EMTRIVA 10 MG/ML ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Emtriva 10 mg/ml Oral Solution

emtricitabine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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.

Contents of the pack and other information

1. What is Emtriva and what is it used for
2. What you need to know before you take Emtriva
3. How to take Emtriva
4. Possible side effects
5. Storing Emtriva
6. Contents of the pack and other information

1. What is Emtriva and what is it used for

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

Emtriva contains the active substanceemtricitabine.This active substance is an antiretroviral drug used to treat HIV infection. Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI) that works by interfering with the normal working of an enzyme (reverse transcriptase) that is essential for the HIV virus to reproduce. Emtriva may decrease the amount of HIV in your blood (viral load). This may also help increase the number of CD4 cells (T cells) in your blood. Emtriva must always be used in combination with other medicines to treat HIV infection.

While you are taking this medicine, you can still pass HIV to others,even if you are taking antiviral therapy and your HIV blood tests show that the virus is under control. Consult your doctor for advice on how to prevent passing HIV to others.

This medicine does not cure HIV infection.When you are taking Emtriva, you may still develop infections or other illnesses associated with HIV infection.

2. What you need to know before you take Emtriva

Do not take Emtriva

• If you are allergicto emtricitabine or any of the other ingredients of this medicine (listed in section 6).

If this happens, contact your doctor immediately.

Warnings and precautions

• If you have had kidney disease,or if blood tests have shown kidney problems, tell your doctor.Before starting treatment, your doctor may ask you to have blood tests to check how well 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 blood tests during treatment to monitor your kidneys.

• If you are over 65 years of age, tell your doctor.Emtriva has not been studied in patients over 65 years of age. If you are over 65 and have been prescribed Emtriva, your doctor will monitor you carefully.

• Tell 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 greater risk of severe liver complications, which may 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 your liver function.

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

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

• Bone problems.Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). Among the many risk factors for developing this disease are the duration of combination antiretroviral therapy, the use of corticosteroids, alcohol consumption, severe immunosuppression, 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.

Taking Emtriva with other medicines

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

Tell your doctor or pharmacistif you are taking, have recently taken, or might take any other medicines.

Do not stop your treatment without consulting your doctor.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

• Do not breastfeed your child while taking Emtriva.This is because the active ingredient of this medicine passes into breast milk. It is known that the virus can pass to the baby through breast milk.

Driving and using machines

Emtriva may cause dizziness. If you feel dizzy while taking Emtriva, do not driveor operate tools or machines.

Emtriva oral solution contains:

Orange-yellow S (E110) may cause allergic reactions. Methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) may also cause allergic reactions (mainly delayed). This medicine contains 36 mg of sodium (main component of cooking/table salt) in each 24 ml. This is equivalent to 1.8% of the maximum recommended daily intake of sodium for an adult.

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

3. How to take Emtriva

• Always take this medicine exactly as your doctor has told you.If you are not sure, check with your doctor or pharmacist.

The recommended dose is:

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

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

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 pack to measure the correct dose. The cup has lines that indicate each ml of solution.

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

• Always take the dose recommended by your doctor.This is to ensure that your medicine 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 less frequently.

• Your doctor will prescribe Emtriva with other antiretroviral medicines.Consult the package leaflets of the other antiretrovirals to find out how to take these medicines.

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

If you take more Emtriva than you should

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

If you forget to take Emtriva

It is important that you do not miss 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 the usual time.

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

If you feel like vomiting

If it has been less than 1 hour since you took Emtriva,take another dose. You do not need to take another dose if you vomit after 1 hour of taking Emtriva.

If you stop treatment with Emtriva

• Do not stop taking Emtriva without consulting your doctor.Stopping treatment with Emtriva may reduce the effectiveness of the anti-HIV therapy recommended 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 your treatment with Emtriva without first talking to your doctor. Some patients have had 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 stop treatment as this may lead to worsening of hepatitis.

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor about any of the following side effects:

Very common side effects

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

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

Other possible side effects

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

• dizziness, weakness, difficulty sleeping, nightmares
• vomiting, digestive problems with discomfort after meals, stomach pain
• rash (including red spots or patches, 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
• pain

Blood tests may also show:

• low white blood cell count (reduced white blood cell count may make you more prone to infections)
• increased triglycerides (fatty acids), bilirubin, or sugar in the blood
• liver and pancreas problems

The following side effects are uncommon(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 very commonlyexperienced changes in skin colorincluding darkening of the skin in patches, and commonlyexperienced anemia(low red blood cell count). If red blood cell production decreases, the child may show symptoms of tiredness or shortness of breath.

Reporting of side effects

If you experience 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 Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Emtriva

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 the month shown.

Store in a refrigerator (between 2°C and 8°C) until opening.

After opening the bottle, do not store above 25°C. The contents of the bottle must be used within 45 days of opening. It is recommended to write the date of removal from the refrigerator on the carton.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container contents and additional information

Composition of Emtriva

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

• The other ingredients are:Cotton candy flavor, disodium edetate, hydrochloric acid, methylparahydroxybenzoate (E218), propylene glycol, propylparahydroxybenzoate (E216), sodium hydroxide, monobasic sodium phosphate hydrate, orange yellow S (E110), purified water, xylitol (E967).

Appearance of the product and container contents

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

Emtriva is also available in hard capsules. These are suitable only 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

Manufacturer

Gilead Sciences Ireland UC

IDA Business & Technology Park

Carrigtohill

County Cork

Ireland

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

Date of last revision of this leaflet:

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.