"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)./"...
Ziac Consumer (continued)
Dizziness, lightheadedness, tiredness, and drowsiness may occur as your body adjusts to the medication. Nausea, stomach upset, diarrhea, cough, constipation and trouble sleeping may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.
To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
This product may reduce blood flow to your hands and feet, causing them to feel cold. Smoking may worsen this effect. Dress warmly and avoid tobacco use.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
The hydrochlorothiazide in this product may cause too much body water and salts to be lost (dehydration). Tell your doctor immediately if you have any of these unlikely but serious symptoms of dehydration: very dry mouth, extreme thirst, muscle cramps/weakness, fast heartbeat, severe dizziness, unusual decrease in the amount of urine, fainting, seizures.
Tell your doctor immediately if any of these unlikely but serious side effects occur: very slow/irregular heartbeat, swelling of the ankles/feet, sudden/unexplained weight gain, loss of feeling/tingling in the fingers/toes, hair loss, decrease in vision, eye pain, mental/mood changes, decreased sexual ability/interest, muscle/joint pain, persistent nausea/vomiting, yellowing eyes/skin, severe stomach/abdominal pain, dark urine, nervousness, shaking, confusion, easy bruising/bleeding, signs of infection (e.g., fever, persistent sore throat), change in the amount of urine (not including the normal increase in urine when you first start this drug).
Seek immediate medical attention if this rare but very serious side effect occurs: trouble breathing.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Ziac (bisoprolol and hydrochlorothiazide) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to bisoprolol or hydrochlorothiazide; or to other beta blockers (e.g., metoprolol, atenolol); or to other thiazide diuretics (e.g., chlorothiazide); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain types of heart rhythm problems (e.g., sinus bradycardia, second- or third-degree atrioventricular block), certain serious heart conditions (cardiogenic shock, severe heart failure), inability to urinate (anuria).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, heart failure (treated, stable type), lung disease (e.g., asthma, bronchitis, chronic obstructive pulmonary disease-COPD), overactive thyroid (hyperthyroidism), diabetes, gout, untreated salt imbalance (e.g., high calcium, low potassium/magnesium), loss of too much body water (dehydration), blood circulation problems (e.g., peripheral vascular disease), certain muscle diseases (e.g., myasthenia gravis), lupus, recent nerve surgery (e.g., sympathectomy).
Before having surgery, tell your doctor or dentist that you are taking this medication.
This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
Drink plenty of fluids while taking this medication to help prevent dizziness. Too much sweating, diarrhea, or vomiting may cause you to feel lightheaded. Avoid heavy exercise and hot weather. Report prolonged diarrhea or vomiting to your doctor.
If you have diabetes, this product may mask the fast/pounding heartbeat you would usually feel when your blood sugar level falls too low (hypoglycemia). Other symptoms of a low blood sugar level, such as dizziness/sweating, are unaffected by this drug. This product also may make it harder to control your blood sugar levels. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor immediately if you have symptoms of high blood sugar such as increased thirst, hunger, and urination. Your anti-diabetic medication or diet may need to be adjusted.
This medication may reduce the potassium levels in your blood. Ask your doctor about adding potassium to your diet. A potassium supplement may be prescribed by your doctor.
This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.
Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at greater risk for side effects while using this drug.
During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor.
This drug passes into breast milk and could have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.
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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.
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