Combivir
lamivudine, zidovudine
lamivudine/zidovudine
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them even if their signs of illness are the same as yours.
If you get any of the side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What Combivir is and what it is used for
What you need to know before you take Combivir
How to take Combivir
Possible side effects
How to store Combivir
Contents of the pack and other information
Combivir contains two active ingredients that are used to treat HIV infection: lamivudine and zidovudine. Both of these belong to a group of antiretroviral medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs).
Combivir does not completely cure HIV infection; it reduces the amount of virus in your body, and keeps it at a low level. It 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.
Not everyone responds to treatment with Combivir in the same way. Your doctor will monitor the effectiveness of your treatment.
if you are allergic to lamivudine or zidovudine, or any of the other ingredients of this medicine (listed in section 6)
if you have a very low red blood cell count (anaemia) or a very low white blood cell count (neutropenia).
Some people taking Combivir or other combination treatments for HIV are more at risk of serious side effects. You need to be aware of the extra risks:
if you have ever had liver disease, including hepatitis B or C (if you have hepatitis B infection, do not stop Combivir without your doctor’s advice, as your hepatitis may come back)
if you have kidney disease
if you are seriously overweight (especially if you are a woman)
Some people taking medicines for HIV infection develop other conditions, which can be serious. You
need to know about important signs and symptoms to look out for while you are taking Combivir.
HIV infection is spread by sexual contact with someone who has the infection, or by transfer of infected blood (for example, by sharing injection needles). You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy.
Discuss with your doctor the precautions needed to avoid infecting other people.
Remember to tell your doctor or pharmacist if you begin taking a new medicine while you are taking Combivir.
other medicinal products containing lamivudine, to treat HIV infection or hepatitis B infection
emtricitabine, to treat HIV infection
stavudine, to treat HIV infection
ribavirin or injections of ganciclovir to treat viral infections
high doses of co-trimoxazole, an antibiotic
cladribine, used to treat hairy cell leukaemia
These include:
sodium valproate, to treat epilepsy
interferon, to treat viral infections
pyrimethamine, to treat malaria and other parasitic infections
dapsone, to prevent pneumonia and treat skin infections
fluconazole or flucytosine, to treat fungal infections such as candida
pentamidine or atovaquone to treat parasitic infections such as Pneumocystis jirovecii
pneumonia (often referred to as PCP)
amphotericin or co-trimoxazole, to treat fungal and bacterial infections
probenecid, to treat gout and similar conditions, and given with some antibiotics to make them more effective
vincristine, vinblastine or doxorubicin, to treat cancer. Tell your doctor if you are taking any of these.
These include:
if you are taking clarithromycin, take your dose at least 2 hours before or after you take your Combivir.
medicines (usually liquids) containing sorbitol and other sugar alcohols (such as xylitol, mannitol, lactitol or maltitol), if taken regularly.
If you are pregnant, if you become pregnant or if you are planning to become pregnant talk to your doctor about the risks and benefits to you and your baby of taking Combivir.
Combivir and similar medicines may cause side effects in unborn babies. If you have taken Combivir during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child. In children whose mothers took NRTIs during pregnancy, the benefit from the protection against HIV outweighed the risk of side effects.
A small amount of the ingredients in Combivir can also pass into your breast-milk. If you’re breast-feeding, or thinking about breast-feeding:
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
Swallow Combivir tablets, with some water. Combivir can be taken with or without food.
If you cannot swallow the tablets whole, you may crush and combine them with a small amount of food or drink, and take all the dose immediately.
Combivir helps to control your condition. You need to keep taking it every day to stop your illness getting worse. You may still develop other infections and illnesses linked to HIV infection.
Take the tablets at regular times, leaving approximately 12 hours between each tablet.
The usual starting dose of Combivir is one half tablet (½) taken in the morning and one whole tablet taken in the evening.
The usual starting dose of Combivir is one half tablet (½) taken in the morning and one half tablet (½) taken in the evening.
For children who weigh less than 14 kg lamivudine and zidovudine (the ingredients of Combivir) should be taken separately.
If you accidentally take too much Combivir, tell your doctor or your pharmacist, or contact your nearest hospital emergency department for further advice.
If you forget to take a dose, take it as soon as you remember. Then continue your treatment as before. Do not take a double dose to make up for a forgotten dose.
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 Combivir 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, Combivir should be stopped and your HIV treatment changed.
Like all medicines, this medicine can cause side effects, but not everyone gets them.
When you are being treated for HIV, it can be hard to tell whether a symptom is a side effect of Combivir or other medicines you are taking, or an effect of the HIV disease itself. So it is very important to talk to your doctor about any changes in your health.
It is important to read the information later in this section under ‘Other possible side effects of combination therapy for HIV’.
These may affect more than 1 in 10 people:
headache
feeling sick (nausea).
These may affect up to 1 in 10 people:
being sick (vomiting)
diarrhoea
stomach pains
loss of appetite
feeling dizzy
tiredness, lack of energy
fever (high temperature)
general feeling of being unwell
difficulty in sleeping (insomnia)
muscle pain and discomfort
joint pain
cough
irritated or runny nose
skin rash
hair loss (alopecia).
Common side effects that might show up in 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 increased amount in the blood of bilirubin (a substance produced in the liver) which may make your skin appear yellow.
These may affect up to 1 in 100 people:
feeling breathless
wind (flatulence)
itching
muscle weakness.
An uncommon side effect that may show up in blood test is:
a decrease in the number of cells involved in blood clotting (thrombocytopenia) or in all kinds of blood cells (pancytopenia).
These may affect up to 1 in 1000 people:
serious allergic reaction causing swelling of the face, tongue or throat which may cause difficulty in swallowing or breathing
liver disorders, such as jaundice, enlarged liver or fatty liver, inflammation (hepatitis)
lactic acidosis (excess lactic acid in the blood; see the next section, ‘Other possible side effects of combination therapy for HIV’)
inflammation of the pancreas (pancreatitis)
chest pain; disease of the heart muscle (cardiomyopathy)
fits (convulsions)
feeling depressed or anxious, not being able to concentrate, feeling drowsy
indigestion, taste disturbance
changes in the colour of your nails, your skin or the skin inside your mouth
a flu-like feeling – chills and sweating
tingly feelings in the skin (pins and needles)
sensation of weakness in the limbs
breakdown of muscle tissue
numbness
passing urine more often
enlarged breasts in men.
Rare side effects that may show up in blood tests are:
an increase in an enzyme called amylase
a failure of the bone marrow to produce new red blood cells (pure red cell aplasia).
These may affect up to 1 in 10,000 people:
A very rare side effect that may show up in blood tests is:
a failure of the bone marrow to produce new red or white blood cells (aplastic anaemia).
Combination therapy such as Combivir may cause other conditions to develop during HIV treatment.
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 are taking Combivir:
Some people taking Combivir 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.
deep, rapid, difficult breathing
drowsiness
numbness or weakness in the limbs
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:
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.
stiffness in the joints
aches and pains (especially in the hip, knee or shoulder)
difficulty moving.
If you notice any of these symptoms:
Combination therapy for HIV can also cause:
increased levels of lactic acid in the blood, which on rare occasions can lead to lactic acidosis
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 listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
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 carton. Do not store above 30oC.
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 to protect the environment.
The active substances are lamivudine and zidovudine. The other ingredients are
tablet core; microcrystalline cellulose, sodium starch glycollate (gluten free), magnesium stearate, colloidal silicon dioxide
tablet film-coat; hypromellose, titanium dioxide, macrogol 400 and polysorbate 80.
Combivir film-coated tablets are provided in cartons, containing blister packs or bottles with a child resistant-closure. Each pack type contains 60 film-coated tablets. They are white to off-white, capsule- shaped scored tablets marked with the code GXFC3 on both sides.
GlaxoSmithKline Pharmaceuticals S.A. ul. Grunwaldzka 189
60-322 Poznan Poland
ViiV Healthcare BV
Van Asch van Wijckstraat 55H 3811 LP Amersfoort
Netherlands
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