What is the most important information I should know about baclofen?
Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.
What is baclofen?
Baclofen is used in adults and children at least 12 years old to treat muscle pain, spasms, and stiffness in people with multiple sclerosis or spinal cord injury or disease.
Baclofen may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking baclofen?
You should not use baclofen if you are allergic to it.
Tell your doctor if you have ever had:
- mental illness or psychosis;
- epilepsy or other seizure disorder;
- problems with balance;
- high blood pressure, or fast heart rate;
- a stroke or blood clot; or
- kidney disease.
Using baclofen may increase your risk of developing an ovarian cyst. Talk with your doctor about your own risk.
Tell your doctor if you are pregnant or plan to become pregnant, or breastfeeding or plan to breastfeed. If you take baclofen while pregnant or breastfeeding, withdrawal symptoms such as tremors, stiff muscles, or seizure may occur in the baby.
How should I take baclofen?
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.
Shake the oral suspension (liquid).
Measure a dose 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).
The oral granules can also be given through a feeding tube. 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.
You may have withdrawal symptoms if you stop using baclofen suddenly. Ask your doctor before stopping the medicine.
Store the oral suspension (liquid) at room temperature away from moisture and heat. Throw Fleqsuvy away after 2 months of first opening.
Store Ozobax in the refrigerator, do not freeze.
What happens if I miss a dose?
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include increasing drowsiness, dizziness, sleepiness, trouble focusing on objects, shallow breathing, seizure, or muscle weakness leading to loss of consciousness.
What should I avoid while taking baclofen?
Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.
Do not share this medicine with another person, even if they have the same symptoms you have.
What are the possible side effects of baclofen?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- severe drowsiness, breathing problems;
- confusion, hallucinations;
- muscle weakness, itching, tingling, or twitching in your hands, arms, feet, or legs; or
- fever.
Common side effects 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 FDA at 1-800-FDA-1088.
What other drugs will affect baclofen?
Using baclofen with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.
Other drugs may affect baclofen, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.
Where can I get more information?
Your doctor or pharmacist can provide more information about baclofen.
