Each white round tablet contains 300mg (marked "WELLCOME X4F") of the active ingredient zidovudine.

Retrovir Tablets also contain some inactive ingredients. These are: microcrystalline cellulose, sodium starch glycollate,

povidone K30, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol 400 and polyethylene glycol 8000.

Retrovir 300mg Tablets come in packs of 60 tablets.

Glaxo Wellcome Operations, Greenford, Middlesex, UB6 0NN makes Retrovir Tablets. Glaxo Wellcome, Stockley Park,

Middlesex, U811 1BT is licensed to sell them in the UK.

Retrovir belongs to a group of medicines called antivirals. It is used to delay the progression of HIV in both patients

suffering from progressive HIV infection and those who have gone on to develop the symptoms of AIDS. In order to

understand how Retrovir works, it will help you to know how HIV multiplies within the body.

HIV reproduces itself by entering CD4 cells (important cells in your immune system) and turns them into 'mini factories'

producing more viruses which, in turn, infect more cells. The CD4 cell dies when the new HIV viruses are released. If this

process goes untreated, eventually there are too few CD4 cells left to fight off diseases and infections - a condition which

usually leads to AIDS.

Retrovir does not kill HIV, but works by entering the CD4 cells infected with it, helping to stop the production of new

viruses and their despatch to other cells. Retrovir therefore helps to preserve your ability to resist disease by helping to

prevent further deterioration of the immune system.

• Do you have any blood disorder, eg anaemia?
• Do you have liver or kidney disease?
• Have you previously had an allergic reaction to Retrovir or zidovudine?

If the answer is "YES" to any of these questions, and if you have not already discussed them with your doctor, go back to him BEFORE starting treatment.

• HIV positive women who become pregnant, who are thinking of having a child or who are breast feeding should always discuss this with their doctor.
• Retrovir can be taken by HlV-positive pregnant women (after the first three months of pregnancy) to reduce the risk of transmitting HIV to their unborn child. Retrovir is given to the woman up to and during labour and is stopped after delivery. It is also given to the new born baby for the first six weeks of life.
• It is important to carefully weigh the benefit of reducing the risk of HIV infection against the unknown possibility of the infant experiencing side effects in later life. If you are taking Retrovir to reduce the risk of having an infected baby, please discuss any concerns that you may have with your doctor.

• As part of your treatment, your doctor may offer you other medication. These will be all right to take along with Retrovir as long as your doctor knows about your condition and any medicines you are taking.
• Retrovir may interact with certain medicines, these may make side effects worse. It is important that you tell your doctor if you are taking any of the following medicines (ask your doctor if you are not sure)
• Phenytoin, ribavirin and probenecid
• Paracetamol, aspirin, codeine, morphine, indomethacin, ketoprofen, naproxen, oxazepam, lorazepam, cimetidine, clofibrate, dapsone and isoprinosine.
• Pentamidine, pyrimethamine, co-trimaxazole, amphotericin, flucytosine, ganciclovir, interferon, vincristine, vinblastine and doxorubicin.
• In patients who take vitamin supplements, herbal remedies or homeopathic medicines only a few side-effects have bean seen, so if you feel benefit from these, continue taking them but keep your doctor informed.

• Alcohol can affect your response to many medications and you should discuss this matter in more detail with your doctor who will be familiar with your own particular case.

It is important to take your medicine in the way your doctor has told you to. The label on your pack should tell you how

many tablets to take and how often to take them. If the label doesn't say, or if you are not sure, ask your doctor or

pharmacist.

• The dose prescribed will vary from patient to patient and will depend on a number of factors, including the stage of infection. Your doctor will decide the most appropriate dosage for you (this may be between 500 mg and 1000mg per day).
• Swallow the tablets whole with some water.
• If you forget to take a dose, don't worry. Simply take h as soon as you remember and then continue as before. If you think you may have difficulty in remembering to take your tablets at the times specified, it's a good idea to use a pocket timer or wrist-watch alarm to remind you.
• If you take a larger dose than prescribed this is not likely to cause you any harm, but you should let your doctor know as soon as possible if this happens.
• If someone else takes your medicine by mistake, tell your doctor at once.
• Because your medicine controls and does not cure your condition, you will normally need to take it continually. You should not stop treatment unless your doctor tells you to.
• Remember that treatment with Retrovir does not reduce the risk of passing HIV on to others by sexual contact or blood transfer. You will still remain infectious while taking Retrovir.

• Retrovir is normally well tolerated. In patients with early HIV infection side-effects are less common than in patients with AIDS. However, because of the way it works, it may sometimes cause side-effects. There are two types:

1. The first can occur during the first 4 to 5 weeks of treatment and consists of nausea, vomiting and headache. Very rarely, muscular aches and a rash may also develop. In the vast majority of cases, all these effects disappear on their own after a few weeks, a fact worth bearing in mind if you experience them. Check with your doctor if they do not go away or become distressing.
2. The second can develop after four to six weeks of treatment and affects your bone marrow's production of blood cells. Most commonly, production of red blood cells is reduced, resulting in anaemia. If this happens, the symptoms are tiredness and shortness of breath. Also, less commonly, the production of a type of white blood cell may be reduced which can make you more prone to infections. Studies have shown that these side effects occur in 5% or less of patients being treated for early HIV infection, although they may be more common in patients with AIDS.

• These effects are generally reversible end h is important to note that, with the lower treatment doses currently being prescribed, anaemia is now less common than when Retrovir was first introduced.
• If you get either type of these side-effects, tell your doctor. He is likely to either reduce your dose or temporarily interrupt your treatment, usually for between two and four weeks, in order to allow your blood time to recover.
• Tell your doctor or pharmacist if you notice any other side-effects from your medicine which are not mentioned here.

Keep your tablets in a safe place, below 30°C and away from direct sunlight. Keep them out of reach of children.

Do not take any tablets after the "use by" date on the pack.

If your doctor tells you to stop taking the tablets, please return any which are left over to your pharmacist. Only keep them if your doctor tells you to.

This leaflet was last revised in March 1996.

© 1996 The Glaxo Wellcome Group of Companies.

Retrovir is a Trade mark of The Glaxo Wellcome Group of Companies.