STRIBILD® INFORMATION FOR PATIENTS
PREFACE You have been prescribed StribildÂŽ to treat HIV-infection. This booklet is designed to support you in using Stribild and to inform you on how it works. This guide is based on the package leaflet supplied with Stribild1 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 contracts for information. If you have any questions 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 SciencesNetherlands BV, Claude Debussylaan 22, 1082 MD Amsterdam.
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GETTING STARTED WITH STRIBILD
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WHAT IS HIV?
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WHAT IS STRIBILD?
07
BE CAREFULL
09
OTHER MEDICINES AND STRIBILD
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HOW DOES STRIBILD 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 STRIBILD?
The human immunodeficiency virus (HIV) infects specific
HIV-infection can be treated with Stribild.
cells of the immune system, known as CD4 cells.
Stribild causes the viral load to drop, through the
Prolonged infection weakens the immune system. The
inhibition of viral replication. As a result, virus replication is
virus continues to create multiple copies of itself, causing
reduced and many of the remaining virus particles are
your CD4 cell count to reduce. As a result, your body is
eliminated from the body
less capable of fighting infections and illnesses. Stribild contains a combination of active substances, in one At the same time these infections and illnesses occur,
tablet. Also, Stribild can be taken with certain medication
there is the risk of Acquired Immune Deficiency Syndrome
for other diseases, however not with all medications (see
(AIDS). To prevent AIDS, it is important to treat HIV in time
page 9: ‘Other medicines and Stribild’). This treatment is
with the proper treatment. This allows the immune system
for use by adults aged 18 years and older.
is to reduce the amount of viral particles to an
ACTIVE SUBSTANCES IN STRIBILD:
undetectable level (undetectable viral load). As a result,
• elvitegravir
the numer of CD4 cells will remain sufficient, i.e. the
• cobicistat
immune system is more capable to fight off infections and
• emtricitabine
diseases. HIV can be transmitted from an infected person
• tenofovirdisoproxil
to an uninfected person through body fluids, such as genital fluids (semen, pre-seminal fluid, rectal fluid and vaginal fluids) during unprotected sexual contact (vaginal, anal and oral), donor semen, donor tissue, blood
INFORMATION FOR PATIENTS
to continue to do its job The primary goal of HIV-treatment
products, blood from contaminated needles, or mother to child during pregnancy, childbirth and breast-feeding.
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BE CAREFUL Elvitegravir is an antiretroviral medicine known as an
What do you need to know before taking Stribild?
integrase inhibitor, cobicistat is a booster
Restrictions apply to all medications, including Stribild.
(pharmacokinetic enhancer) of the effects of elvitegravir, without anti-HIV activity, emtricitabine and tenofovirdisoproxil are antiretroviral medicines. Each tablet contains 150 mg elvitegravir, 150 mg cobicistat, 200 mg emtricitabine and 245 mg tenofovirdisoproxil.
DO NOT TAKE STRIBILD IF: • you are allergic to elvitegravir, cobicistat, emtricitabine, tenofovirdisoproxil or any of the other ingredients of this medicine (see package leaflet for a full list); • you stopped on the advice of your doctor after problems
with
a
medicine
containing
tenofovirdisoproxilfumarate BE CAREFULL IF: • you have kidney problems, or have had kidney problems, or if tests have shown problems with your INFORMATION FOR PATIENTS
kidneys; • you have liver problems or a history of liver diseases, including hepatitis; • you are over 65 years of age; • you are intolerant to lactose. 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.
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OTHER MEDICINES AND STRIBILD Are you taking any other medicines? Stribild may interact with other medicines. DO NOT TAKE STRIBILD AND TELL YOUR DOCTOR
• lovastatin, simvastatin, used to lower blood cholesterol
IMMEDIATELY IF YOU ARE TAKING:
• pimozide, used to treat abnormal thoughts or feelings
• alfuzosin, used to treat an enlarged prostate gland
• sildenafil, when used to treat pulmonary arterial
• amiodarone, quinidine , used to correct irregular heartbeats • carbamazepine, phenobarbital, phenytoin,used to
hypertension • oral administered midazolam, triazolam, used to help you sleep and/or relieve anxiety
prevent seizures • rifampicin, used to prevent and treat tuberculosis and other infections treat migraine haedache • cisapride, used to relieve certain stomach problems • St. John’s wort (Hypericum perforatum, a herbal remedy used for depressions and anxiety) or products that contain it
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INFORMATION FOR PATIENTS
• dihydro-ergotamine, ergotamine, ergometrine , used to
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TALK TO YOUR DOCTOR IF YOU ARE TAKING:
IT IS ALSO IMPORTANT TO TALK TO YOUR DOCTOR
• medicines containing: tenofovirdisoproxilfumaraat,
IF YOU ARE TAKING:
tenofoviralafenamide, lamivudine, adefovirdipivoxil • medicines that may damage your kidneys, examples include: aminoglycosides (such as streptomycin, neomycin and gentamicin), vancomycin (for bacterial infections), foscarnet, ganciclovir, cidofovir (for viral infections), amfotericin B, pentamidine (for fungal infections), interleukin-2, also called aldesleuki (to treat cancer), non-steroidal anti-inflammatory drugs (NSAID’s, to relieve bone or muscle pain)
• antifungals, used to treat fungal infections, such as: ketoconazole, itraconazole, voriconazole, posaconazole and fluconazole • antiviral medicines used to treat hepatitis C: boceprevir, ledipasvir/sofosbuvir and sofosbuvir/velpatasvir • antibiotics, used to treat bacterial infections including tuberculosis, containing: rifabutin, clarithromycin and telithromycin • antidepressants, used to treat depression: medicines containing trazodone or escitalopram • sedatives and hypnotics, used to treat anxiety: buspirone, clorazepate, diazepam, estazolam, flurazepam, zolpidem and lorazepam • immunosuppressants, used to control your body’s immune respons after a transplant, such as: ciclosporing, sirolimus and tacrolimus
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• corticosteroids including: betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone • medicines used to treat diabetes; metformin • morphine like medicines, used to treat drug addiction:
methadone,
buprenorphine
and
naloxone
• bronchodilators, used to treat asthma and other lungrelated problems: salmeterol • cholesterol lowering medicines, such as: rosuvastatin, atorvastatin, pravastatin, fluvastatin and pitavastatin • medicines used to treat gout: colchicine antacids, used to treat heartburn or acid reflux, such as: aluminium/magnesium hydroxide
• contraceptive pill, used to prevent pregnancy • erectile dysfunction medicines, used to treat impotence, such as: sildenafil, tadalafil and vardenafil • heart medicines, such as: digoxin, disopyramide, flecainide, lidocaine, mexiletine, propafenone, metoprolol, timolol, amlodipine, diltiazem, felodipine, nicardipine, nifedipine and verapamil • medicines used to treat pulmonary arterial hypertension: bosentan • anticoagulants, used to thin the blood such as: warfarin and dabigatran
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. If you are consider stopping your treatment with Stribild, contact your doctor to discuss the possibilities. Do not stop your treatment without contacting your doctor. For full details about using Stribild please refer to the package leaflet.
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HOW DOES STRIBILD WORK?
OPTIMAL USE
How do you know if Stribild is working well?
When you take Stribild, the active substances enter your
In order to determine whether Stribild works for
blood stream through the digestive tract. Stribild then
you, blood is taken for examination.
disappears from your blood and you need to take another
Intake of Stribild
dose. The recommended dose is one tablet every day. Test results can show whether the amount of virus (viral load) has decreased and the amount of
When you miss a dose, less Stribild is present in your
CD4 cells has increased.
body to inhibit viral replication. This has two serious disadvantages. First, because there is less Stribild, the
You can still pass on HIV when taking this medicine,
virus is better able to multiply and attack the immune
although the risk is lowered by effective
system. Second, the virus may change its shape while
antiretroviral therapy. Discuss with your doctor the
multiplying, and the new virus may become resistant. If the virus develops resistance, the active substances in
This medicine is not a cure for HIV infection. While
Stribild are no longer able to effectively inhibit the virus.
taking Stribild you may still develop infections or other
If you consider stopping your treatment with Stribild,
illnesses associated with HIV infection.
talk to your doctor or nurse. They can assist you in finding the proper solution.
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INFORMATION FOR PATIENTS
precautions needed to avoid infecting other people.
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ONE TABLET EVERY DAY What to be aware of when taking Stribild? Once you have started Stribild, two things are of importance. First, the level of Stribild in your body must be maintained. Second, you should immediately talk to your doctor if you notice any side effects.
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, make sure you set up a monitoring system. For example, use a pill organizer, labelled with the days of the week, in which you can store your daily dose.
The recommended dose is one tablet every day, with food, at about the same time. Thereby, the risk of
There are also daily pill boxes that you attach as a keychain to allow you quick access to spare tablets.
missing a dose is minimized. However, the absorption after intake, or if you are suffering from severe diarrhea. On page 31 ‘Seven Important Tips’ you can read what to do in these situations.
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 always have some extra tablets with you.
Choose a convenient time of intake For instance, when you take Stribild in the evening during diner, it become a habit and the risk of missing a dose is minimized.
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If necessary, set an alarm clock You could set an alarm clock on your mobile phone to remind you to take Stribild. There are also pill organizers with a built-in alert system.
INFORMATION FOR PATIENTS
of Stribild is disrupted if you vomit less than 1 hour
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MISED A DOSE? Stribild during your holiday During holidays, daily routines are often broken, especially if you are travelling across time zones.
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 medication. Discuss in advance with your doctor or HIV-consulent what to do in
If you are travelling to a different time zone, please
this situation.
consult your doctor about the best dosing schedule. It is best to maintain the 24 hour interval between
In general, the following applies:
doses.
...If you notice within 18 hours
take the tablet as soon as possible (with food)
... If you notice after 18 hours of more
skip the missed dose
WAIT AND TAKE THE NEXT DOSE AT YOUR USUAL TIME (WITH FOOD).
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INFORMATION FOR PATIENTS
Did you miss a dose...
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POSSIBLE SIDE EFFECTS doctor for a new prescription. This is very 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 Stribild, take another tablet with food. If you are suffering from severe diarrhoea, there is a risk that Stribild is not absorbed or insufficiently absorbed by the body. Therefore, contact your doctor if you are suffering from severe diarrhea for more than two days. Do not stop taking Stribild without talking to your doctor. When your supply of Stribild starts to run low, refill your prescription at your pharmacist.
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Like all medicines, Stribild can cause side effects, although the differs between individuals. When treating HIV infection, it is not always possible to tell whether some of the unwanted effects are caused by Stribild, other medicines that you are taking at the same time, or by the HIV disease itself. 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), stomach pain. • Any signs of inflammation or infection. If you notice the side effects described above, tell your doctor immediately.
INFORMATION FOR PATIENTS
When your supply of Stribild starts to run low, go to your
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Very common side effects
• other allergic reactions
(may affect more than 1 in 10 people)
• tiredness
• diarrhoea • vomiting
Tests may also show:
• nausea
• low white blood cell count (which can make you more
• feeling weak • headache, dizziness • rash
prone to infection) • increased sugar, fatty acids (triglycerides), bilirubin in your blood • liver and pancreas problems
Tests may also show:
• increased levels of creatinine in your blood
• decreases in phosphate levels in the blood • increased levels of creatine kinase in the blood
Uncommon side effects (may affect up to 1 in every 100 people treated)
(may affect up to 1 in 10 people) • decreased appetite • difficulty sleeping (insomnia), abnormal dreams • pain, stomach pain • problems with digestion resulting in discomfort after meals (dyspepsia)
• suicidal ideation and suicide attempt (in patients who have had depressions or mental health problems before), depression • back pain caused by kidney problems, including kidney failure. Your doctor may do blood tests to see if your kidneys are working properly. • damage to kidney tubule cells
• feeling bloated
• swelling of the face, lips, tongue or throat
• constipation, wind (flatulence)
• pain in de abdomen (tummy) caused by
• rashes (including red sports or blotches sometimes with blistering and swelling of the skin), which may
inflammation of the pancreas (pancreatitis)
INFORMATION FOR PATIENTS
Common side effects
• breakdown of muscle, muscle pain or weakness
be allergic reactions, itching, changes in skin colour including darkening of the skin in patches
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Tests may also show:
Other effects that may be seen during HIV treatment
• anaemia (low red blood cell count)
During HIV therapy there may be an increase in weight and
• decreased levels of potassium in the blood
in levels of blood lipids and glucose. This is partly linked to
• changes to your urine
restored health and life style, and in case of blood lipids sometimes to HIV medicines themselves. Your doctor will
Rare side effects
test for these changes.
• yellow skin or eyes, itching, or pain in the abdomen (tummy) caused by inflammation of the liver
Some patients may develop a bone disease called
(hepatitis)
osteonecrosis (death of bone tissue caused by loss of
• fatty liver
blood supply to the bone) Signs of osteonecrosis are:
• inflammation of the kidney (nephritis)
• joint stiffness;
• passing a lot of urine and feeling thirsty
• joint aches and pains (especially of the hip, knee,
(nephrogenic diabetes insipidus) • softening of the bones (with bone pain and
and shoulder); • difficulty with movement.
sometimes resulting in fractures) pharmacist. This includes any possible side effects not listed in the leaflet. You can also report side effects directly via the national reporting system: Nederlandse Bijwerkingen Centrum Lareb Website: www.lareb.nl By reporting side effects you can help provide more information on the safety of this medicine.
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INFORMATION FOR PATIENTS
If you get any side effects, talk to your doctor or
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PREGNANCY AND BREAST-FEEDING
CO-INFECTION
You cannot use Stribild during pregnancy, unless this is
Hepatitis
specifically discussed with your doctor.
Patients with liver disease, including chronic hepatitis B or C, who are treated with antiretrovirals, have a higher risk
Contraception
of severe and potentially fatal liver complications. If you
Woman are advised to use effective contraception while
are infected with the hepatitis B-virus, your doctor should
taking Stribild to avoid pregnancy.
carefully consider the best treatment regimen for you.
Pregnancy
If you are infected with the hepatitis B-virus and stop
If you are pregnant, think you may be pregnant or are
taking Stribild, you may put yourself at risk of severe
planning to have a baby, ask your doctor for advice before
acute liver complications. It is therefore important to not
you start taking this medicine.
stop taking Stribild without talking to your doctor.
INFORMATION FOR PATIENTS
Breast-feeding Do not breast-feed during treatment with Stribild. Active substances in this medicines are excreted in breast milk. It is also recommended that you do not breast-feed to avoid passing the virus to the baby through breast milk.
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HEALTHY LIFESTYLE
SEVEN IMPORTANT TIPS
Tips for a healthy lifestyle The HIV-virus suppresses your immune system.
1.
Take one tablet at about the same time every day.
Although Stribild reduces this suppression, it is still
This makes it easier to remember your daily intake
important to not impose an extra burden on your
of Stribild. For example, take Stribild every day with
immune system, and adopt a healthy lifestyle.
a particular meal.
Life healthy, eat healthy, sleep well 2.
Take one tablet every day with food (breakfast, lunch, dinner)
HEALTHY LIFESTYLE • perform physical activity (e.g. walking, playing sports, cycling) on regular basis
3.
Do not chew, crush or split the tablet.
4.
If you vomit less than 1 hour after taking Stribild,
• do relaxation exercises (e.g. yoga) • eat fruit and vegetables
take another tablet.
• quit smoking 5. SLEEP WELL • maintain a regular sleep pattern
It is important not to miss a dose of Stribild. If you do miss a dose: • If you notice within 18 hours of the time you usually
• relax before going to bed (e.g. reading, a hot bath)
take Stribild, you must take the tablet with food as
• do not work out before going to bed
soon as possible. Then take the next dose as usual.
• do not drink coffee or eat chocolate in the evening
• If you notice 18 hours or more after the time you
• do not eat large meals before going to bed
usually take Stribild, then do not take the missed
• ensure a dark, quiet bedroom (use earplugs if necessary)
dose. Wait and take the next dose, with food, at
INFORMATION FOR PATIENTS
• liit or avoid the use of alcohol and recreational drugs
your usual time.
• do not oversleep
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FREQUENTLY ASKED QUESTIONS 6.
If you are taking an antacid or a multivitamin
Why have I been prescribed this medicine?
supplement, take it at least 4 hours before or at
Stribild is an anti-human immunodeficiency virus (HIV)
least 4 hours after Stribild.
medicine. This means that this medicine contributes to the treatment of HIV-infection. It helps prevent the HIV
7.
Make sure you always have a supply of Stribild at
from replicating and creating copies of itself, and slows
home. Remember to request for a prescription to
down the progression of the disease.
refill in time. If you leave home or travelling, always take Stribild with you.
What does my medicine look like? Stribild tablets are green, capsule-shaped, debossed on one side with “GSI” and the number “1” surrounded by a square box on the other side of the tablet. Stribild comes must be kept in the bottle to help protect your tablet). The silica gel desiccant is packaged in a separate sachet or canister and should not be swallowed. How does this medicine work? HIV infects specific cells of the immune system and therefore weakens the immune system. The HIV-virus creates multiple copies of itself that continue to weaken the immune system. As a result, your body is
FREQUENTLY ASKED QUESTIONS
in bottes of 30 tablets, and a silica gel desiccant (that
less capable of fighting infections and illnesses.
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Stribild reduces the amount of viral particles by inhibiting
Who can prescribe Stribild?
the replication of the virus. The treatment is successful if
Stribild is a prescription medicine that can only be
the amount of viral particles (viral load) in your blood is
prescribed by a healthcare professional. You should
reduced to an undetectable level. Then, the number of
only take this medication if it has been prescribed by
CD4 cells will increase, i.e. the immune system recovers
your doctor.
from its weakened state. If you are allergic to emtricitabine, tenofovirdisoproxil or
Stribild contains four active substances: elvitegravir,
any of the other ingredients of this medicine (you can find
cobicistat, emtricitabine and tenofovirdisoproxil. These
all ingredients in the package leaflet) or if you use any of
are antiretroviral medicines. Each tablet contains
the other medicines mentioned on page 10 ‘Other
150 mg elvitegravir, 150 mg cobicistat, 200 mg
medicines and Stribild’.
emtricitabine and 245 mg tenofovirdisoproxil. Does my medicine reduce the risk of me transmitting Does this medicine cure HIV?
HIV to other people?
No, this medicine is not a cure for HIV-infection. To
You can still transmit HIV when taking this medicines,
control your HIV-infection and infections or other
although the risk is lowered by effective antiretroviral
illnesses associated with HIV-infection, you should
therapy. Discuss with your doctor the precautions
always take this medication exactly as your doctor
needed to avoid infecting other people. This medicine is
has prescribed it.
not a cure for HIV-infection. While taking Stribild you may still develop infections or other illnesses associated
FREQUENTLY ASKED QUESTIONS
When should I not take this medication? What are the ingredients of Stribild?
with HIV-infection.
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How do I take my medicine? Always take this medication exactly as your doctor has
What do I need to tell my doctor before I start
prescribed it. Check with your doctor or pharmacist if
Tell your doctor or pharmacist if you are taking, have recently
you are not sure. The recommended daily intake is one
taken or are going to take any other medicines. Tell your
tablet every day with food. Do not chew, crush or split
doctor if you are allergic to any of the ingredients (see
the tablet. If you taka an antacid or an multivitamin
package leaflet for a full list) or if you are pregnant, are likely
supplement take it at least 4 hours before or at least
become pregnant or if you are breastfeeding.
taking this medicine?
4 hours after Stribild. Also tell your doctor if you have kidney problems, How should I store this medicine?
liver problems, or a history of kidney or liver disease,
Store Stribild in its original packaging to protect from
including hepatitis.
out of sight and reach of children. Do not use this
Can this medicine cause side effects?
medication after the expiry date. Ask your pharmacist how
As with all medicines, you may get side effects. On page 23
to throw away medicines you no longer use.
you will find possible side effects. For a full list of side effects, please refer to the package leaflet that is supplied with your medication. If you notice any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in the package leaflet.
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FREQUENTLY ASKED QUESTIONS
moisture. Keep the bottle tightly closed. Keep the tablets
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Is it possible to experience serious side
Should I take this medicine if I am pregnant or if I am
effects while taking Stribild?
breast-feeding?
Yes. You should look out for symptoms of inflammation,
If you are pregnant, think you may be pregnant or are
infection or lactic acidosis, such as deep, rapid breathing,
planning to have a baby, ask your doctor for advice
tiredness or drowsiness, feeling sick (nausea), being sick
before taking this medicine. Use effective contraception
(vomiting), stomach pain. If you notice one of these
while taking Stribild to avoid getting pregnant.
symptoms, please tell your doctor immediately. For more information, please refer to the package leaflet.
Do not breast-feed during treatment with this substances in this medicine are excreted in breast
It is important to not miss a dose of Stribild. If you notice
milk. FREQUENTLY ASKED QUESTIONS
medicine. This is because some of the active What do I do if I miss a dose of my medicine? within 18 hours of the time you usually take your medication, take the tablet as soon as you remember. Take
It is also recommended that you do not breast-feed
the tablet with food and then take the next dose at the
to avoid transmitting the virus to the baby through
usual time. If you notice 18 hours or more after the time
breast milk.
you usually take Stribild, then do not take the missed dose. Wait and take the next dose at your usual time. If you vomit in less than 1 hour after taking your medication, take another tablet with food. Do not stop taking Stribild without first talking to your doctor.
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STD/NL/17-06//1047 Date of preparation: August 2017
REFERENCES 1. Package leaflet Stribild. 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