Emtriva 10 mg/ml oral solution

Emtriva is a treatment for Human Immunodeficiency Virus (HIV) infection in adults, children and infants above 4 months of age. Emtriva oral solution is particularly suitable for people who have difficulty in swallowing Emtriva hard capsules.

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

You can still pass on HIV to others while you?re taking this drug, so it is important to take precautions to avoid infecting other people.

This medicine is not a cure for HIV infection. While taking Emtriva you may still develop infections or other illnesses associated with HIV infection.

Do not take Emtriva

• If you are allergic(hypersensitive) to emtricitabine or any of the other ingredients of Emtriva 10 mg/ml oral solution listed at the end of this leaflet.

If this applies to you, tell your doctor immediately.

Take special care with Emtriva

• Tell your doctor if you have had kidney disease, or if tests have shown problems with your kidneys. Before starting treatment, your doctor may order blood tests to assess kidney function

and may advise you to take a reduced dose of the oral solution or prescribe Emtriva hard capsules. Your doctor may also order blood tests during treatment to monitor your kidneys.

• Talk to your doctor if you are over 65. Emtriva has not been studied in patients over 65 years of age. If you are older than this and are prescribed Emtriva, your doctor will monitor you carefully.
• Do not give Emtriva to infants under 4 months of age.
• 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 a higher risk of severe and potentially fatal liver complications. If you have hepatitis B infection, your doctor will carefully consider the best treatment regimen for you. If you have a history of liver disease or chronic hepatitis B infection your doctor may conduct blood tests in order to carefully monitor liver function.
• If you are diabetic, overweight or have high cholesterol, talk to your doctor. Combination antiretroviral therapies may raise blood sugar, increase blood fats (hyperlipaemia), cause changes to body fat, and resistance to insulin (see section 4, Possible side effects).
• Once you start taking Emtriva, look out for possible signs of lactic acidosis. Medicines containing nucleoside analogues, including Emtriva, can cause lactic acidosis (excess of lactic acid in your blood), together with an enlarged liver. This is a rare but serious side effect; it has occasionally been fatal. Lactic acidosis occurs more often in women, particularly if they are very overweight. If you have liver disease you may also be more at risk of getting this condition. While you are being treated with Emtriva, your doctor will monitor you closely for any signs that you may be developing lactic acidosis. Signs are:
• Deep, rapid breathing
• Drowsiness
• Nausea (feeling sick), vomiting and stomach pain If you notice any of these symptoms, tell your doctor immediately.
• Look out for infections. If you have advanced HIV disease (AIDS) and another infection, you may develop inflammation or worsening of the symptoms of infection when you start treatment with Emtriva. These may be signs that your body?s improved immune system is fighting infection. If you notice signs of inflammation or infection soon after you start taking Emtriva, tell your doctor at once.
• 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). The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease. Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement. If you notice any of these symptoms please inform your doctor.

Taking other medicines

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

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. They will advise if Emtriva can be taken with your other medicines.

Do not stop your treatment without contacting your doctor.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

• You must not take Emtriva during pregnancy unless specifically directed by your doctor. There are no clinical data on the use of Emtriva in pregnant women and it is not usually used unless absolutely necessary.
• If you could get pregnant during treatment with Emtriva, you must use an effective method of contraception to stop you getting pregnant.
• If you become pregnant, or plan to become pregnant, ask your doctor about the potential benefits and risks of your antiretroviral therapy to you and your child.

If you have taken Emtriva during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child. In children whose mothers took NRTIs during pregnancy, the benefit from the protection against HIV outweighed the risk of side effects.

• Do not breast-feed if you are taking Emtriva. It is not yet known whether the active substance in this medicine passes into human breast milk. It is known that the virus can be passed to the baby in breast milk.

Driving and using machines

Emtriva may cause dizziness. If you experience dizziness while taking Emtriva, do not drive and do not use any tools or machines.

Important information about some of the ingredients of Emtriva oral solution

Sunset yellow (E110) may cause allergic reactions. The methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) may cause allergic reactions (possibly delayed). This medicine contains 254 mg of sodium per dose which should be taken into consideration by patients on a controlled sodium diet.

• Always take Emtriva exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual dose:

• Adults: Your doctor will advise the correct amount of Emtriva oral solution to be taken. 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 your body weight. Examples of body weight and the corresponding doses and volumes of the oral solution to be taken each day are given in the table below:

Per day Body weight kg Emtricitabine dose mg How much 10 mgml solution to take ml 5 kg 30 mg 3 ml 10 kg 60 mg 6 ml 15 kg 90 mg 9 ml 20 kg 120 mg 12 ml 25 kg 150 mg 15 ml 30 kg 180 mg 18 ml 35 kg 210 mg 21 ml 40 kg 240 mg 24 ml

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

If you are unsure how much Emtriva you should take ask your doctor or pharmacist.

• Always take the dose recommended by your doctor. This is to make sure that your medicine is fully effective, and to reduce the risk of developing resistance to the treatment. Do not change the dose unless your doctor tells you to.
• If you have problems with your kidneys, your doctor may advise you to take Emtriva less frequently.
• Your doctor will prescribe Emtriva with other antiretroviral medicines. Please refer to the patient information leaflets of the other antiretrovirals for guidance on how to take those medicines.

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

If you take more Emtriva than you should

If you accidentally take too much Emtriva oral solution, contact your doctor or nearest emergency department for advice. Keep the oral solution bottle with you so that you can easily describe what you have taken.

If you forget to take Emtriva

It is important not to miss a dose of Emtriva.

If you do miss a dose of Emtriva, take it as soon as you can, and then take your next dose at its regular time.

If it is almost time for your next dose anyway, forget about the missed dose. Wait and take the next dose at the regular time. Do not take a double dose to make up for a forgotten dose.

If you are sick(vomit)
If it?s less than an hour since you took Emtriva, take another dose. You do not need to take another dose if you were sick more than an hour after taking Emtriva.

If you stop taking Emtriva

• Don?t stop taking Emtriva without talking to your doctor. Stopping treatment with Emtriva may reduce the effectiveness of the anti-HIV therapy recommended by your doctor. Speak with your doctor before you stop, particularly if you are experiencing any side effects or you have another illness. Contact your doctor again before you restart taking Emtriva oral solution.
• If you have both HIV infection and hepatitis B, it is especially important not to stop your Emtriva treatment without talking to your doctor first. Some patients have had blood tests or symptoms indicating that their hepatitis has got worse after stopping Emtriva. You may require blood tests for several months after stopping treatment. In some patients with advanced liver disease or cirrhosis, stopping treatment is not recommended as this may lead to worsening of hepatitis.

Tell your doctor immediately about new or unusual symptoms after you stop treatment, particularly symptoms you associate with hepatitis B infection.

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

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

Tell your doctor about any of the following side effects:

Very common side effects
( These can affect more than 1 user in 10)

• headache, diarrhoea, feeling sick (nausea)
• muscle pain and weakness (if creatine kinase levels in the blood are increased)

Common side effects
( These can affect 1 to 10 users in 100)

• dizziness, weakness, difficulty sleeping, abnormal dreams
• being sick (vomiting), problems with digestion resulting in discomfort after meals, stomach pain
• rashes (including red spots or blotches sometimes with blistering and swelling of the skin), which may be allergic reactions, itching, changes in skin colour including darkening of the skin in patches
• pain

Tests may also show:

• low white blood cell count (a reduced white blood cell count can make you more prone to infection)
• increased triglycerides (fatty acids), bile or sugar in the blood
• liver and pancreas problems

Uncommon side effects
( These can affect 1 to 10 users in 1,000)

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

Children given emtricitabine experienced changes in skin colour including darkening of the skin in patches (very common) and anaemia (common). Anaemia means the production of red blood cells is reduced, and a child may have symptoms of tiredness or breathlessness.

Medicines like Emtriva can cause lactic acidosis (excess lactic acid in the blood). The following may be signs of lactic acidosis:

• Deep, rapid breathing
• Drowsiness
• Nausea (feeling sick), vomiting and stomach pain If you notice any of these symptoms, tell your doctor immediately.

Combination antiretroviral therapy (including Emtriva) may change your body shape, by changing the way body fat is distributed. You may lose fat from your legs, arms and face; gain fat around the abdomen (tummy) and internal organs; get larger breasts or fatty lumps on the back of the neck (?buffalo hump?). The cause and the long-term effects of these changes are not yet known.

Combination antiretroviral therapy may also cause hyperlipaemia (increased fats in the blood) and resistance to insulin. Your doctor will test for these changes.

If you get any of the side effects listed, or if you notice any side effects not listed in this leaflet, tell your doctor.

Keep out of the reach and sight of children.

Do not use Emtriva after the expiry date which is stated on the bottle and outer carton after {EXP}. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C ? 8°C) until opened.

After opening the bottle, do not store above 25ºC. The content of the bottle should be used up within 45 days of opening. It is advised to write the date of removal from the refrigerator on the package.

If there is any solution left in the bottle after 45 days, this should be discarded according to local requirements 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. These measures will help to protect the environment.

What Emtriva contains

• The active substance isemtricitabine. One ml of Emtriva oral solution contains 10 mg emtricitabine (10 mg/ml).
• The other ingredients are: cotton candy flavouring, disodium edetate, hydrochloric acid, methyl parahydroxybenzoate (E218), propylene glycol, propyl parahydroxybenzoate (E216), sodium hydroxide, sodium phosphate monobasic hydrate, sunset yellow (E110), purified water, xylitol (E967).

What Emtriva looks like and contents of the pack

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

Emtriva is also available as hard capsules. These are only suitable for patients who weigh at least 33 kg and can swallow hard capsules. There is a separate Package Leaflet for Emtriva 200 mg hard capsules.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Gilead Sciences International Limited
Cambridge
CB21 6GT
United Kingdom

Manufacturer:
Gilead Sciences Limited
IDA Business & Technology Park
Carrigtohill Co. Cork
Ireland

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien Gilead Sciences Belgium BVBA TélTel 32 0 24 01 35 79 LuxembourgLuxemburg Gilead Sciences Belgium BVBA TélTel 32 0 24 01 35 79

Gilead Sciences International Ltd Te 44 0 20 7136 8820 Magyarország Gilead Sciences International Ltd Tel 44 0 20 7136 8820

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Lietuva
Gilead Sciences International Ltd
Tel: + 44 (0) 20 7136 8820

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