"The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the marketing of selexipag (Uptravi, Actelion Registration Ltd) for the treatment of adults with pulmonary arterial hypertension (PAH)./"...
(amlodipine and valsartan) Tablets
Read the Patient Information that comes with EXFORGE before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or treatment. If you have any questions about EXFORGE, ask your doctor or pharmacist.
What is the most important information I should know about EXFORGE?
- EXFORGE can cause harm or death to an unborn baby.
- Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant.
- If you get pregnant while taking EXFORGE, tell your doctor right away.
What is EXFORGE?
EXFORGE contains 2 prescription medicines:
- when 1 medicine to lower your high blood pressure is not enough
- as the first medicine to lower high blood pressure if your doctor decides you are likely to need more than 1 medicine.
EXFORGE has not been studied in children under 18 years of age.
What should I tell my doctor before taking EXFORGE?
Tell your doctor about all of your medical conditions, including if you:
- are pregnant or plan to become pregnant. See “What is the most important information I should know about EXFORGE?”
- are breastfeeding or plan to breastfeed. EXFORGE may pass into your milk. Do not breastfeed while you are taking EXFORGE.
- have heart problems
- have liver problems
- have kidney problems
- are vomiting or having a lot of diarrhea
- have ever had a reaction called angioedema, to another blood pressure medicine. Angioedema causes swelling of the face, lips, tongue, throat, and may cause difficulty breathing.
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Some of your other medicines and EXFORGE could affect each other, causing serious side effects.
Especially tell your doctor if you take:
- simvastatin or other cholesterol-lowering medicine
- other medicines for high blood pressure or a heart problem
- water pills (diuretics)
- potassium supplements. Your doctor may check the amount of potassium in your blood periodically.
- a salt substitute. Your doctor may check the amount of potassium in your blood periodically.
- nonsteroidal anti-inflammatory drugs (like ibuprofen or naproxen)
- medicines used to prevent and treat fungal skin infections (such as ketoconazole, itraconazole)
- medicines used to treat bacterial infections (such as clarithromycin, telithromycin)
- certain antibiotics (rifamycin group), a drug used to protect against transplant rejection (cyclosporine) or an antiretroviral drug used to treat HIV/AIDS infection (ritonavir). These drugs may increase the effect of valsartan.
- lithium, a medicine used in some types of depression
Know the medicines you take. Keep a list of your medicines and show it to your doctor or pharmacist when you get a new medicine. Talk to your doctor or pharmacist before you start taking any new medicine. Your doctor or pharmacist will know what medicines are safe to take together.
How should I take EXFORGE?
- Take EXFORGE exactly as your doctor tells you.
- Take EXFORGE once each day.
- EXFORGE can be taken with or without food.
- If you miss a dose, take it as soon as you remember. If it is close to your next dose, do not take the missed dose. Just take the next dose at your regular time.
- If you take too much EXFORGE, call your doctor or Poison Control Center, or go to the emergency room.
- Tell all your doctors or dentist you are taking EXFORGE
- are going to have surgery
- go for kidney dialysis
What should I avoid while taking EXFORGE?
You should not take EXFORGE during pregnancy. See “What is the most important information I should know about EXFORGE?”
What are the possible side effects of EXFORGE?
EXFORGE may cause serious side effects including:
- harm to an unborn baby causing injury and even death. See “What is the most important information I should know about EXFORGE?”
- low blood pressure (hypotension). Low blood
pressure is most likely to happen if you:
- take water pills
- are on a low-salt diet
- get dialysis treatments
- have heart problems
- get sick with vomiting or diarrhea
- drink alcohol
Lie down if you feel faint or dizzy. Call your doctor right away.
- more heart attacks and chest pain (angina) in people that already have severe heart problems. This may happen when you start EXFORGE or when there is an increase in your dose of EXFORGE. Get emergency help if you get worse chest pain or chest pain that does not go away.
- kidney problems. Kidney problems may become worse in people that already have kidney disease. Some people will have changes in blood tests for kidney function and may need a lower dose of EXFORGE. Call your doctor if you have swelling in your feet, ankles, or hands or unexplained weight gain. If you have heart failure, your doctor should check your kidney function before prescribing EXFORGE.
- laboratory blood test changes in people with heart failure. Some people with heart failure who take valsartan, 1 of the medicines in EXFORGE, have changes in blood tests including increased potassium and decreased kidney function.
The most common side effects of EXFORGE include:
- swelling (edema) of the hands, ankles, or feet
- nasal congestion, sore throat, and discomfort when swallowing
- upper respiratory tract infection (head or chest cold)
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of EXFORGE. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store EXFORGE?
- Store EXFORGE at room temperature between 59°F to 86°F (15°C to 30°C).
- Keep EXFORGE dry (protect it from moisture).
Keep EXFORGE and all medicines out of the reach of children.
General Information about EXFORGE
Medicines are sometimes prescribed for conditions that are not mentioned in the patient information leaflet. Do not use EXFORGE for a condition for which it was not prescribed. Do not give EXFORGE to other people, even if they have the same symptoms that you have. It may harm them.
This patient information leaflet summarizes the most important information about EXFORGE. If you would like more information about EXFORGE, talk with your doctor. You can ask your doctor or pharmacist for information about EXFORGE that is written for health professionals. For more information go to www.EXFORGE.com or call 1-888-839-3674.
What are the ingredients in EXFORGE?
Active ingredients: Amlodipine besylate and valsartan
The inactive ingredients of all strengths of the tablets are colloidal silicon dioxide, crospovidone, magnesium stearate, and microcrystalline cellulose. Additionally, the 5/320 mg and 10/320 mg strengths contain iron oxide yellow and sodium starch glycolate. The film coating contains hypromellose, iron oxides, polyethylene glycol, talc, and titanium dioxide.
What is high blood pressure (hypertension)?
Blood pressure is the force of blood in your blood vessels when your heart beats and when your heart rests. You have high blood pressure when the force is too much. EXFORGE can help your blood vessels relax so your blood pressure is lower. Medicines that lower blood pressure lower your chance of having a stroke or heart attack.
High blood pressure makes the heart work harder to pump blood throughout the body and causes damage to blood vessels. If high blood pressure is not treated, it can lead to stroke, heart attack, heart failure, kidney failure, and vision problems.
Last reviewed on RxList: 8/14/2015
This monograph has been modified to include the generic and brand name in many instances.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Get tips on handling your hypertension.