Patient leaflet - NEVIRAPINE WOCKHARDT 400MG PROLONGED-RELEASE TABLETS
1. What Nevirapine Wockhardt 400mg Prolonged-Release Tablets are and what they are used for
Nevirapine Wockhardt 400mg Prolonged-Release Tablets belongs to a group of medicines called antiretrovirals, used in the treatment of Human Immunodeficiency Virus (HIV-1) infection.
The active substance of your medicine is called nevirapine. 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 Wockhardt 400mg Prolonged-Release Tablets helps control HIV-1 infection. Nevirapine Wockhardt 400mg Prolonged-Release Tablets is indicated for the treatment of HIV-1 infected adults, adolescents and children three years and above and able to swallow tablets. You must take Nevirapine Wockhardt 400mg Prolonged-Release Tablets together with other antiretroviral medicines. Your doctor will recommend the best medicines for you. Nevirapine Wockhardt 400mg prolonged-release tablets should only be used after a two-week treatment with another type of Nevirapine (immediate-release tablets or suspension) unless you are currently on Nevirapine and are switching to the prolonged-release form.
2. What you need to know before you take Nevirapine Wockhardt
400mg Prolonged-Release Tablets
Do not take Nevirapine Wockhardt 400mg Prolonged-Release Tablets:
- if you are allergic to nevirapine or any of the other ingredients of this medicine (listed in section 6 “What Nevirapine Wockhardt 400mg Prolonged-Release Tablets contains”)
if you have taken Nevirapine Wockhardt 400mg Prolonged-Release Tablets 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 Wockhardt 400mg Prolonged-Release Tablets 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 Wockhardt 400mg Prolonged-Release Tablets from working properly. Warnings and precautions
- Talk to your doctor or pharmacist before taking Nevirapine Wockhardt 400mg Prolonged-Release Tablets.
During the first 18 weeks of treatment with Nevirapine Wockhardt 400mg Prolonged-Release Tablets 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 • Fever • general swelling
- blistering • shortness of breath
- mouth sores • muscle or joint pain
- inflammation of the eye • general feelings of illness • swelling of the face • abdominal pain
YOU SHOULD DISCONTINUE TAKING NEVIRAPINE WOCKHARDT 400MG PROLONGED-RELEASE TABLETS 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 Nevirapine Wockhardt 400mg prolonged-Release Tablets. If you experience symptoms suggesting damage of the liver, such as • loss of appetite • yellow skin (jaundice) • feeling sick (nausea) • abdominal pain
- vomiting
you should discontinue taking Nevirapine Wockhardt 400mg Prolonged-Release Tablets and must contact your doctor immediately. If you develop severe liver, skin or hypersensitivity reactions whilst taking Nevirapine Wockhardt 400mg Prolonged-Release Tablets, NEVER TAKE NEVIRAPINE WOCKHARDT 400MG PROLONGED-RELEASE TABLETS again without referring to your doctor.
You must take the dose of Nevirapine Wockhardt 400mg Prolonged-Release Tablets as prescribed by your doctor. This is especially important within the first 14 days of treatment (see more information in “How to take Nevirapine Wockhardt 400mg Prolonged-Release Tablets”).
The following patients are at increased risk of developing liver problems:
- women
- infected with hepatitis B or C
- abnormal liver function tests
- treatment-naïve patients with higher CD4 cell counts at the start of Nevirapine Wockhardt 400mg Prolonged-Release Tablets 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 Nevirapine Wockhardt 400mg Prolonged-Release Tablets 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. In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection. Autoimmune disorders may occur many months after the start of treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment. 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. If you are taking nevirapine and zidovudine concomitantly please inform your doctor since he might need to check your white blood cells. Do not take Nevirapine Wockhardt 400mg Prolonged-Release Tablets
after an exposure to HIV unless you have been diagnosed with HIV and instructed to do so by your doctor. Nevirapine Wockhardt 400mg Prolonged-Release Tablets 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. You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy. Discuss with your doctor the precautions needed to avoid infecting other people.
Prednisone should not be used to treat a rash related to Nevirapine Wockhardt 400mg Prolonged-Release Tablets.
If you are taking oral contraceptives (e.g.“pill”) or other hormonal methods of birth control during treatment with Nevirapine Wockhardt 400mg Prolonged-Release Tablets, you should use a barrier contraception (e.g. condoms) in addition to prevent pregnancy and further HIV transmission. If you are receiving post-menopausal hormone therapy, ask your doctor for advice before taking this medicine.
If you are taking or are prescribed rifampicin to treat tuberculosis please inform your doctor before taking this medicine with Nevirapine Wockhardt 400mg Prolonged-Release Tablets.
Nevirapine Wockhardt 400mg Prolonged-Release Tablets prolonged-release tablets or parts of tablets may occasionally be passed and seen in the stool (faeces).These may look like whole tablets, but have not been found to affect the efficacy of nevirapine. Inform your doctor if you find tablet pieces in your faeces. Children and adolescents
Nevirapine Wockhardt 400mg prolonged-release tablets can be taken by children if they:
- are ≥ 8 years of age and weigh 43.8kg or more
- are older than 3 years of age and below 8 years of age and weigh 25kg or more
- have a body surface area of 1.17 square metres or above. Other medicines and Nevirapine Wockhardt 400mg Prolonged-Release Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Inform your doctor about all other medicines you are taking before you start taking Nevirapine Wockhardt 400mg Prolonged-Release Tablets. 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 medicines you are taking in combination with Nevirapine Wockhardt 400mg Prolonged-Release Tablets.
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)
- etravirine (another medicine to treat HIV-infection)
- rilpivirine (another medicine to treat HIV-infection)
- delavirdine (another medicine to treat HIV-infection)
- zidovudine (another medicine to treat HIV-infection)
- boceprevir (medicine to treat hepatitis C)
- telaprevir (medicine to treat hepatitis C)
- elvitegravir/cobicistat (another medicine to treat HIV-infection). Your doctor will carefully monitor the effect of Nevirapine Wockhardt 400mg Prolonged-Release Tablets and any of these medicines if you are taking them together.
Taking Nevirapine Wockhardt 400mg Prolonged-Release Tablets with food and drink
There are no restrictions on taking Nevirapine Wockhardt 400mg Prolonged-Release Tablets with food and drink.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
You should stop breast-feeding if you are taking Nevirapine Wockhardt 400mg Prolonged-Release Tablets. 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
You may experience fatigue when taking Nevirapine Wockhardt 400mg Prolonged-Release Tablets. Use caution when engaging in activities such as
driving, using any tools or machines. If you experience fatigue you should avoid potentially hazardous tasks such as driving or using any tools or machines.
Nevirapine Wockhardt 400mg Prolonged-Release Tablets contain lactose
Nevirapine Wockhardt 400mg Prolonged-Release Tablets prolonged-release 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 Wockhardt 400mg Prolonged-Release Tablets.
3. How to take Nevirapine Wockhardt 400mg Prolonged-Release Tablets
You should not use Nevirapine Wockhardt 400mg Prolonged-Release Tablets 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 this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Tablets must be swallowed whole and not divided, broken, chewed or crushed.
The recommended dose is:
Adults:
The dose is one 200mg Nevirapine tablet per day for the first 14 days of treatment (“lead-in” period).
A separate treatment initiation pack with 200mg Nevirapine tablets is available for this lead-in period. After 14 days, the usual dose is one 400mg prolonged-release tablet once a day.
VERY IMPORTANT - take only one 200mg Nevirapine tablet per day for the first 14 days
(“lead-in”period). If you have any rash during this period, do not start taking Nevirapine Wockhardt 400mg prolonged-release tablets but consult your doctor.
NEVER divide Nevirapine Wockhardt 400mg prolonged release tablets to get a 200mg dose.
The 14-day“lead-in”period has been shown to lower the risk of skin rash. Patients who are already on immediate-release tablets or oral suspension can switch to prolonged-release tablets without lead-in period. As Nevirapine Wockhardt 400mg Prolonged-Release Tablets 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.
You should continue to take Nevirapine Wockhardt 400mg Prolonged-Release Tablets for as long as instructed by your doctor.
As explained in‘Warnings and precautions’, 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 Wockhardt 400mg Prolonged-Release Tablets treatment. Your doctor might then decide to restart you on a lower dose.
If you have a renal or hepatic dysfunction of any degree please use only Nevirapine 200mg tablets.
Only take Nevirapine Wockhardt 400mg Prolonged-Release Tablets prolonged-release tablets by mouth. Do not chew your prolonged-release tablets. You may take Nevirapine Wockhardt 400mg Prolonged-Release Tablets with or without food.
If you take more Nevirapine Wockhardt 400mg Prolonged-Release Tablets than you should
Do not take more Nevirapine Wockhardt 400mg Prolonged Release Tablets than prescribed by your doctor and described in this leaflet. There is at present little information on the effects of Nevirapine Wockhardt 400mg Prolonged-Release Tablets overdose. Consult your doctor if you have taken more Nevirapine Wockhardt 400mg Prolonged-Release Tablets than you should. If you forget to take Nevirapine Wockhardt 400mg Prolonged-Release Tablets
Try not to miss a dose. If you notice you missed a dose within 12 hours of when it was due, take the missed dose as soon as possible. If it has been more than 12 hours since the dose was due only take the next dose at the usual time. If you stop taking NevirapineWockhardt 400mg Prolonged-ReleaseTablets
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 Wockhardt 400mg Prolonged-Release Tablets correctly, as described above, unless your doctor instructs you to stop.
If you stop taking Nevirapine Wockhardt 400mg Prolonged-Release Tablets for more than 7 days your doctor will instruct you to start the 14 day‘lead-in’ period with Nevirapine Wockhardt 400mg Prolonged-Release Tablets tablets (described above) once again, before returning to the once daily dose with Nevirapine Wockhardt 400mg Prolonged-Release Tablets.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves. Your doctor will test for these changes.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
As mentioned in ‘Warnings and precautions’, above, the most important side effects of Nevirapine Wockhardt 400mg Prolonged-Release Tablets are severe and life threatening skin reactions and serious liver damage. These reactions occur mainly in the first 18 weeks of treatment with Nevirapine Wockhardt 400mg Prolonged-Release Tablets. This is therefore an important period which requires close monitoring by your doctor. If you ever observe any rash symptoms, inform your doctor immediately.
When rash occurs it is normally mild to moderate. However, in some patients a rash, which appears as a blistering skin reaction, can be severe or life-threatening (Stevens-Johnson syndrome and toxic epidermal necrolysis) and deaths have been recorded. Most of the cases of both severe rash and mild/ moderate rash occur in the first six weeks of treatment.
If rash occurs and you also feel sick, you must stop treatment and visit your doctor immediately.
Hypersensitivity (allergic) reactions can occur. Such reactions may appear in the form of anaphylaxis (a severe form of allergic reaction) with symptoms such as:
- rash
- swelling of the face
- difficulty breathing (bronchial spasm)
- anaphylactic shock.
Hypersensitivity reactions can also occur as rash with other side effects such as: • fever
- blistering of your skin
- mouth sores
- inflammation of the eye
- swelling of the face
- general swelling
- shortness of breath
- muscle or joint pain
- a reduction in the numbers of your white blood cells (granulocytopenia) • general feelings of illness
- severe problems with liver or kidneys (liver or kidney failure). Tell your doctor immediately if you experience rash and any of the other side effects of a hypersensitivity (allergic) reaction. Such reactions can be life-threatening.
Abnormal liver functioning has been reported with the use of Nevirapine Wockhardt 400mg Prolonged-Release Tablets. 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. Tell your doctor if you experience any of the following clinical symptoms of liver damage:
- loss of appetite
- feeling sick (nausea)
- vomiting
- yellow skin (jaundice)
- abdominal pain.
The side effects described below have been experienced by patients given Nevirapine 200mg tablets during the 14 day lead-in phase: Common (may affect up to 1 in 10 people):
- rash
- fever
- headache
- abdominal pain
- feeling sick (nausea)
- loose stools (diarrhoea)
- feeling tired (fatigue).
Uncommon (may affect up to 1 in 100 people):
allergic reactions (hypersensitivity)
- allergic reaction characterized by rash, swelling of the face, difficulty breathing (bronchial spasm) or anaphylactic shock
- drug reaction with systemic symptoms (drug reaction with eosinophilia and systemic symptoms)
- sudden and intense inflammation of the liver (fulminant hepatitis) • severe and life-threatening skin rashes (Stevens Johnson Syndrome/toxic epidermal necrolysis)
- yellow skin (jaundice)
- hives (urticaria)
- fluid under the skin (angioneurotic oedema)
- vomiting
- muscle pain (myalgia)
- joint pain (arthralgia)
- decreased numbers of white blood cells (granulocytopenia) • abnormal liver function tests
- decreased blood phosphorus
- increased blood pressure.
Rare (may affect up to 1 in 1000 people):
- inflammation of the liver (hepatitis)
- decreased numbers of red blood cells (anaemia).
The side effects described below have been experienced by patients given Nevirapine Wockhardt 400mg prolonged-release tablets once daily in the maintenance phase:
Common (may affect up to 1 in 10 people):
- rash
- headache
- abdominal pain
- feeling sick (nausea)
- inflammation of the liver (hepatitis)
- feeling tired (fatigue)
- abnormal liver function tests
- fever
- vomiting
- loose stools (diarrhoea).
Uncommon (may affect up to 1 in 100 people):
- allergic reactions (hypersensitivity)
- allergic reaction characterized by rash, swelling of the face, difficulty breathing (bronchial spasm) or anaphylactic shock
- drug reaction with systemic symptoms (drug reaction with eosinophilia and systemic symptoms)
- sudden and intense inflammation of the liver (fulminant hepatitis) • severe and life-threatening skin rashes (Stevens Johnson Syndrome/toxic epidermal necrolysis)
- decreased numbers of red blood cells (anaemia)
- decreased numbers of white blood cells (granulocytopenia) • yellow skin (jaundice)
- hives (urticaria)
- fluid under the skin (angioneurotic oedema)
- muscle pain (myalgia)
- joint pain (arthralgia)
- decreased blood phosphorus
- increased blood pressure.
The following events have also been reported when Nevirapine Wockhardt 400mg Prolonged-Release Tablets 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 Wockhardt 400mg Prolonged-Release Tablets is used in combination with other agents; however, it is unlikely that these events are due to treatment with Nevirapine Wockhardt 400mg Prolonged-Release Tablets.
Additional side effects in children and adolescents
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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.This includes any possible side effects not listed in this leaflet.You can also report side effects directly via the Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard or search for the MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
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5. How to store Nevirapine Wockhardt 400mg Prolonged-Release Tablets
Keep this medicine out of the sight and reach of children.
Bottles: Use tablets for up to 30 days from the date of first opening the bottle. Take unused tablets back to the pharmacy.
Do not use this medicine after the expiry date which is stated on the carton and on the blister or bottle after“EXP”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Nevirapine Wockhardt 400mg Prolonged-Release Tablets contain
- The active substance is nevirapine.
- Other ingredient are lactose, hypromellose and magnesium stearate. What Nevirapine Wockhardt 400mg Prolonged-Release Tablets looks like and contents of the pack
White to off-white oval shaped biconvex prolonged-release tablets; debossed with‘H’on one side and‘N1’on other side. Approximate tablet dimensions are 19 x 9 x 7 mm.
Nevirapine Wockhardt 400mg prolonged-release tablets are supplied in blister strips containing 30 or 90 tablets per carton or plastic bottles containing 30 tablets. Not all pack sizes may be marketed.
Nevirapine is also available as immediate release tablets containing 200mg nevirapine.
Marketing Authorisation Holder
Wockhardt UK Ltd., Ash Road North
Wrexham, LL13 9UF, UK
Manufacturer
CP Pharmaceuticals Ltd., Ash Road North
Wrexham, LL13 9UF, UK
This leaflet was last revised in April 2023
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Product name
Reference number
Nevirapine Wockhardt 400mg Prolonged-Release Tablets:
PL 29831/0675