Label: information for the user

Stribild 150 mg/150 mg/200 mg/245 mg film-coated tablets

elvitegravir/cobicistat/emtricitabina/tenofovir disoproxil

Read this label carefully before starting to take this medicine, as it contains important information for you.

- Keep this label, as you may need to read it again.

- If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1. What is Stribild and for what it is used

2. What you need to know before starting to take Stribild

3. How to take Stribild

4. Possible side effects

5. Storage of Stribild

6. Contents of the pack and additional information

Stribild contains four active ingredients:

• elvitegravir,a medication known as an integrase inhibitor

• cobicistat,a booster (pharmacokinetic enhancer) of the effects of elvitegravir

•emtricitabine,a medication known as a nucleoside reverse transcriptase inhibitor (NRTI) analogue

•tenofovir disoproxil fumarate,a medication known as a nucleotide reverse transcriptase inhibitor

Stribild is a single-tablet regimen for the treatment of human immunodeficiency virus (HIV) infection in adults.

Stribild is also used to treat adolescents aged 12 to 18 years who weigh at least 77 pounds (35 kg), who have been treated with other HIV medications that have caused side effects.

Stribild reduces the amount of HIV present in the body. This improves the immune system and decreasesthe risk of developing diseases associated with HIV infection.

Do not take Stribild

•If you are allergic to elvitegravir, cobicistat, emtricitabina, tenofovir, tenofovir disoproxilor to any of the other components of this medication (listed in section 6 of this leaflet).

• If you have stopped taking a medication that containstenofovir disoproxilon the advice of your doctor, after having kidney function problems.

• If you are taking one of the following medications:

- alfuzosin(used to treat an enlarged prostate)

- amiodarone, quinidine(used to correct irregular heartbeats)

- dabigatran(used to prevent and treat blood clots)

- carbamazepine, phenobarbital, phenytoin(used to prevent seizures)

- rifampicin(used to prevent and treat tuberculosis and other infections)

- dihydroergotamine, ergotamine, ergometrine(used to treat migraines)

- cisapride(used to relieve certain stomach problems)

-St. John's Wort(Hypericum perforatum, a herbal remedy used for depression and anxiety) or products containing it

- lovastatin, simvastatin(used to reduce cholesterol in the blood)

- pimozide, lurasidone(used to treat abnormal thoughts or feelings)

-sildenafil(used to treat pulmonary arterial hypertension, a lung disease that makes it hard to breathe)

-midazolamgiven orally, triazolamm(used to help sleep and/or relieve anxiety)

?If you find yourself in any of these circumstances, do not take Stribild and consult your doctor immediately.

Warnings and precautions

You must remain under the supervision of yourdoctor while taking Stribild.

While taking this medicationyou may still transmit HIV to others,although effective antiviral treatment reduces the risk. Consult your doctor about what precautions are necessary to avoid infecting others. This medication is not a cure for HIV infection. While you are taking Stribild, you may still experience infections or other diseases associated with HIV infection.

Consult your doctor before starting to take Stribild:

•If you have kidney problems,or have had kidney problems, or if your blood tests have shown kidney problems. Your doctor will carefully consider whether to treat you with Stribild.

Stribild may affect the kidneys. Before starting treatment, your doctor will ask you to have some blood tests to check kidney function. Your doctor will also ask you to have some blood tests during treatment to monitor kidney function.

Stribild is usually not taken with other medications that can damage the kidneys (see Taking Stribild with other medicines). If this is unavoidable, your doctor will monitor kidney function more frequently.

• If you have liver problems or a history of liver disease, including hepatitis.

Patients with liver disease, including chronic hepatitis B or C, treated with antiretrovirals, have a higher risk of severe and potentially life-threatening liver complications. If you have hepatitis B infection, your doctor will carefully consider the best treatment regimen for you.

If you have hepatitis B infection, liver problems may worsen after stopping Stribild administration. It is essential that you do not stop taking Stribild without first talking to your doctor: see section 3, Do not interrupt treatment with Stribild.

•If you are over 65 years old. Stribild has not been studied in patients over 65 years old. If you are over this age and have been prescribedStribild, your doctor will monitor you closely.

?If you find yourself in any of these circumstances, consult your doctor before starting to take Stribild.

While taking Stribild

Once you start taking Stribild, be aware of:

• anysigns of inflammation or infection

• bone problems

?If you notice any of these symptoms, inform your doctor immediately.

Children and adolescents

Do not administer this medication to childrenunder 12 years old. Stribild has not been studied in children under 12 years old and weighing less than 35 kg.

Other medicines and Stribild

There are some medicines that should never be taken with Stribild.

These have been mentioned earlier, in the section “Do not take Stribild if you are taking one of these medicines”.

Inform your doctor or pharmacist if you are taking or have recently taken any other medication. Stribild may interact with other medicines. As a result, the blood levels of Stribild or other medicines may be affected. This may prevent your medicines from working correctly or worsen their potential side effects. In some cases, your doctor may need to adjust the dose or check your blood concentrations.

It is especially important to consult with your doctorif you are taking any of the following medicines:

• any other medicine that contains:

- tenofovir disoproxil

- tenofovir alafenamide

- lamivudine

- adefovir dipivoxil

• medicines that may damage the kidneys,such as:

-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 known as aldesleukin (for cancer treatment)

- nonsteroidal anti-inflammatory drugs (NSAIDs, for relieving bone or muscle pain)

It is also important to consult with your doctorif you are taking any of the following types of medicines:

• antifungals,used to treat fungal infections, such as:

- ketoconazole, itraconazole, voriconazole, fluconazole, and posaconazole

• antivirals,used to treat hepatitis C virus infection:

- ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, and sofosbuvir/velpatasvir/voxilaprevir

•antibiotics,used to treat bacterial infections, including tuberculosis, that contain:

- rifabutin, clarithromycin, or telithromycin

• antidepressants,used to treat depression:

- medicines that contain trazodone or escitalopram

• sedatives and hypnotics,used to treat anxiety:

- buspirone, clorazepate, diazepam, estazolam, flurazepam, and zolpidem

•immunosuppressants,used to control the body's immune response after a transplant, such as:

- cyclosporine, sirolimus, and tacrolimus

• corticosteroids,including:

- betamethasone, budesonide, fluticasone, mometasone, prednisone, and triamcinolone.

These medicines are used to treat allergies, asthma, inflammatory bowel disease, eye, joint, and muscle inflammation, and other inflammatory conditions.

• medicines used to treat diabetes:

- metformin

• birth control pill,used to prevent pregnancy

•medicines for erectile dysfunction,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 prevent and treat blood clots, such as:

- warfarin, edoxaban, apixaban, and rivaroxaban

•bronchodilators,used to treat asthma and other lung problems:

- salmeterol

• medicines for reducing cholesterol,such as:

- rosuvastatin, atorvastatin, pravastatin, fluvastatin, and pitavastatin

• medicines used to treat gout:

- colchicine

• antacids,used to treat heartburn or acid reflux, such as:

- aluminum/magnesium hydroxide

?If you are taking anantacid or a multivitamin supplement,take it at least 4 hours before or at least 4 hours after Stribild.

?Inform your doctor if you are taking these or other medicines. Do not interrupt your treatment without consulting your doctor.

Pregnancy and lactation

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

•Inform your doctor immediately if you become pregnant, think you may be pregnant, or intend to become pregnant.Pregnant women should not take Stribild. The amount of this medication in the blood may decrease during pregnancy, making it less effective.

• Use an effective method of contraceptionwhile taking Stribild.

Do not breastfeed your child during treatment with Stribild. This is because some of the active ingredients in this medication pass into breast milk. If you are an HIV-positive woman, it is recommended that you do not breastfeed to avoid transmitting the virus to the baby through breast milk.

Driving and operating machinery

Stribild may cause dizziness, fatigue, and insomnia. If these affect you during treatment with Stribild, do not drive or use tools or machinery.

Stribild contains lactose

If your doctor has told you that you have a intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Recommended dose for adults and adolescents aged 12 to 18 years weighing at least 35 kg:

•One tablet per day by mouth, with food.Do not chew, crush, or divide the tablet.

Always take the recommended dose prescribed by your doctor.This is to ensure that your medication is completely effective, and to reduce the risk of developing treatment resistance. Do not change the dose unless your doctor tells you to.

If you are taking an antacidsuch as aluminum/magnesium hydroxide or amultivitamin supplement, take it at least 4 hours before or at least 4 hours after Stribild.

If you take more Stribild than you should

If you accidentally take more than the recommended dose of Stribild, you may be at a higher risk of experiencing possible side effects with this medication (see section 4, Possible side effects).

Consult your doctor or go to the nearest emergency service immediately. Bring the tablet container with you so that you can easily describe what you have taken.

If you forget to take Stribild

It is essential that you do not forget a dose of Stribild.

If you forget a dose:

•and you realize it within 18 hoursafter the time you normally take Stribild, you must take the tablet as soon as possible. Take the tablet always with food. Then take the next dose as usual.

•and you realize it 18 hours or moreafter the time you normally take Stribild, do not take the missed dose. Wait and take the next dose, with food, at the usual time.

If you vomit within 1 hour of taking Stribild,take another tablet with food.

Do not interrupt treatment with Stribild

Do not interrupt treatment with Stribild without first speaking with your doctor. Interrupting Stribild can severely affect your response to future treatments. If Stribild is interrupted for any reason, consult with your doctor before restarting treatment with Stribild.

When you see that you have little Stribild left,go to your doctor or pharmacist to get more. This is very important, as the amount of virus may start to increase if the medication is interrupted even for a short period of time. It is possible that the disease will then become more difficult to treat.

If you have HIV and hepatitis B,it is especially important not to suspend your treatment with Stribild without first speaking with your doctor. You may need to have blood tests for several months after suspending treatment. In some patients with advanced liver disease or cirrhosis, treatment is not recommended as this can cause a worsening of hepatitis, a potentially fatal situation.

?Talk to your doctor immediatelyabout new or unusual symptoms after suspending treatment, particularly symptoms associated with hepatitis B infection (such as yellow discoloration of the skin or the white part of the eyes, dark brown urine, light-colored stools, loss of appetite for several days, nausea or vomiting, or stomach pain).

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

During HIV treatment, there may be an increase in weight and blood glucose and lipid levels. This may be partly related to recovery of health and lifestyle, and in the case of blood lipids, sometimes to the HIV medications themselves. Your doctor will monitor these changes.

Like all medications, this medication can produce side effects, although not everyone will experience them. When treating HIV infection, it is not always possible to distinguish whether some unwanted effects are due to Stribild or to other medications being taken at the same time or to the HIV disease itself.

Severe side effects: report to a doctor immediately

•Lactic acidosis (excess lactic acid in the blood) is a rare but potentially fatal side effect of some HIV medications. Lactic acidosis occurs more frequently in women, especially if they are overweight, and in people with liver disease. The following may be signs of lactic acidosis:

- rapid and deep breathing

- fatigue or drowsiness

- nausea (gagging) and vomiting

- stomach pain

?If you think you may have lactic acidosis, report to your doctor immediately.

•Any sign 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 weakened immune system), signs and symptoms of inflammation from previous infections may occur shortly after starting HIV treatment. It is believed that these symptoms are due to an improvement in the body's immune response, which allows it to fight off infections that may have been present without obvious symptoms. In addition to opportunistic infections, autoimmune disorders (a disease that occurs when the immune system attacks healthy tissues in the body) may also occur after starting HIV treatment. Autoimmune disorders may occur many months after treatment begins. If you notice any symptoms of infection or other symptoms, such as muscle weakness, weakness that starts in the hands and feet and moves to the trunk, palpitations, tremors, or hyperactivity, report to your doctor immediately for necessary treatment.

?If you notice any signs of inflammation or infection, report to your doctor immediately.

Frequent side effects

(may affect more than 1 in 10 patients treated)

• diarrhea

• vomiting

• nausea (gagging)

• weakness

• headache, dizziness

• eruption

The tests may also show:

• decreased phosphate levels in the blood

•increased levels of creatine kinase in the blood, which may cause muscle pain and weakness

Frequent side effects

(may affect up to 1 in 10 patients treated)

• decreased appetite

• difficulty sleeping (insomnia), abnormal dreams

• pain, stomach pain

• digestive problems with discomfort after meals (dispepsia)

• feeling bloated

• constipation, gas (flatulencia)

•eruptions (including red patches or spots sometimes with blisters and swelling of the skin), which may be allergic reactions, itching, changes in skin color such as darkening of the skin in patches

• other allergic reactions

• fatigue

The tests may also show:

• low white blood cell count (which may make you more prone to infections)

• increased levels of sugar, fatty acids (triglycerides), and bilirubin in the blood

• liver and pancreas problems

• increased levels of creatinine in the blood

Rare side effects

(may affect up to 1 in 1,000 patients treated)

• lactic acidosis (see Severe side effects: report to a doctor immediately)

• yellowing of the skin or eyes, itching, or stomach pain caused by liver inflammation (hepatitis)

• fat liver

• kidney inflammation (nefritis)

• increased urine volume and sensation of thirst (diabetes insípida nefrogénica)

• weakening of the bones (with bone pain and sometimes leading to fractures)

You may experience muscle rupture, weakening of the bones (with bone pain and sometimes leading to fractures), muscle pain, muscle weakness, and decreased levels of potassium or phosphate in the blood due to damage to the renal tubular cells.

?If you consider any of the side effects you experience to be severe, report to your doctor.

Other effects that may be observed during HIV treatment

The frequency of the following side effects is not known (the frequency cannot be estimated from the available data).

•Bone problems. Some patients treated with combined antiretroviral medications like Stribild may develop a bone disease calledosteonecrosis(death of bone tissue due to a loss of blood supply to the bone). Taking this type of medication for a prolonged period, taking corticosteroids, drinking alcohol, having a very weakened immune system, and being overweight may be some of the many risk factors for developing this disease. The signs of osteonecrosis are:

- joint stiffness

- joint pain and discomfort (especially in the hip, knee, and shoulder)

- difficulty moving

Other effects in children

•Children who received emtricitabine presented very frequently changes in skin color that include

- dark patches on the skin

• Children presented frequently low red blood cell count (anemia)

- this may cause the child to feel tired or short of breath

?If you notice any of these symptoms, report to your doctor.

?If you experience side effects, consult your doctor or pharmacist, even if they are side effects that do not appear in this prospectus.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through thenational notification system included in eAppendix V. Mediating the reporting of side effects you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the bottle and on the box after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture. Keep the bottle perfectly closed.

Medicines should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Stribild

The active principles are: elvitegravir, cobicistat, emtricitabina, and tenofovir disoproxil. Each Stribild film-coated tablet contains 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabina, and 245 mg of tenofovir disoproxil (equivalent to 300 mg of tenofovir disoproxil fumarate or 136 mg of tenofovir).

The other components are

Core tablet:

Croscarmelosa sodium, hydroxypropylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium lauryl sulfate.

Film coating:

Indigo carmine lake (E132), macrogol 3350 (E1521), partially hydrolyzed polyvinyl alcohol (E1203), talc (E553B), titanium dioxide (E171), yellow iron oxide (E172).

Appearance of the product and contents of the package

Stribild tablets are green, capsule-shaped, and marked on one face with "GSI" and on the other face with the number "1" surrounded by a square box. Stribild is available in bottles of 30 tablets (with a silica gel desiccant that must be kept in the bottle to help protect the tablets). The silica gel desiccant is contained in a separate sachet or container and should not be taken.

This medicine is available in packages of 1 bottle of 30 film-coated tablets and 90 (3 bottles of 30) film-coated tablets. Only some package sizes may be marketed.

Marketing authorization holder

Gilead Sciences Ireland UC

Carrigtohill

County Cork, T45 DP77

Ireland

Responsible manufacturer

Gilead Sciences Ireland UC

IDA Business & Technology Park

Carrigtohill

County Cork

Ireland

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Last review date of this leaflet: <{MM/AAAA}><{mes AAAA}>.

For more detailed information about this medicine, please visit the website of the European Medicines Agency: http://www.ema.europa.eu.