Patient leaflet - Ambrisentan Teva 5 mg film-coated tablets
1. What Ambrisentan is and what it is used for
Ambrisentan Film-coated Tablets 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, 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.
2. What you need to know before you take Ambrisentan
Do not take Ambrisentan
- 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).
Warnings and precautions
Talk to your doctor or pharmacist 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 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.
Children
Do not give this medicine to children aged under 8 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.
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 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.
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 contains lactose, lecithin (derived from soya) and sodium
If you have been told by your doctor that you have an intolerance to some sugars contact your doctor before taking this medicinal product.
If you are allergic to peanut or soya, do not use this medicine (see section 2 ‘Do not take Ambrisentan’).
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
3. How to take Ambrisentan
Adults
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
How much Ambrisentan to take
The recommended 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.
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 | 2.5 mg, once a day* |
* Ambrisentan is not suitable for a dosage of 2.5 mg. For this dosage, other medicinal products containing 2.5 mg ambrisentan should be used.
Your doctor may decide to increase your dose. It is 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.
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.
[Appliclable to unit dose blister packs only:]
Taking out a tablet
These tablets come in special packaging to prevent children removing them.
- 1. Do not try and push the tablet directly out of the pocket. The tablet cannot be pushed out through the foil. Instead the foil must be peeled back.
- 2. First, separate one blister cell from the rest of the strip at the perforations
- 3. Then carefully peel off the backing to open the pocket
- 4. You can then remove the tablet from the pocket
If the aluminum foil has not come off and the pocket is still sealed, the tablet can now be pushed through the aluminum foil.
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 take more tablets than prescribed.
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 to make up for a forgotten dose.
If you stop taking Ambrisentan
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.
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.
Serious side effects
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. This is a common side effect that may affect up to 1 in 10 people. Symptoms include:
- shortness of breath
- extreme tiredness
- swelling in the ankles and legs.
Reduced number of red blood cells (anaemia)
This is a very common side effect that may affect more than 1 in 10 people. Sometimes this requires a blood transfusion. Symptoms include:
- tiredness and weakness
- shortness of breath
- generally feeling unwell.
Low blood pressure (hypotension)
This is a common side effect that may affect up to 1 in 10 people. Symptoms include:
- light-headedness.
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’.
Other side effects
Very common (may affect more than 1 in 10 people)
- headache
- dizziness
- palpitations (fast or irregular heart beats)
- shortness of breath getting worse 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).
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.
Side effects in children and adolescents
These are expected to be similar to those listed above for adults.
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: 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.
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 information
What Ambrisentan Film-coated Tablets 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, film-coating (comprising of part hydrolyzed polyvinyl alcohol, titanium dioxide (E171), talc, macrogol 3350, lecithin (soya) (E322)).
What Ambrisentan Film-coated Tablets looks like and contents of the pack
Ambrisentan 5 mg film-coated tablet is a white to off white oblong-shaped tablet with ‘5’ debossed on one side and ‘405’ on the other side.
Ambrisentan 10 mg film-coated tablet is a white to off white oblong-shaped tablet with ‘10’ debossed on one side and ‘406’ on the other side.
Ambrisentan is supplied as 5 mg and 10 mg film-coated tablets in blister packs of 10, 30, 60 and 120 tablets and in unit dose blister packs of 10x1, 30x1, 60x1 and 120x1 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Teva UK Limited, Ridings Point, Whistler Drive, Castleford, WF10 5HX, United Kingdom
Manufacturer
Merckle GmbH, Ludwig-Merckle-Strasse 3, Blaubeuren, Baden-Wuerttemberg, 89143, Germany
OR*
Balkanpharma-Dupnitsa AD, 3 Samokovsko Shosse Str., Dupnitsa, 2600, Bulgaria
This leaflet was last revised in 10/2024.
PL 00289/2266
PL 00289/2267
*Only the actual site of batch release will appear on the printed version of the leaflet.