Seysara

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IMPORTANT SAFETY INFORMATION
PRESCRIBING INFORMATION
PATIENT INFORMATION

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IMPORTANT SAFETY INFORMATION

INDICATION

SEYSARA is a prescription medicine used to treat moderate to severe acne vulgaris in people 9 years and older. SEYSARA should not be used for the treatment or prevention of infections. It is not known if SEYSARA is safe and effective for use for longer than 12 weeks. It is not known if SEYSARA is safe and effective in children under 9 years of age.

IMPORTANT SAFETY INFORMATION

Do not take SEYSARA: if you are allergic to medicines in the tetracycline-class. Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.

Before taking SEYSARA, tell your healthcare provider about all of your medical conditions, including if you: have diarrhea or watery stools, have vision problems, or are pregnant, breastfeeding or plan to become pregnant or breastfeed. SEYSARA may harm your unborn baby and can pass into your breastmilk and harm your baby if you are breastfeeding. Taking SEYSARA during the second and third trimesters of pregnancy may cause serious side effects on the growth of bone and teeth of your baby. Stop taking SEYSARA and call your healthcare provider right away if you become pregnant during your treatment. You should not breastfeed during treatment with SEYSARA.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. SEYSARA and other medicines can affect each other causing serious side effects. Especially tell your healthcare provider if you take: a blood thinner, a penicillin antibiotic medicine, antacids that contain aluminum, calcium or magnesium or iron-containing products, an acne medication taken by mouth that contains isotretinoin or acitretin.

Avoid sunlight or artificial sunlight, such as a tanning booth or sunlamp. You could get severe sunburn. Use sunscreen and wear loose-fitting clothes that cover your skin while out in sunlight. Stop taking SEYSARA if you get sunburn. You should not drive or operate dangerous machinery until you know how SEYSARA affects you. Tetracyclines may cause you to feel dizzy or lightheaded, or have a spinning feeling (vertigo).

SEYSARA may cause serious side effects, including:

Harm to an unborn baby.
SEYSARA may permanently turn a baby or child’s teeth yellow-gray-brown during tooth development. You should not use SEYSARA during tooth development. Tooth development happens in the second and third trimesters of pregnancy, and from birth to 8 years.
SEYSARA may slow bone growth in infants and children. Slow bone growth is reversible after stopping treatment with SEYSARA.
Diarrhea can happen with most antibiotics, including SEYSARA. This diarrhea may be caused by an infection (Clostridium difficile) in your intestines. Call your healthcare provider right away if you get watery or bloody stools.
Central nervous system effects such as light headedness, dizziness, and a spinning feeling (vertigo) may go away during your treatment with SEYSARA or if treatment is stopped. Call your healthcare provider if these symptoms do not go away.
Increased pressure around the brain (intracranial hypertension). This condition may lead to vision changes and permanent vision loss. You may be more likely to get intracranial hypertension if you are a female of childbearing potential and are overweight or have a history of intracranial hypertension. Stop taking SEYSARA and tell your healthcare provider right away if you have blurred vision, vision loss, or headaches.
Sensitivity to sunlight (photosensitivity).

The most common side effect of SEYSARA is nausea. These are not all the possible side effects of SEYSARA. Call your doctor for medical advice about side effects. 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 Patient Information and Full Prescribing Information.

Seysara^® is a registered trademark of Almirall, LLC.
© Almirall, LLC, Exton, PA 19341. All rights reserved. US-SEY-1900001 01/20

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