Zovilam Film-Coated Tablets

ZOVILAM belongs to a group of antiviral medicines, also known as antiretrovirals, called nucleoside reverse transcriptase inhibitors (NRTIs). ZOVILAM 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. ZOVILAM is also used as a prophylaxis against occupation exposure, such as disposal of sharp objects (for instance needles and scalpels).

Do not take ZOVILAM

• If you are hypersensitive (allergic) to lamivudine or zidovudine or any of the other ingredients of ZOVILAM tablets (listed in section 6).
• If you have a very low red blood cell count (anaemia) or a very low white blood cell count (neutropenia).
• If you are taking ZOVILAM tablets, you must not take it with stavudine, zalcitabine or ribavirin.
• ZOVILAM should not be given to children of younger than 12 years.
• ZOVILAM should not be taken with any other medicines containing lamivudine or medicines containing emtricitabine.

Warnings and precautions

Take special care with ZOVILAM:

• Not everyone responds to treatment with ZOVILAM in the same way. The doctor will monitor the effectiveness of your treatment and if necessary separate preparations of lamivudine and zidovudine will be given where dosage adjustment is needed.
• You may develop very low red blood cell count, or a very low white blood cell count, especially if you have advanced HIV infection (AIDS), and because of this experience fever or chills when taking zidovudine and therefore, ZOVILAM.
• Inflammation of the pancreas have occurred in patients treated with lamivudine and zidovudine, and therefore, ZOVILAM, and because of this experience stomach pain, nausea and vomiting when taking zidovudine and therefore, ZOVILAM.
• ZOVILAM can cause a condition called lactic acidosis, together with an enlarged liver. This rare but serious side effect occurs more often in women. If you have liver disease you may also be more at risk of getting this condition while being treated with ZOVILAM. The doctor will monitor you for any signs of developing lactic acidosis. Possible signs of lactic acidosis are:
• Deep, rapid breathing.
• Drowsiness.
• Numbness or weakness in the limbs.
• Nausea, vomiting and stomach pain.
• Loss of appetite or weight loss.
• Your body shape may change. If you are taking combination antiretroviral therapy for HIV you may find that your body shape changes, because of changes in fat distribution:
• Fat may be lost from your legs, arms or face.
• Extra fat may build up around your tummy (abdomen), or on the breasts or internal organs.
• Fatty lumps (sometimes called buffalo hump) may appear on the back of your neck.
• If you notice changes in your body shape, tell your doctor.
• With HIV infection (AIDS) your immune system is weakened, and you are more likely to develop serious infections (opportunistic infections). When starting treatment, you may find that old, hidden infections flare up, causing signs and symptoms of inflammation, usually within the first three months of starting treatment. These symptoms are probably caused by the body’s immune system becoming stronger, so that the body starts to fight these infections.
• If you have ever had liver disease, including hepatitis B or C (if you have hepatitis infection), you are at an increased risk of severe and potentially fatal liver effects and may require blood tests to monitor your liver function. Do not stop ZOVILAM without the doctor’s advice, as the hepatitis may come back. If liver function abnormalities recur, ZOVILAM should be stopped permanently. Contact your doctor IMMEDIATELY if you experience any symptoms of liver problems, such as loss of appetite, nausea, vomiting, jaundice (yellowing of the skin and/or eyes), dark coloured urine, pale coloured stools, pain/ache or sensitivity to touch in your right abdominal area (below your ribs). These could be signs of serious liver dysfunction which your doctor will need to monitor closely.
• You must contact the medical practitioner if you experience joint aches and pain, joint stiffness or difficulty in movement. You may have bone problems. Some patients taking combination therapy for HIV develops 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 advanced HIV disease and/or 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.
• You may continue to develop other infections and other illnesses associated with HIV disease. You should therefore keep in regular contact with the medical practitioner while taking ZOVILAM.
• ZOVILAM helps to control HIV infection but is not a cure. You will need to take it every day. You must not stop taking ZOVILAM without first talking to the doctor. If you are concerned that you may be developing symptoms of a hypersensitivity reaction, call the doctor immediately who will advise whether you must stop taking ZOVILAM. It must be realised that the use of ZOVILAM tablets do not reduce the risk of transmitting the HIV infection to others through sexual contact or by blood transfer. If you are sexually active, you should continue to use appropriate precautions to prevent this.
• To protect other people from becoming infected with HIV:
• A condom must be used when someone has oral or penetrative sex.
• Blood transfer should be avoided – for example, needles must not be shared.

Children and adolescents

ZOVILAM must not be given to children younger than 12 years.

Other medicines and ZOVILAM

Always tell your healthcare provider if you are taking any other medicine. (This includes all complementary or traditional medicines).

Do not share medicines prescribed for you with any other person. Always take ZOVILAM exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your will be stabilised on the separate preparations of lamivudine and zidovudine before your doctor will switch you over to ZOVILAM.

Adults and children over the age of 12 years

The recommended dose of ZOVILAM is one tablet twice a day. ZOVILAM can be taken with or without food. If you must discontinue treatment with one of the active ingredients of ZOVILAM or the dosage must be reduced, separate preparations of lamivudine and zidovudine are available. Take the tablets at regular times, leaving approximately 12 hours between each tablet.

Treatment following exposure

Treatment will start after exposure occurred and should be preferably within 1 to 2 hours. The HIV status of the source must be confirmed. If the source is infected with HIV, it is recommended that the prophylactic course be continued for a period of 4 weeks.

Recommended dose

Duration: ZOVILAM dosage

1. Days 1 – 3: One (1) ZOVILAM tablet taken twice a day.
2. Days 4 – 28: One (1) ZOVILAM tablet taken twice a day.

Treatment should be stopped as soon as the source material is confirmed not be infected with HIV.

Special populations

Kidney disease

Your doctor may decide to adjust your dosage and recommend that you receive separate preparations.

Liver disease

Your doctor may decide to adjust your dosage and recommend that you receive separate preparations. Your doctor will tell you how long your treatment with ZOVILAM will last. Do not stop treatment early because you are feeling better.

Blood disorders

If you have a very low red blood cell count (anaemia) or a very low white blood cell count (neutropenia), your doctor may decide to adjust your dosage and recommend that you receive separate preparations.

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

If you take more ZOVILAM than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison control centre.

If you forget take ZOVILAM

If you forget to take a dose of ZOVILAM, take it as soon as you remember and then continue as before. Do not take a double dose to make up for forgotten individual doses.

If you stop taking ZOVILAM

Do not stop taking the tablets unless the doctor instructs you to. When the ZOVILAM supply starts to run low, get more from a healthcare provider or pharmacy. This is very important because the amount of virus in your blood may increase if ZOVILAM is stopped for even a short time. The virus may develop resistance to ZOVILAM and become harder to treat.

ZOVILAM tablets can have side effects. Not all side effects reported for ZOVILAM are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking ZOVILAM, please consult your health care provider for advice.

If any of the following happens, stop taking ZOVILAM and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Lactic acidosis (signs include deep, rapid, difficult breathing, drowsiness, numbness or weakness in the limbs, nausea, vomiting, abdominal (stomach) pain.
• Shortness of breath and difficulty breathing. These are all very serious side effects. If you have them, you may have had a serious reaction to ZOVILAM. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

Frequent side effects:

• Decreased number of red blood cells, too few white blood cells.
• Ear, nose and throat infections.
• Too much lactate in the blood.
• Loss of appetite.
• Headache.
• Difficulty to sleep.
• Feeling dizzy.
• Cough, irritated or runny nose.
• Nausea, vomiting, abdominal pain or cramps, diarrhoea.
• Rash.
• Loss of hair.
• Redness of the skin.
• Pain.
• Pain in joint.
• Muscle disorders including musculoskeletal pain.
• Tiredness.
• Feeling of bodily discomfort.
• Fever.
• An increase in certain liver enzymes and an increased amount in the blood of bilirubin (a substance produced in the liver) which may make your skin appear yellow.

Less frequent side effects:

• A decrease in the number of cells involved in blood clotting or in all kinds of blood cells.
• A failure of the bone marrow to produce new red or white blood cells.
• Changes in body or face shape due to changes in fat distribution (these changes may include an increase amount of fat in the upper back and neck (“buffalo hump”), in the breasts and around the trunk, as well as loss of fat from the legs, arms and face).
• Unpleasant tingling feeling in arms or legs, numbness, tingling, a burning sensation or weakness of hands and feet.
• Sleepiness, loss of mental sharpness, fits (seizures).
• Disease of the heart muscle.
• Shortness of breath and/or difficulty breathing.
• Wind, changes in the colour of the inside of the mouth, changes in taste, heartburn, inflammation of pancreas, enlargement of the spleen, inflammation of the mouth, an increase in an enzyme called serum amylase.
• Inflammation of the liver, liver disorders such as enlargement of the liver with fatty degeneration.
• Sudden swelling of the skin or mucous membranes (e.g. throat or tongue) with difficulty breathing.
• Itching, changes in the colour of your nails and skin, allergic skin reaction/nettle-rash.
• Muscle disease.
• Passing urine more often.
• Growth of breasts in men.
• Generalised pain, lack of energy, chills, chest pain, flu-like symptoms (chills and sweating).
• Anxiety, depression.
• Breakdown of muscle tissue/tenderness or weakness.

Frequency not known:

• If you are taking combination therapy for HIV you may develop a condition called osteonecrosis. With this condition, parts of the bone tissue die because of reduced blood supply to the bone. Signs of this condition include stiffness in the joints, aches and pains (especially in the hip, knee or shoulder) and difficulty moving.
• Too much sugar in the blood.
• Abnormal breathing, sore throat.
• Weakness.

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

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of ZOVILAM.

Store all medicines out of reach of children.

• Store at or below 30 °C.
• Store in the original container.
• Do not remove from the carton until required for use.
• Keep the bottles tightly closed.
• Protect from light/moisture.
• Do not store in a bathroom.
• Do not use after the expiry date stated on the label.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).