Do not take VIRAMUNE
- if you are allergic (hypersensitive) to nevirapine or any of the other ingredients of VIRAMUNE. See Section 6 of this leaflet for a list of other ingredients (?What VIRAMUNE contains?).
- if you have taken VIRAMUNE before and had to stop the treatment because you suffered from:
- severe skin rash
- skin rash with other symptoms for example:
- 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 VIRAMUNE 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 VIRAMUNE from working properly.
Take special care with VIRAMUNE
During the first 18 weeks of treatment with VIRAMUNE it is very important that you and your doctor watch out for signs of liver or skin reactions. These can become severe and even life threatening. You are at greatest risk of such a reaction during the first 6 weeks of treatment.
If you experience severe rash or hypersensitivity (allergic reactions that may appear in the form of rash) accompanied by other side effects such as
- mouth sores,
- inflammation of the eye,
- swelling of the face,
- general swelling,
- shortness of breath,
- muscle or joint pain,
- general feelings of illness,
- or abdominal pain YOU SHOULD DISCONTINUE TAKING VIRAMUNE AND YOU MUST CONTACT your doctor IMMEDIATELY as such reactions can be potentially life-threatening or lead to death. If you ever have only mild rash symptoms without any other reaction please inform your doctor immediately, who will advise you whether you should stop taking VIRAMUNE.
If you experience symptoms suggesting damage of the liver, such as
- loss of appetite,
- feeling sick (nausea),
- yellow skin (jaundice),
- abdominal pain you should discontinue taking VIRAMUNE and must contact your doctor immediately.
If you develop severe liver, skin or hypersensitivity reactions whilst taking VIRAMUNE, NEVER TAKE VIRAMUNE again without referring to your doctor.
You must take the dosage of Viramune as prescribed by your doctor. This is especially important within the first 14 days of treatment (see more information in ?How to take VIRAMUNE?).
The following patients are at increased risk of developing liver problems:
- infected with hepatitis B or C
- abnormal liver function tests
- treatment-naïve patients with higher CD4 cell counts at the start of Viramune therapy (women more than 250 cells/mm³, men more than 400 cells/mm³)
- pre-treated patients with detectable HIV-1 plasma viral load and higher CD4 cell counts at the start of Viramune therapy (women more than 250 cells/mm³, men more than 400 cells/mm³)
In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection (AIDS defining illness), 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.
Changes of body fat may occur in patients receiving combination antiretroviral therapy. Contact your doctor if you notice changes in body fat (see section 4 ? POSSIBLE SIDE EFFECTS?).
Some patients taking combination antiretroviral therapy 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 weakness of the immune system and higher body mass index 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.
VIRAMUNE is not a cure for HIV infection. Therefore, you may continue to develop infections and other illnesses associated with HIV infection. You should therefore remain in regular contact with your doctor. In addition, VIRAMUNE does not prevent the risk of passing on HIV to others through blood or sexual contact. Use appropriate precautions to prevent passing on HIV to other people. Please refer to your doctor.
Use in children
VIRAMUNE tablets can be taken by:
- children 16 years of age or older
- children under 16 years of age who:
- weigh 50 kg or more
- or have a body surface area above 1.25 square metres.
For smaller children an oral suspension liquid form is available.
Taking other medicines
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 VIRAMUNE. 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 VIRAMUNE.
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 VIRAMUNE 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 VIRAMUNE. This is because VIRAMUNE can be partly washed out of your blood by dialysis.
Taking VIRAMUNE with food and drink
There are no restrictions on taking VIRAMUNE with food and drink.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
You should stop breast-feeding if you are taking VIRAMUNE. 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.
Driving and using machines
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.
Important information about some of the ingredients of VIRAMUNE
VIRAMUNE 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 VIRAMUNE.