Combivir

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

COMBIVIR contains the active ingredients lamivudine and zidovudine. COMBIVIR is used, alone or in combination with other antiretrovirals, to slow down the progression of human immunodeficiency virus (HIV) infection which can lead to Acquired Immune Deficiency Syndrome (AIDS) and other related illnesses (e.g. AIDS-related Complex (ARC)).
For more information, see Section 1. Why am I taking COMBIVIR? in the full CMI.

Do not use if you have ever had an allergic reaction to COMBIVIR or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I take COMBIVIR? in the full CMI.

Some medicines may interfere with COMBIVIR and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

More instructions can be found in Section 4. How do I take COMBIVIR? in the full CMI.

For more information, see Section 5. What should I know while taking COMBIVIR? in the full CMI.

Side effects that have been reported include sweating, body odour, chills, swelling of the lips/tongue, flu-like symptoms, fever, increased sensitivity to pain, back pain, enlarged glands, chest pain, weakness, weight loss, loss of appetite, vomiting or nausea, generally feeling unwell, breast enlargement in men, widening of blood vessels leading to low blood pressure and feeling faint, fainting, constipation, gas from the stomach or bowel, blood in the stool, diarrhoea, difficulty in swallowing, mouth ulcers, bleeding gums, heartburn, abdominal discomfort or pain, muscle aches or pains, muscle shaking or spasm or twitching, muscle disease, enlarged fatty liver, abnormal results of liver function blood tests, confusion, depression, nervousness, loss of mental clarity, dizziness, headaches, sleeplessness, fatigue or tiredness, cough, sore throat, hay fever, sinus problems, hoarseness, changes to perception of taste, acne, itchiness, skin rash, changes in nail, skin or mouth colour, vision problems, sensitivity to light, hearing loss, passing too much urine or increased frequency of urination, increased bruising or bleeding, hair loss.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

Active ingredients: lamivudine and zidovudine

This leaflet provides important information about using COMBIVIR. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using COMBIVIR.

Where to find information in this leaflet:

COMBIVIR contains the active ingredients lamivudine and zidovudine.

COMBIVIR belongs to a group of medicines known as antiretrovirals.

COMBIVIR is used, alone or in combination with other antiretrovirals, to slow down the progression of human immunodeficiency virus (HIV) infection which can lead to Acquired Immune Deficiency Syndrome (AIDS) and other related illnesses (e.g. AIDS-related Complex (ARC)).

COMBIVIR does not cure AIDS or HIV infection however it slows down production of HIV in the body. In this way it stops ongoing damage to the body’s immune system which fights infection.

You can still pass on HIV when taking this medicine through sexual activity or through passing on blood or bodily secretions which carry the HIV virus, although the risk is lowered by taking antiretroviral therapy.

You should use proper precautions to prevent this from occurring. Discuss with your doctor the precautions needed to avoid infecting other people.

While taking COMBIVIR and/or any other therapy for HIV, you may continue to develop other infections and other complications of HIV infection. You should keep in regular contact with your doctor.

The active ingredients in COMBIVIR are available separately. Lamivudine is available under the brand name 3TC (tablets and oral solution) and zidovudine is available under the brand name Retrovir (capsules and oral solution).

Always check the ingredients to make sure you can use this medicine.

If you have a long-standing viral infection of your liver (hepatitis B) it may flare up. This can cause serious illness particularly if your liver is already not working very well. If you have both HIV and hepatitis B, when you stop taking COMBIVIR your doctor is likely to arrange tests from time to time to check how well your liver is working and to measure virus levels.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Talk to your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Your doctor can discuss with you the benefits and risks of taking COMBIVIR whilst pregnant or breastfeeding.

People with advanced HIV infection (AIDS) have weak immune systems and are more likely to develop serious infections (opportunistic infections). When they start treatment, the immune system becomes stronger and so the body starts to fight infections.

Symptoms of infection and inflammation may develop, caused by either:

The symptoms of autoimmune disorders may develop many months after you start taking medications to treat your HIV infection.

Symptoms may include:

If you get symptoms of infection or if you notice any of the symptoms above, tell your doctor immediately. Do not take other medicines for the infection without your doctor’s advice.

COMBIVIR is not recommended for use in children under 12 years of age. COMBIVIR is a fixed dose combination tablet and as such it cannot be adjusted according to the size and weight of the patient.

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with COMBIVIR and affect how it works.

If you take ribavirin (e.g. Ibavyr) and COMBIVIR together it may cause or worsen anaemia (low red blood cells). Tell your doctor if you notice symptoms of anaemia such as tiredness and shortness of breath.

Tell your doctor or pharmacist if you are taking any of the medicines below:

COMBIVIR should not be taken with stavudine or zalcitabine.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect COMBIVIR.

COMBIVIR should be taken regularly at the same time each day.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember and then go back to taking your medicine as you would normally.

Do not take a double dose to make up for the dose you missed.

If you think that you have used too much COMBIVIR, you may need urgent medical attention.

You should immediately:

You should do this even if there are no signs of discomfort or poisoning.

Ensure you have blood tests when you are meant to. It is important that your doctor monitors your health and checks the levels of red and white blood cells. If you develop anaemia or neutropenia your doctor may reduce your dose or stop COMBIVIR.

Remind any doctor, dentist or pharmacist you visit that you are taking COMBIVIR.

This is especially important for any medicines that might have an effect on your liver, kidneys, red or white blood cells or other cells in the body.

COMBIVIR helps to control your condition, but it is not a cure for HIV infection. You need to keep taking it everyday to stop your illness from getting worse. Because COMBIVIR does not cure HIV infections, you may still develop other infections and illnesses linked to HIV.

Be careful before you drive or use any machines or tools until you know how COMBIVIR affects you.

COMBIVIR may cause headache and tiredness in some people.

Follow the instructions on the pack on how to take care of your medicine properly.

Store it in a cool dry place (below 30°C) away from moisture, heat or sunlight; for example, do not store it:

Keep it where young children cannot reach it.

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

Within the first few weeks of treatment with anti-HIV medicines, some people, particularly those that have been HIV positive for some time, may develop inflammatory reactions (e.g. pain, redness, swelling, high temperature) which may resemble an infection and may be severe. It is thought that these reactions are caused by a recovery in the body's ability to fight infections, previously suppressed by HIV.

If you become concerned about any new symptoms, or any changes in your health after starting HIV treatment, discuss with your doctor immediately.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

 

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

See your doctor if you feel generally unwell with a loss of appetite, nausea, vomiting, itching, yellowness of the skin or eyes or have dark coloured urine.

Other side effects not listed here may occur in some people.

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

This medicine is only available with a doctor's prescription.

Do not take this medicine if you are allergic to any of these ingredients.

COMBIVIR tablets available in bottles are white to off-white, film-coated, capsule-shaped tablets, scored tablet engraved with "GXFC3" on both tablet faces (AUST R 61488). The bottle contains 60 tablets.

COMBIVIR tablets available in blister packs are white to off-white film-coated capsule-shaped scored tablets, engraved with "GXFC3" on both tablet faces (AUST R 61489). The blister pack contains 60 tablets.

Not all pack sizes and types may be marketed.

ViiV Healthcare Pty Ltd

Level 4, 436 Johnson Street

Abbotsford VIC 3067

Australia

Trademarks are owned by or licenced to the ViiV Healthcare group of companies.

© 2023 ViiV Healthcare group of companies or its licensor.

This leaflet was prepared on 7 September 2023.

Version 9.0