Zerit (Stavudine)

Zerit 20 mg hard capsules

Zerit 30 mg hard capsules

Zerit 40 mg hard capsules

Stavudine

WHAT ZERIT IS AND WHAT IT IS USED FOR

Zerit belongs to a group of antiviral medicines, also known as antiretrovirals, called nucleoside reverse transcriptase inhibitors (NRTIs).

These are used to treat Human Immunodeficiency Virus (HIV) infection.

This medicinal product, in combination with other antiretrovirals, reduces the HIV viral load and keeps it at a low level. It also increases CD4 cell counts. These CD4 cells play an important role in maintaining a healthy immune system to help fight infection. Response to treatment with Zerit varies between patients. Your doctor will therefore be monitoring the effectiveness of your treatment.

Zerit may improve your condition, but it is not a cure for your HIV infection. Treatment with Zerit has not been shown to reduce the risk of passing HIV infection on to others by sexual contact or by blood transfer. Therefore, you must continue to take appropriate precautions to avoid giving the virus to others.

During your treatment, other infections linked to your weakened immunity (opportunistic infections) may arise. These will require specific and sometimes preventive treatment.

BEFORE YOU TAKE ZERIT

Do not take Zerit:

If you are allergic (hypersensitive) to stavudine or any of the other ingredients of Zerit. Contact your doctor or pharmacist for advice.

Take special care with Zerit:

Before treatment with Zerit, you should have told your doctor:

• if you suffer from kidney disease or liver disease (such as hepatitis),
• if you have had peripheral neuropathy (persistent numbness, tingling, or pain in the feet and/or hands), or
• if you have suffered from pancreatitis (inflammation of the pancreas).

The class of medicines to which Zerit belongs (NRTIs) can cause a sometimes fatal condition called lactic acidosis, together with an enlarged liver. This condition usually does not occur until a few months after onset of treatment. This rare, but very serious side effect occurs more often in women, particularly if very overweight. In addition, rare cases of liver failure/renal failure or fatal hepatitis have been reported.

Patients with chronic hepatitis B or C and treated with antiretroviral agents are at increased risk for severe and potentially fatal liver adverse events and may require blood tests for control of liver function.

If you develop one of the following, contact your doctor:

• persistent numbness, tingling or pain in feet and/or hands (this may indicate the beginning of peripheral neuropathy, an adverse effect on the nerves), muscular weakness or
• abdominal pain, nausea or vomiting, or
• rapid deep breathing, drowsiness (which may indicate pancreatitis, liver disturbance such as hepatitis, or lactic acidosis).

In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is believed that these symptoms are due to an improvement in the body’s immune response, enabling the body to fight infections that may have been present with no obvious symptoms. If you notice any symptoms of infection, please inform your doctor immediately.

Redistribution, accumulation, or loss of body fat may occur in patients receiving antiretroviral therapy. Some NRTIs, such as stavudine, have been associated with a loss of body fat (lipoatrophy). Contact your doctor if you notice changes in body fat.

Bone problems:

some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease.

Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement. If you notice any of these symptoms please inform your doctor.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Except for zidovudine, which interferes with the activity of stavudine, Zerit may be taken with many of the other medicines commonly used in patients with HIV infection. These include the protease inhibitors (such as nelfinavir) and NRTIs. Please tell your doctor if you are taking doxorubicin or ribavirin as undesirable interactions may occur.

Taking Zerit with food and drink:

For maximum effect, Zerit should be taken on an empty stomach, and preferably at least one hour before a meal. If this is not possible, the capsules may also be taken with a light meal.

Pregnancy and breast-feeding:

Pregnancy

If you become pregnant, or are planning to become pregnant, you must contact your doctor to discuss the potential adverse effects and the benefits and risks of your antiretroviral therapy to you and your child. Lactic acidosis (sometimes fatal) has been reported in pregnant women who received stavudine in combination with other antiretroviral treatment.

If you have taken Zerit during your pregnancy, your doctor may request regular visits to monitor the development of your child. Such visits may include blood tests and other diagnostic tests.

In children whose mother took nucleoside and nucleotide analogues during pregnancy, the benefit from the reduced chance of being infected with HIV is greater than the risk of suffering from side effects.

Breast-feeding

Tell your doctor if you are breast-feeding. It is recommended that HIV-infected women should not breast-feed under any circumstances in order to avoid transmission of HIV to the baby.

Driving and using machines:

It is unlikely that Zerit affects the ability to drive or operate machinery.

Important information about some of the ingredients of Zerit:

These capsules contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

HOW TO TAKE ZERIT

Always take Zerit exactly as your doctor has told you. You should check with your doctor if you are not sure. Your doctor has defined your daily dose based on your weight and individual characteristics.

Please follow these recommendations closely as they will give you the best chance to delay development of a resistance to the medicinal product. Do not change the dose on your own. Continue to take this medicine until your doctor tells you otherwise.

For adults whose body weight is 30 kg or more, the usual starting dose is 30 or 40 mg given twice daily (with approximately 12 hours between each dose).

To obtain optimal absorption, the capsules should be swallowed with a glass of water, preferentially at least one hour before a meal and on an empty stomach. If this is not possible, Zerit may also be taken with a light meal.

If you have problems swallowing capsules you should ask your doctor about the possibility of changing to the solution form of this medicine or you could carefully open the capsule and mix its contents with some food.

Use in Children

For children whose body weight is 30 kg or more, the usual starting dose is 30 or 40 mg given twice daily (with approximately 12 hours between each dose).

Children older than 3 months, whose body weight is less than 30 kg, should receive 1 mg/kg twice daily.

If you take more Zerit than you should:

If you have taken too many capsules or if someone accidentally swallows some, there is no immediate danger. However, you should contact your doctor or the nearest hospital for advice.

If you forget to take Zerit:

If you accidentally miss a dose, then simply take your normal dose when the next one is due. Do not take a double dose to make up for a forgotten dose.

If you stop taking Zerit:

The decision to stop using Zerit should be discussed with your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

POSSIBLE SIDE EFFECTS

Like all medicines, Zerit can cause side effects, although not everybody gets them.

When treating HIV infection, it is not always possible to differentiate between unwanted effects caused by Zerit, or those caused by any other medicines you may be taking at the same time, or by the complications of the infection. For this reason, it is important that you inform your doctor of any change in your health.

Therapy for HIV including stavudine often causes changes in body shape due to changes in fat distribution. These may include loss of fat from legs, arms and face (lipoatrophy), and development of fatty lumps on the back of the neck (“buffalo hump”). Loss of body fat has been shown to be not fully reversible after discontinuation of stavudine. It occurs more often with Zerit compared to other HIV medicines. Your doctor should monitor for clinical signs and symptoms of changes in your body shape. Tell your doctor if you notice any changes in your body shape or loss of fat from your legs, arms, and face. When these signs occur, consideration should be given to discontinuing ZERIT treatment.

The frequency of possible side effects listed below is defined using the following convention:

very common:	affects more than 1 user in 10
common:	affects 1 to less than 10 users in 100
uncommon:	affects 1 to less than 10 users in 1,000
rare:	affects 1 to less than 10 users in 10,000
very rare:	affects less than 1 user in 10,000
not known:	frequency cannot be estimated from the available data

Patients treated with Zerit have reported the following side effects:

Common:

• asymptomatic hyperlactatemia (build up of acid in your blood)
• lipoatrophy or lipodystrophy syndrome (body changes due to fat redistribution, accumulation, or loss of body fat),
• depression
• peipheral neurologic symptoms including peripheral neuropathy, paresthesia, and peripheral neuritis (numbness, weakness, tingling or pain in the arms and legs)
• dizziness, abnormal dreams, headache
• insomnia (difficulty sleeping), somnolence (sleepiness), abnormal thinking,
• diarrhoea, abdominal pain (stomach pain of discomfort),
• nausea, dyspepsia (indigestion)
• rash, pruritus (itching)
• fatigue (extreme tiredness)

Uncommon:

• lactic acidosis (build up of acid in your blood) in some cases involving motor weakness (weakness in your arms, legs or hands)
• gynaecomastia (breast enlargement in men)
• anorexia (loss of appetite), anxiety, emotional lability
• pancreatitis (inflammation of the pancreas), vomiting
• hepatitis, jaundice (yellow of the skin or eyes)
• urticaria (itchy rash), arthralgia (joint pain)
• myalgia (aching muscles), asthenia (unusual tiredness or weakness)

Frequency not known:

• anemia, thrombocytopenia, neutropenia (blood disorders)
• diabetes mellitis, hyperglycaemia (high sugar levels in the blood)
• motor weakness (most often reported in the setting of symptomatic hyperlacetatemia or lactic acidosis syndrome
• liver failure, hepatitis (infiamation of the liver) and hepatic steatosis (fat in the liver)

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell you doctor or pharmacist.

HOW TO STORE ZERIT

Keep out of the reach and sight of children.

Store below 25 °C (aclar/alu blisters) Do not store above 30°C. (HDPE bottles) Store in the original package.

Do not use Zerit after the expiry date which is stated on the carton, the bottle label and/or the blister after EXP. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

FURTHER INFORMATION

What Zerit contains

The active substance is stavudine

The other ingredients of the powder contained in the hard capsule are: lactose (120 mg, 180mg, or 240mg), magnesium stearate, microcrystalline cellulose and sodium starch glycolate.

The ingredients of the capsule shell are gelatine, iron oxide colorant (E172), silicon dioxide, sodium laurilsulphate and titanium dioxide colorant (El71).

The capsule shells are marked using edible black printing ink containing shellac, propylene glycol, purified water, potassium hydroxide and iron oxide (El72).

What Zerit looks like and content of the pack

• Zerit 20 mg hard capsules are brown and marked with “BMS 1965″ on one side and “20″ on the other side.
• Zerit 30 mg hard capsules are light and dark orange and marked with “BMS 1966″ on one side and “30″ on the other side.
• Zerit 40 mg hard capsules are dark orange and marked with “BMS 1967″ on one side and “40″ on the other side.
• Zerit 20 mg, 30 mg & 40 mg hard capsules are supplied in blister packs of 56 hard capsules or bottles of 60 hard capsules. To help protect the capsules from excessive moisture, the bottle includes a desiccant canister.