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ATAZANAVIR TEVA 150 MG CAPSULES HARD

Active substance(s): ATAZANAVIR SULFATE

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Transcript
TEVA UK Ref:

21 September 2015

2 What you need to know before you take
Atazanavir

Do not take Atazanavir
• if you are allergic to atazanavir or any of the other
ingredients of this medicine (listed in section 6)
• if you have moderate to severe liver problems. Your doctor
will evaluate how severe your liver disease is before
deciding whether you can take Atazanavir
• if you are taking any of these medicines: see also Other
medicines and Atazanavir
• rifampicin, an antibiotic used to treat tuberculosis
• astemizole or terfenadine (commonly used to treat allergy
symptoms, these medicines may be available without
prescription); cisapride (used to treat gastric reflux,
sometimes called heartburn); pimozide (used to treat
schizophrenia); quinidine or bepridil (used to correct heart
rhythm); ergotamine, dihydroergotamine, ergonovine,
methylergonovine (used to treat headaches); and alfuzosin
(used to treat enlarged prostatic gland)
• quetiapine (used to treat schizophrenia, bipolar disorder
and major depressive disorder)
• medicines containing St. John’s Wort (Hypericum
perforatum, a herbal preparation)
• triazolam and oral (taken by mouth) midazolam (used to
help you sleep and/or to relieve anxiety)
• simvastatin and lovastatin (used to lower blood
cholesterol).

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 immunosuppression, higher
body mass index, among others, 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.
Hyperbilirubinaemia (an increase in the level of bilirubin in the
blood) has occurred in patients receiving atazanavir. The signs
may be a mild yellowing of the skin or eyes. If you notice any
of these symptoms please inform your doctor.
Serious skin rash, including Stevens-Johnson syndrome, has
been reported in patients taking atazanavir. If you develop a
rash inform your doctor immediately.
If you notice a change in the way your heart beats (heart
rhythm changes), please inform your doctor.
Children and adolescents
Atazanavir capsules can be taken by children at least 6 years
of age and older and weighing at least 15 kg who are able to
swallow the capsules (see section 3 How to take Atazanavir).

Atazanavir with food and drink
It is important that you take Atazanavir with food (a meal or a
substantial snack) as this helps the body absorb the medicine.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant or planning to become
pregnant. Also be sure to talk to your doctor about
breast-feeding. Patients should not breast-feed while taking
Atazanavir. It is recommended that women infected with HIV
do not breast-feed because the virus might be transmitted
through the breast milk.

2,5 mm

PHARMACODE

OPTICAL CODE
5 mm

Driving and using machines
If you feel dizzy or lightheaded, contact your doctor
immediately. Do not drive or use machines if affected.
Atazanavir contains lactose
If you have been told by your doctor that you have an
intolerance to some sugars (e.g. lactose), contact your doctor
before taking this medicinal product.

3 How to take Atazanavir
Always take this medicine exactly as your doctor has told you.
Check with your doctor if you are not sure. This way, you can
be sure your medicine is fully effective and you reduce the risk
of the virus developing resistance to the treatment.
The recommended adult dose of Atazanavir capsules is
300 mg once daily with 100 mg ritonavir once daily and with
food, in combination with other anti-HIV medicines. Your
doctor may adjust the dose of Atazanavir according to your
anti-HIV therapy.

35 mm

OPTICAL CODE
5 mm

PRODUCT NAME
CODE

GLUE AREA
NO PRINTING

Children receiving Atazanavir may require their heart to be
monitored. Your child's doctor will decide this.

420 mm
LOPINAVIR / RITONAVIR (320 x 420 mm) - RUSIJA.indd 1

Some medicines may interact with ritonavir, a medicine that is
taken with Atazanavir. It is important to tell your doctor if you
are taking fluticasone or budesonide (given by nose or inhaled
to treat allergic symptoms or asthma).

GLUE AREA
NO PRINTING

35 mm

Atazanavir is not a cure for HIV infection. You may continue to
develop infections or other illnesses linked to HIV infection.
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.

2,5 mm
84 mm

35 mm

Atazanavir capsules may be used by adults and children
6 years of age and older. Your doctor has prescribed
Atazanavir for you because you are infected by the HIV that
causes Acquired Immunodeficiency Syndrome (AIDS). It is
normally used in combination with other anti-HIV medicines.
Your doctor will discuss with you which combination of these
medicines with Atazanavir is best for you.

In some patients with advanced HIV infection (AIDS) and a
history of opportunistic infection, 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.

10 mm

Atazanavir is an antiviral (or antiretroviral) medicine. It is one
of a group called protease inhibitors. These medicines control
Human Immunodeficiency Virus (HIV) infection by stopping a
protein that the HIV needs for its multiplication. They work by
reducing the amount of HIV in your body and this in turn,
strengthens your immune system. In this way Atazanavir
reduces the risk of developing illnesses linked to HIV infection.

10 mm

1 What Atazanavir is and what it is used for

Kidney stones have been reported in patients taking
atazanavir. If you develop signs or symptoms of kidney stones
(pain in your side, blood in your urine, pain when you urinate),
please inform your doctor immediately.

20 mm

What Atazanavir is and what it is used for
What you need to know before you take Atazanavir
How to take Atazanavir
Possible side effects
How to store Atazanavir
Contents of the pack and other information

Warnings and precautions
Some people will need special care before or while taking
Atazanavir. Talk to your doctor or pharmacist before taking
Atazanavir, make sure your doctor knows if you:
• have hepatitis B or C
• have type A or B haemophilia
• have diabetes
• require haemodialysis
• are taking oral contraceptives ("the Pill") to prevent
pregnancy
• are taking omeprazole or other proton pump inhibitors; or
famotidine or other H2-receptor antagonists (used to treat
diseases related to the acid in the stomach)
• notice changes in body fat. Redistribution, accumulation, or
loss of body fat may occur in patients receiving antiretroviral
therapy.

There are other medicines that may not mix with Atazanavir.
Tell your doctor if you are taking, have recently taken, or
might take any other medicines. It is especially important to
mention these:
• other medicines to treat HIV infection
• boceprevir (used to treat hepatitis C)
• sildenafil, vardenafil, or tadalafil (used by men to treat
impotence (erectile dysfunction))
• if you are taking an oral contraceptive ("the Pill") with
Atazanavir, be sure to take it exactly as instructed by your
doctor and not miss any doses
• any medicines used to treat diseases related to the acid in
the stomach (e.g. antacids, H2-blockers and proton pump
inhibitors)
• medicines to lower blood pressure, to slow heart rate, or to
correct heart rhythm
• atorvastatin, pravastatin, and fluvastatin (used to lower
blood cholesterol)
• salmeterol (used to treat asthma)
• nevirapine and efavirenz (used to treat HIV)
• cyclosporin, tacrolimus, and sirolimus (medicines to
decrease the effects of body's immune system)
• certain antibiotics (rifabutin, clarithromycin)
• ketoconazole, itraconazole, and voriconazole (antifungals)
• warfarin (anticoagulant, used to reduce the blood clots)
• carbamazepine, phenytoin, phenobarbital, lamotrigine
(antiepileptics)
• irinotecan (used to treat cancer)
• sedative agents (e.g. midazolam administered by injection)
• buprenorphine (used to treat opioid addiction and pain).

90 mm

WHAT IS IN THIS LEAFLET:

Tell your doctor at once if any of the above apply to you.

Other medicines and Atazanavir
You must not take Atazanavir with certain medicines. These
are listed under Do not take Atazanavir, at the start of
section 2.

140 mm

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.

Do not take sildenafil with Atazanavir when sildenafil is used
for the treatment of pulmonary arterial hypertension.
Sildenafil is also used for the treatment of erectile dysfunction.
Tell your doctor if you are using sildenafil for the treatment of
erectile dysfunction.

160 mm

PACKAGE LEAFLET: INFORMATION FOR THE USER

320 mm

9

S I D E

ATAZANAVIR 150 mg, 200 mg AND 300 mg
CAPSULES, HARD

1.
2.
3.
4.
5.
6.

Version:

125 mm

F R O N T

231-30-90010-A LEA ATAZANAVIR 100-200-300MG CAPS HARD TUK
PHARMACODE

10.04.2014. 08:55

TEVA UK Ref:

9

21 September 2015

S I D E

For children (6 to less than 18 years of age), your child's
doctor will decide the right dose based on your child's weight.
The dose of Atazanavir capsules for children is calculated by
body weight and is taken once daily with food and 100 mg
ritonavir as shown below:
Body Weight (kg)

Atazanavir Dose
once daily (mg)

Ritonavir Dose*
once daily (mg)

15 to less than 20

150

100

20 to less than 40

200

100

At least 40

300

100

125 mm

*Ritonavir capsules, tablets or oral solution may be used.
There are no dosing recommendations for Atazanavir in
paediatric patients less than 6 years of age or weighting less
than 15 kg.
Take Atazanavir capsules with food (a meal or a substantial
snack). Swallow the capsules whole. Do not open the
capsules.
If you take more Atazanavir than you should
If you accidentally take more Atazanavir capsules than your
doctor recommended, contact your HIV doctor at once or
contact the nearest hospital for advice.
If you forget to take Atazanavir
If you miss a dose, take the missed dose as soon as possible
with food and then take your next scheduled dose at its
regular time. If it is almost time for your next dose, do not take
the missed dose. Wait and take the next dose at its regular
time. Do not take a double dose to make up for a forgotten
dose.

2,5 mm
84 mm

2,5 mm

35 mm

GLUE AREA
NO PRINTING

If you stop taking Atazanavir
Do not stop taking Atazanavir before talking to your doctor.
If you have any further questions on the use of this medicine,
ask your doctor.

4 Possible side effects

10 mm

70 mm

Like all medicines, this medicine can cause side effects,
although not everybody gets them. When treating HIV
infection, it is not always easy to identify what side effects are
caused by Atazanavir, by the other medicines you are taking,
or by the HIV infection itself. Tell your doctor if you notice
anything unusual about your health.

2,5 mm

PHARMACODE

Patients treated with atazanavir have reported the following
side effects:
Common: may affect up to 1 in 10 people
• headache
• ocular icterus (presence of jaundice seen in the white part of
the eyes)
• vomiting (being sick), diarrhoea, stomach pain of discomfort
(abdominal pain), nausea (feeling sick), indigestion
(dyspepsia)
• yellowing of the skin and/or eyes (jaundice)
• rash
• body changes due to fat redistribution, accumulation, or loss
of body fat (lipodistrophy syndrome), extreme tiredness
(fatigue).

2,5 mm

GLUE AREA
NO PRINTING

50 mm

Version:

Uncommon: may affect up to 1 in 100 people
• life-threatening irregular heart beat (torsades de pointes)
• numbness, weakness, tingling or pain in the arms and legs
(peripheral neuropathy)
• allergic reaction (hypersensitivity)
• body cannot remove sugar from the blood normally
(diabetes mellitus)
• high sugar levels in the blood (hyperglycaemia)
• unusual tiredness or weakness (asthenia)
• weight decreased, weight gain, anorexia (loss of appetite),
appetite increased
• depression, anxiety, sleep disorder
• disorientation, loss of memory (amnesia), dizziness,
sleepiness (somnolence), abnormal dreams
• fainting (syncope), high blood pressure (hypertension)

• shortness of breath (dyspnoea)
• inflammation of the pancreas (pancreatitis), inflammation of
the stomach (gastritis), mouth ulcers and cold sores
(stomatitis aphthous), impairment of the sense of taste
(dysgeusia), flatulence (wind), dry mouth, abdominal
distension (bloating)
• inflammation of the liver (hepatitis)
• severe swelling of the skin and other tissues most often the
lips or the eyes (angioedema)
• itchy rash (urticaria), unusual hair loss or thinning (alopecia),
itching (pruritus)
• muscle shrinkage (muscle atrophy), joint pain (arthralgia),
aching muscles (myalgia)
• formation of kidney stones (nephrolithiasis), kidney
inflamation (interstitial nephritis), blood in the urine
(hematuria), excess protein in the urine (proteinuria),
increased frequency of urination (pollakiuria)
• breast enlargement in men (gynaecomastia)
• chest pain, generally feeling unwell (malaise), fever
• difficulty sleeping (insomnia)
• serious skin rashes (allergic reactions including rash, a high
temperature, increased levels of liver enzymes seen in blood
tests, an increase in a type of white blood cell [esosinophilia],
and/or enlarged lymph nodes) (see section 2)
• gallstones and gallbladder inflammation (gallbladder
disorders).
Rare: may affect up to 1 in 1,000 people
• irregular heart beat (QTc prolongation)
• abnormal manner of walking (gait disturbance)
• swelling (oedema), fast or irregular heart beat (palpitation)
• enlargement of the liver and spleen (hepatosplenomegaly)
• visible accumulation of fluid under the skin (vesiculobullous
rash), skin rash (eczema), widening of blood vessels
(vasodilatation)
• allergic reactions including serious skin rash, a high
temperature and enlarged lymph nodes (Stevens-Johnson
syndrome) (see section 2)
• aching muscles, muscle tenderness of weakness, not caused
by exercise (myopathy)
• kidney pain.
People who already have type A or B haemophilia may notice
increased bleeding.
There have been reports of raised blood sugar and developing
or worsening of diabetes in people using protease inhibitors.
Also, there have been reports of unusual heart beat in both
adult and paediatric patients using atazanavir.
Changes in body fat have been seen in some patients taking
antiretroviral therapy. These changes include increased
amounts of fat in the upper back and neck ("buffalo hump"),
breast, and around the abdomen ("belly"). Loss of fat from the
legs, arms and face may also happen. The cause and
long-term health effects of these conditions are not known at
this time.
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 Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.

6 Contents of the pack and other information
What Atazanavir contains
• The active substance is atazanavir.
Each 150 mg hard capsule contains atazanavir sulphate
corresponding to 150 mg of atazanavir.
Each 200 mg hard capsule contains atazanavir sulphate
corresponding to 200 mg of atazanavir.
Each 300 mg hard capsule contains atazanavir sulphate
corresponding to 300 mg of atazanavir.
• The other ingredients in the caspule fill are crospovidone,
lactose monohydrate and magnesium stearate.
• The other ingredients in the capsule shell are:
150 mg and 200 mg: gelatine, indigotine (E132) and titanium
dioxide (E171)
300 mg: gelatine, indigotine (E132), titanium dioxide (E171),
red iron oxide (E172) and yellow iron oxide (E172)
• The other ingredients in the printing ink are shellac, iron
oxide black (E172), propylene glycol (E1520) and ammonia
solution, concentrated 28%.
What Atazanavir looks like and contents of the pack
Atazanavir 150 mg hard capsules are non transparent size 1
capsules with overall closed length 19.4 ± 0.3 mm with dark
blue cap, and black mark 150 on light blue body. The content
of the capsule is light yellow powder.
Atazanavir 200 mg hard capsules are non transparent size 0
capsules with overall closed length 21.7 ± 0.3 mm with blue
cap, and black mark 200 on blue body. The content of the
capsule is light yellow powder.
Atazanavir 300 mg hard capsules are non transparent size 00
capsules with overall closed length 23.3 ± 0.3 mm with red
cap, and black mark 300 on blue body. The content of the
capsule is light yellow powder.
150 mg and 200 mg: Atazanavir stored in blisters is available
in a pack size of 60 and 60 x 1 capsules.
150 mg and 200 mg: Atazanavir stored in bottles is available in
a pack size of 60 capsules.
300 mg: Atazanavir stored in blisters is available in pack sizes
of 30, 30 x 1, 60 and 90 capsules.
300 mg: Atazanavir stored in bottles is available in a pack size
of 30 and 3 x 30 capsules.

10 mm

Not all pack sizes may be marketed.
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG, UK
Manufacturer
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.), Prilaz baruna
Filipovica 25, Zagreb, 10000, Croatia
This leaflet was last revised in 09/2015.
PL 00289/1902
PL 00289/1903
PL 00289/1904

5 How to store Atazanavir
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 outer carton, bottle or blister foil after EXP. The expiry
date refers to the last day of that month.
Store below 30°C.
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.

90010-A

420 x 320

420 mm
LOPINAVIR / RITONAVIR (320 x 420 mm) - RUSIJA.indd 2

10.04.2014. 08:55

320 mm

B A C K

231-30-90010-A LEA ATAZANAVIR 100-200-300MG CAPS HARD TUK

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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