TRIMBOW 88 MICROGRAMS / 5 MICROGRAMS / 9 MICROGRAMS INHALATION POWDER - patient leaflet, side effects, dosage

Trimbow

88 micrograms/5 micrograms/9 micrograms inhalation powder

beclometasone dipropionate/for­moterol fumarate dihydrate/gly­copyrronium

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

• – – Keepthisleaflet­.Youmayneedto­readitagain.

• — - Ifyouhaveanyfur­therquestions,as­kyourdoctoror­pharmacist.

• - This medicine has been prescribed foryou only. Do not pass it on to others. Itmay harm them, even iftheir signs ofillness are the same as yours.

• - Ifyou get any side effects talk to your doctor orpharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. WhatTrimbowisand what itis used for

• 2. What you need to know before you use Trimbow

• 3. HowtouseTrimbow

• 4. Possible side effects

• 5. Howtostore­Trimbow

• 6. Contents of the pack and other information

1. whattrimbowis and what it is used for

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

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

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

Formoteroland glycopyrronium aremedicines called long-acting bronchodilators. Theyact in differentwaysto relaxthe muscles inyour airways, helping to open the airways wider and allowingyou to breathe more easily.

Regular treatment with these three active substances helps to relieve and prevent symptoms such as shortness ofbreath, wheezing and cough in adult patientswith chronic obstructive pulmonary disease (COPD). Trimbow can reduce exacerbations (fare-ups) of COPD symptoms. COPD is a serious long-term 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 trimbow

Do not use Trimbow

Ifyou are allergic to beclometasone dipropionate, formoterol fumarate dihydrate and glycopyrronium orto any of the otheringredients ofthis medicine (listed in section 6).

Warnings and precautions

Trimbowis used as a maintenance treatment foryour obstructive lung disease. Do not use this medicine to treat a sudden attack of breathlessness orwheezing.

Ifyourbreathing getsworse

Ifyou develop worsening shortness of breath orwheezing (breathingwith awhistling sound), straight after inhalingyourme­dicine, stop using Trimbow inhaler and useyour quick-acting „reliever“ inhaler straightaway. You should contact your doctor straightaway. Your doctorwillasses­syoursymptoms and ifnecessary may start you on a different treatment.

See also section 4, „Possible side effects“.

Ifyour lung disease gets worse

Ifyour symptoms get worse or are difficult to control(e.g. ifyou are using a separate „reliever“ inhaler more frequently) orifyour „reliever“ inhaler does not improveyoursym­ptoms, seeyour doctor immediately. Your lung disease may be getting worse and yourdoctormay need to prescribe different treatment.

Talk to your doctor or pharmacist before using Trimbow:

• ifyou have any heart problems, such as angina (heart pain, pain in the chest), a recent heart attack (myocardial infarction), heart failure, narrowing ofthe arteries around your heart (coronary heart disease), disease of your heart valves orany otherabnormalities ofyour heart or ifyou have a condition known as hypertrophic obstructive cardiomyopathy (also known as HOCM, a conditionwhere the heart muscle is abnormal).
• ifyou have disorders ofyour heart rhythm such as irregular heart rate, a fast pulse rate orpalpitations orifyou have been told that your heart trace (ECG) is abnormal.
• ifyou have narrowing ofthe arteries (also known as arteriosclerosis), ifyou have high blood pressure or ifyou have an aneurysm (abnormal bulging of the bloodvessel wall).
• ifyou have an overactive thyroid gland.
• ifyou have lowblood levels of potassium (hypokalaemia). The combination ofTrimbowwith some other lung medicines ormedicines such as diuretics (medicines that make the body losewater, to treat heart disease or high blood pressure), can cause a sharp fall inyourblood levelofpotassium. Therefore, your doctor may wish to measure the potassium levels inyourblood from timeto time.
• ifyou have any disease ofyour liver orkidneys.
• ifyou have diabetes. High doses of formoterol may increaseyourblood glucose and thereforeyou may need to haveextra blood tests to checkyourblood sugarwhenyou start using this medicine, and from time to time during treatment.
• ifyou have a tumourof the adrenalgland (known as a phaeochromocytoma).
• ifyou are due to have an anaesthetic. Depending on the type of anaesthetic, it may be necessary to stop using Trimbowat least 12 hours before the anaesthesia.
• ifyou are being, or have ever been, treated for tuberculosis (TB) or ifyou have a chest infection.
• ifyou have an eye problem called narrow-angle glaucoma.
• ifyou have difficulty passing urine.
• ifyou have an infection of the mouth or throat.

If any ofthe above applies toyou, tellyourdoctor­beforeyou useTrimbow:

Ifyou have or have had any medical problems orany allergies or ifyou are not sure ifyou can useTrimbow, talk to yourdoctoror pharmacist before using the inhaler.

Ifyou are already using Trimbow

Ifyou are usingTrimbowor high doses ofother inhaled corticosteroids over long periods andyou come into a situation ofstress (e.g. being taken to hospitalafter 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 increaseyourdose of corticosteroids to copewith the stress and may prescribe them as tablets orinjections.

Contact your doctor ifyou experience blurred vision orothervisual disturbances.

Children and adolescents

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

Other medicines and Trimbow

Tellyour doctor orpharmacist ifyou are taking, have recently taken ormight take any othermedicines. This includes medicines similar to Trimbowused foryourlung disease.

Some medicines may increase the effects ofTrimbowand yourdoctormay wish to monitoryou carefully ifyou are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).

Do not use this medicine with a beta-blocker medicine (used fortreating certain heart problems such as angina or for reducing blood pressure) unlessyour doctor has chosen a beta-blocker that does not affect yourbreathing. Beta-blockers (including beta-blocker eye-drops) may reducethe effects offormoterolor make it notwork at all. On the otherhand, using other beta2-agonist medicines (whichwork in the same way as formoterol) may increase the effiectsoffor­moterol.

Using Trimbow together with:

- symptoms ofdepression ormental disorders such as monoamine oxidase inhibitors (forexample phenelzine and isocarboxazid), tricyclicanti­depressants (for example amitriptyline and imipramine), phenothiazines

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

• medicines for treating Parkinson’s disease (levodopa), to treat an underactive thyroid gland (levothyroxne), medicines containing oxytocin (which causes uterine contraction) and alcoholcan increase the chances of formoterol side effects on the heart.
• monoamine oxdase 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 (digoxn) can cause a fall inyourblood potassium level. This may increase the likelihood of abnormal heart rhythms.
• othermedicines used to treat obstructive lung disease (theophylline, aminophylline or corticosteroids) and diuretics may also cause a fall inyourpotassi­um level.
• some anaesthetics can increase the risk of abnormal heart rhythms.

Pregnancy and breast-feeding

Ifyou are pregnant orbreast-feeding, think you may be pregnant or are planning to have a baby, askyour doctor or pharmacist foradvice before using this medicine.

You should only useTrimbowduring pregnancy ifyou are advised to do so byyourdoctor. Itis preferable to avoid the use of Trimbowduring labourdue to the inhibitory effects offormoterol on uterine contractions.

You should not use Trimbowduring breast-feeding. You andyour doctor must make a decisionwhether to discontinue breastfeeding or to discontinue/abstain from Trimbow therapy taking into account the benefit ofbreast-feeding foryourchild and the benefit oftherapy foryou.

Driving and using machines

Trimbowis unlikely to affectyour ability to drive and use machines.

Trimbowcontains lactose

Lactose contains small amounts of milk proteins.

• 3. Howto useTrimbow

Always use this medicine exactly asyourdoctoror pharmacist has toldyou. Check withyour doctor orpharmacist ifyou are not sure.

Adults

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

Ifyou feelthat the medicine is not very effective, talk to yourdoctor.

Ifyou have been using a different inhaler containing beclometasone dipropionate previously, askyour doctor for advice, as the effective dose ofbeclometasone dipropionate inTrimbowfor the treatment ofyour obstructive lung disease may be lower than that of some other inhalers.

Route of administration

Trimbowis forinhalation use.

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

Instructions for use

A. Contents of the Package

Forinformation on the contents ofthe pack, see section 6.

If the package contents are not the same as described in section 6, return your inhaler to the person who supplied it and get a new one.

• Do not remove the inhalerfrom the pouch ifyou do not intend to use it immediately.
• Only useyour inhaler as indicated.
• Keep the coverclosed untilyou need to take a dose from yourinhaler.
• Whenyou are not using your inhaler keep itina clean and dry place.
• Do not attempt to takeyour inhaler apart forany reason.

C. Key features ofyour inhaler

Taking a dose from your inhaler requiresjust three simple steps: Open, Inhale, Close

D. Before using a new inhaler

• 1. Openthepouchand takeout your inhaler.

0 Do not useyourinhalerifthe pouch is not sealed oritis damaged – return it to the personwho supplied it and get a newone.

0 Use the label on the boxto write down the dateyou open the pouch.

• 2. Inspect your inhaler.

0 Ifyourinhaler­looks broken ordamaged, return ittothe person who supplied it and get a newone.

• 3. Check the Dose CounterWindow­.Ifyour inhaler is new you will see "120” in the Dose Counter Window.

0 Do not use a newinhalerif the numbershown is less than „120“ – return it to the person who supplied it and get a newone.

120

_

e. how to use your inhaler

E.I.Open

• 1. Hold your inhaler firmly in the upright position.

• 2. Check the number of doses left: any number between "1” and "120” shows that there are doses left.

0 If the Dose CounterWindowshows „0“ there are no doses left – dispose ofyour inhaler and get a newone.

• 3. Open the cover fully.

  
  

• 4. Beforeinha­lingbreatheou­tasfarasiscom­fortable.

0 Donot breathe out throughyourinhaler.

E.2.Inhale

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

• 1. Liftyourinhaler up,bringittoy­ourmouthandpla­ceyour lipsaroundthe­mouthpiece.

0 Donot cover the airvent when holdingyour inhaler.

0 Donot inhalethroughthe­airvent.

• 2. Take a forceful and deep breath through your mouth.

0 You may notice a taste whenyou takeyour dose.

0 You may hearor feel a click whenyou take your dose.

0 Donot inhalethroughy­ournose.

0 Donot removeyour inhaler from your lips during the inhalation.

• 3. Removeyourin­halerfromyourmou­th.

• 4. Hold your breath for 5to10 seconds oras long asis comfortable.

• 5. Breatheoutslow­ly.

0 Donot breathe out throughyourinhaler.

• Ifyou are not sureyou are receivingyourdose correctly contact yourpharmacist ordoctor.

E.3.Close

• 1. Moveyourin­halerbacktothe­uprightpositi­onandclosethe cover fully.

• 2. Check that the dose counter has gone down by one.

• Ifyou are not sure the dose counter has gone down by one after inhalation, wait untilyournext scheduled dose and take this as normal. Do not take an extra dose.

• 3. Ifyou need to take another dose, repeat steps E.1 to E.3.

• F. Cleaning

• Normally, it is not necessary to cleanyour inhaler.
• Ifnecessary, you may cleanyourinha­lerafterusewith a dry cloth or tissue.

0 Donot clean your inhalerwithwater orotherliquids. Keep it dry.

• G. Storage and Disposal

For information on storage conditions and disposal instructions, see section 5.

If you use more Trimbow than you should

Itis important thatyou take your dose as advised by your doctor. Do not exceed your prescribed dosewithout talking to your doctor.

Ifyou use moreTrimbowthan you should, side effects, as described in section 4, may occur.

Tellyour doctor ifyou have used moreTrimbowthan you should and ifyou experience any of these symptoms. Yourdoctor may wish to carry out some blood tests.

If you forget to use Trimbow

Useitas soon as you remember. Ifitis almost time foryournext dose, do not take the doseyou have missed, butjust take the next dose at the correct time. Do not double the dose.

If you stop using Trimbow

Itis important to useTrimbowevery day. Do not stop using Trimboworlowerthe dose, even ifyou are feeling better oryou have no symptoms. Ifyouwant to do this, talk toyourdoctor.

Ifyou have any further questions on the use ofthis medicine, askyour doctoror pharmacist

4. possible side effects

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

There isarisk ofworsening shortness ofbreath and wheezing immediately afterusingTrim­bowand thisis known as paradoxical bronchospasm (may affect uptol in 1,000 people). If this occurs you should stop usingTrimbowand useyour quick-acting „reliever“ inhalerstraightaway to treat the shortness of breath and wheezing. You should contact yourdoctor straightaway.

Tell your doctor immediately

• ifyou experience any allergic reactions like skin allergies, hives, skin itching, skin rash (may affect upto1 in100 people), reddening of the skin, swelling of the skin or mucous membranes especially ofthe eyes, face, lips and throat (may affect upto1 in 1,000 people).
• ifyou experience eye pain or discomfort, temporary blurring of vision, visualhalos or coloured images in association with red eyes. These maybe signs of an acute attack ofnarrow-angle glaucoma (may affect upto1 in 10,000 people).

Tellyour doctor ifyou have any ofthe followingwhile usingTrimbowas they could be symptoms of a lung infection (may affect upto1 in10 peoplewith COPD):

• feverorchills
• increased mucus production, change in mucus colour
• increased cough orincreased breathing difficulties.

Possible side effects

are listed belowaccording to theirfrequency.

Common (may affect upto1 in10 people)

• sorethroat
• runny or stuffy nose and sneezing

0108007570/01

• Fungal inFections oF the mouth. Rinsingyour mouth or gargling uuthwater and brushingyour teeth immediately aFter inhalation may help toprevent these side effects
• hoarseness
• headache
• urinary tract inFection.

Uncommon (may affect up to1in100 people)

• Flu
• inFammation oFthe sinuses
• itchy, runny or blocked nose
• Fungal inFections oF the throat oroF the Food pipe (oesophagus)
• Fungal inFections oF thevagina
• restlessness
• trembling
• dizziness
• abnormal or reduced sense oF taste
• numbness
• inFammation oFthe ear
• irregular heart beat
• changes in the electrocardiogram (heart trace)
• unusually Fast heart beat and disorders oF the heart rhythm
• palpitations (Feeling oF abnormal beating oFthe heart)
• reddening oFthe Face
• increased blood Fowto some tissues in the body
• asthma attack
• cough and productive cough
• irritation oFthe throat
• nosebleeds
• redness oF the pharynx
• dry mouth
• diarrhoea
• swallowing difficulties
• Feeling sick
• upsetstomach
• stomach discomFort aFter meals
• burning sensation oF the lips
• tooth decay
• skin rash, hives, skin itching
• inFammation oFthe mucous membrane oF the mouthwith orwithout ulcers
• increased sweating
• muscle cramps and pain in muscles
• pain in arms orlegs
• pain in muscles, bones orjoints oFthe chest
• tiredness
• increase oFblood pressure
• Fallin the leveloFsome constituents oFyourblood: oF certain white blood cells called granulocytes, oFpotassium oroF cortisol
• increase in the leveloFsome constituents oFyourblood: glucose, C-reactive protein, numberoFplatelets, insulin, Free Fatty acid or ketones.

Rare (may affect uptol in 1,000 people)

• Fungal inFections oF the chest
• decreased appetite
• sleep disorders (sleeping too little or too long)
• crushing chest pain
• sensation oF a missed heart beat oroF extra heart beats, unusually slowheart beat
• worsening oFasthma
• leakage oF blood From a vessel into the tissues surrounding it
• decrease oF blood pressure
• weakness
• pain in the back oF the mouth and throat
• inFammation oFthe pharynx
• drythroat
• painFul and Frequent urination
• difficulty and pain when passing urine
• inFammation oFthe kidneys.

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

• lowlevel in the number oF certain blood cells called platelets
• Feeling breathless or short oFbreath
• swelling oF the hands and Feet
• growth retardation in children and adolescents.

Not known (Frequency cannot be estimated From the available data)

• blurredvision.

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

• problems with howyouradrenal­glandswork (adrenal suppression)
• decrease in bone mineraldensity (thinning oF the bones)
• clouding oFthe lens oFyoureyes (cataract).

Trimbow does not contain a high-dose inhaled corticosteroid, but yourdoctor may wish to measure the cortisol levels in your blood From time to time.

The Following side effects can also occurwith 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
• Feelingworried, nervous, over-excitedorirritable.

These events are more likely to occurin children.

Reporting of side effects

IFyou get any side effects talk toyour doctororpharmacist. This includes any possible side effects not listed inthis leaFet.

You can alsoreport side effects directlyvia:

United Kingdom: YellowCard Scheme

Website: orsearch ForMHRAYellowCard in theGooglePlay orAppleApp Store

Ireland: HPRAPharmacovi­gilanceWebsite:

By reporting side effectsyou can help provide more inFormation on the saFety oF this medicine.

• 5. Howto store Trimbow

Keep this medicine out oFthe sight and reach oFchildren.

Donot use this medicine aFterthe expiry datewhich is stated on the label and carton aFter EXP. The expiry date reFers to the last day oF that month.

Donot store above 25°C.

Keep the inhaler inthe original package in orderto protect From moisture and only remove From the pouch immediately beFore First use.

AFterFrst opening the pouch the medicine should be used within 6weeks and stored in a dry place. Use the adhesive label on the outer carton towrite down the date you open the pouch and stick this label to the bottom oF the inhaler

Medicines should not be disposed oFvia wastewater or householdwaste. Ask your pharmacist howto dispose oFmedicines no longer required. These measures will help to protect the environment.

• 6. Content of the pack and other information

WhatTrimbow looks like and contents of the pack

Trimbowis a white to almost white inhalation powder.

Itis provided in awhite plastic inhaler called NEXThalerwith a grey mouthpiece coverand a counterForthe inhalations. Each inhaleris packed in a sealed protective pouch (aluminium Foil package).

Trimbowis available in packs containing one inhaler, and in multipacks comprising two or three inhalers, providing 120 inhalations each (120, 240 or360 inhalations).

Not all pack sizes may be marketed.

Marketing Authorisation Holder

:

Chiesi Farmaceutici S.p.A.

Via Palermo26/A

43122 Parma

Italy

Great Britain :

Chiesi Limited

333StyalRoad

Manchester

M22 5LG

UK

Manufacturer

Chiesi Farmaceutici S.p.A.

Via San Leonardo 96

43122 Parma

Italy

For any inFormation about this medicine, please contact the localrepresentative oF the MarketingAutho­risation Holder:

Great Britain

Chiesi Ltd

Tel: + 44 (0)161 488 5555

United Kingdom (Northern Ireland)

Chiesi Farmaceutici S.p.A.

Tel: + 39 0521 2791

Ireland

Chiesi Farmaceutici S.p.A.

Tel: + 39 0521 2791

This leaflet was last revised in 04/2021.

Other sources of information

Detailed inFormation onthis medicine is available on the European MedicinesAgency website:.