Viread

What Viread is and what it is used for

Atripla contains three active substances that are used to treat human immunodeficiency virus (HIV) infection:
•Efavirenz is a non-nucleoside reverse transcriptase inhibitor (NNRTI)
•Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI)
•Tenofovir is a nucleotide reverse transcriptase inhibitor (NtRTI) Each of these active substances, also known as antiretroviral medicines, work by interfering with an enzyme (reverse transcriptase) that is essential for the virus to multiply. Atripla is a treatment for Human Immunodeficiency Virus (HIV) infection in adults aged 18 years and over who have previously been treated with other antiretroviral medicines and have their HIV-1 infection under control for at least three months. Patients must not have experienced failure of a previous HIV therapy.

How to take Viread

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is: One tablet taken each day by mouth. Atripla should be taken on an empty stomach (commonly defined as 1 hour before or 2 hours after a meal) preferably at bedtime. This may make some side effects (for example, dizziness, drowsiness) less troublesome. Swallow Atripla whole with water. Atripla must be taken every day. If your doctor decides to stop one of the components of Atripla, you may be given efavirenz, emtricitabine and/or tenofovir disoproxil separately or with other medicines for the treatment of your HIV infection. If you take more Atripla than you should If you accidentally take too many Atripla tablets you may be at increased risk of experiencing possible side effects with this medicine (see section 4, Possible side effects). Contact your doctor or nearest emergency department for advice. Keep the tablet bottle with you so that you can easily describe what you have taken. If you forget to take Atripla It is important not to miss a dose of Atripla. If you do miss a dose of Atripla within 12 hours of when it is usually taken, take it as soon as you can, and then take your next dose at its regular time. If it is almost time (less than 12 hours) for your next dose anyway, 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 forgotten tablet. If you throw up the tablet (within 1 hour after taking Atripla), you should take another tablet. Do not wait until your next dose is due. You do not need to take another tablet if you were sick more than 1 hour after taking Atripla. 8 If you stop taking Atripla Don’t stop taking Atripla without talking to your doctor. Stopping Atripla can seriously affect your response to future treatment. If Atripla is stopped, speak to your doctor before you restart taking Atripla tablets. Your doctor may consider giving you the components of Atripla separately if you are having problems or need your dose adjusted. When your supply of Atripla starts to run low, get more from your doctor or pharmacist. This is very important because the amount of virus may start to increase if the medicine is stopped for even a short time. The virus may then become harder to treat. If you have both HIV infection and hepatitis B, it is especially important not to stop your Atripla treatment without talking to your doctor first. Some patients have had blood tests or symptoms indicating that their hepatitis has got worse after stopping emtricitabine or tenofovir disoproxil (two of the three components of Atripla). If Atripla is stopped your doctor may recommend that you resume hepatitis B treatment. You may require blood tests to check how your liver is working for 4 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 your hepatitis, which may be life-threatening. 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 medicine, ask your doctor or pharmacist.

Possible side effects

During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves. Your doctor will test for these changes. Like all medicines, this medicine can cause side effects, although not everybody gets them. Possible serious side effects: tell your doctor immediately
•Lactic acidosis (excess lactic acid in the blood) is a rare (may affect up to 1 in every 1,000 patients) but serious side effect that can be fatal.

The following side effects may be signs of lactic acidosis:
•deep rapid breathing
•drowsiness
•feeling sick (nausea), being sick (vomiting) and stomach pain. If you think you may have lactic acidosis, contact your doctor immediately. Other possible serious side effects

The following side effects are uncommon (these may affect up to 1 in every 100 patients):
• allergic reaction (hypersensitivity) that may cause severe skin reactions (Stevens-Johnson syndrome, erythema multiforme, see section 2)
• swelling of the face, lips, tongue or throat
• angry behaviour, suicidal thoughts, strange thoughts, paranoia, unable to think clearly, mood being affected, seeing or hearing things that are not really there (hallucinations), suicide attempts, personality change (psychosis), catatonia (a condition in which the patient is rendered motionless and speechless for a period). 9
• pain in the abdomen (stomach), caused by inflammation of the pancreas
• forgetfulness, confusion, fitting (seizures), incoherent speech, tremor (shaking)
• yellow skin or eyes, itching, or pain in the abdomen (stomach) caused by inflammation of the liver
• damage to kidney tubules Psychiatric side effects in addition to those listed above include delusions (false beliefs), neurosis. Some patients have committed suicide. These problems tend to occur more often in those who have a history of mental illness. Always notify your doctor immediately if you have these symptoms. Side effects to the liver: If you are also infected with hepatitis B virus, you may experience a worsening of hepatitis after discontinuation of treatment (see section 3).

The following side effects are rare (these may affect up to 1 in every 1,000 patients):
• liver failure, in some cases leading to death or liver transplant. Most cases occurred in patients who already had liver disease, but there have been a few reports in patients without any existing liver disease
• inflammation of the kidney, passing a lot of urine and feeling thirsty
• back pain caused by kidney problems, including kidney failure. Your doctor may do blood tests to see if your kidneys are working properly
• softening of the bones (with bone pain and sometimes resulting in fractures) which may occur due to damage to the kidney tubule cells
• fatty liver If you think that you may have any of these serious side effects, talk to your doctor. Most frequent side effects

The following side effects are very common (these may affect more than 1 in 10 patients)
• dizziness, headache, diarrhoea, feeling sick (nausea), being sick (vomiting)
• rashes (including red spots or blotches sometimes with blistering and swelling of the skin), which may be allergic reactions
• feeling weak Tests may also show:
• decreases in phosphate levels in the blood
• increased levels of creatine kinase in the blood that may result in muscle pain and weakness Other possible side effects

The following side effects are common (these may affect up to 1 in 10 patients)
• allergic reactions
• disturbances of coordination and balance
• feeling worried or depressed
• difficulty sleeping, abnormal dreams, difficulty concentrating, drowsiness
• pain, stomach pain
• problems with digestion resulting in discomfort after meals, feeling bloated, wind (flatulence)
• loss of appetite
• tiredness
• itching
• changes in skin colour including darkening of the skin in patches often starting on hands and soles of feet 10 Tests may also show:
• low white blood cell count (a reduced white blood cell count can make you more prone to infection)
• liver and pancreas problems
• increased fatty acids (triglycerides), bilirubin or sugar levels in the blood

The following side effects are uncommon (these may affect up to 1 in every 100 patients):
• breakdown of muscle, muscle pain or weakness
• anaemia (low red blood cell count)
• a feeling of spinning or tilting (vertigo), whistling, ringing or other persistent noise in the ears
• blurred vision
• chills
• breast enlargement in males
• decreased sexual drive
• flushing
• dry mouth
• increased appetite Tests may also show:
• decreases in potassium in the blood
• increases in creatinine in the blood
• proteins in urine
• increased cholesterol in the blood The breakdown of muscle, softening of the bones (with bone pain and sometimes resulting in fractures), muscle pain, muscle weakness and decreases in potassium or phosphate in the blood may occur due to damage to kidney tubule cells.

The following side effects are rare (these may affect up to 1 in every 1,000 patients)
• itchy rash to the skin caused by a reaction to sunlight

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system: United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store Ireland HPRA Pharmacovigilance Earlsfort Terrace IRL
•Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie e-mail: [email protected] Malta ADR Reporting Website: www.medicinesauthority.gov.mt/adrportal 11 By reporting side effects you can help provide more information on the safety of this medicine. 5. How to store Atripla 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 bottle and carton after {EXP}. The expiry date refers to the last day of that month. Store in the original package in order to protect from moisture. Keep the bottle tightly closed. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

How to Store Viread

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 bottle and carton after {EXP}. The expiry date refers to the last day of that month. Store in the original package in order to protect from moisture. Keep the bottle tightly closed. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.