Rimabotulinum Toxin Type B Injection 5000 units/mL (2 mL)

Instructions

This medicine should only be used by a person who has been trained to recognize when and how it should be used.

This medicine should be given by a trained health care provider.

If you miss a dose, contact your doctor for instructions.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Tell your doctor if symptoms do not get better or if they get worse.

Keep all appointments for medical exams and tests while on this medicine.

Cautions

During pregnancy, this medicine should be used only when clearly needed. Talk to your doctor about the risks and benefits.

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

This medicine is associated with a rare but very serious medical condition. Please speak with your doctor about symptoms you should look out for while on this medicine. Notify your doctor immediately if you develop those symptoms.

Rarely, this medicine may spread to other areas of the body and cause serious (possibly fatal) side effects. This can happen hours, days or weeks after receiving a dose. Seek medical help right away if you have trouble breathing, severe difficulty swallowing or speaking, chest pain, unusual muscle weakness, loss of bladder control, or changes in vision.

Your ability to stay alert or to react quickly may be impaired by this medicine. Do not drive or operate machinery until you know how this medicine will affect you.

Please check with your doctor before drinking alcohol while on this medicine.

Contact your doctor if you develop any signs of a new infection such as fever, cough, sore throat, or chills.

It is unknown if this medicine passes into breast milk. Ask your doctor before breastfeeding.

This medicine should be used with caution in patients with breathing difficulties.

Call your doctor right away if you notice slow or shallow breathing.

Some patients have serious side effects from this medicine. Ask your pharmacist to show you the information from the Food and Drug Administration (FDA) and discuss it with you.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

• back pain
• dizziness
• dry mouth
• dry eyes
• drooping or swollen eyelids
• lack of energy and tiredness
• headaches
• pain, redness, swelling near injection
• irritation of the eyes
• nausea
• neck pain or stiffness
• sensitivity to light
• skin tingling, burning or prickly feeling
• upper respiratory infection
• blurring or changes of vision
• watering of the eyes

Call your doctor or get medical help right away if you notice any of these more serious side effects:

• loss of bladder control
• fainting
• flu-like symptoms
• unusual or long-lasting hoarseness
• muscle weakness
• shortness of breath
• difficulty speaking
• difficulty swallowing
• weakness

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.