Zerit 40 mg.

WHAT ZERIT AND WHAT IT IS USED?
Zerit belongs to a group of antiviral drugs, known as antiretrovirals, called nucleoside reverse transcriptase inhibitors (NRTIs).
They are used for the treatment of infections caused by the human immunodeficiency virus (HIV).
This product, in combination with other antiretrovirals, reduces viral load (amount of virus) 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, "fight" infection. The response to treatment with Zerit varies between patients. Therefore, your doctor will monitor the effectiveness of your treatment.

Zerit may improve your condition, but it does not cure your HIV infection. Treatment with Zerit does not reduce the risk of transmission of HIV to others through sexual contact or blood contamination. Therefore, you must continue to take appropriate precautions to prevent transmission of the virus to others.

During treatment may occur and other infections associated with lowered immunity (opportunistic infections). These will require specific and sometimes preventive treatment.

2 BEFORE YOU TAKE ZERIT
Do not take Zerit:
If you are allergic (hypersensitive) to stavudine or any of the other ingredients of Zerit.
Ask your doctor or pharmacist for advice.

Take special care with Zerit:
Before starting treatment with Zerit, you should tell your doctor:
■ if you have kidney or liver disease (such as hepatitis)
■ if you have had peripheral NEUROPATHY (persistent numbness or tingling, or pain in the feet and / or hands) or
■ have suffered from pancreatitis (inflammation of the pancreas).
The class of medicines to which it belongs Zerit (NRTIs), can sometimes lead to a fatal condition called lactic acidosis, together with an enlarged liver. This condition usually does not appear until a few months of treatment. This rare but very serious side effect occurs more often in women, particularly if very overweight. Furthermore, there are reports of rare cases of liver failure / renal failure or fatal hepatitis. 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.

Contact your doctor at the onset of:
■ persistent numbness, tingling or pain in the feet and / or hands (this may be a sign of early 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 damage, such as hepatitis or lactic acidosis).
In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection may occur signs and symptoms of inflammation from previous infections soon after anti-HIV treatment. It is assumed that these symptoms are due to an improvement in the immune response, allowing it to fight infections that may have been present with no obvious symptoms. If you notice any symptoms of infection, please inform your doctor immediately. In addition to opportunistic infections may also occur and autoimmune disorders (conditions that occur when the immune system attacks healthy tissue of the body) after taking drugs to treat HIV infection. Autoimmune diseases may occur many months after initiation of treatment. If you notice any signs of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and passing up the body, heart palpitations, trembling or hyperactivity, tell your doctor immediately to seek necessary treatment.
In patients taking Zerit, may occur Redistribution, accumulation or loss of body fat. Some NRTIs, such as Zerit are associated with 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 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 administered with other drugs commonly used in patients with HIV infection. These include the protease inhibitors (such as nelfinavir) and reverse transcriptase inhibitors (NRTIs). Please tell your doctor if you are taking hydroxyurea, doxorubicin or ribavirin as possible 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 be taken with a light meal.

Pregnancy and lactation
Ask your doctor or pharmacist before taking any medicine.

pregnancy
If you are pregnant or planning a pregnancy, you should discuss with your doctor about the side effects and the benefits and risks that hides your antiretroviral therapy to you and your child. In pregnant women taking Zerit in combination with other antiretroviral treatment, cases of lactic acidosis (sometimes fatal).
If you are taking Zerit during pregnancy, your doctor may request regular visits to monitor the development of your child. Such visits may include blood tests and other diagnostic tests.

breastfeeding
Tell your doctor if you are breast-feeding. Recommended that women infected with HIV should not breastfeed under any circumstances in order to avoid transmission of HIV to the infant.

Driving and using machines:
Zerit may cause dizziness and drowsiness.
If you experience these symptoms, do not drive or use any tools or machines.

Important information about some of the ingredients of Zerit:
These capsules contain lactose. If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine.

3 HOW TO TAKE ZERIT?
Always take Zerit, exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Your doctor will determine your dose based on your weight and individual characteristics. Please follow these recommendations closely as they will give you the best chance to delay the development of resistance (insensitivity) to this product. Do not change dose and continue taking it unless your doctor tells you otherwise.
In adults weighing 30 kg or more, the usual starting dose is 30 to 40 mg twice daily (approximately 12 hours between each dose).
For optimal absorption, the capsules should be swallowed with a glass of water, preferably one hour before a meal and on an empty stomach. If this is not possible, Zerit may be administered with a light meal.
If you have trouble swallowing capsules, ask your doctor about the possibility to go to the drug in the form of a solution or can carefully open the capsule and mix its contents with some food.

Use in children
For children weighing 30 kg or more, the usual starting dose is 30 to 40 mg twice daily (approximately 12 hours between each dose).
Children older than 3 months of age, weighing less than 30 kg, should receive 1 mg / kg twice daily. If you take more than the amount of Zerit
If you take more than the amount of capsules or if someone accidentally swallows the capsule, there is no immediate danger. However, seek advice from your doctor or nearest hospital.
If you forget to take Zerit
If you miss a dose, then simply take your normal dose when the time for the next intake. Do not take a double dose to make up for a missed dose.

If you stop taking Zerit
You should discuss with your doctor the decision to discontinue the use of Zerit.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4 POSSIBLE SIDE EFFECTS
Like all medicines, Zerit can cause side effects, although not everybody gets them.
In the treatment of HIV infection is not always possible to differentiate between unwanted effects caused by Zerit, and caused by other concomitant medications or complications of the infection. Therefore, it is important to tell your doctor about any changes in your health.
HIV treatment including stavudine often leads to changes in body shape due to fat redistribution. This may include loss of fat from legs, arms and face (lipoatrophy) and the development of fatty lumps in the neck ('buffalo hump'). Losing fat is not completely reversible after discontinuation of stavudine. This occurred more frequently in patients treated with Zerit, compared with other anti-HIV medicines. Your doctor should monitor you for any clinical signs or symptoms of change in body shape. Tell your doctor if you notice any changes in your body shape or loss of fat from legs, arms or face. If these signs should be given to discontinuation of Zerit.
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 10 users in 100
uncommon: affects 1 to 10 users in 1000
rare: affects 1 to 10 users in 10,000
very rare: affects less than 1 user in 10,000

Following adverse reactions in patients treated with Zerit:
common:
■ asimpromatichna hyperlactatemia (build up of lactic acid in the blood)
■ syndrome of lipoatrophy or lipodystrophy (changes in body shape due to 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
■ diarrhea, abdominal pain (pain or discomfort in the stomach)
■ rash, pruritus (itching)
■ fatigue (extreme tiredness)

Uncommon:
■ lactic acidosis (a buildup of lactic acid in the blood) in some cases associated with motor weakness (weakness in the arms and legs)
■ gynecomastia (enlarged breasts in men)
■ anorexia (loss of appetite), anxiety, emotional lability,
■ pancreatitis (inflammation of the pancreas), vomiting,
■ hepatitis (liver inflammation), jaundice (yellow coloring of the skin or eyes)
■ urticaria (itchy rash), arthralgia (joint pain)
■ myalgia (MUSCLE PAIN), asthenia (unusual tiredness or weakness) Rare
■ anemia
■ hyperglycemia (high blood sugar)
■ hepatic steatosis (fat accumulation in the liver) Very Rare
■ thrombocytopenia, neutropenia (a blood disorder)
■ diabetes
■ motor weakness (most often reported in terms of symptomatic hyperlactatemia or lactic acidosis syndrome)
■ hepatic failure
If any of the side effects gets serious, or if you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.

5 HOW TO STORE ZERIT?
Keep out of reach of children.
Do not use Zerit after the expiry date stated on the carton, the bottle label and / or blisters. The expiry date refers to the last day of that month.
Do not store above 25 ° C. (Aclar / aluminum blisters)
Keep at temperatures below 30 ° C. (Bottles HDPE) Store in the original container.
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.

6 FURTHER INFORMATION
What Zerit contains
- The active substance is stavudine (40 mg).
- The other ingredients of the powder contained in the hard capsule are lactose (240 mg), magnesium stearate, microcrystalline cellulose and sodium starch glycolate.
- The ingredients of the capsule are gelatin, iron oxide colorant (E172), silicon dioxide, sodium lauryl sulfate and titanium dioxide colorant (E171).
- The capsule shells using edible black ink containing shellac, propylene glycol, purified water, potassium hydroxide and iron oxide (E172).

Zerit looks like and contents of the pack
Zerit 40 mg hard capsules are dark orange marked with "BMS 1967" on one side and "40" on the other.
Zerit 40 mg hard capsules are supplied in blister packs of 56 hard capsules or bottles of 60 hard capsules. To protect the capsules from excessive moisture, the bottle includes a desiccant.