400 mg prolonged-release tablet er
nevirapine
What Viramune is and what it is used for
Viramune belongs to the drug group antiretroviral agents, which are used in the treatment of infection with the Human Immunodeficiency Virus ( HIV – 1).
The active substance in your medicine is called nevirapine. Nevirapine belongs to a class of antiretroviral drugs called non-nucleoside reverse transcriptase inhibitors (NNRTIs). Reverse transcriptase is an enzyme that HIV needs to reproduce. Nevirapine prevents reverse transcriptase from working. By preventing reverse transcriptase from working, Viramune helps control HIV -1 infection.
Viramune is intended for the treatment of HIV -infected adults, adolescents, and children over three years of age who can swallow tablets. You must use Viramune together with other antiretroviral medicines. Your doctor will recommend the medications that are best for you.
Viramune prolonged-release tablets should only be used after a two-week treatment with another type of Viramune (immediate-release or suspension tablets ) unless you are currently taking Viramune and switching to prolonged-release tablets.
What you need to know before you use Viramune
Do not take Viramune
- if you are allergic to nevirapine or any of the other ingredients of this medicine (listed in section 6).
- if you have used Viramune before and have to stop because of:
- severe skin rashes
- skin rash with other symptoms such as:
- fever
- blistering
- mouth ulcers
- eye inflammation
- facial swelling
- general swelling
- shortness of breath
- muscle or joint pain
- general malaise
- abdominal pain
- hypersensitivity reaction (allergic reactions)
- inflammation of the liver ( hepatitis )
- if you have severe liver disease
- if you had to stop treatment with Viramune on a previous occasion due to changes in liver function
- if you take products containing the plant St. John’s wort (Hypericum perforatum). This (traditional) herbal medicine may cause Viramune not to work as intended.
Warnings and precautions
Talk to your doctor or pharmacist before using Viramune.
During the first 18 weeks of treatment with Viramune, you and your doctor must watch for signs of liver or skin reactions. These can become severe and even life-threatening. There is the greatest risk of such reactions during the first 6 weeks of treatment.
| If you get severe skin rashes or hypersensitivity (allergic reactions that can appear in the form of skin rashes) along with other side effects such as fever , blisters, mouth ulcers, eye inflammation, facial swelling, general swelling, shortness of breath, muscle or joint pain, general malaise, or abdominal pain should YOU STOP USING VIRAMUNE AND CONTACT YOUR DOCTOR IMMEDIATELY because such reactions can be potentially life-threatening or lead to death. If you ever get symptoms of a mild rash without any other reactions, tell your doctor immediately, for advice on whether to stop using Viramune. If you get symptoms that indicate liver damage, such as loss of appetite, nausea, vomiting, yellow skin (jaundice), abdominal pain should stop using Viramune and contact your doctor immediately. If you develop a serious liver, skin, or hypersensitivity reaction while using Viramune, you should NEVER USE VIRAMUNE again without first talking to your doctor. You must use Viramune at the dosage prescribed by your doctor. This is especially important during the first 14 days of treatment (for more information, see How to take Viramune) |
The following patients are at higher risk of developing liver problems:
- women
- hepatitis B or C infected
- elevated values of liver function tests
- previously untreated patients with high CD4 values when starting Viramune treatment (women more than 250 cells/mm 3, men more than 400 cells/mm 3 )
- previously treated patients with measurable HIV -1 viral load in plasma and high CD4 values when starting Viramune treatment (women more than 250 cells/mm 3, men more than 400 cells/mm 3 ).
In some patients with advanced HIV infection (AIDS) who previously had an opportunistic infection (which can be attributed to AIDS disease), signs and symptoms of inflammation from the previous infection may occur shortly after starting anti-HIV treatment. These symptoms are probably due to an improvement in the body’s immune response, which enables the body to fight infections that may have existed before, but did not cause any symptoms. Inform your doctor immediately if you notice any symptoms of infection.
In addition to opportunistic infections, autoimmune disorders (conditions where the immune system attacks healthy body tissue) can also occur after you start taking medicines to treat your HIV infection. Autoimmune disorders may occur several months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, a weakness that starts in the hands or feet and moves to the trunk, palpitations, tremors, or hyperactivity, inform your doctor immediately to get the necessary treatment.
Changes in fat distribution may occur in patients receiving combined antiretroviral therapy. Contact your doctor if you notice changes in body fat (see section 4 “ Possible side effects ” ).
Some patients receiving combination antiretroviral therapy may develop a bone disease called osteonecrosis (tissue death of the bone tissue caused by the restricted blood supply to the bone). Some of the many risk factors for developing the disease are: long-term combination antiretroviral therapy, use of corticosteroids, alcohol consumption, weakened immune system, and higher body mass index. Signs of osteonecrosis are joint stiffness and pain (especially in the hip, knee, and shoulders) and difficulty moving. Tell your doctor if you experience any of these symptoms.
If you are taking nevirapine and zidovudine at the same time, inform your doctor as he/she may need to check your white blood cells.
Do not take Viramune after being exposed to the HIV unless you have been diagnosed with HIV and instructed by your doctor to take Viramune.
Prednisone should not be used to treat rashes due to Viramune.
If you take oral contraceptives (for example, the pill ) or other hormonal contraceptives during treatment with Viramune, you should also use a barrier method (for example, a condom) to prevent pregnancy.
If you are receiving hormone replacement for menopause symptoms, consult your doctor before taking this medicine.
If you are taking or have been prescribed rifampicin to treat tuberculosis, inform your doctor before taking the medicine together with Viramune.
Viramune prolonged-release tablets, or parts of tablets, can sometimes pass through the body and be seen in the stool. They may look like whole tablets but have not been seen to affect the effect of nevirapine.
Children and young people
Viramune 400 mg prolonged-release tablets can be used by children if they:
- are ≥ 8 years old and weigh 43.8 kg or more
- are older than 3 years and younger than 8 years and weigh 25 kg or more
- have a body surface area of 1.17 m 2 or more
For smaller children, oral suspension in liquid form is available.
Other medicines and Viramune
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Tell your doctor about all other medicines you are taking before you start taking Viramune tablets. The reason is that the doctor may need to decide whether your other medicines are still working and whether the dose needs to be changed. Carefully read the package leaflets of all the other HIV medicines that you will use together with Viramune.
You must tell your doctor if you are using or have recently used:
- St. John’s wort (Hypericum perforatum, (traditional) herbal remedies for mild depression)
- rifampicin ( tuberculosis drug)
- rifabutin ( tuberculosis drug)
- macrolides e.g. clarithromycin ( antibiotics )
- fluconazole (for fungal infections)
- ketoconazole (for fungal infections)
- itraconazole (for fungal infections)
- methadone (for opiate withdrawal)
- warfarin (blood thinner)
- hormonal contraceptives (e.g. birth control pills )
- atazanavir ( HIV medicine)
- lopinavir/ritonavir ( HIV medicine)
- fosamprenavir ( HIV medicine)
- efavirenz ( HIV medicine)
- etravirine ( HIV medicine)
- rilpivirine ( HIV medicine)
- zidovudine ( HIV medicine)
- elvitegravir/cobicistat ( HIV medicine)
Your doctor will closely monitor the effect of Viramune and these medicines if you use them together.
Viramune with food and drink
There are no obstacles to taking Viramune with food and drink.
Pregnancy and breastfeeding
If you are pregnant or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Breastfeeding is not recommended for women living with HIV because HIV infection can be transmitted to the baby through breast milk.
If you are breastfeeding or thinking about starting to breastfeed, you should discuss this with your doctor as soon as possible.
Driving ability and use of machinery
You may feel tired while using Viramune. Be careful when doing activities such as driving or using machinery. If you feel tired, avoid tasks that may be risky, such as driving or using tools or machinery.
Viramune contains lactose
Viramune prolonged-release tablets contain lactose (milk sugar). If you have an intolerance to some sugars, consult your doctor before taking this medicine.
How to use Viramune
You should not use Viramune alone. You must use it with at least two other antiretroviral medicines. Your doctor will recommend the best medicines for you.
Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Dosage:
Adults:
During the first 14 days (introduction period), the dose is one Viramune tablet 200 mg once a day. A separate starter pack of Viramune tablets 200 mg is available for this insertion period. After 14 days, the usual dose is one 400 mg prolonged-release tablet once a day.
| It is very important that you only take one Viramune tablet per day during the first 14 days (the break-in period). If you get any skin rashes during this period, do not start Viramune prolonged-release tablets, contact your doctor instead. |
This 14-day insertion period has been shown to result in a lower risk of skin rashes.
Patients who are already being treated with immediate-release tablets or oral suspension can switch to prolonged-release tablets without a break-in period.
As Viramune will always be given together with other drugs that inhibit the HIV, you must follow the instructions for these drugs carefully. These can be found in the package leaflets for these medicines.
Viramune is also available as an oral suspension (for all ages, weights, and BSA groups).
You should continue to use Viramune for as long as your doctor recommends.
In the “Warnings and precautions” section above, it is stated that your doctor will monitor liver tests and be aware of unwanted effects, such as skin rashes. Depending on the development, the doctor may decide to interrupt or end treatment with Viramune. The doctor may then decide to resume the treatment with a lower dose.
If you have impaired kidney or liver function, use only Viramune 200 mg tablets or Viramune 50 mg/5 ml oral suspension.
Viramune prolonged-release tablets should only be taken by mouth. Do not chew the tablets. Viramune can be taken with or without food.
If you have taken too much Viramune
Do not use more Viramune than your doctor has prescribed and as described in this leaflet. There is currently limited information on the effects of Viramune in overdose. Contact a doctor if you have taken too much Viramune.
If you forget to take Viramune
Try not to miss a dose. If you notice a missed dose within 12 hours of the scheduled time, take the missed dose as soon as possible. If it has been more than 12 hours after the scheduled time, just take the next dose at the regular time instead.
If you stop taking Viramune
Taking all your doses of HIV medicine at the right time
- leads to a large increase in the effectiveness of your combination of antiretroviral drugs
- and reduces the risk of your HIV infection becoming resistant to your antiretroviral drugs.
It is important to continue using Viramune correctly as directed above unless your doctor instructs you to stop.
If you stop treatment with Viramune prolonged-release tablets for more than 7 days, your doctor will suggest that you start the 14-day loading period with Viramune tablets (see above) again before returning to once-daily treatment with Viramune prolonged-release tablets.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
During HIV treatment, weight gain and increased levels of blood fats and blood sugar may occur. This is partly related to restored health and lifestyle, but in the case of blood lipids, there can sometimes be a connection with the HIV drugs themselves. The doctor will do tests to find such changes.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
In the section “Warnings and precautions”, above, it is stated that the most important side effects of Viramune tablets are severe and life-threatening skin reactions and serious liver damage. These reactions mainly occur during the first 18 weeks of treatment with Viramune. This period, therefore, requires careful follow-up by your doctor.
If you ever observe any skin rash, inform your doctor immediately.
When skin rashes occur, they are normally mild to moderate in severity. However, in some patients, the rash, which appears as blistering of the skin, can be severe or life-threatening ( Stevens-Johnson syndrome and toxic epidermal necrolysis ) and death has been reported. Most cases of rash, both severe and mild to moderate, appear in the first 6 weeks.
If skin rash and nausea occur at the same time, you must stop the treatment and see your doctor immediately.
Hypersensitivity reactions (allergic reactions) may occur. Such reactions can occur in the form of anaphylaxis (a severe form of allergic reaction ) with symptoms such as:
- rash
- facial swelling
- breathing difficulties (spasms in the airways)
- anaphylactic shock
Hypersensitivity reaction can also appear as a skin rash along with other side effects such as:
- fever
- blisters on the skin
- mouth ulcers
- eye inflammation
- facial swelling.
- general swelling
- shortness of breath
- muscle or joint pain
- a decrease in the number of white blood cells ( granulocytopenia )
- general malaise
- severe liver or kidney problems (liver or kidney failure )
Tell your doctor immediately if you get a rash and any of the other side effects associated with a hypersensitivity reaction ( allergic reaction ). Such reactions can be life-threatening.
Abnormal liver function has been reported with treatment with Viramune. This includes some cases of inflammation of the liver ( hepatitis ) which can be sudden and intense ( fulminant hepatitis ) and liver failure, both of which can lead to death.
Inform your doctor if you experience any of the following clinical symptoms of liver damage:
- loss of appetite
- nausea
- vomiting
- yellow skin (jaundice)
- abdominal pain
The side effects listed below have been reported from patients using Viramune 200 mg tablets during the 14-day loading period:
Common (may affect up to 1 in 10 users):
- rash
- fever
- headache
- abdominal pain
- nausea
- loose stools (diarrhea)
- fatigue
Uncommon (may affect up to 1 in 100 users):
- allergic reaction (hypersensitivity)
- allergic reaction such as skin rash, facial swelling, difficulty breathing ( bronchospasm ), or anaphylactic shock
- drug-induced reaction with general symptoms (drug-induced reaction with eosinophilia (increased number of white blood cells of a certain type) combined with general 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 accumulation under the skin ( angioedema )
- vomiting
- muscle pain ( myalgia )
- joint pain ( arthralgia )
- reduced number of white blood cells ( granulocytopenia )
- abnormal liver function tests
- decreased blood phosphorus
- increased blood pressure
Rare (may affect up to 1 in 1,000 users):
- inflammation of the liver ( hepatitis )
- reduced number of red blood cells ( anemia )
The side effects listed below have been reported from patients using Viramune prolonged-release tablets once daily as maintenance therapy.
Common (may affect up to 1 in 10 users):
- rash
- headache
- abdominal pain
- nausea
- inflammation of the liver ( hepatitis )
- fatigue
- abnormal liver function tests
- fever
- vomiting
- loose stools (diarrhea)
Uncommon (may affect up to 1 in 100 users):
- allergic reaction (hypersensitivity)
- allergic reaction such as skin rash, facial swelling, difficulty breathing ( bronchospasm ), or anaphylactic shock
- drug-induced reaction with general symptoms (drug-induced reaction with eosinophilia (increased number of white blood cells of a certain type) combined with general symptoms)
- sudden and intense inflammation of the liver ( fulminant hepatitis )
- severe and life-threatening skin rashes (Stevens-Johnson syndrome/toxic epidermal necrolysis )
- reduced number of red blood cells ( anemia )
- reduced number of white blood cells ( granulocytopenia )
- yellow skin (jaundice)
- hives ( urticaria )
- fluid accumulation under the skin ( angioedema )
- muscle pain ( myalgia )
- joint pain ( arthralgia )
- decreased blood phosphorus
- increased blood pressure
When Viramune has been used together with other HIV medicines, the following side effects have also been reported:
- decreased number of red blood cells or platelets
- inflammation of the pancreas
- decreased or abnormal sensation in the skin
These side effects often occur during treatment with other HIV drugs and can be expected when Viramune is used in combination with other drugs. However, it is unlikely that these side effects are caused by the treatment with Viramune.
Additional side effects in children and adolescents
A decrease in white blood cells ( granulocytopenia ) may occur, which is more common in children. A decrease in red blood cells ( anemia ), which may be related to the nevirapine treatment, is also observed more often in children. As with skin rashes, please inform your doctor of any side effects.
How to store Viramune
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the carton and blister card after “EXP”. The expiration date is the last day of the specified month.
Viramune should be used within 2 months of opening.
This medicine does not require any special storage instructions.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is nevirapine. Each prolonged-release tablet contains 400 mg of nevirapine.
- Other ingredients are lactose (as monohydrate), hypromellose, yellow iron oxide, and magnesium stearate.
Appearance and package sizes of the medicine
Yellow, oval, and biconvex prolonged-release tablets. The prolonged-release tablets are approx. 9.3 mm x 19.1 mm and are embossed with V04 on one side and the company’s logo on the other side. Viramune prolonged-release tablet er 400 mg is supplied in blisters with 30 or 90 prolonged-release tablets er per carton. Alternatively, there are 30 prolonged-release tablets of 400 mg in a jar. Not all pack sizes may be marketed.
Viramune is also available as an oral suspension or as tablet.
Marketing Authorisation Holder
Boehringer Ingelheim International GmbH
Binger Strasse 173
55216 Ingelheim am Rhein
Germany
Manufacturer
Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Strasse 173
55216 Ingelheim am Rhein
Germany
or
Boehringer Ingelheim France
100-104 avenue de France
75013 Paris
France
Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine:
| België/Belgique/BelgienBoehringer Ingelheim SComm Tél/Tel: +32 2 773 33 11 | LithuaniaBoehringer Ingelheim RCV GmbH & Co KG Lietuvos filialasPhone: +370 5 2595942 |
| BulgariaBöringer Ingelheim РЦВ ГмбХ и Ко КГ – branch БългарскиPhone: +359 2 958 79 98 | Luxembourg/LuxembourgBoehringer Ingelheim SCommTél/Tel: +32 2 773 33 11 |
| Czech RepublicBoehringer Ingelheim coil. s iPhone: +420 234 655 111 | MagyarországBoehringer Ingelheim RCV GmbH & Co KGMagyarországi FióktelepeTel.: +36 1 299 8900 |
| DenmarkBoehringer Ingelheim Danmark A/SPhone: +45 39 15 88 88 | MaltaBoehringer Ingelheim Ireland Ltd.Phone: +35 31 295 9620 |
| DeutschlandBoehringer Ingelheim Pharma GmbH & Co. KGPhone: +49 (0) 800 77 90 900 | The NetherlandsBoehringer Ingelheim bvPhone: +31 (0) 800 22 55 889 |
| EstoniaBoehringer Ingelheim RCV GmbH & Co KG Eesti branchPhone: +372 612 8000 | NorwayBoehringer Ingelheim Norway KSPhone: +47 66 76 13 00 |
| GreeceBoehringer Ingelheim Ελλάς Μονοπροσωπη AETel: +30 2 10 89 06 300 | AustriaBoehringer Ingelheim RCV GmbH & Co KGPhone: +43 1 80 105 7870 |
| SpainBoehringer Ingelheim España, SAPhone: +34 93 404 51 00 | PolishBoehringer Ingelheim Sp. z o. oTel.: +48 22 699 0 699 |
| FranceBoehringer Ingelheim France SASTel: +33 3 26 50 45 33 | PortugalBoehringer Ingelheim Portugal, Lda.Phone: +351 21 313 53 00 |
| HrvatskaBoehringer Ingelheim Zagreb dooPhone: +385 1 2444 600 | RomaniaBoehringer Ingelheim RCV GmbH & Co KG Viena – Sucursala BucurestiPhone: +40 21 302 2800 |
| IrelandBoehringer Ingelheim Ireland Ltd.Phone: +353 1 295 9620 | SlovenijaBoehringer Ingelheim RCV GmbH & Co KGPodružnica LjubljanaPhone: +386 1 586 40 00 |
| IcelandVistor hf.Phone: +354 535 7000 | Slovenian RepublicBoehringer Ingelheim RCV GmbH & Co KGorganizačná zložkaPhone: +421 2 5810 1211 |
| ItalyBoehringer Ingelheim Italia SpAPhone: +39 02 5355 1 | Finland/FinlandBoehringer Ingelheim Finland KyPhone/Tel: +358 10 3102 800 |
| CyprusBoehringer Ingelheim Ελλάς Μονοπροσωπη AETel: +30 2 10 89 06 300 | SwedenBoehringer Ingelheim ABPhone: +46 8 721 21 00 |
| LatviaBoehringer Ingelheim RCV GmbH & Co KGLatvijas branchPhone: +371 67 240 011 | United Kingdom(Northern Ireland)Boehringer Ingelheim Ireland Ltd.Phone: +353 1 295 9620 |