Package leaflet: Information for the user

Viramune 200 mg tablets

nevirapine
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

What Viramune is and what it is used for
What you need to know before taking Viramune
How to take Viramune
Possible side effects
How to store Viramune
Contents of the pack and other information

1. What Viramune is and what it is used for

Viramune belongs to a group of medicines called antiretrovirals, used in the treatment of human immunodeficiency virus (HIV-1) infection.
The active substance in this 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 blocks the activity of reverse transcriptase. By blocking reverse transcriptase activity, Viramune helps control HIV-1 infection.
Viramune is indicated for the treatment of HIV-1 infected adults, adolescents, and children of all ages.
You must take Viramune together with other antiretroviral medicines. Your doctor will recommend the most appropriate medicines for you.
If Viramune has been prescribed for a child, all the information in this leaflet applies to him (in this case, read "the child" wherever the leaflet refers to "you").

2. What you need to know before taking Viramune

Do not take Viramune

if you are allergic to nevirapine or to any of the other ingredients of this medicine (listed in section 6).
if you have previously taken Viramune and had to stop treatment because you experienced:
severe skin rash
skin rash with other symptoms, for example:
fever
blisters
mouth ulcers
eye inflammation
facial swelling
general swelling
shortness of breath
muscle or joint pain
general feeling of being unwell
abdominal pain
hypersensitivity reactions (allergic reactions)
liver inflammation (hepatitis)
if you have severe liver disease
if you previously had to stop treatment with Viramune due to abnormalities in liver function
if you are taking medicines containing St. John’s wort (Hypericum perforatum). This substance may prevent Viramune from working properly.

Warnings and precautions
Talk to your doctor or pharmacist before taking Viramune.
During the first 18 weeks of treatment with Viramune, it is very important that you and your doctor
remain alert for any signs of liver-related or skin-related reactions. These reactions can become
serious and even life-threatening. Your risk of such reactions is highest during the first 6 weeks of
treatment.
If a severe skin rash or hypersensitivity (i.e., allergic reactions that may present as a rash) occurs,
accompanied by other adverse effects such as

fever,
blisters,
mouth ulcers,
eye inflammation,
facial swelling,
general swelling,
shortness of breath,
muscle or joint pain,
general feeling of being unwell,
or abdominal pain,
YOU MUST STOP TAKING VIRAMUNE AND CONTACT YOUR DOCTOR IMMEDIATELY, as these
reactions can potentially be life-threatening or fatal.
If you develop only a mild skin rash without any other reaction, you should still inform your doctor
immediately; your doctor will advise you whether you should discontinue Viramune.

If symptoms indicating liver damage occur, such as

loss of appetite,
feeling unwell (nausea),
vomiting,
yellowing of the skin or eyes (jaundice),
abdominal pain,
you must stop taking Viramune and contact your doctor immediately.

If you develop severe liver-related, skin-related, or hypersensitivity reactions while taking Viramune,
DO NOT TAKE VIRAMUNE AGAIN WITHOUT FIRST CONSULTING YOUR DOCTOR.
You must take only the dose of Viramune prescribed by your doctor. This is particularly important
during the first 14 days of treatment (see more information in “ How to take Viramune” ).
The following patients are at higher risk of developing liver problems:

women
patients co-infected with hepatitis B or C
patients with abnormal liver function tests
treatment-naïve patients with higher CD4+ cell counts at the start of Viramune therapy (women >250 cells/mm³, men >400 cells/mm³)
previously treated patients with detectable HIV-1 viral load in the blood and higher CD4+ cell counts at the start of Viramune therapy (women >250 cells/mm³, men >400 cells/mm³).

In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections (AIDS-defining illnesses), inflammatory signs and symptoms of prior infections may occur shortly after starting anti-HIV treatment. These symptoms are believed to result from improved immune response, enabling the body to fight infections that may have been present without obvious symptoms. If you notice any signs of infection, inform your doctor immediately.
In addition to opportunistic infections, autoimmune disorders (a condition in which the immune system attacks healthy body tissue) may also occur after starting medications for HIV infection. Autoimmune disorders may appear several months after starting treatment. If you notice any signs of infection or other symptoms such as muscle weakness, initial weakness in hands and feet progressing toward the trunk, palpitations, tremors, or hyperactivity, inform your doctor immediately to receive necessary treatment.
A change in body fat distribution may occur in patients treated with 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 due to reduced blood supply to the bones). Duration of combination antiretroviral therapy, use of corticosteroids, alcohol consumption, severe immune deficiency, and higher body mass index may be among the many risk factors for developing this condition. Signs of osteonecrosis include joint stiffness, discomfort, and pain (especially in the hips, knees, and shoulders), and difficulty moving. Contact your doctor if you experience any of these symptoms.
If you are taking nevirapine together with zidovudine, inform your doctor, as you may need monitoring of white blood cell levels in your blood.
Do not take Viramune after exposure to HIV virus if you have not been diagnosed with the disease and it has not been prescribed by your doctor.
Prednisone should not be used to treat a skin rash related to taking Viramune.
If you are using oral contraceptives (e.g., “the pill”) or other hormonal birth control methods during treatment with Viramune, you must also use a barrier method of contraception (e.g., a condom) to prevent pregnancy and further transmission of HIV.
If you are on post-menopausal hormone replacement therapy, consult your doctor before taking this medicine.
If you are taking or have been prescribed rifampicin for tuberculosis treatment, inform your doctor before taking this medicine with Viramune.

Children and adolescents
Viramune tablets can be taken by:

children aged at least 16 years
children under 16 years of age who:
weigh at least 50 kg
or have a body surface area greater than 1.25 square meters.

An oral suspension formulation is available for younger children.

Other medicines and Viramune
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Inform your doctor about all medicines you are taking before starting treatment with Viramune. Your doctor may need to check whether they remain effective and may adjust their dosage. Read carefully the package leaflet of all other HIV medicines you are taking in combination with Viramune.
It is particularly important that you inform your doctor if you are taking or have recently taken:

St. John’s wort (Hypericum perforatum, a herbal remedy for depression)
rifampicin (a medicine for treating tuberculosis)
rifabutin (a medicine for treating tuberculosis)
macrolides, e.g., clarithromycin (a medicine for treating bacterial infections)
fluconazole (a medicine for treating fungal infections)
ketoconazole (a medicine for treating fungal infections)
itraconazole (a medicine for treating fungal infections)
methadone (a medicine for opioid dependence)
warfarin (a medicine to reduce blood clotting)
hormonal contraceptives (e.g., “the pill”)
atazanavir (another medicine for treating HIV)
lopinavir/ritonavir (another medicine for treating HIV)
fosamprenavir (another medicine for treating HIV)
efavirenz (another medicine for treating HIV)
etravirine (another medicine for treating HIV)
rilpivirine (another medicine for treating HIV)
zidovudine (another medicine for treating HIV)
elvitegravir/cobicistat (another medicine for treating HIV)

Your doctor will carefully monitor the effects of Viramune and each of these medicines if you are taking them together.
If you are undergoing renal dialysis, your doctor will consider adjusting the dose of Viramune, as dialysis may partially remove Viramune from the blood.

Viramune with food and drink
There are no restrictions regarding taking Viramune with food or drink.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
Breastfeeding is not recommended for HIV-positive women, as HIV infection can be transmitted to the infant through breast milk.
If you are breastfeeding or considering breastfeeding, you must discuss this with your doctor as soon as possible.

Driving and using machines
Fatigue may occur while taking Viramune. Be cautious when performing activities such as driving or operating tools or machinery. If you experience fatigue, avoid potentially dangerous activities such as driving or operating tools or machinery.

Viramune contains lactose and sodium
Viramune tablets contain lactose (milk sugar).
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
Viramune tablets contain less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially ‘sodium-free’.

3. How to take Viramune

Dosage:
The dose is one 200 mg tablet once daily for the first 14 days of treatment (“induction phase”). After 14 days, the usual dose is one 200 mg tablet twice daily.

It is very important that you take only one tablet of Viramune daily during the first 14 days (“induction phase”). If you develop any skin rash during this period, do not increase the dose, but contact your doctor immediately.

The initial 14-day “induction phase” has been shown to reduce the incidence of skin reactions.

Since Viramune must always be taken in combination with other antiretroviral medicines, you must also carefully follow the instructions for the other medicines you are taking. These instructions are available in the respective package leaflets.

Viramune is also available in a liquid formulation as an oral liquid suspension, which is particularly suitable for:

patients who have difficulty swallowing tablets
or children weighing less than 50 kg
or children whose body surface area is less than 1.25 square meters (your doctor will calculate the body surface area)

You must continue taking Viramune for the duration prescribed by your doctor.

As explained in the section “Warnings and precautions” above, your doctor will carry out regular check-ups, including liver function tests, and will monitor for adverse effects such as skin rash. Depending on the results, your doctor may decide to temporarily interrupt or discontinue treatment with Viramune. Your doctor may consider restarting the medicine at a lower dose.

Take Viramune tablets by mouth only. Do not chew the tablets. You may take Viramune with or without food.

If you take more Viramune than you should
Do not take more Viramune than prescribed by your doctor and described in this leaflet. Currently, there is limited information on the effects of Viramune overdose. If you have taken more than the prescribed dose, consult your doctor immediately.

If you forget to take Viramune
Try not to miss any doses. If you remember within 8 hours of the missed dose, take it as soon as possible. If more than 8 hours have passed, take only the next dose at the scheduled time.

If you stop taking Viramune
By taking all doses at the correct times:

you greatly increase the effectiveness of your antiretroviral medicines
you reduce the risk that your HIV infection becomes resistant to the medicines you are taking.

It is important to continue taking Viramune correctly as described above, unless your doctor tells you to stop treatment.

If you stop taking Viramune for more than 7 days, your doctor will advise you on how to restart the 14-day “induction phase” (described above) before returning to the dose of two tablets daily.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

During HIV therapy, weight gain and increases in blood lipid and glucose levels may occur. This is partly related to the recovery of health status and lifestyle, and in the case of blood lipids, sometimes to the HIV medications themselves. Your doctor will monitor these changes.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

As described above in "Warnings and precautions" , the most important side effects of Viramune are skin reactions and serious liver damage, which can be severe and life-threatening. These reactions mainly occur during the first 18 weeks of treatment with Viramune. This is therefore a critical period requiring close medical monitoring.

If you notice any signs of a skin reaction, inform your doctor immediately.

When occurring, rash is usually mild or moderate. However, in some patients, a rash appearing as a blistering skin eruption can be severe or life-threatening (Stevens-Johnson syndrome and toxic epidermal necrolysis), and cases of death have been reported.

The majority of both severe and mild/moderate skin reactions occurred within the first six weeks of treatment.

If you develop a rash and also feel unwell, you must stop treatment and see your doctor immediately.

Hypersensitivity (allergic) reactions may occur. Such reactions may present as anaphylaxis (a severe form of allergic reaction) with symptoms such as:

skin rash
swelling of the face
difficulty breathing (bronchospasm)
anaphylactic shock

Hypersensitivity reactions may also present as skin rash together with other side effects such as:

fever
skin blisters
mouth ulcers
eye inflammation
facial swelling
generalised swelling
shortness of breath
muscle or joint pain
reduction in white blood cell count (granulocytopenia)
general feeling of being unwell
severe liver or kidney problems (liver or kidney function failure).

Inform your doctor immediately if you develop a skin rash and any of the other side effects associated with hypersensitivity (allergy). These reactions can be life-threatening.

Liver function abnormalities have been reported with the use of Viramune, including some cases of liver inflammation (hepatitis), which may be sudden and severe (fulminant hepatitis), and liver function failure, both of which can be fatal.

Inform your doctor if you experience any of the following clinical symptoms of liver damage:

loss of appetite
feeling unwell (nausea)
vomiting
yellowing of the skin (jaundice)
abdominal pain

The side effects listed below have been reported in patients treated with Viramune:

Very common (may affect more than 1 in 10 people):

skin rash

Common (may affect up to 1 in 10 people):

decrease in white blood cell count (granulocytopenia)
allergic reactions (hypersensitivity)
headache
feeling unwell (nausea)
vomiting
abdominal pain
loss of faeces (diarrhoea)
liver inflammation (hepatitis)
feeling tired (fatigue)
fever
abnormal liver function tests

Uncommon (may affect up to 1 in 100 people):

allergic reaction characterised by skin rash, facial swelling, difficulty breathing (bronchospasm), or anaphylactic shock
reduction in red blood cell count (anaemia)
yellowing of the skin (jaundice)
severe, life-threatening skin rashes (Stevens-Johnson syndrome/toxic epidermal necrolysis)
urticaria
fluid accumulation under the skin (angioedema)
joint pain (arthralgia)
muscle pain (myalgia)
low blood phosphate levels
increased blood pressure

Rare (may affect up to 1 in 1,000 people):

sudden and severe liver inflammation (fulminant hepatitis)
drug reaction with systemic symptoms (drug reaction with eosinophilia and systemic symptoms, DRESS).

The following side effects have also been reported when Viramune was used in combination with other antiretroviral agents:

reduction in red blood cell or platelet count
inflammation of the pancreas
reduced or abnormal skin sensation. These cases are commonly associated with other antiretroviral agents and may occur when Viramune is used in combination with other agents; however, it is unlikely that these changes are caused by Viramune treatment.

Additional side effects in children and adolescents
A decrease in white blood cell count (granulocytopenia) may occur more commonly in children. A reduction in red blood cells (anaemia), which may be associated with nevirapine therapy, is also more commonly observed in children. As with skin rashes, inform your doctor of any side effects.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Viramune

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after “Exp.” and on the blister after “EXP”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Viramune contains

The active substance is nevirapine. Each tablet contains 200 mg of nevirapine.
The other components are:
microcrystalline cellulose,
lactose (as monohydrate),
povidone K25,
sodium stearyl fumarate,
colloidal silicon dioxide, and
magnesium stearate.

Description of the appearance of Viramune and contents of the pack
White, oval, biconvex tablets. On one side the code “54 193” is imprinted, separated by a single score line dividing “54” and “193”. On the opposite side the company logo is imprinted.
The score line is not intended to divide the tablet into equal doses.
Viramune tablets are packed in blisters. Packs contain 14, 60 or 120 tablets. Not all pack sizes may be marketed.
Viramune is also available as an oral suspension.

Marketing Authorization 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 Hellas Single Member S.A.
5th km Paiania – Markopoulo
Koropi Attiki, 19441
Greece
or
Boehringer Ingelheim France
100-104 avenue de France
75013 Paris
France

For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Boehringer Ingelheim SComm Boehringer Ingelheim RCV GmbH & Co KG
Tél/Tel: +32 2 773 33 11 Lietuvos filialas
Tel.: +370 5 2595942

България Luxembourg/Luxemburg
Бьорингер Ингелхайм РЦВ ГмбХ и Ко КГ - Boehringer Ingelheim SComm
клон България Tél/Tel: +32 2 773 33 11
Тел: +359 2 958 79 98

Česká republika Magyarország
Boehringer Ingelheim spol. s r.o. Boehringer Ingelheim RCV GmbH & Co KG
Tel: +420 234 655 111 Magyarországi Fióktelepe
Tel.: +36 1 299 8900

Danmark Malta
Boehringer Ingelheim Danmark A/S Boehringer Ingelheim Ireland Ltd.
Tlf.: +45 39 15 88 88 Tel: +35 31 295 9620

Deutschland Nederland
Boehringer Ingelheim Pharma GmbH & Co. KG Boehringer Ingelheim B.V.
Tel: +49 (0) 800 77 90 900 Tel: +31 (0) 800 22 55 889

Eesti Norge
Boehringer Ingelheim RCV GmbH & Co KG Boehringer Ingelheim Danmark
Eesti Filiaal Norwegian branch
Tel: +372 612 8000 Tlf: +47 66 76 13 00

Ελλάδα Österreich
Boehringer Ingelheim Ελλάς Μονοπρόσωπη Boehringer Ingelheim RCV GmbH & Co KG
Α.Ε. Tel: +43 1 80 105-7870
Tηλ: +30 2 10 89 06 300

España Polska
Boehringer Ingelheim España, S.A. Boehringer Ingelheim Sp. z o.o.
Tel: +34 93 404 51 00 Tel.: +48 22 699 0 699

France Portugal
Boehringer Ingelheim France S.A.S. Boehringer Ingelheim Portugal, Lda.
Tél: +33 3 26 50 45 33 Tel: +351 21 313 53 00

Hrvatska România
Boehringer Ingelheim Zagreb d.o.o. Boehringer Ingelheim RCV GmbH & Co KG
Tel: +385 1 2444 600 Viena – Sucursala Bucuresti
Tel: +40 21 302 2800

Ireland Slovenija
Boehringer Ingelheim Ireland Ltd. Boehringer Ingelheim RCV GmbH & Co KG
Tel: +353 1 295 9620 Podružnica Ljubljana
Tel: +386 1 586 40 00

Ísland Slovenská republika
Vistor ehf. Boehringer Ingelheim RCV GmbH & Co KG
Tel: +354 535 7000 organizačná zložka
Tel: +421 2 5810 1211

Italia Suomi/Finland
Boehringer Ingelheim Italia S.p.A. Boehringer Ingelheim Finland Ky
Tel: +39 02 5355 1 Puh/Tel: +358 10 3102 800

Κύπρος Sverige
Boehringer Ingelheim Ελλάς Μονοπρόσωπη Boehringer Ingelheim AB
Α.Ε. Tel: +46 8 721 21 00
Tηλ: +30 2 10 89 06 300

Latvija United Kingdom (Northern Ireland)
Boehringer Ingelheim RCV GmbH & Co KG Boehringer Ingelheim Ireland Ltd.
Latvijas filiāle Tel: +353 1 295 9620
Tel: +371 67 240 011

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu .

Package leaflet: information for the user

Viramune 50 mg/5 mL oral suspension

nevirapine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

What Viramune is and what it is used for
What you need to know before taking Viramune
How to take Viramune
Possible side effects
How to store Viramune
Package contents and other information

1. What Viramune is and what it is used for

Viramune belongs to a group of medicines called antiretrovirals, used in the treatment of human immunodeficiency virus (HIV-1) infection.
The active substance in the 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 blocks the activity of reverse transcriptase. By blocking reverse transcriptase activity, Viramune helps control HIV-1 infection.
Viramune is indicated for the treatment of HIV-1 infected adults, adolescents, and children of all ages. You must take Viramune together with other antiretroviral medicines. Your doctor will recommend the most appropriate medicines for you.
If Viramune has been prescribed for a child, all the information contained in this leaflet applies to him (in this case, read "the child" wherever the leaflet refers to you).

2. What you need to know before taking Viramune

Do not take Viramune

if you are allergic to nevirapine or to any of the other ingredients of this medicine (listed in section 6).
if you have previously taken Viramune and had to stop treatment because you experienced:
- severe skin rash
- skin rash with other symptoms, for example:
  - fever
  - blisters
  - mouth ulcers
  - eye inflammation
  - facial swelling
  - general swelling
  - shortness of breath
  - muscle or joint pain
  - general feeling of illness
  - abdominal pain
  - hypersensitivity reactions (allergic reactions)
  - liver inflammation (hepatitis)
if you have severe liver disease
if you previously had to discontinue treatment with Viramune due to abnormalities in liver function
if you are taking medicines containing St. John's wort (Hypericum perforatum). This substance may prevent Viramune from working properly.

Warnings and precautions
Talk to your doctor or pharmacist before taking Viramune.
During the first 18 weeks of treatment with Viramune, it is very important that you and your doctor
remain alert for any signs of liver- or skin-related reactions. These may become serious and even life-
threatening. Your risk of such reactions is highest during the first 6 weeks of treatment.
If a severe skin rash or hypersensitivity (i.e., allergic reactions which may present as a rash) occurs,
accompanied by any of the following adverse effects:

fever,
blisters,
mouth ulcers,
eye inflammation,
facial swelling,
general swelling,
shortness of breath,
muscle or joint pain,
general feeling of illness,
or abdominal pain,
YOU MUST STOP TAKING VIRAMUNE AND CONTACT YOUR DOCTOR IMMEDIATELY, as these
reactions may be potentially life-threatening or fatal.
If you develop only a mild skin rash without any other reaction, you should still inform your doctor
immediately, who will advise you whether to discontinue Viramune.

If symptoms indicating liver damage occur, such as

loss of appetite,
feeling unwell (nausea),
vomiting,
yellowing of the skin (jaundice),
abdominal pain,
you must stop taking Viramune and contact your doctor immediately.

If you develop severe liver-related, skin-related, or hypersensitivity reactions while taking Viramune,
DO NOT TAKE VIRAMUNE AGAIN WITHOUT FIRST CONSULTING YOUR DOCTOR.
You must take only the dose of Viramune prescribed by your doctor. This is particularly important
during the first 14 days of treatment (see further information in How to take Viramune ).
The following patients are at higher risk of developing liver problems:

women
patients co-infected with hepatitis B or C
patients with abnormal liver function tests
patients who have never been treated before and have a higher CD4+ cell count at the start of Viramune therapy (women above 250 cells/mm³, men above 400 cells/mm³)
patients previously treated, with detectable HIV-1 viral load in the blood and higher CD4+ cell count at the start of Viramune therapy (women above 250 cells/mm³, men above 400 cells/mm³).

In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections (AIDS-defining illnesses), inflammatory signs and symptoms of prior infections may occur shortly after starting anti-HIV treatment. These symptoms are believed to result from improved immune response, enabling the body to fight infections that may have been present without obvious symptoms. If you notice any signs of infection, inform your doctor immediately.
In addition to opportunistic infections, autoimmune disorders (a condition in which the immune system attacks healthy body tissue) may also occur after starting medicines for HIV infection. Autoimmune disorders may occur several months after starting treatment. If you notice any signs of infection or other symptoms such as muscle weakness, initial weakness in hands and feet spreading towards the trunk, palpitations, tremor, or hyperactivity, inform your doctor immediately to receive necessary treatment.
A change in body fat distribution may occur in patients treated with 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 due to reduced blood supply to the bones). Duration of combination antiretroviral therapy, use of corticosteroids, alcohol consumption, severe immune deficiency, and higher body mass index may be among the many risk factors for developing this condition. Signs of osteonecrosis include joint stiffness, discomfort, and pain (especially in hips, knees, and shoulders), and difficulty moving. Contact your doctor if you notice any of these symptoms.
If you are taking nevirapine and zidovudine concomitantly, inform your doctor, as you may need to have your white blood cell levels monitored.
Do not take Viramune after exposure to HIV virus if you have not been diagnosed with the disease and have not been prescribed this medicine by your doctor.
Prednisone must not be used to treat a skin rash related to Viramune.
If you are taking oral contraceptives (e.g., "the pill") or other hormonal birth control methods during treatment with Viramune, you must also use a barrier method of contraception (e.g., a condom) to prevent pregnancy and further transmission of HIV.
If you are on post-menopausal hormone replacement therapy, consult your doctor before taking this medicine.
If you are taking or have been prescribed rifampicin for the treatment of tuberculosis, inform your doctor before taking this medicine with Viramune.

Children and adolescents
Oral suspension of Viramune can be taken by children of all ages, always following the instructions provided by the doctor.
Viramune is also available in tablets, which can be taken by:

children aged at least 16 years
children under 16 years of age who:
- weigh at least 50 kg
- or whose body surface area is greater than 1.25 square meters.

Other medicines and Viramune
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Inform your doctor about all medicines you are taking before starting treatment with Viramune. Your doctor may need to check whether they remain effective and may adjust their dosage. Read the package leaflet of all other HIV medicines you are taking in combination with Viramune carefully.
It is particularly important that you inform your doctor if you are taking or have recently taken:

St. John's wort (Hypericum perforatum, a herbal remedy for depression)
rifampicin (a medicine for the treatment of tuberculosis)
rifabutin (a medicine for the treatment of tuberculosis)
macrolides e.g., clarithromycin (a medicine for the treatment of bacterial infections)
fluconazole (a medicine for the treatment of fungal infections)
ketoconazole (a medicine for the treatment of fungal infections)
itraconazole (a medicine for the treatment of fungal infections)
methadone (a medicine for the treatment of opioid dependence)
warfarin (a medicine to reduce blood clotting)
hormonal contraceptives (e.g., the "pill")
atazanavir (another medicine for the treatment of HIV)
lopinavir/ritonavir (another medicine for the treatment of HIV)
fosamprenavir (another medicine for the treatment of HIV)
efavirenz (another medicine for the treatment of HIV)
etravirine (another medicine for the treatment of HIV)
rilpivirine (another medicine for the treatment of HIV)
zidovudine (another medicine for the treatment of HIV)
elvitegravir/cobicistat (another medicine for the treatment of HIV)

Your doctor will carefully monitor the effect of Viramune and each of these medicines if you are taking them together.
If you are undergoing renal dialysis, your doctor will consider adjusting the dose of Viramune, as dialysis may partially remove Viramune from the blood.

Viramune with food and drinks
There are no restrictions regarding taking Viramune with food or drinks.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
Breastfeeding is not recommended for HIV-positive women, as HIV infection can be transmitted to the infant through breast milk.
If you are breastfeeding or considering breastfeeding, you must discuss this with your doctor as soon as possible.

Driving and using machines
Fatigue may occur while taking Viramune. Be cautious when engaging in activities such as driving or operating tools or machinery. If you experience fatigue, avoid potentially dangerous activities such as driving or operating tools or machinery.

Viramune contains sucrose, sorbitol, methyl parahydroxybenzoate, propyl parahydroxybenzoate and sodium
Viramune oral suspension contains 150 mg of sucrose per mL. This should be taken into account in patients with diabetes mellitus. If your doctor has diagnosed you with intolerance to certain sugars, contact them before taking this medicine. It may be harmful to teeth.
Viramune oral suspension contains 162 mg of sorbitol per mL. Sorbitol is a source of fructose. If your doctor has told you (or the child) that you are intolerant to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, speak with your doctor before (you or the child) take this medicine.
Viramune oral suspension contains methyl parahydroxybenzoate and propyl parahydroxybenzoate. These excipients may, over time, cause allergic reactions.
Viramune oral suspension contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially 'sodium-free'.

3. How to take Viramune

Do not take Viramune on your own initiative. You must take it in combination with at least two other antiretroviral medicines. Your doctor will prescribe the most appropriate medicines for you.
Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The usual dose is the same for all adults (20 mL).
Your doctor will calculate the dose for the child based on age, weight, or body surface area. Make sure the child's doctor clearly explains to you the dose to be administered.

For adults
The adult dose is 20 mL (200 mg) once daily for the first 14 days of treatment (“induction phase”). After 14 days, the usual dose is 20 mL (200 mg) twice daily.
It is very important that you take only 20 mL of Viramune per day during the first 14 days (“induction phase”). If you develop any skin rash during this period, do not increase the dose but contact your doctor immediately.
Viramune is also available as 200 mg tablets for adults (patients aged 16 years and older).

For children
The dose for children is 4 mg/kg body weight or 150 mg/m² body surface area once daily for the first 14 days of treatment (“induction phase”). After this, treatment will be increased to two doses per day. Your doctor will calculate the correct dose based on the child's weight or body surface area.
It is very important that the child takes Viramune only once daily during the first 14 days (“induction phase”). If the child develops any skin rash during this period, do not increase the dose but contact the doctor immediately.
Viramune is also available as 200 mg tablets for older children, particularly adolescents weighing more than 50 kg or whose body surface area exceeds 1.25 m². Your doctor will inform you precisely about the appropriate dose for the child and will regularly monitor the child's weight and body surface area to ensure correct dosing. In case of doubt, consult your doctor or pharmacist.

Viramune oral suspension must be gently shaken before administration. Measure the exact dose using an oral dosing syringe.
If you are an adult and choose a dosing device (e.g. a dosing cup or spoon), make sure you take the entire dose, as some of the Viramune may remain in the cup or spoon. To do this, thoroughly rinse the device used and drink the rinse water.
The oral dosing syringe and dosing cup are not supplied with Viramune oral suspension. Ask your pharmacist for a dosing syringe or cup if you do not already have one.

The 14-day “induction phase” has been shown to reduce the incidence of skin reactions.
Since Viramune must always be taken with other antiretroviral medicines, you must also carefully follow the instructions provided in the package leaflets of these other medicines.
You must continue taking Viramune for the duration prescribed by your doctor.

As explained in the section “Warnings and precautions” above, your doctor will perform periodic checks, including liver function tests, and will monitor for adverse effects such as skin rash. Depending on the results, your doctor may decide to temporarily interrupt or discontinue treatment with Viramune. Your doctor may also decide whether to restart the medicine at a lower dose.

Viramune oral suspension is a liquid formulation and must be taken by mouth only.
Gently shake the bottle before use.

If you take more Viramune than you should
Do not take more Viramune than prescribed by your doctor and described in this leaflet. Currently, there is limited information on the effects of Viramune overdose. If you have taken more Viramune than prescribed, consult your doctor immediately.

If you forget to take Viramune
Try not to miss any doses. If you realize within 8 hours that you have missed a dose, take the missed dose as soon as possible. If more than 8 hours have passed, take only the next dose at the scheduled time.

If you stop taking Viramune
Taking all doses at the correct times:

greatly increases the effectiveness of your antiretroviral medicines
reduces the likelihood that HIV infection will become resistant to the medicines you are taking.

It is important to continue taking Viramune correctly as described above, unless your doctor tells you to stop treatment.
If you stop taking Viramune for more than 7 days, your doctor will advise you on how to restart the 14-day “induction phase” (described above) before returning to the twice-daily dose.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

During HIV therapy, an increase in weight and in blood levels of lipids and glucose may occur.
This is partly related to the recovery of health status and lifestyle, and, in the case of blood lipids,
sometimes also to the HIV medicines themselves. Your doctor will monitor these changes.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

As described above in “Warnings and precautions”, the most important side effects of Viramune are skin reactions and serious liver damage, which can be severe and life-threatening. These reactions occur mainly during the first 18 weeks of treatment with Viramune. This is therefore a critical period requiring close medical monitoring.

If you notice any sign of a skin reaction, inform your doctor immediately.

When occurring, the rash is usually mild or moderate. However, in some patients, a rash appearing as a skin eruption with blisters may be severe or life-threatening (Stevens-Johnson syndrome and toxic epidermal necrolysis), and fatal cases have been reported.

The majority of both severe and mild/moderate skin reactions occurred within the first six weeks of treatment.

If a rash develops and you also feel unwell, you must stop treatment and see your doctor immediately. Pay particular attention to any skin rash in the child. Although such rashes may appear normal (e.g. diaper rash), they could be rashes caused by Viramune. When in doubt, consult the child’s doctor.

Hypersensitivity (allergic) reactions may occur. These reactions may present as anaphylaxis (a severe form of allergic reaction) with symptoms such as:

skin rash
swelling of the face
difficulty breathing (bronchospasm)
anaphylactic shock

Hypersensitivity reactions may also present as skin rashes together with other side effects such as:

fever
skin blisters
mouth ulcers
eye inflammation
swelling of the face
general swelling
shortness of breath
muscle or joint pain
reduction in white blood cell count (granulocytopenia)
general feeling of being unwell
severe liver or kidney problems (liver or kidney dysfunction).

Inform your doctor immediately if you develop a skin rash and any of the other side effects associated with hypersensitivity (allergy). These reactions can be life-threatening.

Abnormal liver function has been reported with the use of Viramune, including some cases of liver inflammation (hepatitis), which may be sudden and severe (fulminant hepatitis), and liver dysfunction, both of which can be fatal.

Inform your doctor if you experience any of the following clinical symptoms of liver damage:

loss of appetite
feeling unwell (nausea)
vomiting
yellowing of the skin (jaundice)
abdominal pain

The side effects listed below have been reported in patients treated with Viramune:

Very common (may affect more than 1 in 10 people):

skin rash

Common (may affect up to 1 in 10 people):

decrease in white blood cell count (granulocytopenia)
allergic reactions (hypersensitivity)
headache
feeling unwell (nausea)
vomiting
abdominal pain
loss of faeces (diarrhoea)
liver inflammation (hepatitis)
feeling of tiredness (fatigue)
fever
abnormal liver function tests

Uncommon (may affect up to 1 in 100 people):

allergic reaction characterised by skin rash, swelling of the face, difficulty breathing (bronchospasm), or anaphylactic shock
decrease in red blood cell count (anaemia)
yellowing of the skin (jaundice)
severe, life-threatening skin rashes (Stevens-Johnson syndrome/toxic epidermal necrolysis)
urticaria
fluid accumulation under the skin (angioedema)
joint pain (arthralgia)
muscle pain (myalgia)
decreased levels of phosphorus in the blood
increased blood pressure

Rare (may affect up to 1 in 1,000 people):

sudden and severe liver inflammation (fulminant hepatitis)
drug reaction with systemic symptoms (drug reaction with eosinophilia and systemic symptoms, DRESS).

The following side effects have also been reported when Viramune has been used in combination with other antiretroviral agents:

decrease in red blood cells or platelets,
inflammation of the pancreas,
reduced or abnormal skin sensitivity.

These cases are commonly associated with other antiretroviral agents and may occur when Viramune is used in combination with other agents; however, it is unlikely that these changes are caused by treatment with Viramune.

Additional side effects in children and adolescents

A decrease in white blood cell count (granulocytopenia) may occur more commonly in children. A decrease in red blood cells (anaemia), which may be associated with nevirapine therapy, is also more commonly observed in children. As with skin rashes, inform your doctor of any side effects.

Reporting of side effects

If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Viramune

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after "Exp.". The expiry date refers to the last day of that month.
Viramune should be used within 6 months after first opening the bottle.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Viramune contains

The active substance is nevirapine. Each 5 mL contains 50 mg of the active substance nevirapine (as monohydrate).
The other ingredients are: carbomer, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sorbitol, sucrose, polysorbate 80, sodium hydroxide and water.

Description of the appearance of Viramune and contents of the pack
Viramune oral suspension is a homogeneous, white to almost white suspension.
Viramune oral suspension is available in plastic bottles, each containing 240 mL of suspension.
Viramune is also available as 200 mg tablets for older children and adults.

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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Boehringer Ingelheim SComm
Boehringer Ingelheim RCV GmbH & Co KG
Tél/Tel: +32 2 773 33 11
Lietuvos filialas
Tel.: +370 5 2595942

България Luxembourg/Luxemburg
Бьорингер Ингелхайм РЦВ ГмбХ и Ко КГ -
Boehringer Ingelheim RCV GmbH & Co KG
клон България
Тел: +359 2 958 79 98
Boehringer Ingelheim SComm
Tél/Tel: +32 2 773 33 11

Česká republika Magyarország
Boehringer Ingelheim spol. s r.o.
Tel: +420 234 655 111
Boehringer Ingelheim RCV GmbH & Co KG
Magyarországi Fióktelepe
Tel.: +36 1 299 8900

Danmark Malta
Boehringer Ingelheim Danmark A/S
Tlf.: +45 39 15 88 49
Boehringer Ingelheim Ireland Ltd.
Tel: +35 31 295 9620

Deutschland Nederland
Boehringer Ingelheim Pharma GmbH & Co. KG
Tel: +49 (0) 800 77 90 900
Boehringer Ingelheim B.V.
Tel: +31 (0) 800 22 55 889

Eesti Norge
Boehringer Ingelheim RCV GmbH & Co KG
Eesti Filiaal
Tel: +372 612 8000
Boehringer Ingelheim Danmark
Norwegian branch
Tlf: +47 66 76 13 00

Ελλάδα Österreich
Boehringer Ingelheim Ελλάς Μονοπρόσωπη Α.Ε.
Tηλ: +30 2 10 89 06 300
Boehringer Ingelheim RCV GmbH & Co KG
Tel: +43 1 80 105-7870

España Polska
Boehringer Ingelheim España, S.A.
Tel: +34 93 404 51 00
Boehringer Ingelheim Sp. z o.o.
Tel.: +48 22 699 0 699

France Portugal
Boehringer Ingelheim France S.A.S.
Tél: +33 3 26 50 45 33
Boehringer Ingelheim Portugal, Lda.
Tel: +351 21 313 53 00

Hrvatska România
Boehringer Ingelheim Zagreb d.o.o.
Tel: +385 1 2444 600
Boehringer Ingelheim RCV GmbH & Co KG
Viena – Sucursala Bucuresti
Tel: +40 21 302 2800

Ireland Slovenija
Boehringer Ingelheim Ireland Ltd.
Tel: +353 1 295 9620
Boehringer Ingelheim RCV GmbH & Co KG
Podružnica Ljubljana
Tel: +386 1 586 40 00

Ísland Slovenská republika
Vistor ehf.
Tel: +354 535 7000
Boehringer Ingelheim RCV GmbH & Co KG
organizačná zložka
Tel: +421 2 5810 1211

Italia Suomi/Finland
Boehringer Ingelheim Italia S.p.A.
Tel: +39 02 5355 1
Puh/Tel: +358 10 3102 800

Κύπρος Sverige
Boehringer Ingelheim Ελλάς Μονοπρόσωπη Α.Ε.
Tηλ: +30 2 10 89 06 300
Boehringer Ingelheim AB
Tel: +46 8 721 21 00

Latvija United Kingdom (Northern Ireland)
Boehringer Ingelheim RCV GmbH & Co KG
Latvijas filiāle
Tel: +371 67 240 011
Boehringer Ingelheim Ireland Ltd.
Tel: +353 1 295 9620

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu .

Package leaflet: Information for the user

Viramune 400 mg prolonged-release tablets

nevirapine
Please read this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

What Viramune is and what it is used for
What you need to know before taking Viramune
How to take Viramune
Possible side effects
How to store Viramune
Contents of the pack and other information

1. What Viramune is and what it is used for

Viramune belongs to a group of medicines called antiretrovirals, used in the treatment of human immunodeficiency virus (HIV-1) infection.
The active substance of the 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 blocks the activity of reverse transcriptase. By blocking the activity of reverse transcriptase, Viramune helps control HIV-1 infection.
Viramune is indicated for the treatment of HIV-1 infected adults, adolescents, and children of all ages. You must take Viramune in combination with other antiretroviral medicines. Your doctor will recommend the most appropriate medicines for you.
Viramune extended-release tablets should only be used after a two-week treatment period with another type of Viramune (immediate-release tablets or oral suspension), except in cases where you are currently on Viramune therapy and are switching to the extended-release formulation.

2. What you should know before taking Viramune

Do not take Viramune

if you are allergic to nevirapine or to any of the other ingredients of this medicine (listed in section 6).
if you have previously taken Viramune and had to stop treatment because you experienced:
- severe skin rash,
- skin rash accompanied by other symptoms, for example:
  - fever
  - blisters
  - mouth ulcers
  - eye inflammation
  - facial swelling
  - general swelling
  - shortness of breath
  - muscle or joint pain
  - general feeling of illness
  - abdominal pain
  - hypersensitivity reactions (allergic reactions)
  - liver inflammation (hepatitis)
if you have severe liver disease
if you previously discontinued treatment with Viramune due to liver function abnormalities
if you are taking medicines containing St. John’s wort (Hypericum perforatum). This substance may prevent Viramune from working properly.

Warnings and precautions
Talk to your doctor or pharmacist before taking Viramune.
During the first 18 weeks of treatment with Viramune, it is very important that you and your doctor
remain alert for any signs of liver-related or skin reactions. These may become serious and even life-
threatening. Your risk of such reactions is highest during the first 6 weeks of treatment.
If you develop a severe skin rash or hypersensitivity (i.e., allergic reactions which may present as a
rash) accompanied by any of the following adverse effects:

fever,
blisters,
mouth ulcers,
eye inflammation,
facial swelling,
general swelling,
shortness of breath,
muscle or joint pain,
general feeling of illness,
or abdominal pain,
YOU MUST STOP TAKING VIRAMUNE AND CONTACT YOUR DOCTOR IMMEDIATELY, as these
reactions can potentially be life-threatening or fatal.
If you develop only a mild skin rash without any other reaction, you should still inform your doctor
immediately. Your doctor will advise you whether you should discontinue taking Viramune.

If symptoms indicating liver damage occur, such as

loss of appetite,
feeling unwell (nausea),
vomiting,
yellowing of the skin or eyes (jaundice),
abdominal pain,
you must stop taking Viramune and contact your doctor immediately.

If you develop severe liver-related, skin, or hypersensitivity reactions while taking Viramune, DO
NOT TAKE VIRAMUNE AGAIN without first consulting your doctor.
You must take only the dose of Viramune prescribed by your doctor. This is particularly important
during the first 14 days of treatment (see further information in “How to take Viramune”).
The following patients are at increased risk of developing liver problems:

women
patients co-infected with hepatitis B or C
patients with abnormal liver function test results
patients who have never been previously treated and have higher CD4+ cell counts at the start of Viramune therapy (women >250 cells/mm³, men >400 cells/mm³)
patients who have been previously treated, with detectable HIV-1 viral load in the blood and higher CD4+ cell counts at the start of Viramune therapy (women >250 cells/mm³, men >400 cells/mm³).

In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections (AIDS-defining illnesses), inflammatory signs and symptoms of prior infections may occur shortly after starting anti-HIV treatment. These symptoms are believed to result from an improved immune response, allowing the body to fight infections that may have been present without obvious symptoms. If you notice any signs of infection, inform your doctor immediately.
In addition to opportunistic infections, autoimmune disorders (a condition in which the immune system attacks healthy body tissue) may also occur after starting medications for HIV infection. Autoimmune disorders may occur several months after starting treatment. If you notice any signs of infection or other symptoms such as muscle weakness, initial weakness in hands and feet spreading toward the trunk, palpitations, tremor, or hyperactivity, contact your doctor immediately for necessary treatment.
Changes in body fat distribution may occur in patients treated with 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 due to reduced blood supply to the bones). Duration of combination antiretroviral therapy, use of corticosteroids, alcohol consumption, severe immune deficiency, and higher body mass index may be among the many risk factors for developing this condition. Signs of osteonecrosis include joint stiffness, discomfort, and pain (particularly in the hips, knees, and shoulders), and difficulty moving. Contact your doctor if you experience any of these symptoms.
If you are taking nevirapine together with zidovudine, inform your doctor, as you may need to have your white blood cell levels monitored.
Do not take Viramune after exposure to HIV virus if you have not been diagnosed with the disease and have not been prescribed this medicine by your doctor.
Prednisone must not be used to treat a skin rash related to taking Viramune.
If you are using oral contraceptives (e.g., “the pill”) or other hormonal birth control methods while taking Viramune, you must also use a barrier method of contraception (e.g., a condom) to prevent pregnancy and further transmission of HIV.
If you are undergoing post-menopausal hormone replacement therapy, consult your doctor before taking this medicine.
If you are taking or have been prescribed rifampicin for the treatment of tuberculosis, inform your doctor before taking this medicine with Viramune.
Extended-release tablets of Viramune or parts of the tablets may occasionally be seen in the stool. They may resemble intact tablets, but this has not been shown to affect the efficacy of nevirapine.

Children and adolescents
Viramune 400 mg extended-release tablets may be taken by children if:

they are ≥8 years of age and weigh 43.8 kg or more
they are older than 3 years and younger than 8 years and weigh 25 kg or more
they have a body surface area of 1.17 m² or more.

An oral suspension is available for younger children.

Other medicines and Viramune
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Inform your doctor about all medications you are taking before starting treatment with Viramune. Your doctor may need to check whether they remain effective and may adjust their dosage. Read the package leaflet of all other HIV medicines you are taking in combination with Viramune carefully.
It is particularly important that you inform your doctor if you are taking or have recently taken:

St. John’s wort (Hypericum perforatum, a herbal remedy for depression)
rifampicin (a medicine used to treat tuberculosis)
rifabutin (a medicine used to treat tuberculosis)
macrolides e.g., clarithromycin (a medicine used to treat bacterial infections)
fluconazole (a medicine used to treat fungal infections)
ketoconazole (a medicine used to treat fungal infections)
itraconazole (a medicine used to treat fungal infections)
methadone (a medicine used to treat opioid dependence)
warfarin (a medicine used to reduce blood clotting)
hormonal contraceptives (e.g., “the pill”)
atazanavir (another medicine used to treat HIV)
lopinavir/ritonavir (another medicine used to treat HIV)
fosamprenavir (another medicine used to treat HIV)
efavirenz (another medicine used to treat HIV)
etravirine (another medicine used to treat HIV)
rilpivirine (another medicine used to treat HIV)
zidovudine (another medicine used to treat HIV)
elvitegravir/cobicistat (another medicine used to treat HIV)

Your doctor will carefully monitor the effects of Viramune and each of these medicines if you are taking them together.

Taking Viramune with food and drink
There are no restrictions on taking Viramune with food or drink.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Breastfeeding is not recommended for HIV-positive women, as HIV infection can be transmitted to the infant through breast milk.
If you are breastfeeding or considering breastfeeding, you must discuss this with your doctor as soon as possible.

Driving and using machines
Viramune may cause fatigue. Be cautious when engaging in activities such as driving or operating machinery. If you experience fatigue, avoid potentially dangerous activities such as driving or operating tools or machinery.

Viramune contains lactose
Viramune extended-release tablets contain lactose (milk sugar).
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Viramune

Dosage
Adults
The dose is one 200 mg Viramune tablet daily for the first 14 days of treatment (“induction phase”). A separate pack of 200 mg immediate-release tablets of Viramune is available for the induction phase. After 14 days, the usual dose is one 400 mg extended-release tablet once daily.

It is very important that you take only one tablet of Viramune per day during the first 14 days (“induction phase”). If you develop any skin rash during this period, do not start taking the extended-release tablets of Viramune, but contact your doctor immediately.

The 14-day “induction phase” has been shown to reduce the incidence of skin reactions.

Patients already being treated with immediate-release tablets or oral suspension may switch directly to extended-release tablets without undergoing the induction phase.

Since Viramune must always be taken with other antiretroviral medicines, you must also carefully follow the instructions for the other medicines you are taking. These are available in the respective package leaflets.

Viramune is also available as an oral suspension (for all age groups, weight, and body surface area).

You must continue taking Viramune for the duration prescribed by your doctor.

As explained in the section “Warnings and precautions” above, your doctor will perform periodic checks, including liver function tests, and monitor for adverse effects such as skin rash. Depending on the results, your doctor may decide to temporarily interrupt or discontinue treatment with Viramune. Your doctor may consider restarting the medicine at a lower dose.

If you have any degree of renal or hepatic impairment, use only Viramune 200 mg tablets or Viramune 50 mg/5 mL oral suspension.

Take Viramune extended-release tablets by mouth only. Do not chew the extended-release tablets. You may take Viramune with or without food.

If you forget to take Viramune
Try not to miss any doses. If you realize within 12 hours that you have missed a dose, take the missed dose as soon as possible. If more than 12 hours have passed, take only the next dose at the scheduled time.

If you stop taking Viramune
Taking all doses at the correct times:

greatly increases the effectiveness of your antiretroviral medicines
reduces the likelihood that HIV infection will become resistant to the medicines you are taking.

It is important to continue taking Viramune correctly as described above, unless your doctor advises you to stop treatment.

If you stop taking Viramune for more than 7 days, your doctor will instruct you to restart the 14-day “induction phase” with Viramune tablets (as described above) before resuming once-daily extended-release tablets.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

During HIV therapy, an increase in weight and in blood lipid and glucose levels may occur.
This is partly related to the recovery of health status and lifestyle, and in the case of blood lipids, sometimes also to the HIV medicines themselves. Your doctor will monitor these changes.

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
As described above in "Warnings and precautions", the most important side effects of Viramune are skin reactions which can be severe and life-threatening, and serious liver damage. These reactions occur mainly within the first 18 weeks of treatment with Viramune. This is therefore a critical period requiring close medical monitoring.

If you notice any sign of a skin reaction, inform your doctor immediately.
When it occurs, the rash is usually mild or moderate. However, in some patients, a rash appearing as a skin eruption with blisters can be severe or life-threatening (Stevens-Johnson syndrome and toxic epidermal necrolysis), and fatal cases have been reported.
The majority of both severe and mild/moderate skin reactions occurred within the first six weeks of treatment.

If a rash develops and you also feel unwell, you must stop treatment and contact your doctor immediately.

Hypersensitivity (allergic) reactions may occur. These reactions may present as anaphylaxis (a severe form of allergic reaction) with symptoms such as:

skin rash
swelling of the face
difficulty breathing (bronchospasm)
anaphylactic shock

Hypersensitivity reactions may also present as skin rashes together with other side effects such as:

fever
skin blisters
mouth ulcers
eye inflammation
swelling of the face
general swelling
shortness of breath
muscle or joint pain
reduction in white blood cell count (granulocytopenia)
general feeling of being unwell
severe liver or kidney problems (liver or kidney failure).

Inform your doctor immediately if you develop a skin rash and any of the other side effects associated with hypersensitivity (allergic) reactions. These reactions can be life-threatening.

Inform your doctor if you experience any of the following clinical signs of liver damage:

loss of appetite
feeling unwell (nausea)
vomiting
yellowing of the skin (jaundice)
abdominal pain

The following side effects were reported in patients treated with Viramune 200 mg tablets during the 14-day induction phase:
Common (may affect up to 1 in 10 people):

skin rash
fever
headache
abdominal pain
feeling unwell (nausea)
loose stools (diarrhea)
feeling tired (fatigue)

Uncommon (may affect up to 1 in 100 people):

allergic reactions (hypersensitivity)
allergic reaction characterized by skin rash, swelling of the face, difficulty breathing (bronchospasm), or anaphylactic shock
drug reaction with systemic symptoms (drug reaction with eosinophilia and systemic symptoms)
sudden and severe liver inflammation (fulminant hepatitis)
severe, life-threatening skin rashes (Stevens-Johnson syndrome/toxic epidermal necrolysis)
yellowing of the skin (jaundice)
urticaria
fluid under the skin (angioneurotic edema)
vomiting
muscle pain (myalgia)
joint pain (arthralgia)
decrease in white blood cell count (granulocytopenia)
abnormal liver function tests
decreased blood phosphorus levels
increased blood pressure

Rare (may affect up to 1 in 1,000 people):

liver inflammation (hepatitis)
reduction in red blood cell count (anaemia)

The following side effects were reported in patients treated with once-daily extended-release Viramune tablets during the maintenance phase:
Common (may affect up to 1 in 10 people):

skin rash
headache
abdominal pain
feeling unwell (nausea)
liver inflammation (hepatitis)
feeling tired (fatigue)
abnormal liver function tests
fever
vomiting
loose stools (diarrhea)

Uncommon (may affect up to 1 in 100 people):

allergic reactions (hypersensitivity)
allergic reaction characterized by skin rash, swelling of the face, difficulty breathing (bronchospasm), or anaphylactic shock
drug reaction with systemic symptoms (drug reaction with eosinophilia and systemic symptoms)
sudden and severe liver inflammation (fulminant hepatitis)
severe, life-threatening skin rashes (Stevens-Johnson syndrome/toxic epidermal necrolysis)
reduction in red blood cell count (anaemia)
decrease in white blood cell count (granulocytopenia)
yellowing of the skin (jaundice)
urticaria
fluid under the skin (angioneurotic edema)
muscle pain (myalgia)
joint pain (arthralgia)
decreased blood phosphorus levels
increased blood pressure

The following side effects have also been reported when Viramune was used in combination with other antiretroviral agents:

reduction in red blood cell or platelet count
inflammation of the pancreas
reduced or abnormal skin sensation. These cases are commonly associated with other antiretroviral agents and may occur when Viramune is used in combination with other agents; however, it is unlikely that these changes are caused by Viramune treatment alone.

Additional side effects in children and adolescents
A decrease in white blood cell count (granulocytopenia) may occur more commonly in children. Reduction in red blood cells (anaemia), which may be associated with nevirapine therapy, is also more commonly observed in children. As with skin rashes, inform your doctor of any side effects.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Viramune

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or bottle after "Exp." and on the blister after "EXP". The expiry date refers to the last day of that month.
Viramune should be used within 2 months of opening the bottle.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Viramune contains

The active substance is nevirapine. Each prolonged-release tablet contains 400 mg of nevirapine.
The other components are lactose (as monohydrate), hypromellose, yellow iron oxide, and magnesium stearate.

Description of the appearance of Viramune and the contents of the pack
Prolonged-release tablets, yellow, oval, biconvex. The prolonged-release tablets
are approximately 9.3 mm × 19.1 mm in size, with "V04" engraved on one side and the company logo on the
opposite side. Viramune 400 mg prolonged-release tablets are available in blisters containing 30 or 90
prolonged-release tablets per pack. Alternatively, the pack of 30 prolonged-release tablets
is also available in a bottle. Not all pack sizes may be marketed.
Viramune is also available as an oral suspension or as tablets.

Marketing Authorization 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder: