eyelid swelling

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

• increased levels of insulin in the blood (hormone regulating blood sugar)
• increased levels of free fatty acids
• increased glycerol levels
• 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 http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Foradil

Do not store above 25°C.
Keep in the original packaging to protect from moisture.
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.
Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
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. Package contents and other information

What Foradil contains

• The active substance is formoterol fumarate. Each Foradil capsule contains 12 micrograms of formoterol fumarate.
• The other ingredient is lactose monohydrate.

Description of the appearance of Foradil and contents of the pack
Each pack of Foradil contains 3 or 6 blisters of 10 capsules and one inhaler.
Marketing Authorization Holder
Sandoz S.p.A.
L.go U. Boccioni 1
21040 Origgio (VA)
Italy
Manufacturer
Novartis Farma S.p.A.
Viale Luigi Sturzo 43
20154 Milano MI
Italy
Novartis Farma S.p.A.
Via Provinciale Schito 131
80058 Torre Annunziata NA
Italy