FIRST Baclofen

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

FIRST Baclofen should not be used to treat muscle spasms caused by inflammatory (rheumatic) disorders.

FIRST Baclofen may also be used for other purposes not mentioned in this medication guide.

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

Your dose may change if you switch to a different brand, strength, or form of this medicine. Avoid medication mistakes 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 the liquid medicine with the measuring device provided (not a kitchen spoon).

Shake and pour the entire packet of oral granules to dissolve in your mouth or swallow it whole at once, with or without liquids. You can 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 worsen.

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

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

Some forms of FIRST Baclofen oral solution are stored in the refrigerator. Others are stored at room temperature. Ask your pharmacist how to properly store FIRST Baclofen oral solution.

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

You should not use FIRST Baclofen 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 FIRST Baclofen will harm an unborn baby. If you take FIRST Baclofen 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 FIRST Baclofen.

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

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

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

Common side effects of FIRST Baclofen 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.

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

Drinking alcohol while taking FIRST Baclofen can lead to serious side effects.

Do not drive or engage in activities that are dangerous until you understand how this medicine affects you. Dizziness or drowsiness can result in falls, accidents, or serious injuries.

Using FIRST Baclofen with other medications that cause drowsiness can increase this effect. Consult your doctor before taking opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Other drugs may influence how FIRST Baclofen works, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all other medicines you are taking.