PATIENT INFORMATION

Dispense with Patient Information available at:

www.solcohealthcare.com/druglabeling/nebivolol-tablets.pdf

Nebivolol Tablets

(ne biv′ oh lol)

Read the Patient Information that comes with nebivolol tablets before you start taking it and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. If you have any questions about nebivolol tablets, ask your doctor or pharmacist.

WHAT ARE NEBIVOLOL TABLETS?

Nebivolol tablets are a kind of prescription medicine called a “beta-blocker”. Nebivolol tablets treat:

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High blood pressure (hypertension)

Nebivolol tablets can lower blood pressure when used by itself and with other medicines.

Nebivolol tablets are not approved for children less than 18 years of age.

WHO SHOULD NOT TAKE NEBIVOLOL TABLETS?

Do not take nebivolol tablets if you:

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Have heart failure and are in the ICU or need medicines to keep up your blood circulation

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Have a slow heartbeat or your heart skips beats (irregular heartbeat)

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Have severe liver damage

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Are allergic to any ingredient in nebivolol tablets. The active ingredient is nebivolol. See the end of this leaflet for a list of ingredients.

WHAT SHOULD I TELL MY DOCTOR BEFORE TAKING NEBIVOLOL TABLETS?

Tell your doctor about all of your medical problems, including if you:

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Have asthma or other lung problems (such as bronchitis or emphysema)

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Have problems with blood flow in your feet and legs (peripheral vascular disease) Nebivolol tablets can make symptoms of blood flow problems worse.

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Have diabetes and take medicine to control blood sugar

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Have thyroid problems

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Have liver or kidney problems

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Had allergic reactions to medications or have allergies

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Have a condition called pheochromocytoma

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Are pregnant or trying to become pregnant. It is not known if nebivolol tablets are safe for your unborn baby. Talk with your doctor about the best way to treat high blood pressure while you are pregnant.

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Are breastfeeding. It is not known if nebivolol passes into your breast milk. You should not breastfeed while using nebivolol tablets.

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Are scheduled for surgery and will be given anesthetic agents

Tell your doctor about all the medicines you take. Include prescription and non-prescription medicines, vitamins, and herbal products. Nebivolol tablets and certain other medicines can affect each other and cause serious side effects.

Keep a list of all the medicines you take. Show this list to your doctor and pharmacist before you start a new medicine.

HOW SHOULD I TAKE NEBIVOLOL TABLETS?

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Do not suddenly stop taking nebivolol tablets. You could have chest pain or a heart attack. If your doctor decides to stop nebivolol tablets, your doctor may slowly lower your dose over time before stopping it completely.

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Take nebivolol tablets every day exactly as your doctor tells you. Your doctor will tell you how many nebivolol tablets to take and how often. Your doctor may start with a low dose and raise it over time.

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Do not stop taking nebivolol tablets or change your dose without talking with your doctor.

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Take nebivolol tablets with or without food.

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If you miss a dose, take your dose as soon as you remember, unless it is close to the time to take your next dose. Do not take 2 doses at the same time. Take your next dose at the usual time.

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If you take too many nebivolol tablets, call your doctor or poison control center right away.

WHAT ARE POSSIBLE SIDE EFFECTS OF NEBIVOLOL TABLETS?

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Low blood pressure and feeling dizzy. If you feel dizzy, sit or lie down and tell your doctor right away.

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Tiredness

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Slow heartbeat

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Headache

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Leg swelling due to fluid retention (edema). Tell your doctor if you gain weight or have trouble breathing while taking nebivolol tablets.

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If you are diabetic or take medicine for high blood sugar or if you have a tendency to have low blood sugar, nebivolol tablets can mask/cover some of the signs and symptoms that would tell you that your blood sugar may be low, like heart palpitations or rapid heart beating. Ask your doctor for other signs that may alert you when having low blood sugar.

Tell your doctor if you have any side effects that bother you or don’t go away.

HOW SHOULD I STORE NEBIVOLOL TABLETS?

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Store nebivolol tablets between 68° to 77°F (20° - 25°C).

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Nebivolol tablets come in a child-resistant package.

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Safely throw away nebivolol tablets that are out of date or no longer needed.

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Keep nebivolol tablets and all medicines out of the reach of children.

GENERAL INFORMATION ABOUT NEBIVOLOL TABLETS

Doctors sometimes prescribe medicines for conditions not included in the patient information leaflets.

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Only use nebivolol tablets for the medical problem it was prescribed for.

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Do not give nebivolol tablets to other people, even if they have the same symptoms. It may harm them.

This leaflet summarizes the most important information about nebivolol tablets. For more information:

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Talk with your doctor.

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Ask your doctor or pharmacist for information about nebivolol tablets that is written for healthcare professionals.

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Please contact Solco Healthcare US, LLC at 1-866-257-2597.

WHAT ARE IN NEBIVOLOL TABLETS?

Active Ingredient: Nebivolol

Inactive Ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80, pregelatinized starch, sodium lauryl sulfate, D&C Red No. 27 Aluminum Lake (10 mg), FD&C Blue No. 2 Aluminum Lake (2.5 mg and 20 mg), and FD&C Yellow No. 6 Aluminum Lake (5 mg)

WHAT IS HIGH BLOOD PRESSURE (HYPERTENSION)?

Blood pressure is the force in your blood vessels when your heart beats and when your heart rests. You have high blood pressure when the force is too great.

High blood pressure makes the heart work harder to pump blood through the body and causes damage to the blood vessels. Nebivolol tablets can help your blood vessels relax so your blood pressure is lower. Medicines that lower your blood pressure lower your chance of having a stroke or heart attack.

Manufactured by:

Zhejiang Huahai Pharmaceutical Co., Ltd.

Xunqiao, Linhai, Zhejiang 317024, China

Distributed by:

Solco Healthcare US, LLC

Somerset, NJ 08873, USA

Revised: 12/2023