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|Baclofen Tablets

Baclofen

Baclofen is used for:

Treating muscle spasms caused by multiple sclerosis or other diseases. It may also be used for other conditions as determined by your doctor.

Baclofen is a muscle relaxant. It reduces the frequency and severity of muscle spasms that occur as a result of neurological disorders such as multiple sclerosis.

Do NOT use Baclofen if:

• you are allergic to any ingredient in Baclofen

Contact your doctor or health care provider right away if any of these apply to you.

Before using Baclofen:

Some medical conditions may interact with Baclofen. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have epilepsy or seizures, or have had a stroke
• if you have kidney problems or kidney failure

Some MEDICINES MAY INTERACT with Baclofen. However, no specific interactions with Baclofen are known at this time.

Ask your health care provider if Baclofen may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Baclofen:

Use Baclofen as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• take Baclofen by mouth with or without food.
• If you miss a dose of Baclofen, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Baclofen.

Important safety information:

• Baclofen may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Baclofen with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Baclofen; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Baclofen is not recommended for use in CHILDREN younger than 12 years of age; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor . You will need to discuss the benefits and risks of using Baclofen during while you are pregnant. It is not known if Baclofen is found in breast milk. Do not breast-feed while taking Baclofen.

If you suddenly stop taking Baclofen, you may experience WITHDRAWAL symptoms, including hallucinations and seizures. Therefore, except for serious adverse reactions, the dose should be reduced slowly when the drug is discontinued.

Possible side effects of Baclofen:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; drowsiness; fatigue; headache; nausea; sleeplessness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; confusion; frequent urination; increased weakness of arms or legs; seizures; slurred speech; sore throat; vomiting.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include coma; drowsiness; muscle weakness; seizures; slow breathing; vomiting.

Store Baclofen at room temperature, below 86 degrees F (30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep the container tightly closed. Keep Baclofen out of the reach of children and away from pets.

General information:

• If you have any questions about Baclofen, please talk with your doctor, pharmacist, or other health care provider.
• Baclofen is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Baclofen. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.