STAVUDINE-40MG+LAMIVUDINE-150MG+NEVIRAPINE-200MG
STAVUDINE
| Information for patients |
| Drug Information |
Stavudine 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 Stavudine varies between patients. Your doctor will therefore be monitoring the effectiveness of your treatment. Stavudine may improve your condition, but it is not a cure for your HIV infection. Treatment with Stavudine 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. |
| Drug Alert |
| Alert |
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| Before Consuming the Medicine |
| Avoid Drug |
If you are allergic (hypersensitive) to stavudine or any of the other ingredients of Stavudine. Contact your doctor or pharmacist for advice. |
| Drug Special Care |
Before treatment with Stavudine, 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 Stavudine 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 Stavudine. 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 Stavudine 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. |
| Drug Drug Interactions |
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 Stavudine in combination with other antiretroviral treatment. If you have taken Stavudine 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. |
| Drug Pregnancy Interaction |
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 Stavudine in combination with other antiretroviral treatment. If you have taken Stavudine 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. |
| Drug Breast feeding Interaction |
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. |
| Drug Machinery Interaction |
Stavudine may cause dizziness and drowsiness. If you are affected, do not drive and do not use any tools or machines. |
| Drug More Information |
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 Stavudine in combination with other antiretroviral treatment. If you have taken Stavudine 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. |
| How to take the Medicine |
| Consumption Info |
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| Drug quanitty |
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, Stavudine 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. |
| Drug Dose |
Always take Stavudine 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. |
| Excess Drug Consumption |
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. |
| Forgot Drug Consumption |
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. |
| Stop Drug Consumption |
The decision to stop using Stavudine 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 |
| General Information |
Like all medicines, Stavudine 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 Stavudine, 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 Stavudine 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 STAVUDINE treatment. |
| Common Drug Side Effects |
?? 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) |
| Rare Drug Side Effects |
?? anemia ?? hyperglycaemia (high sugar levels in the blood) ?? hepatic steatosis (fat in the liver) |
| Very Rare Drug Side Effects |
?? thrombocytopenia, neutropenia (blood disorders) ?? diabetes mellitis ?? motor weakness (most often reported in the setting of symptomatic hyperlacetatemia or lactic acidosis syndrome) ?? liver failure |
| Drug Side Effects Symptoms |
?? anemia ?? hyperglycaemia (high sugar levels in the blood) ?? hepatic steatosis (fat in the liver) |
| How to Store the Medicine |
| How to Store the Medicine |
Keep out of the reach and sight of children. Do not use Stavudine 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. Store below 25°C (aclar/alu blisters) Do not store above 30°C. (HDPE bottles) Store in the original package. 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. |
LAMIVUDINE
| Information for patients |
| Drug Information |
The active ingredient in Lamivudine is lamivudine. Lamivudine is a type of medicine known as an anti-retroviral.It belongs to a group of medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs).Lamivudine 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.Not everyone responds to treatment with Lamivudine in the same way. Your doctor will monitor the effectiveness of your treatment. |
| Drug Alert |
| Alert |
•if you’re allergic (hypersensitive) to lamivudine . |
| Before Consuming the Medicine |
| Avoid Drug |
•if you’re allergic (hypersensitive) to lamivudine . |
| Drug Special Care |
Some people taking Lamivudine or other combination treatments for HIV are more at risk of serious side effects. You need to be aware of the extra risks: • if you have ever had liver disease, including hepatitis B or C (if you have hepatitis B infection,don’t stop Lamivudine without your doctor’s advice, as your hepatitis may come back) •if you’re seriously overweight (especially if you’re a woman) •if you’re diabetic and using insulin. •if you or your child has a kidney problem, your dose may be altered. Talk to your doctor if any of these apply to you. You may need extra check-ups, including blood tests, while you’re taking your medicine. See Section 4 for more information. Look out for important symptoms Some people taking medicines for HIV infection develop other conditions, which can be serious. You need to know about important signs and symptoms to look out for while you’re taking Lamivudine. Protect other people HIV infection is spread by sexual contact with someone who has the infection, or by transfer of infected blood (for example, by sharing injection needles). Lamivudine will not stop you passing HIV infection on to other people. To protect other people from becoming infected with HIV: •Use a condom when you have oral or penetrative sex. •Don’t risk blood transfer — for example, don’t share needles |
| Drug Drug Interactions |
Tell your doctor or pharmacist if you’re taking any other medicines, or if you’ve taken any recently, including herbal medicines or other medicines you bought without a prescription.Remember to tell your doctor or pharmacist if you begin taking a new medicine while you’re taking Lamivudine. These medicines should not be used with Lamivudine: •other medicines containing lamivudine, (used to treat HIV infection or hepatitis B infection) •emtricitabine (used to treat HIV infection) •high doses of co-trimoxazole, an antibiotic. |
| Drug Pregnancy Interaction |
If you are pregnant, if you become pregnant, or are planning to become pregnant, talk to your doctor about the risks and benefits and risks to you and your baby of taking Lamivudine.Lamivudine and similar medicines may cause side effects in unborn babies. If you become pregnant while you’re taking Lamivudine, your baby may be given extra check-ups (including blood tests) to make sure it is developing normally.Children whose mothers took NRTIs (medicines like Lamivudine) during pregnancy had a reduced risk of being infected with HIV. This benefit is greater than the risk of having side effects |
| Drug Breast feeding Interaction |
Women who are HIV-positive must not breast-feed, because HIV infection can be passed on to the baby in breast milk. If you’re breast-feeding, or thinking about breast-feeding |
| Drug Machinery Interaction |
Lamivudine is unlikely to affect your ability to drive or use machines. |
| Drug More Information |
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| How to take the Medicine |
| Consumption Info |
If you are a diabetic, please note that each dose (150 mg = 15 ml) contains 3 g sugar. Lamivudine contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Lamivudine. Sucrose may be harmful to the teeth. Lamivudine also contains preservatives (parahydroxybenzoates) which may cause allergic reactions (possibly delayed). |
| Drug quanitty |
Adults and adolescents over 12 years of age The usual dose of Lamivudine is 30 ml a day (300 mg) to be taken as 15 ml (150 mg) twice a day at regular times, leaving approximately 12 hours between each dose. Children 3 months to 12 years of age The usual dose of Lamivudine is 4 mg/kg twice daily up to a maximum of 300 mg daily. Give each dose to your child at regular times, leaving approximately 12 hours between each dose.Use the oral dosing syringe supplied with the pack to measure your dose accurately |
| Drug Dose |
1Remove the bottle cap. Keep it safely 2Hold the bottle firmly. Push the plastic adapter into the neck of the bottle. 3Insert the syringe firmly into the adapter. 4Turn the bottle upside down. 5Pull out syringe plunger until the syringe contains the first part of your full dose. 6Turn the bottle the correct way up. Remove the syringe from the adapter. 7Put the syringe into your mouth, placing the tip of the syringe against the inside of your cheek. Slowly push the plunger in, allowing time to swallow. Don’t push too hard and squirt the liquid into the back of your throat or you may choke. 8.Repeat steps 3 to 7 in the same way until you have taken your whole dose. For example, if your dose is 15 ml, you need to take one and a half syringe-fulls of medicine. 9Take the syringe out of the bottle and wash it thoroughly in clean water. Let it dry completely before you use it again. 10Close the bottle tightly with the cap, leaving the adaptor in place. Always take Lamivudine exactly as your doctor has told you to. Check with your doctor or pharmacist if you’re not sure. Lamivudine can be taken with or without food. Stay in regular contact with your doctor Lamivudine helps to control your condition. You need to keep taking it every day to stop your illness getting worse. You may still develop other infections and illnesses linked to HIV infection.Keep in touch with your doctor, and don’t stop taking Lamivudine without your doctor’s advice. |
| Excess Drug Consumption |
Accidentally taking too much Lamivudine is unlikely to cause any serious problems. If you take too much, tell your doctor or your pharmacist, or contact your nearest hospital emergency department for further advice. |
| Forgot Drug Consumption |
If you forget to take a dose, take it as soon as you remember. Then continue your treatment as before.Don’t take a double dose to make up for a missed dose. |
| Stop Drug Consumption |
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| Possible Side Effects |
| General Information |
When you’re being treated for HIV, it can be hard to tell whether a symptom is a side effect of Lamivudine or other medicines you are taking, or an effect of the HIV disease itself. So it is very important to talk to your doctor about any changes in your health.As well as the side effects listed below for Lamivudine, other conditions can develop during combination therapy for HIV. |
| Common Drug Side Effects |
•headache •feeling sick (nausea) •being sick (vomiting) •diarrhoea •stomach pains •tiredness, lack of energy •fever (high temperature) •general feeling of being unwell •muscle pain and discomfort •joint pain •difficulty in sleeping (insomnia) •cough •irritated or runny nose •rash •hair loss (alopecia). |
| Rare Drug Side Effects |
•a decrease in the number of cells involved in blood clotting (thrombocytopenia) •a low red blood cell count (anaemia) or low white blood cell count (neutropenia) •an increase in the level of liver enzymes |
| Very Rare Drug Side Effects |
serious allergic reaction causing swelling of the face, tongue or throat which may cause difficulty in swallowing or breathing lactic acidosis •inflammation of the pancreas (pancreatitis) •breakdown of muscle tissue •liver disorders, such as jaundice, enlarged liver or fatty liver, inflammation (hepatitis). A rare side effect that may show up in blood tests is: •increase in an enzyme called amylase tingling or numbness of the arms, legs, hands or feet. A very rare side effect that may show up in blood tests is •a failure of the bone marrow to produce new red blood cells (pure red cell aplasia). |
| Drug Side Effects Symptoms |
Tell your doctor or pharmacist if any of the side effects gets severe or troublesome, or if you notice any side effects not listed in this leaflet. Other possible side effects of combination therapy for HIV Combination therapy such as Lamivudine may cause other conditions to develop during HIV treatment. Old infections may flare up People with advanced HIV infection (AIDS) have weak immune systems, and are more likely to develop serious infections (opportunistic infections). When these people start treatment, they may find that old, hidden infections flare up, causing signs and symptoms of inflammation. These symptoms are probably caused by the body’s immune system becoming stronger, so that the body starts to fight these infections. If you get any symptoms of infection while you’re taking Lamivudine: Tell your doctor immediately. Don’t take other medicines for the infection without your doctor’s advice. Your body shape may change People taking combination therapy for HIV may find that their body shape changes, because of changes in fat distribution: •Fat may be lost from the legs, arms or face. •Extra fat may build up around the tummy (abdomen), or on the breasts or internal organs. •Fatty lumps (sometimes called buffalo hump) may appear on the back of the neck. It is not yet known what causes these changes, or whether they have any long-term effects on your health. If you notice changes in your body shape: Tell your doctor. Lactic acidosis is a rare but serious side effect Some people taking Lamivudine, or other medicines like it (NRTIs), develop a condition called lactic acidosis, together with an enlarged liver. Lactic acidosis is caused by a build-up of lactic acid in the body. It is rare; if it happens, it usually develops after a few months of treatment. It can be life-threatening, causing failure of internal organs. Lactic acidosis is more likely to develop in people who have liver disease, or in obese (very overweight) people, especially women. Signs of lactic acidosis include: •deep, rapid, difficult breathing •drowsiness •numbness or weakness in the limbs •feeling sick (nausea), being sick (vomiting) •stomach pain. During your treatment, your doctor will monitor you for signs of lactic acidosis. If you have any of the symptoms listed above, or any other symptoms that worry you: See your doctor as soon as possible. You may have problems with your bones Some people taking combination therapy for HIV develop 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 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. Signs of osteonecrosis include: •stiffness in the joints •aches and pains (especially in the hip, knee or shoulder) •difficulty moving. If you notice any of these symptoms: Tell your doctor. Other effects may show up in blood tests Combination therapy for HIV can also cause: •increased levels of lactic acid in the blood, which on rare occasions can lead to lactic acidosis •increased levels of sugar and fats (triglycerides and cholesterol) in the blood resistance to insulin (so if you’re diabetic, you may have to change your insulin dose to control your blood sugar). |
| How to Store the Medicine |
| How to Store the Medicine |
Keep out of the reach and sight of children Do not take Lamivudine after the expiry date shown on the container. Discard one month after first opening.Do not store above 25oC. If you have any unwanted Lamivudine, don’t dispose of it in your waste water or your household rubbish.Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment |
NEVIRAPINE
| Information for patients |
| Drug Information |
NEVIRAPINE belongs to a group of medicines called antiretrovirals, used in the treatment of Human Immunodeficiency Virus (HIV-1) infection. The active ingredient of your medicine is called nevirapine. The active ingredient is the substance in this medicine that reduces the amount of viruses in the blood thus improving your medical condition. Nevirapine belongs to a class of anti-HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs). Reverse transcriptase is an enzyme that HIV needs in order to multiply. Nevirapine stops reverse transcriptase from working. By stopping reverse transcriptase from working, NEVIRAPINE helps control HIV-1 infection. You must take NEVIRAPINE together with other antiretroviral medicines. Your doctor will recommend the best medicines for you. |
| Drug Alert |
| Alert |
- if you are allergic (hypersensitive) to nevirapine or any of the other ingredients of NEVIRAPINE. See Section 6 of this leaflet for a list of other ingredients (“What NEVIRAPINE contains”). - if you have taken NEVIRAPINE before and had to stop the treatment because you suffered from: - severe skin rash |
| Before Consuming the Medicine |
| Avoid Drug |
- if you are allergic (hypersensitive) to nevirapine or any of the other ingredients of NEVIRAPINE. See Section 6 of this leaflet for a list of other ingredients (“What NEVIRAPINE contains”). - if you have taken NEVIRAPINE before and had to stop the treatment because you suffered from: - severe skin rash - skin rash with other symptoms for example: - fever - blistering - mouth sores - inflammation of the eye - swelling of the face - general swelling - shortness of breath - muscle or joint pain - general feelings of illness - abdominal pain - hypersensitivity (allergic) reactions - inflammation of the liver (hepatitis) - if you have severe liver disease - if you have had to stop NEVIRAPINE treatment in the past because of changes in your liver function - if you are taking a medicine containing the herbal substance St John’s Wort (Hypericum perforatum). This herbal substance may stop NEVIRAPINE from working properly. |
| Drug Special Care |
During the first 18weeks of treatment with NEVIRAPINE It is very important that you and your doctor watchout For signs of liver or skin reactions.These can be come Severe and even life threatening.You are at greatest risk Of such areation during the first 6weeks of treatment. If you experience sever erashor hypersensitivity (allergic reactions that may appear in the form of rash) accompanied by other sideeffects such as - fever, - blistering, - mouthsores, - inflammation of the eye, - swelling of the face, - general swelling, - shortness of breath, - muscle or jointpain, - general feelings of illness, - or abdominal pain YOU SHOULD DISCONTINUE TAKING NEVIRAPINEAND YOU MUST CONTACT your doctor IMMEDIATELY as such reaction scan be potentially life-threatening or leadtodeath. If you ever have only mild rash symptoms without Any other reaction please inform your doctor immediately,who will advise you whether you should stoptaking NEVIRAPINE. |
| Drug Drug Interactions |
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Inform your doctor about all other medicines you are taking before you start taking NEVIRAPINE. Your doctor might need to monitor whether your other medicines are still working and adjust doses. Carefully read the package leaflet of all other HIV medicinal products you are taking in combination with NEVIRAPINE. It is particularly important that you tell your doctor if you are taking or have recently taken: - St John’s Wort (Hypericum perforatum, medicine to treat depression) - rifampicin (medicine to treat tuberculosis) - rifabutin (medicine to treat tuberculosis) - macrolides e.g. clarithromycin (medicine to treat bacterial infections) - fluconazole (medicine to treat fungal infections) - ketoconazole (medicine to treat fungal infections) - itraconazole (medicine to treat fungal infections) - methadone (medicine used for treatment of opiate addicts) - warfarin (medicine to reduce blood clotting) - hormonal contraceptives (e.g. the “pill”) - atazanavir (another medicine to treat HIV-infection) - lopinavir/ritonavir (another medicine to treat HIV-infection) - fosamprenavir (another medicine to treat HIV-infection) - efavirenz (another medicine to treat HIV-infection) Your doctor will carefully monitor the effect of NEVIRAPINE and any of these medicines if you are taking them together. If you are undergoing kidney dialysis, your doctor may consider a dose adjustment of NEVIRAPINE. This is because NEVIRAPINE can be partly washed out of your blood by dialysis |
| Drug Pregnancy Interaction |
Ask your doctor or pharmacist for advice before taking any medicine. |
| Drug Breast feeding Interaction |
You should stop breast-feeding if you are taking NEVIRAPINE. It is in general recommended that you do not breast-feed if you have HIV infection because it is possible that your baby can become infected with HIV through your breast milk |
| Drug Machinery Interaction |
There are no specific studies on the ability to drive vehicles and use machinery. If you feel that your ability to drive or use machines may be affected you should not drive or use machines. |
| Drug More Information |
NEVIRAPINE tablets contain lactose (milk sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking NEVIRAPINE |
| How to take the Medicine |
| Consumption Info |
If you experience symptoms suggesting damage of The liver,such as - lossofappetite, - feelingsick(nausea), - vomiting, - yellowskin(jaundice), - abdominalpain youshoulddiscontinuetakingNEVIRAPINEandmust contactyourdoctorimmediately. If you develop severe liver, skin or hypersensitivity Reactions whilst taking NEVIRAPINE ,NEVER TAKE NEVIRAPINE again without referring to your doctor. You must take the dosage of Nevirapine as prescribed By your doctor. This is especially important within The first 14 days of treatment (see more information in“How to take NEVIRAPINE”). Taking NEVIRAPINE with food and drink There are no restrictions on taking NEVIRAPINE with food and drink |
| Drug quanitty |
The dose is one 200 mg tablet per day for the first 14 days of treatment (“lead-in” period). After 14 days, the usual dose is one 200 mg tablet twice a day. It is very important that you take only one NEVIRAPINE tablet a day for the first 14 days (“lead-in” period). If you have any rash during this period, do not increase the dose but consult your doctor. The 14-day ”lead-in” period has been shown to lower the risk of skin rash |
| Drug Dose |
You should not use NEVIRAPINE on its own. You must take it with at least two other antiretroviral medicines. Your doctor will recommend the best medicines for you Always take NEVIRAPINE exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Only take NEVIRAPINE tablets by mouth. Do not chew your tablets. You may take NEVIRAPINE with or without food.As NEVIRAPINE must always be taken together with other HIV antiretroviral medicines, you should follow the instructions for your other medicines carefully. These are supplied in the package leaflets for those medicines. NEVIRAPINE is also available in liquid form as an oral suspension. This is particularly suitable if: - you have problems swallowing tablets - or you are a child weighing less than 50 kg - or you are a child having a body surface area less than 1.25 square metres (your doctor will work out your surface area). You should continue to take NEVIRAPINE for as long as instructed by your doctor. As explained in ‘Take special care with NEVIRAPINE’, above, your doctor will monitor you with liver tests or for undesirable effects such as rash. Depending on the outcome your doctor may decide to interrupt or stop your NEVIRAPINE treatment. Your doctor might then decide to restart you on a lower dose. |
| Excess Drug Consumption |
Do not take more Nevirapine than prescribed by your doctor and described in this leaflet. There is at present little information on the effects of .Nevirapine overdose. Consult your doctor if you have taken more .Nevirapine than you should. |
| Forgot Drug Consumption |
Try not to miss a dose. If you notice that you have missed a dose within 8 hours, take the next dose as soon as possible. If you notice it more than 8 hours later, take the next dose at the usual time. |
| Stop Drug Consumption |
Taking all doses at the appropriate times: - greatly increases the effectiveness of your combination antiretroviral medicines - reduces the chances of your HIV infection becoming resistant to your antiretroviral medicines. It is important that you continue taking .nevirapine correctly, as described above, unless your doctor instructs you to stop. If you stop taking .nevirapine for more than 7 days your doctor will instruct you to start the 14 day ‘lead-in’ period (described above) once again, before returning to the twice daily dose. If you have any further questions on the use of this product, ask your doctor or pharmacist |
| Possible Side Effects |
| General Information |
loss of appetite - feeling sick (nausea) - vomiting - yellow skin (jaundice) - abdominal pain |
| Common Drug Side Effects |
- decreased numbers of white blood cells (granulocytopenia) - allergic reactions (hypersensitivity) - headache - feeling sick (nausea) - vomiting - abdominal pain - loose stools (diarrhoea) - inflammation of the liver (hepatitis) - muscle pain (myalgia) - feeling tired (fatigue) - fever - abnormal liver function tests |
| Rare Drug Side Effects |
sudden and intense inflammation of the liver |
| Very Rare Drug Side Effects |
- drug rash with systemic symptoms (drug rash with eosinophilia and systemic symptoms) - allergic reaction characterized by rash, swelling of the face, difficulty breathing (bronchial spasm) or anaphylactic shock - decreased numbers of red blood cells (anaemia) - yellow skin (jaundice) - severe and life-threatening skin rashes (Stevens- Johnson syndrome/toxic epidermal necrolysis) - hives (urticaria) - fluid under the skin (angioedema) - joint pain (arthralgia) |
| Drug Side Effects Symptoms |
rash Abnormal liver functioning has been reported with the use of NEVIRAPINE. This includes some cases of inflammation of the liver (hepatitis), which can be sudden and intense (fulminant hepatitis), and liver failure, which can be both fatal. Combination antiretroviral therapy may cause changes in body shape due to changes in fat distribution. These may include loss of fat from legs, arms and face, increased fat in the abdomen (belly) and other internal organs, breast enlargement and fatty lumps on the back of the neck (‘buffalo hump’). The cause and long-term health effects of these conditions are not known at this time. Combination antiretroviral therapy may also cause raised lactic acid and sugar in the blood, hyperlipaemia (increased fats in the blood) and resistance to insulin. The following events have also been reported when NEVIRAPINE has been used in combination with other antiretroviral agents: - decreased numbers of red blood cells or platelets - inflammation of the pancreas - decrease in or abnormal skin sensations These events are commonly associated with other antiretroviral agents and may be expected to occur when NEVIRAPINE is used in combination with other agents; however, it is unlikely that these events are due to treatment with NEVIRAPINE. Use in children A reduction in white blood cells (granulocytopenia) can occur, which is more common in children. A reduction in red blood cells (anaemia), which may be related to nevirapine therapy, is also more commonly observed in children. As with rash symptoms, please inform your doctor of any side effects. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. |
| How to Store the Medicine |
| How to Store the Medicine |
Keep out of the reach and sight of children. Do not use .nevirapine after the expiry date which is stated on the carton and on the blister after “EXP”. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions. 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. |
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