Patient leaflet - Formexa 200 micrograms/6 micrograms per actuation pressurised inhalation solution

1. What Formexa is and what it is used for

Formexa is a pressurised inhalation solution containing two active substances which are inhaled through your mouth and delivered directly into your lungs.

The two active substances are beclometasone dipropionate and formoterol fumarate dihy-drate. Beclometasone dipropionate belongs to a group of medicines called corticosteroids that have an anti-inflammatory action reducing the swelling and irritation in your lungs.

Formoterol fumarate dihydrate, which belongs to a group of medicines called long-acting bronchodilators that relax the muscles in your airways and helps you to breathe more easily. These two active substances make breathing easier. They also help to prevent asthma symptoms such as shortness of breath, wheezing and coughing.

Formexa is used to treat asthma in adults. If you are prescribed Formexa it is likely that either:

Your asthma is not adequately controlled by
using inhaled corticosteroids and “as needed” short-acting bronchodilators or
Your asthma is responds well to treatment
with both corticosteroids and long-acting bronchodilators.

2. What you need to know before you use Formexa

Do not use Formexa

if you are allergic to beclometasone
dipropionate or formoterol fumarate dihydrate 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 Formexa if you have any of the following:

heart problems, such as angina (heart pain,
pain in the chest), heart failure, narrowing of the arteries, valvular heart disease or any other known abnormalities of your heart.
high blood pressure or if you know that you
have an aneurysm (an abnormal bulging of the blood vessel wall).
disorders of your heart rhythm such as
increased or irregular heart rate, a fast pulse rate or palpitations or if you have been told that your heart trace is abnormal.
an overactive thyroid gland.
low blood levels of potassium.
any disease of your liver or kidneys.
diabetes (if you inhale high doses of
formoterol your blood glucose may increase. When you start using this medicine and from time to time during treatment you may need to have some additional blood tests to check your blood sugar).
tumour of the adrenal gland (known as a
phaeochromocytoma).
are due to have an anaesthetic. Depending
on the type of anaesthetic, it may be necessary to stop taking Formexa for at least 12 hours before the anaesthesia.
if you are being, or have ever been, treated
for tuberculosis (TB) or if you have a known viral or fungal infection of your chest.
if you must avoid alcohol for any reason

If any of the above applies to you, always inform your doctor before you use Formexa.

If you have or had any medical problems or allergies or if you are not sure whether you can use Formexa talk to your doctor, asthma nurse or pharmacist before using this medicine.

Your doctor may wish to measure the potassium levels in your blood from time to time especially if your asthma is severe. Like many bronchodilators Formexa can cause a sharp fall in your serum potassium level (hypokalaemia). This is because a lack of oxygen in the blood and combined with some other treatments you may be taking together with Formexa, can make the fall in potassium level worse.

If you take higher doses of inhaled corticosteroids over long periods, you may have more of a need for corticosteroids in situations of stress. Stressful situations might include being taken to hospital after an accident, having a serious injury or before an operation. In this case, the doctor treating you will decide whether you may need to increase your dose of corticosteroids and may prescribe some steroid tablets or a steroid injection.

Should you need to go to the hospital, remember to take all of your medicines and inhalers with you, including Formexa and any medicines or tablets bought without a prescription, in their original packaging, if possible.

Contact your doctor if you experience blurred vision or other visual disturbances. Children and adolescents

Formexa should not be used in children and adolescent less than 18 years old.

Other medicines and Formexa:

Tell your doctor, pharmacist or nurse if you are taking, have recently taken any other medicines, including medicines obtained without a prescription. This is because Formexa may affect the way some other medicines work. Also, some medicines may affect the way Formexa works. In particular tell your doctor, pharmacist of nurse if you are using any of the following medicines:

some medicines may increase the effects of
Formexa and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).
beta-blocker medicines. Beta blockers are
medicines used to treat many conditions including heart problems, high blood pressure and glaucoma (increased pressure in the eyes). If you need to use beta blockers including eyes drops, the effect of formoterol may be reduced or formoterol may not work at all.
beta adrenergic drugs (drugs which work in
the same way as formoterol) may increase the effects of formoterol.
medicines for treating abnormal heart rhythms
(quinidine, disopyramide, procainamide).
medicines used to treat allergic reactions
(antihistamines).
medicines to treat symptoms of depression
or mental disorders such as monoaminoxidase, inhibitors (for example phenelzine and isocarboxazid), tricyclic antidepressants (for example amitryptiline and imipramine), phenothiazines.
medicines to treat Parkinson’s Disease
(L-dopa).
medicines to treat an underactive thyroid
gland (L-thyroxine).
medicines containing oxytocin (which causes
uterine contraction).
medicines to treat mental disorders such as
monoaminoxidase inhibitors (MAOIs), including drugs with similar properties like furazolidone and procarbazine.
medicines to treat heart disease (digoxin).
other medicines used to treat asthma
(theophylline, aminophylline or steroids).
diuretics (water tablets).

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

Pregnancy, breast-feeding and fertility

There are no clinical data on the use of Formexa during pregnancy.

Formexa should not be used if you are pregnant, think that you might be pregnant or are planning

to become pregnant, or if you are breast-feeding, unless you are advised to do so by your doctor

Driving and using machines

Formexa is unlikely to affect your ability to drive and use machines.

Formexa contains alcohol

Formexa contains 9 mg of alcohol (ethanol) in each actuation which is equivalent to 0.25 mg/ kg per dose of two actuations. The amount in two actuations of this medicine is equivalent to less than 1 ml of wine or beer.

The small amount of alcohol in this medicine will not have any noticeable effects.

3. How to use Formexa

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will give you a regular check-up to make sure you are taking the optimal dose of Formexa. Your doctor will adjust your treatment to the lowest dose that best controls your symptoms.

Dosages:

Adults and the elderly

The recommended dose is two actuations twice daily

The maximum daily dose is 4 actuations. Remember: You should always have your quick-acting “reliever” inhaler with you at all times to treat worsening symptoms of asthma or a sudden asthma attack.

At-risk patients:

There is no need for dose adjustment if you are older. No information is available regarding the use of Formexa in people with liver or kidney problems.

Use in children and adolescents less than 18 years of age

Children and adolescents aged less than 18 years must NOT take this medicine. Formexa is effective for the treatment of asthma in a dose of beclometasone dipropionate which may be lower than that of some other inhalers containing beclometasone dipropionate. If you have been using a different inhaler containing beclometasone dipropionate previously, your doctor will advise you on the exact dose of Formexa you should take for your asthma.

Do not increase the dose

If you feel that the medicine is not very effective, always talk to your doctor before increasing the dose.

If your asthma gets worse:

If your symptoms get worse or are difficult to control (e.g. if you are using a separate “reliever” inhaler more frequently) or if your “reliever” inhaler does not improve your symptoms, see your doctor immediately. Your asthma may be getting worse and your doctor may need to change your dose of Formexa or prescribe alternative treatment.

Method of administration:

Formexa is for inhalation use.

This medicine is contained in a pressurised canister in a plastic casing with a mouthpiece. There is a counter (or dose indicator) on the back of the inhaler, which tells you how many doses (or puffs) are left. Each time you press the canister, a puff of medicine is released and the counter will count down by one (or the dose indicator rotates by a small amount. The number of puffs remaining is displayed in intervals of 20). Take care not to drop the inhaler as this may cause the counter (or dose indicator) to count down.

Testing your inhaler

Before using the inhaler for the first time or if you have not used the inhaler for 14 days or more, you should test your inhaler to make sure that is working properly.

1.
Remove the protective cap from the
mouthpiece.
2.
Hold your inhaler upright with the
mouthpiece at the bottom.
3. Direct the mouthpiece away from yourself and firmly depress the canister to release one puff.
4. Check the dose counter (or inidicator). If you

are testing your inhaler for the first time, the counter (or dose indicator) should read 120 or 180. How to use your inhaler

Whenever possible, stand or sit in an upright position when inhaling.

Before start inhaling, check the dose counter (or indicator): any number between “1” and “120” or “180” shows that there are doses left. If the dose counter (or indicator) shows “0” there are no doses left – dispose of your inhaler and get a new one.1. Remove the protective cap from the

mouthpiece and check that the mouthpiece is clean and free from dust and dirt or any other foreign objects.

2. Breathe out as slowly and deeply as possible.
3.
Hold the canister vertically with its body upwards and put your lips around the mouthpiece.
Do not bite the mouthpiece.
4. Breathe in slowly and deeply through your mouth and, just after starting to breathe in press down firmly on the top of the inhaler to release one actuation. If you have weak hands, it may be easier to hold the inhaler with both hands: hold the upper part of the inhaler with both index fingers and its lower part with both thumbs.
5. Hold your breath for as long as possible and finally, remove the inhaler from your mouth and breathe out slowly. Do not breathe into the inhaler.

If you need to take another puff, keep the inhaler in the vertical position for about half a minute, then repeat steps 2 to 5.

Important: Do not perform steps 2 to 5 too quickly.

After use, close with the protective cap and check the dose counter (or indicator). To lower the risk of a fungal infection in the mouth and throat, rinse your mouth, gargle with water or brush your teeth each time you use your inhaler.

You should get a new inhaler when the counter (or indicator) shows the number 20. Stop using the inhaler when the counter shows 0 as any actuations left in the device may not be enough to give you a full dose and start using the new inhaler.

If you see 'mist' coming from the top of the inhaler or the sides of your mouth, this means that Formexa will not be getting into your lungs as it should. Take another puff, following the instruction starting again from step 2. If you think the effect of Formexa is too much or not enough, tell your doctor or pharmacist. If you find it difficult to operate the inhaler while starting to breathe in you may use the Aero Chamber Plus™ spacer device. Ask your doctor, pharmacist or a nurse about this device. It is important that you read the package leaflet which is supplied with your AeroChamber Plus™ spacer device and that you follow the instructions on how to use and how to clean it, carefully.

xxxxxxx/xxxx Cleaning

You should clean your inhaler once a week. When cleaning, do not remove the canister from the actuator and do not use water or other liquids to clean your inhaler.

To clean your inhaler:

1.
Remove the protective cap from the
mouthpiece by pulling it away from your inhaler.
2.
Wipe inside and outside of the mouthpiece
and the actuator with a clean, dry cloth or tissue.
3. Replace the mouthpiece cover.

If you use more Formexa than you should:

Taking more formoterol than you should can
have the following effects: feeling sick, being sick, heart racing, palpitations, disturbances of heart rhythm, certain changes in the electrocardiogram (heart trace), headache, trembling, feeling sleepy, too much acid in the blood, low blood potassium levels, high levels of glucose in the blood. Your doctor may wish to carry out some blood tests to check your blood potassium and blood glucose levels.
Taking too much beclometasone dipropionate
can lead short-term problems with your adrenal glands. This will get better within a few days however your doctor may need to check your serum cortisol levels. Tell your doctor if you have any of these symptoms.

If you forget to use Formexa:

Take it as soon as you remember. If it is almost time for your next dose, do not take the dose you have missed, just take the next dose at the correct time. Do not take a double dose to make up for a forgotten dose.

If you stop using Formexa

Even if you are feeling better, do not stop using Formexa or lower the dose. If you want to do this, talk to your doctor. It is very important for you to use Formexa regularly even though you may have no symptoms.

If you have any further questions on the use of 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. As with other inhaler treatments there is a risk of worsening shortness of breath and wheezing immediately after using Formexa and this is known as paradoxical bronchospasm. If this occurs, you should STOP using Formexa immediately and use your quick-acting “reliever” inhaler straightaway to treat the symptoms of shortness of breath and wheezing. You should contact your doctor immediately.

Tell your doctor immediately if you experience any hypersensitivity reactions like skin allergies, skin itching, skin rash, reddening of the skin, swelling of the skin or mucous membranes especially of the eyes, face, lips and throat. Other possible side effects are listed below according to their frequency.

Common: may affect up to 1 in 10 people

fungal infections (of the mouth and throat) • headache
hoarseness
sore throat

Uncommon: may affect up to 1 in 100 people

palpitations, unusually fast heart beat and
heart rhythm disorders
some changes in the electrocardiogram
(ECG)
increase in blood pressure
flu like symptoms
sinus inflammation
rhinitis
inflammation of the ear
throat irritation
cough and productive cough
asthma attack
fungal infections of the vagina
nausea
abnormal or impaired sense of taste • burning of the lips
dry mouth
swallowing difficulties
indigestion
upset stomach
diarrhoea
pain in muscle and muscle cramps • reddening of the face and throat
increased blood flow to some tissues in the
body
excessive sweating
trembling
restlessness
dizziness
nettle rash or hives.
alterations of some constituents of the blood:
o fall in the number of white blood cells o increase in the number of blood platelets o fall in the level of potassium in the blood o increase in blood sugar level
o increase in the blood level of insulin free
fatty acid and ketones.

The following side effects have also been reported as “uncommon” in patients with Chronic Obstructive pulmonary disease”:

pneumonia; tell your doctor if you notice any
of the following symptoms: increase in sputum production, change in sputum colour, fever, increasing cough, increased breathing problems
reduction of the amount of cortisol in the
blood; this is caused by the effect of corticosteroids on your adrenal gland • irregular heart beat

Rare: may affect up to 1 in 1 000 people

chest tightness
missed heart beat (caused by premature
contraction of the heart’s ventricles) • decrease in blood pressure
kidney inflammation
swelling of skin and mucous membrane
persisting for several days

Very rare: may affect up to 1 in 10 000 people

shortness of breath
worsening of asthma
a fall in the number of blood platelets • swelling of the hands and feet

Using high-dose inhaled corticosteroids over a long time can cause in very rare cases systemic effects.These include:

problems with how your adrenal glands work
(adreno-suppression)
decrease in bone mineral density (thinning
of the bones)
growth retardation in children and
adolescents
increased pressure in your eyes (glaucoma) • cataracts

Not known (frequency cannot be estimated from the available data):

Sleeping problems
depression or anxiety
nervousness
feeling over-excited or irritable: these events
are more likely to occur in children but the frequency is not known.
blurred vision

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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Formexa

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

For the pharmacist:

Store in a refrigerator (2-8 °C), in an upright position, for a maximum of 18 months. For the patients:

Do not use this medicine beyond 3 months from the date you get the inhaler from your pharmacist and never use after the expiry date which is stated on the carton and label after Exp. The expiry date refers to the last day of that month.

Store the inhaler below 25°C.

If the inhaler has been exposed to severe cold, warm it with your hands for a few minutes before using. Never warm it by artificial means. Warning: The canister contains a pressurised liquid. Do not expose the canister to temperatures higher than 50 °C. Do not pierce the canister.

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 to protect the environment.

6. Contents of the pack and other information

What Formexa contains

The active substances are beclometasone dipropionate and formoterol fumarate dihydrate. Each actuation/metered dose from the inhaler contains 200 micrograms of beclometasone dipropionate and 6 micrograms of formoterol fumarate dihydrate. This corresponds to a delivered dose from the .mouthpiece of 177.7 micrograms of beclometasone dipropionate and 5.1 micrograms of formoterol fumarate dihydrate.

The other ingredients are: norflurane (HFA 134-a), ethanol anhydrous, hydrochloric acid.

What Formexa looks like and contents of the pack

Formexa is a pressurised solution contained in a 19 ml pressurised aluminium container sealed with a metering valve and fitted into a white plastic actuator which incorporates a dose counter (120 actuations pack) or a dose indicator (180 actuations pack), with a green plastic protective cap.

This medicine contains fluorinated greenhouse gases.

For 120 actuations: Each inhaler contains 10,23 g of 1,1,1,2-Tetrafluoroethane corresponding to 0,0148 tonne CO₂equivalent (global warming potential GWP = 1430).

For 180 actuations: Each inhaler contains 13,99 g of 1,1,1,2-Tetrafluoroethane corresponding to 0,0204 tonne CO₂equivalent (global warming potential GWP = 1430).

Each pack contains:

1 pressurised container (which provides 120 actuations)

2 pressurised containers (which provide 120 actuations each)

3 pressurised containers (which provide 120 actuations each)

1 pressurised container (which provides 180 actuations)

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Milpharm Limited

1 Roundwood Avenue,

Stockley Park, Uxbridge,

UB11 1AF,

United Kingdom

Manufacturer

ELPEN Pharmaceutical Co. Inc.

Zapani, Block 1048, Keratea, 19001, Greece Or