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What Retrovir is and what it is used for
Retrovir is used to treat HIV (human immunodeficiency virus) infection. The active ingredient in Retrovir is zidovudine. Retrovir is a type of medicine known as an antiretroviral. It belongs to a group of medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs). Retrovir does not get rid of HIV infection; it reduces the amount of virus in your body, and keeps it at a low level. Retrovir also increases the CD4 cell count in your blood. CD4 cells are a type of white blood cells that are important in helping your body to fight infection. Retrovir is used, in combination with other medicines (‘combination therapy’), to treat HIV in adults and children. To control your HIV infection, and to stop your illness getting worse, you must keep taking all your medicines. If you’re pregnant, your doctor may want you to take Retrovir, to help prevent you passing HIV on to your unborn baby. After the birth, your baby may be given Retrovir to help prevent it from getting infected with HIV. HIV infection is spread by sexual contact with someone who’s got the infection, or by transfer of infected blood (for example, by sharing injection needles).
How to take Retrovir
Your doctor will give you this medicine by infusing it into a vein (a drip). It is diluted before use and is given slowly over a one-hour period. It is usually only given for short periods of time (up to 2 weeks) while you or your child are unable to take Retrovir by mouth. How much Retrovir will you be given? Adults and adolescents over 12 years old: The dose of Retrovir you receive will depend on your weight. The usual dose is 1 mg or 2 mg for each kg of bodyweight every four hours. Children: Your doctor will decide on the correct dose of Retrovir for your child, depending on the size of the child. Pregnancy, childbirth and newborn babies: You should not normally take Retrovir during the first 14 weeks of your pregnancy. After week 14, the usual dose is 500 mg given as 100 mg five times per day taken by mouth each day until you start to go into labour. During the labour and birth, your doctor may give you injections of Retrovir, until your baby’s umbilical cord has been clamped. Your newborn baby may also be given Retrovir to help prevent it from getting infected with HIV. People with kidney or liver problems: If you have severe kidney or liver problems, you may be given a lower dose of Retrovir, depending on how well your kidneys or liver are working. Ask your doctor or pharmacist for advice.
Possible side effects
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. Treatment with zidovudine (Retrovir) often causes a loss of fat from legs, arms and face (lipoatrophy). This loss of body fat has been shown to be not fully reversible after discontinuation of zidovudine. Your doctor should monitor for signs of lipoatrophy. Tell your doctor if you notice any loss of fat from your legs, arms, and face. When these signs occur, Retrovir should be stopped and your HIV treatment changed. Like all medicines, this medicine can cause side effects, but not everyone gets them. Some side effects may show up in your blood tests, and may not appear until 4 to 6 weeks after you start taking Retrovir. If you get any of these effects, and if they are severe, your doctor may advise you to stop taking Retrovir. As well as the effects listed below, other conditions can develop during combination therapy for HIV. It is important to read the information in ‘Other possible side effects of combination therapy for HIV’. 5
Very common side effects These may affect more than 1 in 10 people taking Retrovir:
• feeling sick (nausea).
Common side effects These may affect up to 1 in 10 people taking Retrovir:
• being sick (vomiting)
• stomach pains
• feeling dizzy
• aching muscles
• generally feeling unwell.
Common side effects that may show up in your blood tests are:
• a low red blood cell count (anaemia) or low white blood cell count (neutropenia or leucopenia)
• an increase in the level of liver enzymes
• an increased amount in the blood of bilirubin (a substance produced in the liver) which may make your skin appear yellow.
Uncommon side effects These may affect up to 1 in 100 people taking Retrovir:
• skin rash (red, raised or itchy skin)
• feeling breathless
• fever (high temperature)
• general aches and pains
• wind (flatulence)
Uncommon side effects that may show up in your blood tests are:
• a decrease in the number of cells involved in blood clotting (thrombocytopenia), or in all kinds of blood cells (pancytopenia).
Rare side effects These may affect up to 1 in 1000 people taking Retrovir:
• lactic acidosis (excess lactic acid in the blood; see the next section, ‘Other possible side effects of combination therapy for HIV’)
• liver disorders, such as jaundice, enlarged liver or fatty liver
• inflammation of the pancreas
• chest pain; disease of the heart muscle
• fits (convulsions)
• feeling depressed or anxious; not being able to sleep (insomnia); not being able to concentrate; feeling drowsy
• indigestion; loss of appetite; taste disturbance
• changes in the colour of your nails, your skin, or the skin inside your mouth
• a flu-like feeling — chills, sweating and cough 6
• tingly feelings in the skin (pins and needles)
• passing urine more often
• enlarged breasts in men. A rare side effect that may show up in your blood tests is:
• a decrease in the number of a type of red blood cell (pure red cell aplasia).
Very rare side effects A very rare side effect that may affect up to 1 in 10,000 people taking Retrovir, and may show up in blood tests is:
• a failure of the bone marrow to produce new blood cells (aplastic anaemia). If you get any side effects Talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Other possible side effects of combination therapy for HIV Some other conditions may develop during HIV treatment. Old infections may flare up People with advanced HIV infection (AIDS) have weak immune systems, and are more likely to develop serious infections (opportunistic infections). When these people start treatment, they may find that old, hidden infections flare up, causing signs and symptoms of inflammation. These symptoms are probably caused by the body’s immune system becoming stronger, so that the body starts to fight these infections. In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection. Autoimmune disorders may occur many months after the start of treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment. If you get any symptoms of infection while you’re taking Retrovir: Tell your doctor immediately. Don’t take other medicines for the infection without your doctor’s advice. Lactic acidosis is a rare but serious side effect Some people taking Retrovir develop a condition called lactic acidosis, together with an enlarged liver. Lactic acidosis is caused by a build-up of lactic acid in the body. It is rare; if it happens, it usually develops after a few months of treatment. It can be life-threatening, causing failure of internal organs. Lactic acidosis is more likely to develop in people who have liver disease, or in obese (very overweight) people, especially women. Signs of lactic acidosis include:
• deep, rapid, difficult breathing
• numbness or weakness in the limbs
• loss of appetite, weight loss
• feeling sick (nausea), being sick (vomiting)
• stomach pain. 7 During your treatment, your doctor will monitor you for signs of lactic acidosis. If you have any of the symptoms listed above, or any other symptoms that worry you: See your doctor as soon as possible. You may have problems with your bones Some people taking combination therapy for HIV develop a condition called osteonecrosis. With this condition, parts of the bone tissue die because of reduced blood supply to the bone. People may be more likely to get this condition:
• if they have been taking combination therapy for a long time
• if they are also taking anti-inflammatory medicines called corticosteroids
• if they drink alcohol
• if their immune systems are very weak
• if they are overweight. Signs of osteonecrosis include:
• stiffness in the joints
• aches and pains (especially in the hip, knee or shoulder)
• difficulty moving. If you notice any of these symptoms: Tell your doctor. Other effects may show up in tests Combination therapy for HIV can also cause:
• increased levels of lactic acid in the blood, which on rare occasions can lead to lactic acidosis This effect may show up in the blood tests you’ll have while you’re taking Retrovir.
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 Yellow Card Scheme website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
How to Store Retrovir
Keep this medicine out of the sight and reach of children. Keep the vials in the outer carton. Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month. Do not store above 30 °C (86 °F).
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