NEVIRAPINA 200 mg Tablet

Зміст інструкції

1. Nevirapina Aurobindo 200 mg tablets
   1. What is Nevirapina Aurobindo and what is it used for
   2. What you need to know before taking Nevirapina Aurobindo
   3. How to take Nevirapina Aurobindo
   4. Possible side effects
   5. How to store Nevirapina Aurobindo
   6. Package contents and other information

Nevirapina Aurobindo 200 mg tablets

Generic medicine

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, pharmacist or nurse.
• 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, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

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

Nevirapina Aurobindo 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 Aurobindo helps to control HIV-1 infection.
Nevirapina Aurobindo is indicated for the treatment of adults, adolescents and children of all ages
infected with HIV-1 virus. You must take Nevirapina Aurobindo with other antiretroviral medicines. The
doctor will recommend the most suitable medicines for you.

If Nevirapina Aurobindo has been prescribed for the child, all the information contained in
this leaflet refers to him/her).

2. What you need to know before taking Nevirapina Aurobindo

Do not take Nevirapina Aurobindo:

• If you are allergic to nevirapine or any of the other ingredients of this medicine (listed in section 6, “Contents of the pack and other information”).
• If you have taken Nevirapina Aurobindo in the past and had to stop treatment because you suffered from:
• severe skin rash;
• skin rash with other symptoms, for example:
• fever;
• blisters;
• mouth sores;
• 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 in the past you have had to stop treatment with Nevirapina Aurobindo due to changes in liver function.
• If you are taking medicines containing St. John's Wort extract (Hypericum perforatum).This substance can prevent Nevirapina Aurobindo from working correctly.

Warnings and precautions
Talk to your doctor or pharmacist before using Nevirapina Aurobindo.

During the first 18 weeks of therapy with Nevirapina Aurobindo it is very important that
you and your doctor pay attention to the appearance of any signs of liver or
skin reactions. These can become serious and even life-threatening. You are at the highest 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
may appear as a skin rash) accompanied by other side effects such as:

• fever,
• blisters,
• mouth sores,
• eye inflammation,
• facial swelling,
• general swelling,
• shortness of breath,
• muscle or joint pain,
• general feeling of being unwell,
• abdominal pain.

YOU MUST STOP TAKING NEVIRAPINE AUROBINDO 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, still inform
your doctor immediately, who will advise you whether you need to stop taking Nevirapina
Aurobindo.
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 Aurobindo and contact your doctor immediately.

If you develop severe liver, skin or hypersensitivity reactions while taking Nevirapina
Aurobindo, DO NOT TAKE IT AGAIN without first consulting your doctor.
You must only take the dose of Nevirapina Aurobindo prescribed by your doctor.
This is particularly important during the first 14 days of treatment (see more
information in “How to take Nevirapina Aurobindo”) .
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 Nevirapina Aurobindo 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 Nevirapina Aurobindo 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), signs and symptoms of previous infections may occur shortly after starting anti-HIV treatment.
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, tell 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, tell 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 (death of bone tissue, caused by reduced blood flow
to the bones). The duration of combination antiretroviral therapy, the use of corticosteroids, the
consumption of alcohol, 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 at the same time, tell your doctor as they may
need to check your white blood cell count.
Do not take Nevirapina Aurobindo after exposure to the HIV virus unless you have been
diagnosed with the disease and it has been prescribed by your doctor. Nevirapina Aurobindo does not cure
HIV infection. Therefore, you may continue to contract infections and other diseases associated
with HIV infection. You should therefore respect your doctor’s check-ups during treatment. 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
Nevirapina Aurobindo.
If you are taking oral contraceptives (e.g. “the pill”) or other hormonal methods of birth control during treatment with Nevirapina Aurobindo, 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 Aurobindo.
Children and adolescents
Nevirapina Aurobindo tablets can be taken by:

• Children over the age of 16.
• Children under the age of 16 who:
• weigh at least 50 kg,
• or have a body surface area greater than 1.25 square meters.

For younger children, nevirapine is available in liquid suspension form.

Other medicines and Nevirapina Aurobindo
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 Aurobindo. Your doctor may need to check if other
medicines continue to be effective and change their doses. Read the leaflet carefully
of all other medicines for HIV that you are taking in combination with Nevirapina
Aurobindo.
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 (other medicines to treat HIV infection).

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

Nevirapina Aurobindo with food, drinks and alcohol
There are no restrictions on taking Nevirapina Aurobindo with food and drinks.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
You should stop breastfeeding if you are taking Nevirapina Aurobindo. In general, it is
recommended not to breastfeed if you have HIV infection because the baby
can contract HIV infection through breast milk.

Driving and operating machinery
Fatigue may occur while using nevirapine. Caution is recommended when
performing activities such as driving vehicles and using tools or machinery. If you experience
fatigue, you should avoid any potentially dangerous activity such as driving or using
any tools or machinery.

Nevirapina Aurobindo contains lactose monohydrate
If your doctor has told you that you have an intolerance to some sugars, contact them before
taking this medicine.

3. How to take Nevirapina Aurobindo

Do not take Nevirapina Aurobindo 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 per day for the first 14 days of treatment (“induction phase”). After 14 days, the usual dose is one 200 mg tablet twice a day.
It is very important that you take only one tablet of Nevirapina Aurobindo per day 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 Nevirapina Aurobindo 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.
Nevirapina is also available in liquid form as an oral suspension. This is particularly suitable if:

• you have difficulty swallowing tablets,
• or you are a child weighing less than 50 kg,
• or you are a child with a body surface area of less than 1.25 square meters (your doctor will calculate your body surface area).

You must continue to take Nevirapina Aurobindo 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 adverse effects, such as skin rash. Depending on the outcome, your doctor may decide to temporarily interrupt or stop treatment with Nevirapina Aurobindo. Your doctor may decide to restart the medicine with a lower dose.
Take Nevirapina Aurobindo tablets only by mouth. Do not chew the tablets. You can take Nevirapina Aurobindo with or without food.

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

If you forget to take Nevirapina Aurobindo
Try not to miss any dose. If you realise you have forgotten a dose within 8 hours, take the missed dose as soon as possible. If more than 8 hours have passed, take only the next dose at the scheduled time.
Do not take a double dose to make up for a missed dose.

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

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

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

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 nevirapina are skin reactions and severe liver damage, which can be serious and life-threatening. These reactions occur mainly during the first 18 weeks of treatment with nevirapina. This is therefore an important period that requires close monitoring by the doctor.
If you notice any signs 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 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:

• 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 sores;
• 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;
• severe problems with the liver or kidneys (hepatic or renal 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.
Abnormalities in liver function have been reported with the use of nevirapina. This includes 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 following side effects have been reported by patients treated with nevirapina:
Very common (may affect up to 1 in 10 people):

• 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 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 rashes (Stevens-Johnson syndrome/toxic epidermal necrolysis);
• hives;
• fluid under the skin (angioedema);
• joint pain (arthralgia);
• muscle pain (myalgia);
• decreased 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 nevirapina 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 nevirapina is used in combination with others; however, it is unlikely that these changes are caused by treatment with nevirapina.

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 nevirapina therapy, is also more commonly observed in children. As with rashes, inform the 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 website 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 Aurobindo

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 label or
blister after SCAD. 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. Package contents and other information

What Nevirapina Aurobindo contains

• The active ingredient is nevirapine. Each tablet contains 200 mg of nevirapine (as anhydrous).
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (Type A), povidone (K-30), anhydrous colloidal silica and magnesium stearate.

Description of the appearance of Nevirapina Aurobindoand package contents
Tablet.
White to off-white, oval-shaped, biconvex tablets, imprinted with “J” and “80” on
both sides of the score line and with a score line on the other side. The score line
is intended to aid in swallowing the tablet more easily and is not for dividing the tablet into
equal doses.
Nevirapina Aurobindo tablets are available in blister packs made of transparent PVC/PVdC –
aluminium foil and in HDPE bottles with a polypropylene closure.
Packs:

Blister pack: 1, 7, 10, 14, 60 and 120 tablets.

Bottle: 60 and 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l.
via San Giuseppe 102

• 21047 - Saronno (VA) Italy

Manufacturers
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000
Malta

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
France: NEVIRAPINE ARROW LAB 200 mg sécable tablet
Germany: Nevirapin Aurobindo 200 mg Tablets
Italy: Nevirapina Aurobindo
Malta: Nevirapine Aurobindo 200 mg tablets
Netherlands: Nevirapine Aurobindo 200 mg tablets
Spain: Nevirapina Aurobindo 200 mg EFG tablets
United Kingdom: Nevirapine 200 mg tablets