lansoprazole

Perrigo New York Inc

Perrigo Lansoprazole Delayed-Release Capsules, 15 mg Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each capsule)
• Purpose
• lansoprazole Uses
• Warnings
  • Do not use
  • Ask a doctor before use if you have
  • Ask a doctor or pharmacist before use if you are taking
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding,
  • Keep out of reach of children.
• Directions
  • lansoprazole Other information
• Inactive ingredients
  • Consumer Information
• Package/Label Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient (in each capsule)

Lansoprazole 15 mg

Purpose

Acid reducer

lansoprazole Uses

• •treats frequent heartburn (occurs 2 or more days a week)
• •not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

Warnings

Allergy alert: Do not use if you are allergic to lansoprazole

Do not use

• •if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.

Ask a doctor before use if you have

• •liver disease
• •had heartburn over 3 months. This may be a sign of a more serious condition.
• •heartburn with lightheadedness, sweating or dizziness
• •chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
• •frequent chest pain
• •frequent wheezing, particularly with heartburn
• •unexplained weight loss
• •nausea or vomiting
• •stomach pain

Ask a doctor or pharmacist before use if you are taking

• •warfarin (blood-thinning medicine)
• •prescription antifungal or anti-yeast medicines
• •digoxin (heart medicine)
• •theophylline (asthma medicine)
• •tacrolimus (immune system medicine)
• •atazanavir (medicine for HIV infection)

Stop use and ask a doctor if

• •your heartburn continues or worsens
• •you need to take this product for more than 14 days
• •you need to take more than 1 course of treatment every 4 months
• •you get diarrhea

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

• •adults 18 years of age and older
• •this product is to be used once a day (every 24 hours), every day for 14 days
• •it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours

14-Day Course of Treatment

• •swallow 1 capsule with a glass of water before eating in the morning
• •take every day for 14 days
• •do not take more than 1 capsule a day
• •swallow whole. Do not crush or chew capsules.
• •do not use for more than 14 days unless directed by your doctor

Repeated 14-Day Courses (if needed)

• •you may repeat a 14-day course every 4 months
• •do not take for more than 14 days or more often than every 4 months unless directed by a doctor
• •children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition.

Other information

• •read the directions, warnings and package insert before use
• •keep the carton and package insert. They contain important information.
• •store at 20-25˚C (68-77˚F)
• •keep product out of high heat and humidity
• •protect product from moisture

Inactive ingredients

D&C red no. 28, D&C yellow no. 10, FD&C blue no. 1, gelatin, hypromellose, low substituted hydroxypropyl cellulose, mannitol, meglumine, methacrylic acid copolymer, pharmaceutical ink, polyethylene glycol, polysorbate 80, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide

1-800-719-9260

Consumer Information

Lansoprazole Delayed-Release Capsules 15 mg

Acid Reducer

• May take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours

Please read the entire package insert before taking Lansoprazole Delayed-Release Capsules 15 mg.

Save for future reference.

How Lansoprazole Delayed-Release Capsules 15 mg Treats Your Frequent Heartburn

Lansoprazole Delayed-Release Capsules 15 mg stops acid production at the source – the pumps that release acid into the stomach. Lansoprazole Delayed-Release Capsules 15 mg is taken once a day (every 24 hours), every day for 14 days.

What You Can Expect When Taking Lansoprazole Delayed-Release Capsules 15 mg

Frequent heartburn can occur anytime during the 24-hour period (day or night). Take Lansoprazole Delayed-Release Capsules 15 mg in the morning before eating. Lansoprazole Delayed-Release Capsules 15 mg is clinically proven to treat frequent heartburn. Although some people get complete relief of symptoms within 24 hours, it may take 1 to 4 days for full effect. Make sure you take Lansoprazole Delayed-Release Capsules 15 mg every day for 14 days to treat your frequent heartburn.

Who Should Take Lansoprazole Delayed-Release Capsules 15 mg

Adults (18 years and older) with frequent heartburn – when you have heartburn 2 or more days a week.

Who Should NOT Take Lansoprazole Delayed-Release Capsules 15 mg

People who have one episode of heartburn a week or less, or who want immediate relief of heartburn.

How to Take Lansoprazole Delayed-Release Capsules 15 mg

14-DAY Course of Treatment

• •Swallow 1 capsule with a glass of water before eating in the morning.
• •Take every day for 14 days.
• •Do not take more than 1 capsule a day.
• •Swallow whole. Do not crush or chew capsules.
• •Do not use for more than 14 days unless directed by your doctor.

When to Take Lansoprazole Delayed-Release Capsules 15 mg Again

You may repeat a 14-day course of therapy every 4 months.

When to Talk to Your Doctor

Do not take for more than 14 days or more often than every 4 months unless directed by a doctor.

Warnings and When to Ask Your Doctor

Allergy alert: Do not use if you are allergic to lansoprazole

Do not use

• •if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.

Ask a doctor before use if you have

• •liver disease
• •had heartburn over 3 months. This may be a sign of a more serious condition.
• •heartburn with lightheadedness, sweating or dizziness
• •chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
• •frequent chest pain
• •frequent wheezing, particularly with heartburn
• •unexplained weight loss
• •nausea or vomiting
• •stomach pain

Ask a doctor or pharmacist before use if you are taking

• •warfarin (blood-thinning medicine)
• •prescription antifungal or anti-yeast medicines
• •digoxin (heart medicine)
• •theophylline (asthma medicine)
• •tacrolimus (immune system medicine)
• •atazanavir (medicine for HIV infection)

Stop use and ask a doctor if

• •your heartburn continues or worsens
• •you need to take this product for more than 14 days
• •you need to take more than 1 course of treatment every 4 months
• •you get diarrhea

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Tips for Managing Heartburn

• •Avoid foods or drinks that are more likely to cause heartburn, such as rich, spicy, fatty and fried foods, chocolate, caffeine, alcohol and even some acidic fruits and vegetables.
• •Eat slowly and do not eat big meals.
• •Do not eat late at night or just before bedtime.
• •Do not lie flat or bend over soon after eating.
• •Raise the head of your bed.
• •Wear loose-fitting clothing around your stomach.
• •If you are overweight, lose weight.
• •If you smoke, quit smoking.

Clinical studies prove Lansoprazole Delayed-Release Capsules 15 mg effectively treats frequent heartburn

In three clinical studies, Lansoprazole Delayed-Release Capsules 15 mg was shown to be significantly better than placebo in treating frequent heartburn.

How Lansoprazole Delayed-Release Capsules 15 mg is Sold

Lansoprazole Delayed-Release Capsules 15 mg is available in 14 capsule, 28 capsule and 42 capsule sizes. These sizes contain one, two and three 14-day courses of treatment, respectively. Do not use for more than 14 days in a row unless directed by your doctor. For the 28 count (two 14-day courses) and the 42 count (three 14-day courses), you may repeat a 14-day course every 4 months.

For Questions or Comments About Lansoprazole Delayed-Release Capsules 15 mg

Call 1-800-719-9260