Ambisentan Teva

Patient Information Leaflet

Ambrisentan Teva 5 mg film-coated tablets, 10 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Ambrisentan Teva is and what it is used for
2. What you need to know before taking Ambrisentan Teva
3. How to take Ambrisentan Teva
4. Possible side effects
5. How to store Ambrisentan Teva
6. Contents of the pack and other information

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

Ambrisentan Teva contains the active substance ambrisentan. It belongs to a group of medicines
called other antihypertensives (used for the treatment of high blood pressure).
It is used for the treatment of pulmonary arterial hypertension (PAH) in adults. PAH is
characterized by high blood pressure in the blood vessels that carry blood from the heart to the lungs (the
pulmonary arteries). In people with PAH, these arteries become narrowed, causing the heart to
work harder to pump blood through them. This leads to symptoms such as fatigue, dizziness, and shortness of breath.
Ambrisentan Teva relaxes the pulmonary arteries, making it easier for the heart to pump blood through them.
This reduces blood pressure and alleviates symptoms.
Ambrisentan Teva may also be used in combination with other medicines used to treat PAH.

2. What you need to know before taking Ambrisentan Teva

Do not take Ambrisentan Teva:
if you are allergic to ambrisentan, peanuts, soy, or any of the other ingredients
of this medicine (listed in section 6).
if you are pregnant, if you are planning a pregnancy, or if there is a possibility of becoming pregnant
because you are not using a reliable method of birth control (contraception). Read the information
provided in the section “Pregnancy”.
if you are breastfeeding. Read the information provided in the section “Breastfeeding”.
if you have a liver disease. Consult your doctor. Your doctor will determine whether this
medicine is suitable for you.
if you have scarring of lung tissue of unknown origin (idiopathic pulmonary fibrosis).

Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine:
if you have liver problems.
if you suffer from anaemia (reduced number of red blood cells).
if you have swelling in your hands, ankles or feet caused by fluid retention ( peripheral oedema ).
if you suffer from a lung disease in which the blood vessels in the lungs are blocked ( pulmonary
veno-occlusive disease ).
Your doctor will decide whether Ambrisentan Teva is suitable for you.

You will need to have regular blood tests
Before starting treatment with Ambrisentan Teva and at regular intervals during treatment, your
doctor will perform blood tests to check:
whether you have anaemia.
whether your liver is functioning properly.

It is important that you undergo these blood tests regularly throughout the entire period of taking Ambrisentan Teva.

Signs of impaired liver function include:
loss of appetite
nausea
vomiting
elevated body temperature (fever)
abdominal pain
yellowing of the skin or whites of the eyes (jaundice)
dark-coloured urine
itching of the skin

Contact your doctor immediately if you notice any of these symptoms.

Children and adolescents
Ambrisentan Teva is not recommended for children and adolescents under 18 years of age, as its safety and efficacy have not been established in this age group.

Other medicines and Ambrisentan Teva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.

Your doctor may need to adjust the dose of Ambrisentan Teva if you start treatment with cyclosporine A (a medicine used after organ transplantation or for the treatment of psoriasis).

If you are taking rifampicin (an antibiotic used to treat serious infections), your doctor will need to monitor you when starting treatment with Ambrisentan Teva.

If you are taking other medicines used to treat PAH (e.g. iloprost, epoprostenol, sildenafil), your doctor may need to monitor you.

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

Pregnancy
Ambrisentan Teva may cause harm to the unborn child if conception occurs before, during, or shortly after treatment.
If there is any possibility that you could become pregnant, use a reliable method of birth control
(contraception) while taking Ambrisentan Teva. Discuss this with your doctor.
Do not take Ambrisentan Teva if you are pregnant or planning to become pregnant.
If you become pregnant or suspect you are pregnant while taking Ambrisentan Teva, contact your doctor immediately.
If you are a woman of childbearing potential, your doctor will ask you to undergo a pregnancy test before starting Ambrisentan Teva and at regular intervals during treatment.

Breastfeeding
It is not known whether ambrisentan passes into breast milk.
Do not breastfeed while taking Ambrisentan Teva. Discuss this with your doctor.

Fertility
If you are a man taking Ambrisentan Teva, this medicine may reduce the number of spermatozoa in the semen. If you have any doubts or questions, consult your doctor.

Driving and using machines
Ambrisentan Teva may cause side effects such as low blood pressure, dizziness or fatigue (see section 4), which may affect your ability to drive or operate machinery. The symptoms of your illness may also make you feel less able to drive or use machinery.
Do not drive or operate machinery if you do not feel well.

Ambrisentan Teva contains lactose, soy lecithin, and sodium.
The Ambrisentan Teva tablets contain small amounts of a sugar called lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
The Ambrisentan Teva tablets contain soy lecithin. If you are allergic to peanuts or soy, do not use this medicine (see section 2 “Do not take Ambrisentan Teva”).
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Ambrisentan Teva

Always take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
How much Ambrisentan Teva to take
The recommended dose of Ambrisentan Teva is one 5 mg tablet once daily. Your doctor
may decide to increase the dose to 10 mg once daily.
If you are taking ciclosporin A, do not take more than one 5 mg tablet of Ambrisentan Teva once daily.
How to take Ambrisentan Teva
It is best to take the tablet at the same time each day. Swallow the tablet whole with a
glass of water.
Do not crush, split, or chew the tablet. Ambrisentan Teva may be taken with or without food.
[Applicable only to single-dose blister packs:]
Removing a tablet
These tablets are contained in special packaging designed to prevent access by children.

1. Do not try to push the tablet directly out of the blister. The tablet cannot be pushed through the foil. The foil must be removed.
2. First, separate one blister from the rest of the strip at the perforations.

3. Then carefully remove the foil to uncover the blister.

4. The tablet can now be removed from the blister.

If you take more Ambrisentan Teva than you should
Taking too many tablets increases the likelihood of side effects such as headache,
flushing, dizziness, nausea, or low blood pressure which may cause lightheadedness.
Consult your doctor or pharmacist if you have taken more tablets than prescribed.
If you forget to take Ambrisentan Teva
If you miss a dose of Ambrisentan Teva, take the tablet as soon as you remember and
then continue your treatment as usual.
Do not take a double dose to make up for a forgotten tablet.
If you stop taking Ambrisentan Teva
Do not stop taking Ambrisentan Teva without consulting your doctor.
Ambrisentan Teva is a treatment you need to continue taking to control PAH.
Do not stop taking Ambrisentan Teva unless agreed with your doctor.
If you have any further questions about the use of this medicine, consult 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 should pay attention to:
Allergic reactions
This is a common side effect which may affect up to 1 in 10 people. You may notice rash, itching and swelling (usually of the face, lips, tongue or throat) which may cause difficulty in breathing or swallowing.
Swelling (edema), especially of the ankles and feet
This is a very common side effect which may affect more than 1 in 10 people.
Heart failure
This occurs because the heart does not pump enough blood, causing shortness of breath, extreme tiredness and swelling of the ankles and legs. This is a common side effect which may affect up to 1 in 10 people.
Anaemia (reduction in the number of red blood cells)
This is a blood disorder which may cause tiredness, weakness, shortness of breath and a general feeling of being unwell. Blood transfusions may sometimes be required. This is a very common side effect which may affect more than 1 in 10 people.
Hypotension (low blood pressure)
This may cause dizziness. This is a common side effect which may affect up to 1 in 10 people.
Contact your doctor immediately if you experience any of these side effects or if they occur suddenly after taking Ambrisentan Teva.
It is important to have regular blood tests to monitor for anaemia and to check that your liver is working properly. Make sure you have also read the information
provided in section 2 under the headings “You will need to have regular blood tests” and “Signs of liver problems include:”.
Other side effects include
Very common side effects:
headache
dizziness
palpitations (fast or irregular heartbeat)
worsening of shortness of breath soon after starting treatment with Ambrisentan Teva
runny or stuffy nose, nasal congestion or pain in the sinuses
nausea
diarrhoea
feeling tired.
In combination with tadalafil (another medicine for PAH)
In addition to the above:
skin flushing
vomiting
chest pain/discomfort.
Common side effects:
blurred vision or other visual disturbances
fainting
abnormal liver function test results
runny nose
constipation
stomach (abdominal) pain
chest pain or discomfort
skin flushing
vomiting
weakness
nosebleeds
rash.
In combination with tadalafil
In addition to the above, except for abnormal liver function test results:
ringing in the ears ( tinnitus ), only with combination therapy.
Uncommon side effects:
liver damage
liver inflammation 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, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ambrisentan Teva

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 dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ambrisentan Teva contains

• The active substance is ambrisentan.
• Each film-coated tablet contains 5 or 10 mg.
• The other components are monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, magnesium stearate and film coating (composed of partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), talc, macrogol 3350, soy lecithin (E322)).

Description of the appearance of Ambrisentan Teva and contents of the pack
Ambrisentan Teva 5 mg film-coated tablets are white to off-white, oval-shaped tablets, printed with "5" on one side and "405" on the other.
Ambrisentan Teva 10 mg film-coated tablets are white to off-white, oval-shaped tablets, printed with "10" on one side and "406" on the other.
Ambrisentan Teva is available as 5 mg and 10 mg film-coated tablets in blister packs containing 10, 30, 60 and 120 tablets, and in unit dose blister packs containing 10x1, 30x1, 60x1 and 120x1 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
TEVA B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands
Manufacturer
Balkanpharma Dupnitsa AD, 3 Samokovsko Shosse Str., Dupnitsa 2600, Bulgaria
Merckle GmbH, Ludwig-Merckle-Strasse 3, 89143 Blaubeuren, Germany
TEVA UK Ltd, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom