200 mg hard capsules
emtricitabine
1. What Emtriva is and what it is used for
Emtriva is a treatment for human immunodeficiency virus ( HIV ) infection in adults, children, and infants aged 4 months and older. Emtriva 200 mg hard capsules are only suitable for patients weighing at least 33 kg.
Emtriva contains the active substance emtricitabine. This active substance is an antiretroviral drug used to treat HIV – infection. Emtricitabine is a nucleoside-type reverse transcriptase inhibitor (NRTI) that acts by affecting the normal function of an enzyme (reverse transcriptase) that the HIV needs for its reproduction (multiplication). Emtriva can lower the amount of HIV in the blood (amount of virus). It can also increase the number of T cells called CD4 cells. Emtriva should always be taken in combination with other medicines for HIV.
You can still transmit HIV infection while taking this medicine even though the risk is reduced with effective antiviral therapy. Discuss with your doctor the necessary steps to avoid infecting others.
This medicine does not cure HIV – infection. While you are taking Emtriva, you may still develop 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 any of the other ingredients of this medicine (listed in section 6).
→ If this applies to you, tell your doctor immediately.
Warnings and cautions
• Tell your doctor if you have a history of kidney disease or if tests have shown that you have kidney problems. Before starting treatment, your doctor may prescribe some blood tests to check your kidney function. Depending on the results of these tests, your doctor may advise you to take the capsules less often. Your doctor may also prescribe blood tests during treatment to check your kidneys.
• Talk to 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 that and have been prescribed Emtriva, your doctor will monitor you closely.
• Tell your doctor if you already have or have had liver disease, including hepatitis. Patients with liver disease, including chronic hepatitis B or C, treated with antiretroviral agents are at increased risk of severe and potentially fatal liver complications. If you have hepatitis B, your doctor will carefully choose the best treatment for you. If you have or have had liver disease or chronic hepatitis B, your doctor may take blood samples to closely monitor your liver function.
• Be observant of infection. If you have advanced-stage HIV ( AIDS ) and another infection, you may develop inflammation or worsening of the symptoms of an existing infection when you start treatment with Emtriva. This may be a sign that your body’s improved immune system is fighting infection. If you notice any signs of inflammation or infection shortly after you start taking Emtriva, tell your doctor immediately.
In addition to opportunistic infection, you can autoimmune disorders (a condition in which the immune system attacks healthy body tissue) may also occur after you start taking medicines to treat your HIV – infection. Autoimmune disorders can occur several months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, a weakness that starts in the hands or feet and moves to the torso, palpitations, tremors, or hyperactivity, inform your doctor immediately for the necessary treatment.
• Skeletal problems. Some patients receiving combination antiretroviral therapy may develop a skeletal disease called osteonecrosis (bone tissue dies due to lost blood supply to the skeletal bone). Some of the many risk factors for developing the disease are long-term antiretroviral combination therapy, use of corticosteroids, alcohol consumption, a severe weakening of the immune system, and higher body mass index. Signs of osteonecrosis are stiffness in the joints and pain (especially in the hip, knee, and shoulders) and difficulty moving. Tell your doctor if you experience any of these symptoms.
Other medicines and Emtriva
You should not take Emtriva if you are already taking other medicines containing emtricitabine or lamivudine, which are also used to treat HIV infection unless your doctor tells you to.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You should not stop treatment without talking to your doctor.
Children and young people
Do not give Emtriva to infants under 4 months of age.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, 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 taken Emtriva during your pregnancy, your doctor may ask you to have regular blood tests and other diagnostic tests to check on your baby’s development. For children with a mother who has taken NRTIs during pregnancy, the benefit of HIV protection outweighs the risk of side effects.
• Do not breastfeed if you are taking Emtriva. This is because the active substance in this medicine is excreted in human breast milk. It is known that viruses can be transmitted to infants via breast milk.
Driving and using machines
Emtriva may cause dizziness. Do not drive or use any tools or machines if you feel dizzy while taking Emtriva.
How to take Emtriva
• Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is:
• Adults: one 200 mg hard capsule a day with or without food. Swallow the hard capsule together with a glass of water.
• Children and adolescents up to 18 years of age who weigh at least 33 kg and who can swallow hard capsules: one 200 mg hard capsule a day with or without food.
Tell your doctor if you have difficulty swallowing the capsules.
• Always take the dose prescribed by your doctor to ensure that the medicine is 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. Read the package leaflets of the other antiretroviral medicines for instructions on how to take these medicines.
If you take more Emtriva than you should
If you accidentally take too many Emtriva hard capsules, contact your doctor or nearest emergency department for advice. Save the box so you can easily describe what you have taken.
If you forget to take Emtriva
You mustn’t miss a dose of Emtriva.
If you miss a dose of Emtriva within 12 hours of the time it is usually taken, take it as soon as possible, and then take the next dose at its usual time.
If it is almost time (less than 12 hours) for the next dose, do not take the missed dose. Wait and take the next dose at its regular time. Do not take a double dose to make up for a forgotten hard capsule.
If you vomit
If it has been less than an hour since you took Emtriva, take a new capsule. You do not need to take a new capsule if you vomit more than an hour after taking Emtriva.
If you stop using Emtriva
• Do not stop taking Emtriva without talking to your doctor. Discontinuing treatment with Emtriva may result in a reduced effect of the anti- HIV treatment recommended by your doctor. Talk to your doctor before quitting, especially if you experience any side effects or have any other illness. Contact your doctor again before starting to take Emtriva capsules again.
• If you have both HIV – infection and chronic hepatitis B infection, it is especially important not to stop your Emtriva treatment without first talking to your doctor. Some patients’ blood tests or symptoms have shown that their hepatitis has worsened when treatment with Emtriva is stopped. You may need to submit blood samples for several months after stopping treatment. In patients with advanced liver disease or cirrhosis, discontinuation of treatment is not recommended as this may lead to a worsening of hepatitis infection in some patients.
Inform your doctor immediately about any new and unexpected symptoms that occur after stopping treatment, especially symptoms that you usually associate with your hepatitis B infection.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
During HIV treatment, weight gain and increased levels of lipids and glucose in the blood may occur. This is partly related to restored health and lifestyle, but when it comes to blood lipids, there can sometimes be a connection with HIV drugs. The doctor will perform tests to find such changes.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor if you get any of the following side effects:
The most common side effects are
These side effects are very common (may affect more than 10 in 100 patients)
• headache, diarrhea, nausea
• muscle pain and muscle weakness (if creatine kinase in the blood is elevated)
Other possible side effects are
These side effects are common (may affect up to 10 in 100 people)
• dizziness, weakness, difficulty sleeping, abnormal dreams
Vomiting, indigestion which results in discomfort after meals, abdominal pain
• skin rash (including red spots and blemishes sometimes with blistering and swelling of the skin) which may be allergic reactions, itching, discoloration of the skin including patchy darkening of the skin
• pain
Samples can also show:
• low white blood cell count (a decrease in white blood cell count may make you more likely to get an infection )
• elevated levels of triglycerides (fatty acids) in the blood, increased amount of bile pigments in the blood, or increased blood sugar
• liver and pancreatic problems
These side effects are uncommon (may affect up to 1 in 100 people)
• anemia (low red blood cell count )
• swelling of the face, lips, tongue, or throat
Other possible side effects are
In children receiving emtricitabine, discoloration of the skin, including patchy darkening of the skin, was also a very common side effect and anemia (low red blood cell count ) was a common side effect. If the production of red blood cells is reduced, a child may experience symptoms of fatigue or shortness of breath.
5. How to store 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 can, blister, and carton after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
The active substance is emtricitabine. Each Emtriva hard capsule contains 200 mg of emtricitabine.
• The other ingredients are:
Capsule contents: microcrystalline cellulose (E460), crospovidone, magnesium stearate (E572), povidone (E1201)
Capsule shell: gelatin, indigotin (E132), titanium dioxide (E171)
Marking ink content: black iron oxide (E172), shellac (E904)
What the medicine looks like and the contents of the pack
Emtriva hard capsule has a white, opaque base with a light blue, opaque top. Each capsule is marked with “200 mg” on the top and “GILEAD” and [Gilead logo] on the bottom with black ink. Emtriva is supplied in jars or blister packs containing 30 capsules.
Marketing Authorization Holder and Manufacturer
Gilead Sciences Ireland UC
Carrigtohill
County Cork, T45 DP77
Ireland
Manufacturer:
Gilead Science Ireland UC
IDA Business & Technology Park
Carrigtohill
County Cork
Ireland