Patient Leaflet Updated 15-Mar-2022 | Zentiva
Ambrisentan 10 mg film-coated tablets
Ambrisentan 5 mg film-coated tablets
Ambrisentan 10 mg film-coated tablets
ambrisentan
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
The name of the product is Ambrisentan film-coated tablets (called Ambrisentan throughout this leaflet). These tablets contain 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.
Ambrisentan widens the pulmonary arteries, making it easier for the heart to pump blood through them. This lowers the blood pressure and relieves the symptoms.
Ambrisentan may also be used in combination with other medicines used to treat PAH.
Talk to your doctor or pharmacist before taking Ambrisentan if you have:
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:
Signs that your liver may not be working properly include:
If you notice any of these signs:
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.
Ambrisentan may harm unborn babies conceived before, during or soon after treatment.
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.
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.
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.
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.
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:
If you forget a dose of Ambrisentan, just take the tablet as soon as you remember, then carry on as before.
Ambrisentan is a treatment that you will need to keep on taking to control your PAH.
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.
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.
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):
In combination with tadalafil (another PAH medicine)
In addition to the above:
Common (may affect up to 1 in 10 people):
In combination with tadalafil
In addition to the above, except abnormal blood test results for liver function:
Uncommon (may affect up to 1 in 100 people):
In combination with tadalafil
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.
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.
White PVC/PVDC/ aluminium blisters:
This medicinal product does not require any special temperature storage conditions. Store in the original blister packaging to protect from light.
Transparent PVC/PE/PVDC/ aluminium blisters:
This medicinal product does not require any special temperature storage conditions. Store in the original packaging to protect from light.
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.
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.
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This leaflet was last revised in December 2021
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