VOLIBRIS 10 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

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

What Volibris is and what it is used for

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. 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.

What you need to know before you take Volibris

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
• anaemia (a reduced number of red blood cells)
• swelling in the hands, ankles or feet caused by fluid (peripheral oedema)
• 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’re 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 and adolescents

Volibris is not recommended for children and adolescents aged under 18 years as the safety and effectiveness is not known in this age group.

Other medicines and Volibris

Tell your doctor or pharmacist if you’re taking, have recently taken or might take any other medicines.

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

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

If you’re taking other medicines used 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’re 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’re 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 Volibris is transferred to breast milk.

^ Don’t breast-feed while you’re 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’re feeling unwell.

3 how to take volibris

Always take this medicine exactly as your doctor or pharmacist has told you to.

Check with your doctor or pharmacist if you’re not sure.

How much Volibris to take

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.

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

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

How to take Volibris

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

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 two doses at the same time to make up for a forgotten dose.

Don’t stop taking Volibris without your doctor’s advice

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.

4

Possible side effects

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

Conditions you and your doctor need to look out for:

Allergic reactions

This is a common side effect that may affect up to one 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 one in 10 people

Heart failure

This is due to the heart not pumping out enough blood, causing shortness of breath, extreme tiredness and swelling in the ankles and legs. This is a common side effect that may affect up to one in 10 people

Anaemia (reduced number of red blood cells)

This is a blood disorder which can cause tiredness, weakness, shortness of breath, and generally feeling unwell. Sometimes this requires a blood transfusion. This is a very common side effect that may affect more than one in 10 people

Hypotension (low blood pressure)

This can cause light-headedness. This is a common side effect that may affect up to one in 10 people

^ Tell your doctor straight away if you 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 include

Very common side effects:

• headache
• dizziness
• palpitations (fast or irregular heart beats)
• worsening shortness of breath 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 side effects:

• 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) only when taking the combination treatment.

Uncommon side effects:

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

In combination with tadalafil

• sudden hearing loss.

5 how to store volibris

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 and blister 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.

6 contents of the pack and other information

What Volibris contains

The active substance is ambrisentan.

Each film-coated tablet contains 5 or 10 mg.

The other ingredients are: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, polyvinyl alcohol, talc (E553b), titanium dioxide (E171), macrogol 3350, lecithin (soya) (E322) and Allura red AC Aluminium Lake (E129).

What Volibris looks like and contents of the pack

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

Volibris 10 mg film-coated tablet (tablet) is a deep pink, oval, convex tablet engraved with ‘GS’ on one face and ‘KE3’ on the other.

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 24

Ireland

Manufacturer

Glaxo Operations UK Ltd (trading as GlaxoWellcome Operations) Harmire Road

Barnard Castle

Co. Durham DL12 8DT

United Kingdom