Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - volibris

Document Subject

Generated Narrative: MedicinalProductDefinition mpa2ad7d6c832ea8692cbcd9e308086f01

identifier: http://ema.europa.eu/identifier/EU/1/08/451/005

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Volibris 2.5 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-a2ad7d6c832ea8692cbcd9e308086f01

identifier: http://ema.europa.eu/identifier/EU/1/08/451/005

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - volibris

Attesters

What is in this leaflet

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

Volibris contains the active substance ambrisentan. It belongs to a group of medicines called other antihypertensives (used to treat high blood pressure).

It is used to treat pulmonary arterial hypertension (PAH) in adults, adolescents and children aged 8 years and over. PAH is high blood pressure in the blood vessels (the pulmonary arteries) that carry blood from the heart to the lungs. In people with PAH, these arteries get narrower, so the heart has to work harder to pump blood through them. This causes people to feel tired, dizzy and short of breath.

Volibris widens the pulmonary arteries, making it easier for the heart to pump blood through them. This lowers the blood pressure and relieves the symptoms.

Volibris may also be used in combination with other medicines used to treat PAH.

Don't take Volibris:

• if you are allergic to ambrisentan, soya, or any of the other ingredients of this medicine (listed in section 6)
• if you are pregnant, if you are planning to become pregnant, or if you could become pregnant because you are not using reliable birth control (contraception). Please read the information under Pregnancy
• if you are breast-feeding. Read the information under Breast-feeding
• if you have liver disease. Talk to your doctor, who will decide whether this medicine is suitable for you
• if you have scarring of the lungs, of unknown cause (idiopathic pulmonary fibrosis).

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

• if you have liver problems

• if you have anaemia (a reduced number of red blood cells)

• if you have swelling in the hands, ankles or feet caused by fluid (peripheral oedema)

• if you have lung disease where the veins in the lungs are blocked (pulmonary veno-occlusive disease).

  Your doctor will decide whether Volibris is suitable for you.

You will need regular blood tests Before you start taking Volibris, and at regular intervals while you are taking it, your doctor will take blood tests to check:

• whether you have anaemia

• whether your liver is working properly.

  It is important that you have these regular blood tests for as long as you are taking Volibris.

Signs that your liver may not be working properly include:

• loss of appetite
• feeling sick (nausea)
• being sick (vomiting)
• high temperature (fever)
• pain in your stomach (abdomen)
• yellowing of your skin or the whites of your eyes (jaundice)
• dark-coloured urine
• itching of your skin.

If you notice any of these signs:

Tell your doctor immediately.

Children Do not give this medicine to children aged under 8 years as the safety and effectiveness is not known in this age group.

Other medicines and Volibris Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

If you start taking cyclosporine A (a medicine used after transplant or to treat psoriasis), your doctor may need to adjust your dose of Volibris.

If you are taking rifampicin (an antibiotic used to treat serious infections), your doctor will monitor you when you first start taking Volibris.

If you are taking other medicines to treat PAH (e.g. iloprost, epoprostenol, sildenafil) your doctor may need to monitor you.

Tell your doctor or pharmacist if you are taking any of these medicines.

Pregnancy Volibris may harm unborn babies conceived before, during or soon after treatment.

If it is possible you could become pregnant, use a reliable form of birth control (contraception) while you are taking Volibris. Talk to your doctor about this.

Don t take Volibris if you are pregnant or planning to become pregnant.

If you become pregnant or think that you may be pregnant while you are taking Volibris, see your doctor immediately.

If you are a woman who could become pregnant, your doctor will ask you to take a pregnancy test before you start taking Volibris and regularly while you are taking this medicine.

Breast-feeding It is not known if the active substance of Volibris can pass into breast milk.

Don t breast-feed while you are taking Volibris. Talk to your doctor about this.

Fertility If you are a man taking Volibris, it is possible that this medicine may lower your sperm count. Talk to your doctor if you have any questions or concerns about this.

Driving and using machines Volibris may cause side effects, such as low blood pressure, dizziness, tiredness (see section 4), that may affect your ability to drive or use machines. The symptoms of your condition can also make you less fit to drive or use machines.

Don t drive or use machines if you are feeling unwell.

Volibris contains lactose Volibris tablets contain small amounts of a sugar called lactose. If you have been told by your doctor that you have an intolerance to some sugars:

Contact your doctor before taking this medicinal product.

Volibris contains lecithin derived from soya If you are allergic to soya, do not use this medicine (see section 2 Don t take Volibris ).

Volibris 5 mg and 10 mg tablets contain a colouring called allura red AC aluminium lake (E129) This may cause allergic reactions (see section 4).

Volibris contains sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially sodium- free .

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

How much Volibris to take

Adults The usual dose of Volibris is one 5 mg tablet, once a day. Your doctor may decide to increase your dose to 10 mg, once a day.

If you take cyclosporine A, do not take more than one 5 mg tablet of Volibris, once a day.

Adolescents and children aged 8 years to less than 18 years

Usual starting dose of Volibris Weighing 35 kg or more One 5 mg tablet, once a day Weighing at least 20 kg, and less than 35 kg One 2.5 mg tablet, once a day

Your doctor may decide to increase your dose. It s important that children attend their regular doctor s appointments, as their dose needs to be adjusted as they get older or gain weight.

If taken in combination with cyclosporin A, the dose of Volibris for adolescents and children weighing less than 50 kg will be limited to 2.5 mg once daily, or 5 mg once daily if they weigh 50 kg or more.

How to take Volibris It is best to take your tablet at the same time each day. Swallow the tablet whole, with a glass of water, do not split, crush or chew the tablet. You can take Volibris with or without food.

Taking out a tablet from a blister pack (5 mg and 10 mg tablets only) These tablets come in special packaging to prevent children removing them.

1. Separate one tablet: tear along the cutting lines to separate one pocket from the strip.

2. Peel back the outer layer: starting at the coloured corner, lift and peel over the pocket.

3. Push out the tablet: gently push one end of the tablet through the foil layer.

Volibris 2.5 mg tablets are provided in a bottle, not a blister pack.

If you take more Volibris than you should If you take too many tablets you may be more likely to have side effects, such as headache, flushing, dizziness, nausea (feeling sick), or low blood pressure that could cause light-headedness:

Ask your doctor or pharmacist for advice if you take more tablets than prescribed.

If you forget to take Volibris If you forget a dose of Volibris, just take the tablet as soon as you remember, then carry on as before.

Don t take a double dose at the same time to make up for a forgotten dose.

If you stop taking Volibris Volibris is a treatment that you will need to keep on taking to control your PAH.

Don t stop taking Volibris unless you have agreed this with your doctor.

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

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

Serious side effects Tell your doctor if you get any of these: Allergic reactions This is a common side effect that may affect up to 1 in 10 people. You may notice:

• a rash or itching and swelling (usually of the face, lips, tongue or throat), which may cause difficulty in breathing or swallowing.

Swelling (oedema), especially of the ankles and feet This is a very common side effect that may affect more than 1 in 10 people.

Heart failure This is due to the heart not pumping out enough blood. This is a common side effect that may affect up to 1 in 10 people. Symptoms include:

• shortness of breath
• extreme tiredness
• swelling in the ankles and legs.

Reduced number of red blood cells (anaemia) This is a very common side effect that may affect more than 1 in 10 people. Sometimes this requires a blood transfusion. Symptoms include:

• tiredness and weakness
• shortness of breath
• generally feeling unwell.

Low blood pressure (hypotension) This is a common side effect that may affect up to 1 in 10 people. Symptoms include:

• light-headedness.

  Tell your doctor straight away if you (or your child) get these effects or if they happen suddenly after taking Volibris.

It is important to have regular blood tests, to check for anaemia and that your liver is working properly. Make sure that you have also read the information in section 2 under You will need regular blood tests and Signs that your liver may not be working properly .

Other side effects Very common (may affect more than 1 in 10 people)

• headache
• dizziness
• palpitations (fast or irregular heart beats)
• shortness of breath getting worse shortly after starting Volibris
• a runny or blocked nose, congestion or pain in the sinuses
• feeling sick (nausea)
• diarrhoea
• feeling tired.

In combination with tadalafil (another PAH medicine) In addition to the above:

• flushing (redness of the skin)
• being sick (vomiting)
• chest pain/discomfort.

Common (may affect up to 1 in 10 people)

• blurry or other changes to vision
• fainting
• abnormal blood test results for liver function
• a runny nose
• constipation
• pain in your stomach (abdomen)
• chest pain or discomfort
• flushing (redness of the skin)
• being sick (vomiting)
• feeling weak
• nose bleed
• rash.

In combination with tadalafil In addition to the above, (except abnormal blood test results for liver function):

• ringing in the ears (tinnitus).

Uncommon (may affect up to 1 in 100 people)

• liver injury
• inflammation of the liver caused by the body s own defences (autoimmune hepatitis).

In combination with tadalafil

• sudden hearing loss.

Side effects in children and adolescents These are expected to be similar to those listed above for adults.

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 package after EXP.

The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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 Volibris contains

The active substance is ambrisentan. Each film-coated tablet contains 2.5 mg, 5 mg or 10 mg ambrisentan.

For the 2.5 mg tablets: The other ingredients are: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, polyvinyl alcohol, talc, titanium dioxide (E171), macrogol and lecithin (soya) (E322).

For the 5 mg or 10 mg tablets: The other ingredients are: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, polyvinyl alcohol, talc, titanium dioxide (E171), macrogol, lecithin (soya) (E322) and allura red AC aluminium lake (E129).

What Volibris looks like and contents of the pack

Volibris 2.5 mg film-coated tablet (tablet) is a white, 7 mm round, convex tablet engraved with GS
on one side and K11 on the other.

Volibris 5 mg film-coated tablet (tablet) is a pale pink, 6.6 mm square, convex tablet engraved with GS on one side and K2C on the other.

Volibris 10 mg film-coated tablet (tablet) is a deep pink, 9.8 mm 4.9 mm oval, convex tablet engraved with GS on one side and KE3 on the other.

Volibris is supplied as 2.5 mg film-coated tablets in bottles. Each bottle contains 30 tablets.

Volibris is supplied as 5 mg and 10 mg film-coated tablets in unit dose blister packs of 10 1 or 30 1 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder GlaxoSmithKline (Ireland) Limited 12 Riverwalk Citywest Business Campus Dublin Ireland

Manufacturer

GlaxoSmithKline Trading Services Limited 12 Riverwalk Citywest Business Campus Dublin Ireland

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 GlaxoSmithKline (Ireland) Limited Tel: + 370 80000
GlaxoSmithKline (Ireland) Limited Te .: + 359 80018Luxembourg/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 GlaxoSmithKline (Ireland) Limited Tel.: + 36 80088Danmark GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 dk-info@gsk.com

Malta GlaxoSmithKline (Ireland) Limited Tel: + 356 80065Deutschland GlaxoSmithKline GmbH & Co. KG Tel.: + 49 (0)89 36044 8produkt.info@gsk.com

Nederland GlaxoSmithKline BV Tel: + 31 (0)33 2081Eesti GlaxoSmithKline (Ireland) Limited Tel: + 372 8002Norge GlaxoSmithKline AS Tlf: + 47 22 70 20
GlaxoSmithKline A.E.B.E. : + 30 210 68 82 sterreich GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0 at.info@gsk.com Espa a GlaxoSmithKline, S.A. Tel: + 34 900 202 es-ci@gsk.com

Polska GSK Services Sp. z o.o. Tel.: + 48 (0)22 576 9France Laboratoire GlaxoSmithKline T l: + 33 (0)1 39 17 84 diam@gsk.com

Portugal GlaxoSmithKline Produtos Farmac uticos, Lda. Tel: + 351 21 412 95 FI.PT@gsk.com Hrvatska GlaxoSmithKline (Ireland) Limited Tel: + 385 800787Rom nia GlaxoSmithKline (Ireland) Limited Tel: + 40 800672Ireland GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955Slovenija GlaxoSmithKline (Ireland) Limited Tel: + 386 80688 sland Vistor hf. S mi: + 354 535 7Slovensk republika GlaxoSmithKline (Ireland) Limited Tel: + 421 800500Italia GlaxoSmithKline S.p.A. Tel: + 39 (0)45 7741 Suomi/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 GlaxoSmithKline (Ireland) Limited Tel: + 371 80205United 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: