Patient leaflet - AMBRISENTAN AXUNIO 5 MG FILM-COATED TABLETS
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
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– Keep this leaflet. You may need to read it again.
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– If you have any further questions, ask your doctor, pharmacist or nurse.
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– 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.
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– If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet
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1. What Ambrisentan is and what it is used for
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2. What you need to know before you take Ambrisentan
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3. How to take Ambrisentan
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4. Possible side effects
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5. How to store Ambrisentan
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6. Contents of the pack and other information
1. what ambrisentan is and what it is used for
2. what you need to know before you take if you are allergic to ambrisentan, soya, or any of the other ingredients of this medicine (listed in section 6)
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 Ambrisentan is suitable for you.
You will need regular blood tests
Before you start taking Ambrisentan, 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 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.
Ambrisentan 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 Ambrisentan
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 Ambrisentan 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 Ambrisentan.
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
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’re taking Ambrisentan. Talk to your doctor about this.
^ Don’t take Ambrisentan if you are pregnant or planning to become pregnant.
^ If you become pregnant or think that you may be pregnant while you’re 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.
Breast-feeding
It is not known if Ambrisentan is transferred to breast milk.
^ Don’t breast-feed while you're taking Ambrisentan.
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.
Driving and using machines
3. how to take ambrisentan
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 Ambrisentan to take
The usual dose of Ambrisentan 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 Ambrisentan, once a day.
How to take Ambrisentan
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.
Taking out a tablet
These tablets come in special packaging to prevent children removing them.
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1. Separate one blister cavity from the blister package by tearing it along the perforation.
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2. Peel off the lidding foil and take out the tablet.
If you take more Ambrisentan 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 forget a dose of Ambrisentan, 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.
Ambrisentanis a treatment that you will need to keep on taking to control your PAH.
^ Don’t stop taking
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:
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 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’.
Other side effects include
- headache
- dizziness
- palpitations (fast or irregular heart beats)
- 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 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.
Reporting of side effects
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 Yellow Card Scheme.
Website: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.
5. how to store ambrisentan
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 informationambrisentan 5 mg film-coated tablets:
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– The active substance is ambrisentan.
Each film-coated tablet contains 5 mg ambrisentan.
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– The other ingredients are: Tablet core: microcrystalline cellulose, croscarmellose sodium,
lactose monohydrate, magnesium stearate. Film coat: polyvinyl alcohol-partial hydrolysed, titanium dioxide (E171), talc , macrogol , lecithin (soya) (E322), allura red AC aluminium lake (E129).
Ambrisentan 10 mg film-coated tablets:
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– The active substance is ambrisentan.
Each film-coated tablet contains 10 mg ambrisentan.
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– The other ingredients are: Tablet core: microcrystalline cellulose, croscarmellose sodium,
What Ambrisentan looks like and contents of the pack
Ambrisentan 5 mg film-coated tablet
Ambrisentan 5 mg film-coated tablet is a light pink, round, biconvex film-coated tablet debossed with ‘5’ on one side and with a dimension of approximately 7.0 mm.
Ambrisentan 10 mg film-coated tablet
Ambrisentan 10 mg film-coated tablet is a deep pink, oval, biconvex film-coated tablet debossed with ‘10’ on one side and with a dimension of approximately 9.9 mm x 5.0 mm.
Ambrisentan is supplied as 5 mg and 10 mg film-coated tablets in unit dose blister packs (Aluminium/Aluminium foil blisters or PVC/PVDC/Aluminium foil blisters) of 10×1 or 30×1 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
axunio Pharma GmbH
Van-der-Smissen-StraBe 1
22767 Hamburg
Germany
Manufacturer
Delorbis Pharmaceuticals LTD
Ergates Industrial Area
Athinon 17
2643 Ergates
Cyprus
This medicinal product is authorised in the Member States of the EEA under the following names:
Germany: Ambrisentan axunio 5 mg Filmtablette
Ambrisentan axunio 10 mg Filmtablette
This leaflet was last revised in September 2019.
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