Trydonis - patient leaflet, side effects, dosage

1. What Trydonis is and what it is used for

Trydonis is a medicine to help breathing that contains the three active substances:

• beclometasone dipropionate,
• formoterol fumarate dihydrate and
• glycopyrronium.

Beclometasone dipropionate belongs to a group of medicines called corticosteroids which act to reduce the swelling and irritation in your lungs.

Formoterol and glycopyrronium are medicines called long-acting bronchodilators. They act in different ways to relax the muscles in your airways, helping to open the airways wider and allowing you to breathe more easily.

Regular treatment with these three active substances helps to relieve and prevent symptoms such as shortness of breath, wheezing and cough in adult patients with chronic obstructive pulmonary disease (COPD). Trydonis can reduce exacerbations (flare-ups) of COPD symptoms. COPD is a serious longterm disease in which the airways become blocked and air sacs inside the lungs become damaged, leading to difficulty breathing.

2. What you need to know before you use Trydonis

Do not use Trydonis:

If you are allergic to beclometasone dipropionate, formoterol fumarate dihydrate and glycopyrronium or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions:

Trydonis is used as a maintenance treatment for your COPD. Do not use this medicine to treat a sudden attack of breathlessness or wheezing.

If your breathing gets worse:

If you develop worsening shortness of breath or wheezing (breathing with a whistling sound), straight after inhaling your medicine, stop using Trydonis inhaler and use your quick-acting “reliever” inhaler straightaway. You should contact your doctor straightaway. Your doctor will assess your symptoms and if necessary may start you on a different treatment.

See also section 4, “Possible side effects”.

If your COPD 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 COPD may be getting worse and your doctor may need to prescribe different treatment.

Talk to your doctor or pharmacist before using Trydonis:

• if you have any heart problems, such as angina (heart pain, pain in the chest), a recent heart

attack (myocardial infarction), heart failure, narrowing of the arteries around your heart (coronary heart disease), disease of your heart valves or any other abnormalities of your heart or if you have a condition known as hypertrophic obstructive cardiomyopathy (also known as HOCM, a condition where the heart muscle is abnormal).

• if you have disorders of your heart rhythm such as irregular heart rate, a fast pulse rate or

palpitations or if you have been told that your heart trace (ECG) is abnormal.

• if you have narrowing of the arteries (also known as arteriosclerosis), if you have high blood

pressure or if you have an aneurysm (abnormal bulging of the blood vessel wall).

• if you have an overactive thyroid gland.
• if you have low blood levels of potassium (hypokalaemia). The combination of Trydonis with

some other COPD medicines or medicines such as diuretics (medicines that make the body lose water, to treat heart disease or high blood pressure), can cause a sharp fall in your blood level of potassium. Therefore, your doctor may wish to measure the potassium levels in your blood from time to time.

• if you have any disease of your liver or kidneys.
• if you have diabetes. High doses of formoterol may increase your blood glucose and therefore

you may need to have extra blood tests to check your blood sugar when you start using this medicine, and from time to time during treatment.

• if you have a tumour of the adrenal gland (known as a phaeochromocytoma).
• if you are due to have an anaesthetic. Depending on the type of anaesthetic, it may be necessary

to stop using Trydonis at least 12 hours before the anaesthesia.

• if you are being, or have ever been, treated for tuberculosis (TB) or if you have a chest

infection.

• if you have an eye problem called narrow-angle glaucoma.
• if you have difficulty passing urine.
• if you have an infection of the mouth or throat.

If any of the above applies to you, tell your doctor before you use Trydonis.

If you have or have had any medical problems or any allergies or if you are not sure if you can use Trydonis, talk to your doctor or pharmacist before using the inhaler.

If you are already using Trydonis

If you are using Trydonis or high doses of other inhaled corticosteroids over long periods and you come into a situation of stress (e.g. being taken to hospital after an accident, having a serious injury or before an operation) you may need more of this medicine. In such a situation, your doctor may need to increase your dose of corticosteroids to cope with the stress and may prescribe them as tablets or injections.

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

Children and adolescents

Do not give this medicine to children and adolescents below the age of 18 years.

Other medicines and Trydonis

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines similar to Trydonis used for your lung disease.

Some medicines may increase the effects of Trydonis and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).

Do not use this medicine with a beta-blocker medicine (used for treating certain heart problems such as angina or for reducing blood pressure) unless your doctor has chosen a beta-blocker that does not affect your breathing. Beta-blockers (including beta-blocker eye-drops) may reduce the effects of formoterol or make it not work at all. On the other hand, using other beta2-agonist medicines (which work in the same way as formoterol) may increase the effects of formoterol.

Using Trydonis together with:

• medicines for treating

• – abnormal heart rhythms (quinidine, disopyramide, procainamide),

• – allergic reactions (antihistamines),

• – symptoms of depression or mental disorders such as monoamine oxidase inhibitors (for example phenelzine and isocarboxazid), tricyclic antidepressants (for example amitriptyline and imipramine), phenothiazines

can cause some changes in the electrocardiogram (ECG, heart trace). They may also increase the risk of disturbances of heart rhythm (ventricular arrhythmias).

• medicines for treating Parkinson’s disease (levodopa), to treat an underactive thyroid gland (levothyroxine), medicines containing oxytocin (which causes uterine contraction) and alcohol can increase the chances of formoterol side effects on the heart.
• monoamine oxidase inhibitors (MAOIs), including medicines with similar properties like furazolidone and procarbazine, used to treat mental disorders, can cause a rise in blood pressure.
• medicines for treating heart disease (digoxin) can cause a fall in your blood potassium level. This may increase the likelihood of abnormal heart rhythms.
• other medicines used to treat COPD (theophylline, aminophylline or corticosteroids) and diuretics may also cause a fall in your potassium level.
• some anaesthetics can increase the risk of abnormal heart rhythms.
• Disulfiram, a medicine used in the treatment of people with alcoholism (drinking problems) or metronidazole, an antibiotic to treat infection in your body can cause side effects (e.g. feeling sick, being sick, stomach pain) due to the small amount of alcohol in Trydonis.

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 using this medicine.

You should only use Trydonis during pregnancy if you are advised to do so by your doctor. It is preferable to avoid the use of Trydonis during labour due to the inhibitory effects of formoterol on uterine contractions.

You should not use Trydonis during breast-feeding. You and your doctor must make a decision whether to discontinue breast-feeding or to discontinue/abstain from Trydonis therapy taking into account the benefit of breast-feeding for your child and the benefit of therapy for you.

Driving and using machines

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

3. How to use Trydonis

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Adults

The recommended dose is two puffs in the morning and two puffs in the evening.

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

If you have been using a different inhaler containing beclometasone dipropionate previously, ask your doctor for advice, as the effective dose of beclometasone dipropionate in Trydonis for the treatment of COPD may be lower than that of some other inhalers.

Route of administration

Trydonis is for inhalation use.

You should inhale the medicine through your mouth and this takes the medicine directly into your lungs.

This medicine is contained in a pressurised container in a plastic inhaler with a mouthpiece.

Trydonis is available in three container sizes:

• a container providing 60 puffs
• a container providing 120 puffs
• a container providing 180 puffs.

If you have been prescribed a container providing 60 pu ffs or 120 pu ffs

There is a counter on the back of the inhaler, which tells you how many doses are left. Each time you press the pressurised container, a puff of medicine is released and the counter will count down by one. Take care not to drop the inhaler as this may cause the counter to count down.

If you have been prescribed a container providing 180 puffs

There is an indicator on the back of the inhaler, which tells you how many doses are left. Each time you press the pressurised container, a puff of medicine is released and 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 dose indicator to count down.

Testing your inhaler

Before using the inhaler for the first time, you should test your inhaler to make sure that it is working properly, as follows.

• 1. Depending on the container size prescribed to you, check that the dose counter reads 61 or 121 and that the dose indicator reads 180

• 2. Remove the protective cap from the mouthpiece

• 3. Hold your inhaler upright with the mouthpiece at the bottom

• 4. Direct the mouthpiece away from yourself and firmly press the pressurised container to release one puff

• 5. Check the dose counter or dose indicator. If you are testing your inhaler for the first time, the counter should read:

  60

  – when using the container providing 60 puffs

  
  

  120

  – when using the container providing 120 puffs

  
  

  180

  – when using the container providing 180 puffs

  
  

  DOSE

  COUNTER

  
  

  □OSE COUNTER

  
  

  DOSE INDICATOR

  
  

How to use your inhaler

Stand or sit up when inhaling.

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

• 1. Remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free from dust and dirt.

• 2. Breathe out as slowly and deeply as possible, in order to empty your lungs.

• 3. Hold the inhaler upright with the mouthpiece at the bottom and place the mouthpiece between

your teeth without biting it. Then place your lips around the mouthpiece, with the tongue flat under it.

• 4. Breathe in slowly and deeply through your mouth to fill your lungs with air (this should take about 4–5 seconds). Just after starting to breathe in, press down firmly on the top of the pressurised container to release one puff.

• 5. Hold your breath for as long as possible and, finally, remove the inhaler from your mouth and breathe out slowly. Do not breathe out into the inhaler.

• 6. Check that the dose counter (60/120 puffs) has moved down by one or that the dose indicator (180 puffs) has rotated by a small amount.

For the second puff, keep the inhaler in the upright position for about half a minute, then repeat steps 2 to 5.

If you see ‚mist‘ coming from the top of the inhaler or the sides of your mouth, this means that Trydonis will not be getting into your lungs as it should. Take another puff, following the instructions starting again from step 2.

After use, replace the protective cap.

To prevent a fungal infection in the mouth and throat, rinse your mouth or gargle with water without swallowing it or brush your teeth after each use of your inhaler.

When to get a new inhaler

You should get a replacement when the counter or indicator shows the number 20. Stop using the inhaler when the counter or indicator shows 0, as any medicine left in the inhaler may not be enough to give you a full puff.

If you have a weak grip, 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.

If you find it difficult to use the inhaler while starting to breathe in, you may use the AeroChamber Plus spacer device. Ask your doctor or pharmacist about this device.

It is important that you read the package leaflet which is supplied with your AeroChamber Plus spacer device and that you carefully follow the instructions on how to use the AeroChamber Plus spacer device and how to clean it.

Cleaning of the Trydonis inhaler

You should clean your inhaler once a week.

• 1. Do not remove the pressurised container from the inhaler and do not use water or other liquids to clean your inhaler.

• 2. Remove the protective cap from the mouthpiece by pulling it away from your inhaler.

• 3. Wipe inside and outside of the mouthpiece and the inhaler with a clean, dry cloth or tissue.

• 4. Replace the mouthpiece cap.

If you use more Trydonis than you should

It is important that you take your dose as advised by your doctor. Do not exceed your prescribed dose without talking to your doctor.

If you use more Trydonis than you should, side effects, as described in section 4, may occur.

Tell your doctor if you have used more Trydonis than you should and if you experience any of these symptoms. Your doctor may wish to carry out some blood tests.

If you forget to use Trydonis

Use it as soon as you remember. If it is almost time for your next dose, do not take the dose you have missed, but just take the next dose at the correct time. Do not double the dose.

If you stop using Trydonis

It is important to use Trydonis every day. Do not stop using Trydonis or lower the dose, even if you are feeling better or you have no symptoms. If you want to do this, talk to your doctor.

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.

There is a risk of worsening shortness of breath and wheezing immediately after using Trydonis and this is known as paradoxical bronchospasm (may affect up to 1 in 1,000 people). If this occurs you should stop using Trydonis and use your quick-acting “reliever” inhaler straightaway to treat the shortness of breath and wheezing. You should contact your doctor straightaway.

Tell your doctor immediately

• if you experience any allergic reactions like skin allergies, hives, skin itching, skin rash (may affect up to 1 in 100 people), reddening of the skin, swelling of the skin or mucous membranes especially of the eyes, face, lips and throat (may affect up to 1 in 1,000 people).
• if you experience eye pain or discomfort, temporary blurring of vision, visual halos or coloured images in association with red eyes. These may be signs of an acute attack of narrow-angle glaucoma (may affect up to 1 in 10,000 people).

Tell your doctor if you have any of the following while using Trydonis as they could be symptoms of a lung infection (may affect up to 1 in 10 people):

• fever or chills
• increased mucus production, change in mucus colour
• increased cough or increased breathing difficulties.

Possible side effects are listed below according to their frequency.

Common (may affect up to 1 in 10 people):

• sore throat
• runny or stuffy nose and sneezing
• fungal infections of the mouth. Rinsing your mouth or gargling with water and brushing your

teeth immediately after inhalation may help to prevent these side effects

Rare (may affect up to 1 in 1,000 people):
	fungal infections of the chest		leakage of blood from a vessel into the
	decreased appetite		tissues surrounding it
	sleep disorders (sleeping too little or too		decrease of blood pressure
	long)		weakness
	crushing chest pain		pain in the back of the mouth and throat
	sensation of a missed heart beat, unusually		inflammation and redness of the pharynx
	slow heart beat		dry throat
			painful and frequent urination
			difficulty and pain when passing urine
			inflammation of the kidneys.

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

• low level in the number of certain blood cells called platelets
• feeling breathless or short of breath
• swelling of the hands and feet
• growth retardation in children and adolescents.
• Not known (frequency cannot be estimated from the available data): blurred vision.

Using high-dose inhaled corticosteroids over a long time can cause in very rare cases effects on the body:

• problems with how your adrenal glands work (adrenal suppression)
• decrease in bone mineral density (thinning of the bones)
• clouding of the lens of your eyes (cataract).

Trydonis does not contain a high-dose inhaled corticosteroid, but your doctor may wish to measure the cortisol levels in your blood from time to time.

The following side effects can also occur with high-dose inhaled corticosteroids used over a long time, but the frequency is not known (frequency cannot be estimated from the available data) at present:

• depression
• feeling worried, nervous, over-excited or irritable.

These events are more likely to occur in children.

Reporting of side effects

If you get any side effects talk to your doctor or pharmacist. 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.

5. How to store Trydonis

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

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.

Prior to dispensing :

Store in a refrigerator (2°C-8°C).

Do not freeze.

Do not expose to temperatures higher than 50°C.

Do not pierce the pressurised container.

60 actuation pressurised container: After dispensing, the inhaler may be stored at a

temperature up to 25°C for a maximum of 2 months.

120 and 180 actuation pressurised container: After dispensing, the inhaler may be stored at a temperature up to 25°C for a maximum of 4 months.

Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

• 6. Content of the pack and other information

What Trydonis looks like and contents of the pack

Trydonis is a pressurised inhalation, solution.

Trydonis comes in a pressurised container (coated aluminium), with a metering valve. The pressurised container is inserted in a plastic inhaler. This incorporates a mouthpiece provided with a plastic protective cap, and either a dose counter (containers with 60 and 120 puffs) or a dose indicator (containers with 180 puffs).

Each pack contains one pressurised container either providing 60 puffs, 120 puffs or 180 puffs. Additional there are multipacks containing either 2 or 3 pressurised containers with 120 puffs, each.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A

43122 Parma

Italy

Manufacturers

Chiesi Farmaceutici S.p.A.

Via San Leonardo 96

43122 Parma

Italy

Chiesi SAS

2 rue des Docteurs Alberto et Paolo Chiesi

41260 La Chaussée Saint Victor

France

Chiesi Pharmaceuticals GmbH

Gonzagagasse 16/16

1010 Wien

Austria

For any information about this medicine, please

Authorisation Holder:

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contact the local representative of the Marketing

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United Kingdom (Northern Ireland)

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This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency website:

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