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DARUNAVIR SANDOZ 800MG FILM-COATED TABLETS

Active substance(s): DARUNAVIR / DARUNAVIR

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Package leaflet: Information for the patient

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Darunavir 800mg film-coated tablets
Darunavir
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 is it used for?
Darunavir is used to treat adults and children (3 years of age and above, at least 40 kilograms
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.
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

Purpose of the medicine

Avanafil

to treat erectile dysfunction

Astemizole or terfenadine

to treat allergy symptoms

Triazolam and oral (taken by
mouth) midazolam

to treat some stomach conditions

Cisapride

to help you sleep and/or relieve anxiety

Colchicine (if you have
kidney and/or liver problems)

to treat gout

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, ranolazine
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

this anti-HIV medicine belongs to the same class as
Darunavir

Alfuzosin

to treat enlarged prostate

Sildenafil

to treat high blood pressure in the pulmonary circulation

Ticagrelor

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 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 film-coated tablets 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 or have recently taken 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)
• 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, fluconazole, 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,
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.’
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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 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 film-coated tablets are intended for once daily use only.
Dose for adults who have not taken antiretroviral medicines before (your doctor will
determine this)
The usual dose of Darunavir is 800 milligram (2 tablets containing 400 milligram of Darunavir or
1 tablet containing 800 milligram of Darunavir) once daily. You must take Darunavir every day
and always in combination with 150 milligram of cobicistat or 100 milligram 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 milligram tablet at the same time, once a day, every day.
• Take Darunavir always together with 150 milligram of cobicistat or100 milligram 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 cobicistat or ritonavir
as recommended by your doctor.
Dose for adults who have taken antiretroviral medicines before (your doctor will
determine this)
The dose is either:
• 800 milligram Darunavir (2 tablets containing 400 milligram of Darunavir or 1 tablet
containing 800 milligram of Darunavir ) together with 150 milligram cobicistat or 100 milligram
ritonavir once daily.
OR
• 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.
Please discuss with your doctor which dose is right for you.
Dose for children 3 years of age and above, weighing more than 40 kilograms who have
not taken antiretroviral medicines before (your child’s doctor will determine this)
• The usual dose of Darunavir is 800 milligram (2 tablets containing 400 milligram of Darunavir
or 1 tablet containing 800 milligram of Darunavir) together with 100 milligram ritonavir once daily.
Dose for children 3 years of age and above, weighing more than 40 kilograms who have
taken antiretroviral medicines before (your child’s doctor will determine this)
The dose is either:
• 800 milligram Darunavir (2 tablets containing 400 milligram of Darunavir or 1 tablet
containing 800 milligram of Darunavir ) together with 100 milligram ritonavir once daily.
OR
• 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.
Please discuss with your doctor which dose is right for you.
Instructions for children 3 years of age and above, weighing more than 40 kilograms
• Take 800 milligram Darunavir (2 tablets containing 400 milligram of Darunavir or 1 tablet
containing 800 milligram of Darunavir ) at the same time, once a day, every day.
• Take Darunavir always together with 100 milligram 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.

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 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
• 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 (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, the blister and on
the bottle after EXP. The expiry date refers to the last day of that month.
After first opening of the bottle: 6 months, when not stored above 25°C.
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 any medicines you no longer use. These measures will help protect the environment.

6 Contents of the pack and other information
What Darunavir contains

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, 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 coloured) urine, pale coloured
stools (bowel movements), nausea, vomiting, loss of appetite, or pain, aching, or sensitivity on
your right side below your ribs.

The active substance is darunavir. Each film-coated tablet contains 800 mg of darunavir.
The other ingredients are:
• Tablet core: cellulose, microcrystalline (E460), silica, colloidal anhydrous (E551), crospovidone
(type A) (E1202), magnesium stearate (E470b).
• Tablet coating: poly (vinyl alcohol) (E1203), macrogol (3350) (E1521), titanium dioxide (E171),
talc (E553b), iron oxide red (E172).
What Darunavir looks like and contents of the pack
Dark red oval shaped film-coated tablet, debossed with ‘800’ on one side and plain on the other side.
Dimensions: approximately 20.2 x 10.1 mm
Darunavir is packed in Aluminium-PVC/PE/PVDC perforated blisters or in HDPE bottles
stoppered with polypropylene (PP), child resistant closure.
Pack size:
Bottle packs: 30, 60 (2x30), 90 (3x30), 120 (4x30), 240 (8x30) film-coated tablets
Perforated blister packs: 10, 30, 60, 90, 120 film-coated tablets
Perforated unit dose blister packs: 30x1 film-coated tablets
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz Limited, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK
Manufacturer
LEK farmacevtska družba d.d.Verovškova 57, 1526 Ljubljana, Slovenia
or
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, Sachsen-Anhalt, 39179 Barleben, Germany
or
Remedica Ltd, Aharnon Street, Limassol Industrial Estate, 3056 Limassol, Cyprus
This leaflet was last revised in 02/2017
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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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