Emtriva 10 mg/ml oral solution

Package leaflet: Information for the user

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, talk to your doctor or pharmacist, even if the adverse reactions are not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Emtriva is and what it is used for

Emtriva is a medicine used to treat human immunodeficiency virus (HIV) infection in adults, children, and infants aged 4 months and older. Emtriva oral solution is particularly suitable for patients who have difficulty swallowing Emtriva's hard capsules.

Emtriva contains the active substance emtricitabine. This active substance is an antiretroviral medicine used to treat HIV infection. Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI) that works by interfering with the normal function of an enzyme (reverse transcriptase) essential for HIV virus replication. Emtriva can reduce the amount of HIV in your blood (viral load). This may also help increase the number of T-cells called CD4 cells. Emtriva must always be used in combination with other medicines for the treatment of HIV infection.

While taking this medicine, you may still transmit HIV to others, although effective antiviral treatment reduces this risk. Consult your doctor about the precautions needed to avoid infecting other people.

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

2. What you need to know before taking Emtriva

Do not take Emtriva

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

?If this happens, call 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 request blood tests to check how well your kidneys are working and may advise you to take a reduced dose of the oral solution or prescribe Emtriva hard capsules. Your doctor may also request periodic blood tests during treatment to monitor your kidney function.

• If you are over 65 years old, tell your doctor. Emtriva has not been studied in patients over 65 years of age. If you are older than this 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, who are treated with antiretrovirals, have an increased risk of severe liver complications, which may be fatal. If you have 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 may develop inflammation or worsening of infection symptoms when you start treatment with Emtriva. 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, contact your doctor immediately.

In addition to opportunistic infections, autoimmune disorders (a condition in which 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 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 moving upwards towards the trunk, palpitations, tremors, or hyperactivity, inform your doctor immediately to receive necessary treatment.

• Bone problems. Some patients receiving combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by reduced blood supply to the bone). Among the numerous risk factors for developing this condition are duration of combination antiretroviral therapy, use of corticosteroids, alcohol consumption, severe immunosuppression, and high body mass index. Symptoms of osteonecrosis include joint stiffness, pain, and discomfort (particularly in the hip, knee, and shoulder) and difficulty moving. If you experience any of these symptoms, inform your doctor.

Children and adolescents

Do not give Emtriva to infants under 4 months of age.

Taking Emtriva with other medicines

You must not take Emtriva if you are already taking other medicines containing emtricitabine or lamivudine, which are also used to treat HIV infection, unless directed by your doctor.

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to 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 become pregnant, consult your doctor or pharmacist before using this medicine.

If you have taken Emtriva during pregnancy, your doctor may request periodic blood tests and other diagnostic tests to monitor your child's development. 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 if you are 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 use of machines

Emtriva may cause dizziness. If you experience dizziness during treatment with Emtriva, do not drive or operate tools or machinery.

Emtriva oral solution contains:

Orange-yellow S (E110) may cause allergic-type reactions. Methylparahydroxybenzoate (E218) and propylparahydroxybenzoate (E216) may also cause allergic-type reactions (mainly delayed). This medicine contains 36 mg of sodium (a main component of table/cooking salt) in each 24 ml. This corresponds to 1.8% of the maximum daily sodium intake recommended 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

• Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

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 body weight. The table below provides some examples of weights and the corresponding daily doses and volumes of oral solution to be taken:

Make sure you understand how to measure and take the correct amount of oral solution based on the weight of the person being treated. Use the dosing cup provided in the package to measure the correct dose. The cup has markings indicating each mL of solution.

If you are unsure about how much Emtriva to take, consult your doctor or pharmacist.

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

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

• Your doctor will prescribe Emtriva together with other antiretroviral medicines. Refer to the package leaflets of the other antiretrovirals for instructions on how to take them.

Emtriva is also available in hard capsules. These are suitable only for patients weighing at least 33 kg who are able to swallow hard capsules. The blood levels achieved after taking one 200 mg Emtriva hard capsule are similar to those achieved after taking 24 mL of oral solution. If you wish to switch from oral solution to capsules, please consult your doctor.

If you take more Emtriva than you should

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

If you forget to take Emtriva

It is important not to miss a dose of Emtriva.

If you miss a dose of Emtriva within 12 hours of your usual dosing time, take it as soon as possible, then take your next dose at the regular time.

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

If you feel like vomiting

If less than one hour has passed since you took Emtriva, take another dose. You do not need to take another dose if you vomited more than one 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 your prescribed HIV therapy. 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 Emtriva treatment without first talking to your doctor. Some patients have had blood test results or symptoms indicating that their hepatitis worsened after stopping Emtriva. You may need blood tests for several months after stopping treatment. In patients with advanced liver disease or cirrhosis, interrupting treatment is not recommended, as this may lead to worsening of hepatitis.

Contact your doctor immediately about any new or unusual symptoms after stopping treatment, particularly symptoms you associate with hepatitis B virus infection.

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

4. Possible adverse effects

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

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Inform your doctor about any of the following adverse effects:

Most frequent adverse effects

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

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

Other possible adverse effects

The following adverse 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
• skin rashes (including red spots or pimples, sometimes with blisters and skin swelling), which may be allergic reactions, itching, changes in skin colour such as darkening of the skin in patches
• pain

Blood tests may also show:

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

The following adverse effects are uncommon (may affect up to 1 in every 100 patients):

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

Other possible effects

Children who received emtricitabine also very commonly experienced changes in skin colour, including darkening of the skin in spots, and commonly anaemia (low red blood cell count). If red blood cell production decreases, the child may have symptoms of tiredness or shortness of breath.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Annex V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Emtriva

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

Do not use this medicine after the expiry date stated on the vial and carton after "EXP". The expiry date refers to the last day of the month indicated.

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

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

If any solution remains in the vial after 45 days, it should be disposed of according to 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 and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Emtriva

• The active substance is emtricitabine. Each ml of Emtriva oral solution contains 10 mg of emtricitabine (10 mg/ml).

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

Presentation of the product and contents of the pack

Emtriva oral solution is a clear, orange to dark orange-coloured solution supplied in 170 ml bottles with a dosing cup.

Emtriva is also available as hard capsules. These are suitable only for patients weighing at least 33 kg who can swallow hard capsules. A different package leaflet is provided for Emtriva 200 mg hard capsules.

Marketing Authorisation Holder

Gilead Sciences Ireland UC
Carrigtohill
County Cork, T45 DP77
Ireland

Manufacturer

Gilead Sciences Ireland UC
IDA Business & Technology Park
Carrigtohill
County Cork
Ireland

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet:

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