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DUOMEVOLEN 200 MG/245 MG FILM-COATED TABLETS

Active substance(s): EMTRICITABINE / TENOFOVIR DISOPROXIL PHOSPHATE

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Duomevolen (Emtricitabine/Tenofovir disoproxil) 200/245 mg Tablets - PIL - UK

• Just taking Duomevolen 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.

Package leaflet: Information for the user

Duomevolen 200 mg/245 mg
film-coated tablets

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

emtricitabine/tenofovir disoproxil

Duomevolen 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.
• Duomevolen is used to treat Human Immunodeficiency Virus 1 (HIV-1) infection in
adults.
• It is also used to treat HIV in adolescents aged 12 to less than 18 years who weigh at
least 35 kg, and who have already been treated with other HIV medicines that are no longer
effective or have caused side effects.
− Duomevolen should always be used combined with other medicines to treat HIV infection.
− This medicine 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 Duomevolen you may still develop
infections or other illnesses associated with HIV infection.
• Duomevolen is also used to reduce the risk of getting HIV-1 infection in adults, 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 Duomevolen
Do not take Duomevolen if you are allergic to emtricitabine, tenofovir, tenofovir disoproxil
phosphate, or any of the other ingredients of this medicine (listed in section 6).
 If this applies to you, tell your doctor immediately.

• Know your hepatitis B virus (HBV) infection status before starting Duomevolen. If you have
HBV, there is a serious risk of liver problems when you stop taking Duomevolen, whether or
not you also have HIV. It is important not to stop taking Duomevolen without talking to your
doctor : see section 3, Do not stop taking Duomevolen.

• You must be HIV negative before you start to take Duomevolen 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 Duomevolen to reduce your risk unless you are confirmed to be HIV negative. People
who do have HIV must take Duomevolen in combination with other medicines.
• 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 or 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 starting
Duomevolen, or at any time while taking Duomevolen.

While taking Duomevolen to reduce the risk of getting HIV:
• Take Duomevolen 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 this medicine, 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.

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Duomevolen contains phosphate
This product contains 46 mg phosphate per tablet. Tell your doctor if you cannot take phosphates
or if you are on a reduced phosphate diet.

3. How to take Duomevolen
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 Duomevolen to treat HIV is:
• Adults: one tablet each day. Where possible, with food.
• Adolescents aged 12 to less than 18 years who weigh at least 35 kg: one tablet each day,
whenever possible with food.

Children and adolescents

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.

Duomevolen is not for use in children under 12 years of age.
Other medicines and Duomevolen
Do not take this medicine if you are already taking other medicines that contain the components
of Duomevolen (emtricitabine and tenofovir disoproxil phosphate) or any other antiviral medicines
that contain tenofovir alafenamide, lamivudine or adefovir dipivoxil.
Taking Duomevolen 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.

• Other medicines containing didanosine (for treatment of HIV infection): Taking Duomevolen
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 (excess lactic acid in the blood), which sometimes causes death, have been reported
when medicines containing tenofovir disoproxil 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.
Duomevolen with food and drink
Whenever possible, this medicine should be taken with food.
Pregnancy and breast-feeding
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.
Pregnancy
Although there are limited clinical data on the use of Duomevolen in pregnant women, it is not
usually used unless absolutely necessary.

Warnings and precautions
Talk to your doctor or pharmacist before taking Duomevolen.

Duomevolen contains lactose
Tell your doctor if you are lactose-intolerant or intolerant to other sugars.

The recommended dose of Duomevolen to reduce the risk of getting HIV is:

• Ledipasvir/sofosbuvir or sofosbuvir/velpatasvir to treat hepatitis C infection.

Duomevolen can only help reduce your risk of getting HIV before you are infected.

Duomevolen can cause dizziness. If you feel dizzy while taking this medicine, do not drive nor use
any tools or machines.

Elderly
Talk to your doctor if you are over 65. This medicine has not been studied in patients over 65 years
of age.

It is also important to tell your doctor if you are taking :

Before taking Duomevolen to reduce the risk of getting HIV:

Date: 19/08/17

• Duomevolen 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. Duomevolen should not be given to adolescents with
existing kidney problems. If you have kidney problems, your doctor may advise you to stop
taking Duomevolen or, if you already have HIV, to take Duomevolen less frequently.
Duomevolen is not recommended if you have severe kidney disease or are on dialysis.

• 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.

1. What Duomevolen is and what it is used for

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Breast-feeding
Do not breast-feed during treatment with Duomevolen. 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.

While taking Duomevolen to treat HIV or to reduce the risk of getting HIV:

Bone problems (sometimes resulting in fractures) may also occur due to damage to kidney
tubule cells (see section 4. Possible side effects).

What is in this leaflet
1. What Duomevolen is and what it is used for
2. What you need to know before you take Duomevolen
3. How to take Duomevolen
4. Possible side effects
5. How to store Duomevolen
6. Contents of the pack and other information

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If you have taken Duomevolen 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.

Driving and using machines

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.

Duomevolen 200 mg/245 mg
Filmtabletten

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

• Adults: one tablet each day, whenever possible with food.

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 Duomevolen 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 an adult taking Duomevolen to reduce the risk of getting HIV, take Duomevolen
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 Duomevolen than you should
If you accidentally take more than the recommended dose of this medicine, 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 forget to take Duomevolen
It is important not to miss a dose of Duomevolen.
• If you notice within 12 hours of the time you usually take Duomevolen, 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 Duomevolen, forget about the
missed dose. Wait and take the next dose, preferably with food, at your usual time.
If you vomit less than 1 hour after taking Duomevolen, take another tablet. You do not need to
take another tablet if you were sick more than 1 hour after taking this medicine.
Do not stop taking Duomevolen
• If you take this medicine for treatment of HIV infection, stopping tablets may reduce the
effectiveness of the anti-HIV therapy recommended by your doctor.
• If you are taking this medicine to reduce the risk of getting HIV, do not stop taking it or miss
any doses. Stopping use of Duomevolen, or missing doses, may increase your risk of getting
HIV infection.
 Do not stop taking this medicine without contacting your doctor.
• If you have hepatitis B, it is especially important not to stop your treatment with this medicine
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.

If you become pregnant, or plan to become pregnant, ask your doctor about the potential benefits
and risks of therapy with Duomevolen to you and your child.

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Duomevolen (Emtricitabine/Tenofovir disoproxil) 200/245 mg Tablets - PIL - UK

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible serious side effects:
• 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.
Other side effects
Very common
(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
(may affect up to 1 in 10 people):
• 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
(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

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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.
Other effects in children
• Children given emtricitabine very commonly experienced changes in skin colour including
• darkening of the skin in patches
• Children commonly experienced low red blood cell count (anaemia).
• this may cause the child to be tired or breathless
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.
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 via the Yellow Card Scheme,
Website: 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 Duomevolen
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.
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 Duomevolen contains
• The active substances are emtricitabine and tenofovir disoproxil (as the phosphate salt).
Each film-coated tablet contains 200 mg of emtricitabine and 245 mg of tenofovir disoproxil
(equivalent to 291 mg of tenofovir disoproxil phosphate or 136 mg of tenofovir).
• The other ingredients are microcrystalline cellulose (E460), mannitol ( E421), croscarmellose
sodium, colloidal anhydrous silica, stearic acid ( E570), lactose monohydrate, hypromellose
(E464), titanium dioxide (E171), Triacetin [ E1518] and indigo carmine aluminium lake (E132).
What Duomevolen looks like and contents of the pack
Duomevolen are blue coloured, oval shaped, biconvex, film-coated tablets plain on both sides.
Duomevolen is supplied in white plastic bottles. Each bottle contains one or more silica gel sachets
depending on the pack size. The sachets must be kept in the bottle to help protect your tablets and
should not be swallowed.
The following pack sizes are available:
Outer cartons containing 1 bottle of 30 film - coated tablets, 3 bottles of 30 film-coated tablets (90
tablets) and 1 bottle of 90 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Amneal Pharma Europe Limited
70 Sir John Rogerson’s Quay
Dublin 2, Ireland
Manufacturer:
Lupin (Europe) Limited
Victoria Court,
Bexton Court,
Knutsford, Cheshire,
UK
This leaflet was last revised in August 2017

Rare
(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.
Not known (frequency cannot be estimated from the available data):
• Bone problems. Some patients taking combination antiretroviral medicines such as
Duomevolen 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

Packinsert Size : 450 x 390 mm, Folding Size: 80 x 45 mm, Colours:
Date: 19/08/17

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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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