baclofen (oral)

Generic Name: baclofen (oral)

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

Baclofen is a muscle relaxer that is used 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.

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001724097_PB

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round, white, imprinted with LCI 1330

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round, white, imprinted with LCI 1337

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oval, white, imprinted with V, 22 65

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oval, white, imprinted with V, 22 66

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round, white, imprinted with BAC 10, 832

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round, white, imprinted with 832 BC 20

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round, white, imprinted with LCI 1330

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round, white, imprinted with LCI 1337

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Baclofen 10 mg 008321054

round, white, imprinted with BAC 10, U S

Baclofen 10 mg 009046475

round, white, imprinted with LCI 1330

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-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 008321055

round, white, imprinted with BAC 20, U S

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-WAT

round, white, imprinted with 20, DAN 5731

baclofen 5mg 502680105

round, white, imprinted with 16, 09

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, weak or shallow breathing;
• confusion, hallucinations;
• itching, tingling, or twitching in your hands, arms, feet, or legs;
• fever; or
• a seizure.

Common side effects may include:

• drowsiness, dizziness, weakness, tiredness;
• 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.

Do not use baclofen at a time when you need muscle tone for safe balance and movement during certain activities.

Do not stop using baclofen suddenly, or you could have unpleasant withdrawal symptoms.

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

Tell your doctor if you have ever had:

• mental illness or psychosis;
• a nervous system disorder;
• epilepsy or other seizure disorder;
• 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 specific risk.

Tell your doctor if you are pregnant or breastfeeding.

If you take baclofen during pregnancy, your newborn baby may have withdrawal symptoms such as tremors, rigid muscles, or a seizure. Follow your doctor's instructions about tapering your dose as your due date approaches.

If you take baclofen while breastfeeding, withdrawal symptoms may occur in the nursing baby. Ask your doctor if it is safe for you to breastfeed while taking this medicine.

Baclofen is not approved for use by anyone younger than 12 years old.

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) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

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

You should not stop using baclofen suddenly or you could have serious or fatal withdrawal symptoms. Follow your doctor's instructions about tapering your dose.

Store at room temperature away from moisture and heat.

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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.

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

Overdose symptoms may include muscle weakness, vomiting, severe dizziness or drowsiness, dilated or pinpoint pupils, shallow breathing, seizure, or loss of consciousness.

Do not use baclofen at a time when you need muscle tone for safe balance and movement during certain activities. In some situations, it may be dangerous for you to have reduced muscle tone.

Drinking alcohol with this medicine can cause side effects.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

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 your current medicines and any medicine you start or stop using.

Your pharmacist can provide more information about baclofen.

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