VIRAMUNE 200 mg Coated Tablets

Зміст інструкції

1. Viramune 200 mg tablets
   1. What is Viramune and what it is used for
   2. What you need to know before taking Viramune
   3. How to take Viramune
   4. Possible side effects
   5. How to store Viramune
   6. Contents of the pack and other information
2. Viramune 50 mg/5 mL oral suspension
   1. What is Viramune and what is it used for
   2. What you need to know before taking Viramune
   3. How to take Viramune
   4. Possible side effects
   5. How to store Viramune
   6. Contents of the pack and other information
3. Viramune 400 mg prolonged-release tablets
   1. What is Viramune and what it is used for
   2. What you need to know before taking Viramune
   3. How to take Viramune
   4. Possible side effects
   5. How to store Viramune
   6. Contents of the pack and other information

Viramune 200 mg tablets

nevirapine

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Viramune is and what it is used for
• 2. What you need to know before you take Viramune
• 3. How to take Viramune
• 4. Possible side effects
• 5. How to store Viramune
• 6. Contents of the pack and other information

1. What is Viramune 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 to multiply. Nevirapine blocks the activity
of reverse transcriptase. By blocking the activity of reverse transcriptase, Viramune helps to control
HIV-1 infection.
Viramune is indicated for the treatment of adults, adolescents and children of all ages infected with
HIV-1 virus.
You must take Viramune with other antiretroviral medicines. Your doctor will recommend the medicines
most suitable for you.

If Viramune has been prescribed for the child, all the information contained in this leaflet
is addressed to him (in this case understand “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 any of the other ingredients of this medicine (listed in section 6).
• if you have taken Viramune before and had to stop treatment because you suffered from:
• severe skin rash
• skin rash with other symptoms, for example:
• fever
• blisters
• ulcers in the mouth
• eye inflammation
• facial swelling
• general swelling
• shortness of breath
• muscle or joint pain
• general feeling of being unwell
• abdominal pain
• hypersensitivity (allergic) reactions
• liver inflammation (hepatitis)
• if you have severe liver disease
• if in the past you have had to stop treatment with Viramune due to changes in liver function
• if you are taking medicines containing St John's Wort extract (Hypericum perforatum). This substance can prevent Viramune from working correctly.

Warnings and precautions
Talk to your doctor or pharmacist before taking Viramune.
During the first 18 weeks of therapy with Viramune it is very important that you and your doctor
pay attention to the appearance of any signs of reactions affecting the liver or
skin. These can become serious and even life-threatening. You are at greatest
risk of these reactions during the first 6 weeks of treatment.
If you develop a severe skin rash or hypersensitivity (i.e. allergic reactions that
can appear as a rash) accompanied by other unwanted effects such as

• fever,
• blisters,
• ulcers in the mouth,
• eye inflammation,
• facial swelling,
• general swelling,
• shortness of breath,
• muscle or joint pain,
• general feeling of being unwell,
• or abdominal painYOU MUST STOP TAKING VIRAMUNE AND CONTACTIMMEDIATELY your doctor as these reactions can be potentially life-threateningor cause death.If you have only had a mild skin rash without any other reaction, still inform yourdoctor immediately, who will advise you whether to stop taking Viramune.

If symptoms appear indicating liver damage, such as

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

If you develop severe reactions affecting the liver, skin or hypersensitivity while taking
Viramune, DO NOT TAKE IT AGAIN without first consulting your doctor.
You must only take 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 test values
• patients never previously treated with a higher CD4 cell count at the start of Viramune therapy (women more than 250 cells/mm³, men more than 400 cells/mm³)
• patients previously treated, with detectable HIV-1 viral load in the blood and with a higher CD4 cell count at the start of Viramune therapy (women more than 250 cells/mm³, men more than 400 cells/mm³).

In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection
(disease that defines AIDS), shortly after starting anti-HIV treatment, inflammatory signs and symptoms of previous infections may occur. These symptoms are thought to be due to an
improvement in the body’s immune response, which allows the body to fight
infections that may have been present without obvious symptoms. If you notice any symptoms of
infection, please inform your doctor immediately.
In addition to opportunistic infections, autoimmune disorders (a
condition that occurs when the immune system attacks healthy tissue in the body) may also occur after you
have started taking medicines to treat HIV infection. Autoimmune disorders
can occur many months after starting treatment. If you notice any symptoms of infection or
other symptoms such as muscle weakness, initial weakness in hands and feet that rises towards the trunk of
the body, palpitations, tremor or hyperactivity, inform your doctor immediately for
necessary treatment.
In patients treated with combination antiretroviral therapy, a change in
body fat may occur. 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 reduced blood flow to the bones).
The duration of combination antiretroviral therapy, the use of corticosteroids, alcohol consumption, severe weakening of the immune system and a higher body mass index may
be some of the numerous risk factors for the development of this disease. Signs of osteonecrosis
are joint stiffness, discomfort and pain (especially in the hips, knees and shoulders) and
difficulty moving. See your doctor if you notice any of these symptoms.
If you are taking nevirapine and zidovudine concurrently, tell your doctor as they may
need to check your white blood cell levels.

Do not take Viramune after exposure to the HIV virus unless you have been diagnosed with the disease and
it has been prescribed by your doctor.
Prednisone should not be used to treat a skin rash related to taking
Viramune.
If you are taking oral contraceptives (e.g. "the pill") or other hormonal methods of birth control during treatment with Viramune, you should 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, ask your doctor for advice before taking
this medicine.
If you are taking or have been prescribed rifampicin to treat tuberculosis, tell 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. Tell your doctor about all the medicines you are taking before you start
treatment with Viramune. Your doctor may need to check whether they are still
HIV medicines that you are taking in combination with Viramune.
It is particularly important that you tell your doctor if you are taking or have recently taken:

• St John's Wort ( Hypericum perforatum, medicine for the treatment of depression)
• rifampicin (medicine for the treatment of tuberculosis)
• rifabutin (medicine for the treatment of tuberculosis)
• macrolides e.g. clarithromycin (medicine for the treatment of bacterial infections)
• fluconazole (medicine for the treatment of fungal infections)
• ketoconazole (medicine for the treatment of fungal infections)
• itraconazole (medicine for the treatment of fungal infections)
• methadone (medicine for the treatment of opioid addictions)
• warfarin (medicine for reducing 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) The doctor will carefully monitor the effect of Viramune and each of these medicines if you are taking them in combination. If you are undergoing renal dialysis, your doctor will consider an adjustment of the dose of Viramune, as dialysis can partially remove Viramune from the blood.

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

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant ask your doctor
or pharmacist for advice before taking this medicine.
Breastfeeding is not recommendedfor HIV-positive women as HIV infection can be
transmitted to the baby through breast milk.
If you are breastfeeding or are thinking about breastfeeding you must talk toyour doctor as soon as possible.

Driving and using machines
While using Viramune, you may experience fatigue. Be careful when
engaged in activities such as driving or using any tools or machinery. If you feel tired, you should avoid potentially dangerous activities such as driving or using any
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 them 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

Do not take Viramune on your own initiative. You must take it in association with at least two other
antiretroviral medicines. Your doctor will prescribe the medicines most suitable for you.
Take this medicine following your doctor’s instructions exactly. If you have any doubts, consult
your doctor or pharmacist.
Dosage:
The dose is one 200 mg tablet 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 for the first 14 days (“induction
phase”). If you develop any skin rash during this period, do not increase the dose,
but contact your doctor.
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 relating to the other medicines you are taking; these are available in
their respective package leaflets.
Viramune is also available in liquid formulation, as a liquid oral suspension, which is
particularly indicated in cases of:

• problems swallowing the 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 to take Viramune for the time established by your doctor.
As explained in the "Warnings and precautions"section, above, your doctor will perform periodic
checks, such as liver function tests, and assess the appearance of undesirable effects, such as
skin rash. Depending on the outcome, your doctor may decide to temporarily interrupt or
stop treatment with Viramune. Your doctor may decide to restart the medicine with a
lower dosage.
Take Viramune tablets only by mouth. Do not chew the tablets. You can take Viramune with
or without food.

If you take more Viramune than you should
At the moment there is little information about the effects of Viramune overdose. If you have
taken more Viramune than the prescribed dose, consult your doctor.

If you forget to take Viramune
Try not to miss any dose. If you realise within 8 hours that you have forgotten 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 appropriate times:

• greatly increases the effectiveness of your antiretroviral medicines
• decreases the possibility that HIV infection becomes resistant to the medicines you are taking.

It is important to continue taking Viramune correctly, as described above, unless your
doctor asks you to stop treatment.
If you stop Viramune for more than 7 days, your doctor will explain how to restart the 14 days of
“induction phase” (described above) before returning to the dose of two tablets daily.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

During HIV therapy, an increase in weight and levels of lipids and glucose in the blood may occur.
This is partly related to the restoration of health and lifestyle, and in the case of blood lipids, sometimes to the
HIV medications themselves. The doctor will check for these changes.
Like all medicines, this medicine can cause side effects, although not everyone will experience 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 within the first 18 weeks of treatment with Viramune. This is therefore an important
period that requires close monitoring by the doctor.
If you notice any signs of a skin reaction, inform your doctor immediately.
When it occurs, the rash is usually mild or moderate. However, in some patients, a rash, which appears as a
blistering skin rash, can be severe or life-threatening (Stevens-Johnson syndrome and toxic epidermal necrolysis),
and cases of death have been reported.
Most cases, both as severe skin reactions and as mild/moderate skin reactions, have occurred within the first six
weeks of treatment.
If you develop a rash and also feel unwell, you should stop treatment and go to your doctor immediately.
Hypersensitivity (allergic) reactions may occur. These reactions can manifest 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 can also manifest as skin rashes 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
• decreased number of white blood cells (granulocytopenia)
• general feeling of being unwell
• serious liver or kidney problems (liver or kidney failure).

Inform your doctor immediately if you develop a skin rash and any of the other hypersensitivity (allergic)
reaction side effects. These reactions can be life-threatening.
Abnormal liver function has been reported with the use of Viramune, these include some cases of liver
inflammation (hepatitis), which can be sudden and severe (fulminant hepatitis) and liver 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 by 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):

• decreased number of white blood cells (granulocytopenia)
• allergic reactions (hypersensitivity)
• headache
• feeling unwell (nausea)
• vomiting
• abdominal pain
• loose stools (diarrhea)
• liver inflammation (hepatitis)
• feeling tired (fatigue)
• fever
• abnormal liver function tests

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

• allergic reaction characterized by skin rash, facial swelling, difficulty breathing (bronchospasm) or anaphylactic shock
• decreased number of red blood cells (anemia)
• yellowing of the skin (jaundice)
• severe and life-threatening skin rashes (Stevens-Johnson syndrome/toxic epidermal necrolysis)
• hives
• fluid under the skin (angioedema)
• joint pain (arthralgia)
• muscle pain (myalgia)
• low 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).

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

• decreased number of 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, these changes are unlikely to be caused by treatment with Viramune.

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also
report side effects directly through 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 which is stated on the package after “Scad.” and on the
blister after “EXP”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Viramune contains

• The active ingredient is nevirapine. Each tablet contains 200 mg of nevirapine.
• The other ingredients are:
• microcrystalline cellulose,
• lactose (as monohydrate),
• povidone K25,
• sodium starch glycolate,
• colloidal silicon dioxide and
• magnesium stearate.

Description of the appearance of Viramune and contents of the pack
White, oval, biconvex tablets. The code “54 193” is imprinted on one side, with a single
engraved line separating the "54" and "193". The company logo is imprinted on the opposite side.
The engraved line is not intended for breaking the tablet.
Viramune tablets are packaged in blisters, the pack contains 14, 60 or 120 tablets. Not all pack sizes
may be marketed.
Viramune is also available as an oral suspension.

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 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 on this medicinal product, contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/Belgien
Boehringer Ingelheim SComm
Tél/Tel: +32 2 773 33 11

Lietuva
Boehringer Ingelheim RCV GmbH & Co KG
Lietuvos filialas
Tel.: +370 5 2595942

България
Бьорингер Ингелхайм РЦВ ГмбХ и Ко КГ -
клон България
Тел: +359 2 958 79 98

Luxembourg/Luxemburg
Boehringer Ingelheim SComm
Tél/Tel: +32 2 773 33 11

Česká republika
Boehringer Ingelheim spol. s r.o.
Tel: +420 234 655 111

Magyarország
Boehringer Ingelheim RCV GmbH & Co KG
Magyarországi Fióktelepe
Tel.: +36 1 299 8900

Danmark
Boehringer Ingelheim Danmark A/S
Tlf: +45 39 15 88 88

Malta
Boehringer Ingelheim Ireland Ltd.
Tel: +35 31 295 9620

Deutschland
Boehringer Ingelheim Pharma GmbH & Co. KG
Tel: +49 (0) 800 77 90 900

Nederland
Boehringer Ingelheim B.V.
Tel: +31 (0) 800 22 55 889

Eesti
Boehringer Ingelheim RCV GmbH & Co KG
Eesti Filiaal
Tel: +372 612 8000

Norge
Boehringer Ingelheim Norway KS
Tlf: +47 66 76 13 00

Ελλάδα
Boehringer Ingelheim Ελλάς Μονοπρόσωπη Α.Ε.
Tηλ: +30 2 10 89 06 300

Österreich
Boehringer Ingelheim RCV GmbH & Co KG
Tel: +43 1 80 105-7870

España
Boehringer Ingelheim España, S.A.
Tel: +34 93 404 51 00

Polska
Boehringer Ingelheim Sp. z o.o.
Tel.: +48 22 699 0 699

France
Boehringer Ingelheim France S.A.S.
Tél: +33 3 26 50 45 33

Portugal
Boehringer Ingelheim Portugal, Lda.
Tel: +351 21 313 53 00

Hrvatska
Boehringer Ingelheim Zagreb d.o.o.
Tel: +385 1 2444 600

România
Boehringer Ingelheim RCV GmbH & Co KG
Viena – Sucursala Bucuresti
Tel: +40 21 302 2800

Ireland
Boehringer Ingelheim Ireland Ltd.
Tel: +353 1 295 9620

Slovenija
Boehringer Ingelheim RCV GmbH & Co KG
Podružnica Ljubljana
Tel: +386 1 586 40 00

Ísland
Vistor hf.
Tel: +354 535 7000

Slovenská republika
Boehringer Ingelheim RCV GmbH & Co KG
organizačná zložka
Tel: +421 2 5810 1211

Italia
Boehringer Ingelheim Italia S.p.A.
Tel: +39 02 5355 1

Suomi/Finland
Boehringer Ingelheim Finland Ky
Puh/Tel: +358 10 3102 800

Κύπρος
Boehringer Ingelheim Ελλάς Μονοπρόσωπη Α.Ε.
Tηλ: +30 2 10 89 06 300

Sverige
Boehringer Ingelheim AB
Tel: +46 8 721 21 00

Latvija
Boehringer Ingelheim RCV GmbH & Co KG
Latvijas filiāle
Tel: +371 67 240 011

United Kingdom (Northern Ireland)
Boehringer Ingelheim Ireland Ltd.
Tel: +353 1 295 9620

Altre fonti d’informazioni
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, http://www.ema.europa.eu .

Viramune 50 mg/5 mL oral suspension

nevirapine

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Viramune is and what it is used for
• 2. What you need to know before you take Viramune
• 3. How to take Viramune
• 4. Possible side effects
• 5. How to store Viramune
• 6. Contents of the pack and other information

1. What is Viramune and what is it used for

Viramune belongs to a group of medicines called antiretrovirals, used in the treatment
of infection with the human immunodeficiency virus (HIV-1).
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 to multiply. Nevirapine blocks the activity
of reverse transcriptase. By blocking the activity of reverse transcriptase, Viramune helps to control
HIV-1 infection.
Viramune is indicated for the treatment of adults, adolescents and children of all ages infected with
HIV-1. You must take Viramune with other antiretroviral medicines. Your doctor will recommend the
medicines that are most suitable for you.

If Viramune has been prescribed for the child, all the information contained in this leaflet
is addressed to him (in this case understand “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 any of the other ingredients of this medicine (listed in section 6).
• if you have taken Viramune before and had to stop treatment because you suffered from:
• severe skin rash
• skin rash with other symptoms, for example:
• fever
• blisters
• ulcers in the mouth
• eye inflammation
• facial swelling
• general swelling
• shortness of breath
• muscle or joint pain
• feeling generally unwell
• abdominal pain
• hypersensitivity (allergic) reactions
• liver inflammation (hepatitis)
• if you have severe liver disease
• if you have had to stop treatment with Viramune in the past due to changes in liver function
• if you are taking medicines containing St John's Wort extract (Hypericum perforatum). This substance can prevent Viramune from working correctly.

Warnings and precautions
Talk to your doctor or pharmacist before taking Viramune.
During the first 18 weeks of therapy with Viramune it is very important that you and your doctor
pay attention to the appearance of any signs of reactions affecting the liver or
skin. These can become serious and even life-threatening. You are at the greatest
risk of these reactions during the first 6 weeks of treatment.
If you develop a severe skin rash or hypersensitivity (i.e. allergic reactions that
may appear as a rash) accompanied by other unwanted effects such as

• fever,
• blisters,
• ulcers in the mouth,
• eye inflammation,
• facial swelling,
• general swelling,
• shortness of breath,
• muscle or joint pain,
• feeling generally unwell,
• or abdominal painYOU MUST STOP TAKING VIRAMUNE AND CONTACTIMMEDIATELY your doctor because these reactions can be potentially life-threateningor cause death.If you have only had a mild skin rash without any other reaction, still inform yourdoctor immediately, who will advise you whether to stop taking Viramune.

If symptoms appear that indicate liver damage, such as

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

If you develop severe reactions affecting the liver, skin or hypersensitivity while taking
Viramune, DO NOT TAKE IT AGAIN without first consulting your doctor.
You must only take the dose of Viramune prescribed by your doctor. This is
particularly important during the first 14 days of treatment (see more information
inHow 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 test values
• patients never treated before with a higher CD4 cell count at the start of Viramune therapy (women more than 250 cells/mm³, men more than 400 cells/mm³).

Viramune (women more than 250 cells/mm³, men more than 400 cells/mm³)

• patients previously treated, with detectable HIV-1 viral load in the blood and with a higher CD4 cell count at the start of Viramune therapy (women more than 250 cells/mm³, men more than 400 cells/mm³).

In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection
(disease that defines AIDS), shortly after starting anti-HIV treatment, inflammatory signs and symptoms of previous infections may occur. These symptoms are believed to be due to an
improvement in the body's immune response, which allows the body to fight
infections that may have been present without obvious symptoms. If you notice any symptoms of
infection, please inform your doctor immediately.
In addition to opportunistic infections, autoimmune disorders (a
condition that occurs when the immune system attacks healthy tissue in the body) may also occur after you
have started taking medicines to treat HIV infection. Autoimmune disorders
can occur many months after starting treatment. If you notice any symptoms of infection or
other symptoms such as muscle weakness, initial weakness in hands and feet that rises towards the trunk of
the body, palpitations, tremor or hyperactivity, immediately inform your doctor to request
the necessary treatment.
In patients treated with combination antiretroviral therapy, a change in
body fat may occur. 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 (bone tissue death, caused by reduced blood flow to the bones).
The duration of combination antiretroviral therapy, the use of corticosteroids, alcohol consumption, severe immune system weakness, a higher body mass index, may
be some of the numerous risk factors for the development of this disease. Signs of osteonecrosis
are stiffness of the joints, discomfort and pain (especially in the hips, knees and shoulders) and
difficulty in movement. See your doctor if you notice any of these symptoms.
If you are taking nevirapine and zidovudine at the same time, tell your doctor as they may
need to check your white blood cell levels.

Do not take Viramune after exposure to the HIV virus unless you have been diagnosed with the disease and
it has been prescribed by your doctor.
Prednisone should not be used to treat a skin rash related to taking
Viramune.
If you are taking oral contraceptives (e.g. "the pill") or other hormonal methods of birth control during treatment with Viramune, you should also use a barrier method of contraception (e.g. a condom) to prevent pregnancy and further
HIV transmission.
If you are undergoing post-menopausal hormone replacement therapy, ask your doctor for advice before taking
this medicine.
If you are taking or have been prescribed rifampicin to treat tuberculosis, tell your doctor before
taking this medicine with Viramune.

Children and adolescents
Viramune oral suspension can be taken by children of all ages. Always following the
instructions provided by the doctor.
Viramune is also available in tablets that 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
Tell your doctor or pharmacist if you are taking, have recently taken or may take
any other medicines. Tell your doctor about all the medicines you are taking before you start
treatment with Viramune. Your doctor may need to check if you are continuing to take
HIV medicines that you are taking in combination with Viramune.
It is particularly important that you tell your doctor if you are taking or have recently taken:

• St John's Wort (Hypericum perforatum, medicine for the treatment of depression)
• rifampicin (medicine for the treatment of tuberculosis)
• rifabutin (medicine for the treatment of tuberculosis)
• macrolides e.g. clarithromycin (medicine for the treatment of bacterial infections)
• fluconazole (medicine for the treatment of fungal infections)
• ketoconazole (medicine for the treatment of fungal infections)
• itraconazole (medicine for the treatment of fungal infections)
• methadone (medicine for the treatment of opioid dependence)
• warfarin (medicine for reducing 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)

The doctor will carefully check the effect of Viramune and each of these medicines if you are
taking them in combination.
If you are undergoing kidney dialysis, your doctor will consider an adjustment to the dose of
Viramune as dialysis can partially remove Viramune from the blood.

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

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, ask your doctor
or pharmacist for advice before taking this medicine.
Breastfeeding is not recommendedfor HIV-positive women as HIV infection can be
transmitted to the baby through breast milk.
If you are breastfeeding or thinking about breastfeeding you must talk toyour doctor as soon as possible.

Driving and using machines
While using Viramune, you may experience fatigue. Be careful when
engaging in activities such as driving or using any tools or machinery. If you feel tired, you should avoid potentially dangerous activities such as driving or using any
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
people with diabetes mellitus. If your doctor has diagnosed you with an intolerance to certain sugars,
contact him before taking this medicine. It may be harmful to your teeth.
Viramune oral suspension contains 162 mg of sorbitol per mL. Sorbitol is a source of fructose.
If your doctor has told you that you (or your child) are intolerant to certain sugars, or if you have a diagnosis of
hereditary fructose intolerance, a rare genetic disease in which patients cannot
metabolize fructose, talk to your doctor before you (or your child) take this medicine.
Viramune oral suspension contains methyl parahydroxybenzoate and propyl parahydroxybenzoate. These
excipients may cause allergic reactions over time.
Viramune oral suspension contains less than 1 mmol (23 mg) of sodium per dosage unit, i.e.
essentially ‘sodium-free’.

3. How to take Viramune

Do not take Viramune on your own initiative. You must take it in association with at least two other
antiretroviral medications. Your doctor will prescribe the most suitable medications for you.
Take this medication following your doctor's instructions exactly. If you have any doubts, consult
your doctor or pharmacist.
The usual dose is the same for all adults (20 mL).
The doctor will calculate the dose for the child. The calculation will be based on age and weight or
body surface area. Make sure your child's doctor clearly indicates which dose you should
administer.
For adults
The dose for adults is 20 mL (200 mg) once a day for the first 14 days of treatment
(“induction phase”). After 14 days, the usual dose is 20 mL (200 mg) twice a day.
It is very important that you take only 20 mL of Viramune per day for the first 14 days (“induction
phase”). If you develop any rash during this period, do not increase the dose, but
contact your doctor.
Viramune is also available in 200 mg tablets for adults (patients aged 16 years or older).
For children
The dose for children is 4 mg/kg of body weight or 150 mg/m of body surface area once a
day for the first 14 days of treatment (“induction phase”). Then you will switch to two
administrations a day, the doctor will calculate the correct dose based on weight or body
surface area of the child.
It is very important that the child takes Viramune only once a day for the first 14 days
(“induction phase”). If they develop any rash during this period, do not increase the
dose, but contact your doctor.
Viramune is also available in 200 mg tablets, for older children, particularly
adolescents, who weigh more than 50 kg or whose body surface area is greater than 1.25 m . The doctor will
inform you precisely about the indicated dose for the child, constantly monitoring their weight and
body surface area to ensure the correct dose is administered. If you have any doubts, consult
your doctor or pharmacist.
Viramune oral suspension should be shaken gently before administration. Measure the
exact dose using a dosing syringe.
If you are an adult and choose a dosing system (for example, a measuring cup or teaspoon),
make sure to take the entire dose, as some Viramune may remain in the cup or
teaspoon. To do this, rinse the instrument used thoroughly and drink the rinse water.
The dosing syringe for oral administration and the measuring cup are not supplied with
Viramune oral suspension. Ask your pharmacist for a syringe or measuring cup if you do not
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 medications, you must also carefully follow
the instructions relating to the other medications you are taking, which are available in
their respective package leaflets.
You must continue to take Viramune for the time established by your doctor.
As explained in the “Warnings and precautions”section, above, the doctor will perform
periodic checks such as liver function tests and assess the appearance of adverse
effects, such as rash. Depending on the outcome, the doctor may decide to temporarily interrupt or stop
treatment with Viramune. The doctor may decide to restart the
medication with a lower dosage.
Viramune oral suspension is a liquid suspension that must be taken only by mouth.
Shake the bottle gently before use.

If you take more Viramune than you should
At the moment there is little information about the effects of Viramune overdose. If you have
taken more Viramune than the prescribed dose, consult your doctor.

If you forget to take Viramune
Try not to miss any dose. If you realize within 8 hours of forgetting 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 appropriate times:

• greatly increases the effectiveness of your antiretroviral medications
• decreases the likelihood that HIV infection becomes resistant to the medications you are taking.

It is important to continue taking Viramune correctly, as described above, unless your
doctor asks you to stop treatment.
If you discontinue Viramune for more than 7 days, your doctor will explain how to restart the 14 days of
“induction phase” (described above) before returning to the twice-daily dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

During HIV therapy, an increase in weight and levels of lipids and glucose in the blood may occur.
This is partly related to the restoration of health and lifestyle, and in the case of blood lipids, sometimes to the HIV medications themselves. The doctor will check these changes.
Like all medicines, this medicine can cause side effects, although not everyone will experience 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 an important period that requires
close monitoring by the doctor.
If you notice any signs of a skin reaction, inform your doctor immediately.
When it occurs, the rash is usually mild or moderate. However, in some patients
a rash, which appears as a skin rash with blisters, can be severe or life-threatening (Stevens-Johnson syndrome and toxic epidermal necrolysis), and cases of death have been reported.
Most cases, both as severe skin reactions and as mild/moderate skin reactions, have occurred in the first six weeks of treatment.
If you develop a rash and also feel unwell, you should stop
treatment and see your doctor immediately. Pay particular attention to any skin rash that develops in a child. Although these rashes may appear normal (for example
diaper rash), they may be rashes caused by Viramune. If in doubt, consult your
child's doctor.
Hypersensitivity (allergic) reactions may occur. These reactions can manifest 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 can also manifest as skin rashes 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
• decreased number of white blood cells (granulocytopenia)
• general feeling of unwellness
• serious problems with the liver or kidneys (liver or kidney failure).

Inform your doctor immediately if you develop a skin rash and any of the other side effects
from a hypersensitivity (allergic) reaction. These reactions can be life-threatening.
Abnormal liver function has been reported with the use of Viramune, these include
some cases of liver inflammation (hepatitis), which can be sudden and severe (fulminant hepatitis) and liver failure, which can both 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 by 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):

• decreased number of white blood cells (granulocytopenia)
• allergic reactions (hypersensitivity)
• headache
• feeling unwell (nausea)
• vomiting
• abdominal pain
• loose stools (diarrhea)
• liver inflammation (hepatitis)
• feeling tired (fatigue)
• fever
• abnormal liver function tests

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

• allergic reaction characterized by skin rash, swelling of the face, difficulty breathing (bronchospasm) or anaphylactic shock
• decreased number of red blood cells (anemia)
• yellowing of the skin (jaundice)
• severe and life-threatening skin rashes (Stevens-Johnson syndrome/toxic epidermal necrolysis)
• hives
• fluid under the skin (angioedema)
• joint pain (arthralgia)
• muscle pain (myalgia)
• low 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).

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

• decreased number of red blood cells or platelets,
• inflammation of the pancreas
• and reduced or abnormal skin sensitivity.

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

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

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through 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 which is stated on the package and the bottle after
“Exp.”. The expiry date refers to the last day of that month.
Viramune must be used within 6 months of the first opening of the bottle.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Viramune contains

• The active ingredient is nevirapine. Each 5 mL contains 50 mg of the active ingredient nevirapine (as hemihydrate).
• 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 suspension, from white to almost white.
Viramune oral suspension is available in plastic bottles, each containing 240 mL of
suspension.
Viramune is also available in the form of 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

België/Belgique/Belgien
Boehringer Ingelheim SComm
Tél/Tel: +32 2 773 33 11

Lietuva
Boehringer Ingelheim RCV GmbH & Co KG
Lietuvos filialas
Tel.: +370 5 2595942

България
Бьорингер Ингелхайм РЦВ ГмбХ и Ко КГ -
клон България
Тел: +359 2 958 79 98

Luxembourg/Luxemburg
Boehringer Ingelheim SComm
Tél/Tel: +32 2 773 33 11

Česká republika
Boehringer Ingelheim spol. s r.o.
Tel: +420 234 655 111

Magyarország
Boehringer Ingelheim RCV GmbH & Co KG
Magyarországi Fióktelepe
Tel.: +36 1 299 8900

Danmark
Boehringer Ingelheim Danmark A/S
Tlf: +45 39 15 88 49

Malta
Boehringer Ingelheim Ireland Ltd.
Tel: +35 31 295 9620

Deutschland
Boehringer Ingelheim Pharma GmbH & Co. KG
Tel: +49 (0) 800 77 90 900

Nederland
Boehringer Ingelheim B.V.
Tel: +31 (0) 800 22 55 889

Eesti
Boehringer Ingelheim RCV GmbH & Co KG
Eesti Filiaal
Tel: +372 612 8000

Norge
Boehringer Ingelheim Norway KS
Tlf: +47 66 76 13 00

Ελλάδα
Boehringer Ingelheim Ελλάς Μονοπρόσωπη Α.Ε.
Tηλ: +30 2 10 89 06 300

Österreich
Boehringer Ingelheim RCV GmbH & Co KG
Tel: +43 1 80 105-7870

España
Boehringer Ingelheim España, S.A.
Tel: +34 93 404 51 00

Polska
Boehringer Ingelheim Sp. z o.o.
Tel.: +48 22 699 0 699

France
Boehringer Ingelheim France S.A.S.
Tél: +33 3 26 50 45 33

Portugal
Boehringer Ingelheim Portugal, Lda.
Tel: +351 21 313 53 00

Hrvatska
Boehringer Ingelheim Zagreb d.o.o.
Tel: +385 1 2444 600

România
Boehringer Ingelheim RCV GmbH & Co KG
Viena – Sucursala Bucuresti
Tel: +40 21 302 2800

Ireland
Boehringer Ingelheim Ireland Ltd.
Tel: +353 1 295 9620

Slovenija
Boehringer Ingelheim RCV GmbH & Co KG
Podružnica Ljubljana
Tel: +386 1 586 40 00

Ísland
Vistor hf.
Tel: +354 535 7000

Slovenská republika
Boehringer Ingelheim RCV GmbH & Co KG
organizačná zložka
Tel: +421 2 5810 1211

Italia
Boehringer Ingelheim Italia S.p.A.
Tel: +39 02 5355 1

Suomi/Finland
Boehringer Ingelheim Finland Ky
Puh/Tel: +358 10 3102 800

Κύπρος
Boehringer Ingelheim Ελλάς Μονοπρόσωπη Α.Ε.
Tηλ: +30 2 10 89 06 300

Sverige
Boehringer Ingelheim AB
Tel: +46 8 721 21 00

Latvija
Boehringer

United Kingdom (Northern Ireland)
Boehringer Ingelheim Ireland Ltd.
Tel: +353 1 295 9620

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

Viramune 400 mg prolonged-release tablets

nevirapine

Read this leaflet carefully before taking this medicine, as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Viramune is and what it is used for
• 2. What you need to know before you take Viramune
• 3. How to take Viramune
• 4. Possible side effects
• 5. How to store Viramune
• 6. Contents of the pack and other information

1. What is Viramune and what it is used for

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

2. What you need to know before taking 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 taken Viramune before and had to stop treatment because you suffered from:
• severe skin rash,
• skin rash with other symptoms, for example:
• fever
• blisters
• ulcers in the mouth
• eye inflammation
• facial swelling
• general swelling
• shortness of breath
• muscle or joint pain
• general feeling of being unwell
• abdominal pain
• hypersensitivity (allergic) reactions
• liver inflammation (hepatitis)
• if you have severe liver disease
• if you have had to stop treatment with Viramune in the past due to changes in liver function
• if you are taking medicines containing St John's Wort extract (Hypericum perforatum). This substance can prevent Viramune from working correctly.

Warnings and precautions
Talk to your doctor or pharmacist before taking Viramune.
During the first 18 weeks of therapy with Viramune it is very important that you and your doctor
pay attention to the appearance of any signs of reactions affecting the liver or
skin. These can become serious and even life-threatening. You are at the highest
risk of these reactions during the first 6 weeks of treatment.
If you develop a severe skin rash or hypersensitivity (i.e. allergic reactions that
can appear as a rash) accompanied by other undesirable effects such as

• fever,
• blisters,
• ulcers in the mouth,
• eye inflammation,
• facial swelling,
• general swelling,
• shortness of breath,
• muscle or joint pain,
• general feeling of being unwell,
• or abdominal painYOU MUST STOP TAKING VIRAMUNE AND CONTACTIMMEDIATELY your doctor as these reactions can be potentially life-threateningor cause death.If you have only had a mild skin rash without any other reaction, immediately inform yourdoctor, who will advise you if you need to stop taking Viramune.

If symptoms appear indicating liver damage, such as

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

If you develop severe reactions affecting the liver, skin or hypersensitivity while taking
Viramune, DO NOT TAKE IT 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 test values
• patients never treated previously with a higher CD4 cell count at the start of Viramune therapy (women more than 250 cells/mm³, men more than 400 cells/mm³)
• patients previously treated, with detectable HIV-1 viral load in the blood and a higher CD4 cell count at the start of Viramune therapy (women more than 250 cells/mm³, men more than 400 cells/mm³).

In some patients with advanced HIV infection (AIDS) and with a history of opportunistic infection
(disease that defines AIDS), shortly after the start of anti-HIV treatment, inflammatory signs and
symptoms of previous infections may occur. These symptoms are believed to be due to an
improvement in the body's immune response, which allows the body to fight
infections that may have been present without obvious symptoms. If you notice any symptoms of
infection, please inform your doctor immediately.
In addition to opportunistic infections, autoimmune disorders (a
condition that occurs when the immune system attacks healthy tissue in the body) may also occur after you
have started taking medicines to treat HIV infection. Autoimmune disorders
can occur many months after starting treatment. If you notice any symptoms of infection or
other symptoms such as muscle weakness, initial weakness in hands and feet that rises up the trunk of the
body, palpitations, tremor or hyperactivity, inform your doctor immediately to request
the necessary treatment.
In patients treated with combination antiretroviral therapy, a change in
body fat may occur. 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 (bone tissue death, caused by reduced blood flow to the bones).
The duration of combination antiretroviral therapy, the use of corticosteroids, alcohol consumption, severe immune system weakness, and a higher body mass index may
be some of the numerous risk factors for the development of this disease. Signs of osteonecrosis
are joint stiffness, discomfort and pain (especially in the hips, knees and shoulders) and
difficulty moving. See your doctor if you notice any of these symptoms.
If you are taking nevirapine and zidovudine at the same time, tell your doctor as they may
need to check your white blood cell levels.
Do not take Viramune after exposure to the HIV virus unless you have been diagnosed with the disease and
it has been prescribed by your doctor.
Prednisone should not be used to treat a skin rash related to taking
Viramune.
If you are taking oral contraceptives (e.g. "the pill") or other hormonal methods of birth control during treatment with Viramune, you should also use a barrier method of contraception (e.g. a condom) to prevent pregnancy and further
HIV transmission.
If you are on post-menopausal hormone replacement therapy, ask your doctor for advice before taking
this medicine.
If you are taking or have been prescribed rifampicin to treat tuberculosis, tell your doctor before
taking this medicine with Viramune.
Viramune prolonged-release tablets or parts of tablets may occasionally
be present in the stool. They may look like whole tablets but this has not been shown to affect
the effectiveness of nevirapine.

Children and adolescents
Viramune 400 mg prolonged-release tablets can be taken by children if:

• they are  8 years of age and weigh 43.8 kg or more
• they are over 3 years of age and under 8 years of age and weigh 25 kg or more
• they have a body surface area of 1.17 m or more.

An oral suspension 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. Tell your doctor about all the medicines you are taking before you start
treatment with Viramune. Your doctor may need to check if you are still taking
HIV medicines that you are taking in combination with Viramune.
It is particularly important that you tell your doctor if you are taking or have recently taken:

• St John's Wort ( Hypericum perforatum, medicine for the treatment of depression)
• rifampicin (medicine for the treatment of tuberculosis)
• rifabutin (medicine for the treatment of tuberculosis)
• macrolides e.g. clarithromycin (medicine for the treatment of bacterial infections)
• fluconazole (medicine for the treatment of fungal infections)
• ketoconazole (medicine for the treatment of fungal infections)
• itraconazole (medicine for the treatment of fungal infections)
• methadone (medicine for the treatment of opioid dependence)
• warfarin (medicine for reducing 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 check the effect of Viramune and each of these medicines if you are
taking them in combination.

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

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor
or pharmacist for advice before taking this medicine.
Breastfeeding is not recommendedfor HIV-positive women as HIV infection can be
transmitted to the baby through breast milk.
If you are breastfeeding or are thinking about breastfeeding you must talk toyour doctor as soon as possible.

Driving and using machines
When taking Viramune you may experience fatigue. Be careful when engaging in
activities such as driving or using any tools or machinery. If you experience fatigue you should avoid potentially dangerous activities such as driving or using any
tools or machinery.

Viramune contains lactose
Viramune prolonged-release tablets contain lactose (milk sugar).
If your doctor has told you that you have an intolerance to some sugars, contact them before taking
this medicine.

3. How to take Viramune

You should not take Viramune on your own initiative. You must take it in association with at least two other
antiretroviral medicines. Your doctor will prescribe the medicines most suitable for you.
Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult
your doctor or pharmacist.
Dosage:
Adults
The dose is one Viramune 200 mg tablet per day for the first 14 days of treatment ("induction
phase"). A separate pack of Viramune 200 mg immediate-release tablets is available for the induction phase. After 14 days, the usual dose is one 400 mg extended-release tablet once a day.
It is very important that you take only one Viramune tablet per day for the first 14 days (“induction
phase”). If you develop any skin rash during this period, do not start taking
Viramune extended-release tablets, but contact your doctor.
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 can
switch to extended-release tablets without the induction phase.
Since Viramune must always be taken with other antiretroviral medicines, you must also follow
carefully the instructions relating to the other medicines you are taking. These are available in
their respective package leaflets.
Viramune is also available as an oral suspension (for all age groups, weight and SC).
You must continue to take Viramune for the time established by your doctor.
As explained in the "Warnings and precautions"paragraph, described above, your doctor will perform
periodic checks such as liver function tests and assess the appearance of adverse
effects, such as skin rash. Depending on the outcome, your doctor may decide to temporarily interrupt
or stop treatment with Viramune. Your doctor may decide to restart the
medicine with a lower dosage.
If you have renal or hepatic dysfunction of any severity, use only Viramune 200 mg
tablets or Viramune 50 mg/5 mL oral suspension.
Take Viramune extended-release tablets only by mouth. Do not chew the extended-release tablets. You can take Viramune with or without food.

If you take more Viramune than you should
At the moment there is little information about the effects of Viramune overdose. If you have
taken more Viramune than the prescribed dose, consult your doctor.

If you forget to take Viramune
Try not to miss any dose. If you realise within 12 hours of having forgotten 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 appropriate times:

• greatly increases the effectiveness of your antiretroviral medicines
• decreases the possibility that 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 Viramune for more than 7 days, your doctor will explain how to restart the 14 days of
“induction” phase with Viramune tablets (described above), before returning to taking
Viramune extended-release tablets once a day.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

During HIV therapy, an increase in weight and levels of lipids and glucose in the blood may occur.
This is partly related to the restoration of health and lifestyle, and in the case of blood lipids, sometimes to the HIV medicines themselves. Your doctor will check for these
changes.
Like all medicines, this medicine can cause side effects, although not everyone
will experience them.

As described above, in"Warnings and precautions", the most important side effects of
Viramune are skin reactions that can be serious and life-threatening, and serious liver damage. These reactions occur mainly during the first
18 weeks of treatment with Viramune. This is therefore an important period that requires
close monitoring by your doctor.
If you notice any signs of a skin reaction, inform your doctor immediately.
When it occurs, the rash is usually mild or moderate. However, in some patients
a rash, which appears as a skin rash with blisters, can be severe or life-threatening (Stevens-Johnson syndrome and toxic epidermal necrolysis) and cases of death have been reported.
Most cases, both as severe skin reactions and as mild/moderate skin reactions, occurred
within the first six weeks of treatment.
If you develop a rash and also feel unwell, you should stop the
treatment and go to your doctor immediately.
Hypersensitivity (allergic) reactions may occur. These reactions can manifest 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 can also manifest as skin rashes 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
• decreased number of white blood cells (granulocytopenia)
• general feeling of being unwell
• serious problems with the liver or kidneys (liver or kidney failure).

Inform your doctor immediately if you develop a skin rash and any of the other effects
of a hypersensitivity (allergic) reaction. These reactions can be life-threatening.
Abnormal liver function has been reported with the use of Viramune, these include
some cases of liver inflammation (hepatitis), which can be sudden and severe (fulminant hepatitis) and liver failure, both of which can be fatal.
Tell 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 following side effects have been reported by 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 and life-threatening skin rashes (Stevens-Johnson syndrome/toxic epidermal necrolysis)
• yellowing of the skin (jaundice)
• hives
• fluid under the skin (angioedema)
• vomiting
• muscle pain (myalgia)
• joint pain (arthralgia)
• decreased number of white blood cells (granulocytopenia)
• abnormal liver function tests
• decreased phosphorus in the blood
• increased blood pressure

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

• liver inflammation (hepatitis)
• decreased number of red blood cells (anemia)

The following side effects have been reported by patients treated with Viramune extended-release tablets once daily 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 and life-threatening skin rashes (Stevens-Johnson syndrome/toxic epidermal necrolysis)
• decreased number of red blood cells (anemia)
• decreased number of white blood cells (granulocytopenia)
• yellowing of the skin (jaundice)
• hives
• fluid under the skin (angioedema)
• muscle pain (myalgia)
• joint pain (arthralgia)
• decreased phosphorus in the blood
• increased blood pressure

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

• decreased number of 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, these changes are unlikely to be caused by treatment with Viramune.

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system detailed 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 which is stated on the box or the bottle after
“Exp.” and on the blister after “EXP”. The expiry date refers to the last day of that month.
Viramune must be used within 2 months of opening the bottle.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Viramune contains

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

Description of the appearance of Viramune and contents of the pack
Prolonged-release, yellow, oval, biconvex tablets. The prolonged-release tablets
measure approximately 9.3 mm x 19.1 mm, have V04 imprinted on one side and the company logo on the
opposite side. Viramune 400 mg prolonged-release tablets are available in blisters, with 30 or 90
prolonged-release tablets per pack. Alternatively, the 30-tablet pack of 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 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 on this medicine, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Boehringer Ingelheim SComm
Tél/Tel: +32 2 773 33 11

Lietuva
Boehringer Ingelheim RCV GmbH & Co KG
Lietuvos filialas
Tel.: +370 5 2595942

България
Бьорингер Ингелхайм РЦВ ГмбХ и Ко КГ -
клон България
Тел: +359 2 958 79 98

Luxembourg/Luxemburg
Boehringer Ingelheim SComm
Tél/Tel: +32 2 773 33 11

Česká republika
Boehringer Ingelheim spol. s r.o.
Tel: +420 234 655 111

Magyarország
Boehringer Ingelheim RCV GmbH & Co KG
Magyarországi Fióktelepe
Tel.: +36 1 299 8900

Danmark
Boehringer Ingelheim Danmark A/S
Tlf: +45 39 15 88 88

Malta
Boehringer Ingelheim Ireland Ltd.
Tel: +35 31 295 9620

Deutschland
Boehringer Ingelheim Pharma GmbH & Co. KG
Tel: +49 (0) 800 77 90 900

Nederland
Boehringer Ingelheim B.V.
Tel: +31 (0) 800 22 55 889

Eesti
Boehringer Ingelheim RCV GmbH & Co KG
Eesti Filiaal
Tel: +372 612 8000

Norge
Boehringer Ingelheim Norway KS
Tlf: +47 66 76 13 00

Ελλάδα
Boehringer Ingelheim Ελλάς Μονοπρόσωπη Α.Ε.
Tηλ: +30 2 10 89 06 300

Österreich
Boehringer Ingelheim RCV GmbH & Co KG
Tel: +43 1 80 105-7870

España
Boehringer Ingelheim España, S.A.
Tel: +34 93 404 51 00

Polska
Boehringer Ingelheim Sp. z o.o.
Tel.: +48 22 699 0 699

France
Boehringer Ingelheim France S.A.S.
Tél: +33 3 26 50 45 33

Portugal
Boehringer Ingelheim Portugal, Lda.
Tel: +351 21 313 53 00

Hrvatska
Boehringer Ingelheim Zagreb d.o.o.
Tel: +385 1 2444 600

România
Boehringer Ingelheim RCV GmbH & Co KG
Viena – Sucursala Bucuresti
Tel: +40 21 302 2800

Ireland
Boehringer Ingelheim Ireland Ltd.
Tel: +353 1 295 9620

Slovenija
Boehringer Ingelheim RCV GmbH & Co KG
Podružnica Ljubljana
Tel: +386 1 586 40 00

Ísland
Vistor hf.
Tel: +354 535 7000

Slovenská republika
Boehringer Ingelheim RCV GmbH & Co KG
organizačná zložka
Tel: +421 2 5810 1211

Italia
Boehringer Ingelheim Italia S.p.A.
Tel: +39 02 5355 1

Suomi/Finland
Boehringer Ingelheim Finland Ky
Puh/Tel: +358 10 3102 800

Κύπρος
Boehringer Ingelheim Ελλάς Μονοπρόσωπη Α.Ε.
Tηλ: +30 2 10 89 06 300

Sverige
Boehringer Ingelheim AB
Tel: +46 8 721 21 00

Latvija
Boehringer Ingelheim RCV GmbH & Co KG
Latvijas filiāle
Tel: +371 67 240 011

United Kingdom (Northern Ireland)
Boehringer Ingelheim Ireland Ltd.
Tel: +353 1 295 9620

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