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EMTRICITABINE/ TENOFOVIR DISOPROXIL APOTEX EUROPE BV 200 MG/245 MG FILM-COATED TABLETS

Active substance(s): EMTRICITABINE / TENOFOVIR DISOPROXIL

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Emtricitabine/ Tenofovir disoproxil 200 mg/245 mg filmcoated tablets
Module 1.3

Product Information

Version: 2017-04

Module 1.3.1

Patient Information Leaflet

Replaces : 2016-09

Package leaflet: Information for the user
Emtricitabine/ Tenofovir disoproxil 200 mg/245 mg film-coated tablets
Emtricitabine/tenofovir disoproxil

Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Emtricitabine/ Tenofovir disoproxil Tablet is and what it is used for
2. What you need to know before you take Emtricitabine/ Tenofovir disoproxil Tablet
3. How to take Emtricitabine/ Tenofovir disoproxil Tablet
4. Possible side effects
5. How to store Emtricitabine/ Tenofovir disoproxil Tablet
6. Contents of the pack and other information

1. What Emtricitabine/ Tenofovir disoproxil Tablet is and what it is used for
Emtricitabine/ Tenofovir disoproxil Tablet contains two active substances, emtricitabine and
tenofovir disoproxil. Both of these active substances are antiretroviral medicines which are used
to treat HIV infection. Emtricitabine is a nucleoside reverse transcriptase inhibitor and tenofovir
is a nucleotide reverse transcriptase inhibitor. However, both are generally known as NRTIs and
they work by interfering with the normal working of an enzyme (reverse transcriptase) that is
essential for the virus to reproduce itself.
Emtricitabine/ Tenofovir disoproxil Tablet is used to treat Human Immunodeficiency Virus
1 (HIV-1) infection, in adults aged 18 years and over.
 Emtricitabine/ Tenofovir disoproxil Tablet should always be used combined with other
medicines to treat HIV infection.
 Emtricitabine/ Tenofovir disoproxil Tablet can be administered in place of emtricitabine
and tenofovir disoproxil used separately at the same doses.
People who are HIV positive can still pass on HIV when taking this medicine, although the risk
is lowered by effective antiretroviral therapy. Discuss with your doctor the precautions needed to
avoid infecting other people.
This medicine is not a cure for HIV infection. While taking Emtricitabine/ Tenofovir disoproxil
Tablet you may still develop infections or other illnesses associated with HIV infection.

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Emtricitabine/ Tenofovir disoproxil Tablet is also used to reduce the risk of getting
HIV-1 infection, when used as a daily treatment, together with safer sex practices:
See section 2 for a list of precautions to take against HIV infection.

2. What you need to know before you take Emtricitabine/ Tenofovir disoproxil Tablet
Do not take Emtricitabine/ Tenofovir disoproxil Tablet to treat HIV or to reduce risk of
getting HIV If you are allergic to emtricitabine, tenofovir, tenofovir disoproxil fumarate, or any
of the other ingredients of this medicine (listed in section 6).
→ If this applies to you, tell your doctor immediately.
Before taking Emtricitabine/ Tenofovir disoproxil Tablet to reduce the risk of getting HIV:
Emtricitabine/ Tenofovir disoproxil Tablet can only help reduce your risk of getting HIV before
you are infected.


You must be HIV negative before you start to take Emtricitabine/ Tenofovir disoproxil
Tablet to reduce the risk of getting HIV. You must get tested to make sure that you do not
already have HIV infection. Do not take Emtricitabine/ Tenofovir disoproxil Tablet to reduce
your risk unless you are confirmed to be HIV negative. People who do have HIV must take
Emtricitabine/ Tenofovir disoproxil Tablet in combination with other drugs.



Many HIV tests can miss a recent infection. If you get a flu-like illness, it could mean you
have recently been infected with HIV.
These may be signs of HIV infection:
 tiredness
 fever
 joint ot muscle aches
 headache
 vomiting or diarrhoea
 rash
 night sweats
 enlarged lymph nodes in the neck or groin
→ Tell your doctor about any flu-like illness – either in the month before stating
Emtricitabine/ Tenofovir disoproxil Tablet, or at any time while taking Emtricitabine/
Tenofovir disoproxil Tablet.

Warnings and Precautions
While taking Emtricitabine/ Tenofovir disoproxil Tablet to reduce the risk of getting HIV:

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Take Emtricitabine/ Tenofovir disoproxil Tablet every day to reduce your risk, not just
when you think you have been at risk of HIV infection. Do not miss any doses of
Emtricitabine/ Tenofovir disoproxil Tablet, or stop taking it. Missing doses may increase your
risk of getting HIV infection.



Get tested for HIV regularly.



If you think you were infected with HIV, tell your doctor straight away. They may want to do
more tests to make sure you are still HIV negative.



Just taking Emtricitabine/ Tenofovir disoproxil Tablet may not stop you getting HIV.
 Always practice safer sex. Use condoms to reduce contact with semen, vaginal fluids,
or blood.
 Do not share personal items that can have blood or body fluids on them, such as
toothbrushes and razor blades. Do not share or re-use needles or other injection or
drug equipment.
 Get tested for other sexually transmitted infections such as syphilis and gonorrhoea.
These infections make it easier for HIV to infect you.

Ask your doctor if you have any more questions about how to prevent getting HIV or spreading
HIV to other people.
While taking Emtricitabine/ Tenofovir disoproxil Tablet to treat HIV or to reduce the risk
of getting HIV:


Emtricitabine/ Tenofovir disoproxil Tablet may affect your kidneys. Before and during
treatment, your doctor may order blood tests to measure kidney function. Tell your doctor if
you have had kidney disease, or if tests have shown kidney problems. If you have kidney
problems, your doctor may advise you to stop taking Emtricitabine/ Tenofovir disoproxil
Tablet or, if you already have HIV, to take Emtricitabine/ Tenofovir disoproxil Tablet less
frequently. Emtricitabine/ Tenofovir disoproxil Tablet is not recommended if you have severe
kidney disease or are on dialysis.
Bone problems (sometimes resulting in fractures) may also occur due to damage to kidney
tubule cells (see section 4, Possible side effects).



Talk to your doctor if you have a history of liver disease, including hepatitis. Patients
infected with HIV who also have liver disease (including chronic hepatitis B or C), who are
treated with antiretrovirals, have a higher risk of severe and potentially fatal liver
complications. If you have hepatitis B or C, your doctor will carefully consider the best
treatment regimen for you.



Know your hepatitis B virus (HBV) infection status before starting Emtricitabine/
Tenofovir disoproxil Tablet. If you have HBV, there is a serious risk of liver problems when
you stop taking Emtricitabine/ Tenofovir disoproxil Tablet, whether or not you also have

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HIV. It is important not to stop taking Emtricitabine/ Tenofovir disoproxil Tablet without
talking to your doctor: see section 3, Do not stop taking Emtricitabine/ Tenofovir disoproxil
Tablet.



Talk to your doctor if you are over 65. Emtricitabine/ Tenofovir disoproxil Tablet has not
been studied in patients over 65 years of age.

Children and adolescents
Emtricitabine/ Tenofovir disoproxil Tablet is not for use in children and adolescents under 18
years of age.
Other medicines and Emtricitabine/ Tenofovir disoproxil Tablet
Do not take Emtricitabine/ Tenofovir disoproxil Tablet if you are already taking other
medicines that contain the components of Emtricitabine/ Tenofovir disoproxil Tablet,
(emtricitabine and tenofovir disoproxil fumarate), or any other antiviral medicines that contain
tenofovir alafenamide, lamivudine or adefovir dipivoxil.
Taking Emtricitabine/ Tenofovir disoproxil Tablet with other medicines that can damage
your kidneys: It is especially important to tell your doctor if you are taking any of these
medicines including
 aminoglycosides (for bacterial infection)
 amphotericin B (for fungal infection)
 foscarnet (for viral infection)
 ganciclovir (for viral infection)
 pentamidine (for infections)
 vancomycin (for bacterial infection)
 interleukin-2 (to treat cancer)
 cidofovir (for viral infection)
 non-steroidal anti-inflammatory drugs (NSAIDs, to relieve bone or muscle pains)
If you are taking another antiviral medicine called a protease inhibitor to treat HIV, your doctor
may order blood tests to closely monitor your kidney function.
It is also important to tell your doctor if you are taking ledipasvir/sofosbuvir to treat hepatitis C
infection.
Taking Emtricitabine/ Tenofovir disoproxil Tablet with Other medicines containing
didanosine (for treatment of HIV infection): Taking Emtricitabine/ Tenofovir disoproxil Tablet
with other antiviral medicines that contain didanosine can raise the levels of didanosine in your
blood and may reduce CD4 cell counts. Rarely, inflammation of the pancreas and lactic acidosis

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(excess lactic acid in the blood), which sometimes causes death, have been reported when
medicines containing tenofovir disoproxil fumarate and didanosine were taken together. Your
doctor will carefully consider whether to treat you with combinations of tenofovir and didanosine.
→ Tell your doctor if you are taking any of these medicines. Tell your doctor or pharmacist if
you are taking, have recently taken or might take any other medicines
Emtricitabine/ Tenofovir disoproxil Tablet with food and drink


Whenever possible, Emtricitabine/ Tenofovir disoproxil Tablet should be taken with food.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before taking this medicine.


Although there are limited clinical data on the use of Emtricitabine/ Tenofovir disoproxil
Tablet in pregnant women, it is not usually used unless absolutely necessary.



If you are a woman who could get pregnant during treatment with Emtricitabine/ Tenofovir
disoproxil Tablet, you must use an effective method of contraception to avoid becoming
pregnant.



If you become pregnant, or plan to become pregnant, ask your doctor about the potential
benefits and risks of therapy with Emtricitabine/ Tenofovir disoproxil Tablet to you and your
child.

If you have taken Emtricitabine/ Tenofovir disoproxil Tablet during your pregnancy, your doctor
may request regular blood tests and other diagnostic tests to monitor the development of your
child. In children whose mothers took NRTIs during pregnancy, the benefit from the protection
against HIV outweighed the risk of side effects.


Do not breast-feed during treatment with Emtricitabine/ Tenofovir disoproxil Tablet.
This is because the active substances in this medicine pass into human breast milk.



If you are a woman with HIV it is recommended that you do not breast-feed, to avoid passing
the virus to the baby in breast milk.

Driving and using machines
Emtricitabine/ Tenofovir disoproxil Tablet can cause dizziness. If you feel dizzy while taking
Emtricitabine/ Tenofovir disoproxil Tablet, do not drive and do not use any tools or machines.
Emtricitabine/ Tenofovir disoproxil Tablet contains lactose

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Tell your doctor if you are lactose-intolerant or intolerant to other sugars. If you know you
are lactose-intolerant, or if you have been told that you have an intolerance to any other sugars,
talk to your doctor before taking this medicine.
3. How to take Emtricitabine/ Tenofovir disoproxil Tablet


Always take this medicine exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.

The recommended dose of Emtricitabine/ Tenofovir disoproxil Tablet to treat HIV or to
reduce the risk of getting HIV is:


Adults: one tablet each day. Whenever possible, Emtricitabine/ Tenofovir disoproxil Tablet
should be taken with food.

If you have difficulty swallowing, you can use the tip of a spoon to crush the tablet. Then mix the
powder with about 100 ml (half a glass) of water, orange juice or grape juice, and drink
immediately.


Always take the dose recommended by your doctor. This is to make sure that your
medicine is fully effective, and to reduce the risk of developing resistance to the treatment.
Do not change the dose unless your doctor tells you to.



If you are being treated for HIV infection your doctor will prescribe Emtricitabine/
Tenofovir disoproxil Tablet with other antiretroviral medicines. Please refer to the patient
information leaflets of the other antiretrovirals for guidance on how to take those medicines.



If you are taking Emtricitabine/ Tenofovir disoproxil Tablet to reduce the risk of getting
HIV, take Emtricitabine/ Tenofovir disoproxil Tablet every day, not just when you think you
have been at risk of HIV infection.

Ask your doctor if you have any questions about how to prevent getting HIV or prevent spreading
HIV to other people.

If you take more Emtricitabine/ Tenofovir disoproxil Tablet than you should
If you accidentally take more than the recommended dose of Emtricitabine/ Tenofovir disoproxil
Tablet, contact your doctor or nearest emergency department for advice. Keep the tablet bottle
with you so that you can easily describe what you have taken.
If you miss a dose
It is important not to miss a dose of Emtricitabine/ Tenofovir disoproxil Tablet.

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If you notice within 12 hours of the time you usually take Emtricitabine/ Tenofovir
disoproxil Tablet, take the tablet preferably with food as soon as possible. Then take the next
dose at your usual time.
If you notice 12 hours or more after the time you usually take Emtricitabine/ Tenofovir
disoproxil Tablet, forget about the missed dose. Wait and take the next dose, preferably with
food, at your usual.

If you vomit less than 1 hour after taking Emtricitabine/ Tenofovir disoproxil Tablet, take
another tablet. You do not need to take another tablet if you were sick more than 1 hour after
taking Emtricitabine/ Tenofovir disoproxil Tablet.
Do not stop taking Emtricitabine/ Tenofovir disoproxil Tablet


If you take Emtricitabine/ Tenofovir disoproxil Tablet for treatment of HIV
infection, stopping tablets may reduce the effectiveness of the anti-HIV therapy
recommended by your doctor.



If you are taking Emtricitabine/ Tenofovir disoproxil Tablet to reduce the risk of
getting HIV, do not stop taking Emtricitabine/ Tenofovir disoproxil Tablet or miss any
doses. Stopping use Emtricitabine/ Tenofovir disoproxil Tablet, or missing doses, may
increase your risk of getting HIV infection.

→ Do not stop taking Emtricitabine/ Tenofovir disoproxil Tablet without contacting
your doctor.


If you have hepatitis B, it is especially important not to stop your Emtricitabine/ Tenofovir
disoproxil Tablet treatment without talking to your doctor first. You may require blood tests
for several months after stopping treatment. In some patients with advanced liver disease or
cirrhosis, stopping treatment is not recommended as this may lead to worsening of your
hepatitis, which may be life threatening.
→ Tell your doctor immediately about new or unusual symptoms after you stop treatment,
particularly symptoms you associate with hepatitis B infection.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Possible serious side effects:

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Lactic acidosis (excess lactic acid in the blood) is a rare but potentially life-threatening side
effect. Lactic acidosis occurs more often in women, particularly if they are overweight, and in
people with liver disease. The following may be signs of lactic acidosis:
 deep rapid breathing
 drowsiness
 feeling sick (nausea), being sick (vomiting)
 stomach pain


If you think you may have lactic acidosis, get medical help immediately.



Any signs of inflammation or infection. In some patients with advanced HIV infection
(AIDS) and a history of opportunistic infections (infections that occur in people with a weak
immune system), signs and symptoms of inflammation from previous infections may occur
soon after anti-HIV treatment is started. It is thought that these symptoms are due to an
improvement in the body’s immune response, enabling the body to fight infections that may
have been present with no obvious symptoms.



Autoimmune disorders, when the immune system attacks healthy body tissue, may also
occur after you start taking medicines to treat HIV infection. Autoimmune disorders may
occur many months after the start of treatment. Look out for any symptoms of infection or
other symptoms such as:
 muscle weakness
 weakness beginning in the hands and feet and moving up towards the trunk of the
body
 palpitations, tremor or hyperactivity

If you notice these or any symptoms of inflammation or infection, get
medical help immediately.

Possible side effects
Very common side effects
(may affect more than 1 in 10 people)
 diarrhoea, being sick (vomiting), feeling sick (nausea)
 dizziness, headache
 rash
 feeling weak
Tests may also show:
 decreases in phosphate in the blood
 increased creatine kinase
Common side effects
(may affect up to 1 in 10 people)

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pain, stomach pain
difficulty sleeping, abnormal dreams
problems with digestion resulting in discomfort after meals, feeling bloated, flatulence
rashes (including red spots or blotches sometimes with blistering and swelling of the skin),
which may be allergic reactions, itching, changes in skin colour including darkening of the
skin in patches
other allergic reactions, such as wheezing, swelling or feeling light-headed

Tests may also show:
 low white blood cell count (a reduced white blood cell count can make you more prone to
infection)
 increased triglycerides (fatty acids), bile or sugar in the blood
 liver and pancreas problems
Uncommon side effects
(may affect up to 1 in 100 people)
 pain in the abdomen (tummy) caused by inflammation of the pancreas
 swelling of the face, lips, tongue or throat
 anaemia (low red blood cell count)
 breakdown of muscle, muscle pain or weakness which may occur due to damage to the
kidney tubule cells
Tests may also show:





decreases in potassium in the blood
increased creatinine in your blood
changes to your urine

Rare side effects:
(may affect up to 1 in 1,000 people)
 Lactic acidosis (see Possible serious side effects)
 fatty liver
 yellow skin or eyes, itching, or pain in the abdomen (tummy) caused by inflammation of the
liver
 inflammation of the kidney, passing a lot of urine and feeling thirsty, kidney failure, damage
to kidney tubule cells
 softening of the bones (with bone pain and sometimes resulting in fractures)
 back pain caused by kidney problems

Damage to kidney tubule cells may be associated with breakdown of muscle, softening of the
bones (with bone pain and sometimes resulting in fractures), muscle pain, muscle weakness and
decreases in potassium or phosphate in the blood.

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If you notice any of the side effects listed above or if any of the side effects get
serious, talk to your doctor or pharmacist.
The frequency of the following side effects is not known.
 Bone problems. Some patients taking combination antiretroviral medicines such as Truvada
may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood
supply to the bone). Taking this type of medicine for a long time, taking corticosteroids,
drinking alcohol, having a very weak immune system, and being overweight, may be some of
the many risk factors for developing this disease. Signs of osteonecrosis are:
 joint stiffness
 joint aches and pains (especially of the hip, knee and shoulder)
 difficulty with movement
→ If you notice any of these symptoms tell your doctor.
During treatment for HIV there may be an increase in weight and in levels of blood lipids and
glucose. This is partly linked to restored health and life style, and in the case of blood lipids
sometimes to the HIV medicines themselves. Your doctor will test for these changes.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information
on the safety of this medicine.
5. How to store Emtricitabine/ Tenofovir disoproxil Tablet
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle and carton after
{EXP}. The expiry date refers to the last day of that month.
Store below 25°C. Store in the original package in order to protect from moisture.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how
to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Emtricitabine/ Tenofovir disoproxil Tablet contains


The active substances are emtricitabine and tenofovir disoproxil. Each Emtricitabine/
Tenofovir disoproxil film-coated tablet contains 200 mg of emtricitabine and 245 mg of
tenofovir disoproxil (equivalent to 300 mg of tenofovir disoproxil fumarate or 136 mg of
tenofovir).

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The other ingredients are Lactose Anhydrous, Magnesium stearate, Silica-Colloidal
Anhydrous, Crospovidone, Macrogol 8000, Talc E553b, Titanium Dioxide E171, Indigo
carmine aluminium lake 12-14 % (FD&C Blue No.2) (E132), Polyvinyl Alcohol EG-05PW.

What Emtricitabine/ Tenofovir disoproxil Tablet looks like and contents of the pack
Emtricitabine/ Tenofovir disoproxil film-coated tablets are Blue, capsule shaped, biconvex coated
tablets. Engraved “APO” on one side “E-T” on the other side.
Emtricitabine/ Tenofovir disoproxil 200mg/245mg film-coated tablets are supplied in HDPE
bottles with polypropylene child-resistant cap as well as PVC/Aclar film and aluminium foil
blisters of 30 tablets. Each bottle contains a 1 g 50/50 Silica/Activated Carbon StripPax desiccant
that must be kept in the bottle to help protect your tablets. The 1 g 50/50 Silica/Activated Carbon
StripPax desiccant is contained in a separate canister and should not be swallowed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Apotex Europe B.V.
Darwinweg 20, 2333 CR, Leiden, The Netherlands
Manufacturer
Apotex Inc. (Signet Site)
150 Signet Drive, Toronto, Ontario M9L 1T9, Canada
Apotex Nederland BV
Archimedesweg 2, 2333 CN Leiden, The Netherlands
This medicinal product is authorized in the Member States of the EEA under the following
names:
Germany:
Italy:
Spain:
The Netherlands:
United Kingdom:

Emtricitabin/ Tenofovirdisoproxil Apotex Europe BV 200 mg/245 mg,
Filmtabletten
Emtricitabina e Tenofovir disoproxil Apotex Europe BV
Emtricitabina/Tenofovir disoproxil Apotex Europe BV AG 200mg/245mg
comprimidos recubiertos con película EFG
Emtricitabine/ Tenofovirdisoproxil Apotex Europe BV 200 mg/245 mg,
filmomhulde tabletten
Emtricitabine/Tenofovir disoproxil Apotex Europe BV 200 mg/245 mg,
film-coated tablets

This leaflet was last revised in 04/2017.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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