Emtriva 200 mg. 30 capsules

Emtriva 200 mg. 30 capsules
€ 299.00
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Emtriva is used to treat infections with the human immunodeficiency virus (HIV) in adults, children and infants, and over 4 months. Emtriva 200 mg hard capsules are only suitable for patients weighing more than 33 kg. For people who have difficulty in swallowing Emtriva capsules has Emtriva oral solution. 

Emtriva 200 mg. 30 capsules

 
 
WHAT EMTRIVA AND WHAT IT IS USED FOR?
Emtriva is used to treat infections with the human immunodeficiency virus (HIV) in adults, children and infants, and over 4 months. Emtriva 200 mg hard capsules are only suitable for patients weighing more than 33 kg. For people who have difficulty in swallowing Emtriva capsules has Emtriva oral solution.
Emtriva contains the active substance emtricitabine. This active substance is an antiviral drug that is used for the treatment of infection with HIV. Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI), which acts by interfering with the normal activity of an enzyme (reverse transcriptase), which is essential to reproduce an HIV virus. Emtriva may lower the amount of HIV in the blood (viral load). It can also help increase the number of T-cells called CD4 cells. For the treatment of infection by HIV Emtriva should always be combined with other drugs.
While taking this medication, it is still possible to transmit HIV-virus to others, it is important to take precautions to avoid infecting others.
This medicine is not a cure for HIV infection. While taking Emtriva you may still develop infections or other illnesses associated with infection with HIV.

2. BEFORE YOU TAKE EMTRIVA
Do not take Emtriva:
• If you are allergic (hypersensitive) to emtricitabine or any of the other ingredients of Emtriva 200 mg hard capsules 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 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 the capsules at lower or prescribe Emtriva oral solution. Your doctor may order blood tests during treatment to monitor renal 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 and are prescribed Emtriva, your doctor will monitor you carefully.
Do not give Emtriva to infants under 4 months of age.
Tell your doctor if you have had or have liver disease, including hepatitis. The risk of severe and potentially fatal liver complications is increased in patients with liver disease, including chronic hepatitis B or C, treated with antiretroviral drugs. If you have hepatitis B, your doctor will carefully consider the best treatment regimen for you. If you had or have liver disease or chronic hepatitis B, your doctor may order blood tests to monitor closely the function of your liver.
Tell your doctor if you are diabetic, overweight or have high cholesterol. Combination antiretroviral therapy may lead to increased blood sugar, increased fats in the blood (hyperglycemia), changes in body fat and insulin resistance (see section 4 Possible side effects).

When 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 the blood) together with an enlarged liver. This is a rare but serious side effect, which is sometimes fatal. Lactic acidosis occurs more often in women, particularly if they are overweight. If you suffer from liver disease you may also be at increased risk of developing this condition. During your treatment with Emtriva, your doctor will monitor you closely for signs of lactic acidosis development. Signs are:
• Deep, rapid breathing
• drowsiness
• nausea (feeling sick), vomiting and abdominal pain

If you notice any of these symptoms, contact your doctor immediately.
Keep an eye out for infections. If you have advanced disease with HIV (AIDS) and other infection is possible when initiating therapy with Emtriva may develop inflammation or worsening symptoms of infection. This may indicate that the improved immune system of the body is fighting infection. If you notice signs of inflammation or infection soon after you start taking Emtriva, tell your doctor immediately.

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 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 containing emtricitabine, lamivudine or zalcitabine, which are also used to treat infection with HIV, 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.
Do not stop your treatment without contacting your doctor.

Pregnancy and lactation
Ask your doctor or pharmacist before taking any medicine.
• You should not take Emtriva during pregnancy unless specifically directed by your doctor. Although there are limited clinical data on the use of Emtriva in pregnant women, it is usually not used unless absolutely necessary.
• If you could become pregnant during therapy with Emtriva, you should use an effective method of contraception to prevent pregnancy.
• If you are 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 during pregnancy taking Emtriva, your doctor may order regular blood tests and other diagnostic tests to monitor the development of your child. In children whose mothers took NRTIs during pregnancy, the benefits of protection against HIV is greater than the risk of side effects.
• Do not breast-feed if you are taking Emtriva. This is because the active substance of this medication passes into 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 feel dizzy while taking Emtriva, do not drive or use any tools or machines.

3. HOW TO TAKE EMTRIVA?
• Always take Emtriva exactly as your doctor tells you. If you are not sure, ask your doctor or pharmacist.

The usual dose is:
• Adults: one capsule of 200 mg daily with or without food. Take the capsules with a glass of water.
• Children and adolescents under 18 years of age, weigh at least 33 kg and who are able to swallow capsules: one capsule of 200 mg daily with or without food.
For infants older than 4 months of age, children and patients who are unable to swallow capsules, and in patients with kidney problems, Emtriva is also available in liquid form (such as oral solution). Tell your doctor if you have difficulty swallowing capsules.
• Always take the dose recommended by your doctor. This ensures full effectiveness of the drug and reduce the risk of developing resistance to the treatment. Do not change your dose unless recommended by your doctor.
• If you have kidney problems, your doctor may advise you to take Emtriva less frequently.
• Your doctor will prescribe Emtriva with other antiretroviral drugs. Please refer to the leaflets of the other antiretrovirals for guidance on how to take these medications.

If you take more than the dose of Emtriva
If you accidentally take too much Emtriva capsules, ask advice from your doctor or the nearest emergency room. Take a cardboard box to easily 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 the usual time of its adoption, take it as soon as possible and then take your next dose at the usual time.
If it is almost time (less than 12 hours) for your next dose, skip the missed dose. Wait and take the next dose at the usual time. Do not take a double dose to make up for a forgotten capsule.

If you vomit
If it was earlier than one hour after taking Emtriva, take another capsule. No need to take another capsule if you were sick more than an hour after taking Emtriva.

If you stop taking Emtriva
• Do not stop taking Emtriva before checking with your doctor. Stopping treatment with Emtriva may reduce the effectiveness of anti-HIV therapy recommended by your doctor. Talk to your doctor before stopping treatment, particularly if you get any side effects or you have another illness. Contact your doctor before you start taking the capsules again Emtriva.
• If you have both HIV infection and hepatitis B, it is especially important not to stop taking Emtriva before checking with your doctor. Blood tests or symptoms in some patients showed worsening of hepatitis after discontinuation of Emtriva. After stopping treatment may require blood tests for several months. Patients with advanced liver disease or cirrhosis not recommended to stop the treatment, since some of them may lead to a worsening of hepatitis.
Tell your doctor immediately if after discontinuation of new or unusual symptoms, especially if these are symptoms you associate with your infection with hepatitis B.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
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 may affect more than 1 user in 10)
• headache, diarrhea, 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, trouble sleeping, vivid dreams
• vomiting, digestive problems, leading to discomfort after eating, stomach pain
• rashes (including red spots or blotches sometimes with blistering and swelling of the skin), which may have allergic reactions, itching, changes in skin color including dark spots on the skin
• pain

Tests may also show:
• low white blood cell count (a reduced white blood cell count can make you more susceptible to infections)
• increased triglycerides (fatty acids), bile or blood sugar
• problems with the liver and pancreas

Uncommon side effects
(These can affect 1 to 10 users in 1000)
• anemia (low red blood cells)
• swelling of the face, lips, tongue or throat

Children who have been given emtricitabine experienced changes in skin color including dark spots on the skin (very common) and anemia (often). Anemia means that the formation of red blood cells is reduced, and the child may have symptoms of tiredness or breathlessness.
Medicines like Emtriva can cause lactic acidosis (excess of lactic acid in the blood). The following may be signs of lactic acidosis:
• Deep, rapid breathing
• drowsiness
• nausea (feeling sick), vomiting and abdominal pain

If you notice any of these symptoms, contact your doctor immediately.
Combination antiretroviral therapy (including Emtriva) may change the shape of the body, changing the distribution of adipose tissue. You may lose fat from legs, arms and face; to accumulate fat in the abdomen and internal organs; to increase breast and fatty lumps on the neck ('buffalo hump'). The reasons for these changes and long-term effects are not known.
Combination antiretroviral therapy may also cause hyperglycemia (elevated fats in the blood) and resistance to insulin. Your doctor will test for these changes.
If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE EMTRIVA?
Keep out of reach of children.
Emtriva not use after the expiry date stated on the bottle, blister pack and carton after "EXP". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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. FURTHER INFORMATION
What does Emtriva?
• The active substance is emtricitabine. Each capsule contains 200 mg of Emtriva emtricitabine.
• The other ingredients are:
Capsule contents: microcrystalline cellulose (E460), crospovidone, magnesium stearate (E572), povidone (E1201)
Capsule: gelatin, indigotine (E132), titanium dioxide (E171) Printing ink containing: black iron oxide (E172), shellac (E904)
Emtriva looks like and contents of the pack?
Emtriva capsules have a white opaque body with light blue opaque cap. In black ink on the cap of each capsule is printed with "200 mg", on the body
- The word "GILEAD" and [logo Gilead]. Emtriva is supplied in bottles or blisters containing 30 capsules.
Emtriva is available as an oral solution for use in children and infants aged 4 months and over, in patients who have difficulty swallowing and those with kidney problems. About Emtriva 10 mg / ml oral solution has a separate leaflet.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:

UK

Manufacturer:
Gilead Sciences Limited
 
 
€ 299.00
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