Brand name : LIOFEN (Baclofen,
Lioresal)
Canadian Brand Names : Lioresal Lioresal Double
Strength
Description LIOFEN (Baclofen, Lioresal)
Baclofen is used to help relax certain muscles in your body. It relieves
the spasms, cramping, and tightness of muscles caused by medical problems
such as multiple sclerosis or certain injuries to the spine. Baclofen
does not cure these problems, but it may allow other treatment, such
as physical therapy, to be more helpful in improving your condition.
Baclofen acts on the central nervous system (CNS) to produce its muscle
relaxant effects. Its actions on the CNS may also cause some of the
medicine's side effects. Baclofen may also be used to relieve other
conditions as determined by your doctor.
LIOFEN (Baclofen, Lioresal) is available only with your doctor's
prescription.
Once a medicine has been approved for marketing for a certain use,
experience may show that it is also useful for other medical problems.
Although this use is not included in product labeling, baclofen is
used in certain patients with trigeminal neuralgia (severe burning
or stabbing pain along the nerves in the face); also called ''tic douloureux.''
This product is available in the following dosage forms: Tablet
Before Using LIOFEN (Baclofen, Lioresal)
In deciding to use a medicine, the risks of taking the medicine must
be weighed against the good it will do. This is a decision you and
your doctor will make. For this medicine, the following should be considered:
Allergies :Tell your doctor if you have ever had any unusual or allergic
reaction to this medicine or any other medicines. Also tell your health
care
professional if you have any other types of allergies, such as to foods,
dyes, preservatives, or animals. For non-prescription products, read
the label or package ingredients carefully.
Pediatric; Studies on this medicine have been done only in adult patients,
and there is no specific information comparing use of baclofen in children
with use in other age groups.
Geriatric:Side effects such as hallucinations, confusion or mental
depression, other mood or mental changes, and severe drowsiness may
be especially
likely to occur in elderly patients, who are usually more sensitive
than younger adults to the effects of baclofen.Pregnancy:
Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are
no adequate studies in pregnant women OR no animal studies have been conducted
and there are no adequate studies in pregnant women. Breastfeeding:There are
no adequate studies in women for determining infant risk when using this medication
during breastfeeding. Weigh
the potential
benefits against the potential risks before taking this medication
while breastfeeding.Drug Interactions:Although certain medicines should
not be used together at all, in other cases two different medicines may be
used together
even if an
interaction might occur. In these cases, your doctor may want to change
the dose, or other precautions may be necessary. Tell your healthcare
professional if you are taking any other prescription or nonprescription
(over-the-counter [OTC]) medicine.Other Interactions:Certain medicines
should not be used at or around the time of eating food or eating certain types
of food since interactions
may occur.
Using alcohol or tobacco with certain medicines may also cause interactions
to occur. Discuss with your healthcare professional the use of your
medicine with food, alcohol, or tobacco.Other Medical Problems:The presence
of other medical problems may affect the use of this medicine. Make sure you
tell your doctor if
you have any other medical
problems, especially:Type 2 diabetes mellitus—Baclofen may raise
blood sugar levels
Epilepsy or Kidney disease or
Mental or emotional problems or
Stroke or other brain disease—The chance of side effects may be increased
Proper Use:Dosing
The dose of this medicine will be different for different patients.
Follow your doctor's orders or the directions on the label. The following
information includes only the average doses of this medicine. If your
dose is different, do not change it unless your doctor tells you to
do so.
The amount of medicine that you take depends on the strength of the
medicine. Also, the number of doses you take each day, the time allowed
between doses, and the length of time you take the medicine depend
on the medical problem for which you are using the medicine.
For oral dosage form (tablets):
o For muscle relaxation:
+ Adults and teenagers—At first, the dose is 5 milligrams (mg) three
times a day. Then, each dose may be increased by 5 mg every three days until
the desired response is reached. No more than 80 mg should be taken within
a twenty-four-hour period.
+ Children—Use and dose must be determined by your doctor.
Missed Dose :If you miss a dose of LIOFEN (Baclofen, Lioresal) , take
it as soon as possible. However, if it is almost time for your next
dose, skip
the missed dose
and go back to your regular dosing schedule. Do not double doses.
Storage :
Store the medicine in a closed container at room temperature, away
from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Precautions
Do not suddenly stop taking this medicine. Unwanted effects may occur
if the medicine is stopped suddenly. Check with your doctor for the
best way to reduce gradually the amount you are taking before stopping
completely.
This medicine will add to the effects of alcohol and other CNS depressants
(medicines that slow down the nervous system, possibly causing drowsiness).
Some examples of CNS depressants are antihistamines or medicine for
hay fever, other allergies, or colds; sedatives, tranquilizers, or
sleeping medicine; prescription pain medicine or narcotics; barbiturates;
medicine for seizures; other muscle relaxants; or anesthetics, including
some dental anesthetics. Check with your doctor before taking any of
the above while you are using baclofen.
This medicine may cause drowsiness, dizziness, vision problems, or
clumsiness or unsteadiness in some people. Make sure you know how you
react to this medicine before you drive, use machines, or do anything
else that could be dangerous if you are not alert, well-coordinated,
and able to see well.
For diabetic patients:
This medicine may cause your blood sugar levels to rise. If you
notice a change in the results of your blood or urine sugar test or
if you have any questions about this, check with your doctor.
Side Effects LIOFEN (Baclofen, Lioresal)
Along with its needed effects, a medicine may cause some unwanted
effects. Although not all of these side effects may occur, if they
do occur they may need 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 (seeing
or hearing things that are not there) Mental depression or other
mood changes Ringing or buzzing in the ears Skin rash or itching
Symptoms of overdose LIOFEN (Baclofen, Lioresal)
Blurred or double vision Convulsions (seizures) Muscle weakness
(severe) Shortness of breath or unusually slow or troubled breathing
Vomiting
Some side effects may occur that usually do not need medical attention.
These side effects may go away during treatment as your body adjusts
to the medicine. Also, your health care professional may be able to
tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side
effects continue or are bothersome or if you have any questions about
them:
More common
Confusion
Dizziness or lightheadedness
Drowsiness
Nausea
Unusual weakness, especially muscle weakness
Less common or rare LIOFEN (Baclofen, Lioresal)
Abdominal or stomach pain or discomfort
Clumsiness, unsteadiness, trembling, or other problems with muscle control
Constipation Diarrhea Difficult or painful urination or decrease in amount
of urine False sense of well-being
Frequent urge to urinate or uncontrolled urination
Headache
Loss of appetite
Low blood pressure
Muscle or joint pain
Numbness or ngling in hands or feet
Pounding heartbeat
Sexual problems in males
Slurred speech or other speech problems
Stuffy nose
Swelling of anklesTrouble in sleeping Unexplained muscle stiffness Unusual excitement
Unusual tiredness
Weight gain
After you stop using this medicine, it may still produce some side
effects that need attention. During this period of time, check with
your doctor immediately if you notice the following side effects LIOFEN
(Baclofen, Lioresal): Convulsions (seizures)
Hallucinations
Increase in muscle spasm, cramping, or tightness
Mood or mental changes
Unusual nervousness or restlessness
