5 mg, 10 mg film-coated tablets
ambrisentan
1. What Ambrisentan Sandoz is and what it is used for
Ambrisentan Sandoz contains the active substance ambrisentan. It belongs to a group of medicines called other antihypertensive drugs (used to treat high blood pressure ).
Ambrisentan Sandoz 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 Sandoz dilates the pulmonary arteries and makes it easier for the heart to pump blood through them. This lowers blood pressure and relieves symptoms.
Ambrisentan Sandoz can also be used in combination with other medicines used to
treat PAH.
Ambrisentan contained in Ambrisentan Sandoz may also be approved for the treatment of other diseases not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Ambrisentan Sandoz
Do not take Ambrisentan Sandoz
- if you are allergic to ambrisentan or any of the other ingredients of this medicine (listed in section 6)
- if you are pregnant, planning to become pregnant, or if you may 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 before taking Ambrisentan Sandoz 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 ( pulmonaryveno-occlusive disease ).
Your doctor will decide if Ambrisentan Sandoz is right for you.
You need to take blood samples regularly
Before you start taking Ambrisentan Sandoz 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 Sandoz.
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 Sandoz is not recommended for children and adolescents under the age of 18 as safety and efficacy are not known for this age group.
Other medicines and Ambrisentan Sandoz
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 Sandoz 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 Sandoz
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
Ambrisentan Sandoz 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 Sandoz. Discuss this with your doctor.
Do not take Ambrisentan Sandoz if you are pregnant or planning to become pregnant.
If you become pregnant or suspect that you may be pregnant while taking Ambrisentan Sandoz, contact your 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 Sandoz and regularly while you are taking this medicine.
Breast-feeding
It is not known if Ambrisentan Sandoz passes into breast milk.
Do not breast-feed while taking Ambrisentan Sandoz. Discuss this with your doctor.
Fertility
If you are a man taking Ambrisentan Sandoz, there may be a risk that the medicine will reduce the number of sperm. Talk to your doctor if you have any questions about this.
Driving and using machines
Ambrisentan Sandoz 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.
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.
Do not drive or use machines unless you are feeling well.
Ambrisentan Sandoz contains lactose
Ambrisentan Sandoz film-coated tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Ambrisentan Sandoz.
How to take Ambrisentan Sandoz
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 Sandoz to take
The usual dose of Ambrisentan Sandoz 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 Sandoz tablet once a day.
How to take Ambrisentan Sandoz
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 Sandoz with or without food.
If you forget to take Ambrisentan Sandoz
If you forget to take a dose of Ambrisentan Sandoz, 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.
Do not stop using Ambrisentan Sandoz without consulting your doctor.
Ambrisentan Sandoz is a treatment that you must continue to take to control your PAH.
Do not stop taking Ambrisentan Sandoz 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 Sandoz.
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 are :
- headache
- dizziness
- palpitations (fast or irregular heartbeat)
- aggravated shortness of breath shortly after starting treatment with Ambrisentan Sandoz
- 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 Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Ambrisentan Sandoz
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
The active substance is ambrisentan.
Each film-coated tablet contains 5 mg or 10 mg of ambrisentan.
The other ingredients are lactose monohydrate, microcrystalline cellulose, pregelatinized maize starch, magnesium stearate, polyvinyl alcohol, titanium dioxide (E171), polyethylene glycol, talc, and iron oxide (E172).
What the medicine looks like and the contents of the pack
Ambrisentan Sandoz 5 mg film-coated tablet is a pink, round, film-coated tablet with “5” debossed on one side.
Ambrisentan Sandoz 10 mg film-coated tablet is a pink, oval film-coated tablet with “10” debossed on one side.
Ambrisentan Sandoz is available as 5 mg and 10 mg film-coated tablets in blister packs of 10 or 30 tablets or single-dose blister packs of 10×1 or 30×1 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer
Chanelle Medical, Dublin Road, H62 FH90 Loughrea, Galway, Ireland
or
Akciju Sabiedriba “Grindeks”, Krustpil data, LV-1057 Riga, Latvia
or
Pharma Pack Hungary Kft, Vasut utca 13, 2040 Budaörs, Hungary
or
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany