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DARUNAVIR ZENTIVA 800MG FILM-COATED TABLETS

Active substance(s): DARUNAVIR / DARUNAVIR

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Package leaflet: Information for the user
Darunavir 800 mg film-coated tablets

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

1.

What darunavir is and what it is used for

Darunavir contains the active substance darunavir. Darunavir is an antiretroviral medicine
used in the treatment of human immunodeficiency virus (HIV) infection. It belongs to a group
of medicines called protease inhibitors. Darunavir works by reducing the amount of HIV in
your body. This will improve your immune system and reduces the risk of developing
illnesses linked to HIV infection.
Darunavir 800 mg is used to treat adults and children (3 years of age and above, at least 40 kg
body weight) who are infected by HIV and

who have not used antiretroviral medicines before.

in certain patients who have used antiretroviral medicines before (your doctor will
determine this).
Darunavir must be taken in combination with a low dose of cobicistat or ritonavir and other
anti-HIV medicines. Your doctor will discuss with you which combination of medicines is
best for you.
2.

What you need to know before you take darunavir

Do not take darunavir

if you are allergic to darunavir or any of the other ingredients of this medicine (listed
in section 6) or to cobicistat or ritonavir.

if you have severe liver problems. Ask your doctor if you are unsure about the severity
of your liver disease. Some additional tests might be necessary.

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Do not combine darunavir with any of the following medicines
If you are taking any of these, ask your doctor about switching to another medicine.

Avanafil (to treat erectile dysfunction).

Astemizole or terfenadine (to treat allergy symptoms).

Triazolam and oral (taken by mouth) midazolam (to help you sleep and/or relieve
anxiety).

Cisapride (to treat some stomach conditions).

Colchicine (if you have kidney and/or liver problems; to treat gout or familial
Mediterranean fever).

Lurasidone, pimozide, quetiapine or sertindole (to treat psychiatric conditions).

Ergot alkaloids like ergotamine, dihydroergotamine, ergometrine and methylergonovine
(to treat migraine and headaches).

Amiodarone, bepridil, dronedarone, quinidine, renolazine and systemic lidocaine (to
treat certain heart disorders e.g. abnormal heart beat).

Lovastatin and simvastatin (to lower cholesterol levels).

Rifampicin (to treat some infections such as tuberculosis).

The combination product lopinavir/ritonavir (an anti-HIV medicine belonging
to the same class as darunavir).

Elbasvir/grazoprevir (to treat hepatitis C infection).

Alfuzosin (to treat enlarged prostate).

Sildenafil (to treat high blood pressure in the pulmonary circulation).

Quetiapine (to treat schizophrenia, bipolar disorder and major depressive disorder).

Ticagrelor (to help stop the clumping of platelets in the treatment of patients with a
history of a heart attack).

Products that contain St. John’s Wort (Hypericum perforatum).
Warnings and precautions
Talk to your doctor or pharmacist before taking darunavir.
Darunavir is not a cure for HIV infection. You can still pass on HIV when taking this
medicine, although the risk is lowered by effective antiretroviral therapy. Discuss with your
physician the precautions needed to avoid infecting other people.
People taking darunavir may still develop infections or other illnesses associated with HIV
infection. You must keep in regular contact with your doctor.
People taking darunavir may develop a skin rash. Infrequently a rash may become severe or
potentially life-threatening. Please contact your doctor whenever you develop a rash.
In patients taking darunavir and raltegravir (for HIV infection), rashes (generally mild or
moderate) may occur more frequently than in patients taking either medicine separately.
Darunavir has only been used in limited numbers of patients 65 years or older. If you belong
to this age group, please discuss with your doctor if you can use darunavir.
Tell your doctor about your situation BEFORE and DURING your treatment
Make sure that you check the following points and tell your doctor if any of these apply to
you.

Tell your doctor if you have had problems with your liver before, including hepatitis B
or C. Your doctor may evaluate how severe your liver disease is before deciding if you
can take darunavir.

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Tell your doctor if you have diabetes. Darunavir might increase sugar levels
in the blood.
Tell your doctor immediately if you notice any symptoms of infection (for example
enlarged lymph nodes and fever). In some patients with advanced HIV infection
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.
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.
Tell your doctor if you have haemophilia. Darunavir might increase the risk
of bleeding.
Tell your doctor if you are allergic to sulphonamides (e.g. used to treat certain
infections).
Tell your doctor if you notice any musculoskeletal problems. 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.

Children and adolescents
Darunavir 800 mg is not for use in children younger than 3 years of age or weighing less than
40 kg.
Other medicines and darunavir
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
There are some medicines that you must not combine with darunavir. These are mentioned
above under the heading “Do not combine darunavir with any of the following medicines”.
In most cases, darunavir can be combined with anti-HIV medicines belonging to another class
[e.g. NRTIs (nucleoside reverse transcriptase inhibitors), NNRTIs (non-nucleoside reverse
transcriptase inhibitors), CCR5 antagonists and FIs (fusion inhibitors)]. Darunavir with
cobicistat or ritonavir has not been tested with all PIs (protease inhibitors) and must not be
used with other HIV PIs. In some cases dosage of other medicines might need to be changed.
Therefore always tell your doctor if you take other anti-HIV medicines and follow your
doctor’s instruction carefully on which medicines can be combined.
The effects of darunavir might be reduced if you take any of the following products. Tell
your doctor if you take:

phenobarbital, phenytoin (to prevent seizures).
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dexamethasone (corticosteroid).
efavirenz (HIV infection).
telaprevir, boceprevir (hepatitis C infection).
rifapentine, rifabutin (medicines to treat some infections such as tuberculosis)
saquinavir (HIV infection).

The effects of other medicines might be influenced if you take darunavir. Tell your doctor if
you take:

amlodipine, diltiazem, disopyramide, carvedilol, felodipine, flecainide, metoprolol,
mexiletine, nifedipine, nicardipine, propafenone, timolol, verapamil (for heart disease)
as the therapeutic effect or side effects of these medicines may be increased.

apixaban, dabigatran etexilate, rivaroxaban,warfarin (to reduce clotting of the blood) as
their therapeutic effect or side effects may be altered; your doctor may have to check
your blood.

oestrogen-based hormonal contraceptives and hormonal replacement therapy. Darunavir
might reduce its effectiveness. When used for birth control, alternative methods of nonhormonal contraception are recommended.

atorvastatin, pravastatin, rosuvastatin (to lower cholesterol levels). The risk of muscle
tissue disorder might be increased. Your doctor will evaluate which cholesterol
lowering regimen is best for your specific situation.

clarithromycin (antibiotic).

ciclosporin, everolimus, tacrolimus, sirolimus (to treat your immune system) as the
therapeutic effect or side effects of these medicines might be increased. Your doctor
might want to do some additional tests.

corticosteroids including bethametasone, budesonide, fluticasone, mometasone,
prednisone, triamcinolone. These medicines are used to treat allergies, asthma,
inflammatory bowel diseases, inflammatory conditions of the eyes, joints and muscles
and other inflammatory conditions. If alternatives cannot be used, its use should only
take place after medical evaluation and under close monitoring by your doctor for
corticosteroid side effects.

buprenorphine/naloxone (medicines to treat opiate dependence).

salmeterol (medicine to treat asthma)

artemether/lumefantrine (a combination medicine to treat malaria).

dasatinib, everolimus, nilotinib, vinblastine, vincristine (to treat cancer).

sildenafil, tadalafil, vardenafil (for erectile dysfunction or to treat a heart and lung
disorder called pulmonary arterial hypertension).

simeprevir (to treat hepatitis C infection).
The dosage of other medicines might need to be changed since either their own or
therapeutic effect of darunavir or side effects may be influenced when combined. Tell your
doctor if you take:

alfentanil (injectable strong and short-acting painkiller that is used for surgical
procedures).

digoxin (to treat certain heart disorders).

clarithromycin (antibiotic)

ketoconazole, itraconazole, fluconazole, posaconazole, clotrimazole (to treat fungal
infections). Voriconazole should only be taken after medical evaluation.
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rifabutin (against bacterial infections).
sildenafil, vardenafil, tadalafil (for erectile dysfunction or high blood pressure
in the pulmonary circulation).
amitriptyline, desipramine, imipramine, nortriptyline, paroxetine, sertraline, trazodone
(to treat depression and anxiety).
maraviroc (to treat HIV infection).
methadone (to treat opiate dependence).
carbamazepine (to prevent seizures or to treat certain types of nerve pain).
colchicine (to treat gout or familial Mediterranean fever).
bosentan (to treat high blood pressure in the pulmonary circulation).
buspirone, clorazepate, diazepam, estazolam, flurazepam, midazolam that is not taken
orally, zolpidem (sedative agents).
perphenazine, risperidone, thioridazine (to treat psychiatric conditions).
metformin (to treat type 2 diabetes).

This is not a complete list of medicines, Tell your healthcare provider about all medicines
that you are taking.
Darunavir with food and drink
See section 3 “How to take darunavir”.
Pregnancy and breast-feeding
Tell your doctor immediately if you are pregnant or if you are breast-feeding. Pregnant or
breast-feeding mothers must not take darunavir unless specifically directed by the doctor.
It is recommended that HIV infected women must not breast-feed their infants because
of both the possibility of your baby becoming infected with HIV through your breast milk
and because of the unknown effects of the medicine on your baby.
Driving and using machines
Do not operate machines or drive if you feel dizzy after taking darunavir.
Darunavir 800 mg film-coated tablets contain ponceau 4R red (E124)
It may cause allergic reactions.

3.

How to take darunavir

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
Even if you feel better, do not stop taking darunavir and cobicistat or ritonavir without talking
to your doctor.
After therapy has been initiated, the dose or dosage form must not be changed or therapy must
not be stopped without instruction of the doctor.
Darunavir 800 mg is intended for once daily use only.
Dose for adults who have not taken antiretroviral medicines before (your doctor will
determine this)
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The usual dose of darunavir is 800 mg (2 tablets of darunavir containing 400 mg darunavir or
1 tablet of darunavir containing 800 mg darunavir) once daily.
You must take darunavir every day and always in combination with 150 mg of cobicistat or
100 mg of ritonavir and with food. Darunavir cannot work properly without cobicistat or
ritonavir and food. You must eat a meal or a snack within 30 minutes prior to taking your
darunavir and cobicistat or ritonavir. The type of food is not important. Even if you feel
better, do not stop taking darunavir and cobicistat or ritonavir without talking to your doctor.
Instructions for adults

Take one 800 mg tablet at the same time, once a day, every day.

Take darunavir always together with 150 mg of cobicistat or 100 mg of ritonavir.

Take darunavir with food.

Swallow the tablet with a drink such as water or milk.

Take your other HIV medicines used in combination with darunavir and cobicistat or
ritonavir as recommended by your doctor.

Oral suspension containing darunavir has been developed for use in children, but can
also be used in adults in some cases.
Dose for adults who have taken antiretroviral medicines before (your doctor will
determine this)
The dose is either:

800 mg darunavir (2 tablets of darunavir containing 400 mg darunavir or 1 tablet of
darunavir containing 800 mg darunavir) together with 150 mg cobicistat or 100 mg
ritonavir once daily.
OR

600 mg darunavir (1 tablet of darunavir containing 600 mg darunavir) together
with 100 mg ritonavir twice daily.
Please discuss with your doctor which dose is right for you.
Dose for children 3 years of age and above, weighing more than 40 kg who have
not taken antiretroviral medicines before (your child’s doctor will determine this)

The usual dose of darunavir is 800 mg (2 tablets of darunavir containing 400 mg
darunavir or 1 tablet of darunavir containing 800 mg darunavir) together with 100 mg
ritonavir once daily.
Dose for children 3 years of age and above, weighing more than 40 kg who have taken
antiretroviral medicines before (your child’s doctor will determine this)
The dose is:

800 mg darunavir (2 tablets of darunavir containing 400 mg darunavir or 1 tablet of
darunavir containing 800 mg darunavir) together with 100 mg ritonavir once daily.
OR

600 mg darunavir (1 tablet of darunavir containing 600 mg darunavir) together with
100 mg ritonavir twice daily.
Please discuss with your doctor which dose is right for you.
Darunavir oral suspension may be also available. Your doctor will determine whether
darunavir tablets or oral suspension is right for the child.
Instructions for children 3 years of age and above, weighing more than 40 kg
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Take 800 mg darunavir (2 tablets of darunavir containing 400 mg darunavir or 1 tablet
of darunavir containing 800 mg darunavir) at the same time, once a day, every day.
Take darunavir always together with 100 mg of ritonavir.
Take darunavir with food.
Swallow the tablets with a drink such as water or milk.
Take your other HIV medicines used in combination with darunavir and ritonavir as
recommended by your doctor.

Removing the child resistant cap
The plastic bottle comes with a child resistant cap and must be opened as follows:

Push the plastic screw cap down while turning it counter clockwise.

Remove the unscrewed cap.
If you take more darunavir than you should
Contact your doctor, pharmacist or nurse immediately.
If you forget to take darunavir
If you notice within 12 hours, you must take the tablets immediately. Always take
with cobicistat or ritonavir and food. If you notice after 12 hours, then skip the intake and take
the next doses as usual. Do not take a double dose to make up for a forgotten dose.
Do not stop taking darunavir without talking to your doctor first
HIV therapy may increase your sense of well-being. Even when you feel better, do not stop
taking darunavir. Talk to your doctor first.
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.
Tell your doctor if you develop any of the following side effects:

Liver problems that may occasionally be severe have been reported. Your doctor should
do blood tests prior to initiating darunavir. If you have chronic hepatitis B or C
infection, your doctor should check your blood tests more often because you have
an increased chance of developing liver problems. Talk to your doctor about the signs
and symptoms of liver problems. These may include yellowing of your skin or whites
of your eyes, dark (tea coloured) urine, pale coloured stools (bowel movements),
nausea, vomiting, loss of appetite, or pain, aching, or sensitivity on your right side
below your ribs.

Skin rash (more often when used in combination with raltegravir), itching. The rash
is usually mild to moderate. A skin rash might also be a symptom of a rare severe
situation. It is therefore important to contact your doctor if you develop a rash.
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Your doctor will advise you how to deal with your symptoms or whether darunavir
must be stopped.
Other clinically relevant severe side effects were diabetes (common) and inflammation
of the pancreas (uncommon).

Very common side effects (may affect more than 1 in 10 people):

Diarrhoea.
Common side effects (may affect up to 1 in 10 people):

Vomiting, nausea, abdominal pain or distension, dyspepsia, flatulence.

Headache, tiredness, dizziness, drowsiness, numbness, tingling or pain in hands or feet,
loss of strength, difficulty falling asleep.
Uncommon side effects (may affect up to 1 in 100 people):

Chest pain, changes in electrocardiogram, rapid heart beating.

Decreased or abnormal skin sensibility, pins and needles, attention disturbance,
loss of memory, problems with your balance.

Difficulty breathing, cough, nosebleed, throat irritation.

Inflammation of the stomach or mouth, heartburn, retching, dry mouth, discomfort
of the abdomen, constipation, belching.

Kidney failure, kidney stones, difficult discharge of urine, frequent or excessive passage
of urine, sometimes at night.

Urticaria, severe swelling of the skin and other tissues (most often the lips or the eyes),
eczema, excessive sweating, night sweats, hair loss, acne, scaly skin, colouration of
nails.

Muscle pain, muscle cramps or weakness, pain in extremity, osteoporosis.

Slowing down of the thyroid gland function. This can be seen in a blood test.

High blood pressure, flushing.

Red or dry eyes.

Fever, swelling of lower limbs due to fluids, malaise, irritability, pain.

Symptoms of infection, herpes simplex.

Erectile dysfunction, enlargement of breasts.

Sleeping problems, sleepiness, depression, anxiety, abnormal dreams, decrease in
sexual drive.
Rare side effects (may affect up to 1 in 1,000 people):

A reaction called DRESS [severe rash, which may be accompanied by fever, fatigue,
swelling of the face or lymph glands, increase of eosinophils (type of white blood cells),
effects on liver, kidney or lung].

Heart attack, slow heart beating, palpitations.

Visual disturbance.

Chills, feeling abnormal.

A feeling of confusion or disorientation, altered mood, restlessness.

Fainting, epileptic fits, changes or loss of taste.

Mouth sores, vomiting blood, inflammation of the lips, dry lips, coated tongue.

Running nose.

Skin lesions, dry skin.
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Stiffness of muscles or joints, joint pain with or without inflammation.
Changes in some values of your blood cells or chemistry. These can be seen in the
results of blood and/or urine tests. Your doctor will explain these to you. Examples are:
increase in some white blood cells.

Some side effects are typical for anti-HIV medicines in the same family as darunavir. These
are:

Muscle pain, tenderness or weakness. On rare occasions, these muscle disorders have
been serious.
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.

5.

How to store darunavir

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 carton and on the bottle
after EXP. The expiry date refers to the last day of that month.
This medicinal product 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 darunavir contains

The active substance is darunavir. Each tablet contains 800 mg of darunavir.

The other ingredients are Dry Granulation Agent (mixture of Cellulose, microcrystalline
and Calcium phosphate, anhydrous), Croscarmellose sodium, Cellulose,
microcrystalline, Silica, colloidal anhydrous, Magnesium stearate, Opadry II Brown
85F265048 [mixture of Poly(vinyl alcohol) – partially hydrolysed, Titanium dioxide
(E171), Macrogol 3350, Talc, Ponceau 4R aluminium lake (E124), Iron oxide, red
(E172), Iron oxide, yellow (E172).
What darunavir looks like and contents of the pack
Plain, oval, biconvex, dark red film-coated tablets of approx. 20 mm length and 10 mm width.
30 film-coated tablets in HDPE bottle with child-resistant screw cap.
Bundle pack of 3 HDPE bottles with 30 film-coated tablets in each bottle.
Darunavir is also available as 75, 150, 400 and 600 mg film-coated tablets.
Marketing Authorisation Holder
Zentiva
One Onslow Street, Guildford,
Surrey, GU1 4YS, UK
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Manufacturer
Zentiva, k. s., U kabelovny 130, Dolní Měcholupy,
102 37 Prague, Czech Republic

This leaflet was last revised in May 2017

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Expand Transcript

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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