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DARUNAVIR 600 MG FILM-COATED TABLETS

Active substance(s): DARUNAVIR / DARUNAVIR

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Package leaflet: Information for the user
Darunavir 600 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, pharmacist or nurse.
 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, pharmacist or nurse. 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

What is Darunavir?
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.
What it is used for?
Darunavir is used to treat adults who are infected by HIV and who have already used other antiretroviral
medicines and children of 3 years of age and above, and at least 15 kilogram body weight who are
infected by HIV.
Darunavir must be taken in combination with a low dose of 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
ritonavir
 have severe liver problems. Ask your doctor if you are unsure about the severity of your liver
disease. Some additional tests might be necessary.
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.

Medicine
Avanafil
Astemizole or terfenadine
Triazolam and oral (taken by mouth) midazolam
Cisapride
Colchicine (if you have kidney and/or liver
problems)
Pimozide, quetiapine or sertindole
Ergot alkaloids like ergotamine,
dihydroergotamine, ergometrine and
methylergonovine
Amiodarone, bepridil, dronedarone, quinidine,
ranolazine and systemiclidocaine
Lovastatin and simvastatin
Rifampicin
The combination product lopinavir/ritonavir
Alfuzosin
Sildenafil
Ticagrelor

Purpose of the medicine
to treat erectile dysfunction
to treat allergy symptoms
to help you sleep and/or relieve anxiety
to treat some stomach conditions
to treat gout
to treat psychiatric conditions
to treat migraine and headaches

to treat certain heart disorders e.g. abnormal heart
beat
to lower cholesterol levels
to treat some infections such as tuberculosis
this anti-HIV medicine belongs to the same class as
Darunavir
to treat enlarged prostate
to treat high blood pressure in the pulmonary
circulation
to help stop the clumping of platelets in the
treatment of patients with a history of a heart attack

Do not combine Darunavir with products that contain St John’s Wort (Hypericum perforatum).
Warnings and precautions
Talk to your doctor, pharmacist or nurse 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.
 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 antiHIV 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.

Use in children and adolescents
Darunavir is not for use in children younger than 3 years of age or weighing less than 15 kilograms.
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 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)
 dexamethasone (corticosteroid)
 efavirenz (HIV infection)
 telaprevir, boceprevir (hepatitis C virus 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 non-hormonal
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.
fluticasone, budesonide (to control asthma). 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)
prednisone (corticosteroid)
sildenafil, tadalafil, vardenafil (for erectile dysfunction or to treat a heart and lung disorder called
pulmonary arterial hypertension).

The dosage of other medicines might need to be changed since either their own or Darunavir’s therapeutic
effect 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, posaconazole, clotrimazole (to treat fungal infections). Voriconazole
should only be taken after medical evaluation.
 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)
 bosentan (to treat high blood pressure in the pulmonary circulation)
 buspirone, clorazepate, diazepam, estazolam, flurazepam, midazolam that is not taken orally,
zoldipem (sedative agents)
 risperidone, thioridazine (to treat psychiatric conditions).
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.

3.

How to take Darunavir

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has
told you. Check with your doctor, pharmacist or nurse if you are not sure. Even if you feel better, do not
stop taking Darunavir and 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.
Dose for adults who have not taken antiretroviral medicines before (your doctor will determine
this)
You will require a different dose of Darunavir which cannot be administered with these 600 milligram
tablets. Other strengths of Darunavir are available.
Dose for adults who have taken antiretroviral medicines before (your doctor will determine this)
The dose is either:
 600 milligram Darunavir (2 tablets containing 300 milligram of darunavir or 1 tablet containing 600
milligram of darunavir) together with 100 milligram ritonavir twice daily.
or
 800 milligram Darunavir (2 tablets containing 400 milligram of darunavir) together with 100
milligram ritonavir once daily. Darunavir 400 milligram tablets are only to be used to construct the
once daily 800 milligram regimen.
Please discuss with your doctor which dose is right for you.
Instructions for adults
 Take Darunavir always together with ritonavir. Darunavir cannot work properly without ritonavir.
 In the morning, take one 600 milligram Darunavir tablet together with 100 milligram ritonavir.
 In the evening, take one 600 milligram Darunavir tablet together with 100 milligram ritonavir.
 Take Darunavir with food. Darunavir cannot work properly without food. The type of food is not
important.
 Swallow the tablets with a drink such as water or milk.
 Darunavir 150 milligram tablets have been developed for use in children, but can also be used in
adults in some cases.
Dose for children of 3 years of age and above, weighing at least 15 kilograms who have not taken
antiretroviral medicines before (your child’s doctor will determine this)
The doctor will work out the right once daily dose based on the weight of the child (see table below).
This dose must not exceed the recommended adult dose, which is 800 milligram Darunavir together with
100 milligram ritonavir once a day.

The doctor will inform you on how much Darunavir tablets and how much ritonavir (capsules, tablets or
solution) the child must take.
Weight
between 15 and 30 kilograms
between 30 and 40 kilograms
more than 40 kilograms
a

One Darunavir
dose is

One ritonavira dose is

600 milligram
675 milligram
800 milligram

100 milligram
100 milligram
100 milligram

ritonavir oral solution: 80 milligram per millilitre

This medicinal product is not available for all dosing strengths. It is therefore not possible to administer
doses of 675 mg. Other marketed darunavir products should be used to administer this dose.
Dose for children of 3 years of age and above, weighing at least 15 kilograms who have taken
antiretroviral medicines before (your child’s doctor will determine this)
The doctor will work out the right dose based on the weight of the child (see table below). The doctor will
determine if once daily dosing or twice daily dosing is appropriate for the child.
This dose must not exceed the recommended adult dose, which is 600 milligram Darunavir together with
100 milligram of ritonavir two times per day or 800 milligram Darunavir together with 100 milligram
ritonavir once a day.
The doctor will inform you on how many Darunavir tablets and how much ritonavir (capsules, tablets or
solution) the child must take. Tablets of lower strengths are available to construct the appropriate dosing
regimen.
Twice daily dosing
Weight
between 15 and 30 kilograms

One dose is
375 milligram Darunavir + 50 milligram ritonavir twice a day

between 30 and 40 kilograms

450 milligram Darunavir + 60 milligram ritonavir twice a day

more than 40 kilograms*

600 milligram Darunavir + 100 milligram ritonavir twice a day

* For children aged 12 or more and weighing at least 40 kilograms, your child’s doctor will determine if a 800 milligram once
daily dosing may be used. This cannot be administered with these 600 milligram tablets. Other strengths of Darunavir are
available.

Once daily dosing
Weight
between 15 and 30 kilograms
between 30 and 40 kilograms
more than 40 kilograms
a

One Darunavir
dose is

One ritonavira dose is

600 milligram
675 milligram
800 milligram

100 milligram
100 milligram
100 milligram

ritonavir oral solution: 80 milligram per millilitre

This medicinal product is not available for all dosing strengths. It is therefore not possible to administer
doses of 375 mg and 675 mg. Other marketed darunavir products should be used to administer these
doses.
Instructions for children







The child must take Darunavir always together with ritonavir. Darunavir cannot work properly
without ritonavir.
The child must take the appropriate doses of Darunavir and ritonavir two times per day or once a
day. If prescribed Darunavir twice daily the child must take one dose in the morning, and one dose in
the evening. Your child’s doctor will determine the appropriate dosing regimen for your child.
The child must take Darunavir with food. Darunavir cannot work properly without food. The type of
food is not important.
The child must swallow the tablets with a drink such as water or milk.
Darunavir 150 milligram tablets have been developed for use in children weighing less than 40
kilograms, but can also be used in adults some cases.

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 6 hours, you must take your missed dose immediately. Always take with ritonavir
and food. If you notice after 6 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, pharmacist or nurse.

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 colored) urine, pale colored 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. 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: may affect more than 1 in 10 people



diarrhoea.

Common: 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: 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: 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
 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, pharmacist or nurse. 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 outer carton, blister and 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 Darunavir contains


The active substance is darunavir. Each tablet contains 600 milligram of darunavir.



The other ingredients are
Tablet core: microcrystalline cellulose, colloidal anhydrous silica, crospovidone and magnesium
stearate.
Tablet coating: poly (vinyl alcohol) partially hydrolysed, titanium dioxide (E171), macrogol 3350,
talc, iron oxide yellow (E172) and iron oxide red (E172).

What Darunavir looks like and contents of the pack
Darunavir 600 mg are orange, film-coated, oval shaped tablets, scored and debossed with "600" on the
left side of the score on one side and plain on the other side with dimension of about 21.5 mm X 10.6
mm.
The tablet can be divided into equal doses.
Darunavir 600 mg is available in pack sizes of 20, 20x1, 60, 60x1, 200, 200x1, 240 or 240x1 film-coated
tablets in blisters and in HDPE bottles containing 60, 180 (60x3) and 200 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG, UK
Manufacturer
Teva Operations Poland Sp. z.o.o, ul. Mogilska 80., Krakow 31-546, Poland

OR*
Merckle GmbH, Ludwig-Merckle-Straße 3, Blaubeuren 89143, Germany
OR*
Teva Pharma B.V., Swensweg 5, Haarlem 2031 GA, The Netherlands
OR*
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.), Prilaz baruna Filipovica 25, Zagreb 10000, Croatia

This leaflet was last revised in 11/2016
PL 00289/1996
*Only the actual site of batch release will appear on the printed version of the leaflet.

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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