Fleqsuvy

Fleqsuvy is used for adults and children who are at least 12 years old to help with muscle pain, spasms, and stiffness in people with multiple sclerosis or spinal cord injury or disease.

Fleqsuvy should not be used for muscle spasms caused by inflammatory (rheumatic) disorders.

Fleqsuvy may also be used for other reasons that are not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Your dose needs may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using it exactly as directed on the label, or as prescribed by your doctor.

Follow your doctor's dosing instructions very carefully.

Shake the oral suspension (liquid).

Measure liquid medicine with the supplied measuring device (not a kitchen spoon).

Shake and pour the entire oral granules packet to dissolve in your mouth or swallow whole at once, with or without liquids. You may also mix the granules with liquids (milk or apple juice) or soft food (apple sauce, yogurt, or pudding). Take the medicine within 2 hours after mixing.

The oral granules can also be given through a feeding tube.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Call your doctor if your symptoms do not improve, or if they get worse.

Do not stop using Fleqsuvy suddenly. This can cause dangerous side effects or death. Ask your doctor before stopping the medicine.

Store at room temperature away from moisture, heat, and light. Throw away any leftover oral suspension 2 months after you first opened the bottle.

Some Fleqsuvy oral solution brand forms are stored in the refrigerator. Others are stored at room temperature. Ask your pharmacist how to properly store this medicine oral solution.

Use only as directed. Inform your doctor if you are taking other medicines, have other medical conditions, or have any allergies.

You should not use Fleqsuvy if you are allergic to it.

Tell your doctor if you have or have ever had:

• mental illness or psychotic disorders such as schizophrenia;
• seizures or epilepsy;
• problems with posture and balance;
• high blood pressure or a history of a condition called autonomic dysreflexia;
• a stroke, cerebral palsy, or Parkinson's disease;
• if you drink alcohol;
• ovarian cysts; or
• kidney disease.

It is not known if Fleqsuvy will harm an unborn baby. If you take this medicine during pregnancy, your baby could be born with withdrawal symptoms such as tremors or seizures and may need medical treatment. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using Fleqsuvy.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Fleqsuvy may cause serious side effects. Call your doctor right away if you have:

• severe drowsiness;
• trouble standing or sitting up straight, balance problems;
• fever, seizures;
• confusion, hallucinations;
• muscle stiffness, itching, tingling in your hands and feet; or
• high blood pressure—severe headache, blurred vision, pounding in your neck or ears.

Common side effects of Fleqsuvy may include:

• drowsiness, dizziness, weakness, or tiredness.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Take the medicine as soon as you can, but skip the missed dose if it is nearly time for your next dose. Do not take two doses at once.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222.

Signs of overdose may include increased drowsiness, dizziness, vomiting, trouble focusing on objects, shallow breathing, seizures, or muscle weakness that can lead to loss of consciousness.

Drinking alcohol while taking Fleqsuvy can lead to dangerous side effects.

Avoid driving or doing anything risky until you understand how this medicine will affect you. Dizziness or drowsiness can result in falls, accidents, or serious injuries.

Using Fleqsuvy with other drugs that cause drowsiness can make you feel more tired. Check with your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Other drugs may interact with Fleqsuvy, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all other medicines you are taking.