Skip to Content

DARUNAVIR SANDOZ 75MG FILM-COATED TABLETS

Active substance(s): DARUNAVIR

PDF options:  View Fullscreen   Download PDF

PDF Transcript

Package leaflet: Information for the patient

SZ00000LT000

Darunavir 75 mg film-coated tablets
Darunavir 600 mg 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 of 3 years of age and above, and at least 15 kilogram body weight
who are infected by HIV and who have already used other antiretroviral medicines.
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.
• 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 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

Pimozide, quetiapineor 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 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
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 dependance)
• 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.
Darunavir 600 mg film-coated tablets} contain sunset yellow FCF (E110) which may cause allergic reactions.

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 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.

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.

00000000

Continued on the next page >>

a

Weight

One darunavir dose is

One ritonavir a dose is

between 15 and 30 kilograms

600 milligram

100 milligram

between 30 and 40 kilograms

675 milligram

100 milligram

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).

more than 40 kilograms

800 milligram

100 milligram

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

ritonavir oral solution: 80 milligram per milliliter

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 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
other strengths are available and your doctor may have prescribed a certain combination of tablets to construct
the appropriate dosing regimen.
Twice daily dosing
Weight

One dose is

between 15 and 30 kilograms

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
Darunavir 800 milligram once daily dosing may be used. This cannot be administered with these 75 milligram
and 600 milligram tablets. Other strengths of Darunavir are available.
Once daily dosing

a

Weight

One darunavir dose is

One ritonavir a dose is

between 15 and 30 kilograms

600 milligram

100 milligram

between 30 and 40 kilograms

675 milligram

100 milligram

more than 40 kilograms

800 milligram

100 milligram

ritonavir oral solution: 80 milligram per milliliter

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.
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 75 milligram and 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 or 1 tablet containing
800 milligram of Darunavir) together with 100 milligram ritonavir once daily. Darunavir 400 milligram
and 800 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.

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, inflamation 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
By
fects you can help provide
on the safety of this medicine.

5

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.
For blister: Do not store above 30°C
For bottle: This medical 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
any medicines you no longer use. These measures will help protect the environment.

Instructions for adults
• Take Darunavir always together with ritonavir. Darunavir cannot work properly without ritonavir.

6

75 mg:
• In the morning, take 600 milligram Darunavir together with 100 milligram ritonavir.
• In the evening, take 600 milligram Darunavir tablet together with 100 milligram ritonavir.
600 mg:






In the morning, take one 600 milligram Darunavir tablet together with 100 milligram ritonavir.
In the evening, take 600 milligram Darunavir 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 75 milligram tablets have been developed for use in children, but can also be used
in adults in some cases.

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.

How to store Darunavir

Contents of the pack and other information

What Darunavir contains
<{Darunavir 75 mg film-coated tablets}>
The active substance is darunavir.
Each film-coated tablet contains 75 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).
Darunavir 600 mg film-coated tablets}
The active substance is darunavir.
Each film-coated tablet contains 600 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),
sunset yellow FCF (E110).
What Darunavir looks like and contents of the pack

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

Darunavir 75 mg film-coated tablets
White, caplet shaped film-coated tablet, debossed with ‘75’ on one side and plain on the other side.
Dimensions: approximately 8.6 mm x 4.6 mm
Darunavir 600 mg film-coated tablets
Orange oval shaped film-coated tablet, debossed with ‘600’ on one side and plain on the other side.
Dimensions: approximately 20.1 mm 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 75 mg: 480 film-coated tablets
Bottle packs 600 mg: 60, 120 (2x60), 180 (3x60), 240 (4x60) film-coated tablets
Perforated blister packs 75 mg: 10, 30, 60, 90, 120 film-coated tablets
Perforated blister packs 600 mg: 10, 30, 60, 90, 120film-coated tablets
Perforated unit dose blister packs 600 mg: 60x1 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
00000000

SZ00000LT000

+ 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.

Hide