Mylan-Baclofen

Brand Names: Gen-Baclofen

Common Name: baclofen

What is this drug used for?

Baclofen belongs to two groups of medications known as muscle relaxants and antispastics. It is used to treat spasticity (uncontrolled muscle movements) caused by multiple sclerosis, spinal cord injuries, or spinal cord diseases. It is believed to work mainly by relaxing the muscles.

Your doctor may have suggested this medication for conditions other than the ones listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

Is there any reason not to take this drug?

Baclofen should not be used by anyone who is allergic to baclofen or to any of the ingredients of the medication.

What about possible side effects?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

More common:

• confusion
• dizziness or lightheadedness
• drowsiness
• nausea
• unusual weakness

Less common or rare:

abdominal or stomach pain or discomfort changes or problems with urination clumsiness, unsteadiness, trembling, or other problems with muscle control constipation diarrhea false sense of well-being headache loss of appetite low blood pressure muscle or joint pain numbness or tingling in hands or feet

pounding heartbeat sexual problems in males slurred speech or other speech problems stuffy nose swelling of ankles trouble sleeping unexplained muscle stiffness unusual excitement unusual tiredness weight gain

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Less common or rare:

• bloody or dark urine
• chest pain
• fainting
• hallucinations
• mood changes such as depresssion
• ringing or buzzing in the ears
• skin rash or itching

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

What if I am taking other drugs?

There may be an interaction between baclofen and any of the following:

• alcohol or other medications that cause drowsiness (e.g., barbiturates, tranquilizers)
• antidiabetic medications (e.g., glyburide, insulin)
• tricyclic antidepressants (e.g., amitriptyline, imipramine)
• levodopa - carbidopa
• magnesium sulfate
• MAO inhibitors (e.g., phenelzine, tranylcypromine)
• medications used to treat high blood pressure

If you are taking any medications containing this drug, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription) and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or illegal drugs can affect the action of many medications, you should let your prescriber know if you use them.

Other information:

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 this medication.

Kidney function: Because baclofen is primarily removed from the body by the kidneys, people with reduced kidney function shoul be monitored by their doctor while taking baclofen.

Medical conditions: People with certain types of bladder problems, history of seizures, psychiatric disorders, stomach ulcers, or liver problems should use baclofen with caution.

Withdrawal: If baclofen is suddenly stopped after regular use, withdrawal symptoms may occur, including:

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

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

Pregnancy: The safe use of baclofen during pregnancy has not been established. If you are or may become pregnant, speak to your doctor. This medication should be taken during pregnancy only when the potential benefits outweigh the possible risks.

Breast-feeding: The safe use of baclofen while breast-feeding has not been established. This medication should be taken while nursing only when the potential benefits outweigh the possible risks.

Children: The safe use of baclofen by children under the age of 12 years has not been established and is not recommended for use by this age group.

Special Instructions:

The recommended adult dose of baclofen varies according to need but is usually started at doses of 5 mg three times a day for 3 days followed by 10 mg three times a day for 3 days and so on until the best dose is reached. The maximum recommended dose of baclofen is 20 mg four times daily. The tablets can be taken with or without food. Do not stop taking this medication suddenly without speaking to your doctor.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important that this medication be taken exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

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