Do you know those annoying wrinkles between your eyebrows that don't go away? They are called glabellar lines, also known as "frown lines." Clodew is a prescription injectable treatment that temporarily improves the appearance of moderate to severe frown lines in adults.

CLODEW contains the active ingredient botulinum toxin type A.

CLODEW is a prescription medicine that is injected into muscles and used in adults for a short period of time (temporary) to improve the appearance of moderate to severe frown lines between the eyebrows (glabellar lines).

When injected, CLODEW temporarily prevents the nerves from telling facial muscles to flex. The result? In clinical trials, CLODEW has been shown to temporarily improve the appearance of moderate to severe frown lines.

In clinical trials, it has been shown to temporarily improve the appearance of moderate to severe frown lines. In U.S. studies, 68% and 70% of patients who received the treatment had a 2-grade or more improvement in frown lines by day 30, according to physician and patient evaluations. But that’s not all. In a study conducted in Europe and Canada, 54% of patients saw visible results as soon as 2 days after treatment.* And 5 months after treatment, 38% of patients still had visible results.

Do not use CLODEW:

- If you are allergic to botulinum toxin type A or any of the other components of this medicine (listed in section 6);
- If you have myasthenia gravis or Eaton Lambert syndrome (chronic diseases affecting the muscles);
- If you have an infection or inflammation at the proposed injection sites.

If it's your first time receiving a treatment, you might feel a bit nervous, and that's normal! The injection may be associated with localized pain, infection, inflammation, tenderness, swelling, erythema, and/or bleeding/bruising. For specific instructions on what to do before and after the treatment, follow the directions given by your doctor.

Tell your doctor about all your muscle or nerve conditions, such as ALS or Lou Gehrig disease, myasthenia gravis, or Lambert-Eaton syndrome, as you may be at higher risk for serious side effects, including difficulty swallowing and difficulty breathing.

Tell your doctor about all your medical conditions, including: any side effects from botulinum toxin products, including dry eyes; breathing, swallowing, bleeding, or heart problems; plans to undergo surgery; weakness in the muscles of the forehead; drooping eyelids; if you have had surgery on your face; if you are pregnant or breastfeeding, or plan to become pregnant or breastfeed.

Tell your doctor about all the medications you take, including prescription and over-the-counter medicines, vitamins, and dietary supplements.

Be sure to tell your doctor if you have received any other botulinum toxin product in the past and within the last 4 months, and exactly which product you received.

CLODEW unit doses are not interchangeable with those used for other botulinum toxin preparations.

CLODEW should only be injected by doctors with the proper qualifications and experience in treating frown lines between the eyebrows.

CLODEW is injected into the muscles (intramuscularly), directly into the affected area between and above the eyebrows. If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medicines, this medication can cause side effects, although not everyone will experience them.

In general, side effects appear in the first few days after injection and are temporary. Most side effects are mild or moderate in intensity.

If you have any difficulty breathing, swallowing, or speaking after receiving CLODEW, contact your doctor immediately.

• Allergic reactions. Symptoms of an allergic reaction to CLODEW may include itching, rash, hives, wheezing, difficulty breathing, or feeling dizzy or faint. Contact your doctor immediately or seek emergency medical help if you experience wheezing or difficulty breathing, or if you feel dizzy or faint.
• Heart problems. Some people who received botulinum toxin products have experienced irregular heartbeats and heart attacks that have resulted in death.
• Eye problems. Some people who receive CLODEW for treating glabellar lines have experienced dry eye, reduced blinking, and corneal problems. Tell your healthcare provider if you experience eye pain or irritation, sensitivity to light, or changes in your vision.

The most common side effects of CLODEW include:
• headache
• drooping eyelid
• upper respiratory tract infection
• increased white blood cell count. These are not all possible side effects of CLODEW.

Reporting side effects
If you experience side effects, talk to your doctor or pharmacist. Side effects not listed in this leaflet should also be reported.

Side effects can also be reported directly to ANMAT. If you have any issues with the product, you can fill out the form available on the ANMAT website: http://www.anmat.gov.ar/farmacovigilancia/Notificar.asp or call ANMAT responds at 0800-333-1234. By reporting side effects, you can help provide more information about the safety of this medication.

You can find more information, including our Warnings and Precautions, at this link. This information is also included in every box of Clodew to ensure that your doctor has immediate access and can answer any questions or concerns you may have about the treatment and find the most important information you need to know about Clodew.

CLODEW is available at leading medical clinics that offer aesthetic treatments throughout the country.