InfoCons Consumer Protection informs you – GoResp Digihaler – Package Leaflet

Before anything else

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

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor , pharmacist or nurse .
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor , pharmacist or nurse . This includes any possible side effects not listed in this leaflet . See section 4.

ℹ️ 1. What GoResp Digihaler is and what it is used for

GoResp Digihaler contains two different active substances: budesonide and formoterol fumarate dihydrate.

• Budesonide belongs to a group of medicines called ‘corticosteroids’ also known as ‘steroids’. It works by reducing and preventing swelling and inflammation in your lungs and helps you to breathe more easily.
• Formoterol fumarate dihydrate belongs to a group of medicines called ‘long -acting β adrenoceptor agonists’ or ‘bronchodilators’. It works by relaxing the muscles in your airways.

This will help to open the airways and help you to breathe more easily.

GoResp Digihaler is indicated for use in adults 18 years of age and older only.

GoResp Digihaler is NOT indicated for use in children, 12 years of age and younger or adolescents, 13 to 17 years of age.

Your doctor has prescribed this medicine to treat asthma or chronic o bstructive pulmonary disease (COPD).

Asthma When used for asthma, your doctor will prescribe GoResp Digihaler together with a separate ‘reliever inhaler’ such as salbutamol.

• Use GoResp Digihaler every day. This helps to prevent asthma symptoms such as breathlessness and wheezing from occurring.
• Use the ‘reliever inhaler’ when you get asthma symptoms, to make it easier to breathe again.

Do not use GoResp Digihaler 320/9 micrograms as a ‘reliever inhaler’.

Chronic obstructive pulmonary disease (COPD) 63 COPD is a long -term lung disease of the airways in the lungs, which is often caused by cigarette smoking. Symptoms include shortness of breath, cough, chest discomfort and coughing up mucus.

GoResp Digihaler can also be used to treat the symptoms of severe COPD in adults.

⚠️ 2. What you need to know before you use GoResp Digihaler

Do not use GoResp Digihaler

• if you are allergic to budesonide, formoterol fumarate dihydrate, or the other ingredient of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using GoResp Digihaler if

• you are diabetic.
• you have a lung infection.
• you have high blood pressure or you have ever had a heart problem (including an uneven heartbeat, a very fast pulse, narrowing of the arteries or heart failure).
• you have problems with your thyroid or adrenal glands.
• you have low levels of potassium in your blood.
• you have severe liver problems.
• you regularly drink alcohol.

If you have been taking steroid tablets for your asthma or COPD, your doctor may reduce the number of tablets that you take, once you start to use GoResp Digihaler . If you have been taking steroid tablets for a long time, your doctor may want you to have r egular blood tests. When reducing steroid tablets, you may feel generally unwell even though your chest symptoms may be improving. You might experience symptoms such as a stuffy or runny nose, weakness or joint or muscle pain and rash (eczema). If any of t hese symptoms bother you, or if symptoms such as headache, tiredness, nausea (feeling sick) or vomiting (being sick) occur, please contact your doctor immediately . You may need to take other medicines if you develop allergic or arthritic symptoms. You shou ld speak to your doctor if you are concerned as to whether you should continue to use GoResp Digihaler .

Your doctor may consider adding steroid tablets to your usual treatment if you have an illness such as a chest infection or before an operation.

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

Children and adolescents

Do not give t his medicine to children or adolescents under the age of 18 years.

Other medicines and GoResp Digihaler

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:

• β blockers (such as atenolol or propranolol for high blood pressure or a heart condition), including eyedrops (such as timolol for glaucoma).
• Oxytocin which is given to pregnant women to induce labour .
• Medicines for a fast or uneven heartbeat (such as quinidine, disopyramide, proc ainamide and terfenadine).
• Medicines like digoxin, oft en used to treat heart failure.
• Diuretics, also known as ‘water tablets’ (such as furosemide). These are used to treat high blood pressure.
• Steroid tablets that you take by mouth (such as prednisolone).
• Xanthine medicines (such as theophylline or aminophyl line). These are often used to treat asthma.

64 • Other bronchodilators (such as salbutamol).

• Tricyclic antidepressants (such as amitriptyline) and the antidepressant nefazodone.
• Antid epressant medicines such as monoamine oxidase inhibitors and those with similar properties (such as the antibiotic furazolid one and the chemotherapy medicine procarbazine).
• Antipsychotic p henothiazine medicines (such as chlorpromazine and prochlorperazine).
• Medicines called ‘HIV protease inhibitors’ (such as ritonavir) to treat HIV infection.
• Medicines to treat infections (such as ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin and telithromycin).
• Medicines for Parkinson’s disease (such as lev odopa).
• Medicines for thyroid problems (such as levothyroxine).

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

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

Also tell your doctor, pharmacist or nurse if you are going to have a general anaesthetic for an operation or for dental work to help lower any risk of interactio n with the anesthetic you receive.

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, pharmacist or nurse for advice before using GoResp Digihaler . Do NOT use this medicine unless your doctor tells you to.
• If you get pregnant while using GoResp Digihaler , do NOT stop using GoResp Digihaler but talk to your doctor immediately.

Driving and using machines

GoResp Digihaler is not likely to affect your ability to drive or to use tools or machines.

GoResp Digihaler contains lactose

Lactose is a type of sugar found in milk. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before using this medicine.

💊 3. How to use GoResp Digihaler

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

• It is important to use GoResp Digihaler every day, even if you have no asthma or COPD symptoms at the time.
• If you are using GoResp Digihaler for asthma, your doctor will want to regularly check your symptoms.

Asthma Use your GoResp Digihaler every day. This helps to prevent asthma symptoms from occurring.

Recommended dose:

Adults (18 years of age and older) 1 inhalation (actuation), twice a day , taken in the morning and in the evening .

Your doctor may increase this to 2 inhalations, twice a day.

If your symptoms are well controlled, your doctor may ask you to take your medicine once a day.

65 Your doctor will help you to manage your asthma and will adjust the dose of this me dicine to the lowest dose that controls your asthma. If your doctor feels that you need a lower dose than is available from your GoResp Digihaler , your doctor may prescribe an alternative inhaler containing the same active substances as your GoResp Digihal er but with a lower dose of the corticosteroid. If your symptoms are well controlled, your doctor may ask you to take your medicine once a day . However, do not adjust the number of inhalations your doctor has prescribed without talking to your doctor first.

Use your separate ‘reliever inhaler’ to treat asthma symptoms when they happen.

Always keep your ‘reliever inhaler’ with you and use it to relieve sudden attacks of breathlessness and wheezing. Do not use GoResp Digihaler to treat these asthma sym ptoms. It is important that you discuss with your doctor the use of GoResp Digihaler to prevent asthma symptoms from happening; how often you exercise or how often you are exposed to allergens could impact the treatment that is prescribed to you.

Chronic Obstructive Pulmonary Disease (COPD) Recommended dose:

Adults (18 years of age and older):

1 inhalation twice a day , taken in the morning and in the evening.

Your doctor may also prescribe another bronchodilator medicine for example an anticholinergic (such as tiotropium or ipratropium bromide) for your COPD disease.

Preparing your new GoResp Digihaler Before using your new GoResp Digihaler for the first time , you need to prepare it for use as follows:

• Open the foil pouch by tearing at the notch at the top of the foil pouch and take out the inha ler
• Check the dose indicator to see that there are 9 0 inhalations in the inhaler.
• Write the date you opened the foil pouch on the label of the inhaler.
• Do not shake your inhaler before use.

GoResp Digihaler contains integrated electronics, which record and store information on your inhaler usage. This information can then be transmitted to the Digihaler Mobile App (App).

GoResp Digihaler does n ot need to be connected to the App in order for you to take your medicine. The integrated electronics do not control or interfere with the delivery of the medicine through the inhaler.

GoResp Digihaler contains a Quick Response (QR ) code on top of the inhaler. Scanning this QR code with a smartphone or another suitable device will allow you to download the App. Please read the Instructions For Use ( IFU) provided within the App for more information on how to pair your inhaler with the App and on how to use the App.

The App is not intended to substitute the advice of your doctor or nurse. Do not modify your prescribed treatment based on information from the App but always consult with your doctor before making changes to your healthcare treatment .

How to take an inhalation Every time you need to take an inhalation, follow the instructions below.

1. Hold your inhaler with the semi -transparent wine red mouthpiece cover at the bottom.

2. Open the mouthpiece cover by folding it down until one loud click is heard. Your medicine is actively metered. Your inhaler is now ready for use.

3. Breathe out gently (as far as is comfortable). Do not breathe out through your inhaler.

4. Place the mouthpiece between your teeth. Do not bite the mouthpiece. Close your lips around the mouthpiece. Take care not to block the air vents.

Breathe in through your mouth as deeply and as hard as you can.

5. Remove your inhaler from your mouth. You may notice a taste when you take your inhalation.

6. Hold your breath for 10 seconds or as long as you comfortably can.

7. Then breathe out gently (do not breathe out through the inhaler). Close the mouthpiece cover.

If you are to take a second inhalation, repeat steps 1 to 7.

Rinse your mouth with water after every dose and spit it out.

Do not try to take your inhaler apart, remove or twist the mouthpiece cover, it is fixed to your inhaler and must not be taken off. Do not use your Digihaler if it has been damaged or if the mo uthpiece has come apart from your Digihaler . Do not open and close the mouthpiece cover unless you are about to use your inhaler.

Cleaning your Digihaler Keep your Digihaler dry and clean.

If necessary , you may wipe the mouthpiece of your Digihaler after use with a dry cloth or tissue.

Do not immerse your inhaler in water.

When to start using a new Digihaler

• The dose indicator tells you how many doses (inhalations) are left in your inhaler, starting with 90 inhalations when it is full and ending with 0 (zero) inhalations when it is empty .
• The dose indicator, on the rear of the device, shows the number of inhalations remaining as even numbers. The spaces between the even numbers represent the odd number of remaining inhalations.

68 • For inhalations remain ing from 20 downwards to ‘8’, ‘6’, ‘4’, ‘2’ the numbers are displayed in red on a white background. When the numbers become red in the window, you should consult your doctor and obtain a new inhaler.

Note:

• The mouthpiece will still ‘click’ even when your Digihaler is empty.
• If you open and close the mouthpiece without taking an inhalation, the dose indicator will still register it as a count. This dose will be securely held inside the inhaler for when the next inhalation is due. It is impossible to accid entally take extra medicine or a double dose in one inhalation.
• Keep the mouthpiece closed all the time unless you are about to use your inhaler.

Important information about your asthma or COPD symptoms If you feel you are getting breathless or wheezy while using GoResp Digihaler , you should continue to use GoResp Digihaler but go to see your doctor as soon as possible, as you may need additional treatment.

Contact your doctor immediately if:

• Your breath ing is getting worse or you often wake up at night with breathlessness and wheezing.
• Your chest starts to feel tight in the morning or your chest tightness lasts longer than usual.

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

Once your asthma is well controlled your doctor may consider it appropriate to gradually reduce the dose of Go Resp Digihaler .

If you use more GoResp Digihaler than you should

It is important that you take your dose as advised by your doctor. You should not exceed your prescribed dose without seeking medical advice.

If you use more GoResp Digihaler than you shoul d, contact your doctor, pharmacist or nurse for advice.

The most common symptoms that may occur after when you use more GoResp Digihaler than you should are trembling, headache or a rapid heartbeat.

If you forget to use GoResp Digihaler

If you forget to take a dose, take it as soon as you remember. However, do not take a double dose to make up for a forgotten dose. If it is nearly time for your next dose just take your next dose at the usual time.

If you become wheezy or breathless, or d evelop any other symptoms of an asthma attack, use your ‘reliever inhaler’ , then seek medical advice.

If you stop using GoResp Digihaler

Do not stop using your inhaler without telling your doctor first.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

❗ 4. Possible side effects

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

69 Serious side effects If any of the following happen to you, stop using GoResp Digihaler and talk to your doctor immediately:

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

• Swelling of your face, particularly around your mouth (tongue and/or throat and/or difficulty to swallow) or hives together with difficulties to breathe (angioedema) and/or sudden feeling of faintness. This may mean that you are having an allergic reaction, which may also include rash and itching.
• Bronchospasm (tightening of the muscles in the airways which causes wheezing and shortness of breath). If the wheezing comes on suddenly after using this medicine stop using it and talk to your doctor immediately (see b elow) .

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

• Sudden, unexpected and acute wheezing and/or shortness of breath immediately after using your inhaler (also referred to as ‘paradoxical bronchospasm’. If either of these symptoms occur, stop using GoResp Digihaler straightaway and use your ‘reliever inhaler’ if you have one. Contact your doctor immediately as you may need to have your treatment changed.

Other side effects

Common (may affect up to 1 in 10 people )

• Palpitations (awareness of your heart beating), trembling or shaking. If these effects occur, they are usually mild and usually disappear as you continue to use GoResp Digihaler .
• Thrush (a fungal infection) in the mouth. This is less likely to occur if you rinse your mouth out with water after using your medicine.
• Mild sore throat, coughing and a hoarse voice.
• Headache.
• Pneumonia (infection to the lung) in COPD patients.

Tell your doctor if you have any of the following while taking GoResp Digihaler they could be symptoms of a lung infection:

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

Uncommon (may affect up to 1 in 100 people )

• Feeling restless, nervous, agitated, anxious or angry.
• Disturbed sleep.
• Feeling dizzy.
• Nausea (feeling sick).
• Fast heartbeat.
• Bruising of the skin.
• Muscle cramps.
• Blurred vision .

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

• Low levels of potassium in your blood.
• Uneven heartbeat.

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

• Depression.
• Changes in behaviour, especially in children .
• Chest pain or tightness in the chest (angina pectoris).

70 • Disturbance of the heart’s electri cal system which does not cause symptoms (prolongation of the QTc-interval).

• An increase in the amount of sugar (glucose) in your blood, when you have a blood test .
• Taste changes, such as an unpleasant taste in the mouth.
• Changes in your blood pressure.

Inhaled corticosteroids can affect the normal production of steroid hormones in your body, particularly if you use high doses for a long time. The effects include:

• Changes in bone mineral density (thinning of the bones) .
• Cataract (clouding of the lens in the eye) .
• Glaucoma (increased pressure in the eye) .
• A slowing of the rate of growt h of children and adolescents .
• An effect on the adrenal gland (a small gland next to the kidney) . Symptoms of adrenal gl and suppression could be tiredness , weakness, stomach problems, including nausea, vomiting, pain and diarrhoea, darkening of the skin and weight loss.

These effects happen very rarely and are much less likely to happen with inhaled corticosteroids than with corticosteroid tablets.

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 m ore information on the safety of this medicine.

🌡️ 5. How to store GoResp Digihaler

• 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 carton or on the label of your inhaler after EXP. The expiry date refers to the last day of that month.
• Do not store above 25 oC. Keep the mouthpiece cover closed after removal of the foil wrapping.
• Use within 6 months of removing from the foil wrapping. Use the label on the inhaler to write do wn the date you open the foil pouch.
• 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.

📦 6. Contents of the pack and other information

What GoResp Digihaler contains

• The active substances are budesonide and formoterol fumarate dihydrate. Each delivered (inhaled) dose contains 320 micrograms of budesonide and 9 micrograms of formoterol fumarate dihydrate. This is equivalent to a metered dose of 400 micrograms of budesonide and 12 micrograms of formoterol fumarate dihydrate.
• The other ingredient is lactose monohydrate, which may contain milk proteins (see section 2

under ‘ GoResp Digihaler contains lactose’) .

What GoResp Digihaler looks like and contents of the pack

GoResp Digihaler is an inhalation powder.

71 Each GoResp Digihaler inhaler contains 9 0 inhalations and has a white body (with integrated electronics) and a semi -transparent wine red mouthpiece cover. A QR code is located on the top of the inhaler, to enable linking to the Digihaler App.

Packs of 1, 2, and 3 inhalers. Not all pack sizes may be marketed .

Marketing Authorisation Holder

Teva Pharma B.V.

Swensweg 5 2031 GA Haarlem The Netherlands.

Manufacturer

Norton (Waterford) Limited Unit 27/35, 14/15 and 301, IDA Industrial Park Cork Road Waterford, X91 WK68 Ireland Teva Operations Poland Sp. z o.o.

Mogilska 80 Str.

31-546 Kraków Poland For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 38207373 Lietuva UAB Teva Baltics Tel: +370 52660203 България Тева Фарма ЕАД Teл.: +359 24899585 Luxembourg/Luxemburg Teva Pharma Belgium N.V./S.A./AG Belgique/Belgien Tél/Tel: +32 38207373 Česká republika Teva Pharmaceuticals CR, s.r.o.

Tel: +420 251007111 Magyarország Teva Gyógyszergyár Zrt.

Tel.: +36 12886400 Danmark Teva Denmark A/S Tlf.: +45 44985511 Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +44 2075407117 Deutschland TEVA GmbH Tel: +49 73140208 Nederland Teva Nederland B.V.

Tel: +31 8000228400 Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610801 Norge Teva Norway AS Tlf: +47 66775590 Ελλάδα TEVA HELLAS Α .Ε.

Τηλ: +30 21 18805000 Österreich ratiopharm Arzneimittel Vertriebs -GmbH Tel: +43 1970070 España Teva Pharma S.L.U.

Tel: +34 913873280 Polska Teva Pharmaceuticals Polska Sp. z o.o.

Tel.: +48 223459300 France Teva Santé Tél: +33 155917800 Portugal Teva Pharma – Produtos Farmacêuticos Lda Tel: +351 214767550 Hrvatska Pliva Hrvatska d.o.o .

Tel: + 385 13720000 România Teva Pharmaceuticals S.R.L .

Tel: +40 212306524 Ireland Teva Pharmaceuticals Ireland Tel: +44 2075407117 Slovenija Pliva Ljubljana d.o.o.

Tel: +386 15890390 Ísland Teva Pharma Iceland ehf.

Sími: + 354 5503300 Slovenská republika Teva Pharmaceuticals Slovakia s.r.o.

Tel: +421 257267911 Italia Teva Italia S.r.l. Tel: +39 028917981 Suomi/Finland Teva Finland Oy Puh/Tel: +358 201805900 Κύπρος TEVA HELLAS Α .Ε.

Ελλάδα Τηλ: +30 21 18805000 Sverige Teva Sweden AB Tel: +46 42121100 Latvija UAB Teva Baltics filiāle Latvijā Tel: +371 67323666 This leaflet was last revised in .

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu .

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information GoResp Digihaler (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/19/1403).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.