BACLOFEN

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 kidney problems or kidney failure
• If you suffer from nerve damage, bizarre behavior, or have had a stroke
• If you have an infection or very high blood pressure associated with a spinal injury

Some MEDICINES MAY INTERACT with Baclofen. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Epidural morphine because shortness of breath and a significant decrease in blood pressure may occur

This may not be a complete list of all interactions that may occur. 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.

• Baclofen is usually administered into the spinal canal through an implantable infusion pump.
• Baclofen is usually given as an injection at your doctor’s office, hospital, or clinic.
• Do not use Baclofen if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
• If you miss a dose of Baclofen, contact your doctor right away.

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

Important safety information:

• Baclofen may cause dizziness or drowsiness. 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.
• Do not suddenly stop using Baclofen. Your doctor can tell you the best way to slowly reduce the dose.
• If you are using a pump to receive Baclofen, always keep your scheduled refill visits. If you miss an appointment, contact your doctor immediately to reschedule before you run out of medicine.
• Baclofen should not be used in CHILDREN younger than 4 years old; 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 while you are pregnant. It is not known if Baclofen is found in breast milk. If you are or will be breast-feeding while you use Baclofen, check with your doctor. Discuss any possible risks to your baby.

If you suddenly stop taking Baclofen, you may experience WITHDRAWAL symptoms, including high fever, confusion, changes in mental status, severe increase in muscle stiffness and spasms that, in rare cases, has progressed to muscle destruction (causing dark colored urine and muscle weakness, aching, and tenderness), multiple organ failure, and death. If you experience any of the above symptoms, seek immediate medical attention.

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:

Back pain; constipation; diarrhea; dizziness; drowsiness; fatigue; headache; increased breathing; increased salivation; itching; muscle weakness; nausea; problems urinating.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; chills; inability to urinate; loss of muscle tone; seizures.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects.

If OVERDOSE is suspected:

Contact your local Poison Control or emergency room immediately. Symptoms may include dizziness; drowsiness; lightheadedness; loss of consciousness progressing to coma of up to 72 hours duration; loss of muscle tone; seizures; slow or shallow breathing.

Proper storage of Baclofen:

Baclofen is usually handled and stored by a health care provider. If you are using Baclofen at home, store Baclofen as directed by your pharmacist or health care provider. 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.
• Check with your pharmacist about how to dispose of unused medicine.

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.