Ambrisentan 10 mg film-coated tablets

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

• If you are allergic to ambrisentan, peanut, 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).

Talk to your doctor or pharmacist before taking Ambrisentan 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 Ambrisentan is suitable for you.

You will need regular blood tests

Before you start taking Ambrisentan, 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 Ambrisentan.

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.

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

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

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

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

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.

Ambrisentan 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 Ambrisentan. Talk to your doctor about this.
• Do not take Ambrisentan if you are pregnant or planning to become pregnant.
• If you become pregnant or think that you may be pregnant while you are taking Ambrisentan, 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 Ambrisentan and regularly while you are taking this medicine.

It is not known if the active substance, ambrisentan can pass into breast milk.

• Do not breast-feed while you are taking Ambrisentan. Talk to your doctor about this.

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

Ambrisentan 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.

• Do not drive or use machines if you are feeling unwell.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

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

This medicine contains soya lecithin. If you are allergic to peanut or soya, do not use this medicinal product.

This medicine contains a colouring called Allura red AC (E129) which may cause allergic reactions.

Adults

The usual dose of Ambrisentan is one 5 mg tablet, once a day. Your doctor may decide to increase your dose to 10 mg (two 5 mg tablet or one 10 mg tablet), once a day.

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

Adolescents and children aged 8 years to less than 18 years

Usual starting dose of Ambrisentan

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 Ambrisentan 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.

* For doses requiring 2.5 mg strength, another product available on the market should be used.

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 Ambrisentan with or without food.

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 a dose of Ambrisentan, just take the tablet as soon as you remember, then carry on as before.

• Do not take a double dose at the same time to make up for a forgotten dose.

Ambrisentan is a treatment that you will need to keep on taking to control your PAH.

• Do not stop taking Ambrisentan unless you have agreed this with your doctor.

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, causing shortness of breath, extreme tiredness and swelling in the ankles and legs. This is a common side effect that may affect up to 1 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 1 in 10 people.

Hypotension (low blood pressure)

This can cause light-headedness. This is a common side effect that may affect up to 1 in 10 people.

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

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’.

Very common (may affect more than 1 in 10 people):

• headache,
• dizziness,
• palpitations (fast or irregular heartbeats),
• worsening shortness of breath shortly after starting ambrisentan,
• 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) only when taking the combination treatment.

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.

These are expected to be similar to those listed above for adults.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the MHRA Yellow Card Scheme, Website: www.mhra.gov. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is ambrisentan.

Ambrisentan 5 mg film-coated tablets:

Each tablet contains 5 mg ambrisentan.

Ambrisentan 10 mg film-coated tablets:

Each tablet contains 10 mg ambrisentan.

The other ingredients are:

Tablet core: cellulose, microcrystalline (E460); lactose monohydrate; croscarmellose sodium (E468); magnesium stearate (E572).

Tablet coat: polyvinyl alcohol (E1203), titanium dioxide (E171); macrogol MW3350/ polyethylene glycol (E1521); talc (E553b); Allura red AC (E129); lecithin (soya) (E322).

Ambrisentan 5 mg film-coated tablets:

Pale pink square convex film-coated tablets, debossed with “5” on one side, plain on the other side with a nominal length/width of approximately 5.9 mm.

Ambrisentan 10 mg film-coated tablets:

Pink oblong biconvex film-coated tablets, debossed with “10” on one side, plain on the other side with a nominal length of approximately 11.1 mm, a nominal width of approximately 5.6 mm.

Ambrisentan is packed in white PVC/ PVDC/ aluminium blisters and/or transparent PVC/ PE/ PVDC/ aluminium blisters.

Pack size: cardboard boxes containing 10, 30 film-coated tablets in blisters or 10x1, 30x1 film-coatedtablets in unit dose blisters.

Not all pack sizes may be marketed.

Or