Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - laventair

Document Subject

Generated Narrative: MedicinalProductDefinition mp7d204d7b4b6b9533290dd865f462d707

identifier: http://ema.europa.eu/identifier/EU/1/14/899/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: LAVENTAIR ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-dispensed

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-7d204d7b4b6b9533290dd865f462d707

identifier: http://ema.europa.eu/identifier/EU/1/14/899/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - laventair

Attesters

Step-by-step instructions

What is in this leaflet

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

What LAVENTAIR ELLIPTA is

LAVENTAIR ELLIPTA contains two active substances umeclidinium bromide and vilanterol. These belong to a group of medicines called bronchodilators.

What LAVENTAIR ELLIPTA is used for

LAVENTAIR ELLIPTA is used to treat chronic obstructive pulmonary disease (COPD) in adults. COPD is a long-term condition characterised by breathing difficulties that slowly get worse.

In COPD the muscles around the airways tighten. This medicine blocks the tightening of these muscles in the lungs, making it easier for air to get in and out of the lungs. When used regularly, it can help to control your breathing difficulties and reduce the effects of COPD on your everyday life.

LAVENTAIR ELLIPTA should not be used to relieve a sudden attack of breathlessness or wheezing.
If you get this sort of attack you must use a quick-acting reliever inhaler (such as salbutamol). If you do not have a quick-acting inhaler contact your doctor.

Do not use LAVENTAIR ELLIPTA:

• if you are allergic to umeclidinium, vilanterol or any of the other ingredients of this medicine (listed in section 6). If you think this applies to you, do not use this medicine until you have checked with your doctor.

Warnings and precautions
Talk to your doctor before using this medicine:

• if you have asthma (Do not use LAVENTAIR ELLIPTA to treat asthma)
• if you have heart problems or high blood pressure
• if you have an eye problem called narrow-angle glaucoma
• if you have an enlarged prostate, difficulty passing urine or a blockage in your bladder
• if you suffer from epilepsy
• if you have thyroid gland problems
• if you have low potassium in your blood
• if you have diabetes
• if you have severe liver problems

Check with your doctor if you think any of these may apply to you.

Immediate breathing difficulties If you get tightness of the chest, coughing, wheezing or breathlessness immediately after using your LAVENTAIR ELLIPTA inhaler:

stop using this medicine and seek medical help immediately, as you may have a serious condition called paradoxical bronchospasm.

Eye problems during treatment with LAVENTAIR ELLIPTA If you get eye pain or discomfort, temporary blurring of vision, visual halos or coloured images in association with red eyes during treatment with LAVENTAIR ELLIPTA:

stop using this medicine and seek medical help immediately. These may be signs of an acute attack of narrow-angle glaucoma.

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

Other medicines and LAVENTAIR ELLIPTA Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. If you are not sure what your medicine contains talk to your doctor or pharmacist.

Some medicines may affect how this medicine works, or make it more likely that you ll have side effects. These include:

• medicines called beta blockers (such as propranolol), to treat high blood pressure or other heart problems

• ketoconazole or itraconazole, to treat fungal infections

• clarithromycin or telithromycin, to treat bacterial infections

• ritonavir, to treat HIV infection

• medicines that lower the amount of potassium in your blood, such as some diuretics (water tablets) or some medicines used to treat asthma (such as methylxanthine or steroids)

• other long-acting medicines similar to this medicine that are used to treat breathing problems, e.g. tiotropium, indacaterol. Do not use LAVENTAIR ELLIPTA if you already use these medicines.

Tell your doctor or pharmacist if you are taking any of these. Your doctor may wish to monitor you carefully if you are taking any of these medicines as they may increase the side effects of LAVENTAIR ELLIPTA.

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 for advice before using this medicine. Do not use this medicine if you are pregnant unless your doctor tells you that you can.

It is not known whether the ingredients of LAVENTAIR ELLIPTA can pass into breast milk. If you are breast-feeding, you must check with your doctor before you use LAVENTAIR ELLIPTA. Do not use this medicine if you are breast-feeding unless your doctor tells you that you can.

Driving and using machines
It is unlikely that LAVENTAIR ELLIPTA will affect your ability to drive or use machines.

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

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

The recommended dose is one inhalation every day at the same time of day. You only need to inhale once a day because the effect of this medicine lasts for 24 hours. Do not use more than your doctor tells you to use.

Use LAVENTAIR ELLIPTA regularly It is very important that you use LAVENTAIR ELLIPTA every day, as instructed by your doctor. This will help to keep you free of symptoms throughout the day and night.

LAVENTAIR ELLIPTA should not be used to relieve a sudden attack of breathlessness or wheezing. If you get this sort of attack you must use a quick-acting reliever inhaler (such as salbutamol).

How to use the inhaler See Step-by-step instructions at the end of this leaflet for full information.

LAVENTAIR ELLIPTA is for inhalation use. To use LAVENTAIR ELLIPTA, you breathe it into your lungs through your mouth using the ELLIPTA inhaler.

If your symptoms do not improve
If your COPD symptoms (breathlessness, wheezing, cough) do not improve or get worse, or if you are using your quick-acting inhaler more often:

contact your doctor as soon as possible.

If you use more LAVENTAIR ELLIPTA than you should If you accidentally use too much of this medicine, contact your doctor or pharmacist for advice immediately as you may need medical attention. If possible, show them the inhaler, the package or this leaflet. You may notice that your heart is beating faster than usual, you feel shaky, you have visual disturbances, have a dry mouth, or have a headache.

If you forget to use LAVENTAIR ELLIPTA
Do not inhale an extra dose to make up for a forgotten dose. Just inhale your next dose at the usual time.
If you become wheezy or breathless, use your quick-acting reliever inhaler (such as salbutamol), then seek medical advice.

If you stop using LAVENTAIR ELLIPTA
Use this medicine for as long as your doctor recommends. It will only be effective as long as you are using it. Do not stop unless your doctor advises you to, even if you feel better, as your symptoms may get worse.

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

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

Allergic reactions If you have any of the following symptoms after taking LAVENTAIR ELLIPTA stop using this medicine and tell your doctor immediately.

Uncommon side effects (may affect up to 1 in 100 people):

• skin rash (hives) or redness

Rare side effects (may affect up to 1 in 1 000 people):

• swelling, sometimes of the face or mouth (angioedema)
• becoming very wheezy, coughing or having difficulty in breathing
• suddenly feeling weak or light headed (which may lead to collapse or loss of consciousness)

Immediate breathing difficulties Immediate breathing difficulties after using LAVENTAIR ELLIPTA are rare. If you get tightness of the chest, coughing, wheezing or breathlessness immediately after using this medicine:

stop using this medicine and seek medical help immediately, as you may have a serious condition called paradoxical bronchospasm.

Other side effects

Common (may affect up to 1 in 10 people)

• painful and frequent urination (may be signs of a urinary tract infection)
• combination of sore throat and runny nose
• sore throat
• feeling of pressure or pain in the cheeks and forehead (may be signs of inflammation of the sinuses called sinusitis)
• headache
• cough
• pain and irritation in the back of the mouth and throat
• constipation
• dry mouth
• infection of the upper airways.

Uncommon (may affect up to 1 in 100 people)

• irregular heart beat
• faster heart beat
• awareness of heart beat (palpitations)
• muscle spasms
• tremor
• taste disturbance
• hoarseness.

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

• blurred vision
• increase of the measured eye pressure
• decrease in vision or pain in your eyes (possible signs of glaucoma)
• difficulty and pain when passing urine these may be signs of a bladder obstruction or urinary retention.

Not known (frequency cannot be estimated from the available data)

• dizziness.

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.

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, tray and inhaler after EXP . The expiry date refers to the last day of that month.

Keep the inhaler inside the sealed tray in order to protect from moisture and only remove immediately before first use. Once the tray is opened, the inhaler can be used for up to 6 weeks, starting from the date of opening the tray. Write the date the inhaler should be thrown away on the label in the space provided. The date should be added as soon as the inhaler has been removed from the tray.

Do not store above 30 C.

If stored in a refrigerator, allow the inhaler to return to room temperature for at least an hour before use.

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.

What LAVENTAIR ELLIPTA contains
The active substances are umeclidinium bromide and vilanterol.

Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide) and 22 micrograms of vilanterol (as trifenatate).

The other ingredients are lactose monohydrate (see section 2 under LAVENTAIR ELLIPTA contains lactose ) and magnesium stearate.

What LAVENTAIR ELLIPTA looks like and contents of the pack LAVENTAIR ELLIPTA is an inhalation powder, pre-dispensed. The Ellipta inhaler consists of a light grey plastic body, a red mouthpiece cover and a dose counter. It is packaged in a foil laminate tray with a peelable foil lid. The tray contains a desiccant packet, to reduce moisture in the packaging.

The active substances are present as a white powder in separate blisters inside the inhaler.

LAVENTAIR ELLIPTA is available in packs of 1 inhaler containing either 7 or 30 doses and in multipacks containing 90 (3 inhalers of 30) doses. Not all pack sizes may be marketed.

Marketing Authorisation Holder:

GlaxoSmithKline (Ireland) Limited
12 Riverwalk
Citywest Business Campus Dublin Ireland

Manufacturer:

Glaxo Wellcome Production Zone Industrielle No.2 23 Rue Lavoisier
27000 Evreux
France

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

Belgi /Belgique/Belgien
GlaxoSmithKline Pharmaceuticals s.a./n.v. T l/Tel: + 32 (0) 10 85 52 Lietuva
UAB BERLIN-CHEMIE MENARINI BALTIC
Tel: +370 52 691 lt@berlin-chemie.com

• / .
  E
  Te .: +359 2 454 0bcsofia@berlin-chemie.com

Luxembourg/Luxemburg
GlaxoSmithKline Pharmaceuticals s.a./n.v. Belgique/Belgien T l/Tel: + 32 (0) 10 85 52 esk republika
GlaxoSmithKline, s.r.o. Tel: + 420 222 001 cz.info@gsk.com Magyarorsz g
Berlin-Chemie/A. Menarini Kft.
Tel.: +36 23501bc-hu@berlin-chemie.com

Danmark
GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 dk-info@gsk.com Malta
GlaxoSmithKline (Ireland) Limited
Tel: +356 80065Deutschland
BERLIN-CHEMIE AG Tel.: + 49 (0) 30 67Nederland
GlaxoSmithKline BV Tel: + 31 (0)33 2081Eesti
O Berlin-Chemie Menarini Eesti
Tel: +372 667 5ee@berlin-chemie.com Norge
GlaxoSmithKline AS Tlf: + 47 22 70 20
Guidotti Hellas A.E. : + 30 210 8316111- sterreich
GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0 at.info@gsk.com Espa a
FAES FARMA, S.A. Tel: + 34 900 460 aweber@faes.es Polska
GSK Services Sp. z o.o. Tel.: + 48 (0)22 576 9France
MENARINI France T l: + 33 (0)1 45 60 77 Portugal
BIAL, Portela & Ca. SA. Tel: + 351 22 986 61 info@bial.com

Hrvatska Berlin-Chemie Menarini Hrvatska d.o.o.
Tel: +385 1 4821 office-croatia@berlin-chemie.com

Rom nia
GlaxoSmithKline (Ireland) Limited
Tel: +40 800672Ireland
GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955Slovenija
Berlin-Chemie / A. Menarini Distribution Ljubljana d.o.o.
Tel: +386 (0)1 300 2slovenia@berlin-chemie.com

sland
Vistor hf. S mi: + 354 535 7Slovensk republika
Berlin-Chemie / A. Menarini Distribution Slovakia s.r.o.
Tel: +421 2 544 30 slovakia@berlin-chemie.com

Italia
A. Menarini Industrie Farmaceutiche Riunite s.r.l. Tel: +39 (0)55 56Suomi/Finland
GlaxoSmithKline Oy Puh/Tel: + 358 (0)10 30 30
GlaxoSmithKline (Ireland) Limited
: +357 80070Sverige
GlaxoSmithKline AB Tel: + 46 (0)8 638 93 info.produkt@gsk.com

Latvija
SIA Berlin-Chemie/Menarini Baltic
Tel: +371 67103lv@berlin-chemie.com United Kingdom (Northern Ireland) GlaxoSmithKline (Ireland) Limited Tel: + 44 (0)800 221customercontactuk@gsk.com

This leaflet was last revised in

Other sources of information

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