NEVIRAPINA 400 мг Таблетки с пролонгированным высвобождением

Содержание инструкции

1. Nevirapina Teva Italia 400 mg prolonged-release tablets
   1. What is Nevirapina Teva Italia and what it is used for
   2. What you need to know before taking Nevirapina Teva Italia
   3. How to take Nevirapina Teva Italia
   4. Possible side effects
   5. How to store Nevirapina Teva Italia
   6. Contents of the pack and other information

Nevirapina Teva Italia 400 mg prolonged-release tablets

Generic medicine
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 their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even if not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Nevirapina Teva Italia and what it is used for

Nevirapina Teva Italia 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. Nevirapina 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. Nevirapina blocks the activity
of reverse transcriptase. By blocking the activity of reverse transcriptase, Nevirapina Teva Italia helps to
control HIV-1 infection.
Nevirapina Teva Italia is indicated for the treatment of adults, adolescents and children aged 3 years or
older who are able to swallow tablets infected with HIV-1 virus. You must take Nevirapina
Teva Italia together with other antiretroviral medicines. Your doctor will recommend the medicines most
suitable for you.
Nevirapina Teva Italia prolonged-release tablets should only be used after a
two-week treatment with another type of medicine based on nevirapine (immediate-release tablets or
oral suspension), unless you are currently on therapy with
these medicines and are switching to the prolonged-release formulation.

2. What you need to know before taking Nevirapina Teva Italia

Do not takeNevirapina Teva Italia

• if you are allergic to nevirapine or any of the other ingredients of this medicine (listed in section 6 “What Nevirapina Teva Italia contains”).
• if you have taken nevirapine before and had to stop treatment because you suffered from:
• severe skin rash,
• skin rash with other symptoms, for example fever or blisters or ulcers in the mouth or eye inflammation or facial swelling or general swelling or shortness of breath or muscle or joint pain or general feeling of being unwell or abdominal pain
• hypersensitivity (allergic) reaction
• liver inflammation (hepatitis)
• if you have severe liver disease
• if you have had to stop treatment with nevirapine in the past due to changes in liver function
• if you are taking medicines containing the herbal remedy St. John's Wort ( Hypericumperforatum). This substance can prevent Nevirapina Teva Italia from working correctly.

Warnings and precautions
Talk to your doctor or pharmacist before taking Nevirapina Teva Italia.
During the first 18 weeks of therapy with Nevirapina Teva Italia, it is very important that
you and your doctor pay attention to the appearance of any signs of reactions involving
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 a severe skin rash or hypersensitivity (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 pain

YOU MUST STOP TAKING NEVIRAPINA TEVA ITALIA AND
CONTACT YOUR DOCTOR IMMEDIATELYbecause these reactions can be
potentially life-threatening or cause death. If you have only had a mild skin
rash without any other reaction, inform your doctor immediately, who will tell you if
you should stop taking Nevirapina Teva Italia.
If symptoms occur that indicate liver damage, such as

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

If you develop severe liver, skin or hypersensitivity reactions while taking Nevirapina
Teva Italia, DO NOT TAKE ANY MORE NEVIRAPINA TEVA ITALIAwithout first consulting
your doctor.
You must take only the dose of nevirapine prescribed by your doctor. This is
particularly important during the first 14 days of treatment (more information
in “How to take Nevirapina Teva Italia”).
The following patients are at higher risk of developing liver problems:

• women
• patients infected with hepatitis B or C
• patients with abnormal liver function test results
• patients never treated before, with a higher CD4 cell count at the start of nevirapine therapy (women with more than 250 cells/mm³, men with 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 nevirapine therapy (women with more than 250 cells/mm³, men with more than 400 cells/mm³).

In some patients with advanced HIV infection (AIDS) and with a history of opportunistic
infection (disease that defines AIDS), signs and symptoms of inflammatory previous infectionsmay occur
soon after the start of anti-HIV treatment. 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, inform your doctor immediatelyto 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(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 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 hip, 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 you may
need to check your white blood cell levels.

Donot take Nevirapina Teva Italia after an ‘exposure to the HIV virus if you have not been
diagnosed with the disease and it has not been prescribed to you by your doctor. Nevirapina does not cure HIV
infection. Therefore you can still contract infections and other diseases associated with HIV
infection. Therefore you must remain in regular contact with your doctor. You may still transmit HIV while
taking this medicine, although the risk is reduced by the effect of antiretroviral
therapy. Discuss with your doctor the precautions necessary to avoid transmitting
the infection to others.
Prednisone should not be used to treat a skin rash related to taking
nevirapine.
If you are taking oral contraceptives(e.g. "the pill") or other hormonal methods of birth
control during treatment with Nevirapina Teva Italia, you should 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, 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 Nevirapina Teva Italia.
Some patients taking the extended-release formulation of nevirapine have reported
the presence of residues in the stool that may resemble intact tablets. From the data available so far,
this has not shown to affect the therapeutic response of these formulations.

Children and adolescents
Nevirapina Teva Italia 400 mg extended-release tablets can be taken by children if:

• they are 8 years of age or older and weigh at least 43.8 kg
• they are over 3 years old and under 8 years old and weigh at least 25 kg
• their body surface area is equal to or greater than 1.17 m .

For younger children, lower-dose extended-release tablets or
an oral suspension are available.

Other medicines and Nevirapina Teva Italia
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 Nevirapina Teva Italia. Your doctor may need to check if they continue
to be effective and may need to change their dosage. Read the leaflet carefully
of all other medicines for HIV that you are taking in combination with Nevirapina
Teva Italia.
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)
• delavirdine (another medicine for the treatment of HIV)
• zidovudine (another medicine for the treatment of HIV)
• boceprevir (medicine for the treatment of hepatitis C)
• telaprevir (medicine for the treatment of hepatitis C)
• elvitegravir/cobicistat (another medicine for the treatment of HIV)

The doctor will carefully monitor the effect of Nevirapina Teva Italia and each of these
medicines if you are taking them in combination.

Nevirapina Teva Italia with food and drink
There are no restrictions on taking Nevirapina Teva Italia with food and drink.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your doctor or
pharmacist for advice before taking this medicine.
You should stop breastfeeding if you are taking Nevirapina Teva Italia. In general, it
is recommended not to breastfeed if infected with HIV because the baby
can contract HIV infection through breast milk.

Driving and operating machinery
When taking Nevirapina Teva Italia you may experience fatigue. Be careful when
engaged in activities such as driving or operating any tools or machinery. If you experience
fatigue, you should avoid potentially dangerous activities such as driving or operating
any tools or machinery.

3. How to take Nevirapina Teva Italia

Do not take Nevirapina Teva Italia on your own initiative. You must take it with at least two other
antiretroviral medications. Your doctor will prescribe the most suitable medications for you.
Take this medicine following your doctor's instructions exactly at all times. If you have any doubts
consult your doctor or pharmacist.

Dosage:

Adults:
The dose is one 200 mg nevirapine tablet per day for the first 14 days of treatment ("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 200 mg nevirapine tablet per day for the first 14 days
(“induction phase”). If you experience any skin rash during this period, DO NOT start
taking Nevirapina Teva Italia extended-release tablets, but contact your doctor.
The 14-day “induction” phase has been shown to reduce the risk of skin reactions.
Patients already being treated with immediate-release tablets, or with oral suspension,
can switch to extended-release tablets without the induction phase.
Since nevirapine must always be taken with other antiretroviral medications, you must also follow
the instructions relating to the other medications you are taking carefully. These are available
in their respective package leaflets.
If necessary, your doctor will check the availability of the lower dosage of nevirapine extended-release tablets (for children aged at least 3 years and after the induction phase) or as
an oral suspension (for all age groups).
You must continue to take Nevirapina Teva Italia for the time prescribed 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 adverse
effects, such as skin rash. Depending on the outcome, your doctor may decide to
temporarily or permanently interrupt treatment with nevirapine. Your doctor may
decide to have you restart the medication at a lower dosage.
If you suffer from renalor hepaticimpairment of any severity, use only 200 mg
nevirapine tablets or 50 mg/5 ml nevirapine oral suspension. If necessary, your doctor will check the
availability of these additional pharmaceutical forms.
Take Nevirapina Teva Italia extended-release tablets only by mouth. Do not chew the
extended-release tablets. You can take Nevirapina Teva Italia with or without food.

If you take more Nevirapina Teva Italia than you should
Do not take more Nevirapina Teva Italia than prescribed by your doctor and described in this leaflet.
There is currently limited information on the effects of nevirapine overdose. In
case you have taken more Nevirapina Teva Italia than the prescribed dose, consult your doctor.

If you forget to takeNevirapina Teva Italia
Try not to miss any dose. If you realize within 12 hours that you have 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 Nevirapina Teva Italia

• greatly increases the effectiveness of your antiretroviral medications
• decreases the chances that HIV infection becomes resistant to antiretroviral medications. It is important to continue taking Nevirapina Teva Italia correctly, as described above, unless your doctor tells you to stop treatment.

If you stop Nevirapina Teva Italia for more than 7 days, your doctor will explain how to restart
the 14 days of the “induction” phase with nevirapine tablets (as described above) before
returning to taking Nevirapina Teva Italia 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 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
Nevirapina Teva Italia are skin reactions that can be serious and life-threatening, and serious liver damage. These reactions mainly occur within the first 18 weeks of treatment with nevirapine. 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 reaction 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 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:

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

Hypersensitivity reactions can also manifest as rashes with other side effects such as:

• fever
• skin blisters
• ulcers in the mouth
• 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 illness
• serious problems with the liver or kidneys (liver or kidney failure).

Inform your doctor IMMEDIATELYif you develop a rash or other side effects from a hypersensitivity (allergic) reaction. These reactions can be life-threatening.
Abnormal liver function has been reported with the use of nevirapine. 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 side effects listed below have been reported by patients treated with nevirapine 200 mg tablets during the 14-day induction phase:

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

• 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 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 side effects listed below have been reported by patients treated with nevirapine extended-release tablets once a day during the maintenance phase:

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

• 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 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 side effects have also been reported when nevirapine has been 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 nevirapine is used in combination with others; however, it is unlikely that these changes are caused by treatment with nevirapine.

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 rashes, tell your doctor about any side effects.

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 at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nevirapina Teva Italia

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 on the blister or on the
bottle 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 Nevirapina Teva Italia contains

• The active ingredient is nevirapine. Each extended-release tablet contains 400 mg of nevirapine
• The other ingredients are microcrystalline cellulose, povidone, polyethylene oxide, anhydrous colloidal silica and magnesium stearate.

Description of the appearance of Nevirapina Teva Italia and contents of the pack
Nevirapina Teva Italia are oval, biconvex extended-release tablets, white to off-white in colour, approximately 20.5 mm in length and 10 mm in width, with “400” imprinted on one side and
smooth on the other side.
They are available in blister packs of 10, 10x1, 30, 30x1, 60, 60x1, 90, 90x1, 100 and 100x1 and
HDPE bottles containing 30 extended-release tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4
20123 Milano

Manufacturer
TEVA Gyógyszergyár Zrt. Pallagi út 13, Debrecen, 4042 – Hungary
Teva Operations Poland Sp. z.o.o ul. Mogilska 80., Kraków, 31-546 - Poland