EVIPLERA® INFORMATION FOR PATIENTS
PREFACE You have been prescribed EvipleraÂŽ to treat HIV-infection. This booklet is designed to support you in using Eviplera and to inform you on how it works. This guide is based on the package leaflet supplied with Eviplera and should not be used as a replacement. The package leaflet contains the officially approved text. Your doctor, HIV-consulent and pharmacist are the initial contacts for information. If you have any quastions after reading this booklet, please remember to contact one of them.
Š Gilead Sciences Netherlands BV This text was composed in 2017 with reference to the official package leaflet. No information contained in this document should be disclosed to others without written authorisation of Gilead Sciences Netherlands BV, Claude Debussylaan 22, 1082 MD Amsterdam.
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GETTING STARTED WITH EVIPLERA
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WHAT IS HIV?
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WHAT IS EVIPLERA?
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BE CAREFULL
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OTHER MEDICINES AND EVIPLERA
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HOW DOES EVIPLERA WORK?
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OPTIMAL USE
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ONE TABLET EVERY DAY
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KEEP TRACK
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MISSED A DOSE?
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POSSIBLE SIDE EFFECTS
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PREGNANCY AND BREAST-FEEDING
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CO-INFECTION
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HEALTHY LIFESTYLE
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SEVEN IMPORTANT TIPS
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FREQUENTLY ASKED QUESTIONS
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WHAT IS HIV?
WHAT IS EVIPLERA?
The human immunodeficiency virus (HIV) infects
HIV-infection can be treated with Eviplera.
specific cells of the immune system, known as CD4 cells. Prolonged infection weakens the immune system.
Eviplera causes the viral load to drop, through the
The virus continues to create multiple copies of itself,
inhibition of the viral replication. As a result, virus
causing your CD4 cell count to reduce. As a result, your
replication is reduced and many of the remaining virus
body is less capable of fighting infections and illnesses.
particles are eliminated from the body.
At the same time these infections and illnesses occur,
Eviplera contains a combination of active sunstances in
there is the risk of Acquired Immune Deficiency
one tablet. Also, Eviplera can be taken with certain
Syndrome (AIDS). To prevent AIDS, it is important to
medication for other diseases, however not with all
treat HIV in time with the proper treatment. This allows
medications (see page 9: ‘Other medicines and Eviplera’).
the immune system to continue to do its job. The
This treatment is for use by adults aged 18 years and
primary goal of HIV-treatment is to reduce the amount
older.
of viral particles to an undetectable level (undetectable remain sufficient, i.e. the immune system is more
ACTIVE SUBSTANCES IN EVIPLERA:
transmitted from an infected person to an uninfected
• emtricitabine • rilpivirine
person through body fluids, such as genital fluids
• tenofovirdisoproxil
capable to fight off infections and diseases. HIV can be
INFORMATION FOR PATIENTS
viral load). As a result, the number of CD4 cells will
(semen, pre-seminal fluid, rectal fluids and vaginal fluids) during unprotected sexual contact (vaginal, anal
Emtricitabine, rilpivirine and tenofovirdisoproxil are anti-
and oral), donor semen, donor tissue, blood products,
retroviral medicines. Each Eviplera tablet contains
blood from contaminated needles, or mother to child
200 mg emtricitabine, 25 mg rilpivirine and
during pregnancy, childbirth and breast-feeding.
245 mg tenofovirdisoproxil.
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BE CAREFULL
OTHER MEDICINES AND EVIPLERA
What do you need to know befor taking Eviplera?
DO NOT TAKE EVIPLERA IF: • you have allergic reaction to emtricitabine, rilpivirine, tenofovir disoproxil or any of the other ingredients of this medicine. 2
BE CAREFULL IF: • you had kidney disease, or if test have shown kidney problems; • you have liver problems or a history of liver disease, including hepatitis; • you develop a skin rash with the following symptoms: fever, blisters, redness in your eyes and swelling of your face, mouth or body; • you are over 65 years of age. For additional information, please refer to the package leaflet. If any of these conditions apply to you, tell your doctor, even if he or she has not asked.
Are you taking any other medicines? Eviplera may interact with other medicines. DO NOT TAKE EVIPLERA AND TELL YOUR DOCTOR IMMEDIATELY IF YOU ARE TAKING: • carbamazepine, oxcarbazepine, phenobarbital and phenytoïne, (used to treat epilepsy and prevent seizures • rifampicin en rifapentine (used to treat some bacterial infections such as tuberculosis) • omeprazole, lansoprazole, rabeprazole, pantoprazole and esomeprazole (used to prevent and treat stomach ulcers, heartburn, acis reflux INFORMATION FOR PATIENTS
Restrictions apply to all medications, including Eviplera.
disease) • dexamethasone (a corticosteroid medicine used to treat inflammation and suppress the immune system) when taken by mouth or injected (except as a single dose treatment) • products
that
contain
St.
John’s
wort
(Hypericum Perforatum,a herbal remedy used for depression and anxiety)
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TALK TO YOUR DOCTOR IF YOU ARE TAKING: • Medicines that may damage your kidneys,
• Medicines for stomach ulcers, heartburn or acid reflux such as, antacids (aluminium/magnesium
examples include: aminoglycosides (such as
hydroxide or calcium carbonate), H2-antagonists
streptomycin, neomycin and gentamicin),
(famotidine, cimetidine, nizatidine or ranitidine)
vancomycin (for bacterial infections), foscarnet, ganciclovir, cidofovir (for viral infections), amfotericin B, pentamidine (for fungal infections) interleukin-2, also called aldesleukin (to treat
• Methadone, a medicine used to treat opiate addiction, as your doctor may need to change your methadone dose • Dabigatran-etexilate, a medicine used to treat heart conditions.
cancer), non-steroidal anti-inflammatory drugs (NSAID’s, to relieve bone or muscle pains) • Medicines containing didanosine
nucleoside reverse transcriptase- inhibitors (NNRTI’s) • Rifabutin, a medicine to treat some bacterial infections. • Antibiotics used to treat bacterial infections
• If your taking an antacid, take it at least 2 hours before or at least 4 hours after Eviplera. • If your take an H2-antagonist, take it at least 12 hours befor or at least 4 hours after Eviplera H2-antagonists can only be taken once a day if you take Eviplera. H2-antagonists should not be taken in a twice a day regimen.
INFORMATION FOR PATIENTS
(for HIV infection) • Other medicines used for HIV infection: Non-
including tuberculosis containing: clarithromycin, erythromycin
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Tell your doctor or pharmacist if you are taking, have
HOW DOES EVIPLERA WORK?
recently taken or might take any other medicines. If you
How do you know if your treatment is working well?
are considering stopping your treatment with Eviplera,
In order to determine wheter Eviplera works for
contact your doctor to discuss the possibilities. Do not
you, blood is taken for examination..
stop your treatment without contacting your doctor. Test results can show whether the amount of virus For full details about using Eviplera please refer to the
(viral load) has decreased and the amount of CD4
package leaflet.
cells has increased. You an still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy. Discuss with your doctor the precautions needed
This medicine is not a ure for HIV infetion. While taking Eviplera you may still develop infections or other illmesses associated with HIV infection.
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INFORMATION FOR PATIENTS
to avoid infecting other people.
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OPTIMAL USE
ONE TABLET EVERY DAY
Intake of Eviplera
What to be aware of taking Eviplera?
When you take Eviplera, the active substances enter
Once you have started Eviplera, two things are of
your blood stream through the digestive tract. Eviplera
importance. First, the level of Eviplera in your body must
then diasappears from your blood and you need to take
be maintained. Second, you should immediately talk to
another dose. The recommended dose is one tablet
your doctor if you notice any side effects.
every day. food, at about the same time. Thereby, the risk of
your body to inhibit viral replication. This has two
missing a dose is minimized. However, the absorption
serious disadvantages. First, because there is less
of Eviplera is disrupted if you vomit less than 1 hour
Eviplera, the virus is better able to multiply and
after the intake, or if you suffering from severe
attack the immune system. Second, the virus may
diarrhea. On page 18 ‘Missed a dose?’ you can read
change its shape while multiplying, and the new virus
what to do in these situations.
may become resistant. Choose a convenient time of intake If the virus develops resistance, the active substances in
For instance, when you take Eviplera in the evening
Eviplera are no longer able to effectively inhibit the virus.
during diner, t becomes a habit and the risk of
If consider stopping your treatment with Eviplera, talk to
missing a dose is minimized.4
your doctor or nurse. They can assist you in finding the proper solution.
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INFORMATION FOR PATIENTS
The recommended dose is one tablet every day, with When you miss a dose, less Eviplera is present in
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KEEP TRACK Make sure you keep track At times you may not remember if you have taken your daily dose. If this problem occurs frequently,
Eviplera during your holiday During holidays, daily routines are often broken, especially if you are travelling across time zones.
make sure you set up a monitoring system. For example, use a pill organizer, labelled with the days
If you are travelling to a different time zone, please
of the week, in which you can store your daily dose.
consult your doctor about the best dosing schedule.
There are also daily pill boxes that you attach as a
It is best to maintain the 24 hours interval between doses.
keychain to allow you quick access to spare tablets. Have spare tablets handy Life is full of surprises, and it may happen that you are somewhere else than expected at your scheduled time of intake. Therefore it is important to make sure you
If necessary, set an alarm clock You could set an alarm clock on your mobile phone to remind you to take Eviplera. There are also pill organisers with a built-in alert system.
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INFORMATION FOR PATIENTS
always have some extra tablets with you.
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MISSED A DOSE?
When your supply of Eviplera starts to run low, go to your doctor for a new prescription. This is very
Missed a dose? It is normal to occasionally forget something. It may happen that, despite all good intentions and precautions you still forget to take your mediation. Disuss in advance with your doctor or HIV-consulent what to do in this situation.
important because the amount of virus may start to increase if the medicine is stopped for even a short time. The disease may then become harder to treat. Do not take a double dose to compensate for the missed tablet. If you vomit less than 1 hour after taking Eviplera, take
In general, the following applies:
another tablet with food. If you are suffering from severe diarrhoea, there is a risk that Eviplera is not absorbed or insufficiently absorbed by the body.
Did you miss a dose...
Therefore, contact your doctor if you are suffering from severe diarrhoea for more than two days.
... if you notice after 12 hours or more
Do not stop taking Eviplera without talking to your doctor. When your supply of Eviplera starts to run
take the tablet as soon as possible (with food)
skip the missed dose
WAIT AND TAKE THE NEXT DOSE AT YOUR USUAL TIME (WITH FOOD).
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low, refill your prescription at your pharmacist.
INFORMATION FOR PATIENTS
...if you notice within 12 hours
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POSSIBLE SIDE EFFECTS
Very common side effects (may affect more than 1 in 10 people) • diarrhoea, vomiting, nausea
Like all medicines, Eviplera can cause side effects, although
• difficulty sleeping (insomnia)
this differs between individuals. When treating HIV infection,
• dizziness, headache
it is not always possible to tell whether some of the
• rash
unwanted effects are caused by Eviplera, other medicines
• feeling weak
that you are taking at the same time, or by the HIV disease itself.
Test may also show: • decreases in phosphate levels in the blood
Possible serious side effects • Lactic acidosis (excess lactic acid in the blood). The following may be signs of lactic acidosis: deep, rapid breathing, tiredness or drowsiness, feeling sick (nausea), being sick (vomiting),
• increased levels of creatine kinase in the blood that may result in muscle pain and weakness • increased levels of cholesterol and/or pancreatic amylase in the blood • increased levels of liver enzymes in the blood
• Any signs of inflammation or infetion.
Common side effects (may affect up to 1 in 10 people)
If you notice the side effects described above, tell
• decreased appetite
your doctor immediately.
• depression and depressed mood • tiredness, feeling sleepy • drowsiness • pain, stomach pain or discomfort, feeling bloated, dry mouth
INFORMATION FOR PATIENTS
stomach pain.
• abnormal dreams, sleep disorder • problems with digestion resulting in discomfort after meals, wind (flatulence)
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• rashes (including red spots or blotches sometimes
• breakdown of muscle, muscle pain or weakness
with blistering and swelling f the skin), which may
• swelling of the face, lips, tongue or throat
be allergic reactions, itching, changes in skin colour
• signs or symptoms of inflammation or infection
including darkening of the skin in patches
• severe skin reactions including rash accompanied by
• other allergic reactions, such as wheezing, swelling or feeling light headed
fever, swelling and liver problems • damage to kidney tubule cells
Test may also show
Test may also show:
• low white blood cell count (a reduced white
• decreases in potassium in the blood
blood cell count can make you more prone to
• increases in creatinine in your blood
infection)
• changes to your urine
• low platelet count (a type of blood cell involved in
blood cell count) • increased fatty acids (triglycerides), bilirubin or sugar in the blood • pancreas problems
Rare side effects (may affect up to 1 in 1.000 people) • lactic acidosis • back pain caused by kidney problems, including kidney failure. • fatty liver • yellow skin or eyes, itching or pain in de
Uncommon side effects (may affect up to 1 in 100 people) • anaemia (low red blood cell count) • pain in the abdomen (tummy) caused by inflammation of the pancreas
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abdomen caused by inflammation of the liver • inflammation of the kidney, passing a lot of urine and feeling thirsty • softening of the bones (with bone pain and
INFORMATION FOR PATIENTS
clotting blood) • decrease in haemoglobin in your blood (low red
sometimes resulting in fractures)
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Other effects that may be seen during HIV treatment During HIV therapy there may be an increase in weight and levels of blood lipids and glucose. This is partly
PREGNANCY AND BREAST-FEEDING
linked to restored health and life style, and in case of
You cannot use Eviplera during pregnancy, unless this
blood lipids sometimes to the HIV medicines
is specifically discussed with your doctor.
themselves. Your doctor will test for these changes. Contraception Some patients may develop a bone disease called
Woman are advised to use effective contraception
osteonecrosis (death of bone tissue caused by loss of
while taking Eviplera to avoid pregnancy.
bloof supply to the bone. Signs of osteonecrosis are: • joint stiffness;
Pregnancy
• joint aches and pains (especially of the hip,
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before
• difficulty with movement.
you start taking this medicine.
If you get any side effects, talk to your doctor or
Breast-feeding
pharmacist. This includes any possible side effects not
Do not breast-feed during treatment with Eviplera. Active
listed in the leaflet. You can also report side effects
substances in this medicines are excreted in breast milk.
directly via the national reporting system: Nederlandse Bijwerkingen Centrum Lareb
It is also recommended that you do not breast-feed to
Website: www.lareb.nl
avod passing the virus to the baby through breast milk.
By reporting side effects you can help provide more information on the safety of this medicine.
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INFORMATION FOR PATIENTS
knee and shoulder);
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CO-INFECTION Hepatitis Patients with live 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 are infected with the hepatitis B-virus, your doctor should carefully consider the best treatment regimen for you.
HEALTHY LIFESTYLE Tips for a healthy lifestyle The HIV-virus suppresees your immune system. Although Eviplera reduces this suppression, it is still important to not impose an extra burden on your immune system, and adopt a healthy lifestyle. Live healthy, eat healthy, sleep well.
If you are infected with the hepatitis B-virus and stop
HEALTHY LIFESTYLE
taking Eviplera, you may put yourself at risk of severe
• perform physical activity (e.g. walking,
acute liver complications. It is therefore important to not stop taking Eviplera without talking to your doctor.
playing sports, cycling) on regular basis • do relaxation exercises (e.g. yoga) • eat fruits and vegetables • limit or avod the use of alcohol and recreational drugs SLEEP WELL • maintain a regular sleep pattern • relax before going to bed (e.g. reading, a hot bath) • do not work out before going to bed • do not drink coffee or eat chocolate in the evening • do not eat a large meal before going to bed
INFORMATIION FOR PATIENTS
• quit smoking
• ensure a dark, quiet bedroom (use earplugs if necessary) • do not oversleep
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SEVEN IMPORTANT TIPS 1.
Take one tablet at about the same time every day.
If you are taking an antacid
This makes it easier to remember your daily intake
(aluminium/magnesium hydroxide or calcium
of Eviplera. For example, take Eviplera every day
carbonate), take it at least 2 hours before, or at
with a particular meal.
least 4 hours after Eviplera. If you are taking an H2-antagonist (famotidine, cimetidine, nizatidine
2.
Take one tablet every day with food (breakfast,
or ranitidine), take it at least 12 hours before or at
lunch or dinner).
least 4 hours after Eviplera. H2-antagonists can only be taken once a day if you take Eviplera.
3.
Do not chew, crush or split the tablet.
4.
If you vomit less then 1 hour after taking Eviplera,
home. Remember to request for a prescription refill
take another tablet. When in doubt, always contact
in time. If you leave home or travelling, always take
your doctor or HIV-consulent.
Eviplera with you.
7.
5.
Make sure you always have a supply of Eviplera at
It is important not to miss a dose of Eviplera. If you do miss a dose: IMPORTANT TIPS
• If you notice within 12 hours of the time you usually take Eviplera, you must take the tablet with food as soon as possible. Then take the next dose as usual. • If you notice 12 hours or more after the time you usually take Eviplera, then do not take the missed dose. Wait and take the next dose, with food, at your usual time. 6.
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Why have I been prescribed this medicine?
Eviplera reduces the amount of viral particles by inhibiting
Eviplera is an anti-human immunodefiency virus (HIV)
the replication of the virus. The treatment is successful if the
medicine. This means that this medicine contributes to
amount of viral particles (viral load) in your blood is reduced
the treatment of HIV-infection. It helps prevent the HIV
to a undetectable level. Then, the number of CD4 cells will
from replicating and creating copies of itself, and slows
increase, i.e. the immune system recovers from its weakened
down the progression of the disease.
state.
What does my medicine look like?
What are the ingredients of Eviplera?
Eviplera tablets are purplish-pink, capsuleshaped
Eviplera contains three active substances: emtricitabine,
tablets, debossed on one side with “GSI� and plain on
rilpivirine and tenofovirdisoproxil. Each tablet contains
the other side. Eviplera comes in bottes of 30 tablets,
200 mg emtricitabine, 25 mg rilpivirine and 245 mg
and a silica gel desiccant (that must be kept in the
tenofovirdisoproxil.
bottle to help protect your tablet). The silica gel desiccant is packaged in a separate sachet or canister
Does this medicine cure HIV?
and should not be swallowed.
No, this medicine is not a cure for HIV-infection. To control your HIV-infection and infections or other
How does this medicine work?
illnesses associated with HIV-infection, you should
HIV infects specific cells of the immune system and
always take this medication exactly as your doctor has
therefore weakens the immune system. The HIV-virus
prescribed it
creates multiple copies of itself that continue to
FREQUENTLY ASKED QUESTIONS
FREQUENTLY ASKED QUESTIONS
weaken the immune system. As a result, your body is less capable of fighting infections and illnesses. 2
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Who can prescribe Eviplera?
How do I take my medicine?
Eviplera is prescribed medicine that can only be prescribed
Always take this medication exactly as your doctor
by a healthcare professional. You should only take this
has prescribed it. Check with your doctor or
medication if it has been prescribed by your doctor.
pharmacist if you are not sure. The recommended daily intake is one tablet every day with food. Do
When should I not take this medication?
not chew, crush or split the tablet. If you take an
If you are allergic to emtricitabine, rilpivirine,
antacid, take it at least 2 hours before or at least 4
tenofovirdisoproxil or any of the other ingredients in
hours after Eviplera. If you take an H2-antagonist,
this medicine (you can find all ingredients in the
take it at least 12 houors before or at least 4 hours
package leaflet) or if you use any of the other
after Eviplera. H2-antagonists can only be taken
medicines mentioned on page 9 in the section ÍžOther medicines and EvipleraÍ&#x;.
once a day if you take Eviplera .
Store Eviplera in its original packaging to protect from
HIV to other people?
moisture. Keep the bottle tightly closed. Keep the tablets
You can still transmit HIV when taking this medicines,
out of sight and reach of children. Do not use this
although the risk is lowered by effective antiretroviral
medication after the expiry date. Ask your pharmacist how
therapy. Discuss with your doctor the precautions
to throw away medicines you no longer use.
FREQUENTLY ASKED QUESTIONS
How should I store this medicine? Does my medicine reduce the risk of me transmitting
needed to avoid infecting other people. This medicine is not a cure for HIV-infection. While taking Eviplera you may still develop infections or other illnesses associated with HIV-infection.
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What do I need to tell my doctor before I start
Is it possible to experience serious side effects while
taking this medicine?
taking Eviplera?
Tell your doctor or pharmacist if you are taking, have recently
Yes. You should look out for symptoms of inflammation,
taken or are going to take any other medicines. Tell your doctor
infection or lactic acidosis, such as deep, rapid breathing,
if you are allergic to any of the ingredients (see package leaflet
tiredness or drowsiness, feeling sick (nausea), being sick
for a full list) or if you are pregnant, are likely to become
(vomiting), stomach pain. If you notice one of these
pregnant or if you are breastfeeding.
symptoms, please tell your doctor immediately. For more information, please refer to the package leaflet.
Also tell your doctor if you have kidney problems, liver problems, or a history of liver disease, including hepatitis.
What do I do if I miss a dose of my medicine?
Can this medicine cause side effects? As with all medicines, you may get side effects. On page 20
notice within 12 hours of the time you usually take your
you will find possible side effects. For a full list of side
Take the tablet with food and then take the next dose at
effects, please refer to the package leaflet that is supplied
the usual time. If you notice 12 hours or more after the
with your medication. If you notice any side effects, talk to
time you usually take Eviplera, then do not take the
your doctor or pharmacist. This includes any possible side
missed dose. Wait and take the next dose at your usual
effects not listed in the package leaflet.
time. If you vomit less than 1 hour after taking your
FREQUENTLY ASKED QUESTIONS
It is important to not miss a dose of Eviplera. If you medication, take the tablet as soon as you remember.
medication, take another tablet. Do not stop taking Eviplera without first talking to your doctor.
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NOTES Should I take this medicine if I am pregnant or if I am breast-feeding? If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Use effective contraception while taking Eviplera to avoid getting pregnant. Do not breast-feed during treatment with this medicine. This is because some of the active substances in this medicine are excreted in breast milk. It is also recommended that you do not breast-feed to avoid transmitting the virus to the baby through
NOTES
breast milk.
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NOTES
NOTES
NOTES
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188/NL/17-06//1015 Date of preparation: August 2017
REFERENCES 1. Package leaflet Eviplera. www.geneesmiddeleninformatiebank.nl/ 2. Rijksinstituut voor Volksgezondheid en Milieu. Ministerie van Volksgezondheid, Welzijn en Sport. LCI guideline hiv infection. Verkregen op 11 februari 2016, van https://lci.rivm.nl/richtlijnen/hivinfectie 3. Living with HIV and aids. www.nhs.uk/Conditions/HIV/Pages/living-with.aspx. 4. Compliance. www.rivm.nl/Documenten_en_publicaties/Professioneel_ Praktisch/Stappenplannen/Infectieziekten/VSI/VSI_Hiv