Zerit 200 mg powder for oral solution

Zerit belongs to a particular 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 treatment, other infections, linked to a weakened immunity (opportunistic infections) may arise. These will require specific and sometimes preventive treatment.

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 side effects 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 Zerit. Some NRTIs, such as Zerit, 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 Zerit 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 and didanosine, 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 hydroxyurea, 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, Zerit 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 side 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 Zerit 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.

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:

Zerit may cause dizziness and drowsiness.
If you are affected, do not drive and do not use any tools or machines.

Important information about some of the ingredients of Zerit:

After reconstitution with water, the solution contains 50 mg of sucrose per ml of solution. This should be taken into account in patients with diabetes mellitus. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. May be harmful to the teeth.
This product contains methylhydroxybenzoate (E218) and propylhydroxybenzoate (E216) that may cause allergic reactions (possibly delayed).

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, Zerit should be taken 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.
Prepare the ready-to-use solution by mixing the powder with 202 ml of water or by slowly adding water up to the fill mark on the bottle. Then screw the cap on tightly and shake the bottle well until the powder dissolves completely, and take or dispense the solution with the measuring cup provided. For infants who require a dose less than 10 ml, ask your pharmacist for a syringe to use to accurately measure the oral dose. Do not worry if the solution remains slightly hazy after mixing with water; this is normal. If needed, consult your pharmacist for help with this procedure.

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 from birth to 13 days old should receive 0.5 mg/kg twice daily. Children at least 14 days old 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 much of the solution, 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.

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

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 peripheral 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 inflamation of the liver, jaundice yellow of the skin or eyes urticaria itchy rash, arthralgia joint pain myalgia aching muscles, asthenia unusual tiredness or weakness

Rare anemia hyperglycaemia high sugar levels in the blood hepatic steatosis fat in the liver

Very rare
- thrombocytopenia, neutropenia (blood disorders)
- diabetes mellitis
- motor weakness (most often reported in the setting of symptomatic hyperlacetatemia or lactic acidosis syndrome)

liver failure

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.

Keep out of the reach and sight of children.

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

Do not store the dry powder above 30°C. Store in the original package in order to protect from excessive moisture.
The prepared oral solution is stable for 30 days in a refrigerator (2°C -8°C).
Keep the bottle tightly closed.

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.

What Zerit contains

• The active substance is stavudine (200 mg)
• The other ingredients of the powder are: cherry flavour, methylhydroxybenzoate (E218), propylhydroxybenzoate (E216), silicon dioxide, simethicone, sodium carmellose, sorbic acid, stearate emulsifiers and sucrose.

What Zerit looks like and content of the pack

The powder contains 200 mg stavudine. The reconstituted solution contains 1 mg of stavudine per ml. Before reconstitution the Zerit powder appears as off-white to pale-pink, gritty powder. When reconstituted with 202 ml of water, produces 210 ml of a colorless to slightly pink, hazy solution. Zerit 200 mg powder for oral solution is supplied in a bottle containing 200 ml solution.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
BRISTOL-MYERS SQUIBB PHARMA EEIG
Uxbridge Business Park
Sanderson Road
Uxbridge UB8 1DH
United Kingdom

Manufacturer:
Bristol-Myers Squibb S.r.l.
Contrada Fontana del Ceraso
03012 Anagni (FR) - Italy

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BelgiqueBelgiëBelgien BRISTOL-MYERS SQUIBB BELGIUM S.A.N.V. TélTel 32 2 352 76 11 LuxembourgLuxemburg BRISTOL-MYERS SQUIBB BELGIUM S.A.N.V. TélTel 32 2 352 76 11

BRISTOL-MYERS SQUIBB GYÓGYSZERKERESKEDELMI KFT. Te. 359 800 12 400 Magyarország BRISTOL-MYERS SQUIBB GYÓGYSZERKERESKEDELMI KFT. Tel. 36 1 301 9700

eská republika BRISTOL-MYERS SQUIBB SPOL. S R.O. Tel 420 221 016 111 Malta BRISTOL-MYERS SQUIBB S.R.L. Tel 39 06 50 39 61

Danmark BRISTOL-MYERS SQUIBB Tlf 45 45 93 05 06 Nederland BRISTOL-MYERS SQUIBB BV Tel 31 34 857 42 22

Deutschland BRISTOL-MYERS SQUIBB GMBH CO. KGAA Tel 49 89 121 42-0 Norge BRISTOL-MYERS SQUIBB NORWAY LTD Tlf 47 67 55 53 50

Österreich BRISTOL-MYERS SQUIBB GESMBH Tel 43 1 60 14 30 Eesti BRISTOL-MYERS SQUIBB GYÓGYSZERKERESKEDELMI KFT. Tel 372 6827 400

BRISTOL-MYERS SQUIBB A.E. 30 210 6074300 Polska BRISTOL-MYERS SQUIBB POLSKA SP. Z O.O. Tel. 48 22 5796666

España BRISTOL-MYERS SQUIBB, S.A. Tel 34 91 456 53 00 Portugal BRISTOL-MYERS SQUIBB FARMACÊUTICA PORTUGUESA, S.A. Tel 351 21 440 70 00

France BRISTOL-MYERS SQUIBB SARL Tél 33 0810 410 500 România BRISTOL-MYERS SQUIBB GYÓGYSZERKERESKEDELMI KFT. Tel 40 021 272 16 00

IrelandSlovenija
BRISTOL-MYERS SQUIBB PHARMACEUTICALS LTDBRISTOL-MYERS SQUIBB SPOL. S R.O. Tel: + 353 (1 800) 749 749 Tel: + 386 1 236 47 00

Ísland VISTOR HF Sími 354 535 7000 Slovenská republika BRISTOL-MYERS SQUIBB SPOL. S R.O. Tel 421 2 59298411

Italia BRISTOL-MYERS SQUIBB S.R.L. Tel 39 06 50 39 61 SuomiFinland OY BRISTOL-MYERS SQUIBB FINLAND AB PuhTel 358 9 251 21 230

BRISTOL-MYERS SQUIBB A.E 357 800 92666 Sverige BRISTOL-MYERS SQUIBB AB Tel 46 8 704 71 00

United Kingdom BRISTOL-MYERS SQUIBB PHARMACEUTICALS LTDTel 44 0800 731 1736 Latvija BRISTOL-MYERS SQUIBB GYÓGYSZERKERESKEDELMI KFT. Tel 371 67 50 21 85

Lietuva
BRISTOL-MYERS SQUIBB
GYÓGYSZERKERESKEDELMI KFT.
Tel: + 370 5 2790 762

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