Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Lioresal (Baclofen).

Drowsiness/reduced alertness: Lioresal (Baclofen) may affect the mental or physical abilities needed to drive or operate machinery. Avoid driving, operating machinery, or performing other hazardous tasks until you have determined how Lioresal (Baclofen) affects you.

Kidney function: Kidney Disease or reduced kidney function may cause Lioresal (Baclofen) to build up in the body, causing side effects. This occurs because Lioresal (Baclofen) is primarily removed from the body by the kidneys. If you have reduced kidney function or kidney disease, discuss with your doctor how Lioresal (Baclofen) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Lioresal (Baclofen), and whether any special monitoring is needed.

Medical conditions: Certain medical conditions may make it more likely for you to experience serious side effects. People with certain types of bladder problems, stomach ulcers, breathing problems, and seniors with cerebrovascular problems (disorder of the blood vessels supplying the brain) should discuss with their doctor how Lioresal (Baclofen) may affect their medical condition, how their medical condition may affect the dosing and effectiveness of Lioresal (Baclofen), and whether any special monitoring is needed.

Mental health: Lioresal (Baclofen) may cause symptoms of psychosis or Schizophrenia to get worse for people who have mental health problems. If you experience symptoms such as hallucinations, mania (feeling unusually over-excited or uninhibited), or delusional thinking, or notice them in a family member who is taking Lioresal (Baclofen), contact your doctor as soon as possible.

Seizures: Lioresal (Baclofen) may cause a loss of seizure control, causing seizures to occur more often. If you have a history of Epilepsy or medical conditions that increase your risk of seizures, discuss with your doctor how Lioresal (Baclofen) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Lioresal (Baclofen), and whether any special monitoring is needed.

Withdrawal effects: If Lioresal (Baclofen) is suddenly stopped after regular use, withdrawal symptoms may occur, including:

• anxiety with racing heart and sweating
• confusion
• hallucinations (seeing and hearing things that aren't there)
• Insomnia (difficulty sleeping)
• involuntary movements
• psychotic, manic, or paranoid states
• seizures
• worsening of spasticity (loss of control of muscles)

Except when serious side effects occur, the dose should be reduced slowly when stopping the medication (over a period of approximately 1 to 2 weeks).

Pregnancy: The safe use of Lioresal (Baclofen) during pregnancy has not been established. Lioresal (Baclofen) crosses the placental barrier and may affect the developing baby. Babies born to women who have taken Lioresal (Baclofen) during pregnancy may experience withdrawal symptoms after birth. If you are or may become pregnant, speak to your doctor. Lioresal (Baclofen) should be taken during pregnancy only when the potential benefits outweigh the possible risks.

Breast-feeding: Lioresal (Baclofen) passes into breast milk. If you are a breast-feeding mother and are taking Lioresal (Baclofen), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safe use of Lioresal (Baclofen) by children under the age of 12 years has not been established and is not recommended.

Seniors: People over the age of 65 are more likely to experience side effects of taking Lioresal (Baclofen). Doses for seniors should generally be lower and increased more slowly than for other adults.