Product Information

Varenicline tablets

What is this medicine?

VARENICLINE is a smoking cessation medicine. It is used together with behavior modification and counseling support to help you stop smoking.

What should I discuss with my health care provider before taking varenicline?

To make sure you can safely take varenicline, tell your doctor if you have any of these other conditions:

• heart disease, circulation problems;
• kidney disease (or if you are on dialysis);
• a history of depression or mental illness.

FDA pregnancy category C. It is not known whether varenicline will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether varenicline passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medication to anyone under 18 years old

How should I use this medicine?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

You may choose from 2 ways to use varenicline. Ask your doctor which of the following methods is best for you:

• Set a date to quit smoking and start taking varenicline one week before that date. This will allow the drug to build up in your body.
• You may also start taking varenicline before you set a planned quit date. Once you start taking the medicine, choose a quit date that is between 8 and 35 days after you start treatment.

To improve your chances for successful smoking cessation, be sure to quit smoking on your planned quit date. Take varenicline after eating. Take the medicine with a full glass of water. When you first start taking varenicline, you will take a low dose and then gradually increase your dose over the first several days of treatment. Follow your doctor's dosing instructions very carefully.

In most cases, varenicline treatment lasts for 12 weeks. Your doctor may recommend a second 12-week course of varenicline to improve the chance that you will quit smoking long-term.

Use varenicline regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely. You should remain under the care of a doctor while taking varenicline.

What if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What should I avoid while taking varenicline?

This medication may impair your thinking or reactions. You may also have mood or behavior changes when you quit smoking. Until you know how varenicline and the smoking cessation process are going to affect you, be careful if you drive or do anything that requires you to be cautious and alert.

Do not use other medications to quit smoking while you are taking varenicline, unless your doctor tells you to.

What side effects may I notice from this medicine?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any mood or behavior changes, confusion, anxiety, panic attacks, hallucinations, extreme fear, or if you feel impulsive, agitated, aggressive, restless, hostile, depressed, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Your family or other caregivers should also be alert to changes in your mood or behavior.

Call your doctor at once if you have any of these other serious side effects:

• chest pain or pressure, tight feeling in your neck or jaw, pain spreading to your arm or shoulder, vomiting, sweating, general ill feeling;
• feeling light-headed or short of breath;
• sudden numbness or weakness, especially on one side of the body;
• sudden severe headache, confusion, problems with vision, speech, or balance;
• easy bruising, unusual bleeding, blood in your urine or stools, coughing up blood or vomit that looks like coffee grounds;
• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
• the first sign of any blistering type of skin rash, no matter how mild.

Less serious side effects may include:

• nausea (may persist for several months);
• stomach pain, indigestion, constipation, gas;
• weakness, tired feeling;
• dry mouth, unpleasant taste in your mouth;
• headache;
• sleep problems (insomnia) or unusual dreams.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature away from moisture and heat.

Throw away any unused medicine after the expiration date.