Retrovir IV Concentrate for 200 mg/20 ml Solution

RETROVIR IV belongs to a group of antiviral medicines, also known as anti-retrovirals, called nucleoside analogue reverse transcriptase inhibitors (NRTIs).

RETROVIR IV is used for the short-term management of serious HIV infection in patients who are unable to take zidovudine oral formulations. RETROVIR IV is also used during labour and at the birth to prevent the baby getting infected with HIV. RETROVIR IV reduces the amount of HIV virus in the body and keeps it at a low level. It also increases CD4 cell counts. CD4 cells are a type of white blood cell, that play an important role in maintaining a healthy immune system to help fight infection.

You should not receive RETROVIR IV:

• if you are hypersensitive (allergic) to zidovudine or to any of the ingredients of RETROVIR IV (listed in section 6)
• if you have a very low white blood cell count (neutropenia) or very low red blood cell count (anaemia)
• if you are also taking antiretroviral medicines containing stavudine.

If you think any of these apply to you, check with your doctor before he administers RETROVIR IV to you.

Warnings and precautions:

Treatment with RETROVIR IV has not been shown to reduce the risk of passing HIV infection on to others by sexual contact or by blood transfer. You should continue to use appropriate precautions to prevent this. You can still pass on HIV when receiving RETROVIR IV, although the risk is lowered by effective antiretroviral therapy. Discuss with your doctor the precautions needed to avoid infecting other people.

RETROVIR IV helps to control your condition and delay disease progression, but it is not a cure for HIV infection. You may continue to develop other infections and other illnesses associated with HIV disease. You should keep in regular contact with your doctor.

Do not share medicines prescribed for you with any other person. You will never be expected to give yourself RETROVIR IV. It will always be given to you by a person who is qualified to do so. Your doctor will decide on the correct dose to be given to you. Your doctor will give you RETROVIR IV by infusing it into a vein (a drip). It is diluted before use and is given slowly over a one-hour period.

If you have the impression that the effect of RETROVIR IV is too strong or too weak, tell your doctor.

If you receive more RETROVIR IV than you should: Since a health care provider will administer RETROVIR IV, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you forget to receive RETROVIR IV: Since a health care provider will administer RETROVIR IV, it is unlikely that the dose will be missed.

RETROVIR IV can have side effects. Not all side effects reported with RETROVIR IV are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving RETROVIR IV, please consult your doctor, pharmacist or other health care provider for advice.

If any of the following happens, stop receiving RETROVIR IV and tell our doctor immediately:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching.

These are all very serious side effects. If you have them, you may have had a serious reaction to RETROVIR IV. You may need urgent medical attention or hospitalisation.

Conditions to look out for:

Other possible side effects of combination therapy for HIV: Some other conditions may develop during HIV treatment. Old infections might flare up:

Patients with advanced HIV infection (AIDS) have weak immune systems and are more likely to develop serious infections (opportunistic infections). When these patients start treatment, they may find that old, hidden infections such as tuberculosis 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. If you get any symptoms of infection while you are given RETROVIR IV, tell your doctor immediately. Do not take other medicines for the infection without your doctor’s advice.

Your body shape may change: Treatment with RETROVIR IV or other medicines that contain zidovudine may cause a loss of fat from legs, arms and face (lipoatrophy). 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, your doctor will assess if RETROVIR IV should be stopped and your HIV treatment changed. If you stop receiving RETROVIR IV it may take several months to see any lost fat return. You may not regain all of your lost body fat.

Other effects may show up in blood tests:

• Increased blood levels of sugar, fatty acids (triglycerides) and cholesterol may show up in blood tests.

Lactic acidosis is a serious side effect: Some people receiving RETROVIR IV, 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 women and people who have liver disease. Signs of lactic acidosis include: deep, rapid, difficult breathing, weakness in the limbs, loss of appetite, sudden unexplained weight loss, feeling sick (nausea), being sick (vomiting), stomach pain.

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.

Tell your doctor if you notice any of the following:

Frequent side effects:

• headaches
• feeling sick (nausea)
• being sick (vomiting)
• diarrhoea
• stomach pains
• generally feeling unwell (malaise)
• feeling dizzy
• aching muscles.

Frequent side effects that show up in your blood tests are:

• a low red blood cell count (anaemia) or low white blood cell count (neutropenia or leukopenia)
• an increase in the level of liver enzymes
• an increase in lactic acid (see “Lactic acidosis is a serious side effect” above)
• an increased amount of bile (a substance produced in the liver).

Less frequent side effects include:

• skin rash (red, raised or itchy skin)
• feeling breathless
• fever (high temperature)
• general aches and pains
• wind (flatulence)
• weakness
• 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 the nails, skin, or the skin inside the mouth
• a flu-like feeling – chills, sweating and cough
• tingly feelings in the skin (pins and needles)
• passing urine more often
• enlarged breasts in men.

Less frequent side effects that show up in your blood tests are:

• a decrease in the number of cells involved in blood clotting (thrombocytopenia), or all kinds of blood cells (pancytopenia)
• liver disorders, such as enlarged liver or fatty liver
• lactic acidosis (see “Lactic acidosis is a serious side effect” above)
• a reduction in the number of red blood cells (pure red cell aplasia), failure of the bone marrow to produce new blood cells.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Store all medicines out of reach of children. Store at or below 30 °C. Protect from light.