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LATISSE® (bimatoprost ophthalmic solution) 0.03% Important Information
Approved Use
Important Safety Information
If you use/used prescription products for eye pressure problems, use LATISSE® under doctor care. LATISSE® may cause increased brown pigmentation of the colored part of the eye which is likely permanent. Eyelid skin darkening may occur and may be reversible. Only apply at the base of upper lashes. DO NOT APPLY to lower lid. Hair may grow on skin that LATISSE® frequently touches. If you have eye problems/surgery, consult your doctor about use of LATISSE®. Common side effects are itchy and red eyes. If discontinued, lashes gradually return to previous appearance.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
BOTOX® Cosmetic (onabotulinumtoxinA) Important Information
Approved Use
IMPORTANT SAFETY INFORMATION

BOTOX® Cosmetic may cause serious side effects that can be life threatening. Call your doctor or get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX® Cosmetic:

  • Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months
  • Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice (dysphonia), trouble saying words clearly (dysarthria), loss of bladder control, trouble breathing, trouble swallowing. If this happens, do not drive a car, operate machinery, or do other dangerous activities

The dose of BOTOX® Cosmetic is not the same as, or comparable to, another botulinum toxin product.

There has not been a confirmed serious case of spread of toxin effect when BOTOX® Cosmetic has been used at the recommended dose to treat frown lines.

Serious and/or immediate allergic reactions have been reported. They include: itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Tell your doctor or get medical help right away if you are wheezing or have asthma symptoms, or if you become dizzy or faint.

Do not take BOTOX® Cosmetic if you: are allergic to any of the ingredients in BOTOX® Cosmetic (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); have a skin infection at the planned injection site.

Tell your doctor about all your muscle or nerve conditions, such as amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease), myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including severe dysphagia (difficulty swallowing) and respiratory compromise (difficulty breathing) from typical doses of BOTOX® Cosmetic.

Tell your doctor about all your medical conditions, including: plans to have surgery; had surgery on your face; weakness of forehead muscles, such as trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; are pregnant or plan to become pregnant (it is not known if BOTOX® Cosmetic can harm your unborn baby); are breast-feeding or plan to breast-feed (it is not known if BOTOX® Cosmetic passes into breast milk).

Human albumin and spread of viral diseases. BOTOX® Cosmetic contains albumin, a protein component of human blood. The potential risk of spreading viral diseases [eg Creutzfeldt-Jakob Disease (CJD)] via human serum albumin is extremely rare. No cases of viral diseases or CJD have ever been reported in association with human serum albumin.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal products. Using BOTOX® Cosmetic with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX® Cosmetic in the past.

Especially tell your doctor if you: have received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin, such as Myobloc®, Dysport®, or Xeomin® in the past (be sure your doctor knows exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; or take a sleep medicine.

Other side effects of BOTOX® Cosmetic include: dry mouth, discomfort or pain at the injection site, tiredness, headache, neck pain, and eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, and dry eyes.

For more information refer to the Medication Guide or talk with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see BOTOX® Cosmetic full Product Information, including Boxed Warning and Medication Guide.

Important Natrelle® Breast Implants Safety Information

Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants, Natrelle® Silicone-Filled Breast Implants, and Natrelle® Saline-Filled Breast Implants are indicated for females for breast augmentation and breast reconstruction. Breast augmentation includes primary breast augmentation to increase breast size, as well as revision surgery to correct or improve the result of a breast augmentation surgery. Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to severe breast abnormality, as well as revision surgery to correct or improve the result of a breast reconstruction surgery.

For breast augmentation, Natrelle® 410 Breast Implants and Natrelle® Silicone-Filled Breast Implants are indicated for women at least 22 years old, and Natrelle® Saline-Filled Breast Implants are indicated for women at least 18 years old.

Natrelle® Breast Implants are not for women with active infection, existing cancer or pre-cancer of the breast who have not received adequate treatment for those conditions, or women who are currently pregnant or nursing.

Complications for Natrelle® 410 Breast Implants may include: reoperation, implant removal (with or without replacement), implant rupture, and Baker grade III/IV capsular contracture. Complications for Natrelle® Silicone-Filled Breast Implants may include: reoperation, implant removal (with or without replacement), Baker grade III/IV capsular contracture, implant malposition, and asymmetry. Complications for Natrelle® Saline-Filled Breast Implants may include: reoperation, Baker grade III/IV capsular contracture, implant removal, and implant deflation.

For full Product Information, please visit www.allergan.com or call Allergan Product Support at 1 800-433-8871.

Natrelle® Breast Implants are available by prescription only.

USING LATISSE

WHAT TO EXPECT

Great eyelashes don't just happen overnight. That's why it's important to note that LATISSE® solution works gradually and remarkably — with full results at week 16. Once you begin, you must continue applying the topical solution each night and follow the directions for best results. If you stop using LATISSE® at any time, your eyelashes will return to their previous appearance over several weeks to months.

Set your sights on growth.
As the treatment progresses, you'll first begin to see changes in length. Then, gradually, you'll notice more thickness and darkness in your lashes. If you're satisfied with your results by week 8, don't stop there. Stick with the treatment. After week 16, you'll see the full effect of LATISSE® solution — and so will others. After that, you can talk to your doctor about ongoing use.

Results were proven in our clinical study.
The LATISSE® clinical study was conducted at 16 sites across the country and included 278 participants of varying ages (22 to 78). The study tested LATISSE® solution and a vehicle (or placebo), which was LATISEE® without its active ingredient. Neither patients nor Clinical Investigators knew which group received what treatment. By week 16, the results showed that 78% (107/137) of participants experienced a significant increase in overall eyelash prominence (including elements of length, fullness and darkness), compared to 18% (26/141) for the vehicle group.

Clinical trial results showed lashes were:
25% longer (2% for vehicle)
106% fuller (12% for vehicle)
18% darker (3% for vehicle)

Side effects are possible. Here's what to look out for.
LATISSE® does have some side effects, the most common of which are an itching sensation in the eyes and/or eye redness. These were reported in approximately 4% of patients.

Other less common side effects typically occur on the skin close to where LATISSE® is applied, or in the eyes. These include eyelid skin darkening, eye irritation, dryness of the eyes, and redness of the eyelids. Eyelid skin darkening is a result of increased melanin in the skin, making your eyelid skin look a little darker close to where the solution is applied to the skin. This is expected to reverse after several weeks to months if you decide to stop using the product.

If you're using LATISSE® solution and you develop a new ocular condition or reaction (e.g., trauma or infection), experience a sudden decrease in visual acuity, or need to have eye surgery, be sure to talk to your doctor immediately concerning the continued use of LATISSE®.

For more information, please see our Safety and Real Questions, Real Answers pages.

What to Expect from Week 0 to Week 16
 
LATISSE® (bimatoprost ophthalmic solution) 0.03% Important Information
Approved Use
Important Safety Information
If you use/used prescription products for eye pressure problems, use LATISSE® under doctor care. LATISSE® may cause increased brown pigmentation of the colored part of the eye which is likely permanent. Eyelid skin darkening may occur and may be reversible. Only apply at the base of upper lashes. DO NOT APPLY to lower lid. Hair may grow on skin that LATISSE® frequently touches. If you have eye problems/surgery, consult your doctor about use of LATISSE®. Common side effects are itchy and red eyes. If discontinued, lashes gradually return to previous appearance.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
BOTOX® Cosmetic (onabotulinumtoxinA) Important Information
BOTOX® Cosmetic is a prescription medicine that is injected into the area around the side of the eyes to improve the look of moderate to severe crow's feet lines in adults for a short period of time (temporary).
IMPORTANT SAFETY INFORMATION

BOTOX® Cosmetic may cause serious side effects that can be life threatening. Call your doctor or get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX® Cosmetic:

  • Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months
  • Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice (dysphonia), trouble saying words clearly (dysarthria), loss of bladder control, trouble breathing, trouble swallowing. If this happens, do not drive a car, operate machinery, or do other dangerous activities

The dose of BOTOX® Cosmetic is not the same as, or comparable to, another botulinum toxin product.

There has not been a confirmed serious case of spread of toxin effect when BOTOX® Cosmetic has been used at the recommended dose to treat frown lines or crow's feet lines.

Serious and/or immediate allergic reactions have been reported. They include: itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Tell your doctor or get medical help right away if you are wheezing or have asthma symptoms, or if you become dizzy or faint.

Do not take BOTOX® Cosmetic if you: are allergic to any of the ingredients in BOTOX® Cosmetic (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); have a skin infection at the planned injection site.

Tell your doctor about all your muscle or nerve conditions, such as amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease), myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including severe dysphagia (difficulty swallowing) and respiratory compromise (difficulty breathing) from typical doses of BOTOX® Cosmetic.

Tell your doctor about all your medical conditions, including: plans to have surgery; had surgery on your face; weakness of forehead muscles, such as trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; are pregnant or plan to become pregnant (it is not known if BOTOX® Cosmetic can harm your unborn baby); are breast-feeding or plan to breast-feed (it is not known if BOTOX® Cosmetic passes into breast milk).

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal products. Using BOTOX® Cosmetic with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX® Cosmetic in the past.

Especially tell your doctor if you: have received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin, such as Myobloc®, Dysport®, or Xeomin® in the past (be sure your doctor knows exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; take antiplatelets (aspirin-like products) or anticoagulants (blood thinners).

Other side effects of BOTOX® Cosmetic include: dry mouth, discomfort or pain at the injection site, tiredness, headache, neck pain, and eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, and dry eyes.

For more information refer to the Medication Guide or talk with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see BOTOX® Cosmetic full Product Information, including Boxed Warning and Medication Guide.

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