Combivir. 150 mg. 300 mg. 60 tablets
Combivir. 150 mg. / 300 mg. 60 tablets
What is Combivir and what it is used
Combivir is used for the treatment of infection by human immunodeficiency virus (HIV) in adults and children.
Combivir contains two active substances which are used for the treatment of HIV infection: Zidovudine and Lamivudine. Both belong to the class of antiretroviral drugs called nucleoside analogue reverse transcriptase inhibitors (NRTIs).
Combivir does not cure HIV infection: it reduces the amount of virus in your body and keeps it at a low level. It also increases the number of CD4 cells in the blood. CD4 cells are a type of white blood cells that play an important role in keeping the immune system in order to be able to fight infections.
Not everyone responds to treatment with Combivir in the same manner. Your doctor will monitor the effectiveness of treatment.
2. What you should know before taking Combivir
Do not take Combivir:
if you are allergic to lamivudine or zidovudine or any of the other ingredients of this medicine (listed in Section 6);
If you have very low red blood cells (anemia) or very low white blood cell count (neutropenia).
Talk to your doctor if you think any of these apply to you.
Take special care with Combivir
Some people taking Combivir or other combination therapies for the treatment of HIV, are at increased risk for developing serious side effects. You need to know the additional risks:
if you have ever had liver disease, including hepatitis B or C (if you have hepatitis B, you should not discontinue therapy with Combivir without instructions from your doctor as hepatitis can occur again);
if you have kidney disease;
if you are severely overweight (especially if you're a woman);
if you have diabetes and use insulin.
Ask your doctor if any of the above statements apply to you. Your doctor will decide whether the active substances are suitable for you. While taking the drug, you may need to make your further investigations, including blood tests. For more information, see section 4.
Look out for important symptoms
Some people taking medicines for HIV infection develop other conditions that may be serious. You need to know the important signs and symptoms to look out for while taking Combivir.
Read the information 'Other possible side effects of combination therapy for HIV "in section 4 of this leaflet.
Keep other people
HIV infection is spread by sexual contact with someone who is infected or by infected blood (for example, using the same injection needles). Combivir will not stop the transmission of infection to others. To prevent other people from becoming infected with HIV:
Use a condom during oral sex or intercourse with penetration;
Do not expose them to the risk of blood transfer - for example, do not share needles.
Other medicines and Combivir
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including herbal medicines or other medicines you bought without a prescription.
Be sure to tell your doctor or pharmacist if you begin taking any new medicine while you are being treated with Combivir.
The following drugs should not be co-administered with Combivir:
other medicinal products containing lamivudine, that are used for the treatment of HIV infection or hepatitis B infection;
emtricitabine, which is used to treat HIV infection;
stavudine or zalcitabine, which are used to treat HIV infection;
ribavirin injection or ganciclovir, which is used for the treatment of viral infections;
high doses of antibiotic co-trimoxazole;
cladribine used for the treatment of hairy cell leukemia.
Tell your doctor if you are taking any of the above drugs.
Some medicines may increase the risk of side effects or make them worse. These include:
sodium valproate to treat epilepsy;
interferon for treating viral infections;
pyrimethamine for treating malaria and other parasitic infections;
dapsone to prevent pneumonia and the treatment of skin infections;
fluconazole or flucytosine for the treatment of fungal infections such as candida;
pentamidine or atovaquone for the treatment of parasitic infections such as Pneumocystis carinii pneumonia;
amphotericin or co-trimoxazole for treating fungal and bacterial infections;
Probenecid treatment of gout and related conditions, as well as its application to certain antibiotics to enhance their effect;
Methadone used as a heroin substitute;
vincristine, vinblastine or doxorubicin for the treatment of cancer.
Tell your doctor if you are taking any of the above drugs.
Some medicines interact with Combivir
clarithromycin, an antibiotic - if you are taking clarithromycin, take your dose at least 2 hours before or after taking Combivir;
phenytoin for the treatment of epilepsy.
Tell your doctor if you are taking phenytoin. It may be necessary for your doctor to monitor you while taking Combivir.
If you are pregnant, become pregnant or plan to become pregnant, you should tell your doctor to discuss the benefits and risks of taking Combivir for you and your child.
Combivir and similar medicines may cause side effects in unborn babies. If you become pregnant while taking Combivir, your baby can be made further tests (including blood tests) to ensure that it is functioning normally.
The risk of HIV infection is reduced in children whose mothers took NRTIs (medicines as Combivir). This benefit is greater than the risk of adverse reactions.
HIV-positive women should not breastfeed because HIV can be passed to the baby in breast milk.
If you are breastfeeding or plan to breastfeed:
Immediately consult your doctor.
Driving and using machines
Combivir can cause dizziness and other adverse reactions that can reduce your alertness.
Do not drive or operate machinery unless you are feeling well.
3. How to take Combivir
Always take this medicine exactly as your told your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.
Swallow the tablets Combivir with some water. Combivir can be taken with or without food.
If you can not swallow tablets whole, you may crush and mix with a small amount of food or drink, and take all the dose immediately.
Stay in regular contact with your doctor
Combivir helps to keep your condition under control. You have to take each day to prevent worsening of the disease. May still develop infections or other illnesses associated with HIV infection.
Keep in touch with your doctor and stop taking Combivir without first talking to your doctor.
How much to take
Adults and adolescents weighing 30 kg or more:
The usual dose of Combivir is one tablet twice daily.
Take the tablets at the same time, leaving approximately 12 hours apart.
Children weighing between 21 and 30 kg
The usual starting dose is half a tablet of Combivir (1/2) taken in the morning and one whole tablet taken in the evening.
Children weighing 14 to 21 kg
The usual starting dose is half a tablet of Combivir (1/2) taken in the morning and half a tablet (1/2), taken in the evening.
In children weighing less than 14 kg, lamivudine and zidovudine (ingredients of Combivir) should be taken separately.
If you take more than the dose of Combivir
If you accidentally take too high a dose of Combivir, tell your doctor or seek emergency room for advice.
If you forget to take Combivir
If you forget to take a dose, take it as soon as you remember and then continue as before. Do not take a double dose to make up for a missed dose.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
In the treatment of HIV infection is not always possible to detect effects that occur due to Combivir, other medicines you are taking at the same time or by the HIV disease. It is therefore very important that you inform your doctor about any changes in your health.
Together with the following side effects while taking Combivir, upon reception of a combination therapy for the treatment of HIV, can develop other conditions.
It is important to read the information below in this section under 'Other possible side effects of combination therapy for HIV ".
Very common side effects
These may affect more than 1 in 10 people:
Common side effects
These may affect up to 1 in 10 people:
lack of appetite;
fatigue, lack of energy;
fever (high temperature);
difficulty sleeping (insomnia);
muscle pain and discomfort;
irritated or runny nose;
hair loss (alopecia).
Common side effects that may show up in blood tests are:
low red blood cells (anemia) or low white blood cells (neutropenia or leukopenia);
Elevation of liver enzymes;
increasing the amount of bilirubin (a substance produced in the liver) in the blood, which may impart a yellow color to the skin.
Uncommon side effects
These may affect up to 1 in 100 people:
shortness of breath;
Uncommon side effects that may show up in blood tests are:
reducing the number of cells involved in blood clotting (thrombocytopenia) or of all blood cells (pancytopenia).
Rare side effects
These may affect up to 1 in 1000 patients:
serious allergic reaction leading to 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 (see the next section 'Other possible side effects of combination therapy for HIV);
inflammation of the pancreas (pancreatitis);
pain in the chest; heart muscle disease (cardiomyopathy);
feeling depressed or anxiety, inability to concentrate, drowsiness;
indigestion, taste disturbance;
discoloration of the nail, skin or mucous membranes inside the mouth;
flu-like symptoms - chills and sweating;
tingling sensation on the skin;
a feeling of weakness in the limbs;
breakdown of muscle tissue;
more frequent urination;
breast enlargement in men.
Rare side effects that may show up in blood tests are:
increased levels of an enzyme called amylase;
inability of the bone marrow to produce new red blood cells (pure red blood cells).
Very rare side effects
These may affect up to 1 in 10,000 patients:
Very rare side effect that can occur in blood tests is:
inability of the bone marrow to produce new red or white blood cells (aplastic anemia).
If you get side effects
If any of the side effects gets severe or troublesome, or if you notice other effects not listed in this leaflet, tell your doctor or pharmacist.
Other possible side effects of combination therapy for HIV
Combination therapy including a Combivir, may lead to the development of other diseases in the treatment of HIV.
Old infections may flare up
People with advanced HIV infection (AIDS) have weakened immune systems and are more likely to develop serious infections (opportunistic infections) is greater. When these people start treatment, they may find that old, hidden infections flare up, causing signs and symptoms of inflammation. These symptoms are most likely caused by the strengthening of the body's immune system so the body starts to fight these infections.
Furthermore opportunistic infections after taking drugs to treat HIV infection, may develop autoimmune disorders (a condition that develops when the immune system attacks healthy tissues of the body). Autoimmune disorders can develop many months after initiation of treatment. If you notice any signs of infection or other symptoms such as muscle weakness, a weakness that starts from the hands and feet and goes to the body, palpitations, tremors, increased activity, please inform your doctor immediately to seek appropriate treatment.
If you experience symptoms of infection while taking Combivir:
Tell your doctor immediately. Do not take other medicines for the infection without first checking with your doctor.
Your body shape may change
People taking combination therapy for HIV, may find that their body shape changes due to changes in fat distribution:
Fat may be lost from the legs, arms or face;
Extra fat can accumulate around the abdomen, breasts or internal organs;
Fatty lumps (sometimes called "buffalo hump") may appear on the back of the neck.
It is not yet known what causes these changes, or whether they have long-term effects on your health. If you notice changes in your body shape:
Tell your doctor.
Lactic acidosis is a rare but serious side effect
Some people taking Combivir or similar drugs (NRTIs), develop a condition called lactic acidosis, together with an enlarged liver.
Lactic acidosis is caused by a buildup of lactic acid in the body. It is a rare condition. If it occurs, usually develops after a few months of treatment. Can be life-threatening, causing failure of internal organs. Lactic acidosis develops with more likely 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;
During treatment, your doctor will monitor you for signs of lactic acidosis. If you have any of the above symptoms or any other symptoms that worry you:
Talk to your doctor as soon as possible.
You may have bone problems
Some people taking combination therapy for HIV, develop osteonecrosis. In this disease of the bone tissue die because of reduced blood supply to the bone. The likelihood of developing this disease is higher in patients:
If received the combination therapy for a long period of time;
If you are taking anti-inflammatory medicines called corticosteroids;
if you consume alcohol;
if their immune systems are very weak;
if you are overweight.
Signs of osteonecrosis include:
pain (especially of the hip, knee or shoulder);
difficulty in movement.
If you notice any of these symptoms:
Tell your doctor.
Other effects which may occur in blood tests
Combination therapy for HIV may lead to:
elevated levels of lactic acid in the blood, which in rare cases can lead to lactic acidosis;
elevated levels of blood sugar and fats (triglycerides and cholesterol) in the blood;
resistance to insulin (so if you are diabetic, you may need to change the dose of insulin to control blood sugar).
5. How to store Combivir
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the carton.
Do not store above 30 ° C.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and other information
What does Combivir
The active substances in Combivir are lamivudine and zidovudine.
Other ingredients are:
tablet core: microcrystalline cellulose, sodium starch glycollate (gluten), magnesium stearate, colloidal silicon dioxide;
Tablet coating: hypromellose, titanium dioxide, macrogol 400 and polysorbate 80.
Combivir looks like and contents of pack
Combivir tablets are available in blister packs, tamper containing 60 tablets. They are white to off-white tablets, capsule-shaped, scored and marked on both sides with code GXFC3.
Marketing Authorisation Holder and Manufacturer
Glaxo Operations UK Limited, UK;
GlaxoSmithKline Pharmaceuticals S.A., Poland.