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Formoterol Generics

Package leaflet: Information for the patient

Formoterol Generics 12 microgram powder for inhalation, hard capsule

Formoterol fumarate dihydrate


Read all of this leaflet carefully before you start using this medicine because it contains important information for you.


What is in this leaflet

1. What Formoterol Generics is and what it is used for

2. What you need to know before you use Formoterol Generics

3. How to use Formoterol Generics

4. Possible side effects

5. How to store Formoterol Generics

6. Contents of the pack and other information


1. What Formoterol Genericsis and what it is used for

Formoterol Generics contains a medicine called formoterol. This belongs to a group of medicines called ‘long-acting beta-agonists’ or ‘bronchodilators’


It works by relaxing the muscles in your airways. This helps you to breathe more easily. It starts to work within 1 to 3 minutes and the effects last up to 12 hours.


Your doctor has prescribed this medicine to treat your asthma or chronic obstructive pulmonary disease (COPD


Asthma

For asthma, your doctor will prescribe two asthma inhalers: Formoterol Generics and a separate ‘corticosteroid’ inhaler. These should be used together.

Formoterol Generics can also be used before exercise to prevent asthma symptoms caused by exercise.


Chronic obstructive pulmonary disease (COPD)

Formoterol Generics can also be used to treat the symptoms of COPD in adults. COPD is a long-term disease of the airways in the lungs, which is often caused by cigarette smoking.


2. What you need to know before you use Formoterol Generics

Do not use Formoterol Generics

If you are allergic to formoterol or any of the other ingredients of this medicine (listed in section 6).



Warnings and precautions


Talk to your doctor, pharmacist or nurse before using Formoterol Generics.


Before you use Formoterol Generics, tell your doctor or pharmacist if:


If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using Formoterol Generics.

Children


Do not give this medicine to children below 6 years because there is insufficient data on safety and efficacy in this age group.


Other medicines and Formoterol Generics


Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.


In particular tell your doctor or pharmacist, if you are taking any of the following medicines:



If any of the above applies to you, or if you are not sure, talk to your doctor or pharmacist before using Formoterol Generics.


Also tell your doctor or pharmacist if you are going to have a general anaesthetic for an operation or for dental work.


The addition of anticholinergics (such as tiotropium or ipratropium bromide) to the treatment with Formoterol Generics, can help to open your airways even more.


Pregnancy and breast-feeding


If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.


If you get pregnant while using this medicine, do not stop using Formoterol Generics but talk to your doctor immediately.


Driving and using machines

Formoterol Genericsis not likely to affect you being able to drive or use any tools or machines.


Formoterol Generics contains lactose

The excipient lactose contains small amounts of milk proteins, which may cause allergic reactions.


This medicine contains lactose, which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before using this medicine. The amount of lactose in this medicine does not normally cause problems in people who are lactose intolerant.


3. How to use Formoterol Generics


Always use Formoterol Genericsexactly as your doctor, nurse or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.


Do not increase the dose of Formoterol Genericsprescribed by your doctor without talking to your doctor first.


If you are using Formoterol Genericsregularly for asthma or COPD you should continue to use your medicine, even if you have no symptoms.


Continue using the inhaler for as long as you have been told unless you have any problems. In that case, talk to your doctor.


Formoterol Generics must only be used with the inhaler provided. You must not try to inhale Formoterol Generics capsules using another inhaler.

Do not put other types of capsules into the inhaler supplied with Formoterol Generics.


Do not swallow the capsules. The contents of the capsule must be inhaled using the inhaler provided.


Important information about your asthma or COPD symptoms

If you feel you are getting breathless or wheezy while using Formoterol Generics, you should continue to use Formoterol Generics but go to see your doctor as soon as possible, as you may need additional treatment.


Contact your doctor immediately if:


These signs could mean that your asthma or COPD is not being properly controlled and you may need different or additional treatment immediately.


Asthma


Formoterol Generics should not be used in children under 6 years of age.


Adults (18 years old and above)


Children and adolescents (6 to 17 years old)

Your child should not have more than 1 inhalation (1 capsule) at any one time.


Your doctor (or asthma nurse) will help you to manage your asthma. Once your asthma is well controlled your doctor may consider it appropriate to gradually reduce the dose of Formoterol Generics.


Asthma caused by exercise


If you or your child have asthma symptoms caused by exercise, your doctor may advise you or your child to use Formoterol Generics before exercise as well. Formoterol Generics should not be used in children under 6 years of age.


Adults (18 years old and above)


Children and adolescents (6 to 17 years old)


Chronic obstructive pulmonary disease (COPD)



How to use the capsules with the inhaler device


A child should be shown how to use the inhaler correctly and should only use it with the help of an adult.


Pull off the cap.


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



Take one capsule from the pack. Place it in the capsule-shaped compartment at the base of the inhaler. It is important that you only remove the capsule from the pack immediately before use.



Twist the mouthpiece to the closed position until it clicks.


5. Keeping the inhaler upright, firmly squeeze the two 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.


Cleaning your inhaler

If you need to clean the inhaler, wipe the mouthpiece and capsule compartment with a dry cloth or a clean soft brush. Do not use water or liquids.


If you use more Formoterol Generics than you should

If you use more Formoterol Generics than you should, contact your doctor or pharmacist for advice immediately. The following effects may happen: trembling, headache or a rapid heartbeat.


If you forget to use Formoterol Generics


If you stop using Formoterol Generics

Do not stop using Formoterol Generics without talking to your doctor.


If you have any further questions on using your inhaler device, ask your doctor, or pharmacist or nurse.


Possible side effects


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


If the following happens to you, stop using Formoterol Generics and talk to your doctor immediately:

Bronchospasm (tightening of the muscles in the airways which causes sudden wheezing) after inhaling your medicine. This happens very rarely, affecting less than 1 in 10,000 people.



Other possible side effects:

Common (may affect up to 1 in 10 people)



Uncommon (may affect up to 1 in 100 people)

Feeling restless or agitated.



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



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


Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.


How to store Formoterol Generics


Keep this medicine out of the sight and reach of children.


Blister pack: Do not store above 30 ºC and store in the original package in order to protect from moisture.


Bottle pack: Shelf life after first opening of the bottle is 1 month.

Store in the original package in order to protect from moisture.

This medicinal product does not require any special temperature storage conditions


Do not take the capsules out of the pack until you need them.


Do not use Formoterol Generics after the expiry date which is stated on the carton, and bottle or blister after EXP. The expiry date refers to the last day of that month.


If your doctor tells you to stop using Formoterol Generics, please take any unused capsules back to your pharmacist to be destroyed.


Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.


Contents of the pack and other information


What Formoterol Generics contains

The active substance is formoterol fumarate dihydrate. Each capsule contains 12 micrograms of formoterol fumarate dihydrate. This is equivalent to a delivered dose (ex actuator) of 10 microgram of formoterol fumarate dihydrate.

The other excipient is lactose monohydrate, which contains milk proteins.


What Formoterol Generics looks like and contents of the pack

The capsules are supplied in blisters of 10, 30, 60, 120 or 180 capsules + 1 inhaler, and in HDPE bottles of 60, 120 or 180 capsules + 1 inhaler.


Not all pack sizes may be marketed.


Inhaler CE

The device conforms with Directive 93/42/EEC


Marketing Authorisation Holder

{To be completed nationally}


Manufacturer

{To be completed nationally}


Formoterol Generics is authorized in the Member States of the EEA under the following names:

Sweden Formoterol Generics 12 microgram powder for inhalation, hard capsule

France Formoterol Mylan 12 microgrammes, poudre pour inhalation en gélule


This leaflet was last revised in 1 February 2016