Stribild
elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil
elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil
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 Stribild is and what it is used for
What you need to know before you take Stribild
How to take Stribild
Possible side effects
How to store Stribild
Contents of the pack and other information
cobicistat, a booster (pharmacokinetic enhancer) of the effects of elvitegravir
Stribild is a single tablet regimen for the treatment of human immunodeficiency virus (HIV) infection in adults.
Stribild is also used to treat HIV-1 infected 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 have caused side effects.
or any of the other ingredients of this medicine (listed in section 6 of this leaflet).
If you stopped treatment with any medicine containing tenofovir disoproxil on the advice of your doctor following problems with your kidney function.
St. John’s wort (Hypericum perforatum, a herbal remedy used for depression and anxiety) or products that contain it
orally administered midazolam, triazolam (used to help you sleep and/or relieve anxiety)
If any of these applies to you, you should not take Stribild and you should tell your doctor immediately.
You must remain under the care of your doctor while taking Stribild.
Stribild may affect your kidneys. Before starting treatment, your doctor will order blood tests to assess your kidney function. Your doctor will also order blood tests during treatment to monitor your kidneys.
Stribild is not usually taken with other medicines that can damage your kidneys (see Other medicines and Stribild). If this is unavoidable, your doctor will monitor your kidney function more frequently.
Bone problems (manifesting as persistent or worsening bone pain and sometimes resulting in fractures) may also occur due to damage to kidney tubule cells (see section 4, Possible side effects). Tell your doctor if you have bone pain or fractures.
Tenofovir disoproxil may also cause loss of bone mass.
Overall, the effects of tenofovir disoproxil on long term bone health and future fracture risk in adult and paediatric patients are uncertain.
Tell your doctor if you know you suffer from osteoporosis. Patients with osteoporosis are at a higher risk of fractures.
If you have hepatitis B infection liver problems may become worse after you stop taking Stribild. It’s important not to stop taking Stribild without talking to your doctor: see section 3, Do not stop taking Stribild.
If any of these applies to you, talk to your doctor before taking Stribild. While you are taking Stribild
Once you start taking Stribild, look out for:
any signs of inflammation or infection
If you notice any of these symptoms, tell your doctor immediately. Children and adolescents
These are mentioned above under the heading “Do not take Stribild - If you are taking one of these medicines”.
aminoglycosides (such as streptomycin, neomycin and gentamicin), vancomycin (for
bacterial infections)
foscarnet, ganciclovir, cidofovir (for viral infections)
amphotericin B, pentamidine (for fungal infections)
interleukin-2, also called aldesleukin (to treat cancer)
non-steroidal anti-inflammatory drugs (NSAIDs, to relieve bone or muscle pains)
ketoconazole, itraconazole, voriconazole, fluconazole and posaconazole
ledipasvir/sofosbuvir, sofosbuvir/velpatasvir and sofosbuvir/velpatasvir/voxilaprevir
rifabutin, clarithromycin or telithromycin
medicines containing trazodone or escitalopram
buspirone, clorazepate, diazepam, estazolam, flurazepam and zolpidem
ciclosporin, sirolimus and tacrolimus
betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone.
These medicines are used to treat allergies, asthma, inflammatory bowel diseases, inflammatory conditions of the skin, eyes, joints and muscles and other inflammatory conditions. These medicines are generally taken orally, inhaled, injected or applied to the skin or eye. If alternatives cannot be used, its use should only take place after medical evaluation and under close monitoring by your doctor for corticosteroid side effects.
metformin
sildenafil, tadalafil and vardenafil
digoxin, disopyramide, flecainide, lidocaine, mexiletine, propafenone, metoprolol, timolol, amlodipine, diltiazem, felodipine, nicardipine, nifedipine and verapamil
bosentan
warfarin, edoxaban, apixaban and rivaroxaban
salmeterol
rosuvastatin, atorvastatin, pravastatin, fluvastatin and pitavastatin
colchicine
clopidogrel
mineral supplements, vitamins (including multivitamins), antacids and laxatives
If you are taking medicines, oral supplements, antacids or laxatives containing minerals (such as magnesium, aluminium, calcium, iron, zinc), take them at least 4 hours before or at least 4 hours after Stribild.
Tell your doctor if you are taking these or any other medicines. Do not stop your treatment without contacting your doctor.
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.
Stribild can cause dizziness, tiredness or insomnia. If you are affected while taking Stribild, do not drive and do not use any tools or machines.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
If you accidentally take more than the recommended dose of Stribild you may be at increased risk of experiencing possible side effects with this medicine (see section 4, Possible side effects).
Contact your doctor or nearest emergency department immediately for advice. Keep the tablet bottle with you so that you can easily describe what you have taken.
It is important not to miss a dose of Stribild. If you do miss a dose:
Tell your doctor immediately about new or unusual symptoms after you stop treatment, particularly symptoms you associate with hepatitis B infection (such as yellowing of your skin or the white part of your eyes, dark “tea-coloured” urine, light-coloured stools, loss of appetite for several days or longer, feeling or being sick, or stomach-area pain).
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
During HIV therapy 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.
Like all medicines, this medicine can cause side effects, although not everybody gets them. When treating HIV infection, it is not always possible to tell whether some of the unwanted effects are caused by Stribild or by other medicines that you are taking at the same time, or by the HIV disease itself.
deep, rapid breathing
tiredness or drowsiness
feeling sick (nausea), being sick (vomiting)
stomach pain
If you think you may have lactic acidosis, tell your doctor immediately.
If you notice any symptoms of inflammation or infection, tell your doctor immediately.
(may affect at least 1 in every 10 patients treated)
diarrhoea
vomiting
feeling sick (nausea)
weakness
headache, dizziness
rash
Tests may also show:
decreased phosphate in your blood
increased levels of creatine kinase in the blood that may result in muscle pain and weakness
(may affect 1 to 10 in every 100 patients treated)
decreased appetite
difficulty sleeping (insomnia), abnormal dreams
pain, stomach pain
problems with digestion resulting in discomfort after meals (dyspepsia)
feeling bloated
constipation, wind (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
tiredness
Tests may also show:
low white blood cell count (which can make you more prone to infection)
increased sugar, fatty acids (triglycerides), bilirubin in your blood
liver and pancreas problems
increased levels of creatinine in your blood
(may affect up to 1 in every 100 patients treated)
suicidal ideation and suicide attempt (in patients who have had depression 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
swelling of the face, lips, tongue or throat
pain in the abdomen (tummy) caused by inflammation of the pancreas (pancreatitis)
breakdown of muscle, muscle pain or weakness
Tests may also show:
anaemia (low red blood cell count)
decreased levels of potassium in the blood
changes to your urine
(may affect up to 1 in every 1,000 patients treated)
lactic acidosis (see Possible serious side effects: tell a doctor immediately)
yellow skin or eyes, itching, or pain in the abdomen (tummy) caused by inflammation of the liver (hepatitis)
fatty liver
inflammation of the kidney (nephritis)
passing a lot of urine and feeling thirsty (nephrogenic diabetes insipidus)
softening of the bones (with bone pain and sometimes resulting in fractures)
The 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 may occur due to damage to kidney tubule cells.
If any of the side effects get serious tell your doctor. Other effects that may be seen during HIV treatment
The frequency of the following side effects is not known (frequency cannot be estimated from the available data).
Bone problems. Some patients taking combination antiretroviral medicines such as Stribild 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
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 these symptoms tell your doctor.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
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 in the original package in order to protect from moisture. Keep the bottle tightly closed.
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.
Tablet core:
Croscarmellose sodium, hydroxypropyl cellulose (E463), lactose monohydrate, magnesium stearate, microcrystalline cellulose (E460), silicon dioxide (E551), sodium lauryl sulfate.
Film-coating:
Indigo carmine aluminium lake (E132), macrogol 3350 (E1521), polyvinyl alcohol (partially
hydrolysed) (E1203), talc (E553b), titanium dioxide (E171), yellow iron oxide (E172).
Stribild film-coated tablets are green, capsule-shaped tablets, debossed on one side with “GSI” and the number “1” surrounded by a square box on the other side of the tablet. Stribild comes in bottles of
30 tablets (with a silica gel desiccant that must be kept in the bottle to help protect your tablets). The
silica gel desiccant is contained in a separate sachet or canister and should not be swallowed.
The following pack sizes are available: outer cartons containing 1 bottle of 30 film-coated tablets and 90 (3 bottles of 30) film-coated tablets. Not all pack sizes may be marketed.
County Cork, T45 DP77 Ireland
Gilead Sciences Ireland UC
IDA Business & Technology Park Carrigtohill
County Cork Ireland
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Gilead Sciences Belgium SRL-BV Tél/Tel: + 32 (0) 24 01 35 50
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Gilead Sciences Ireland UC
Тел.: + 353 (0) 1 686 1888
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Gilead Sciences Ireland UC
Tel.: + 353 (0) 1 686 1888
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Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888
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Gilead Sciences Netherlands B.V. Tel: + 31 (0) 20 718 36 98
Gilead Sciences Poland Sp. z o.o. Tel: + 48 22 262 8702
Gilead Sciences Sweden AB Tlf: + 46 (0) 8 5057 1849
Gilead Sciences Ελλάς Μ.ΕΠΕ. Τηλ: + 30 210 8930 100
Gilead Sciences GesmbH Tel: + 43 1 260 830
Gilead Sciences, S.L.
Tel: + 34 91 378 98 30
Gilead Sciences Poland Sp. z o.o.
Tel.: + 48 22 262 8702
Gilead Sciences
Tél: + 33 (0) 1 46 09 41 00
Gilead Sciences, Lda.
Tel: + 351 21 7928790
Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1888
Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1888
Gilead Sciences Ireland UC Tel: + 353 (0) 214 825 999
Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1888
Gilead Sciences Sweden AB Sími: + 46 (0) 8 5057 1849
Gilead Sciences Slovakia s.r.o. Tel: + 421 232 121 210
Gilead Sciences S.r.l. Tel: + 39 02 439201
Gilead Sciences Sweden AB Puh/Tel: + 46 (0) 8 5057 1849
Gilead Sciences Ελλάς Μ.ΕΠΕ. Τηλ: + 30 210 8930 100
Gilead Sciences Sweden AB Tel: + 46 (0) 8 5057 1849
Gilead Sciences Poland Sp. z o.o.
Tel: + 48 22 262 8702
Gilead Sciences Ireland UC
Tel: + 44 (0) 8000 113 700