Consumer Medicine Information
What is in this leaflet
- What Nevipin is used for
- Before you take Nevipin
– When you must not take it
– Before you start to take it
– Taking other medicines
- How to take Nevipin
– How much to take
– How to take it
– When to take it
– How long to take it
– If you forget to take it
– If you take too much (overdose)
- While you are taking Nevipin
– Things you must do
– Things you must not do
– Things to be careful of
- Side effects
- After taking Nevipin
- Product description
– What it looks like
This leaflet answers some common questions about Nevipin.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have benefits and risks.
Your doctor has weighed the risks of you using Nevipin against the benefits they expect it will have for you.
Ask your doctor or pharmacist if you have any questions about your medicine or if you have any trouble before, during or after using Nevipin.
This leaflet was last updated on the date at the end of this leaflet. More recent information may be available. The latest Consumer Medicine Information is available from your pharmacist, doctor, or from www.medicines.org.au and may contain important information about the medicine and its use of which you should be aware.
Keep this leaflet with your medicine. You may need to read it again.
What Nevipin is used for
Nevipin is used in the treatment of the infection caused by the Human Immunodeficiency Virus (HIV-1). HIV-1 is the main virus responsible for the development of Acquired Immunodeficiency Syndrome (AIDS).
Nevipin contains the active ingredient Nevirapine. Nevirapine belongs to a group of antiretroviral medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs). It works by inhibiting or interrupting with the enzyme reverse transcriptase that the HIV virus needs to multiply.
Nevipin does not cure or prevent HIV-1 infection or AIDS, but it does hinder the growth of HIV-1.
Nevipin is prescribed in combination with other antiretroviral medicines which hinder the growth of HIV-1 in other ways. When these medicines are taken with Nevipin, the growth of HIV-1 is hindered more effectively.
Nevipin has not been shown to reduce the incidence or frequency of the illnesses caused by AIDS. It is important for you to continue seeing your doctor regularly.
Nevipin does not reduce the risk of or prevent transmission of HIV-1 to others through sexual contact or blood contamination.
Before you take Nevipin
When you must not take it
Do not take Nevipin if you are allergic to nevirapine or any of the other ingredients in Nevipin. These ingredients are listed in full at the end of this leaflet.
This includes rare inherited conditions of galactose and fructose intolerance.
If you are not sure if you have these allergies, you should raise those concerns with your doctor.
Some of the symptoms of an allergic reaction may include:
- shortness of breath
- wheezing or difficulty breathing
- swelling of the face, lips, tongue or other parts of the body
- rash, itching or hives on the skin.
Do not take Nevipin if you have:
- severe liver dysfunction
- previously experienced serious liver or skin reactions while on Nevipin.
If you are not sure whether you should start taking Nevipin, talk to your doctor.
Do not take Nevipin after the expiry date on the carton.
Do not take Nevipin if the packaging is torn or shows signs of tampering.
Before you start to take it
It is essential that your doctor knows your medical history before prescribing Nevipin.
Tell your doctor if you have, or have had, any of the following conditions:
- liver problem/disease or hepatitis
- undergoing dialysis treatment.
If you are not sure if you have, or have had, any of these conditions, you should raise those concerns with your doctor.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
In particular, tell your doctor if you are taking:
- other anti-HIV medicines
- fluconazole, itraconazole, ketoconazole
- oral contraceptives
- corticosteroids (e.g. prednisone)
- rifampicin, rifabutin
- herbal medicines derived from St John’s Wort (Hypericum perforatum)
- medicines used in the treatment of:
– allergies (antihistamines)
– bacterial/fungal infections
– cancer (e.g. cyclophosphamide)
– gastrointestinal motility disorder (e.g. cisapride)
– hypertension or heart conditions (calcium channel blockers)
– irregular heart beats (antiarrhythmics)
– immune disorders or to prevent rejection of transplanted organ (immunosuppressants)
– migraine (ergot derivatives)
– severe pain (e.g. fentanyl).
These medicines may be affected by Nevipin, or may affect how well it works. You may need different amounts of the medicine, or you may need to take different medicines. Your doctor or pharmacist will advise you.
As Nevipin may reduce the effectiveness of oral contraceptives, talk to your doctor about alternative methods of contraception.
Ask for your doctor’s advice if you are pregnant, or likely to become pregnant during your course of medication. Special care is recommended during pregnancy. The benefits of Nevipin must be assessed against possible effects on your unborn baby.
Ask for your doctor’s advice if you wish to breastfeed during your use of Nevipin. Breastfeeding is not recommended during your use of Nevipin because:
- Nevipin enters the breast milk, so your doctor may suggest an alternate method of feeding your child.
- There is a risk of passing the HIV-1 virus to your baby.
How to take Nevipin
Always take Nevipin exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
How much to take
Follow the dosing instructions carefully, especially the once daily dosage during the first 14 days (‘lead-in’ period).
Adults 16 years and older:
- First 14 days: one Nevipin tablet.
- After the first 14 days: one Nevipin tablet twice daily (i.e. at regular 12-hour intervals at about the same time each day: morning and night).
Ask your doctor for more information if you have been advised to take a different dose.
Your doctor will closely monitor you for potential side effects of taking the medicine, in particular during the first 18 weeks of treatment.
How to take it
Nevipin tablets should be swallowed whole (not chewed) with water. The tablets can be taken with or without food.
When to take it
Take your medicine at about the same time each day. Taking it at the same time each day will have the best effect. It will also help you remember when to take it.
How long to take it
Continue taking your medicine for as long as your doctor tells you. This medicine helps to control your condition, but does not cure it. It is important to keep taking your medicine even if you feel well.
If you forget to take it
It is important to take Nevipin as directed.
If you miss a dose, take it as soon as you remember. However, if you remember when it is almost time for your next dose, take only your usual dose at that time.
Do not take a double dose to make up for the dose you missed.
If you have missed taking Nevipin for more than 7 days, contact your doctor before you start taking it again.
You may need to restart using the 14 days (lead-in) once daily dosing procedure.
If you are not sure what to do, talk to your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints.
If you take too much (overdose)
Immediately telephone your doctor, pharmacist or Poisons Information Centre (in Australia telephone 13 11 26; in New Zealand telephone 0800 764 766) for advice, or go to Emergency at your nearest hospital if you think that you or anyone else may have taken too much Nevipin. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
Symptoms of an overdose may include oedema, fatigue, fever, headache, insomnia, lung problems, rash, dizziness, nausea, vomiting, weight loss and erythema nodosum (a condition causing red-purple swellings on the shins, thighs and less commonly, the arms, joint and muscle pains and fever) may occur.
While you are taking Nevipin
Things you must do
Contact your doctor if you experience rash on any parts of the body. Contact your doctor immediately if the rash is accompanied by other symptoms such as fever, blisters, mouth sores, conjunctivitis, facial swelling, muscle or joint aches, swollen lymph glands, or tiredness. These may be symptoms of a hypersensitivity reaction that requires urgent medical attention.
Contact your doctor if you experience any symptoms of liver problems, such as loss of appetite, nausea, vomiting, jaundice (yellowing of the skin and/or eyes), dark coloured urine, pale coloured stools, pain/ache or sensitivity to touch in your right abdominal area (below your ribs).
These could be signs of serious liver dysfunction which your doctor will need to monitor closely and may require stopping treatment with Nevipin.
Liver function tests should be performed at regular intervals, especially during the first 18 weeks of treatment with Nevipin. If the results are abnormal, your doctor will consider either performing more frequent liver function tests (in less severe cases) or stopping treatment with Nevipin altogether (in more severe cases).
Women and patients with higher CD4 cell counts seem to be at increased risk for developing liver problems while taking Nevipin.
In rare instances, temporary weakness or pain of muscles has been seen in neviripine patients experiencing skin and/or liver problems.
If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking Nevipin.
If you are taking oral contraceptives (to prevent pregnancy) you should use additional or different type of contraception. Nevipin may reduce effectiveness of oral contraceptives.
If you become pregnant while taking Nevipin tell your doctor immediately.
If you have had a previous opportunistic infection, and you notice symptoms of inflammation occurring when you first start taking Nevipin, tell your doctor immediately. Symptoms of inflammation include redness, swelling, heat and pain. These symptoms have been reported in some patients who have previously had an infection when combination antiretroviral therapy was started.
Things you must not do
Do not give Nevipin to anyone else, even if they have the same condition as you.
Do not stop taking Nevipin or change the dose without first checking with your doctor. Nevipin helps control your HIV infection but does not cure it. Therefore, Nevipin must be taken every day as your doctor prescribed it.
Things to be careful of
Be careful driving or operating machinery until you know how Nevipin affects you. Nevipin may cause sleepiness or drowsiness in some people. Make sure you know how you react to Nevipin before you drive or operate machinery.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Nevipin. It may be difficult to tell whether side effects are the result of taking Nevipin, effects of the HIV disease or side effects of other medicines you may be taking. For this reason, it is very important to inform your doctor of any change in your condition. Your doctor may need to change your dose or advise you to stop taking Nevipin.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Ask for the advice of your doctor or pharmacist if you have any concerns about the effects of taking Nevipin.
The frequently reported side effects for children were similar to those observed in adults. However, a reduction of white blood cells (granulocytopenia) or red blood cells (anaemia) has been more commonly seen in children.
The major side effect of Nevipin is rash. Rashes are usually mild to moderate, located on the trunk, face, arms and/or legs. However, severe and/or life-threatening rashes (including Stevens Johnson Syndrome and Toxic Epidermal Necrolysis) have been reported with the use of Nevipin. Most of the cases of rash occur in the first six weeks of treatment.
Hypersensitivity (allergic) reactions have also been reported. Such reactions may appear in the form of:
- Anaphylaxis (sudden life-threatening allergic reaction) – sudden signs of rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing
- Rash accompanied by other side effects such as fever, blisters, mouth sores, conjunctivitis, facial swelling, muscle or joint aches, swollen lymph glands, or tiredness.
Contact your doctor immediately if you experience rash and/or any signs of hypersensitivity reactions.
The other most frequently reported side effects of Nevipin are fever, nausea, headache, fatigue, sleepiness, vomiting, diarrhoea, stomach pain, abnormal liver function tests and myalgia (aching muscles, muscle tenderness or weakness, not caused by exercise).
Cases of jaundice (yellowing of the skin and/or eyes), hepatitis, severe and life-threatening liver dysfunction (including fulminant hepatitis and liver failure) have been reported in patients being treated with Nevipin.
Contact your doctor immediately if you experience any symptoms of liver problems, such as loss of appetite, nausea, vomiting, jaundice (yellowing of the skin and/or eyes), dark coloured urine, pale coloured stools, pain/ache or sensitivity to touch in your right abdominal area (below your ribs).
In some patients, 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 and other internal organs
- breast enlargement
- fatty lumps on the back of the neck.
Tell your doctor as soon as possible if you experience any side effects during or after taking Nevipin, so that these may be properly treated.
In addition, other side effects, not listed above, can occur in some patients.
You should tell your doctor or pharmacist if you notice anything unusual, during or after taking Nevipin.
After taking Nevipin
Keep Nevipin where children cannot reach it.
Nevipin tablets in blister packs should be kept in a cool dry place where the temperature stays below 25°C.
Do not store in direct sunlight or heat. For example, do not leave it in the car on hot days.
If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.
What it looks like
Nevipin is the brand name of your medicine.
The tablets are white to off-white, oblong tablets with “200” embossed on one side and “NVP” on the other side.
Blisters of 14, 60 and 100 tablets. Each blister carton is labelled with the Australian Registration Number AUST R 199201.
Each tablet contains 200 mg of nevirapine (active ingredient).
The other ingredients are:
- microcrystalline cellulose
- sodium starch glycollate
- colloidal anhydrous silica
- magnesium stearate.
Southern Cross Pharma Pty Ltd
56 Illabunda Drive
Malua Bay NSW 2536
This leaflet was prepared on 30 July 2013.
Published by MIMS November 2014