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EKSTONIV 400MG PROLONGED-RELEASE TABLETS

Active substance(s): NEVIRAPINE ANHYDROUS

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400 mm
Package leaflet: Information for the patient
Ekstoniv 400mg Prolonged-Release Tablets
Nevirapine
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
- If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Ekstoniv is and what it is used for
2. What you need to know before you take Ekstoniv
3. How to take Ekstoniv
4. Possible side effects
5. How to store Ekstoniv
6. Contents of the pack and other information
1. What Ekstoniv is and what it is used for
Ekstoniv belongs to a group of medicines called antiretrovirals, used in the
treatment of Human Immunodeficiency Virus (HIV-1) infection.
The active substance of your medicine is called nevirapine. Nevirapine
belongs to a class of anti-HIV medicines called non-nucleoside reverse
transcriptase inhibitors (NNRTIs). Reverse transcriptase is an enzyme that
HIV needs in order to multiply. Nevirapine stops reverse transcriptase from
working.
By stopping reverse transcriptase from working, Ekstoniv helps control
HIV-1 infection.
Ekstoniv is indicated for the treatment of HIV-1 infected adults,
adolescents and children three years and above and able to swallow
tablets. You must take Ekstoniv together with other antiretroviral
medicines. Your doctor will recommend the best medicines for you.
Ekstoniv prolonged-release tablets should only be used after a two-week
treatment with another type of Ekstoniv (immediate-release tablets or
suspension) unless you are currently on Ekstoniv and are switching to the
prolonged-release form.
2. What you need to know before you take Ekstoniv

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PRODUCT :

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Ekstoniv (Nevirapine prolonged release) 400mg Tablets
- 30 Tablets
Wockhardt UK

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14th April, 2016

- 18TH APRIL 2016
- 21ST APRIL 2016
- 9TH MAY 2016
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Do not take Ekstoniv:
• if you are allergic to nevirapine or any of the other ingredients of this
medicine
(listed in section 6 “What Ekstoniv contains”).
• if you have taken Ekstoniv before and had to stop the treatment
because you suffered from:
• severe skin rash
• skin rash with other symptoms for example:
• fever
• blistering
• mouth sores
• inflammation of the eye
• swelling of the face
• general swelling
• shortness of breath
• muscle or joint pain
• general feelings of illness
• abdominal pain
• hypersensitivity (allergic) reactions
• inflammation of the liver (hepatitis)
• if you have severe liver disease
• if you have had to stop Ekstoniv treatment in the past because of
changes in your liver function
• if you are taking a medicine containing the herbal substance St. John’s
Wort (Hypericum perforatum). This herbal substance may stop Ekstoniv
from working properly.
Warnings and precautions
• Talk to your doctor or pharmacist before taking Ekstoniv.
• During the first 18 weeks of treatment with Ekstoniv it is very
important that you and your doctor watch out for signs of liver or skin
reactions. These can become severe and even life threatening.
• You are at greatest risk of such a reaction during the first 6 weeks of
treatment.
If you experience severe rash or hypersensitivity (allergic reactions
that may appear in the form of rash) accompanied by other side effects
such as
• fever
• general swelling
• blistering
• shortness of breath
• mouth sores
• muscle or joint pain
• inflammation of the eye
• general feelings of illness
• swelling of the face
• abdominal pain
YOU SHOULD DISCONTINUE TAKING EKSTONIV AND YOU MUST
CONTACT your doctor IMMEDIATELY as such reactions can be
potentially life-threatening or lead to death.
If you ever have only mild rash symptoms without any other reaction
please inform your doctor immediately, who will advise you whether
you should stop taking Ekstoniv.
If you experience symptoms suggesting damage of the liver, such as
• loss of appetite
• yellow skin (jaundice)
• feeling sick (nausea)
• abdominal pain
• vomiting
you should discontinue taking Ekstoniv and must contact your
doctor immediately.
If you develop severe liver, skin or hypersensitivity reactions
whilst taking Ekstoniv, NEVER TAKE EKSTONIV again without
referring to your doctor.
You must take the dose of Ekstoniv as prescribed by your doctor.
This is especially important within the first 14 days of treatment
(see more information in “How to take Ekstoniv”).
The following patients are at increased risk of developing liver
problems:
• women
• infected with hepatitis B or C
• abnormal liver function tests
• treatment-naïve patients with higher CD4 cell counts at the start of
Ekstoniv therapy (women more than 250 cells/mm³, men more than 400
cells/mm³)
• pre-treated patients with detectable HIV-1 plasma viral load and higher
CD4 cell counts at the start of Ekstoniv therapy (women more than 250
cells/mm³, men more than 400 cells/mm³)

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In some patients with advanced HIV infection (AIDS) and a history of
opportunistic infection (AIDS defining illness), signs and symptoms of
inflammation from previous infections may occur soon after anti-HIV
treatment is started. It is believed that these symptoms are due to an
improvement in the body’s immune response, enabling the body to fight
infections that may have been present with no obvious symptoms. If you
notice any symptoms of infection, please inform your doctor immediately.
In addition to the opportunistic infections, autoimmune disorders (a
condition that occurs when the immune system attacks healthy body
tissue) may also occur after you start taking medicines for the treatment of
your HIV infection. Autoimmune disorders may occur many months after
the start of treatment. If you notice any symptoms of infection or other
symptoms such as muscle weakness, weakness beginning in the hands
and feet and moving up towards the trunk of the body, palpitations,

tremor or hyperactivity, please inform your doctor immediately to seek
necessary treatment.
Changes of body fat may occur in patients receiving combination
antiretroviral therapy. Contact your doctor if you notice changes in body
fat (see section 4 “Possible side effects”).
Some patients taking combination antiretroviral therapy may develop a
bone disease called osteonecrosis (death of bone tissue caused by loss of
blood supply to the bone). The length of combination antiretroviral
therapy, corticosteroid use, alcohol consumption, severe weakness of the
immune system and higher body mass index may be some of the many risk
factors for developing this disease. Signs of osteonecrosis are joint stiffness,
aches and pains (especially of the hip, knee and shoulder) and difficulty in
movement. If you notice any of these symptoms please inform your doctor.
If you are taking nevirapine and zidovudine concomitantly please
inform your doctor since he might need to check your white blood cells.
Do not take Ekstoniv after an exposure to HIV unless you have been
diagnosed with HIV and instructed to do so by your doctor. Ekstoniv is not
a cure for HIV infection. Therefore, you may continue to develop infections
and other illnesses associated with HIV infection. You should therefore
remain in regular contact with your doctor. You can still pass on HIV when
taking this medicine, although the risk is lowered by effective
antiretroviral therapy. Discuss with your doctor the precautions needed to
avoid infecting other people.
Prednisone should not be used to treat a rash related to Ekstoniv.
If you are taking oral contraceptives (e.g. “pill”) or other hormonal
methods of birth control during treatment with Ekstoniv, you should use
a barrier contraception (e.g. condoms) in addition to prevent pregnancy
and further HIV transmission.
If you are receiving post-menopausal hormone therapy, ask your doctor
for advice before taking this medicine.
If you are taking or are prescribed rifampicin to treat tuberculosis please
inform your doctor before taking this medicine with Ekstoniv.
Ekstoniv prolonged-release tablets or parts of tablets may occasionally be
passed and seen in the stool (faeces). These may look like whole tablets,
but have not been found to affect the efficacy of nevirapine. Inform your
doctor if you find tablet pieces in your faeces.
Children and adolescents
Ekstoniv 400 mg prolonged-release tablets can be taken by children if they:
• are ≥ 8 years of age and weigh 43.8 kg or more
• are older than 3 years of age and below 8 years of age and weigh 25 kg
or more
• have a body surface area of 1.17 square metres or above.
Other medicines and Ekstoniv
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines. Inform your doctor about all other
medicines you are taking before you start taking Ekstoniv. Your doctor
might need to monitor whether your other medicines are still working
and adjust doses. Carefully read the package leaflet of all other HIV
medicines you are taking in combination with Ekstoniv.
It is particularly important that you tell your doctor if you are taking or
have recently taken:
• St. John’s Wort (Hypericum perforatum, medicine to treat depression)
• rifampicin (medicine to treat tuberculosis)
• rifabutin (medicine to treat tuberculosis)
• macrolides e.g. clarithromycin (medicine to treat bacterial infections)
• fluconazole (medicine to treat fungal infections)
• ketoconazole (medicine to treat fungal infections)
• itraconazole (medicine to treat fungal infections)
• methadone (medicine used for treatment of opiate addicts)
• warfarin (medicine to reduce blood clotting)
• hormonal contraceptives (e.g. the “pill”)
• atazanavir (another medicine to treat HIV-infection)
• lopinavir/ritonavir (another medicine to treat HIV- infection)
• fosamprenavir (another medicine to treat HIV-infection)
• efavirenz (another medicine to treat HIV-infection)
• etravirine (another medicine to treat HIV-infection)
• rilpivirine (another medicine to treat HIV-infection)
• delavirdine (another medicine to treat HIV-infection)
• zidovudine (another medicine to treat HIV-infection)
• boceprevir (medicine to treat hepatitis C)
• telaprevir (medicine to treat hepatitis C)
• elvitegravir/cobicistat (another medicine to treat HIV-infection)
Your doctor will carefully monitor the effect of Ekstoniv and any of these
medicines if you are taking them together.
Taking Ekstoniv with food and drink
There are no restrictions on taking Ekstoniv with food and drink.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before
taking this medicine.
You should stop breast-feeding if you are taking Ekstoniv. It is in general
recommended that you do not breast-feed if you have HIV infection
because it is possible that your baby can become infected with HIV
through your breast milk.
Driving and using machines
You may experience fatigue when taking Ekstoniv. Use caution when
engaging in activities such as driving, using any tools or machines. If you
experience fatigue you should avoid potentially hazardous tasks such as
driving or using any tools or machines.
Ekstoniv contains lactose
Ekstoniv prolonged-release tablets contain lactose (milk sugar).
If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking Ekstoniv.
3. How to take Ekstoniv
You should not use Ekstoniv on its own. You must take it with at least two
other antiretroviral medicines. Your doctor will recommend the best
medicines for you.
Always take this medicine exactly as your doctor has told you. Check with
your doctor or pharmacist if you are not sure. Tablets must be swallowed
whole and not divided, broken, chewed or crushed.
The recommended dose is:
Adults:
The dose is one 200 mg Nevirapine tablet per day for the first 14 days of
treatment (“lead-in” period).
A separate treatment initiation pack with 200 mg Nevirapine tablets is
available for this lead-in period. After 14 days, the usual dose is one
400 mg prolonged-release tablet once a day
VERY IMPORTANT - take only one 200mg Nevirapine tablet per day
for the first 14 days
(“lead-in” period). If you have any rash during this period, do not start
taking Ekstoniv prolonged-release tablets but consult your doctor.
NEVER divide Ekstoniv 400mg prolonged release tablets to get a
200mg dose.

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The 14-day “lead-in” period has been shown to lower the risk of skin rash.
Patients who are already on immediate-release tablets or oral suspension
can switch to prolonged-release tablets without lead-in period.
As Ekstoniv must always be taken together with other HIV antiretroviral
medicines, you should follow the instructions for your other medicines
carefully. These are supplied in the package leaflets for those medicines.
You should continue to take Ekstoniv for as long as instructed by your
doctor.
As explained in ‘Warnings and precautions’, above, your doctor will
monitor you with liver tests or for undesirable effects such as rash.
Depending on the outcome your doctor may decide to interrupt or stop
your Ekstoniv treatment. Your doctor might then decide to restart you on
a lower dose.
If you have a renal or hepatic dysfunction of any degree please use only
Nevirapine 200 mg tablets.
Only take Ekstoniv prolonged-release tablets by mouth. Do not chew your
prolonged-release tablets. You may take Ekstoniv with or without food.
If you take more Ekstoniv than you should
Do not take more Ekstoniv than prescribed by your doctor and described
in this leaflet. There is at present little information on the effects of
Ekstoniv overdose. Consult your doctor if you have taken more Ekstoniv
than you should.
If you forget to take Ekstoniv
Try not to miss a dose. If you notice you missed a dose within 12 hours of
when it was due, take the missed dose as soon as possible. If it has been
more than 12 hours since the dose was due only take the next dose at the
usual time.
If you stop taking Ekstoniv
Taking all doses at the appropriate times:
• greatly increases the effectiveness of your combination antiretroviral
medicines
• reduces the chances of your HIV infection becoming resistant to your
antiretroviral medicines.
It is important that you continue taking Ekstoniv correctly, as described
above, unless your doctor instructs you to stop.
If you stop taking Ekstoniv for more than 7 days your doctor will instruct
you to start the 14 day ‘lead-in’ period with Ekstoniv tablets (described
above) once again, before returning to the once daily dose with Ekstoniv
prolonged-release tablets.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.
4. Possible side effects
During HIV therapy there may be an increase in weight and in levels of
blood lipids and glucose. This is partly linked to restored health and life
style, and in the case of blood lipids sometimes to the HIV medicines
themselves. Your doctor will test for these changes.
Like all medicines, this medicine can cause side effects, although not
everybody gets them.

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As mentioned in ‘Warnings and precautions’, above, the most important
side effects of Ekstoniv are severe and life threatening skin reactions
and serious liver damage. These reactions occur mainly in the first 18
weeks of treatment with Ekstoniv. This is therefore an important period
which requires close monitoring by your doctor.
If you ever observe any rash symptoms, inform your doctor
immediately.
When rash occurs it is normally mild to moderate. However, in some
patients a rash, which appears as a blistering skin reaction, can be severe
or life-threatening (Stevens-Johnson syndrome and toxic epidermal
necrolysis) and deaths have been recorded. Most of the cases of both severe
rash and mild/moderate rash occur in the first six weeks of treatment.
If rash occurs and you also feel sick, you must stop treatment and visit
your doctor immediately.
Hypersensitivity (allergic) reactions can occur. Such reactions may
appear in the form of anaphylaxis (a severe form of allergic reaction) with
symptoms such as:
• rash
• swelling of the face
• difficulty breathing (bronchial spasm)
• anaphylactic shock
Hypersensitivity reactions can also occur as rash with other side effects
such as:
• fever
• blistering of your skin
• mouth sores
• inflammation of the eye
• swelling of the face
• general swelling
• shortness of breath
• muscle or joint pain
• a reduction in the numbers of your white blood cells (granulocytopenia)
• general feelings of illness
• severe problems with liver or kidneys (liver or kidney failure).
Tell your doctor immediately if you experience rash and any of the
other side effects of a hypersensitivity (allergic) reaction. Such
reactions can be life-threatening.
Abnormal liver functioning has been reported with the use of Ekstoniv.
This includes some cases of inflammation of the liver (hepatitis), which can
be sudden and intense (fulminant hepatitis), and liver failure, which can
be both fatal.
Tell your doctor if you experience any of the following clinical
symptoms of liver damage:
• loss of appetite
• feeling sick (nausea)
• vomiting
• yellow skin (jaundice)
• abdominal pain







joint pain (arthralgia)
decreased numbers of white blood cells (granulocytopenia)
abnormal liver function tests
decreased blood phosphorus
increased blood pressure

Rare (may affect up to 1 in 1000 people):
• inflammation of the liver (hepatitis)
• decreased numbers of red blood cells (anaemia)
The side effects described below have been experienced by patients given
Ekstoniv prolonged-release tablets once daily in the maintenance phase:
Common (may affect up to 1 in 10 people):
• rash
• headache
• abdominal pain
• feeling sick (nausea)
• inflammation of the liver (hepatitis)
• feeling tired (fatigue)
• abnormal liver function tests
• fever
• vomiting
• loose stools (diarrhoea)
Uncommon (may affect up to 1 in 100 people):
• allergic reactions (hypersensitivity)
• allergic reaction characterized by rash, swelling of the face, difficulty
breathing (bronchial spasm) or anaphylactic shock
• drug reaction with systemic symptoms (drug reaction with eosinophilia
and systemic symptoms)
• sudden and intense inflammation of the liver (fulminant hepatitis)
• severe and life-threatening skin rashes (Stevens Johnson
Syndrome/toxic epidermal necrolysis)
• decreased numbers of red blood cells (anaemia)
• decreased numbers of white blood cells (granulocytopenia)
• yellow skin (jaundice)
• hives (urticaria)
• fluid under the skin (angioneurotic oedema)
• muscle pain (myalgia)
• joint pain (arthralgia)
• decreased blood phosphorus
• increased blood pressure
The following events have also been reported when Ekstoniv has been
used in combination with other antiretroviral agents:
• decreased numbers of red blood cells or platelets
• inflammation of the pancreas
• decrease in or abnormal skin sensations
These events are commonly associated with other antiretroviral agents
and may be expected to occur when Ekstoniv is used in combination with
other agents; however, it is unlikely that these events are due to treatment
with Ekstoniv.
Additional side effects in children and adolescents
A reduction in white blood cells (granulocytopenia) can occur, which is
more common in children.
A reduction in red blood cells (anaemia), which may be related to
nevirapine therapy, is also more commonly observed in children. As with
rash symptoms, please inform your doctor of any side effects.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly via the national reporting system listed below. By
reporting side effects you can help provide more information on the
safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL – Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
E-mail: medsafety@hpra.ie
5. How to store Ekstoniv
Keep this medicine out of the sight and reach of children.
Bottles: Use tablets for up to 30 days from the date of first opening the
bottle. Take unused tablets back to the pharmacy.
Do not use this medicine after the expiry date which is stated on the
carton and on the blister or bottle after “EXP”. The expiry date refers to the
last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask
your pharmacist how to throw away medicines you no longer use. These
measures will help protect the environment.
6. Contents of the pack and other information
What Ekstoniv contains
• The active substance is nevirapine.
• Other ingredient are lactose, hypromellose and magnesium stearate.
What Ekstoniv looks like and contents of the pack
White to off-white oval shaped biconvex prolonged-release tablets;
debossed with ‘H’ on one side and ‘N1’ on other side.
Approximate tablet dimensions are 19 x 9 x 7 mm.
Ekstoniv 400 mg prolonged-release tablets are supplied in blister strips
containing 30 or 90 tablets per carton or plastic bottles containing 30
tablets. Not all pack sizes may be marketed.
Nevirapine is also available as immediate release tablets containing
200mg nevirapine.
Marketing Authorisation Holder
Wockhardt UK Ltd., Ash Road North, Wrexham, LL13 9UF, UK

Back Side Page

The side effects described below have been experienced by patients given
Ekstoniv 200 mg tablets during the 14 day lead-in phase:

Manufacturer
CP Pharmaceuticals Ltd., Ash Road North, Wrexham, LL13 9UF, UK

Common (may affect up to 1 in 10 people):
• rash
• fever
• headache
• abdominal pain
• feeling sick (nausea)
• loose stools (diarrhoea)
• feeling tired (fatigue)

For any information about this medicine, please contact the local
representative of the Marketing Authorisation Holder:

Uncommon (may affect up to 1 in 100 people):
• allergic reactions (hypersensitivity)
• allergic reaction characterized by rash, swelling of the face, difficulty
breathing (bronchial spasm) or anaphylactic shock
• drug reaction with systemic symptoms (drug reaction with eosinophilia
and systemic symptoms)
• sudden and intense inflammation of the liver (fulminant hepatitis)
• severe and life-threatening skin rashes (Stevens Johnson
Syndrome/toxic epidermal necrolysis)
• yellow skin (jaundice)
• hives (urticaria)
• fluid under the skin (angioneurotic oedema)
• vomiting
• muscle pain (myalgia)

Please be ready to give the following information:
Product name
Reference number

This leaflet was last revised in May 2017
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio
please call, free of charge: 0800 198 5000 (UK only).

Ekstoniv 400mg Prolonged-Release Tablets

PL 29831/0675

This is a service provided by the Royal National Institute of Blind People.
For the Republic of Ireland please call UK +44 1978 661261
This medicinal product is authorised in the United Kingdom and
Ireland under the name
Ekstoniv 400mg Prolonged-Release Tablets.
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