Patient Medication Information: uses, side effects, how to take - Teva-Nevirapine
ABOUT THIS MEDICATION
What the medication is used for:
TEVA-NEVIRAPINE is a medicine used to treat Human Immunodeficiency Virus (HIV) infection, the virus that causes AIDS (Acquired Immune Deficiency Syndrome).
TEVA-NEVIRAPINE does not cure HIV or AIDS, and it is not known if it will help you live longer with HIV. People taking TEVA-NEVIRAPINE may still get infections common in people with HIV (opportunistic infections). Therefore, it is very important that you stay under the care of your doctor.
What it does:
TEVA-NEVIRAPINE is a type of anti-HIV medicine called a "non-nucleoside reverse transcriptase inhibitor" (NNRTI). It works by lowering the amount of HIV in the blood ("viral load"). You must take TEVA-NEVIRAPINE with other anti-HIV medicines. When taken with other anti-HIV medicines, TEVA-NEVIRAPINE can reduce viral load and increase the number of CD4 cells ("T cells"). CD4 cells are a type of immune helper cell in the blood. TEVA-NEVIRAPINE may not have these effects in every patient.
TEVA-NEVIRAPINE is not a cure for HIV infection.
When it should not be used:
- If you are allergic (hypersensitive) to nevirapine or its components (see What the non-medicinal ingredients are).
- If you have a severe liver problem.
- If you have rare hereditary conditions of galactosemia, galactose intolerance, glucose/galactose malabsorption, Lapp lactase deficiency, as this product contains lactose.
- If you are allergic (hypersensitive) to nevirapine or its components (see What the non-medicinal ingredients are) or have used TEVA- NEVIRAPINE and had a severe rash with associated symptoms such as malaise, fatigue, muscle/joint aches, blisters, facial edema (facial swelling), oral lesions, conjunctivitis, and/or hepatitis, eosinophilia (a lot of white blood cells called eosinophils in the blood), granulocytopenia (a decrease in white blood cells called granulocytes in the blood), lymphadenopathy (swelling of the lymph nodes), and renal dysfunction (kidneys not working properly), you must permanently discontinue TEVA-NEVIRAPINE and seek medical evaluation immediately (see WARNINGS AND PRECAUTIONS).
- Do not take TEVA-NEVIRAPINE with St. John’s wort (Hypericum perforatum) as it will reduce nevirapine blood levels.
- Do not take TEVA-NEVIRAPINE with St. John’s wort (Hypericum perforatum) as it will reduce nevirapine blood levels.
What the medicinal ingredient is:
TEVA-NEVIRAPINE tablets contain the active ingredient nevirapine.
What the non-medicinal ingredients are:
Non-medicinal Ingredients (in alphabetical order): Cellulose microcrystalline, lactose monohydrate, magnesium stearate, povidone, silica colloidal anhydrous and sodium starch glycolate.
What dosage forms it comes in:
TEVA-NEVIRAPINE (nevirapine) comes as a tablet containing 200 mg of nevirapine.
WARNINGS AND PRECAUTIONS
| Severe, life-threatening, and in some cases fatal liver toxicity, particularly in the first 18 weeks, has been reported in patients treated with nevirapine, including pregnant women receiving chronic nevirapine therapy in conjunction with other antiretroviral medication. Female gender and higher CD4 counts at the start of therapy may increase the risk of liver problems (see SIDE EFFECTS AND WHAT TO |
DO ABOUT THEM). Severe skin and allergic reactions, including fatal cases have occurred with accompanying symptoms such as severe rash with fever, fatigue, muscle/joint pain, swelling of the face, hepatitis (liver inflammation), blood and kidney problems. If this occurs, discontinue TEVA-NEVIRAPINE and contact your doctor immediately. |
In rare cases liver problems have led to liver failure and can lead to a liver transplant or death. Therefore, if you develop any of the following symptoms of liver problems, stop taking TEVA- NEVIRAPINE and call your doctor right away:
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Your doctor should check you and do blood tests often to check your liver function during the first 18 weeks of therapy. Checks for liver problems should continue regularly during treatment with TEVA-NEVIRAPINE.
Skin Reactions
Skin rash is the most common side effect of TEVA-NEVIRAPINE. Most rashes occur in the first 6 weeks of treatment. In a small number of patients, rash can be serious and result in death. Therefore, if you develop a rash with any of the following symptoms, stop using TEVA-NEVIRAPINE and call your doctor right away:
- general ill feeling or “flu- like” symptoms
- blisters
- fever
- mouth sores
- muscle or joint aches
- swelling of your face
- conjunctivitis (red or inflamed eyes, like “pink- eye”)
- tiredness
- any symptoms of liver problems discussed above
If your doctor tells you to stop treatment with TEVA-NEVIRAPINE because you have experienced the serious liver or skin reactions described above, never take TEVA-NEVIRAPINE again.
These are not all the side effects of TEVA-NEVIRAPINE. See the section SIDE EFFECTS AND WHAT TO DO ABOUT THEM for more information. Tell your doctor if you have any side effects from TEVA-NEVIRAPINE.
BEFORE you use TEVA-NEVIRAPINE, talk to your doctor or pharmacist:
- If you have or have had any diseases of the liver particularly hepatitis B or C infection;
If you are pregnant or intend to become pregnant;
- If you are a breast-feeding mother. It is recommended that HIV infected women not breast-feed, to avoid transmission of the virus to the infant;
- If you are taking any medications, including prescription, non-prescription, herbal or homeopathic remedies;
- If you have any allergies to foods or drugs;
- If you are undergoing dialysis.
INTERACTIONS WITH THIS MEDICATION
Drugs that may interact with TEVA-NEVIRAPINE include:
TEVA-NEVIRAPINE may change the effect of other medicines, and other medicines can change the effect of TEVA-NEVIRAPINE. Tell your doctors and pharmacists about all medicines you take, including non-prescription medicines, vitamins and herbal supplements.
Do not take ketoconazole, rifampin or efavirenz, delavirdine, etravirine, rilpivirine, elvitegravir (in combination with cobicistat) or boceprevir with TEVA-NEVIRAPINE.
Tell your doctor if you take clarithromycin, fluconazole, methadone, rifabutin, indinavir, lopinavir/ritonavir combination, saquinavir or itraconazole.
TEVA-NEVIRAPINE may not be right for you, or you may need careful monitoring.
You should be aware that TEVA-NEVIRAPINE may change the effectiveness of oral contraceptives. Therefore oral contraceptives and other hormonal methods of birth control should not be used as a method of contraception in women taking TEVA-NEVIRAPINE; other methods (barrier) must be used.
PROPER USE OF THIS MEDICATION
Usual dose:
Adult:
Follow the directions exactly as given to you by your doctor or pharmacist regarding the amount and frequency of dosing. The label will usually tell you this information as well. If you are not sure about dosing, ask your doctor or pharmacist.
As a general guide, swallow one tablet (200 mg) once a day for the first 14 days (this lead-in period should be used because it has been found to lessen the frequency of rash) followed by one 200 mg tablet twice daily as part of a multi-drug treatment program. TEVA-NEVIRAPINE tablets can be taken with or without food.
It is important to strictly follow the once daily dose for the first 14 days. Do not start taking TEVA-NEVIRAPINE twice a day if you have any symptoms of liver problems or skin rash (see SIDE EFFECTS AND WHAT TO DO ABOUT THEM). The manufacturer’s recommended dosage and monitoring for the other administered anti-retroviral drugs should be followed.
Overdose:
| In case of drug overdosage, contact a healthcare practitioner (e.g. doctor), hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. |
Missed dose:
If you miss a dose: If you forget to take your medicine, take it as soon as you remember. Then continue as before; do not double your next dosage.
If it is almost time for your next dose, do not take the missed dose. Instead, follow your regular dosing schedule by taking the next dose at its regular time.
If you stop taking TEVA-NEVIRAPINE for more than 7 days, ask your doctor how much to take before you start taking it again. You may need to start with once-a-day dosing.
Avoid doing things that can spread HIV infection, as TEVA-NEVIRAPINE does not stop you from passing HIV infection to others. Do not share needles, other injection equipment or personal items that can have blood or body fluids on them, like toothbrushes and razor blades. Always practice safe sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood.
This medicine is for you. Never give it to someone else, as it may harm them even if their symptoms are the same as yours.
Take your medications exactly as prescribed by your doctor. Do not change the dose without consulting your doctor.
Do not take any other medication including prescription, non-prescription, herbal or homeopathic remedies without your doctor’s advice. Also, inform any other doctor, dentist or pharmacist you consult that you are taking this medication.
Keep out of reach of children.
If you have any other questions about TEVA-NEVIRAPINE, contact your doctor or pharmacist.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
TEVA-NEVIRAPINE can cause serious liver damage and skin reactions that can cause death. Any patients can experience such side effects, but some patients are more at risk than others. See WARNINGS AND PRECAUTIONS.
Other common side effects of TEVA-NEVIRAPINE include nausea, fatigue, fever, headache, vomiting, diarrhea, abdominal pain, skin rash and itching, myalgia (muscle pain) and arthralgia (joint pain). This list of side effects is not complete. Ask your doctor or pharmacist for more information.
Abnormal liver function test results, decrease in red blood cells or white blood cells called granulocytes, decrease in blood phosphorus, increase in blood pressure and hypersensitivity including severe allergic reaction with facial swelling may also occur.
If you feel unwell in any other way or have any symptoms that you do not understand, you should contact your doctor immediately.
Sleepiness can occur. Do not drive or operate machinery if you become drowsy.
Always tell your doctor or pharmacist about any undesirable effects you experience after taking TEVA-NEVIRAPINE, even those not mentioned above.
Changes in body fat have been seen in some patients taking antiretroviral therapy. These changes may include increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the trunk. Loss of fat from the legs, arms and face may also happen. The cause and long-term health effects of these conditions are not known at this time.
Consult your doctor immediately if you experience any symptoms as listed above, or any symptoms that you do not understand.
This is not a complete list of side effects. For any unexpected effects while taking TEVA-NEVIRAPINE, contact your doctor or pharmacist.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist |
| Only if severe | In all cases | |
| Uncommon | ||
Severe liver disease with symptoms such as nausea, abdominal pain, aches, tiredness, lack of appetite, dark urine, pale stools (bowel movement) , yellowing of skin and eyes, and a general ill feeling or “flu-like” symptoms. T Severe skin reactions such as rash, blistering accompanied by symptoms such as fever, muscle/joint pain, tiredness, mouth sores, swelling of the face, conjunctivitis, and a general ill feeling or “flu-like” symptoms. | ||
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HOW TO STORE IT
Store TEVA-NEVIRAPINE tablets at normal room temperature (between 15°C and 30°C). As with all medicines, keep TEVA-NEVIRAPINE tightly closed and out of the reach of children. Do not take your medicine after the expiry date shown on the container.
, HFTEN THEAND
REPORTING SIDE EFFECTS
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information. 3 ways to report:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found by contacting Teva Canada Limited at:
1-800-268-4127 ext. 1255005 (English);
or 1-877-777-9117 (French)
or druginfo@tevacanada.com
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9