Nevirapine PL Recommended Text
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Recommended Text Nevirapine
PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE USER
{(Invented) name strength pharmaceutical form}
Nevirapine
Read all of this leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or health care provider or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
In this leaflet:
1.
What {product name} is and what it is used for
2.
Before you take {product name}
3.
How to take {product name}
4.
Possible side effects
5.
How to store {product name}
6.
Further information
1.
WHAT {PRODUCT NAME} IS AND WHAT IT IS USED FOR
{product name} belongs to a group of antiviral medicines also known as antiretrovirals, called nonnucleoside analogue reverse transcriptase inhibitors (NNRTIs). These are used to treat Human
Immunodeficiency Virus (HIV) infection.
{product name} is used in antiretroviral combination therapy for the treatment of HIV infection.
{product name} reduces the amount of HIV virus in your body, and keeps it at a low level. It also
increases CD4 cell counts. CD4 cells are a type of white blood cell, that play an important role in
maintaining a healthy immune system to help fight infection. Response to treatment with {product
name} varies between patients. Your doctor or health care provider will be monitoring the
effectiveness of your treatment.
{product name} may improve your condition, but it is not a cure for your HIV infection. HIV infection
is a disease spread by contact with blood or sexual contact with an infected individual. Treatment with
{product name} 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 your treatment, other infections linked to your weakened immunity (opportunistic infections)
may arise. These will require specific and sometimes preventive treatment.
2.
BEFORE YOU TAKE {PRODUCT NAME} {TABLETS}{CAPSULES}
Do not take {product name} if
- you are allergic (hypersensitive) to {active ingredient(s)} or any of the other ingredients of
{product name} (see section 6, What {product name} contains).
- you previously experienced hepatitis, severe skin rash, or liver injury while on <{product name}>
<nevirapine> treatment.
Take special care with {product name}
Before using this medicine, you should have told your doctor or health care provider if you suffer from
or have ever suffered from kidney or liver disease.
The first 18 weeks of treatment with {product name} is an important period for close surveillance for
the occurrence of severe and life threatening skin reactions and serious liver injuries! During this
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period the dosage of {product name} prescribed by your doctor or health care provider must be
strictly adhered to, especially during the first 14 days of treatment, the so called 'lead-in' period (see
section 3, How to take {product name}).
Skin reactions
{product name} can result in skin reactions and hypersensitivity reactions, which in the worst cases
can be serious and life-threatening and which have resulted in fatalities (see section 4, Possible Side
Effects). Hypersensitivity (allergic) reactions can occur in the form of rash accompanied by other side
effects such as fever, blistering, mouth sores, eye inflammation, facial swelling, general swelling,
muscle or joint aches, a reduction in white blood cells (granulocytopaenia), general feelings of illness
or severe problems with liver or kidneys.
If you ever have any rash symptoms, please inform your doctor or health care provider immediately,
who will advise you whether you should stop taking {product name} <tablets> <capsules>.
If you experience a severe rash or any rash associated with other side effects of a hypersensitivity
reaction, YOU MUST STOP TAKING {product name} and YOU MUST CONTACT your doctor or
health care provider IMMEDIATELY as such reactions can be potentially life-threatening.
Liver injuries
{product name} can result in liver toxicity, which in the worst cases can be serious and lifethreatening and has resulted in fatalities (see section 4, Possible side effects). Patients with reduced
liver function and patients with hepatitis B or C infection are at increased risk for severe and
potentially fatal liver damage while taking antiretroviral therapy in general, including {product name}.
Female gender and patients with higher CD4 cell counts at the start of {product name} therapy have
an increased risk of developing liver problems.
<Unless the benefit outweighs the risk, {product name} should not be started in women with CD4 cell
counts greater than 250 cells/mm3 or in man with CD4 cell counts greater than 400 cells/mm3.>
If you experience clinical symptoms suggesting an injury of the liver, such as loss of appetite, nausea,
vomiting, jaundice, you should discontinue taking {product name} and must contact your doctor or
health care provider immediately.
If you develop severe liver, skin or hypersensitivity reactions during treatment with {product name},
you must NEVER TAKE {product name} again before you told your doctor or health care
practitioner.
<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 or health care provider immediately.>
<Redistribution, accumulation or loss of body fat may occur in patients receiving combination
antiretroviral therapy. Contact your doctor or health care provider if you notice changes in body fat.>
You will need to take {product name} every day. This medicine helps to control your condition, but it
is not a cure for HIV infection. You may continue to develop other infections and other illnesses
associated with HIV disease. You should keep in regular contact with your doctor or health care
provider. Do not stop taking your medicine without first talking to your doctor or health care provider.
Taking other medicines
Please tell your doctor, health care provider or pharmacist if you are taking or have recently taken any
other medicines, including medicines obtained without a prescription. These may affect the action of
{product name}, or {product name} may affect their action.
Care should be taken to combine <{product name}> <nevirapine> with ketoconazole as nevirapine
decreases ketoconazole levels.
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Since rifampicin reduces the exposure to nevirapine it should not be taken together with <{product
name}> <nevirapine>.
<{product name}> <nevirapine> may decrease methadone in blood which can lead to withdrawal
symptoms. Please inform your doctor or health care provider who may adjust your methadone
medication.
Since {product name} <nevirapine> decreases the effect of oral contraceptives these should not be
used when you take {product name}. You should employ an alternative contraceptive method such as
barrier contraception (e.g. condoms).
Herbal preparations containing St John’s Wort may reduce the exposure to nevirapine and must
therefore not be taken together with <{product name}> <nevirapine>
Taking {product name} with food and drink
<{product name} may be taken with or without food.>
<product specific>
Pregnancy and
If you become pregnant, or are planning to become pregnant, you must contact your doctor or health
care provider to discuss the potential adverse effects and the benefits and risks of your antiretroviral
therapy to you and your child.
If you have taken {product name} during your pregnancy, your doctor or health care provider may
request regular visits to monitor the development of your child. Such visits may include blood tests
and other diagnostic tests.
In children whose mother took nucleoside and nucleotide analogues during pregnancy, the benefit
from the reduced chance of being infected with HIV is greater than the risk of suffering from side
effects.
Breast-feeding
Since nevirapine and the virus pass into breast milk it is recommended that HIV infected woman
taking {product name} do not breast-feed their infants under any circumstances in order to avoid
transmission of HIV.
Driving and using machines
No information on the effects of stavudine on the ability to drive and use machines is
available.
Important information about some of the ingredients of {product name}
<product specific>
3.
HOW TO TAKE {PRODUCT NAME}
Always take {product name} exactly as your doctor or health care provider has told you. You should
check with your doctor, health care provider or pharmacist if you are not sure.
The usual dosage is one 200 mg <tablet><capsule> for the first 14 days of treatment; this 'lead in'
period has been shown to lower the incidence of skin rash. From the third week of treatment on the
dosage is one 200 mg <tablet><capsule> twice daily.
{product name} <may be taken with or without food><product specific>.
If you stop taking {product name} <tablet><capsule> 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.
<{product name} will always be taken in combination with other antiretroviral medication; please
make sure to follow the instructions within the supplied package leaflet.>
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If you take more {product name} than you should
If you have taken too many <tablets><capsules> or if someone accidentally swallows some, there is
no immediate danger. However, you should contact your doctor, health care provider, or the nearest
hospital emergency department for further advice.
If you forget to take {product name}
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 forgotten individual doses.
If you stop taking {product name}
<product specific>
<If you have any further questions on the use of this product, ask your <doctor or health care provider
> <or> <pharmacist>.>
4.
POSSIBLE SIDE EFFECTS
Like all medicines, {product name} 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
{product name}, or those caused by any other medicines you may be taking at the same time, or by the
HIV disease. For this reason, it is important that you inform your doctor or health care provider of any
change in your health.
Short-term adverse reactions to combination antiretroviral therapy are common. After you start taking
{product name} rash, headache, nausea and vomiting, abdominal pain or cramps, diarrhoea, fatigue,
malaise, fever and muscle aches may occur. These reactions are usually mild and disappear within a
few weeks even if treatment is continued.
The most serious adverse reactions are severe and potentially life threatening skin reactions (StevensJohnson syndrome and toxic epidermal necrolysis), serious hepatitis / hepatic failure and
hypersensitivity reactions. They are characterized by rash with constitutional symptoms such as fever,
joint pain, muscle aches and increased size of lymph nodes, plus visceral involvement, such as
hepatitis, eosinophilia, decrease of white blood cells and renal dysfunction. The first 18 weeks of
treatment is a critical period, which requires close monitoring. Most cases of severe rash occur in the
first 6 weeks of treatment.
Commonly reported (greater than 1 in every 100 patients treated) side effects are rash, allergic
reactions, muscle pain, headache, nausea, liver function test abnormalities and hepatitis
The following side effects are uncommon (between 1 in 1,000 and 1 in 100 patients treated):
abdominal pain, jaundice, Steven-Johnson syndrome, hives, fatigue and fever.
There are rare reports (between 1 in 10,000 to 1 in 1,000 patients treated) of decreased white and red
blood cells, hypersensitivity and anaphylaxis (characterised by rash, facial swelling, bronchial spasm
or shock), diarrhoea, liver failure and sudden, rapid very serious hepatitis, toxic epidermal necrolysis
and angioedema (swelling of skin)
The major side effects of {product name} <nevirapine> are severe and life threatening skin reactions
and serious liver injuries. These reactions occur mainly in the first 18 weeks of treatment with
{product name} <nevirapine>. This is therefore an important period which requires close surveillance
(see also section 2, ‘Before you take <product name.’).
< Combination antiretroviral therapy may cause a condition called lactic acidosis, which is a build up
of lactic acid in the body, that can cause dehydration and coma have been reported on rare occasions
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in patients taking NRTIs . Deep, rapid breathing, drowsiness, and non specific symptoms such as
nausea, vomiting and stomach pain, may indicate the development of lactic acidosis. >
<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.>
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor, health care provider or pharmacist.
5.
HOW TO STORE {PRODUCT NAME}
[For storage conditions statements see Appendix III]
Keep out of the reach and sight of children.
<Do not store above ºC>. <Store in the original <container><carton>>
Do not use {product name} after the expiry date which is stated on the <label> <carton> <bottle> <...>
<after {abbreviation used for expiry date}.> <The expiry date refers to the last day of that month.>
<Do not use {product name} if you notice {description of the visible signs of deterioration}.>
<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 {product name} contains
The active ingredient(s) is (are)…
The other ingredient(s) is (are)... <product specific>
What {product name} looks like and contents of the pack
<product specific>
Prequalification Holder and Manufacturer
{Name and address}
<{tel}>
<{fax}>
<{e-mail}>
For any information about this medicinal product, please contact the local representative of the
Prequalification Holder:
{COUNTRY}
{Name}
<{Address}
{Town} {Postal code} – Country>
Tel: + {Telephone number}
<{e-mail}>
June 2006
{COUNTRY}
{Name}
<{Address}
{Town} {Postal code} – Country>
Tel: + {Telephone number}
<{e-mail}>
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This leaflet was last approved in {MM/YYYY}.
Detailed information on this medicine is available on the World Health Organization (WHO) web site:
http://mednet3.who.int/prequal/ .
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