Label: information for the user

Emtriva 10 mg/ml oral solution

emtricitabine

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 only for you, 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.

Emtriva is a medication used to treat human immunodeficiency virus (HIV) infection in adults, children, and infants 4 months of age or older.Emtriva oral solution is especially suitable for patients who have difficulty swallowing the hard capsules of Emtriva.

Emtriva contains the active ingredientemtricitabine.This active ingredient is an antiretroviral drugused to treat HIV infection. Emtricitabine is anucleoside reverse transcriptase inhibitor (NRTI) that acts by interfering with the normal functioning of an enzyme (reverse transcriptase) essential for the HIV virus to replicate. Emtriva may reduce the amount of HIV in the blood (viral load). This may also help increase the number of CD4 T cells. Emtriva must be used always in combination with other medications to treat HIV infection.

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 does not cure HIV infection.When taking Emtriva you may continuesuffering from infections or other diseases associated with HIV infection.

Do not take Emtriva

• If you are allergicto emtricitabine or to any of the other components of this medication(listed in section 6).

?If this happens, call your doctor immediately.

Warnings and precautions

• If you have kidney disease,or if blood tests have shown kidney problems,inform your doctor.Before starting treatment, your doctor may ask you to have some blood tests to check how your kidneys are working and may advise you to take a reduced dose of oral solution or prescribe Emtriva hard capsules. Your doctor may also ask you to have some blood tests during treatment to monitor your kidneys.

• If you are over 65 years old, inform your doctor.Emtriva has not been studied in patientsover 65 years old. If you are over this age and have been prescribed Emtriva, your doctor will monitor you closely.

• Talk to your doctor if you have 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 liver complications that can be fatal. If you have a hepatitis B infection, your doctor will carefully consider the best treatment for you. If you have a history of liver disease or chronic hepatitis B infection, your doctor may perform blood tests to closely monitor liver function.

• Infections.If you have advanced HIV disease (AIDS) and another infection, you maydevelop inflammation or worsening of infection symptoms when starting Emtriva treatment. These may be signs that your improved immune system is fighting the infection. If you notice signs of inflammation or infection soon after starting Emtriva,talk to your doctor immediately..

In addition to opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also appear after you have started taking medications for HIV treatment. Autoimmune disorders may appear many months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness starting in the hands and feet and ascending to the trunk of the body, palpitations, tremors, or hyperactivity, inform your doctor immediately to receive necessary treatment.

• Bone problems.Some patients receiving combined antiretroviral treatment maydevelop a bone disease called osteonecrosis (bone tissue death caused by loss of blood supply to the bone). Among the numerous risk factors for developing this disease are the duration of combined antiretroviral treatment, the use of corticosteroids, alcohol consumption, severe immunodepression, and high body mass index. The symptoms of osteonecrosis are joint stiffness, pain, and discomfort (especially in the hip, knee, and shoulder) and difficulty moving. If you notice any of these symptoms, inform your doctor.

Children and adolescents

Do not give Emtriva to infantsunder 4 months of age.

Emtriva with other medications

Do not take Emtrivaif you are already taking other medications that contain emtricitabine orlamivudine, which are also used to treat HIV infection, unless your doctor tells you to.

Inform your doctor or pharmacistif you are taking, have taken recently, or may need to take any other medication.

Do not stop your treatment without consulting your doctor.

Pregnancy and breastfeeding

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

If you have been taking Emtriva during your pregnancy, your doctor may request periodic blood tests and other diagnostic tests to monitor the development of your child. In children whose mothers took INTIs during pregnancy, the benefit of protection against HIV was greater than the risk of side effects.

• Do not breastfeed your child if you are taking Emtriva.This is because the active ingredient in this medication passes into breast milk. It is known that the virus can pass to the baby through breast milk.

Driving and operating machines

Emtriva may cause dizziness. If you notice dizziness during Emtriva treatment,do not driveor operate tools or machines.

Emtriva oral solution contains:

The yellow-orange S (E110) may cause allergic reactions. Methylparahydroxybenzoate (E218) and propylparahydroxybenzoate (E216) may also cause allergic reactions (in principle, delayed). This medication contains 36 mg of sodium (main component of table salt/for cooking) in each 24 ml. This is equivalent to 1.8% of the maximum daily sodium intake recommended for an adult.

This medication also contains 480 mg of propylene glycol in each 24 ml (maximum single dose), equivalent to a maximum of 12 mg/kg/day.

• Follow exactly the administration instructions for this medication as indicated by your doctor.If you are unsure, consult your doctor or pharmacist again.

The recommended dose is:

• Adults:Your doctor will tell you the correct amount of Emtriva oral solution you should take.Emtriva oral solution can be taken with food or without it.

• Infants, children, and adolescents weighing 40 kg or less:The dose of Emtriva 10 mg/mloral solution is calculated according to your weight. In the table below, some examples of weights and their corresponding doses and volumes of oral solution to be taken each day are given:

Make sure you understand how to measure and take the correct amount of oral solution according to the weight of the person being treated. Use the dosing cup provided in the package to measure the correct dose. The cup has lines that indicate each ml of solution.

If you are unsure of the amount of Emtriva to take, consult your doctor or pharmacist.

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

• If you have kidney problems,your doctor may advise you to take Emtriva lessfrequently.

• Your doctor will prescribe Emtriva with other antiretroviral medications.Consult theprospectuses of the other antiretrovirals to know how to take these medications.

Emtriva is also available in hard capsules. These are only suitable for patients who weigh at least 33 kg and can swallow the hard capsules. The blood levels obtained after taking a hard capsule of Emtriva 200 mg are similar to those obtained after taking 24 ml of oral solution. If you want to change the oral solution for capsules, please consult your doctor.

If you take more Emtriva than you should

If you accidentally took too much Emtriva oral solution, consult your doctor or go to the nearest emergency service. Bring the solution oral bottle with you so that you can easily describe what you have taken.

If you forget to take Emtriva

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

If you forget a dose of Emtriva within 12 hours of when you normally take it,take it as soon as you can, and then take your next dose at your usual time.

If it is almost time for your next dose (less than 12 hours),do not take the missed dose. Wait andtake the next dose at your usual time. Do not take a double dose to compensate for the missed doses.

If you feel like vomiting

If it has been less than an hour since you took Emtriva,take another dose. You do not needto take another dose if you vomited more than an hour after taking Emtriva.

If you interrupt treatment with Emtriva

• Do not stop taking Emtriva without consulting your doctor.Stopping Emtriva treatment may reduce the effectiveness of the recommended HIV therapy by your doctor. Talk to your doctor before stopping, especially if you are experiencing any side effects or have another illness. Contact your doctor again before restarting Emtriva oral solution.

• If you have HIV and hepatitis B infection,it is especially important not to stop yourEmtriva treatment without first talking to your doctor. Some patients have presented blood tests or symptoms indicating that their hepatitis had worsened after stopping Emtriva. You may need to have blood tests for several months after stopping treatment. In patients with advanced liver disease or cirrhosis, it is not recommended to interrupt treatment as this may lead to worsening of hepatitis.

Talk to your doctor immediately about new or unusual symptoms after stopping treatment, especially symptoms associated with hepatitis B virus infection.

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 may produce side effects, although not everyone will experience them.

Inform your doctor about any of the following side effects:

Most common side effects

The following side effects arevery common(may affect more than 10 in every 100 patients):

• headache, diarrhea, nausea
• muscle pain and weakness (if blood creatinine kinase levels increase)

Other possible side effects

The following side effects arecommon(may affect up to 10 in every 100 patients):

• dizziness, weakness, difficulty sleeping, nightmares
• vomiting, digestive problems with discomfort after meals, stomach pain
• skin eruptions (including red patches or spots sometimes with blisters and skin swelling), which may be allergic reactions, itching, changes in skin color such as skin darkening in patches
• pain

Lab tests may also show:

• low white blood cell count (a reduced white blood cell count may make you more prone to infections)
• increased triglycerides (fats), bile, or blood sugar
• problems with the liver and pancreas

The following side effects areuncommon(may affect up to 1 in every 100 patients):

• anemia (low red blood cell count)
• swelling of the face, lips, tongue, or throat

Other possible effects

Children who received emtricitabine also experienced very frequentlyskin color changesincluding skin darkening in patches, and frequentlyanemia(low red blood cell count). If red blood cell production decreases, the child may experience symptoms of fatigue or shortness of breath.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through thenational reporting system included in theAnnex V.By reporting 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 packaging after “CAD”. The expiration date is the last day of the month indicated.

Store in the refrigerator (between 2 °C and 8 °C) until opened.

Once the bottle is opened, do not store at a temperature above 25 °C. The bottle contents must be used before 45 days once opened. It is recommended to note the date of removal from the refrigerator on the packaging.

If solution remains in the bottle after 45 days, it must be disposed of in accordance with local regulations or returned to the pharmacy.

Medications should not be thrown away through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Emtriva Composition

• The active ingredient isemtricitabine. Each milliliter of Emtriva oral solution contains 10 mg ofemtricitabine (10 mg/ml).

• The other components are:Sweetener cotton candy, edetate disodium, hydrochloric acid, methylparahydroxybenzoate (E218), propylene glycol, propylparahydroxybenzoate (E216), sodium hydroxide, monobasic sodium phosphate dihydrate, yellow-orange S

(E110), purified water, xylitol (E967).

Product appearance and packaging contents

Emtriva oral solution is a clear, orange to dark orange solution that comes in 170 ml bottles with a dosing cup.

Emtriva is also available in hard capsules. These are only suitable for patients who weigh at least 33 kg and can swallow the hard capsules. There is a different leaflet for Emtriva 200 mg hard capsules.

Marketing Authorization Holder

Gilead Sciences Ireland UC

Carrigtohill

County Cork, T45 DP77

Ireland

Responsible for manufacturing

Gilead Sciences Ireland UC

IDA Business & Technology Park

Carrigtohill

County Cork

Ireland

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last review date of this leaflet:

The detailed information about this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.