800 mg film-coated tablets 
darunavir

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, 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 give it to others. It may harm them, even if they show symptoms similar to yours.

– If you get any side effects, talk to your doctor, pharmacist,t or nurse. This also applies to any side effects not mentioned in this information. See section 4.

This leaflet contains information about: 
1. What Darunavir Teva is and what it is used for 
2. What you need to know before you take Darunavir Teva 
3. How to take Darunavir Teva 
4. Possible side effects 
5. How to store Darunavir Teva 
6. Contents of the packaging and other information 

What Darunavir Teva is and what it is used for

What Darunavir Teva is

Darunavir Teva contains the active substance darunavir. Darunavir Teva is an antiretroviral medicine used to treat human immunodeficiency virus ( HIV ) infection. It belongs to a group of medicines called protease inhibitors. Darunavir Teva works by reducing the amount of HIV in your body. This will improve your immune system and reduces the risk of developing illnesses associated with HIV – infection.

What is it used for

Darunavir Teva 800 mg tablets are used to treat adults and children (3 years of age and older who weigh at least 40 kg) who are infected with HIV and

  • who have not used antiretroviral medicines before.
  • in some patients who have used antiretroviral medicines before (your doctor will decide).

Darunavir Teva must be taken in combination with a low dose of ritonavir and other HIV medicines. Your doctor will discuss with you which drug combination is best for you.

Darunavir contained in Darunavir Teva may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you take Darunavir Teva

Do not take Darunavir Teva

  • 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 disease. Talk to your doctor if you are unsure about the severity of your liver disease. Additional tests may be necessary.

Do not combine Darunavir Teva with any of the following medicines

If you take any of these, ask your doctor if you can switch to another medicine.

Drug Area of ​​the use of the drug
Avanafil to treat erection problems
Astemizole or terfenadine to treat allergy symptoms
Triazolam and midazolam took by mouth to help you sleep and/or to relieve anxiety
Cisapride to treat certain stomach problems
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
Ergotamine alkaloids such as ergotamine, dihydroergotamine, ergonovine, and methylergometry (methylergonovine) to treat migraine headaches
Amiodarone, bepridil, dronedarone, quinidine, ranolazine to treat certain heart diseases, e.g. irregular heartbeat
Lovastatin, simvastatin, and lomitapide to lower cholesterol levels
Rifampicin to treat certain infections like tuberculosis
The combination drug lopinavir/ritonavir this anti- HIV drug belongs to the same class as darunavir
Elbasvir / grazoprevir to treat hepatitis C infection
Alfuzosin for the treatment of enlarged prostate
Sildenafil for the treatment of high blood pressure in the blood vessels of the lungs
Dabigatran, ticagrelor to prevent platelets from clotting in the treatment of patients who have had a heart attack

Do not take Darunavir Teva with products containing St. John’s wort ( Hypericum perforatum ).

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before taking Darunavir Teva.

Darunavir Teva does not cure HIV – infection. You can still transmit HIV infection when you take this medicine, even though the risk of effective antiviral therapy is reduced. Discuss with your doctor the necessary steps to avoid infecting others.

People taking Darunavir Teva may still develop infections you or other illnesses associated with HIV – infection. You must continue to have regular contact with your doctor.

People taking Darunavir Teva may develop a skin rash. In rare cases, a rash can be serious or potentially life-threatening. Always consult your doctor if you develop a rash.

Rashes (generally mild or moderate) may occur more frequently in patients taking both Darunavir Teva raltegravir (at HIV – infection ) than in patients taking either of these drugs.

Inform your doctor about your situation BEFORE and DURING your treatment

Check the following points and tell your doctor if any of these apply to you.

  • Tell your doctor if you have a history of liver problems, including hepatitis B or C infection. Your doctor may assess the severity of your liver disease before deciding if you can take Darunavir Teva.
  • Tell your doctor if you have diabetes. Darunavir Teva may increase blood sugar levels.
  • Tell your doctor immediately if you notice any symptoms of infection (such as enlarged lymph nodes or 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 treatment with HIV -läkemedel began. It is believed that these symptoms are due to an improvement in the body’s immune response, which enables the body to fight infections that may have been present without giving clear symptoms.
  • In addition to opportunistic infection, you can autoimmune disorders (a condition in which the immune system attacks healthy body tissue) may also occur after you start taking medicines to treat your HIV – infection. Autoimmune disorders can occur several months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, a weakness that starts in the hands or feet and moves to the torso, palpitations, tremors, or hyperactivity, inform your doctor immediately for the necessary treatment.
  • Tell your doctor if you have hemophilia. Darunavir Teva may increase the risk of bleeding.
  • Tell your doctor if you are allergic to sulphonamides (such as those used to treat certain infections ).
  • Tell your doctor if you notice problems with muscles and bones. Some patients taking combination antiviral therapy may develop a skeletal disease called osteonecrosis (dead bone tissue due to loss of blood supply to the skeleton). The duration of combination antiviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression (severely weakened immune system), and high BMI ( body mass index ) can be some of the many risk factors for developing the disease. Signs of osteonecrosis are stiff and aching joints (especially in the hip, knee, and shoulder) and difficulty moving. If you notice any of these symptoms, talk to your doctor.

Older

Darunavir has only been used in a limited number of patients aged 65 years or older. If you belong to this age group, discuss with your doctor if you can use Darunavir Teva.

Children and young people

Darunavir Teva 800 mg tablets should not be used by children under 3 years of age or weighing less than 40 kg.

Other medicines and Darunavir Teva

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

There are certain medicines that you must not combine with Darunavir Teva. These are listed above under the heading “Do not combine Darunavir Teva with any of the following medicines”.

In most cases, Darunavir Teva can be combined with other classes of anti- HIV medicines (eg NRTIs ( nucleoside analogs), NNRTIs (non-nucleoside analogs), 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 -PI preparations. In some cases, the dosage of the other drugs may have to be changed. therefore, always tell your doctor if you are taking other medicines for HIV and carefully follow your doctor’s instructions on which medicines can be combined.

The effect of Darunavir Teva may be reduced if you take any of the following medicines. Tell your doctor if you are taking:

  • phenobarbital, phenytoin (to prevent seizures)
  • dexamethasone ( corticosteroid )
  • efavirenz (against HIV – infection )
  • boceprevir (for hepatitis C infection )
  • rifapentine, rifabutin (medicines to treat certain infections, such as tuberculosis )
  • saquinavir (against HIV – infection ).

The effects of other medicines may be affected if you take Darunavir Teva. Tell your doctor if you are taking:

  • amlodipine, diltiazem, disopyramide, carvedilol, felodipine, flecainide, lidocaine, metoprolol, mexiletine nifedipine, nicardipine, propafenone, timolol, verapamil (for heart disease) as the treatment effect or side effects of these medicines may be increased.
  • apixaban, edoxaban, rivaroxaban, warfarin (to reduce blood clotting) as their treatment effect or side effects may change; Your doctor may need to check your blood.
  • estrogen-based hormonal contraceptives or hormonal replacement therapy. Darunavir Teva may reduce their effect. If these are used as a method of contraception, alternative non-hormonal methods of contraception are recommended.
  • ethinyl estradiol / drospirenone. Darunavir may increase the risk of increased potassium levels caused by drospirenone.
  • atorvastatin, pravastatin, rosuvastatin (to lower cholesterol levels). The risk of muscle damage may be increased. Your doctor will evaluate which cholesterol-lowering treatment best suits your specific situation.
  • clarithromycin ( antibiotic )
  • ciclosporin, everolimus, tacrolimus, sirolimus (to suppress the immune system) as the treatment effect or side effects of these medicines may be increased. Your doctor may want to do additional tests.
  • Corticosteroids include betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone. These medicines are used to treat allergies, asthma, inflammatory bowel diseases, inflammation of the eyes, joints, and muscles, and other inflammatory conditions. If alternative medicines cannot be used, these medicines should only be used after a medical evaluation and under the close supervision of your doctor for side effects of corticosteroids.
  • buprenorphine / naloxone (opioid treatment drug)
  • salmeterol (medicine to treat asthma )
  • artemether/lumefantrine (a combination drug for malaria )
  • dasatinib, everolimus, nilotinib, vinblastine, vincristine (to treat cancer)
  • sildenafil, tadalafil, vardenafil (for erection problems or to treat a lung disease called pulmonary arterial hypertension )
  • telaprevir / pibrentasvir, simeprevir (for treating hepatitis C infection )
  • fentanyl, oxycodone, tramadol (to treat pain).

The dosage of one of the other medicines may need to be changed as either their own or Darunavir Teva’s treatment effect or side effects may be affected if combined. Tell your doctor if you are taking:

  • alfentanil (powerful and short-acting painkiller for injection used in surgery)
  • digoxin (to treat certain heart diseases)
  • clarithromycin ( antibiotic )
  • itraconazole, isavuconazole, fluconazole, posaconazole, clotrimazole (to treat fungal infections). Voriconazole should only be taken after a medical evaluation.
  • rifabutin (against bacterial infections)
  • sildenafil, vardenafil, tadalafil (for erection problems or high blood pressure in the blood vessels in the lungs)
  • amitriptyline, desipramine, imipramine, nortriptyline, paroxetine, sertraline, trazodone (for treating depression and anxiety)
  • maraviroc (to treat HIV – infection )
  • methadone (to treat opiate addiction)
  • carbamazepine, clonazepam (to prevent seizures or to prevent certain types of nerve pain)
  • colchicine (to treat gout or familial Mediterranean fever)
  • bosentan (to treat high blood pressure in the blood vessels of the lungs).
  • buspirone, clorazepate, diazepam, estazolam, flurazepam, midazolam when taken as an injection
  • zolpidem  (sedative)
  • perphenazine, risperidone, thioridazine (for the treatment of psychiatric conditions)
  • metformin (to treat type 2 diabetes ).

This is not a complete list of medicines. Tell your doctor about all the medicines you are taking.

Darunavir Teva with food and drink

See section 3 “How to take Darunavir Teva”.

Pregnancy and breastfeeding

Tell your doctor immediately if you are pregnant, planning to become pregnant, or breast-feeding. Pregnant or breast-feeding mothers should not take Darunavir Teva with ritonavir unless specifically prescribed by a doctor.

HIV- infected women should not breast-feed their infants because there is both a risk of the baby becoming infected with HIV through breast milk and because you do not know how the medicine affects your baby.

Driving and using machines

Do not use machines or drive if you feel dizzy after taking Darunavir Teva.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

How to take Darunavir Teva

Always take this medicine exactly as described in this leaflet or as directed by your doctor, pharmacist, or nurse. If you are not sure, talk to your doctor, pharmacist, or nurse. 

Even if you feel better, do not stop taking Darunavir Teva, and ritonavir without talking to your doctor.

Once treatment has been started, dose one or the dosage form must not be changed and treatment must not be stopped without instructions from a doctor.

Darunavir Teva 800 mg tablets should be used only once a day.

Dosage for adults who have not taken antiretroviral medicines before (your doctor will decide)

The usual dose of Darunavir Teva is 800 mg (1 tablet Darunavir Teva containing 800 mg) once a day.

You must take Darunavir Teva every day and always with 100 mg ritonavir and with food. Darunavir Teva cannot function properly without ritonavir and food. You must eat a meal or snack no more than 30 minutes before taking Darunavir Teva and ritonavir. The type of food is not important. Even if you feel better, do not stop taking Darunavir Teva and ritonavir without talking to your doctor.

Instructions for use for adults

  • Take an 800 mg tablet at the same time, once a day, every day.
  • Always take Darunavir Teva with 100 mg ritonavir.
  • Take Darunavir Teva with food.
  • Swallow the tablet with a drink, e.g. water or milk.
  • Take the other HIV medicines you are taking with Darunavir Teva and ritonavir as prescribed by your doctor.

Dosage for adults who have taken antiretroviral medicines before (your doctor will decide)

Dose one is either:

  • 800 mg Darunavir Teva (1 tablet Darunavir Teva containing 800 mg) together with 100 mg ritonavir once daily.
  • OR
  • 600 mg darunavir (other tablets with darunavir in other strengths must be used for this dose ) together with 100 mg ritonavir twice daily.

Discuss with your doctor which dosage is best for you.

Dosage for children from 3 years of age who weigh at least 40 kg and who have not taken antiretroviral drugs before (your child’s doctor decides this)

  • The usual dose is 800 mg Darunavir Teva (1 tablet Darunavir Teva containing 800 mg) together with 100 mg ritonavir once daily.

Dosage for children from 3 years of age who weigh at least 40 kg and who have taken antiretroviral drugs before (your child’s doctor decides this)

Dose one is either:

  • 800 mg Darunavir Teva (1 tablet Darunavir Teva containing 800 mg) together with 100 mg ritonavir once daily.
  • OR
  • 600 mg Darunavir Teva (other tablets with darunavir in other strengths must be used for this dose ) together with 100 mg ritonavir twice daily.

Discuss with your doctor which dose is right for you.

Instructions for children from 3 years weighing at least 40 kg

  • Take 800 mg Darunavir Teva (1 tablet Darunavir Teva containing 800 mg) at the same time, once a day, every day.
  • Always take Darunavir Teva with 100 mg ritonavir
  • Take Darunavir Teva with food
  • Swallow the tablets with a drink such as water or milk
  • Take your other HIV medicines used in combination with Darunavir Teva and ritonavir as recommended by your doctor

If you take more Darunavir Teva then you should

Contact a doctor, pharmacist, or nurse immediately.

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to take Darunavir Teva

If you notice this within 12 hours, take the tablets immediately. Always take ritonavir tablets and food. If you notice it later than 12 hours after the missed dose, skip the tablets and take the next dose as usual. Do not take a double dose to make up for a forgotten dose.

Do not stop taking Darunavir Teva without talking to your doctor

Anti- HIV drugs can make you feel better. Even if you feel better, do not stop taking Darunavir Teva. Talk to your doctor first.

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

During HIV treatment, weight gain and increased levels of lipids and glucose in the blood may occur. This is partly related to restored health and lifestyle, but when it comes to blood lipids, there can sometimes be a connection with HIV drugs. The doctor will perform tests to find such changes.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor if you experience any of the following side effects:

Liver problems that can sometimes be serious have been reported. Your doctor should take a blood sample before starting treatment with Darunavir Teva. If you have chronic hepatitis B or C infection, your doctor should take blood tests more often because you have an increased risk of developing liver problems. Talk to your doctor about signs and symptoms of liver problems. These may include yellowing of the skin or whites of the eyes, dark (tea-colored) urine, pale stools (bowel movements), nausea, vomiting, loss of appetite, or pain, aches or pains, and discomfort on the right side below the ribs.

Skin rash (more often when used in combination with raltegravir), itching. The rash is usually mild to moderate. A skin rash can also be a symptom of a rare difficult situation. It is therefore important that you talk to your doctor if you get a rash. Your doctor will advise you on how to deal with your symptoms or if treatment with Darunavir Teva needs to be stopped.

Other serious side effects were diabetes (common) and inflammation of the pancreas (less common).

Very common (may affect more than 1 user in 10)

  • diarrhea.

Common (may affect up to 1 in 10 people)

  • vomiting, nausea, stomach pain or tension, indigestion, flatulence
  • headache, fatigue, dizziness, drowsiness, numbness, tingling or pain in hands and feet, weakness, difficulty falling asleep.

Uncommon (may affect up to 1 in 100 people)

  • chest pain, ECG ( electrocardiogram ) changes, rapid heartbeat
  • impaired or abnormal sensitivity of the skin, tingling, attention deficit, memory loss, balance problems
  • difficulty breathing, cough, nosebleeds, irritation of the throat
  • inflammation of the stomach or mouth, heartburn, ulceration, dry mouth, abdominal discomfort, constipation, belching
  • kidney failure, kidney stones, difficulty urinating, frequent or heavy urination, sometimes at night
  • hives, severe swelling of the skin or other tissues (usually lips or eyes), eczema, excessive sweating, night sweats, hair loss, acne, scaly skin, the coloring of the nails
  • muscle pain, muscle cramps or muscle weakness, pain in the extremities, osteoporosis
  • impaired thyroid function. This can be seen in a blood test.
  • high blood pressure, hemorrhage
  • red or dry eyes
  • fever, swelling of the legs due to fluid, malaise, irritability, pain
  • a symptom of infection, herpes simplex
  • erectile dysfunction, breast enlargement
  • sleep problems, drowsiness, depression, anxiety, abnormal dreams, decreased sexual drive.

Rare (may affect up to 1 in 1,000 people)

  • a reaction called DRESS [severe rash that may be followed by fever, fatigue, swelling of the face or lymph nodes, increased eosinophils ( white blood cell type ), the effect on liver, kidney, or lung]
  • heart attack, slow heartbeat, palpitations
  • visual disturbance
  • chills, feeling abnormal
  • state of confusion or disorientation, altered mood, restlessness
  • fainting, epileptic seizures, altered or lost sense of taste
  • cold sores, vomiting, inflammation of the lips, dry lips, coating on the tongue
  • Runny nose
  • skin changes, dry skin
  • stiffness in muscles or joints, joint pain with or without inflammation
  • changes in certain blood levels. These can be seen in the results of blood and urine tests. Your doctor will explain this to you. Examples are: increase in certain white blood cells.

Some side effects are typical of anti- HIV medicines that belong to the same group as darunavir.

These are:

  • muscle aches, soreness, or weakness. In rare cases, muscle problems have been severe.

5. How to store Darunavir Teva

Keep this medicine out of the sight and reach of children.

Blister: Do not store above 30 ° C.

Jar: No special storage instructions.

Do not use this medicine after the expiry date which is stated on the carton or jar after EXP. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is darunavir. One tablet contains 800 mg darunavir.
  • The other ingredients are microcrystalline cellulose (E460), colloidal anhydrous silica (E551), crospovidone, crospovidone (E1202), anhydrous calcium hydrogen phosphate (E341), and magnesium stearate (E407b).
  • The film coating contains partially hydrolyzed polyvinyl alcohol, macrogol, talc (E553b), and red iron oxide (E172).

What the medicine looks like and the contents of the pack

Darunavir Teva is a red, oval, film-coated tablet, with a scoreline on one side and imprinted with “800” on the other side and approximately 21 x 10 mm in size.

The breaker is not for dividing the tablet into equal doses but only for easier swallowing.

Darunavir Teva film-coated tablets are available in blister packs of 10, 30, 60, 90, and 100 film-coated tablets; perforated unit dose blisters in pack sizes of 30×1, 60×1, 90×1, or 100×1 film-coated tablets and in HDPE cans with child-resistant polypropylene caps containing 30, 90 (3×30) or 100 film-coated tablets.

Not all pack sizes may be marketed.

Manufacturer

Teva Operations Poland Sp. zoo, Krakow, Poland

Merckle GmbH, Blaubeuren, Germany

Teva Pharma BV, Haarlem, The Netherlands

PLIVA Hrvatska doo, Zagreb, Croatia

Teva UK Ltd, Eastbourne, United Kingdom

Muhammad Nadeem

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