Generic Medicines
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GENERIC NAME: EMTRICITABINE/TENOFOVIR - ORAL (em-tri-SITE-ah-bean/te-NOE-fo-veer)
USES
This drug is a combination of two different antivirals, emtricitabine
and tenofovir. It is used in combination with other antiviral drugs for
the treatment of HIV infection. They work by slowing the growth of the
virus. Emtricitabine is also called a nucleoside reverse transcriptase
inhibitor, while tenofovir is also called a nucleotide reverse
transcriptase inhibitor. Antiviral drugs help to control your HIV
infection thereby improving your quality of life and lowering your risk of
getting HIV disease complications (e.g., opportunistic infections,
cancer). However, this drug is not a cure for HIV infection and it does
not prevent the spread of HIV to others through sexual contact or blood
contamination (e.g., sharing dirty needles).
HOW TO USE
Take this medication by mouth usually once daily with or without food;
or as directed by your doctor. The dosage is based on your medical
condition and response to therapy. This drug should be prescribed along
with other medicines used to treat HIV. If you are also taking didanosine
enteric-coated tablets, take both drugs either on an empty stomach or with
a light meal. If you are taking the didanosine buffered tablets, take both
drugs on an empty stomach. Continue taking this medication and other
anti-HIV medications exactly as prescribed by your doctor. This medication
works best when the amount of drugs in your body is kept at a constant
level. Therefore, take this drug at evenly spaced intervals. Remember to
use it at the same time each day. Do not take more or less of this drug
than prescribed or stop taking it (or other HIV-related medicine) even for
a short time unless directed to do so by your doctor. Skipping or changing
your dose without approval from your doctor may cause the amount of virus
to increase, make the infection more difficult to treat, or worsen side
effects.
SIDE EFFECTS
See also Warning section. Nausea, vomiting, diarrhea, headache,
dizziness, stomach upset, sweating, muscle pain, joint pain, trouble
sleeping, back pain, gas or change in skin color on your palms or soles of
your feet may occur. If any of these effects persist or worsen, notify
your doctor or pharmacist promptly. Tell your doctor immediately if any of
these serious side effects occur: loss of appetite, depression, chest
pain, numbness or tingling of the hands or feet, change in the amount of
urine, unusual weight loss, unusual tiredness or weakness. This medication
may cause changes in your body fat (e.g., increased fat in the upper back
and stomach, decreased fat in the arms and legs). The cause and long-term
effects of these changes are unknown. Discuss the risks and benefits of
therapy, and how exercise might reduce this side effect, with your doctor.
A serious allergic reaction to this drug is unlikely, but seek immediate
medical attention if it occurs. Symptoms of a serious allergic reaction
include: rash, itching, swelling, severe dizziness, trouble breathing. If
you notice other effects not listed above, contact your doctor or
pharmacist.
PRECAUTIONS
Before taking emtricitabine/tenofovir, tell your doctor or pharmacist
if you think you are allergic to it; or if you have any other allergies.
This medication should not be used if you have certain medical conditions.
Before using this medicine, consult your doctor or pharmacist if you have:
severe kidney disease or require kidney dialysis. Before using this
medication, tell your doctor or pharmacist your medical history,
especially of: liver problems, kidney disease, Hepatitis B infection, bone
problems, obesity. This medication should be used only when clearly needed
during pregnancy. Discuss the risk and benefits with your doctor. It is
not known if either drug passes into breast milk. Because breast milk can
transmit HIV, do not breast-feed.
WARNING
This medication may rarely cause severe (sometimes fatal) liver and blood
disorders (e.g., lactic acidosis, hepatomegaly) when used alone or with
other drugs that also treat HIV. Tell your doctor immediately if you
develop yellowing eyes or skin, dark urine, stomach/abdominal pain,
rapid/shallow breathing, severe drowsiness, or muscle aches. If this drug
is stopped, you must continue to be closely monitored by your doctor.
After the last dose of this drug, you will need your liver function tested
for at least several months.
Before using this medication, tell your doctor or pharmacist of all
prescription and nonprescription/herbal products you may use, especially
of: certain other HIV medicines (e.g., didanosine, lopinavir/ritonavir),
other antiviral medicines (e.g., acyclovir, adefovir, cidofovir,
ganciclovir, lamivudine, abacavir). Tell your doctor or pharmacist if you
are also using other drugs which may be harmful to the kidneys such as:
aminoglycosides (e.g., gentamicin, amikacin), amphotericin B,
cyclosporine, non-steroidal anti-inflammatory drugs - NSAIDS (e.g.,
ibuprofen), tacrolimus, vancomycin. Tenofovir can decrease the
effectiveness of atazanavir (by decreasing blood levels) when you take
them at the same time, which could cause your condition to worsen. If you
are using both of these drugs, then you must also take ritonavir according
to the manufacturer. Consult your doctor or pharmacist for more details.
Check the labels on all your medicines for HIV infection because they may
contain the same ingredients as found in this product. Taking too much of
these drugs will not necessarily improve your condition, and may cause
more side effects. Do not start or stop any medicine without doctor or
pharmacist approval.
OVERDOSE
If overdose is suspected, contact your local poison control center or
emergency room immediately. US residents can call the US national poison
hotline at 1-800-222-1222. Canadian residents should call their local
poison control center directly.
MISSED DOSE
If you miss a dose, use it as soon as you remember. If it is within 2
hours of the next dose, skip the missed dose and resume your usual dosing
schedule. It is important not to miss doses of this drug.
STORAGE
Store at room temperature at 77 degrees F (25 degrees C) away from
light and moisture. Brief storage between 59-86 degrees F (15-30 degrees
C) is permitted. Do not store in bathroom. Keep the desiccant in the
bottle and do not swallow it. Keep all medicines away from children and
pets.
Note : This product information is intended only for residents of the India. Taj Pharmaceuticals Limited, medicines help to treat and prevent a range of conditions—from the most common to the most challenging—for people around the world.