| 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. |
Sign In
Create New Account