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This FAQ is for information only, and has been compiled
from a number of sources to give an overview of the use
and effects of Reductil. It is not a definitive guide to
the effects or implications of use of Reductil, nor is it
intended replace the advice of qualified healthcare professionals.
If you have any concerns about the use of Reductil or any
possible side-effects, consult your healthcare provider.
Who
should take Reductil? Reductil is recommended
for overweight people with an initial body mass index (BMI)
of 30 or higher, or for overweight people with a BMI of
27 or higher if they have other medical risk factors such
as high blood pressure, diabetes, or high cholesterol.
How
and when should I take Reductil? Take one
(1) Reductil capsule a day. You can take Reductil on an
empty stomach or after a meal.
What
if I miss a dose? If you forget to take
a dose of Reductil, do not take an extra capsule to "make
up" for the dose you forgot.
How
long should I take Reductil? The safety
and effectiveness of Reductil have not been determined beyond
one (1) year.
Who should not take Reductil?
Reductil should not be taken by
people who:
- HAVE UNCONTROLLED
OR POORLY CONTROLLED HIGH BLOOD PRESSURE BECAUSE Reductil
SUBSTANTIALLY INCREASES BLOOD PRESSURE IN SOME PATIENTS.
- Are taking prescription
medicines called monoamine oxidase inhibitors (MAOIs)
for depression,
- Parkinson's
disease, or any other disorder.
- Are taking other
weight loss medications that act on the brain (for example:
phentermine). This includes prescription and over-the-counter
medications and herbal products.
- Have had prior
allergic reactions to Reductil or sibutramine.
- Have a diagnosis
of coronary artery disease and/or who have angina pectoris
(heart-related chest pain).
- Have arrhythmias
(irregular heart beats).
- Have had a prior
heart attack.
- Have a diagnosis
of congestive heart failure.
- Have severe
liver or kidney disease.
- Have had a stroke
or symptoms of a stroke.
- Are pregnant
or planning to become pregnant.
- Are breast-feeding
their infants.
- Are suffering
from anorexia nervosa.
- Are taking prescription
medications for depression.
- Have had seizures
(epilepsy or convulsions).
- Have an eye
disorder called narrow angle glaucoma.
- Are under 16
years of age.
- Are taking other
medications that regulate the neurotransmitter serotonin
in the brain (for example: Prozac and related medicines.
If you have any concerns or questions
about whether or not you should take Reductil , talk to
your healthcare provider.
IMPORTANT: It is very important that
you make sure that your healthcare provider knows what medications
you take and what medical conditions and allergies you have.
What
medicines can cause problems if taken at the same time as
Reductil? You cannot take Reductil if you
are taking prescription medicines called monoamine oxidase
inhibitors (MAOIs).
It is especially important to make sure you tell your doctor
if you are taking MAOIs that are sometimes used to treat
depression or Parkinson's disease. Serious, sometimes even
fatal, reactions can occur if Reductil is taken at the same
time MAOIs are taken.
If you are currently taking an MAOI, your doctor will want
you to stop taking it for at least two (2) full weeks before
starting you on Reductil.
If you are currently taking Reductil, your doctor will
want you to stop taking it for at least two (2) full weeks
before starting you on an MAOI.
Reductil should not be taken if you are taking other weight
loss medications that act on the brain (for example: phentermine).
This includes both prescription and over-the-counter medications
and herbal products.
In addition to the above, a rare, but serious medical syndrome
called the "serotonin syndrome" has been reported in patients
when medications like Reductil are taken along with other
drugs that may alter serotonin activity such as: drugs for
depression, certain pain medications, the cough suppressant
dextromethorphan found in many cough medicines, lithium,
and the amino acid tryptophan. The syndrome requires immediate
medical attention and may include one or more of the following
symptoms: restlessness, loss of consciousness, confusion,
disorientation, anxiety, agitation, weakness, tremor, lack
of coordination, fever, shivering, sweating, vomiting and
increased heart rate.
The effects of Reductil may be inhibited by ketoconazole
(an anti-fungal medicine) and to a lesser degree erythromycin
(an antibiotic medicine). You need to make sure your healthcare
provider knows you are taking these medicines before you
take Reductil.
Many over-the-counter cough and cold remedies, as well
as certain allergy products and decongestants, contain medicines
such as phenylpropanolamine, ephedrine, or pseudoephedrine
that may increase blood pressure or heart rate. Before taking
these medications on your own, you should check with your
healthcare provider to make sure it is safe to take these
medicines if you are already taking Reductil.
Is Reductil a controlled substance? Yes,
Reductil is a controlled substance.
What weight losses have been observed with Reductil?
Patients treated with Reductil while on a reduced calorie
diet showed a significant weight loss during the first 6
months of treatment, and significant weight loss was maintained
for one year. In one 12-month study, the average weight
loss in patients taking Reductil 10 mg daily, was 10 lbs.
and in those taking 15 mg daily was about 14 lbs. The average
weight loss in persons on only a reduced calorie diet was
3 1/2 lbs.
What
are some of the more common side effects of Reductil?
In studies the most common side effects were: dry mouth,
constipation, and insomnia (inability to fall asleep). Other
side effects that may occur include: headache, increased
sweating, an increase in blood pressure, and an increase
in heart rate. These side effects are generally mild, and
have usually not caused people to stop taking Reductil.
If you develop a symptom that you think might be a side
effect, stop taking Reductil and notify your healthcare
provider immediately so you can be advised on what to do.
These symptoms include breathing difficulty, shortness
of breath, chest pain, angina, rapid heart beats over 100
beats a minute, pounding or irregular heart beats, restlessness,
lightheadedness, blackout spells, disorientation, depression,
mental confusion, anxiety, nervousness, tremors, loss of
muscle coordination, muscle stiffness or muscle rigidity,
high fever, pain in the eyes, dilated pupils, shivering,
sweating, abdominal pain, nausea or vomiting.
Can
Reductil affect blood pressure or heart rate?
Yes -- Reductil CAN CAUSE INCREASES IN BLOOD PRESSURE IN
SOME PATIENTS.
On average, small increases in blood pressure and small
increases in heart rate were seen in overweight people who
took Reductil in scientifically controlled studies. Reductil
SHOULD NOT be taken by people who have uncontrolled or poorly
controlled high blood pressure.
Are
there any severe side effects? Some weight
loss drugs have been associated with cardiac valve dysfunction
(heart valve disease). In a study, patients who had received
either Reductil or placebo (sugar pills) for periods of
two weeks to 16 months were examined. Three out of 132 patients
who had taken Reductil and two out of 77 patients who had
taken the placebo were found to have heart valve disease.
Can
I take Reductil with nutritional supplements?
Food supplements, like vitamins, minerals and amino acids
(with the exception of tryptophan) can be used along with
Reductil. You should not use herbal or over-the-counter
weight loss products while taking Reductil .
What
about drinking alcoholic beverages? Reductil
may increase the sedative effects of alcohol.
What
about drinking coffee, tea and caffeinated beverages?
Reductil can be safely taken with moderate use of coffee,
tea or caffeinated beverages.
What
if I develop allergic reactions? Stop taking
Reductil and notify your healthcare provider immediately
if you develop a skin rash, hives or other allergic reactions.
What
if I am pregnant or nursing? Reductil
should not be used by pregnant women or nursing mothers.
You should notify your doctor immediately if you become
pregnant or plan to become pregnant.
What
about sexual activity and potential pregnancy?
Women of childbearing potential should use an effective
birth control method while taking Reductil. Check with your
doctor to make sure you are on a medically safe and effective
birth control method while taking Reductil.
Does
Reductil affect the effectiveness of birth control pills?
No.
What
about driving a car or dangerous work activities?
Reductil was studied in healthy people and did not affect
their coordination or impair their judgement. However, Reductil
has the potential to impair judgement, thinking, coordination
or motor skills.
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