FORADIL^® (formoterol fumarate)

Geigy

Information for Patients

What you need to know about Foradil

Please read this leaflet carefully before you start to use your medicine. It contains important information about your medicine.

What's in your medicine

The active ingredient in this medicine is formoterol. This is the new name for eformoterol. The ingredient itself has not changed.

Foradil comes as capsules containing a dry powder. The dry powder is inhaled into the lungs using the inhaler provided in the pack. Each capsule contains 12 micrograms of formoterol fumarate. This is one of a group of medicines called bronchodilators. The gelatin capsules also contain lactose.

Foradil capsules come in blister packs of 60 capsules.

Manufactured by:
Novartis Pharma AG, CH 4332, Stein, Switzerland.

Released onto the market by:
Novartis Pharmaceuticals UK Limited
Wimblehurst Road, Horsham
West Sussex, RH12 5AB
England.

Product licence/authorisation holder:
Novartis Pharmaceuticals UK Limited
Trading as Geigy Pharmaceuticals
Frimley Business Park, Frimley
Camberley, Surrey
GU16 7SR, England.

What this medicine is used for

Foradil is used to treat the wheezing and breathlessness of asthma in patients already receiving inhaled corticosteroids. It makes breathing easier by relaxing muscle spasms in the air passages of the lungs. Regular use of Foradil with inhaled corticosteroids will help to prevent breathing problems.

Foradil is also used to treat reversible airways obstruction in patients with chronic obstructive pulmonary disease (COPD).

Before using your medicine

• Have you ever had an unusual or allergic reaction to formoterol or lactose?
• Is the person taking the medicine under five years of age?

If the answer to either of these questions is YES, do not use your medicine without talking to your doctor again.

• Do you suffer from any heart problems?
• Do you have an overactive thyroid gland?
• Are you diabetic?
• Are you pregnant or breast feeding?

If the answer to any of these questions is YES, tell your doctor or pharmacist.

Are you taking any of the following:

• Medicines for heart conditions including irregular heart beats and angina
• Medicines for high blood pressure
• Beta blockers (either as tablets or eye drops)
• Water tablets (diuretics)
• Medicines for depression, for example, monoamine oxidase inhibitors (MAOIs) or tricyclics
• Anti-histamines or cold remedies (including any bought from the chemist)
• Theophylline or aminophylline?

If the answer to any of these questions is YES, tell your doctor or pharmacist.

Other special warnings

• Your doctor may have given you other medicines for your breathing problems, for example, inhaled steroids. It is very important to keep using these regularly.

DO NOT stop using them or change the dose when you start using Foradil.

• If you feel that you are getting breathless or wheezy while you are using Foradil, you should continue to use it, but go to see your doctor as soon as possible in case you need another medicine.
• Foradil is not suitable for children under the age of 5 years.
• Do not swallow the capsules - they must only be used with the inhaler.
• In some patients, Foradil has been reported to cause dizziness. If you feel dizzy, do not drive or operate machinery.

Using your medicine

Your doctor will tell you how much Foradil to use and when to use it. Follow his/her instructions carefully. If the person taking the medicine is a child, he or she should be shown how to use the inhaler correctly and should only use the inhaler with the help of an adult.

Adults and elderly
Asthma:
The usual dose is 1 or 2 puffs (1 capsule=1 puff) morning and evening.

Chronic obstructive pulmonary disease:
The usual dose is 1 puff in the morning and evening.

Children aged 5 and above
For chest illnesses such as asthma:
The usual dose is 1 or 2 puffs (1 capsule=1 puff) morning and evening.
For COPD: Not suitable for use in children under 18 years of age

Normally the effects of this medicine will last for 12 hours. However, if you do get attacks of wheezing between doses, do not take extra doses of Foradil. Your doctor will have prescribed another medicine for this purpose. If you are not sure about this, check with your doctor.

• Do not stop or reduce the dose of Foradil or any other medicine for your breathing just because you feel better, without talking to your doctor first. It is very important to use these medicines regularly.
• Do not increase your dose of Foradil without talking to your doctor first.
• If you miss a dose, take it as soon as you remember. Then go on as before. Do not double the dose.
• If you feel sick or very shaky or if you have an unusually fast heart beat, your Foradil dose may be too high. Tell your doctor as soon as possible.

How to use the capsules with your inhaler

1. Pull off the cap.

2. Hold the base of the inhaler firmly and turn the mouthpiece in the direction of the arrow to open.

3. Take one of today's capsules out of the blister strip. Place it in the capsule-shaped compartment in the base of the inhaler. It is important that you remove the capsule from the blister pack only immediately before you use it.

4. Twist the mouthpiece to the closed position.

5. Keeping the inhaler upright, firmly squeeze the two blue buttons once only. This will pierce the capsule. Release the buttons. Although the capsule is now pierced, the powder will not be released until you inhale it.

6. Breathe out fully.

7. Place the mouthpiece in your mouth and tilt your head slightly backwards. Close your lips around the mouthpiece and breathe in as quickly and as deeply as you can. As you breathe in, you will inhale the medicine into your lungs.

You should hear the capsule spinning in the inhaler. If you do not hear this whirring noise, the capsule may be stuck in the compartment. If this occurs, open the inhaler and loosen the capsule by prising it out of the compartment. Do not try to loosen the capsule by repeatedly pressing the buttons.

8. If you have heard the whirring noise, hold your breath for as long as you comfortably can while taking the inhaler out of your mouth. Then breathe normally. Open the inhaler to see if any powder is still in the capsule. If there is still powder in the capsule repeat steps 6 to 8.

9. After use, tip out the empty capsule and close the mouthpiece.

10. Replace the cap.

11. If you need to clean the inhaler, wipe the mouthpiece and capsule compartment with a dry cloth. Alternatively, a clean soft brush may be used.

Very occasionally, very small pieces of the capsule shell can enter the mouth. If this happens, you may be able to feel these pieces on your tongue. The capsule shell is made of gelatin which is harmless to humans, and will soften or dissolve in the mouth and be swallowed. The chances of this happening will be increased if the capsule is pierced many times (Step 5); hence it is recommended that you do this only once for each capsule.

Please note: Foradil capsules must only be used with the inhaler provided. You must not try to inhale them using another inhaler. Also, do not put other types of capsules into the inhaler supplied with Foradil.

After using your medicine

Foradil does not usually cause unwanted effects. However, it can do so sometimes in some people.

Some effects could be serious. Tell your doctor immediately:

• If you experience bronchospasm with wheezing or coughing and difficulty in breathing.
• If you have an allergic reaction, for example if you feel faint (low blood pressure), have a rash, or experience itching or facial swelling.

The first of these serious side effects is uncommon (likely to affect fewer than 1 in 100 patients). The second is very rare (likely to affect fewer than 1 in 10,000 patients).

Other side effects:

Common side effects (likely to affect between 1 in 10 and 1 in 100 patients)
Headache, tremor, palpitations

Uncommon side effects (likely to affect between 1 in 100 and 1 in 1,000 patients)
Agitation, anxiety, feeling nervous, difficulties with sleeping, dizziness, distorted sense of tense, fast heart beat, swelling of hands, ankles or feet, throat irritation, muscle cramps, muscle pain

Very rare side effects (likely to affect fewer than 1 in 10,000 patients)
Nausea

Some of these effects may wear off as you get used to the medicine. However if they are severe or last more than a few days, tell your doctor.

If you notice any other side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Storing your medicine

• The expiry date for this medicine is given on the carton. Do not use the medicine after this date.
• Keep your medicine at room temperature in a dry place, out of the reach and sight of children. Do not take the capsules out of the blister pack until you need them. Return any unused medicine to your pharmacist.

REMEMBER: This medicine is for you. Only a doctor can prescribe it for you. Never give it to someone else. It may harm them even if they have the same symptoms as you.

The information in this leaflet applies only to Foradil. This leaflet does not contain the complete information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

Inhaler CE
The device conforms with Directive 93/42/EEC

Date: July 2006

Copyright Novartis Pharmaceuticals UK Limited