Patient leaflet - Ambrisentan Axunio 10 mg film-coated tablets
1. What Ambrisentan is and what it is used for
Ambrisentan 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.
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.
2. What you need to know before you take Ambrisentan
Do not take Ambrisentan:
- 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 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.
If you are 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 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.
Breast-feeding
It is not known if the active substance of Ambrisentan can pass into breast milk.
➞ Do not breast-feed while you are taking Ambrisentan. Talk to your doctor about this. Fertility
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.
➞ 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.
Children and adolescents
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 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 Ambrisentan.
Driving and using machines
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.
Ambrisentan film-coated 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.
Ambrisentan film-coated tablets contain lecithin derived from soya.
If you are allergic to soya, do not use this medicine (see section 2 ‘Do not take Ambrisentan’). Ambrisentan film-coated tablets contain a colouring called allura red AC aluminium lake (E 129).
This may cause allergic reactions (see section 4). Ambrisentan film-coated tablets contain sodium.
This medicinal product contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free’.
If you are taking rifampicin (an antibiotic used to treat serious infections), your doctor will monitor you when you first start taking Ambrisentan.
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 are not sure.
Taking out a tablet from a blister pack
These tablets come in special packaging to prevent children removing them.
How much Ambrisentan to take
The usual dose of Ambrisentan is one 5 mg film-coated 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 film-coated 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.
- 1. Separate one blister cavity from the blister package by tearing it along the perforation.
- 2. Peel off the lidding foil and take out the tablet.
If you stop taking Ambrisentan
By reporting side effects, you can help provide more information on the safety of this medicine. If you take more Ambrisentan than you should
Ambrisentan is a treatment that you will need to keep on taking to control your PAH.
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:
➞ Do not stop taking Ambrisentan unless you have agreed this with your doctor.
➞ Ask your doctor or pharmacist for advice if you take more tablets than prescribed.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
If you forget to take Ambrisentan
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.
4. Possible side effects
- a runny or blocked nose, congestion or pain in the sinuses
Like all medicines, this medicine can cause side effects, although not everybody gets them. Serious side effects
- feeling sick (nausea)
- diarrhoea
Tell your doctor if you get any of these:
- feeling tired.
Allergic reactions
This is a common side effect that may affect up to 1 in 10 people. You may notice:
In combination with tadalafil (another PAH medicine)
In addition to the above:
a rash or itching and swelling (usually of the face, lips, tongue, or throat), which may cause difficulty in breathing or swallowing.
- flushing (redness of the skin)
- being sick (vomiting)
- chest pain/discomfort.
Swelling (oedema), especially of the ankles and feet
Common (may affect up to 1 in 10 people)
- blurry or other changes to vision
This is a very common side effect that may affect more than 1 in 10 people.
- fainting
- abnormal blood test results for liver function
Heart failure
- a runny nose
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:
- constipation
- pain in your stomach (abdomen)
- chest pain or discomfort
- shortness of breath
- flushing (redness of the skin)
- extreme tiredness
- being sick (vomiting)
- swelling in the ankles and legs.
- feeling weak
Reduced number of red blood cells (anaemia)
- nosebleed
This is a very common side effect that may affect more than 1 in 10 people. Sometimes this requires a blood transfusion. Symptoms include:
- rash.
In combination with tadalafil
In addition to the above, (except abnormal blood test results for liver function):
- tiredness and weakness
shortness of breath
- ringing in the ears (tinnitus).
generally feeling unwell.
Uncommon (may affect up to 1 in 100 people)
Low blood pressure (hypotension)
- liver injury
This is a common side effect that may affect up to 1 in 10 people. Symptoms include:
- inflammation of the liver caused by the body’s own defences (autoimmune hepatitis).
light-headedness.
In combination with tadalafil
➞ Tell your doctor straight away if you (or your child) get these effects or if they happen suddenly after taking Ambrisentan.
- sudden hearing loss.
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:
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’.
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
Other side effects
Very common (may affect more than 1 in 10 people)
- headache
- dizziness
- palpitations (fast or irregular heartbeats)
- shortness of breath getting worse shortly after starting Ambrisentan
5. How to store Ambrisentan
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
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.
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 Ambrisentan contains
Marketing Authorisation Holder
Ambrisentan 5 mg film-coated tablets:
The active substance is ambrisentan.
Each film-coated tablet contains 5 mg ambrisentan.
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:
axunio Pharma GmbH
Van-der-Smissen-Straße 1
22767 Hamburg
Germany
Manufacturer
Delorbis Pharmaceuticals Ltd.
Ergates Industrial Area
Athinon Street 17
2643 Ergates
Cyprus
The active substance is ambrisentan.
Each film-coated tablet contains 10 mg ambrisentan.
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).
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.
This medicinal product is authorised in the Member States of the European Economic Area (EEA) and in the United Kingdom (Northern Ireland) under the following names:
Germany: Ambrisentan axunio 5 mg Filmtablette
Ambrisentan axunio 10 mg Filmtablette
United Kingdom
(Northern Ireland): Ambrisentan 5 mg film-coated tablet
Ambrisentan 10 mg film-coated tablet
This leaflet was last revised in May 2022.
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 x 1 or 30 x 1 film-coated tablets. Not all pack sizes may be marketed.
V01 51749965 Code 474
Produkt/Product: AMBRISENTAN 5MG/10MG UK
FILM COATED TABLETS
Packmittel/Packaging: PIL
Format/Size: 180 × 580 mm
Schriftgröße: 10 pt (ZAB 11,5 pt) – 24 pt
Hersteller Artikelnr.: ---
Version: 5. Umlauf
Datum/Date: 20.02.2023
Agentur/Agency: Eigler Communication GmbH