Patient Medication Information: uses, side effects, how to take - Sandoz Ambrisentan Tablets
What is Sandoz Ambrisentan Tablets used for?
Sandoz Ambrisentan Tablets is used in adults to treat high blood pressure in the pulmonary arteries. They are blood vessels that carry blood away from the heart to the lungs. Sandoz Ambrisentan Tablets can be used as an initiation therapy in combination with tadalafil.
How does Sandoz Ambrisentan Tablets work?
Sandoz Ambrisentan Tablets is an endothelin receptor antagonist (ERA). It reduces high blood pressure by relaxing the pulmonary arteries. This makes it easier for the heart to pump blood to the lungs.
What are the ingredients in Sandoz Ambrisentan Tablets?
Medicinal ingredients: ambrisentan
Non-medicinal ingredients: Lactose monohydrate, magnesium stearate, microcrystalline cellulose, starch pregelatinised, polyvinyl alcohol, talc, titanium dioxide, polyethylene glycol and Iron Oxide Red.
Sandoz Ambrisentan Tablets comes in the following dosage forms:
5 mg and 10 mg film-coated tablets
Do not use Sandoz Ambrisentan Tablets if:
- You are pregnant, are planning to become pregnant, or could become pregnant because you are not using reliable birth control (see Other warnings you should know about).
- You are breastfeeding or plan to breastfeed your baby.
- You are allergic to ambrisentan or to any of the other ingredients in the tablet (see What the nonmedicinal ingredients are).
- You have liver disease or abnormal liver test results.
Have a lung condition called Idiopathic Pulmonary Fibrosis (IPF). The symptoms of this condition include:
- Shortness of breath
- Dry cough
- Fatigue
- Joint or muscle pain
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Sandoz Ambrisentan Tablets. Talk about any health conditions or problems you may have, including if you:
- have swelling
- have a low amount of red blood cells (anemia)
- have or ever had liver problems
Other warnings you should know about:
Sandoz Ambrisentan Tablets can cause serious side effects, including:
Peripheral edema (swelling of the legs or hands caused by fluid retention): This may happen within weeks after starting Sandoz Ambrisentan Tablets. You are at a higher risk of experiencing it if you:
- take Sandoz Ambrisentan Tablets with tadalafil
- take high doses of Sandoz Ambrisentan Tablets
- are 65 years of age or older
Tell your healthcare professional if you experience swelling in your hands or legs while taking Sandoz Ambrisentan Tablets.
- Anemia (decreased number of red blood cells): This may happen within weeks after starting Sandoz Ambrisentan Tablets. You are at a higher risk of experiencing it if you take Sandoz Ambrisentan Tablets with tadalafil. Tell your healthcare professional if you experience signs of anemia while taking Sandoz Ambrisentan Tablets.
Liver problems: Stop taking Sandoz Ambrisentan Tablets and tell your healthcare professional right away if you experience:
- signs and symptoms of liver problems
- Worsening of liver disease.
- Allergic reactions: Sandoz Ambrisentan Tablets contains ingredients that may cause allergic reactions. If you experience signs of an allergic reaction while taking Sandoz Ambrisentan Tablets, stop taking it and tell your healthcare professional right away.
See the Serious side effects and what to do about them table, below, for more information on these and other serious side effects.
Driving and operating machinery:
- It is not known whether Sandoz Ambrisentan Tablets affects your ability to drive or use machines.
- You should not drive or use machines until you know how Sandoz Ambrisentan Tablets affects you.
- If you ever feel sleepy or unwell, do not drive or use machines, and tell your healthcare professional.
Male fertility:
During animal studies, reduced fertility was observed in male rats taking ambrisentan, the active ingredient in Sandoz Ambrisentan Tablets. If you are a man taking Sandoz Ambrisentan Tablets, it is possible that Sandoz Ambrisentan Tablets may lower your sperm count. Talk to your healthcare professional if you wish to father a child, or have any questions or concerns about this.
Pregnancy:
- Sandoz Ambrisentan Tablets should not be used during pregnancy. Taking it during pregnancy may cause injury to your baby.
- If you are a woman who could become pregnant, your healthcare professional will ask you to take a pregnancy test before you start taking Sandoz Ambrisentan Tablets and regularly while you are taking Sandoz Ambrisentan Tablets.
- Use a highly effective birth control method while taking Sandoz Ambrisentan Tablets. If you discover that you are pregnant while taking Sandoz Ambrisentan Tablets, contact your healthcare professional as soon as possible.
Breastfeeding:
It is not known whether Sandoz Ambrisentan Tablets can pass into breastmilk. Sandoz Ambrisentan Tablets should not be used during breastfeeding.
Children and adolescents (under 18 years of age):
Sandoz Ambrisentan Tablets is not to be used in children and adolescents under 18 years of age.
Laboratory tests and monitoring:
Your healthcare professional will do tests, including blood tests, before you start Sandoz Ambrisentan Tablets and regularly during treatment. These tests will check:
- The amount of red blood cells in your body.
- That your liver is working properly.
- If you are pregnant.
Depending on your test results, your healthcare professional may adjust your dose, stop or discontinue your treatment with Sandoz Ambrisentan Tablets.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with Sandoz Ambrisentan Tablets:
- Cyclosporine A – used to treat certain autoimmune diseases and to prevent rejection of organ transplants
- Sildenafil, tadalafil – used to treat erectile dysfunction or high blood pressure in the lungs
- Ketoconazole – used to treat fungal skin infections
- Digoxin – used to treat heart conditions
How to take Sandoz Ambrisentan Tablets:
Take Sandoz Ambrisentan Tablets:
- exactly as your healthcare professional tells you.
with or without food.
Usual dose:
- The initial dose of Sandoz Ambrisentan Tablets is 5 mg, once a day. Your healthcare professional may decide to increase your dose to 10 mg, once a day.
- If you take Sandoz Ambrisentan Tablets with tadalafil, your healthcare professional will usually start your dose at 5 mg once a day and increase it to 10 mg once a day after 8 weeks.
- The maximum recommended daily dose is 10 mg.
- If you take cyclosporine A, do not take more than 5 mg of Sandoz Ambrisentan Tablets, once per day.
Overdose:
| If you think you, or a person you are caring for, have taken too much Sandoz Ambrisentan Tablets, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
Missed Dose:
If you forget to take a dose of Sandoz Ambrisentan Tablets, take the missed dose as soon as you remember, then continue with the next dose at your usual time. Do not take a double dose to make up for the one that you missed.
What are possible side effects from using Sandoz Ambrisentan Tablets?
These are not all the possible side effects you may have when taking Sandoz Ambrisentan Tablets. If you experience any side effects not listed here, tell your healthcare professional.
If you take Sandoz Ambrisentan Tablets with tadalafil, you may be more likely to experience some of these side effects.
Side effects may include:
- Headache
- Stuffy nose
- Sore throat
- Constipation
- Pain in the abdomen
- Problems with sinuses
- Feeling sick
- Vomiting
- Feeling weak or tired
- Skin rash
- Hot flashes
- Ringing in the ears
- Changes in vision including blurry vision
If any of these affects you severely, tell your healthcare professional.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| VERY COMMON | |||
| Peripheral edema (swelling of the legs or hands caused by fluid retention): swollen or puffy legs or hands, feeling heavy, achy or stiff | √ | ||
| Anemia (decreased number of red blood cells): fatigue, loss of energy, irregular heartbeats, pale complexion, shortness of breath, weakness | √ | ||
| Flushing (redness of the skin) | √ | ||
| Dyspnea (shortness of breath) | √ | ||
| Dizziness | √ | ||
Palpitations: fast and/or irregular heart beat | √ | ||
| COMMON | |||
| Allergic Reaction: difficulty swallowing or breathing, wheezing; drop in blood pressure; feeling sick to your stomach and throwing up; hives or rash; swelling of the face, lips, tongue or throat | √ | ||
| RARE | |||
| Liver Problems: yellowing of your skin and eyes (jaundice), right upper stomach area pain or swelling, nausea or vomiting, unusual dark urine, unusual tiredness, loss of appetite | √ | ||
| UNKNOWN | |||
| Heart Failure (heart does not pump blood as well as it should): shortness of breath, fatigue and weakness, swelling in ankles, legs and feet, cough, fluid retention, lack of appetite, nausea, rapid or irregular | √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
|---|
| Only if severe | In all cases |
|---|---|
| heartbeat, reduced ability to exercise | |
| Hypotension (low blood pressure): dizziness, fainting, light-headedness, blurred vision, nausea, vomiting, fatigue (may occur when you go from lying or sitting to standing up) | |
| √ | |
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
Store between 15-30°C.
Keep out of reach and sight of children.
If you want more information about Sandoz Ambrisentan Tablets:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.sandoz.ca, or by calling 1-800-361-3062.