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Brimica Genuair (aclidinium / formoterol fumarate dihydrate) – Package leaflet - R03AL05

Updated on site: 05-Oct-2017

Medication nameBrimica Genuair
ATC CodeR03AL05
Substanceaclidinium / formoterol fumarate dihydrate
ManufacturerAstraZeneca AB

Package leaflet: Information for the patient

Brimica Genuair 340 micrograms /12 micrograms inhalation powder aclidinium/formoterol fumarate dihydrate

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

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.

What is in this leaflet

1.What Brimica Genuair is and what it is used for

2.What you need to know before you use Brimica Genuair

3.How to use Brimica Genuair

4.Possible side effects

5.How to store Brimica Genuair

6.Contents of the pack and other information

7.The Genuair inhaler: Instructions for use

1.What Brimica Genuair is and what it is used for

What Brimica Genuair is

This medicine contains two active ingredients called aclidinium and formoterol fumarate dihydrate. Both belong to a group of medicines called bronchodilators. Bronchodilators relax the muscles in your airways, which allows the airways to open more widely and helps you to breathe more easily. The Genuair inhaler delivers the active ingredients directly into your lungs as you breathe in.

What Brimica Genuair is used for

Brimica Genuair is used for adult patients who have breathing difficulties due to a lung disease called chronic obstructive pulmonary disease (COPD), in which the airways and air sacs in the lungs become damaged or blocked. By opening the airways, the medicine helps relieve symptoms such as shortness of breath. Taking Brimica Genuair regularly will help to minimise the effects of COPD on your everyday life.

2. What you need to know before you use Brimica Genuair

Do not use Brimica Genuair:

-if you are allergic to aclidinium, formoterol fumarate dihydrate or to the other ingredient of this medicine, lactose (see section 2 under “Brimica Genuair contains lactose”).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Brimica Genuair, if you have any of the following conditions/symptoms:

-If you have asthma. This medicine should not be used for the treatment of asthma.

-If you have heart problems.

-If you have epilepsy.

-If you have thyroid gland problems (thyrotoxicosis).

-If you have a tumour in one of your adrenal glands (phaeochromocytoma).

-If you have difficulty passing urine or problems due to an enlarged prostate.

-If you have an eye condition called narrow angle glaucoma, which results in high pressure in the eye.

Stop taking Brimica Genuair and seek medical help immediately if you experience any of the following:

-If you have sudden difficulty in breathing or swallowing, if you have swelling of the tongue, throat, lips or face, or a skin rash and/or itching. These may be signs of an allergic reaction.

-If you get sudden tightness of the chest, coughing, wheezing or breathlessness immediately after using the medicine. These may be signs of a condition called “paradoxical bronchospasm”, which is an excessive and prolonged contraction of the airway muscles immediately following treatment with a bronchodilator.

Brimica Genuair is used as a maintenance (long-term) treatment for COPD. You should not use this medicine to treat a sudden attack of breathlessness or wheezing.

If your usual COPD symptoms (breathlessness, wheezing, cough) do not improve or get worse while you are using Brimica Genuair you should continue to use it, but go to see your doctor as soon as possible because you may need another medicine.

If you see halos around lights or coloured images, have eye pain or discomfort or suffer temporary blurring of vision, go to see your doctor for advice as soon as possible.

Dry mouth has been observed with medicines like Brimica Genuair. In the long-term, dry mouth can be associated with tooth decay, so it is important to pay attention to oral hygiene.

Children and adolescents

Brimica Genuair is not for use in children or adolescents below 18 years of age.

Other medicines and Brimica Genuair

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. If you use Brimica Genuair with some other medicines, the effect of Brimica Genuair or the other medicines may be altered.

Tell your doctor or pharmacist if you are taking:

Any medicines that may be similar to Brimica Genuair to treat breathing difficulties.

Medicines that lower the amount of potassium in your blood. These include:

ocorticosteroids that you take by mouth (such as prednisolone),

odiuretics (such as furosemide or hydrochlorothiazide),

ocertain medicines used to treat breathing conditions (such as theophylline).

Medicines called beta blockers that may be used to treat high blood pressure or other heart problems (such as atenolol or propranolol) or to treat glaucoma (such as timolol).

Medicines which can cause a type of change in the electrical activity of the heart known as QT interval prolongation (observed in an electrocardiogram). These include medicines for the treatment of:

odepression (such as monoamine oxidase inhibitors or tricyclic antidepressants),

o bacterial infections (such as erythromycin, clarithromycin, telithromycin), o allergic reactions (anti-histamines).

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, nurse or pharmacist for advice before using this medicine. You should not use Brimica Genuair if you are pregnant or are breast-feeding unless your doctor tells you to do so.

Driving and using machines

Brimica Genuair is unlikely to affect your ability to drive or use machines. In some patients, this medicine may cause blurred vision or dizziness. If you are affected by either of these side effects, do not drive or use machines until the dizziness has cleared or your vision has returned to normal.

Brimica Genuair contains lactose

This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3.How to use Brimica Genuair

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

-The recommended dose is one inhalation twice a day in the morning and evening.

-The effects of Brimica Genuair last for 12 hours; therefore, you should try to use Brimica Genuair at the same time each morning and evening as this will ensure that there is always enough medicine in your body to help you breathe more easily throughout the day and night. Taking your medicine at regular times will also help you to remember to use it.

-Instructions for use: Refer to section 7 at the end of the package leaflet for instructions on how to use the Genuair inhaler. If you are not sure of how to use Brimica Genuair, contact your doctor or pharmacist.

-You can use Brimica Genuair anytime before or after food or drink.

COPD is a long-term disease; therefore, Brimica Genuair must be used every day, twice a day and not only when breathing problems or other symptoms of COPD are experienced.

The recommended dose can be used for elderly patients and for patients with kidney or liver problems. No dose adjustments are necessary in these patients.

If you use more Brimica Genuair than you should

If you think you may have used more Brimica Genuair than you should, you are more likely to experience some of its side effects, such as blurred vision, dry mouth, feeling sick, shaking/tremor, headache, palpitations or an increase in blood pressure, therefore you must immediately contact your doctor or go to the nearest emergency unit. Show the packaging of Brimica Genuair. Medical attention may be needed.

If you forget to use Brimica Genuair

If you forget a dose of Brimica Genuair, just take it as soon as possible and take your next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop using Brimica Genuair

This medicine is for long-term use. If you want to stop treatment, first talk to your doctor, as your symptoms may worsen.

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.

Some side effects may be serious: if you get any of these side effects, tell your doctor immediately.

Uncommon: may affect up to 1 in 100 people

-Muscle weakness, twitching and/or abnormal heart rhythm, as these may be signs of a decrease in the amount of potassium in your blood

-Tiredness, increased thirst and/or a need to pass urine more frequently than usual, as these may be signs of an increase in the amount of sugar in your blood

-Palpitations, as these may be a sign of an unusually fast heart beat or an abnormal heart rhythm

Rare: may affect up to 1 in 1,000 people

-Tightness of the chest, coughing, wheezing or breathlessness immediately after using the medicine

-Sudden difficulty in breathing or swallowing, swelling of the tongue, throat, lips or face, skin rash and/or itching - these may be signs of an allergic reaction

Not known: frequency cannot be estimated from the available data

Swelling of the face, throat, lips or tongue (with or without difficulty breathing or swallowing), severe itchy bumps on the skin (hives) as these may be symptoms of an allergic reaction.

Other side effects which may occur while using Brimica Genuair:

Common: may affect up to 1 in 10 people

-Combination of sore throat and runny nose – these may be signs of nasopharyngitis

-Headache

-Painful and/or frequent urination – these may be signs of a urinary tract infection

-Cough

-Diarrhoea

-A blocked, runny or stuffy nose and/or pain or a feeling of pressure in the cheeks or forehead – these may be symptoms of sinusitis

-Dizziness

-Muscle cramps

-Nausea (feeling sick)

-Difficulty sleeping

-Dry mouth

-Muscle pain

-Swelling of hands, ankles or feet

-Abscess (infection) in the tissues at the base of a tooth

-Increased blood levels of a protein found in muscle called creatine phosphokinase

-Shaking/tremor

-Anxiety

Uncommon:

-Fast heart beat (tachycardia)

-Chest pain or tightness in the chest (angina pectoris)

-Blurred vision

-Changes in the sound of the voice (dysphonia)

-Difficulty passing urine or a feeling that your bladder has not completely emptied (urinary retention)

-An abnormal heart trace (QT interval prolongation) potentially leading to an abnormal heart rhythm

-Distorted sense of taste (dysgeusia)

-Throat irritation

-Inflammation of the mouth (stomatitis)

-Increased blood pressure

-Agitation

-Rash

-Itching of the skin

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 more information on the safety of this medicine.

5.How to store Brimica Genuair

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 inhaler label, carton and inhaler pouch after “EXP”. The expiry date refers to the last day of that month.

This medicine does not require any special temperature storage conditions.

Keep the Genuair inhaler protected inside the sealed pouch until the administration period starts.

To be used within 60 days of opening the pouch.

Do not use Brimica Genuair if you notice that the pack is damaged or shows signs of tampering.

After you have taken the last dose, the inhaler has to be disposed of. Do not throw away any medicines via 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 Brimica Genuair contains

-The active substances are aclidinium bromide and formoterol fumarate dihydrate. Each delivered dose contains 396 micrograms aclidinium bromide equivalent to 340 micrograms of aclidinium and 11.8 micrograms of formoterol fumarate dihydrate.

-The other ingredient is lactose monohydrate.

What Brimica Genuair looks like and contents of the pack

Brimica Genuair is a white or almost white powder.

The Genuair inhaler is a white device fitted with an integral dose indicator and an orange dosage button. The mouthpiece is covered with a removable orange protective cap. It is supplied in a sealed protective aluminium pouch containing a desiccant sachet.

Pack sizes supplied:

Carton containing 1 inhaler with 30 doses.

Carton containing 1 inhaler with 60 doses.

Carton containing 3 inhalers each with 60 doses.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

AstraZeneca AB

SE-151 85 Södertälje

Sweden

Manufacturer:

Industrias Farmacéuticas Almirall, S.A. Ctra. Nacional II, Km. 593

08740 Sant Andreu de la Barca, Barcelona Spain

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

Lietuva

AstraZeneca S.A./N.V.

UAB “BERLIN-CHEMIE MENARINI BALTIC”

Tél/Tel: + 32 2 370 48 11

Tel: +370 52 691 947

България

Luxembourg/Luxemburg

“Берлин-Хеми/А. Менарини България” EООД

AstraZeneca S.A./N.V.

тел.: +359 2 96 55 365

Tél/Tel: + 32 2 370 48 11

Česká republika

Magyarország

Berlin-Chemie/A.Menarini Ceska republika s.r.o.

Berlin-Chemie/A. Menarini Kft.

Tel: +420 267 199 333

Tel.: +36 23501301

Danmark

Malta

AstraZeneca A/S

Associated Drug Co. Ltd

Tlf: +45 43 66 64 62

Tel: +356 2277 8000

Deutschland

Nederland

Berlin-Chemie AG

AstraZeneca BV

Tel: +49 (0) 30 67070

Tel: +31 79 363 2222

AstraZeneca GmbH

 

Tel: +49 41 03 7080

 

Eesti

Norge

Berlin-Chemie Menarini Eesti

AstraZeneca AS

Tel: +372 667 5001

Tlf: +47 21 00 64 00

Ελλάδα

Österreich

MENARINI HELLAS AE

A. Menarini Pharma GmbH.

Τηλ: +30 210 8316111-13

España

Polska

Laboratorios Menarini S.A.

Berlin-Chemie/Menarini Polska Sp. z o.o.

Tel: +34-93 462 88 00

Tel.: +48 22 566 21 00

France

Portugal

MENARINI France

A. Menarini Portugal – Farmacêutica, S.A.

Tél: +33 (0)1 45 60 77 20

Tel: +351 210 935 500

Hrvatska

România

Berlin-Chemie Menarini Hrvatska d.o.o.

Berlin-Chemie A.Menarini S.R.L.

Tel: + 385 1 4821 361

Tel: +40 21 232 34 32

 

Slovenija

Ireland

Berlin-Chemie AG, Podružnica Ljubljana

A. Menarini Pharmaceuticals Ireland Ltd

Tel: +386 01 300 2160

Tel: +353 1 284 6744

 

Ísland

Slovenská republika

Vistor hf.

Berlin-Chemie AG - obchodné zastúpenie v SR

Sími: +354 535 70 00

Tel: +421 2 544 30 730

Italia

Suomi/Finland

Laboratori Guidotti S.p.A.

AstraZeneca Oy

Tel: +39- 050 971011

Puh/Tel: +358 10 23 010

Κύπρος

Sverige

Αλέκτωρ Φαρµακευτική Λτδ

AstraZeneca AB

Τηλ: +357 22490305

Tel: +46 8 553 26 000

Latvija

United Kingdom

SIA Berlin-Chemie/Menarini Baltic

AstraZeneca UK Ltd

Tel: +371 67103210

Tel: +44 1582 836 836

This leaflet was last revised in {month YYYY}.

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

7.The Genuair inhaler: instructions for use

This section contains information on how to use your Genuair inhaler. A video demonstration on how to use the Genuair inhaler is also available on www.genuair.com and through the code below. If you have any questions about how to use your inhaler, please ask your doctor, pharmacist or nurse for assistance.

Before using the Genuair inhaler, please read the full instructions.

Becoming familiar with Brimica Genuair: familiar with its components.

Dose indicator

Protective

Cap

Remove the Genuair inhaler from the pouch and become

Orange button

Coloured control window

Mouthpiece

How to Use Brimica Genuair

Summary

To use your Genuair inhaler there are 2 steps you need to perform after removing the cap:

Step 1: Press and RELEASE the orange button and breathe out completely, away from the inhaler. Step 2: Place your lips tightly around the mouthpiece and inhale STRONGLY and DEEPLY through

the inhaler.

After inhalation, remember to replace the protective cap.

Getting Started

Before first use, tear the sealed pouch along the notch and remove the Genuair inhaler. The pouch and desiccant should be discarded.

When you are about to take your dose of medicine, remove the protective cap by lightly squeezing the arrows marked on each side and pulling outwards (see image 1).

IMAGE 1

Look to see that nothing is blocking the mouthpiece.

Hold the Genuair inhaler horizontally with the mouthpiece towards you and the orange button facing straight up (see image 2).

Hold with the orange button facing straight up. DO NOT TILT.

IMAGE 2

STEP 1: PRESS the orange button all the way down and then RELEASE it (see images 3 and 4).

DO NOT CONTINUE TO HOLD THE ORANGE BUTTON DOWN.

PRESS the orange button

RELEASE the orange

all the way down

button

IMAGE 3

IMAGE 4

Stop and Check: Make sure dose is ready for inhalation

Make sure the coloured control window has changed to green (see image 5).

The green control window confirms that your medicine is ready for inhalation.

Ready to use

GREEN

IMAGE 5

IF THE COLOURED CONTROL WINDOW STAYS RED, PLEASE REPEAT PRESS AND RELEASE ACTIONS (SEE STEP 1).

Before bringing the inhaler to your mouth, breathe out completely. Do not breathe out into the inhaler.

STEP 2:

Put your lips tightly around the mouthpiece of the Genuair inhaler and breathe in STRONGLY and DEEPLY through the mouthpiece (see image 6).

- This strong, deep breath pulls the medicine through the inhaler into your lungs.

ATTENTION: DO NOT HOLD THE ORANGE

BUTTON DOWN WHILE YOU ARE INHALING.

CORRECT

INCORRECT

IMAGE 6

While you breathe in you will hear a “CLICK” which signals that you are using the Genuair inhaler correctly.

Keep breathing in even after you have heard the inhaler “CLICK” to be sure you get the full dose.

Remove the Genuair inhaler from your mouth and hold your breath for as long as is comfortable, then breathe out slowly through your nose.

Note: Some patients may experience a mild sweet or slightly bitter taste, depending on the patient, when inhaling the medicine. Do not take an extra dose if you do not taste anything after inhaling.

Stop and Check: Make sure you have inhaled correctly

Make sure the control window has turned to red (see image 7). This confirms that you have inhaled your full dose correctly.

Inhaled correctly

RED

IMAGE 7

IF THE COLOURED CONTROL WINDOW IS STILL GREEN, PLEASE REPEAT INHALING STRONGLY AND DEEPLY THROUGH THE MOUTHPIECE (SEE STEP 2).

If the window still does not change to red, you may have forgotten to release the orange button before inhaling or may not have inhaled correctly. If that happens, try again.

Make sure you have RELEASED the orange button and take a STRONG deep breath in through the mouthpiece.

Note: If you are unable to inhale correctly after several attempts, consult your doctor.

Once the window has turned red, replace the protective cap by pressing it back onto the mouthpiece (see image 8).

IMAGE 8

When should you get a new Genuair inhaler?

The Genuair inhaler is equipped with a dose indicator to show you approximately how many doses are left in the inhaler. The dose indicator moves down slowly, displaying intervals of 10 (60, 50, 40, 30, 20, 10, 0) (see image A). Every Genuair inhaler will deliver at least 30 or

60 doses depending on the pack size.

When a red striped band appears in the dose indicator (see image A), this means you are nearing your last dose and you should obtain a new Genuair inhaler.

Dose indicator goes down by intervals of 10: 60, 50, 40, 30, 20, 10, 0.

Red-striped band

Dose indicator

IMAGE A

Note: If your Genuair inhaler appears to be damaged or if you lose the cap, your inhaler should be replaced. You DO NOT NEED to clean your Genuair inhaler. However, if you wish to clean it you should do so by wiping the outside of the mouthpiece with a dry tissue or paper towel.

NEVER use water to clean the Genuair inhaler, as this may damage your medicine.

How do you know that your Genuair inhaler is empty?

When 0 (zero) appears in the middle of the dose indicator, you should continue using any doses remaining in the Genuair inhaler.

When the last dose has been prepared for inhalation, the orange button will not return to its full upper position, but will be locked in a middle position (see image B). Even though the orange button is locked, your last dose may still be inhaled. After that, the Genuair inhaler cannot be used again and you should start using a new Genuair inhaler.

Locked

IMAGE B

ANNEX IV

Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)

Scientific conclusions

Taking into account the PRAC Assessment Report on the PSUR(s) for aclidinium bromide / formoterol fumarate dihydrate, the scientific conclusions of CHMP are as follows:

Based on the reasonable possibility of a link between formoterol and angina and given that angina is a recognised effect with formoterol and is listed in the SmPC for formoterol products, the proposal to add angina to section 4.8 of the SmPC for Duaklir/Brimica is considered appropriate. Therefore, the PRAC considered that changes to the product information of medicinal products containing aclidinium bromide – formoterol fumarate dihydrate were warranted.

The CHMP agrees with the scientific conclusions made by the PRAC.

Grounds for the variation to the terms of the marketing authorisation(s)

On the basis of the scientific conclusions for aclidinium bromide / formoterol fumarate dihydrate the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing aclidinium bromide / formoterol fumarate dihydrate is unchanged subject to the proposed changes to the product information

The CHMP recommends that the terms of the marketing authorisation(s) should be varied.

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