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. See section 4.

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

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

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

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

What you need to know before using Ambrisentan Mylan

Do not take Ambrisentan Mylan:

  • if you are allergic to ambrisentan 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 a reliable contraceptive. 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, pharmacist, or nurse before taking this medicine if you have:

  • 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  (pulmonary veno-occlusive disease).

Your doctor will decide if Ambrisentan Mylan is right for you.

You need regular blood tests

Before you start taking Ambrisentan Mylan 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 are taking Ambrisentan Mylan.

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 Mylan 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 Mylan

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 Mylan 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 Mylan.

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 Mylan can harm your 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 Mylan. Discuss this with your doctor.

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

→ If you become pregnant or suspect that you may be pregnant while taking Ambrisentan Mylan, 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 Mylan and regularly while you are taking this medicine.

Breast-feeding

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

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

Fertility

If you are a man taking Ambrisentan Mylan, there is a risk that this medicine may reduce your sperm count. Talk to your doctor if you have any questions about this.

Driving and using machines

Ambrisentan Mylan can cause side effects, such as low blood pressure, dizziness, tiredness (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.

Ambrisentan Mylan contains lactose and allura red AC aluminum lacquer (E129)

Ambrisentan Mylan tablets contain small amounts of a sugar called lactose. If you do not tolerate certain sugars:

→ Contact your doctor before taking this medicine.

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

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

How to take Ambrisentan Mylan

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

How much Ambrisentan Mylan to take

The usual dose of Ambrisentan Mylan 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 tablet of Ambrisentan Mylan once a day.

How to take Ambrisentan Mylan

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 Mylan with or without food.

If you take more Ambrisentan Mylan than you should

If you take too many tablets, you are more likely to get side effects such as headaches, hot flashes, dizziness, nausea, or low blood pressure, which can cause dizziness:

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

If you forget to take Ambrisentan Mylan

If you forget to take a dose of Ambrisentan Mylan, take your tablet as soon as possible, then continue as before.

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

Do not stop using Ambrisentan Mylan without consulting your doctor.

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

→ Do not stop taking Ambrisentan Mylan 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 you have used Ambrisentan Mylan.

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 regular blood tests” 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)
  • worsening shortness of breath shortly after starting treatment with Ambrisentan Mylan
  • runny or stuffy nose, congestion or pain in the sinuses
  • nausea
  • diarrhea
  • fatigue

In combination with tadalafil (another anti-PAH drug)  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

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

  • ringing in the ears ( 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 Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.

5. How to store Ambrisentan Mylan

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 after EXP. The expiration date is the last day of the specified month.

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

What Ambrisentan Mylan contains

The active substance is ambrisentan.

Each film-coated tablet contains 5 mg or 10 mg.

The other ingredients are lactose, see section 2, “Ambrisentan Mylan contains lactose”, microcrystalline cellulose (E460i), croscarmellose sodium, magnesium stearate (E570), polyvinyl alcohol partially hydrolyzed, titanium dioxide (E171), macrogol / PEG, aluminum (AC55b) (E129), see section 2 “Ambrisentan Mylan contains all-red AC aluminum lacquer (E129)” Indigo carmine (E132).

Ambrisentan Mylan’s appearance and packaging sizes

Ambrisentan Mylan 5 mg film-coated tablet (tablet) is a pink, round, biconvex tablet with “M” debossed on one side and “AN” on the other side.

Ambrisentan Mylan 10 mg film-coated tablet (tablet) is a pink, capsule-shaped tablet with “M” debossed on one side and “AN1” on the other side.

Ambrisentan Mylan is available as 5 mg and 10 mg film-coated tablets in packs of 30 tablets and single-dose blister packs of 30×1 tablets or 60×1 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan SAS

117 Allée des Parcs

69800 Saint ‑ Priest

France

Manufacturer

Generics (UK) Limited, Potters Bar, Hertfordshire, EN6 1TL, UK

McDermott Laboratories to Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland

Mylan Hungary Kft, Mylan utca 1, 2900 Komárom, Hungary

Muhammad Nadeem

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