July 24, 2014
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Drug Factsheets

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Mylan-Baclofen

(baclofen)

DIN (Drug Identification Number)

02088398 MYLAN-BACLOFEN 10MG TABLET
02088401 MYLAN-BACLOFEN 20MG TABLET

What side effects are possible with Mylan-Baclofen?

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.

  • abdominal or stomach pain or discomfort
  • constipation
  • decreased sexual ability
  • difficulty sleeping
  • dizziness
  • drowsiness
  • dry mouth
  • fatigue
  • frequent urination
  • headache
  • increased perspiration
  • lightheadedness
  • low blood pressure
  • nausea
  • trouble sleeping
  • vomiting
  • weakness

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

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

  • breathing problems
  • confusion
  • feeling faint or fainting
  • false sense of well-being
  • hallucinations
  • loss of coordination
  • muscle pain
  • nightmares or vivid dreams
  • signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
  • signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
  • signs of heart problems (e.g., tiredness, swelling in the legs, shortness of breath)
  • signs of urinary tract problems (e.g., decreased urine production, difficulty urinating, bloody or dark urine)
  • skin rash or itching
  • trembling
  • vision changes

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • seizures

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.





Are there any other precautions or warnings for Mylan-Baclofen?

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.

Drowsiness/reduced alertness: Baclofen may affect the mental or physical abilities needed to drive or operate machinery. Avoid driving, operating machinery, or performing other hazardous tasks until you have determined how this medication affects you.

Kidney function: Kidney disease or reduced kidney function may cause this medication to build up in the body, causing side effects. This occurs because baclofen is primarily removed from the body by the kidneys. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Medical conditions: People with certain types of bladder problems, history of seizures, psychiatric disorders, stomach ulcers, breathing problems, or liver problems, and seniors with cerebrovascular (disorder of the blood vessels supplying the brain) problems should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

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

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

Except when serious side effects occur, the dose should be reduced slowly when stopping the medication (over a period of approximately 1 to 2 weeks).

Pregnancy: The safe use of baclofen during pregnancy has not been established. Baclofen crosses the placental barrier and may affect the developing fetus. Babies born to women who have taken baclofen during pregnancy may experience withdrawal symptoms after birth. 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: This medication passes into breast milk. If you are a breast-feeding mother and are taking baclofen, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

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.

Seniors: People over the age of 65 are more likely to experience side effects of taking baclofen. Doses for seniors should generally be lower and increase more slowly than for other adults.

What other drugs could interact with Mylan-Baclofen?

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

  • alcohol
  • antihistamines (e.g,. cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine)
  • antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
  • aripiprazole
  • antidiabetes medications (e.g., glyburide, insulin)
  • azelastine
  • barbiturates (e.g., butalbital, phenobarbital)
  • benzodiazepines (e.g., alprazolam, diazepam, lorazepam)
  • brimonidine
  • buprenorphine
  • buspirone
  • carbamazepine
  • chloral hydrate
  • dimenhydrinate
  • droperidol
  • efavirenz
  • gabapentin
  • guanfacine
  • lamotrigine
  • levetiracetam
  • levodopa - carbidopa
  • magnesium sulfate
  • medications used to treat high blood pressure
  • methotrimeprazine
  • metyrosine
  • mirtazapine
  • monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine)
  • other muscle relaxants (e.g., cyclobenzaprine, methocarbamol, orphenadrine)
  • narcotic pain relievers (e.g., codeine, fentanyl, morphine, oxycodone)
  • olopatadine
  • perampanel
  • phenytoin
  • pramipexol
  • ropinirole
  • selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, duloxetine, fluoxetine, paroxetine, sertraline)
  • scopolamine
  • tapentadol
  • topiramate
  • tramadol
  • tricyclic antidepressants (e.g., amitriptyline, imipramine)
  • zopiclone

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.

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