Brand Names: Lioresal

Generic Name: baclofen (Pronunciation: BAK loe fen)

• What is baclofen (Lioresal)?
• What are the possible side effects of baclofen (Lioresal)?
• What is the most important information I should know about baclofen (Lioresal)?
• What should I discuss with my healthcare provider before taking baclofen (Lioresal)?
• How should I take baclofen (Lioresal)?
• What happens if I miss a dose (Lioresal)?
• What happens if I overdose (Lioresal)?
• What should I avoid while taking baclofen (Lioresal)?
• What other drugs will affect baclofen (Lioresal)?
• Where can I get more information?

Baclofen is a muscle relaxer and an antispastic agent.

Baclofen is used to treat muscle symptoms caused by multiple sclerosis, including spasm, pain, and stiffness.

Baclofen may also be used for purposes not listed in this medication guide.

Baclofen 10 mg-GEN

round, white, imprinted with G, BN 10

Baclofen 10 mg-MAJ

round, white, imprinted with 10, Z 4096

Baclofen 10 mg-MYL

round, imprinted with BN 10, G

Baclofen 10 mg-QUA

oval, white, imprinted with V, 22 65

Baclofen 10 mg-TEV

round, white, imprinted with 4096, TV

Baclofen 10 mg-WAT

round, white, imprinted with 10, DAN 5730

Baclofen 10mg-QUA

round, white, imprinted with BAC 10, 832

Baclofen 20 mg-MYL

round, white, imprinted with BN 20, G

Baclofen 20 mg-QUA

oval, white, imprinted with V, 22 66

Baclofen 20 mg-TEV

round, white, imprinted with 4097, TV

Baclofen 20 mg-UPS

round, white, imprinted with 832 BC 20

Baclofen 20 mg-WAT

round, white, imprinted with 20, DAN 5731

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

Call your doctor at once if you have a serious side effect such as:

• seizure (convulsions);
• confusion, hallucinations; or
• an uneven heartbeat.

Less serious side effects may include:

• drowsiness, dizziness, weakness, tired feeling;
• headache;
• sleep problems (insomnia);
• nausea, constipation; or
• urinating more often than usual.

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.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol can increase certain side effects of baclofen.

Do not use baclofen at a time when muscle tone is needed to assure safe balance and movement for certain activities. In some situations, it may endanger your physical safety to be in a state of reduced muscle tone.

You may have withdrawal symptoms such as seizures or hallucinations, when you stop using baclofen after using it over a long period of time.

Do not stop using baclofen without first talking to your doctor. You may need to use less and less before you stop the medication completely.

Using baclofen may increase your risk of developing an ovarian cyst. Talk with your doctor about your specific risk.

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

To make sure you can safely take baclofen, tell your doctor if you have any of these other conditions:

• kidney disease;
• epilepsy or other seizure disorder; or
• a history of stroke or blood clots.

Using baclofen may increase your risk of developing an ovarian cyst. Talk with your doctor about your specific risk.

FDA pregnancy category C. It is not known whether baclofen will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether baclofen passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using baclofen.

Do not give this medication to a child younger than 12 years old.

Older adults may be more sensitive to the effects of this medicine.

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

Call your doctor if your muscle symptoms do not improve after 2 weeks of taking this medication.

Do not stop taking this medication without first talking to your doctor. You may have withdrawal symptoms such as seizures or hallucinations, when you stop using baclofen after using it over a long period of time. You may need to use less and less before you stop the medication completely.

Store at room temperature away from moisture and heat.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

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

Overdose symptoms may include muscle weakness, vomiting, drowsiness, dilated or pinpoint pupils, weak or shallow breathing, fainting, or coma.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol can increase certain side effects of baclofen.

Do not use baclofen at a time when muscle tone is needed to assure safe balance and movement for certain activities. In some situations, it may endanger your physical safety to be in a state of reduced muscle tone.

Before using baclofen, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, other muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by baclofen.

This list is not complete and other drugs may interact with baclofen. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

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Your pharmacist can provide more information about baclofen.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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