Emtriva 200 mg capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Emtriva 200 mg hard capsules

Emtricitabine

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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 and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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 4 months of age and older. Emtriva 200 mg hard capsules are suitable only for patients weighing at least 33 kg. Emtriva oral solution is available for individuals who have difficulty swallowing Emtriva hard capsules.

Emtriva contains the active substance emtricitabine. 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 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 to treat 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 necessary precautions to avoid infecting other people.

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

2. What you need to know before starting 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 the capsules less frequently, or prescribe Emtriva oral solution. Your doctor may also request regular blood tests during treatment to monitor your kidney function.

• Tell your doctor if you are over 65 years old. 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 carefully.

• 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 improving 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 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 up toward the trunk, palpitations, tremors, or hyperactivity, inform your doctor immediately to receive appropriate treatment.

• Bone problems. Some patients receiving combination antiretroviral therapy may develop a bone disease called osteonecrosis (bone tissue death caused by reduced blood supply to the bone). Numerous risk factors for developing this condition include duration of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, and high body mass index. Symptoms of osteonecrosis include joint stiffness, pain, and discomfort (especially 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 lamivudina, 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

If you have taken Emtriva during pregnancy, your doctor may request regular 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 baby if you are taking Emtriva. This is because the active ingredient in 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 experience dizziness during treatment with Emtriva, do not drive or operate tools or machinery.

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: One 200 mg hard capsule once daily, with or without food. Swallow the hard capsules with a glass of water.
• Children and adolescents up to 18 years of age who weigh at least 33 kg and are able to swallow hard capsules: one 200 mg hard capsule once daily, with or without food.

For infants from 4 months of age, children who cannot swallow hard capsules, and patients with renal problems, Emtriva is available in liquid form (oral solution). Inform your doctor if you have difficulty swallowing the capsules.

• Always take the dose prescribed by your doctor. This is to ensure that your medicine 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. Please refer to the package leaflets of the other antiretrovirals for instructions on how to take them.

If you take more Emtriva than you should

If you accidentally take too many Emtriva hard capsules, contact your doctor or go to the nearest emergency department. Take the packaging 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 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 your next dose at the regular time. Do not take a double dose to make up for the missed capsule.

If you feel like vomiting

• If less than one hour has passed since you took Emtriva, take another capsule. You do not need to take another capsule if you vomited more than one hour after taking Emtriva.

If you stop taking Emtriva

• Do not stop taking Emtriva without consulting your doctor. Stopping treatment with Emtriva 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 capsules.

• 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 to have blood tests for several months after stopping treatment. In patients with advanced liver disease or cirrhosis, stopping treatment is not recommended, as this may lead to a worsening of hepatitis.

Talk to your doctor immediately about any new or unusual symptoms after stopping your 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 improved health, lifestyle, and, in the case of blood lipids, sometimes to HIV medicines themselves. Your doctor will monitor these changes.

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

Inform your doctor about any of the following adverse effects:

Most common 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 patches, and commonly anaemia (low red blood cell count). If red blood cell production decreases, the child may experience symptoms of tiredness or shortness of breath.

Reporting of adverse effects

If you experience any 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 bottle, blister pack, and outer packaging after "EXP". The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Emtriva

• The active substance is emtricitabine. Each Emtriva hard capsule contains 200 mg of emtricitabine.
• The other components are:

Capsule contents: Microcrystalline cellulose (E460), Crospovidone, Magnesium stearate (E572), Povidone (E1201)

Capsule shell: Gelatin, Indigotine (E132), Titanium dioxide (E171)

Printing ink: Iron oxide black (E172), Shellac (E904)

Appearance of the product and contents of the pack

The Emtriva hard capsule has an opaque white body and a pale blue opaque cap. Each capsule is printed with “200 mg” on the cap and “GILEAD” and the Gilead logo on the body, inscribed in black ink. Emtriva is available in bottles or blister packs containing 30 capsules.

Emtriva is also available as an oral solution for children and infants aged 4 months or older, patients who have difficulty swallowing, and patients with renal problems. A different patient information leaflet is available for Emtriva 10 mg/ml oral solution.

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

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

Date of the most recent review of this leaflet:

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