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10
$
$10 mail-in
rebate inside
Mail-In
Rebate
This rebate is provided to help with the cost of
your medication.
My physician’s instructions:
• Cleanse _________________________________
________________________________________
• Medicate ________________________________
What you should know
about ROSACEA.
________________________________________
• Moisturize _______________________________
________________________________________
• Protect __________________________________
Look forward to clearer skin and a $10.00 refund
on your next MetroGel® 1% prescription. Just
send in this coupon with your pharmacy receipt,
and we’ll send you a check for $10.00.
This rebate may not be reproduced without written consent. See reverse side for redemption
information. Please allow 3 to 4 weeks for delivery. Rebate offer valid until 12/31/06.
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The powerful one.
________________________________________
• Other ___________________________________
________________________________________
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©2005 Galderma Laboratories,
L.P. Tri-Luma and Galderma are registered trademarks.
This offer may not
be reproduced without written consent.
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DERMATOLOGISTS RECOMMEND
CETAPHIL® CLEANSERS AND MOISTURIZERS
1
$
00
off any Cetaphil® product
,
The powerful one.
MANUFACTURER’S COUPON
EXPIRES 12/31/06
join the cetaphil ® skin care club– www.mycetaphil.com
MetroGel, Cetaphil, and Galderma are registered trademarks.
HSA-3 is a trademark of Galderma.
©2006 Galderma Laboratories, L.P.
Galderma Laboratories, L.P.
14501 N. Freeway
Fort Worth, TX 76177
MET-558 Printed in USA 12/05
,
The powerful one.
www.metrogel.com
Pimples
What is
rosacea?
Rosacea (pronounced rose-AY-shah)
is a condition that mostly affects
the skin of the face—usually in the
area where people blush. There are
a number of symptoms, ranging
from mild to more severe, as you
will see from the following list:
As a result of continual flushing, the skin
eventually becomes irritated and inflamed,
and pimples may appear on the face. These
pimples may be papules (small, red, and solid)
or pustules (pus-filled, like teenage acne).
Moderate
Broken or enlarged blood vessels
Doctors call this telangiectasia (tell-an-jek-TAZEyah). When people with rosacea flush, the
small blood vessels of the face get larger—
eventually showing through the skin. They
may appear as spots or as thin wavy lines.
Mild
Redness
This can look like
nothing more than
a blush or a sunburn. It’s caused
by flushing (when
a large amount of
blood rushes to
the blood vessels
just under the skin,
and the vessels
expand to handle
the flow). Over
time, the redness
does not go away.
2
Mild
Moderate
3
Rosacea is a chronic condition, which means
the symptoms may come and go in cycles and
fluctuate in their degree of severity. Many
people mistake their rosacea for things like
sunburn, windburn, a complexion change,
or acne, and don’t bother to see a doctor.
However, the earlier you see a dermatologist,
the quicker your rosacea can be brought
under control.
Moderate to severe
Enlarged, bumpy nose
This condition is
called rhinophyma
(rhy-no-FYE-muh),
and is present
in the more
advanced stages
of rosacea—
especially in men.
When rosacea
isn’t treated early,
small, knobby
bumps may
gradually appear
on the nose,
giving it a swollen
appearance.
Who gets rosacea?
Rosacea is usually seen in adults. It can affect
those in their 30s to people in their 70s and 80s,
as well as people of all skin colors and skin
types. Most people who get rosacea seem to
flush or blush more often than the average
person and may have parents or grandparents
who have the same symptoms.
Treatment
Beginning treatment usually consists of an oral
and a topical medication. You may see results in
the first few weeks, although full results usually
take up to 12 weeks.
Moderate to severe
How does it start, and
how does it progress?
Although 85% of patients with rosacea stop
using their medication after 3 months, a clinical
study showed that nearly one fourth of patients
relapsed within the first few days. Sixty percent
relapsed within the first 6 months. That’s why
this incurable, chronic condition requires
ongoing control.
The first sign of rosacea is usually rosy
cheeks. As it progresses, the face may get red
in patches and stay red for hours or days at a
time, and eventually, the redness doesn’t go
away at all.
4
5
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Topical medication
Your dermatologist will recommend the right
care for your symptoms. One medication
that may be prescribed for you is the newest
prescription product available for rosacea,
called MetroGel® 1%. It’s the most powerful
strength of metronidazole you can get.
Its exclusive formulation contains HSA-3™, a
combination of ingredients including betadex,
niacinamide (vitamin B3), and propylene glycol.
In a 92% water-based gel, these ingredients
work together to help moisturize your skin while
enhancing the absorption of the medicine. The
result is a smooth, silky texture that feels gentle
on your face.
MetroGel® 1% is also convenient. You need to
use it just once a day, so it’s easy to remember,
and the smooth gel formulation makes it easy
to apply.
MetroGel® 1% contains no alcohol to dry your
skin the way other products can. And even
though some products have ingredients that
can damage the outer layer of your tender skin,
MetroGel® 1% has been proven to not damage
the outer layer of skin and to not cause the skin
to lose moisture. For more information about
MetroGel® 1%, visit www.metrogel.com.
The following adverse experiences have been
reported with the topical use of metronidazole:
burning, skin irritation, dryness, transient
redness, metallic taste, tingling or numbness
of extremities, and nausea.
Before treatment
Oral medication
Capsules or tablets are taken by mouth, usually
once or twice a day. Some of these may have
special treatment instructions, so ask your
doctor or pharmacist about them.
A clinical study showed that patients who
used both an oral antibiotic and a topical
metronidazole-based medication were able
to effectively control their rosacea.
After 5 weeks with MetroGel® 1%
6
Please see brief summary of Prescribing Information on pages 14 and 15.
,
The powerful one.
7
Daily care
Makeup
Following a regular cleansing and medication
routine—once a day or as prescribed by your
doctor—will make treatment easier and more
successful. How and what you use to cleanse
and moisturize your face is also important.
Here are some simple steps to follow:
While you are in the process of getting your
symptoms under control and afterwards,
makeup can help hide your rosacea. Oil-free
foundations with yellow (not pink) undertones
are recommended, as are special green-tone
products specifically designed to be worn under
foundation to disguise facial redness. Yellowtone cover-ups are available from many brands.
Step 1: Cleanse gently with a very mild
cleanser. Avoid products that contain alcohol or
other irritants. Dermatologists often recommend
Cetaphil® Gentle Skin Cleanser, a gentle soapless
product available at most drugstores. It does
an excellent job of cleaning without irritating.
Step 2: Medicate according to your
dermatologist’s instructions.
Step 3: Moisturize with a good-quality,
“noncomedogenic” (meaning it won’t clog
pores) moisturizer as needed. If your treatment
includes a topical medication, you can usually
apply the moisturizer after the medication has
dried. The Cetaphil® product line also includes
a moisturizer, available in both lotion and
cream forms, that is specially designed for
sensitive skin.
In addition, MetroGel® 1% with HSA-3™ has
an exclusive combination of ingredients that
moisturizes your skin while delivering effective
medicine.
Step 4: Protect with a sunscreen of
SPF 15 or higher, even on cloudy days. Look
for a noncomedogenic product that does not
contain alcohol. Cetaphil® Daily Facial Moisturizer with SPF 15 is an excellent choice.
Maintenance
Since rosacea can’t be cured, once your symptoms have cleared up, you will need to continue
using your MetroGel® 1% daily to keep your
clearer, healthier look. Without this regular
therapy, your symptoms may return and
possibly get worse over time.
Keeping your skin clear will take some dedication on your part. Once you have started
to enjoy the results, adding treatment with
MetroGel® 1% to your daily routine won’t seem
like any problem at all. Also, be sure to refill
your prescription regularly so you can continue
your therapy and maintain your good results.
,
8
Please see brief summary of Prescribing Information on pages 14 and 15.
The powerful one.
9
www.metrogel.com
Avoid rosacea triggers
The chart to the right provides a list of things
that can aggravate your rosacea symptoms. It
is unlikely that you will react to them all, but by
being observant you can discover which ones
apply to you and help avoid future flare-ups.
Weather
Sun
Cold
Emotional influences
Stress
You may need to experiment to determine all
of your own personal triggers. You may find it
helpful to keep a daily diary of your food consumption and activities to get a better idea of
what causes your episodes of flushing. Once
you have identified your own triggers, try
staying away from them for a few days. If you
notice a reduction in the frequency and severity
of your flare-ups, you have probably identified
what you should avoid to help keep your
rosacea under control.
A conversation with all of your doctors, in
addition to your dermatologist, may also be
in order, especially if they have prescribed
medication for any other medical conditions
you may have.
Strong winds
Humidity
Anxiety
Temperature-related
Saunas and hot baths
Simple overheating
Excessively warm environments
Physical exertion
Exercise
“Lift and load” jobs
Skin care products
Some cosmetics and hair sprays, especially those
containing alcohol, witch hazel, or fragrances
Topical steroids
Any substance that causes redness or stinging
Beverages
Alcohol, especially red wine, beer, bourbon, gin,
vodka, or champagne
Hot drinks, including hot cider, hot chocolate,
coffee, or tea
Foods
Liver
Chocolate or vanilla
Soy sauce and vinegars
Vegetables, including eggplant, spinach, lima and
navy beans, and peas
Dairy products, including yogurt, sour cream, and
some cheeses
Fruits, including avocados, tomatoes, bananas,
red plums, raisins, figs, and citrus fruits
Hot and spicy foods
10
11
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Call
THE
3 ways you can enroll today in the
Best Face Forward® Program
1-800-273-2091
Visit
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PROGRAM
A complimentary educational program
to help you live better with rosacea
Visit
www.metrogel.com
Fill out
®
Best Face Forward is a free program created
with the advice and input of dermatologists and
their patients with rosacea. You’re eligible to
enroll at no cost and receive all the information
and money-saving coupons it offers.
The Best Face Forward® Program includes:
• Informative newsletters about rosacea with
medical news, practical advice, cosmetic tips,
and personal stories from people with rosacea
• Money-saving coupons, rebates, and special
offers
attached reply card and mail
“Through your newsletter, I’ve learned how
to care for my skin. And knowing names of
helpful products saves me time and trying
to figure it out on my own.”
– Flora B., Kenner, LA
“Finally keeping my rosacea under control
makes a world of difference in how I look
and feel every day.”
– Maureen B., Avon, CT
“Before using MetroGel®, my face stayed so
red, bumpy, and itchy. I just love the feel of
my face now—it’s so soft and feels great.”
– Judy F., Beckley, WV
12
13
Infections and infestations
Bronchitis
Influenza
Nasopharyngitis
System
Organ Class/Preferred Term
Sinusitis
,
BRIEF SUMMARY
Rx Only
For topical use only. Not for oral, ophthalmic or intravaginal use.
INDICATIONS AND USAGE
METROGEL® (metronidazole gel), 1% is indicated for the topical treatment of inflammatory lesions of rosacea.
CONTRAINDICATIONS
METROGEL® (metronidazole gel), 1% is contraindicated in those patients with a history of hypersensitivity
to metronidazole or to any other ingredient in this formulation.
PRECAUTIONS
General: Topical metronidazole has been reported to cause tearing of the eyes. Therefore, contact with the
eyes should be avoided. If a reaction suggesting local skin irritation occurs, patients should be directed to
use the medication less often or discontinue use. Metronidazole is a nitroimidazole and should be used with
care in patients with evidence of, or history of, blood dyscrasia.
Information for Patients: Patients using METROGEL® (metronidazole gel), 1% should receive the following
information and instructions:
1. This medication is to be used as directed.
2. It is for external use only.
3. Avoid contact with the eyes.
4. Cleanse affected area(s) before applying METROGEL® (metronidazole gel), 1%.
5. This medication should not be used for any other condition than that for which it is prescribed.
6. Patients should report any adverse reaction to their physicians.
Drug Interaction: Oral metronidazole has been reported to potentiate the anticoagulant effect of coumarin
and warfarin, resulting in a prolongation of prothrombin time. Drug interactions should be kept in mind when
METROGEL® (metronidazole gel), 1% is prescribed for patients who are receiving anticoagulant treatment,
although they are less likely to occur with topical metronidazole administration because of low absorption.
Carcinogenesis, Mutagenesis and Impairment of Fertility: Metronidazole has shown evidence of carcinogenic
activity in a number of studies involving chronic, oral administration in mice and rats, but not in studies
involving hamsters.
In several long-term studies in mice, oral doses of approximately 225 mg/m2/day or greater (approximately
37 times the human topical dose on a mg/m2 basis) were associated with an increase in pulmonary tumors
and lymphomas. Several long-term oral studies in the rat have shown statistically significant increases in
mammary and hepatic tumors at doses >885 mg/m2/day (144 times the human dose).
Metronidazole has shown evidence of mutagenic activity in several in vitro bacterial assay systems. In addition,
a dose-related increase in the frequency of micronuclei was observed in mice after intraperitoneal injections.
An increase in chromosomal aberrations in peripheral blood lymphocytes was reported in patients with
Crohn’s disease who were treated with 200 to 1200 mg/day of metronidazole for 1 to 24 months. However,
in another study, no increase in chromosomal aberrations in circulating lymphocytes was observed in
patients with Crohn’s disease treated with the drug for 8 months.
In one published study, using albino hairless mice, intraperitoneal administration of metronidazole at a dose
of 45 mg/m2/day (approximately 7 times the human topical dose on a mg/m2 basis) was associated with an
increase in ultraviolet radiation-induced skin carcinogenesis. Neither dermal carcinogenicity nor photocarcinogenicity studies have been performed with METROGEL® (metronidazole gel), 1% or any marketed
metronidazole formulations.
Pregnancy: Teratogenic Effects: Pregnancy Category B. There are no adequate and well-controlled studies
with the use of METROGEL® (metronidazole gel), 1% in pregnant women.
Metronidazole crosses the placental barrier and enters the fetal circulation rapidly. No fetotoxicity was
observed after oral administration of metronidazole in rats or mice at 200 and 20 times, respectively, the
expected clinical dose. However, oral metronidazole has shown carcinogenic activity in rodents. Because animal
reproduction studies are not always predictive of human response, METROGEL® (metronidazole gel), 1%
should be used during pregnancy only if clearly needed.
Nursing Mothers: After oral administration, metronidazole is secreted in breast milk in concentrations similar
to those found in the plasma. Even though blood levels taken after topical metronidazole application are
significantly lower than those achieved after oral metronidazole, a decision should be made whether to
discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother
and the risk to the infant.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Geriatric Use: While specific clinical trials in the geriatric population have not been conducted, sixty-six
patients aged 65 years and older treated with METROGEL® (metronidazole gel), 1% over ten weeks showed
comparable safety and efficacy as compared to the general study population.
ADVERSE REACTIONS
In a controlled clinical trial, 557 patients used METROGEL® (metronidazole gel), 1% and 189 patients used
the gel vehicle once daily. The following table summarizes adverse reactions that occur at a rate of >1% in the
clinical trials:
28 (14.8)
76 (13.6)
3 (1.6)
6 (1.1)
1 (0.5)
8 (1.4)
8 (4.2)
17 (3.1)
Metronidazole
(1.6)
8 (1.4) Gel, 1% Gel3 Vehicle
N=189
N=557
Upper respiratory tract infection
4 (2.1)
14 (2.5)
Patients
with
at infection
least one AE (Number % of patients)
511 (27.0)
186
(33.4)
Urinary
tract
(0.5)
6 (1.1)
Infections
and infestations
282 (14.8)
761 (13.6)
Vaginal mycosis
(1.1)
(0.2)
Bronchitis
6 (1.1)
Musculoskeletal
and connective tissue disorders
53 (1.6)
(2.6)
19
(3.4)
Influenza
12 (0.5)
83 (1.4)
Back pain
(1.1)
(0.5)
Nasopharyngitis
17
(3.1)
Neoplasms
28 (4.2)
(1.1)
4 (0.7)
Sinusitis
32 (1.6)
81 (1.4)
Basal cell carcinoma
(1.1)
(0.2)
Upper respiratory
tract infection
14 (2.5)
Nervous
system disorders
(1.6)
34 (2.1)
(3.2)
18
Urinary
tract infection
1 (0.5)
6 (1.1)
Headache
12
(2.2)
Vaginal mycosis
1 (0.2)
Respiratory,
thoracic and mediastinal disorders
52 (1.1)
(2.6)
22
(3.9)
Musculoskeletal
and connective tissue disorders
53 (2.6)
19
(3.4)
Nasal congestion
(1.6)
6 (1.1)
Back
2 (1.1)
3 (0.5)
Skin
andpain
subcutaneous tissue disorders
12
(6.3)
36
(6.5)
Neoplasms
21 (1.1)
47 (0.7)
Contact dermatitis
(0.5)
(1.3)
Basal
cell carcinoma
23 (1.1)
16 (0.2)
Dry skin
(1.6)
(1.1)
Nervous
disorders
31 (1.6)
18
(3.2)
Vascular system
disorders
(0.5)
8 (1.4)
Headache
1 (0.5)
12
(2.2)
Hypertension
6 (1.1)
Respiratory, thoracic and mediastinal disorders
5 (2.6)
22 (3.9)
Nasal congestion
3 (1.6)
6 (1.1)
Skin and subcutaneous tissue disorders
12 (6.3)
36 (6.5)
Contact dermatitis
1 (0.5)
7 (1.3)
Dry skin
3 (1.6)
6 (1.1)
Vascular disorders
1 (0.5)
8 (1.4)
Hypertension
1 (0.5)
6 (1.1)
MetroGel® (metronidazole gel), 1%
Mail-In Rebate Offer
Submit:
This rebate certificate along with your dated pharmacy receipt.
Circle purchase price and prescription number on receipt.
Send to:
Galderma Laboratories, L.P., c/o Beechwood Associates, Inc.
P.O. Box 1190
Morrisville, NC 27560
Receive:
$10.00 refund check
Rebates are not valid for prescriptions reimbursed under a federally funded health care program, including
Medicare or Medicaid as well as similar state programs, including any state medical assistance programs.
Offer void where prohibited by law, taxed, or restricted. Offer good only in USA. Void in Minnesota,
Massachusetts, Michigan, and Rhode Island, except for prescriptions that are not reimbursed by any thirdparty payer. Manufacturer reserves the right to rescind, revoke, or amend this offer without notice.
By my signature below, I certify that I am not being reimbursed for this product by Medicare or Medicaid,
any other federal or state program, including any state pharmaceutical assistance program or any other thirdparty payers. I also understand that I am responsible for any reporting or other requirements with respect to
receipt of this rebate.
Name (please print) ________________________________________________
Address ______________________________________________________
City ___________________________________ State _____ ZIP _________
E-mail _______________________________________________________
The following table summarizes the highest scores of local cutaneous signs and symptoms of irritation that
were worse than baseline:
Physician’s name _______________________________________________
Metronidazole Gel, 1% Gel Vehicle
Sign/Symptom
N=184
N=544
Dryness
63 (34.2)
138 (25.4)
Mild
41 (22.3)
93 (17.1)
Moderate
20 (10.9)
42 (7.7)
Severe
2 (1.1)
3 (0.6)
Scaling
60 (32.6)
134 (24.6)
Metronidazole
Mild
32 Vehicle
(17.4)
88 (16.2)Gel, 1% Gel
Sign/Symptom
N=184
N=544
Moderate
27
(14.7)
43 (7.9)
Dryness
631 (34.2)
138
(25.4)
Severe
(0.5)
3 (0.6)
Mild
41 (22.3)
93 (17.1)
Pruritus
35
(19.0)
86
(15.8)
Moderate
20
42
Mild
21 (10.9)
(11.4)
53 (7.7)
(9.7)
Severe
2 (1.1)
3 (0.6)
Moderate
13
(7.1)
27
(5.0)
Scaling
601 (32.6)
134
(24.6)
Severe
(0.5)
6 (1.1)
Mild
32 (17.4)
88 (16.2)
Stinging/burning
28
(15.2)
56
(10.3)
Moderate
27
43
Mild
18(14.7)
(9.8)
39 (7.9)
(7.2)
Severe
19 (0.5)
37 (0.6)
Moderate
(4.9)
(1.3)
Pruritus
351 (19.0)
86
Severe
(0.5)
10(15.8)
(1.8)
Mild
21 (11.4)
53 (9.7)
The following additional adverse experiences have been reported with the topical use of metronidazole: skin
Moderate
27 (5.0)
irritation, transient redness, metallic taste, tingling or numbness of extremities,
and nausea. 13 (7.1)
Severe There are no reported human experiences with overdosage
1 (0.5)
6 (1.1)
OVERDOSAGE:
of METROGEL® (metronidazole
Stinging/burning
28 (15.2)
56 (10.3)
gel),
1%. Topically applied metronidazole can be absorbed in sufficient amount
to produce systemic
effects.
DOSAGE
before
METROGEL
MildAND ADMINISTRATION: Areas to be treated should be cleansed39
(9.8) ®
(7.2)application of 18
®
(metronidazole
daily to
Moderategel), 1%. Apply and rub in a thin film of METROGEL (metronidazole
9 (4.9)
7 (1.3) gel), 1% once
entire affected area(s). Patients may use cosmetics after application of METROGEL® (metronidazole gel), 1%.
Severe
1 (0.5)
10 (1.8)
®
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I have complied with all the terms of this offer.
____________________________________________________________
Signature (must be signed in order to be valid)
MetroGel and Galderma are registered trademarks. ©2006 Galderma Laboratories, L.P.
Galderma Laboratories, L.P., 14501 N. Freeway, Fort Worth, TX 76177 MET-558 Printed in USA
Save $1.00
on Cetaphil® cleansers or moisturizers (any size)
HOW SUPPLIED: METROGEL (metronidazole gel), 1% is available in a 45-gram tube.
45 gram tube – NDC 0299-3820-45
Keep out of the reach of children.
Storage Conditions: Store at controlled room temperature: 20˚ to 25˚C (68˚ to 77˚F), excursions permitted
between 59˚ and 86˚F (15˚-30˚C).
Prescribing Information as of June 2005.
Rx Only
US Patent No. 6,881,726
Marketed by:
Manufactured by:
Galderma Production Canada Inc.
Galderma Laboratories, L.P.
Montreal, QC H9X 3N7 Canada
Fort Worth, Texas 76177 USA
P50696-0 0705
Made in Canada.
www.metrogel.com
CONSUMER: Limit one coupon per item purchased. This coupon good only on product indicated.
DEALER: We will reimburse you face value plus 8¢ if submitted in compliance with Galderma Laboratories
Manufacturer’s Coupon Redemption Policy dated 10/92, available upon request. Consumer must pay sales tax.
Good only in USA. Send coupons to Galderma Laboratories, L.P., CMS Department 00020, 1 Fawcett Drive,
Del Rio, TX 78840. Cash value 1/20¢.
Void where prohibited or restricted.
60729
Cetaphil and Galderma are
registered trademarks.
© 2006 Galderma Laboratories, L.P.
5
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12/05
15
00299 31076
MANUFACTURER’S COUPON
2
(8100)3 60729
EXPIRES 12/31/06