GORESP DIGIHALER

Package leaflet: Information for the user

GoResp Digihaler 160 micrograms/4.5 micrograms, inhalation powder

budesonide/formoterol fumarate dihydrate
Please read all of this leaflet carefully before you start using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What GoResp Digihaler is and what it is used for
2. What you need to know before you use GoResp Digihaler
3. How to use GoResp Digihaler
4. Possible side effects
5. How to store GoResp Digihaler
6. Contents of the pack and other information

1. What is GoResp Digihaler and what is it 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 the lungs and helps you breathe more easily.
• Formoterol fumarate dihydrate belongs to a group of medicines called "long-acting β2-adrenergic agonists" or "bronchodilators". It works by relaxing the muscles in the airways, helping to open the airways and making it easier to breathe.

GoResp Digihaler is indicated for use only in adults aged 18 years and older.
GoResp Digihaler is NOT indicated for use in children aged 12 years or younger or in adolescents aged 13 to 17 years.
Your doctor has prescribed this medicine to treat asthma or chronic obstructive pulmonary disease (COPD).

Asthma
GoResp Digihaler may be prescribed for asthma in two different ways:

a) You may be prescribed two inhalers for asthma: GoResp Digihaler together with another “reliever inhaler”, such as salbutamol.

• Use GoResp Digihaler every day to prevent asthma symptoms such as breathlessness and wheezing.
• Use the “reliever inhaler” when you have asthma symptoms, to help you breathe more easily again.

b) GoResp Digihaler may be prescribed as your only asthma inhaler.

• Use GoResp Digihaler every day to prevent asthma symptoms.
• Also use GoResp Digihaler when you need inhalations or puffs to relieve asthma symptoms, to help you breathe more easily again. If agreed with your doctor, you may also use it to prevent the onset of asthma symptoms (for example, during physical exercise or upon exposure to allergens). You do not need a separate reliever inhaler.

COPD
COPD is a long-term airway disease in the lungs, often caused by cigarette smoking. Symptoms include breathlessness, cough, chest discomfort, and cough with sputum. GoResp Digihaler can also be used for the treatment of symptoms of severe COPD in adults.

2. What you should know before using GoResp Digihaler

Do not use GoResp Digihaler
if you are allergic to budesonide, 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 GoResp Digihaler if:

• you have diabetes
• you have a lung infection
• you have high blood pressure or have ever had a heart problem (including irregular heartbeat, very rapid pulse, narrowed arteries or heart failure)
• you have thyroid or adrenal gland problems
• you have low levels of potassium in your blood
• you have severe liver problems
• you regularly drink alcohol

If you are taking steroid tablets for asthma or COPD, your doctor may reduce the number of
tablets you take once you start using GoResp Digihaler. If you have been taking steroid tablets for a long time, your doctor may decide to carry out regular blood tests. Reducing steroid tablets may cause general discomfort, even if your chest symptoms improve.
You may experience symptoms such as nasal congestion or runny nose, weakness or joint and muscle pain, and skin rashes (eczema). If any of these symptoms concern you or if you develop symptoms such as headache, tiredness, nausea (feeling unwell) or vomiting (being sick), contact your doctor immediately. You may need to take other medicines if you develop allergic or arthritic symptoms. Talk to your doctor if you have any doubts about whether to continue using 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 surgery.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents
Do not give this medicine to children or adolescents under 18 years of age.

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, inform 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 heart disease), including eye drops (such as timolol for glaucoma).
• Oxytocin, which is given to pregnant women to induce labour.
• Medicines for fast or irregular heartbeat (such as quinidine, disopyramide, procainamide and terfenadine).
• Medicines such as digoxin, often used to treat heart failure.
• Diuretics, also known as “water tablets” (such as furosemide). These medicines are used to treat high blood pressure.
• Oral steroid tablets (such as prednisolone).
• Xanthine medicines (such as theophylline or aminophylline). These medicines are often used in the treatment of asthma.
• Other bronchodilators (such as salbutamol).
• Tricyclic antidepressants (such as amitriptyline) and the antidepressant nefazodone.
• Antidepressant medicines such as monoamine oxidase inhibitors and medicines with similar properties (such as the antibiotic furazolidone and the chemotherapeutic agent procarbazine).
• Phenothiazine antipsychotic medicines (such as chlorpromazine and prochlorperazine).
• Medicines called “HIV protease inhibitors” (such as ritonavir) used to treat HIV infection.
• Medicines to treat infections (such as ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin and telithromycin).
• Medicines for Parkinson’s disease (such as levodopa).
• Medicines for thyroid problems (such as levothyroxine).

Some medicines may increase the effects of GoResp Digihaler and your doctor may want to monitor you closely if you are taking these medicines (including some medicines used to treat HIV: ritonavir, cobicistat).
If you are taking any of the medicines listed above or are unsure, talk to your doctor, pharmacist or nurse before using GoResp Digihaler.
Also inform your doctor, pharmacist or nurse if you are due to receive a general anaesthetic for surgery or a dental procedure, to reduce the potential risk of interactions with the anaesthetic you receive.

Pregnancy and breastfeeding

• If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor, pharmacist or nurse for advice before using GoResp Digihaler. DO NOT use this medicine unless your doctor tells you to do so.
• If you become pregnant while using GoResp Digihaler, DO NOT stop using GoResp Digihaler, but speak to your doctor immediately.

Driving and using machines
It is unlikely that GoResp Digihaler will affect your ability to drive or use tools or machinery.

GoResp Digihaler contains lactose
Lactose is a type of sugar found in milk. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to use GoResp Digihaler

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor, pharmacist, or nurse.

• It is important to use GoResp Digihaler every day, even if you do not have asthma or COPD symptoms at that moment.
• If you are using GoResp Digihaler for asthma, your doctor will regularly monitor your symptoms.

Asthma
GoResp Digihaler may be prescribed for asthma in two different ways: The dose and timing for using
GoResp Digihaler depend on how it has been prescribed for you.

• If you have been prescribed GoResp Digihaler and another reliever inhaler, read section “(A) Use of GoResp Digihaler and another reliever inhaler”.
• If you have been prescribed GoResp Digihaler as your only inhaler, read section “(B) Use of GoResp Digihaler as the single inhaler for asthma”.

(A) Use of GoResp Digihaler and another reliever inhaler
Use GoResp Digihaler every day to prevent asthma symptoms.
Recommended dose:
Adults (aged 18 years and older)
1 or 2 inhalations (actuations), twice daily, taken in the morning and evening.
Your doctor may increase your dose to 4 inhalations, twice daily.
If your symptoms are well controlled, your doctor may instruct you to take the medicine once
daily.
Your doctor will help manage your asthma and adjust the medicine dose to the lowest level that maintains asthma control. If your doctor believes you require a lower dose than what is available from your GoResp Digihaler, they may prescribe an alternative inhaler containing the same active substances as your GoResp Digihaler but with a lower corticosteroid dose. If your symptoms are well controlled, your doctor may ask you to take the medicine once daily. However, do not change the number of inhalations prescribed by your doctor without first discussing it with them.
Use your other “reliever inhaler” to treat asthma symptoms when they occur.
Always carry 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 symptoms.

(B) Use of GoResp Digihaler as the single inhaler for asthma
Use GoResp Digihaler in this way only if your doctor has specifically prescribed it this way.
Use GoResp Digihaler every day to prevent asthma symptoms.
Recommended dose:
Adults (aged 18 years and older)
1 inhalation in the morning and 1 inhalation in the evening
or
2 inhalations in the morning
or
2 inhalations in the evening.
Your doctor may increase your dose to 2 inhalations twice daily.
Use GoResp Digihaler also as a “reliever inhaler” to treat asthma symptoms when they occur and to prevent their onset (e.g., during physical exercise or upon exposure to allergens).

• If you experience asthma symptoms, take 1 inhalation and wait a few minutes.
• If you do not feel better, take another inhalation.
• Do not take more than 6 inhalations at one time.

Always carry GoResp Digihaler with you and use it to relieve sudden attacks of breathlessness and
wheezing.
A total daily dose exceeding 8 inhalations is generally not required. However, your doctor may allow you to take up to 12 inhalations per day for a limited period.
If you regularly need to take 8 or more inhalations per day, make an appointment with your doctor. Your treatment may need to be adjusted.
DO NOT take more than 12 inhalations in any 24-hour period.
If you are engaging in physical activity and experience asthma symptoms, use GoResp Digihaler as described here.
However, do not use GoResp Digihaler before physical activity to prevent asthma symptoms. It is important that you discuss with your doctor the use of GoResp Digihaler for preventing asthma symptoms; how often you exercise or are exposed to allergens may affect your prescribed treatment.

COPD
Recommended dose:
Adults (aged 18 years and older)
2 inhalations twice daily, taken in the morning and evening.
Your doctor may prescribe another bronchodilator medicine, for example an anticholinergic (such as tiotropium or ipratropium bromide) for COPD.

How to prepare a new GoResp Digihaler
Before using GoResp Digihaler for the first time, you must prepare it for use as follows:

• Open the aluminum foil pouch by tearing at the notch at the top and remove the inhaler.
• Check the dose indicator to ensure the inhaler contains 180 inhalations.
• Record the date you opened the aluminum pouch on the label of the inhaler.
• Do not shake the inhaler before use.

GoResp Digihaler contains integrated electronic components that record and store information
about inhaler use. This information can then be transmitted to the Digihaler mobile app (app).
It is not necessary for GoResp Digihaler to be connected to the app to take the medicine. The
integrated electronic components do not control or interfere with medicine delivery through the
inhaler.
GoResp Digihaler has a Quick Response (QR) code on the top of the inhaler. By scanning this QR code with a smartphone or other suitable device, you can download the app. Read the instructions for use provided within the app for more information on how to pair the inhaler with the app and how to use the app.
The app is not intended to replace the advice of your doctor or nurse. Do not change your prescribed treatment based on information from the app, but always consult your doctor before modifying your treatment.

How to take an inhalation
Each time you need to take an inhalation, follow these steps:

1. Hold the inhaler with the semi-transparent burgundy-colored cap facing downwards.

2. Open the protective cap by folding it downwards until you hear a distinct click. The medicine is actively pre-dosed. The inhaler is now ready for use.

3. Breathe out gently (without forcing). Do not breathe out through the inhaler.
4. Place the mouthpiece between your teeth. Do not bite the mouthpiece. Close your lips around the mouthpiece. Be careful not to block the air inlets.

Breathe in through your mouth as deeply and forcefully as possible.

5. Remove the inhaler from your mouth. You may notice a taste during inhalation.
6. Hold your breath for 10 seconds or as long as possible without discomfort.
7. Breathe out gently (do not breathe out through the inhaler). Close the protective cap.

To take a second inhalation, repeat steps 1 to 7.

Rinse your mouth with water (without swallowing) after each dose.
Do not attempt to disassemble the inhaler, remove or reverse the protective cap, which is fixed to the inhaler and must not be removed. Do not use Digihaler if it is damaged or if the mouthpiece has come off. Do not open and close the protective cap unless you intend to use the inhaler.

Cleaning the Digihaler
Keep the Digihaler dry and clean.
If necessary, the Digihaler mouthpiece can be wiped with a dry cloth or tissue after use.
Do not immerse the inhaler in water.

When to start using a new Digihaler

• The dose indicator shows how many doses (inhalations) remain in the inhaler, starting from 180 inhalations when full, down to 0 (zero) when empty.

• The dose indicator, located on the back of the device, displays the number of remaining inhalations as even numbers. The spaces between the even numbers represent the odd number of remaining inhalations.
• For remaining inhalations from 20 down to “8”, “6”, “4”, “2”, the numbers are displayed in red on a white background. When the numbers turn red in the window, consult your doctor and obtain a new inhaler.

Note:

• The mouthpiece will continue to make a “click” sound even when the Digihaler is empty.
• If the mouthpiece is opened and closed without taking an inhalation, the dose indicator will still register this as a dose delivered. This dose will be safely retained in the inhaler for the next inhalation. It is impossible to accidentally inhale excess medicine or receive a double dose in a single inhalation.
• Always keep the mouthpiece closed unless you intend to use the inhaler.

Important information about asthma or COPD symptoms
If you experience breathlessness or wheezing while using GoResp Digihaler, continue using it but consult your doctor as soon as possible, as you may need additional treatment.
Contact your doctor immediately if:

• your breathing worsens or you wake up frequently at night with breathlessness and wheezing;
• you start experiencing chest tightness in the morning or your chest tightness lasts longer than usual.

These signs may indicate that your asthma or COPD is not adequately controlled, and you may require immediate different or additional treatment.
Once your asthma is well controlled, your doctor may consider gradually reducing your dose of GoResp Digihaler.

If you use more GoResp Digihaler than you should
It is important to take the dose as instructed by your doctor. Do not exceed the prescribed number of doses without consulting your doctor.
If you use more GoResp Digihaler than prescribed, seek advice from your doctor, pharmacist, or nurse.
The most common symptoms that may occur with excessive use of GoResp Digihaler are tremor, headache, and 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 the missed dose. If it is almost time for your next dose, take the next dose at the usual time.
If you experience wheezing or breathlessness or develop other symptoms of an asthma attack, use your “reliever inhaler”, then contact your doctor.

If you stop using GoResp Digihaler
Do not stop using your inhaler without first informing your doctor.
If you have any questions about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
If you experience any side effect, stop using GoResp Digihaler and contact your doctor
immediately:
Rare (may affect up to 1 in 1,000 people)

• Swelling of the face, particularly around the mouth (tongue and/or throat, and/or difficulty swallowing) or hives together with difficulty breathing (angioedema) and/or sudden fainting. This could indicate an ongoing allergic reaction, which may also include rash and itching.
• Bronchospasm (tightening of the muscles in the airways causing wheezing and shortness of breath). If wheezing occurs suddenly after using this medicine, stop using it and contact your doctor immediately (see below).

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

• Sudden, unexpected wheezing and/or shortness of breath immediately after using the inhaler (also known as paradoxical bronchospasm). If any of these symptoms occur, stop using GoResp Digihaler immediately and use your "reliever" inhaler if you have one. Contact your doctor immediately, as your treatment may need to be changed.

Other side effects
Common (may affect up to 1 in 10 people)

• Palpitations (awareness of heartbeat), tremor, or shivering. If these effects occur, they are usually mild and tend to disappear with continued use of GoResp Digihaler.
• Oral thrush (fungal infection) in the mouth. The likelihood of this side effect can be greatly reduced by rinsing your mouth with water after using the medicine.
• Mild sore throat, cough, and hoarseness.
• Headache.
• Lung infection (lung infection) in patients with COPD (common side effect).

Inform your doctor if you experience any of the following symptoms while taking GoResp Digihaler, as they could be signs of a lung infection:

• Fever or chills.
• Increased mucus production, changes in the colour of mucus.
• Worsening cough or increased difficulty breathing.

Uncommon (may affect up to 1 in 100 people)

• Feeling restless, nervousness, agitation, anxiety, or anger.
• Disturbed sleep.
• Dizziness.
• Nausea (feeling unwell).
• 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 the blood.
• Irregular heartbeat.

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

• Depression.
• Behavioural changes, especially in children.
• Chest pain or tightness in the chest (angina pectoris).
• Disturbances in the heart's electrical system that do not cause symptoms (prolongation of QTc interval).
• Increased blood glucose (sugar) levels in blood tests.
• Taste disturbances, such as a bad taste in the mouth.
• Changes in blood pressure.

Inhaled corticosteroids may affect the normal production of steroid hormones in the body, particularly if used at high doses for prolonged periods. Effects include:

• Changes in bone mineral density (thinning of the bones).
• Cataract (clouding of the lens in the eye).
• Glaucoma (increased pressure inside the eye).
• Slowed growth rate in children and adolescents.
• Effects on the adrenal gland (a small gland located next to the kidney). Symptoms of adrenal suppression may include fatigue, weakness, stomach problems such as nausea, vomiting, pain, and diarrhoea, darkening of the skin, and weight loss.

These effects occur very rarely, and the likelihood is much lower with inhaled corticosteroids than with oral corticosteroid tablets.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. 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 GoResp Digihaler

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the label or on the inhaler’s box after Exp./EXP. The expiry date refers to the last day of that month.
• Do not store at temperatures above 25 °C. Keep the protective cap closed after removal of the aluminium wrapper
• Use within 6 months after removal of the aluminium wrapper. Use the label on the inhaler to record the date when you open the aluminium package.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What GoResp Digihaler contains

• The active substances are budesonide and formoterol fumarate dihydrate. Each delivered (inhaled) dose contains 160 micrograms of budesonide and 4.5 micrograms of formoterol fumarate dihydrate. This corresponds to a pre-set dose of 200 micrograms of budesonide and 6 micrograms of formoterol fumarate dihydrate.
• The other component is lactose monohydrate, which may contain milk proteins (see section 2, “GoResp Digihaler contains lactose”).

Description of the appearance of GoResp Digihaler and contents of the pack
GoResp Digihaler is an inhalation powder.
Each GoResp Digihaler inhaler contains 180 inhalations and features a white body (with integrated electronic components) and a semi-transparent burgundy protective cap. A QR code is located on the top of the inhaler, enabling connection with the Digihaler app.
Packs containing 1, 2, or 3 inhalers are available.
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 further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Teva Pharma Belgium N.V./S.A./AG UAB Teva Baltics
Tél/Tel: +32 38207373 Tel: +370 52660203

България Luxembourg/Luxemburg
Тева Фарма ЕАД Teva Pharma Belgium N.V./S.A./AG
Teл.: +359 24899585 Belgique/Belgien
Tél/Tel: +32 38207373

Česká republika Magyarország
Teva Pharmaceuticals CR, s.r.o. Teva Gyógyszergyár Zrt.
Tel: +420 251007111 Tel.: +36 12886400

Danmark Malta
Teva Denmark A/S Teva Pharmaceuticals Ireland
Tlf.: +45 44985511 L-Irlanda
Tel: +44 2075407117

Deutschland Nederland
TEVA GmbH Teva Nederland B.V.
Tel: +49 73140208 Tel: +31 8000228400

Eesti Norge
UAB Teva Baltics Eesti filiaal Teva Norway AS
Tel: +372 6610801 Tlf: +47 66775590

Ελλάδα Österreich
TEVA HELLAS A.E. ratiopharm Arzneimittel Vertriebs-GmbH
Τηλ: +30 2118805000 Tel: +43 1970070

España Polska
Teva Pharma S.L.U. Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +34 913873280 Tel.: +48 223459300

France Portugal
Teva Santé Teva Pharma - Produtos Farmacêuticos Lda
Tél: +33 155917800 Tel: +351 214767550

Hrvatska România
Pliva Hrvatska d.o.o. Teva Pharmaceuticals S.R.L.
Tel: + 385 13720000 Tel: +40 212306524

Ireland Slovenija
Teva Pharmaceuticals Ireland Pliva Ljubljana d.o.o.
Tel: +44 2075407117 Tel: +386 15890390

Ísland Slovenská republika
Teva Pharma Iceland ehf. Teva Pharmaceuticals Slovakia s.r.o.
Sími: + 354 5503300 Tel: +421 257267911

Italia Suomi/Finland
Teva Italia S.r.l. Teva Finland Oy
Tel: +39 028917981 Puh/Tel: +358 201805900

Κύπρος Sverige
TEVA HELLAS A.E. Teva Sweden AB
Ελλάδα Tel: +46 42121100
Τηλ: +30 2118805000

Latvija
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.emea.europa.eu/

Package leaflet: information for the user

GoResp Digihaler 320 micrograms/9 micrograms, inhalation powder

budesonide/formoterol fumarate dihydrate
Please read this leaflet carefully before using this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What GoResp Digihaler is and what it is used for
2. What you need to know before using GoResp Digihaler
3. How to use GoResp Digihaler
4. Possible side effects
5. How to store GoResp Digihaler
6. Contents of the pack and other information

1. What is GoResp Digihaler and what is it 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 the lungs and helps you breathe more easily.
• Formoterol fumarate dihydrate belongs to a group of medicines called "long-acting β₂-adrenergic agonists" or "bronchodilators". It works by relaxing the muscles in the airways, helping to open the airways and making breathing easier.

GoResp Digihaler is indicated for use only in adults aged 18 years and older.
GoResp Digihaler is NOT indicated for use in children aged 12 years or younger or in adolescents aged 13 to 17 years.
Your doctor has prescribed this medicine to treat your asthma or chronic obstructive pulmonary disease (COPD).
Asthma
If used for asthma, your doctor will prescribe GoResp Digihaler together with another "reliever inhaler", such as salbutamol.

• Use GoResp Digihaler every day to prevent asthma symptoms such as breathlessness and wheezing.
• Use the "reliever inhaler" when you have asthma symptoms, to help you breathe more easily again.

Do not use GoResp Digihaler 320/9 micrograms as a reliever inhaler.
COPD
COPD is a long-term lung disease affecting the airways, often caused by cigarette smoking. Symptoms include breathlessness, cough, chest tightness, and cough with sputum. GoResp Digihaler may also be used for the treatment of severe COPD symptoms in adults.

2. What you need to know before using GoResp Digihaler

Do not use GoResp Digihaler
if you are allergic to budesonide, 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 GoResp Digihaler if:

• you have diabetes
• you have a lung infection
• you have high blood pressure or have ever had a heart problem (including irregular heartbeat, very rapid heartbeat, narrowed 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 are taking steroid tablets for asthma or COPD, your doctor may reduce the number of
tablets you take once you start using GoResp Digihaler. If you have been taking steroid tablets for a long time, your doctor may decide to carry out regular blood tests. Reducing steroid tablets may cause general unwellness, even if your chest symptoms improve. You may experience symptoms such as nasal congestion or runny nose,
weakness, joint and muscle pain, and skin rashes (eczema). If any of these symptoms concern you, or if you develop symptoms such as headache, tiredness, nausea (feeling unwell), or vomiting (being sick), contact your doctor immediately. You may need to take other medicines if you develop allergic or arthritic symptoms. Talk to your doctor if you have any doubts about continuing to use GoResp Digihaler.
Your doctor may consider adding steroid tablets to your usual treatment if you develop an illness such as a chest infection or before surgery.
Contact your doctor if you experience blurred vision or other visual disturbances.
Children and adolescents
Do not give this medicine to children or adolescents under 18 years of age.
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:

• Beta-blockers (such as atenolol or propranolol for high blood pressure or heart disease), including eye drops (such as timolol for glaucoma).
• Oxytocin, which is given to pregnant women to induce labour.
• Medicines for fast or irregular heartbeat (such as quinidine, disopyramide, procainamide, and terfenadine).
• Medicines such as digoxin, often used to treat heart failure.
• Diuretics, also known as “water tablets” (such as furosemide). These medicines are used to treat high blood pressure.
• Oral steroid tablets (such as prednisolone).
• Xanthine medicines (such as theophylline or aminophylline). These are often used in the treatment of asthma.
• Other bronchodilators (such as salbutamol).
• Tricyclic antidepressants (such as amitriptyline) and the antidepressant nefazodone.
• Antidepressant medicines such as monoamine oxidase inhibitors and medicines with similar properties (such as the antibiotic furazolidone and the chemotherapeutic agent procarbazine).
• Phenothiazine antipsychotic medicines (such as chlorpromazine and prochlorperazine).
• Medicines called “HIV protease inhibitors” (such as ritonavir) used to treat HIV infection.
• Medicines for infections (such as ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, and telithromycin).
• Medicines for Parkinson’s disease (such as levodopa).
• Medicines for thyroid problems (such as levothyroxine).

Some medicines may increase the effects of GoResp Digihaler, and your doctor may want to monitor you closely if you are taking these medicines (including some medicines for treating HIV: ritonavir, cobicistat).
If you are taking any of the above medicines, or if you are unsure, talk to your doctor, pharmacist, or nurse before using GoResp Digihaler.
Also inform your doctor, pharmacist, or nurse if you are due to receive a general anaesthetic for surgery or a dental procedure, to reduce the potential risk of interactions with the anaesthetic you will receive.
Pregnancy and breastfeeding

• If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor, pharmacist, or nurse for advice before using GoResp Digihaler. DO NOT use this medicine unless your doctor tells you to do so.
• If you become pregnant while using GoResp Digihaler, DO NOT stop using GoResp Digihaler, but speak to your doctor immediately.

Driving and using machines
It is unlikely that GoResp Digihaler will affect your ability to drive or operate tools or machinery.
GoResp Digihaler contains lactose
Lactose is a type of sugar found in milk. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to use GoResp Digihaler

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor, pharmacist, or nurse.

• It is important to use GoResp Digihaler every day, even if you do not have asthma or COPD symptoms at that moment.
• If you are using GoResp Digihaler for asthma, your doctor will regularly monitor your symptoms.

Asthma
Use GoResp Digihaler every day to prevent asthma symptoms.
Recommended dose:
Adults (aged 18 years and older)
1 inhalation (actuation), twice daily, taken in the morning and evening.
Your doctor may increase this dose to 2 inhalations twice daily.
If your symptoms are well controlled, your doctor may instruct you to take the medicine once
daily.
Your doctor will help manage your asthma and adjust the dose of this medicine to the lowest dose that maintains asthma control. If your doctor believes you need a lower dose than what is available from your GoResp Digihaler, they may prescribe an alternative inhaler containing the same active substances as your GoResp Digihaler but with a lower corticosteroid dose. If your symptoms are well controlled, your doctor may instruct you to take the medicine once daily. However, do not change the number of inhalations prescribed by your doctor without first discussing it with your doctor.
Use your other “reliever inhaler” to treat asthma symptoms when they occur.
Always carry your “reliever inhaler” with you and use it to relieve sudden episodes of breathlessness and wheezing. Do not use GoResp Digihaler to treat these asthma symptoms. It is important that you discuss with your doctor the use of GoResp Digihaler to prevent the onset of asthma symptoms; how often you exercise or are exposed to allergens may influence the treatment prescribed for you.

COPD
Recommended dose:
Adults (aged 18 years and older)
1 inhalation twice daily, taken in the morning and evening.
Your doctor may also prescribe another bronchodilator medicine, for example an anticholinergic (such as tiotropium or ipratropium bromide) for COPD.

How to prepare a new GoResp Digihaler
Before using GoResp Digihaler for the first time, you must prepare it for use as follows:

• Open the aluminum foil wrapper by tearing at the notch at the top and remove the inhaler.
• Check the dose indicator to confirm that the inhaler contains 90 inhalations.
• Record the date you opened the aluminum foil pouch on the label of the inhaler.
• Do not shake the inhaler before use.

GoResp Digihaler contains integrated electronic components that record and store information about inhaler use. This information can then be transmitted to the Digihaler mobile app (app).
It is not necessary for GoResp Digihaler to be connected to the app to take the medicine. The
integrated electronic components do not control or interfere with the delivery of the
medicine through the inhaler.
GoResp Digihaler has a quick response code (QR code) on the top of the inhaler. By scanning this QR code with a smartphone or other suitable device, you can download the app. Read the instructions for use provided within the app for more information on how to pair the inhaler with the app and how to use the app.
The app is not intended to replace the advice of your doctor or nurse. Do not change your
prescribed treatment based on information provided by the app, but always consult your
doctor before changing your treatment.

How to perform an inhalation
Each time you need to take an inhalation, follow these instructions:

1. Hold the inhaler with the semi-transparent burgundy-colored cap facing downwards

2. Open the protective cap by folding it downwards until you hear a distinct click. The medicine is actively pre-dosed. The inhaler is now ready for use.

3. Breathe out gently (without forcing). Do not breathe out through the inhaler.
4. Place the mouthpiece between your teeth. Do not bite the mouthpiece. Close your lips around the mouthpiece. Be careful not to block the air inlets.

Breathe in through your mouth as deeply and forcefully as possible.

5. Remove the inhaler from your mouth. You may notice a taste during inhalation.
6. Hold your breath for 10 seconds, or as long as possible without discomfort.
7. Breathe out gently (do not breathe out through the inhaler). Close the protective cap.

To perform a second inhalation, repeat steps 1 to 7.

Rinse your mouth with water after each dose and spit it out.
Do not attempt to disassemble the inhaler, remove or rotate the protective cap, which is fixed to the inhaler and must not be removed. Do not use Digihaler if it is damaged or if the mouthpiece has come off. Do not open and close the protective cap unless you intend to use the inhaler.

Cleaning the Digihaler
Keep Digihaler dry and clean.
If necessary, the Digihaler mouthpiece may be cleaned with a dry cloth or tissue after use.
Do not immerse the inhaler in water.

When to start using a new Digihaler

• The dose indicator shows how many doses (inhalations) remain in the inhaler, starting from 90 inhalations when full, down to 0 (zero) inhalations when empty.

• The dose indicator, located on the back of the device, displays the number of remaining inhalations as even numbers. The spaces between the even numbers represent the odd number of remaining inhalations.
• For remaining inhalations from 20 down to “8”, “6”, “4”, “2”, the numbers are displayed in red on a white background. When the numbers turn red in the window, consult your doctor and obtain a new inhaler.

Note:

• The mouthpiece will continue to make a “click” sound when Digihaler is empty.
• If the mouthpiece is opened and closed without performing an inhalation, the dose indicator will still register it as a dose delivered. This dose will be safely retained in the inhaler for the next inhalation. It is impossible to accidentally inhale excess medicine or receive a double dose in a single inhalation.
• Always keep the mouthpiece closed unless you intend to use the inhaler.

Important information about asthma or COPD symptoms
If you experience breathlessness or wheezing while using GoResp Digihaler, continue using it, but consult your doctor as soon as possible, as you may need additional treatment.
Contact your doctor immediately if:

• your breathing is getting worse or you wake up frequently at night with breathlessness and wheezing;
• you begin to experience chest tightness in the morning or your chest tightness lasts longer than usual.

These signs may indicate that your asthma or COPD is not adequately controlled and you may require immediate different or additional treatment.
Once your asthma is well controlled, your doctor may consider gradually reducing the dose of GoResp Digihaler.

If you use more GoResp Digihaler than you should
It is important that you take the dose as instructed by your doctor. Do not exceed the number of prescribed doses without consulting your doctor.
If you use more GoResp Digihaler than you should, seek advice from your doctor, pharmacist, or nurse.
The most common symptoms that may occur with excessive use of GoResp Digihaler are tremor, headache, and 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 the missed dose. If it is almost time for your next dose, take the dose at the usual time.
If you experience wheezing or breathlessness or develop other symptoms of an asthma attack, use your “reliever inhaler”, then contact your doctor.

If you stop using GoResp Digihaler
Do not stop using your inhaler without first informing your doctor.
If you have any questions about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Serious side effects
If you experience any side effect, stop using GoResp Digihaler and contact your doctor immediately:
Rare ( may affect up to 1 in 1,000 people)

• Swelling of the face, particularly around the mouth (tongue and/or throat, and/or difficulty swallowing) or hives together with difficulty breathing (angioedema) and/or sudden fainting sensation. This could indicate an ongoing allergic reaction, which may also include skin rash and itching.
• Bronchospasm (tightening of the muscles in the airways causing wheezing and shortness of breath). If wheezing occurs suddenly after using this medicine, stop using it and contact your doctor immediately (see below).

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

• Sudden, unexpected wheezing and/or shortness of breath immediately after using the inhaler (also known as paradoxical bronchospasm). If any of these symptoms occur, stop using GoResp Digihaler immediately and use your "reliever" inhaler if you have one. Contact your doctor immediately, as your treatment may need to be changed.

Other side effects
Common ( may affect up to 1 in 10 people)

• Palpitations (awareness of heartbeat), tremor, or shivering. If these effects occur, they are usually mild and tend to disappear with continued use of GoResp Digihaler.
• Oral thrush (fungal infection in the mouth). The likelihood of this occurring is greatly reduced by rinsing your mouth with water after using the medicine.
• Mild sore throat, cough, and hoarseness.
• Headache.
• Lung infection (infection of the lung) in patients with COPD (common side effect).

Inform your doctor if you experience any of the following symptoms while taking GoResp Digihaler, as they may be signs of a lung infection:

• Fever or chills.
• Increased mucus production, changes in mucus colour.
• Worsening cough or increased difficulty breathing.

Uncommon ( may affect up to 1 in 100 people)

• Feeling restless, nervousness, agitation, anxiety, or anger.
• Disturbed sleep.
• Dizziness.
• Nausea (feeling unwell).
• 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 the blood.
• Irregular heartbeat.

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

• Depression.
• Behavioural changes, particularly in children.
• Chest pain or tightness in the chest (angina pectoris).
• Electrical disturbances in the heart that do not cause symptoms (prolongation of the QTc interval).
• Increased blood sugar (glucose) levels in blood tests.
• Taste disturbances, such as a bad taste in the mouth.
• Changes in blood pressure.

Inhaled corticosteroids may affect the normal production of steroid hormones in the body, particularly if used at high doses over prolonged periods. Effects include:

• Changes in bone mineral density (thinning of the bones).
• Cataract (clouding of the lens in the eye).
• Glaucoma (increased pressure inside the eye).
• Slowed growth rate in children and adolescents.
• Effects on the adrenal gland (a small gland located next to the kidney). Symptoms of adrenal suppression may include fatigue, weakness, stomach problems such as nausea, vomiting, pain, and diarrhoea, darkening of the skin, and weight loss.

These effects are very rare and the likelihood is much lower with inhaled corticosteroids than with oral corticosteroid tablets.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. You can also report side effects directly through 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 GoResp Digihaler

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the label or box of the inhaler after Scad./EXP. The expiry date refers to the last day of that month.
• Do not store above 25 °C. Keep the protective cap closed after removal of the aluminium wrapper.
• Use within 6 months after removal of the aluminium wrapper. Use the label on the inhaler to record the date when you open the aluminium case.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents 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 corresponds to a pre-set dose of 400 micrograms of budesonide and 12 micrograms of formoterol fumarate dihydrate.
• The other component is monohydrate lactose, which may contain milk proteins (see section 2, “GoResp Digihaler contains lactose”).

Description of the appearance of GoResp Digihaler and contents of the pack
GoResp Digihaler is an inhalation powder.
Each GoResp Digihaler inhaler contains 90 inhalations and features a white body (with integrated electronic components) and a semi-transparent burgundy protective cap. A QR code is located on the top of the inhaler to enable connection with the Digihaler app.
Packs containing 1, 2 or 3 inhalers are available. Not all pack sizes may be marketed.

Marketing Authorization Holder
Teva Pharma B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

Manufacturers:
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 further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Teva Pharma Belgium N.V./S.A./AG UAB Teva Baltics
Tél/Tel: +32 38207373 Tel: +370 52660203

България Luxembourg/Luxemburg
Тева Фарма ЕАД Teva Pharma Belgium N.V./S.A./AG
Teл.: +359 24899585 Belgique/Belgien
Tél/Tel: +32 38207373

Česká republika Magyarország
Teva Pharmaceuticals CR, s.r.o. Teva Gyógyszergyár Zrt.
Tel: +420 251007111 Tel.: +36 12886400

Danmark Malta
Teva Denmark A/S Teva Pharmaceuticals Ireland
Tlf.: +45 44985511 L-Irlanda
Tel: +44 2075407117

Deutschland Nederland
TEVA GmbH Teva Nederland B.V.
Tel: +49 73140208 Tel: +31 8000228400

Eesti Norge
UAB Teva Baltics Eesti filiaal Teva Norway AS
Tel: +372 6610801 Tlf: +47 66775590

Ελλάδα Österreich
TEVA HELLAS A.E. ratiopharm Arzneimittel Vertriebs-GmbH
Τηλ: +30 2118805000 Tel: +43 1970070

España Polska
Teva Pharma S.L.U. Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +34 913873280 Tel.: +48 223459300

France Portugal
Teva Santé Teva Pharma - Produtos Farmacêuticos Lda
Tél: +33 155917800 Tel: +351 214767550

Hrvatska România
Pliva Hrvatska d.o.o. Teva Pharmaceuticals S.R.L.
Tel: + 385 13720000 Tel: +40 212306524

Ireland Slovenija
Teva Pharmaceuticals Ireland Pliva Ljubljana d.o.o.
Tel: +44 2075407117 Tel: +386 15890390

Ísland Slovenská republika
Teva Pharma Iceland ehf. Teva Pharmaceuticals Slovakia s.r.o.
Sími: + 354 5503300 Tel: +421 257267911

Italia Suomi/Finland
Teva Italia S.r.l. Teva Finland Oy
Tel: +39 028917981 Puh/Tel: +358 201805900

Κύπρος Sverige
TEVA HELLAS A.E. Teva Sweden AB
Ελλάδα Tel: +46 42121100
Τηλ: +30 2118805000

Latvija
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666

Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website: https://www.emea.europa.eu/