5 mg, 10 mg film-coated tablets 
ambrisentan

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor, pharmacist, or nurse.

– This medicine has been prescribed for you only. Do not give it to others. It may harm them, even if they show symptoms similar to yours.

– If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information.

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

1. What Ambrisentan Accord is and what it is used for

Ambrisentan Accord contains the active substance ambrisentan. It belongs to a group of medicines called other antihypertensive drugs (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 (pulmonary arteries) that transport blood from the heart to the lungs. In people with PAH, these arteries become narrower so that the heart has to work harder to pump blood through them. This makes you feel tired, dizzy, and out of breath.

Ambrisentan Accord dilates the pulmonary arteries and makes it easier for the heart to pump blood through them. This lowers blood pressure and relieves symptoms.

Ambrisentan Accord can also be used in combination with other medicines used to treat PAH.

Ambrisentan contained in Ambrisentan Accord may also be approved for the treatment of other diseases not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions and always follow their instructions.

2. What you need to know before using Ambrisentan Accord

Do not use Ambrisentan Accord

Do not take Ambrisentan Accord:

  • if you are allergic to ambrisentan, soy, 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 may become pregnant because you are not using reliable contraception. Read the information under “Pregnancy”
  • if you are breast-feeding. Read the information under “Breastfeeding”
  • if you have liver disease. Talk to your doctor who will decide if this medicine is suitable for you
  • if you have scarring of the lungs, of unknown cause (idiopathic pulmonary fibrosis).

Warnings and cautions

Talk to your doctor before taking this medicine if you have any

  • liver problem
  • anemia (decreased number of red blood cells)
  • swollen hands, ankles, or feet caused by fluid retention (peripheral edema)
  • lung disease which means that the veins in the lungs are blocked ( pulmonaryveno ‑ occlusive disease).

→ Your doctor will decide if Ambrisentan Accord is suitable for you.

You need to take blood samples regularly

Before you start taking Ambrisentan Accord and regularly while you are taking it, your doctor will take a blood test to check:

  • if you have anemia
  • if your liver is working properly.

 It is important that you leave these regular blood tests as long as you take the Ambrisentan Accord.

Signs that your liver may not be working properly are for example:

  • loss of appetite
  • nausea
  • vomiting
  • fever
  • magont
  • yellowing of the skin or whites of the eyes (jaundice)
  • dark-colored urine
  • itching of the skin.

If you notice any of these signs:

→ Tell your doctor immediately.

Children and young people

Ambrisentan Accord is not recommended for children and adolescents under 18 years of age as safety and efficacy are not known for this age group.

Other medicines and Ambrisentan Accord

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 Accord if you start taking ciclosporin A (a medicine used after transplantation or to treat psoriasis ).

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

If you are taking other medicines used to treat PAHs (eg iloprost, epoprostenol, sildenafil) your doctor may need to check you more closely.

→ Tell your doctor or pharmacist if you are taking any of these medicines.

Pregnancy, breastfeeding, and fertility

Pregnancy

Ambrisentan Accord can harm the unborn baby if you become pregnant before, during, or shortly after treatment.

→ If it is possible that you may become pregnant, use a reliable contraceptive while you are taking Ambrisentan Accord. Discuss this with your doctor.

→ Do not take Ambrisentan Accord if you are pregnant or planning to become pregnant.

→ If you become pregnant or suspect that you may be pregnant while taking Ambrisentan Accord, contact a doctor immediately.

If you are a woman and could become pregnant, your doctor will ask you to do a pregnancy test before you start taking Ambrisentan Accord and regularly while you are taking this medicine.

Breast-feeding

It is not known if Ambrisentan Accord passes into breast milk.

→ Do not breast-feed while taking Ambrisentan Accord. Discuss this with your doctor.

Fertility

If you are a man taking Ambrisentan Accord, there may be a risk that Ambrisentan Accord will reduce the number of sperm. Talk to your doctor if you have any questions about this.

Driving and using machines

Ambrisentan Accord can cause side effects, such as low blood pressure, dizziness, fatigue (see section 4) which may affect your ability to drive or use machines. The symptoms of your illness may also make you less fit to drive or use machines.

→ Do not drive or use machines unless you are feeling well.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Ambrisentan Accord contains excipients

Ambrisentan Accord 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 Ambrisentan Accord.

Ambrisentan Accord tablets contain lecithin derived from soy. If you are allergic to soy, do not take this medicine (see section 2 “Do not take Ambrisentan Accord”).

Ambrisentan Accord tablets contain a dye called Allura red AC aluminum lacquer (E129) which may cause allergic reactions (see section 4).

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.

How to use Ambrisentan Accord

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

How much Ambrisentan Accord to take

The usual dose of Ambrisentan Accord is one 5 mg tablet once a day. Your doctor may decide to increase the dose one to 10 mg once a day.

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

How to take Ambrisentan Accord

It is best to take the tablet at the same time each day. Swallow the tablet whole with a glass of water. The tablet should not be split, crushed, or chewed. You can take Ambrisentan Accord with or without food.

Taking out a tablet

The tablets are supplied in special packages to prevent children from taking them out.

If you use more Ambrisentan Accord than you should  

If you take too many tablets, there is a greater risk of side effects such as headaches, hot flashes, dizziness, nausea, or low blood pressure, which may cause dizziness.

→ Ask your doctor or pharmacist for advice if you are taking more tablets than prescribed.

If you forget to use Ambrisentan Accord

If you forget to take a dose of Ambrisentan Accord, take it as soon as possible. Then continue to take the medicine as prescribed.

→ Do not take a double dose to make up for a forgotten dose.

If you stop using Ambrisentan Accord

Do not stop taking Ambrisentan Accord without consulting your doctor.

Ambrisentan Accord is a treatment that you must continue to take to control your PAH.

→ Do not stop taking Ambrisentan Accord without your doctor’s agreement.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Conditions that you and your doctor must be aware of:

Allergic reactions

This is a common side effect that may affect up to 1 in 10 people. You may get a rash or itching and swelling (usually on the face, lips, tongue, or throat), which may cause difficulty breathing or swallowing.

Swelling ( edema ), 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 because the heart does not pump out enough blood which leads to shortness of breath, extreme fatigue, and swollen ankles and legs. It is a common side effect that may affect up to 1 in 10 people.

Anemia (decreased number of red blood cells )

This is a blood disease that can lead to fatigue, weakness, shortness of breath, and general malaise. Sometimes this requires a blood transfusion. It is a very common side effect that may affect more than 1 in 10 people.

Hypotension (low blood pressure )

This can cause dizziness. It is a common side effect that may affect up to 1 in 10people.

→ Tell your doctor immediately if you get these side effects or if they occur suddenly after using Ambrisentan Accord.

It is important that you take regular blood tests, to check if you have anemia and that your liver is functioning properly. Make sure you have also read the information in section 2 under “You need to have blood tests regularly” and “Signs that your liver may not be working properly”.

Other side effects include

Very common side effects:

  • headache
  • dizziness
  • palpitations (fast or irregular heartbeat)
  • aggravated shortness of breath shortly after starting treatment with Ambrisentan Accord
  • runny or stuffy nose, congestion or pain in the sinuses
  • nausea
  • diarrhea
  • fatigue.

In combination with tadalafil (another medicine used to treat PAH)

In addition to the above:

  • hot flashes (reddening of the skin)
  • vomiting
  • pain/discomfort in the chest.

Common side effects:

  • blurred vision or other vision changes
  • fainting
  • abnormal results on blood tests for liver function
  • Runny nose
  • constipation
  • magont
  • chest pain or discomfort
  • hot flashes (reddening of the skin)
  • vomiting
  • feeling weak
  • nosebleeds
  • rash.

In combination with tadalafil (another medicine used to treat PAH)

In addition to the above, with the exception of abnormal liver function values:

  • tinnitus ( tinnitus ), only if you take the combination treatment.

Uncommon side effects:

  • liver damage
  • inflammation of the liver caused by the body’s own immune system (autoimmune hepatitis).

In combination with tadalafil

  • 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 to the producing company. By reporting side effects, you can help increase drug safety information. 

5. How to store Ambrisentan Accord

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 expiration date is the last day of the specified month.

No special storage instructions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

Ambrisentan Accord 5 mg film-coated tablets

  • The active substance is ambrisentan. Each film-coated tablet contains 5 mg of ambrisentan.
  • The other ingredients are Tablet core: microcrystalline cellulose, crushed caramel sodium, lactose monohydrate, magnesium stearate. Film coating: polyvinyl alcohol (partially hydrolyzed), titanium dioxide (E171), talc, macrogol, lecithin (soy) (E322), and Allura red AC aluminum lacquer (E129).

Ambrisentan Accord 10 mg film-coated tablets

  • The active substance is ambrisentan. Each film-coated tablet contains 10 mg of ambrisentan.
  • The other ingredients are Tablet core: microcrystalline cellulose, crushed caramel sodium, lactose monohydrate, magnesium stearate. Film coating: polyvinyl alcohol (partially hydrolyzed), titanium dioxide (E171), talc, macrogol, lecithin (soy) (E322), and Allura red AC aluminum lacquer (E129).

What the medicine looks like and the contents of the pack

Ambrisentan Accord 5 mg film-coated tablet

Ambrisentan Accord 5 mg film-coated tablet is a light pink, round, biconvex tablet debossed with “5” on one side and approximately 7.0 mm in size.

Ambrisentan Accord 10 mg film-coated tablet

Ambrisentan Accord 10 mg film-coated tablet is a dark pink, oval, biconvex tablet debossed with “10” on one side and approximately 9.9 mm x 5.0 mm in size.

Ambrisentan Accord is available as 5 mg and 10 mg film-coated tablets in single-dose blister packs (blisters of aluminum/aluminum foil or blisters of PVC / PVCD / aluminum foil) of 10 x 1 or 30 x 1 tablet.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Accord Healthcare BV

Winthontlaan 200

3526 VK Utrecht

Netherlands

Manufacturer

Delorbis Pharmaceuticals Limited

17 Athinon Street, Ergates Industrial Area

2643 Ergates Nicosia,

Cyprus

Accord Healthcare Limited

Sage House, 319 Pinner Road

North Harrow, Middlesex HA1 4HF,

UK

Laboratori Fundació Dau 
C / C, 12-14 Pol. Ind. Zona Franca,

08040 Barcelona, 
Spain

Wessling Hungary,

Anonymous u. 6., Budapest, 1045,

Hungary

Muhammad Nadeem

Leave a Reply