NEVIRAPINA 400 мг Таблетки с пролонгированным высвобождением

Содержание инструкции

1. Nevirapina Mylan 400 mg prolonged-release tablets
   1. What is Nevirapina Mylan and what it is used for
   2. What you need to know before taking Nevirapina Mylan
   3. How to take Nevirapina Mylan
   4. Possible side effects
   5. How to store Nevirapina Mylan
   6. Package Contents and Other Information

Nevirapina Mylan 400 mg prolonged-release tablets

nevirapine anhydrous

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 those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Nevirapina Mylan and what it is used for

Nevirapina Mylan 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 Mylan helps to
control HIV-1 infection.
Nevirapina Mylan is indicated for the treatment of adults, adolescents and children aged from
3 years and able to swallow tablets, infected with HIV-1 virus. You must take Nevirapina
Mylan with other antiretroviral medicines. Your doctor will recommend the most suitable medicines for
you.
Nevirapina Mylan extended-release tablets must be used only after treatment for a
duration of two weeks with another type of nevirapine (immediate-release tablets or
oral suspension) unless you are currently on nevirapine therapy and are switching
to the extended-release formulation.

If Nevirapina Mylan has been prescribed for your child, all the information in this
leaflet is addressed to your child (in this case read “your child” instead of “you”).

2. What you need to know before taking Nevirapina Mylan

Do not take Nevirapina Mylan

• if you are allergic to nevirapine or any of the other ingredients of this medicine (listed in section 6).
• 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
• 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 a 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 a medicine containing St John's Wort extract (Hypericum perforatum). This substance can prevent Nevirapina Mylan from working correctly.

Warnings and precautions
Talk to your doctor or pharmacist before taking Nevirapina Mylan.
During the first 18 weeks of therapy with Nevirapina Mylan 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 greater risk of such
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 pain
YOU MUST STOP TAKING NEVIRAPINA MYLAN AND CONTACT
YOUR DOCTOR IMMEDIATELY as these reactions can be potentially life-threatening or
cause death. If you have only had a mild skin rash without any other reaction,
still inform your doctor immediately, who will advise you whether to stop taking
Nevirapina Mylan.
If symptoms develop 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 Mylan and contact your doctor immediately.
If you develop severe reactions affecting the liver, skin or hypersensitivity while taking
Nevirapina Mylan, YOU MUST NEVER TAKE NEVIRAPINA again without first consulting
your doctor. You must only take the dose of Nevirapina Mylan prescribed by your doctor.
This is particularly important during the first 14 days of treatment (see further
information in “How to take Nevirapina Mylan”).
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 values
• patients never treated before with a higher CD4 cell count at the start of nevirapine 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 nevirapine 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, inform your doctor immediately to request
the necessary treatment.
In patients treated with combination antiretroviral therapy, a change may occur
in body fat. 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, a severe weakness 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 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 you may
need to check your white blood cell levels.
Do not take nevirapine after exposure to the HIV virus unless you have been diagnosed with the disease and
it has been prescribed for you by your doctor.
Nevirapina does not cure HIV infection. Therefore, you may continue to contract infections and other diseases
associated with HIV infection. While taking therapy, you must therefore respect the doctor's checks
during treatment. You can 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 nevirapine, 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 postmenopausal 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 nevirapine.
The prolonged-release tablets of Nevirapina or parts of the 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. Tell your doctor if you notice tablet fragments in your stool.

Children and adolescents
Nevirapina Mylan 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.

For younger children, smaller prolonged-release tablets or the liquid suspension oral form are available.

Other medicines and Nevirapina Mylan
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 starting
treatment with Nevirapina Mylan.
The doctor may need to check if other medicines continue to be effective and
the HIV you are taking in combination with Nevirapina Mylan.
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)
• 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 Mylan and each of these medicines if you are taking them in combination.

Nevirapina Mylan with food and drink
There are no restrictions regarding taking Nevirapina Mylan 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.
You must stop breastfeeding if you are taking Nevirapina Mylan. In general, it is
recommended not to breastfeed if you have HIV infection because the baby
may contract HIV infection through breast milk.

Driving and using machines
When you take Nevirapina Mylan you may experience fatigue. Be careful when
engaging 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.

Nevirapina Mylan contains lactose and sodium
Nevirapina Mylan prolonged-release tablets contains lactose (milk sugar).
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking
this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; that is, it is essentially
“sodium-free”.

3. How to take Nevirapina Mylan

You must not take Nevirapina Mylan alone. 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.
Dosage:

Adults
The recommended dose is one nevirapine 200 mg tablet per day for the first 14 days of
treatment ("induction phase"). A separate pack of nevirapine 200 mg
immediate-release tablets is available for the induction phase. After 14 days, the usual dose is one
Nevirapina Mylan 400 mg extended-release tablet once a day.

It is very important that you take only one tablet a day of nevirapine for the first 14 days
(“induction phase”). If you develop any rash during this period, do not start
taking Nevirapina Mylan extended-release tablets, but contact your doctor.
The 14-day “induction phase” has been shown to reduce the risk of rash.
Patients already being treated with immediate-release tablets or oral suspension may
switch to extended-release tablets without the induction phase.
Since Nevirapina Mylan must always be taken with other antiretroviral medicines, you should also
carefully follow the instructions relating to the other medicines you are taking. These are available
in their respective package leaflets.

Use in children and adolescents
Nevirapine is also available in extended-release tablet formulation with a lower dosage
(for children aged at least 3 years and after the induction phase) or as an oral suspension
for all age groups (not marketed by the marketing authorisation holder, but available from other
companies for all age groups).
You must continue to take Nevirapina Mylan 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 occurrence of side
effects, such as rash. Depending on the outcome, your doctor may decide to temporarily interrupt
or stop treatment with Nevirapina Mylan. Your doctor may decide to restart the medicine with a
lower dosage.
If you have kidney or liver problems of any severity, use only nevirapine 200 mg
tablets or nevirapine 50 mg/5 ml oral suspension.
Take Nevirapina Mylan extended-release tablets only by mouth with a liquid. Do not chew
or break the extended-release tablets. You can take Nevirapina Mylan with or without food.

If you take more Nevirapina Mylan than you should
Do not take more Nevirapina Mylan than prescribed by your doctor and described in this leaflet.
Currently, there is limited information about the effects of nevirapine overdose. In
case you have taken more Nevirapina Mylan than the prescribed dose, consult your doctor.

If you forget to take Nevirapina Mylan
Try not to miss any dose. If you realise within 12 hours of forgetting 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. Do not take a double dose to make up for the missed one.

If you stop taking Nevirapina Mylan
Taking all doses at the appropriate times:

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

It is important to continue to take Nevirapina Mylan correctly, as described above, unless
your doctor tells you to stop treatment.
If you stop Nevirapina Mylan for more than 7 days, your doctor will explain how to restart the 14
days of “induction phase” with nevirapine tablets (as described above), before returning to
taking Nevirapina Mylan 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 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
nevirapine are skin reactions that can be serious and life-threatening, and serious liver damage. These reactions mainly occur during 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 sign of a rash, 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 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 and mild/moderate rashes, occurred within the first six weeks of treatment.
If you develop a rash and also feel unwell, you should
stop treatment and see 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
• mouth ulcers
• eye inflammation
• swelling of the face
• general swelling
• shortness of breath
• muscle or joint pain
• inflammation of internal organs
• decreased number of white blood cells (granulocytopenia)
• general feeling of unwellness
• serious liver or kidney problems (liver or kidney failure).

Inform your doctor immediately if you develop a rash and any of the other side effects of a hypersensitivity (allergic) reaction. These reactions can be life-threatening.
Liver function abnormalities have 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, 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 nevirapina 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 potentially fatal 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 levels of phosphorus in the blood
• increased blood pressure.

Rare (may affect up to 1 in 1000 people):

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

The following effects have also been reported when nevirapine 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
Nevirapina Mylan is used in combination with other agents; however, it is unlikely that these
changes are caused by treatment with Nevirapina Mylan.

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 rash symptoms, inform your doctor of any side effects.

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 at www.aifa.gov.it/content/segnalazioni-reazioni-
avverse. By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Nevirapina Mylan

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.
For bottle packs: once opened, use within 100 days.
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. Package Contents and Other Information

What Nevirapina Mylan contains

• The active ingredient is nevirapine. Each prolonged-release tablet contains 400 mg of nevirapine.
• The other ingredients are lactose monohydrate (see section 2 Nevirapina Mylan contains lactose), hypromellose and sodium stearylfumarate.

Description of the appearance of Nevirapina Mylan and package contents
Nevirapina Mylan is available in prolonged-release tablets of oval shape, from white to off-white in color, with Mimprinted on one side of the tablet and N403on the other side.
Nevirapina Mylan is available in PVC/Aluminum blisters, containing 14, 30, 30x1 (unit dose blister), 60, 90, 100 and 120 prolonged-release tablets and in white HDPE bottles with opaque white polypropylene screw caps, containing 30, 90, 250 and 500 prolonged-release tablets. The
bottles also contain cotton wool.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano

Manufacturers
Generics [UK] Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
McDermott Laboratories Limited trading as Gerard Laboratories, 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland
Mylan Hungary Kft., H-2900, Komárom, Mylan ú tca. 1, Hungary
Mylan UK Healthcare Limited, Building 20, Station Close, Potters Bar, EN6 1TL, United Kingdom
Mylan Germany GmbH, Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1 Bad Homburg

• v. d. Hoehe Hessen, 61352, Germany

This medicinal product is authorised in the Member States of the European Economic Area and
in the United Kingdom (Northern Ireland):
Austria Nevirapine Mylan 400 mg
Belgium Nevirapine Mylan 400 mg prolonged-release tablets
Denmark Nevirapin Mylan
Finland Nevirapine Mylan
France Névirapine Viatris L.P 400 mg prolonged-release tablet
Germany Nevirapin Mylan 400 mg Retardtabletten
Italy Nevirapina Mylan
Luxembourg Nevirapine Mylan 400 mg prolonged-release tablets
Netherlands Nevirapine Mylan 400 mg, prolonged-release tablets
Portugal Nevirapina Mylan
United Kingdom
(Northern Ireland)
Nevirapine Mylan 400 mg prolonged-release tablets