DARUNAVIR 800 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Darunavir Aurovitas, 800 mg, film-coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
3. What is Darunavir Aurovitas and what is it used for
   1. What is Darunavir Aurovitas
   2. What is it used for
4. Important information before taking Darunavir Aurovitas
   1. When not to take Darunavir Aurovitas
   2. Do not take Darunavir Aurovitas with the following medicines
   3. Warnings and precautions
   4. When to inform the doctor about health status BEFORE and DURING treatment
   5. Elderly patients
   6. Children and adolescents
   7. Darunavir Aurovitas and other medicines
   8. Taking Darunavir Aurovitas with food and drink
   9. Pregnancy and breastfeeding
   10. Driving and using machines
   11. Darunavir Aurovitas, 800 mg, film-coated tablets contain propylene glycol
5. How to take Darunavir Aurovitas
   1. Dose for adults who have not previously taken antiretroviral medicines (as determined by the doctor)
   2. Instructions for adults
   3. Dose for adults who have previously taken antiretroviral medicines (as determined by the doctor)
   4. Dose for children aged 3 years and older with ritonavir, and 12 years and older with cobicistat, weighing more than 40 kg, who have not previously taken antiretroviral medicines (as determined by the child's doctor)
   5. Dose for children aged 3 years and older with ritonavir, and 12 years and older with cobicistat, weighing more than 40 kg, who have previously taken antiretroviral medicines (as determined by the child's doctor)
   6. Instructions for children aged 3 years and older with ritonavir, and 12 years and older with cobicistat, weighing more than 40 kg
   7. Removing the child-resistant cap
   8. Overdose
   9. Missed dose
   10. Vomiting after taking Darunavir Aurovitas and cobicistat or ritonavir
   11. Do not stop taking Darunavir Aurovitas without consulting a doctor
6. Possible side effects
   1. If the patient experiences any of the following symptoms, they should stop taking the tablets and contact their doctor immediately:
   2. Reporting side effects
7. How to store Darunavir Aurovitas
8. Contents of the packaging and other information
   1. What Darunavir Aurovitas contains
   2. What Darunavir Aurovitas looks like and contents of the pack
   3. Pack sizes:
   4. Marketing authorization holder and manufacturer
   5. Marketing authorization holder:
   6. Manufacturer/Importer:
   7. This medicine is authorized in the Member States of the European Economic Area under the following names:
   8. Date of last revision of the leaflet: 09/2023

Leaflet accompanying the packaging: patient information

Darunavir Aurovitas, 800 mg, film-coated tablets

Darunavir

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Darunavir Aurovitas and what is it used for
• 2. Important information before taking Darunavir Aurovitas
• 3. How to take Darunavir Aurovitas
• 4. Possible side effects
• 5. How to store Darunavir Aurovitas
• 6. Contents of the packaging and other information

1. What is Darunavir Aurovitas and what is it used for

What is Darunavir Aurovitas

Darunavir Aurovitas contains the active substance darunavir. Darunavir Aurovitas is an antiretroviral medicine used to treat HIV infection. It belongs to a group of medicines called protease inhibitors. The action of Darunavir Aurovitas is to reduce the amount of HIV in the body. This helps the immune system and reduces the risk of diseases associated with HIV infection.

What is it used for

Darunavir Aurovitas 800 mg is used to treat adults and children (from 3 years of age and weighing at least 40 kg) infected with HIV, including:

• those who have not previously taken other antiretroviral medicines;
• those who have already taken other antiretroviral medicines (the doctor will decide).

Darunavir Aurovitas should be taken in combination with a small dose of cobicistat or ritonavir and other HIV medicines. The doctor will determine the best combination of medicines for the patient.

2. Important information before taking Darunavir Aurovitas

When not to take Darunavir Aurovitas

• if the patient is allergic to darunavir or any of the other ingredients of this medicine (listed in section 6) or to cobicistat or ritonavir;
• if the patient has severe liver problems. In case of doubts about liver problems and their nature, the patient should consult a doctor. Additional tests may be necessary.

The patient should tell their doctor about all medicines they are taking, including those taken orally, inhaled, injected, or applied to the skin.

Do not take Darunavir Aurovitas with the following medicines

If the patient is taking any of the following medicines, they should consult their doctor about changing their treatment.

During treatment with Darunavir Aurovitas, the patient should not take products containing St. John's Wort (Hypericum perforatum).

Warnings and precautions

Before starting treatment with Darunavir Aurovitas, the patient should discuss it with their doctor, pharmacist, or nurse. Darunavir Aurovitas is not a cure for HIV infection. Patients taking Darunavir Aurovitas are still at risk of developing infections or other diseases associated with HIV infection, so they should maintain regular contact with their doctor. A skin rash may occur in patients taking Darunavir Aurovitas. Although rare, it can be severe or life-threatening. If a rash occurs, the patient should contact their doctor. Rash (usually mild or moderate) may occur more frequently in patients taking Darunavir Aurovitas and raltegravir than in patients taking either medicine separately.

When to inform the doctor about health status BEFORE and DURING treatment

After reading the following points, the patient should inform their doctor if any of them apply to them.

• The patient should inform their doctor if they have had liver problems in the past, including viral hepatitis B or C. The doctor will assess the severity of the disease before deciding whether Darunavir Aurovitas can be taken.
• The patient should inform their doctor if they have diabetes. Darunavir Aurovitas may increase blood sugar levels.
• The patient should immediately inform their doctor if they notice signs of infection (e.g., swollen lymph nodes, fever). In some patients with advanced HIV infection and a history of opportunistic infections, symptoms of inflammation related to previous infections may appear soon after starting HIV treatment. It is believed that the appearance of such symptoms is related to the strengthening of the body's immune response, which allows the body to fight off previously hidden infections.
• In addition to opportunistic infections, autoimmune diseases (diseases that occur when the immune system attacks healthy tissues) may also occur after starting HIV treatment. Autoimmune diseases can occur many months after starting treatment. If the patient notices signs of infection or other symptoms such as muscle weakness, weakness starting from the hands and feet and progressing towards the torso, heart palpitations, tremors, or hyperactivity, they should contact their doctor as soon as possible to start necessary treatment.
• The patient should inform their doctor if they have hemophilia. Darunavir Aurovitas may increase the risk of bleeding.
• The patient should inform their doctor if they are allergic to sulfonamides (e.g., used to treat certain infections).
• The patient should inform their doctor about musculoskeletal disorders. In some patients taking combination antiretroviral therapy, a bone disease called osteonecrosis (bone death due to insufficient blood supply) may develop. Risk factors for developing this disease include: duration of combination antiretroviral therapy, use of corticosteroids, alcohol consumption, severe immunosuppression, increased body mass index, and others. Symptoms of osteonecrosis include: pain and stiffness in the joints (especially hips, knees, or shoulders) and difficulty moving. The patient should inform their doctor if they experience any of these symptoms.

Elderly patients

Darunavir Aurovitas has been used in a small number of patients aged 65 or older. If the patient belongs to this age group, they should consult their doctor to see if they can take Darunavir Aurovitas.

Children and adolescents

Darunavir Aurovitas should not be used in children under 3 years of age or weighing less than 40 kg.

Darunavir Aurovitas and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Some medicines should not be taken with Darunavir Aurovitas. A list of these substances is provided in the section "Do not take Darunavir Aurovitas with the following medicines". In most cases, Darunavir Aurovitas can be taken with HIV medicines from another class [e.g., NRTIs (nucleoside reverse transcriptase inhibitors), NNRTIs (non-nucleoside reverse transcriptase inhibitors), CCR5 antagonists, and fusion inhibitors]. However, studies have not been conducted on the simultaneous use of Darunavir Aurovitas and ritonavir with all PIs (protease inhibitors), and it should not be used in combination with other protease inhibitors. In some cases, it may be necessary to change the dosage of other medicines. Therefore, the patient should inform their doctor about the use of other HIV medicines and strictly follow the doctor's recommendations regarding the simultaneous use of other medicines. The effectiveness of Darunavir Aurovitas may be reduced when taken with one of the following products. The patient should inform their doctor if they are taking:

• phenobarbital, phenytoin (antiepileptic drugs);
• dexamethasone (corticosteroid);
• efavirenz (used to treat HIV infection);
• rifapentine, rifabutin (medicines used to treat certain infections, such as tuberculosis);
• saquinavir (used to treat HIV infection).

Taking Darunavir Aurovitas may affect the effectiveness of other medicines, and the doctor may order additional blood tests. The patient should inform their doctor if they are taking:

• amlodipine, diltiazem, disopyramide, carvedilol, felodipine, flecainide, lidocaine, metoprolol, mexiletine, nifedipine, nicardipine, propafenone, timolol, verapamil (medicines used to treat heart diseases) due to the possibility of increased therapeutic effects and side effects of these medicines;
• apixaban, edoxaban, rivaroxaban, warfarin, clopidogrel (anticoagulant medicines) due to the possibility of increased therapeutic effects and side effects of these medicines;
• hormonal contraceptives and hormone replacement therapy containing estrogens. Darunavir Aurovitas may reduce their effectiveness; when used to prevent pregnancy, non-hormonal methods of contraception are recommended;
• ethinyl estradiol/drospirenone. Darunavir Aurovitas may increase the risk of hyperkalemia caused by drospirenone.
• atorvastatin, pravastatin, rosuvastatin (medicines that lower cholesterol levels); there is a possibility of increased risk of muscle damage - the doctor will assess which cholesterol-lowering medicine is suitable in a given situation;
• clarithromycin (antibiotic);
• cyclosporine, everolimus, tacrolimus, sirolimus (medicines that weaken the immune system) due to the possibility of increased therapeutic effects and side effects of these medicines - the doctor may order additional tests;
• corticosteroids, including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone. These medicines are used to treat allergies, asthma, non-specific colitis, skin, eye, joint, and muscle inflammation, and other inflammatory conditions. They are usually taken orally, inhaled, injected, or applied to the skin. If alternative treatment cannot be used, these medicines can only be used after consulting a doctor and under close monitoring for corticosteroid side effects by the doctor;
• buprenorphine/naloxone (medicines used to treat opioid addiction);
• salmeterol (medicine used to treat asthma);
• artemether/lumefantrine (combined medicine used to treat malaria);
• dasatinib, everolimus, irinotecan, nilotinib, vinblastine, vincristine (medicines used to treat cancer);
• sildenafil, tadalafil, vardenafil (medicines used to treat erectile dysfunction or pulmonary arterial hypertension);
• glecaprevir/pibrentasvir (medicine used to treat hepatitis C virus infection);
• fentanyl, oxycodone, tramadol (used to treat pain);
• fesoterodine, solifenacin (used to treat urological disorders).

The patient should tell their doctor about all medicines they are taking. This is not a complete list of medicines.

Taking Darunavir Aurovitas with food and drink

See section 3 "How to take Darunavir Aurovitas".

Pregnancy and breastfeeding

If the patient is pregnant or planning to become pregnant, they should inform their doctor immediately. Pregnant women should not take Darunavir Aurovitas with ritonavir without special recommendation from their doctor. Pregnant women should not take Darunavir Aurovitas with cobicistat. Due to the potential risk of side effects in breastfed children, women should not breastfeed while taking Darunavir Aurovitas. It is not recommended for HIV-infected women to breastfeed, as HIV can be transmitted to the child through breast milk. If the patient is breastfeeding or plans to breastfeed, they should consult their doctor as soon as possible.

Driving and using machines

The patient should not drive or operate machines if taking Darunavir Aurovitas causes dizziness.

Darunavir Aurovitas, 800 mg, film-coated tablets contain propylene glycol

This medicine contains 111.12 mg of propylene glycol in each film-coated tablet. Before administering the medicine to a child under 4 weeks of age, the patient should consult their doctor or pharmacist, especially if the child is taking other medicines containing propylene glycol or alcohol.

3. How to take Darunavir Aurovitas

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist. If the patient notices significant improvement, they should not stop taking Darunavir Aurovitas with cobicistat or ritonavir without consulting their doctor. After starting treatment, the patient should not change the dose, form of the medicine, or stop treatment without consulting their doctor first. Darunavir Aurovitas, 800 mg, film-coated tablets is only intended for once-daily use. This medicine is only available in film-coated tablets and is therefore not suitable for patients who cannot swallow intact tablets, such as small children. For these patients, the availability of darunavir-containing products in an appropriate pharmaceutical form should be checked.

Dose for adults who have not previously taken antiretroviral medicines (as determined by the doctor)

The usual dose of Darunavir Aurovitas is 800 mg (1 tablet containing 800 mg) once daily. Darunavir Aurovitas should be taken with 150 mg of cobicistat or 100 mg of ritonavir and with food. Darunavir Aurovitas does not work properly without cobicistat or ritonavir and food. The patient should eat a meal or snack within 30 minutes before taking Darunavir Aurovitas and cobicistat or ritonavir. The type of food is not important. Even if the patient feels better, they should not stop taking Darunavir Aurovitas and cobicistat or ritonavir without consulting their doctor.

Instructions for adults

• Take one 800 mg tablet at the same time, once daily, every day.
• Take Darunavir Aurovitas always with 150 mg of cobicistat or 100 mg of ritonavir.
• Take Darunavir Aurovitas with food.
• Swallow the tablets with a drink, such as water or milk.
• Take other HIV medicines in combination with Darunavir Aurovitas and cobicistat or ritonavir as prescribed by the doctor.

Dose for adults who have previously taken antiretroviral medicines (as determined by the doctor)

The patient may need a different dose of Darunavir Aurovitas, which cannot be administered with 800 mg tablets. Other strengths of Darunavir Aurovitas are available. The dose is:

• 800 mg of Darunavir Aurovitas (1 tablet containing 800 mg of Darunavir Aurovitas) with 150 mg of cobicistat or 100 mg of ritonavir once daily. OR
• 600 mg of Darunavir Aurovitas (1 tablet containing 600 mg of Darunavir Aurovitas) with 100 mg of ritonavir twice daily.

The patient should discuss with their doctor which dose is suitable for them.

Dose for children aged 3 years and older with ritonavir, and 12 years and older with cobicistat, weighing more than 40 kg, who have not previously taken antiretroviral medicines (as determined by the child's doctor)

• The usual dose of Darunavir Aurovitas is 800 mg (1 tablet containing 800 mg of Darunavir Aurovitas) with 100 mg of ritonavir or 150 mg of cobicistat once daily.

Dose for children aged 3 years and older with ritonavir, and 12 years and older with cobicistat, weighing more than 40 kg, who have previously taken antiretroviral medicines (as determined by the child's doctor)

The dose is:

• 800 mg of Darunavir Aurovitas (1 tablet containing 800 mg of Darunavir Aurovitas) with 100 mg of ritonavir or 150 mg of cobicistat once daily. OR
• 600 mg of Darunavir Aurovitas (1 tablet containing 600 mg of Darunavir Aurovitas) with 100 mg of ritonavir, twice daily.

The patient should discuss with their doctor which dose is suitable for them.

Instructions for children aged 3 years and older with ritonavir, and 12 years and older with cobicistat, weighing more than 40 kg

• Take 800 mg of Darunavir Aurovitas (1 tablet containing 800 mg of Darunavir Aurovitas) at the same time, once daily, every day.
• Take Darunavir Aurovitas always with 100 mg of ritonavir or 150 mg of cobicistat.
• Take Darunavir Aurovitas with food.
• Swallow the tablets with a drink, such as water or milk.
• Take other HIV medicines in combination with Darunavir Aurovitas and ritonavir or cobicistat as prescribed by the doctor.

Removing the child-resistant cap

The plastic bottle is provided with a child-resistant cap and should be opened as follows:

• Press the plastic cap down and turn it to the left.
• Remove the unscrewed cap.

Overdose

In case of overdose, the patient should immediately contact their doctor, pharmacist, or nurse.

Missed dose

If a dose is missed within 12 hours, the patient should take the missed tablets as soon as possible. Each dose should be taken with cobicistat or ritonavir and with food. If a dose is missed after 12 hours, the patient should skip the missed dose and take the next dose at the usual time. The patient should not take a double dose to make up for the missed dose.

Vomiting after taking Darunavir Aurovitas and cobicistat or ritonavir

If the patient vomits within 4 hours of taking the medicine, they should take another dose of Darunavir Aurovitas and cobicistat or ritonavir as soon as possible with food. If the patient vomits more than 4 hours after taking the medicine, they should not take another dose of Darunavir Aurovitas and cobicistat or ritonavir until the next scheduled dose. If in doubt about what to do in case of a missed dose or vomiting, the patient should contact their doctor.

Do not stop taking Darunavir Aurovitas without consulting a doctor

HIV medicines can improve the patient's condition, but even if they feel better, they should not stop taking Darunavir Aurovitas without consulting their doctor first. If the patient has any further doubts about taking this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

During HIV treatment, weight gain and increased lipid and glucose levels in the blood may occur. This is partly related to the improvement in health and lifestyle, and in the case of lipid levels in the blood, sometimes to the HIV treatment itself. The doctor will monitor these changes. Like all medicines, Darunavir Aurovitas can cause side effects, although not everybody gets them.

If the patient experiences any of the following symptoms, they should stop taking the tablets and contact their doctor immediately:

Liver problems have been reported, which in rare cases were severe. The doctor will perform blood tests before starting Darunavir Aurovitas. If the patient has chronic viral hepatitis B or C, the doctor should perform blood tests more frequently, as there is an increased risk of liver problems. The patient should discuss with their doctor the symptoms of liver problems, which may include: yellowing of the skin or eyes, dark urine (tea-colored), pale stools, nausea, vomiting, loss of appetite, or pain and discomfort below the ribs on the right side. Skin rash (more common when taken with raltegravir), itching. The rash is usually mild or moderate. However, the rash can also be a symptom of a rare, severe disease. Therefore, the patient should discuss with their doctor if a rash occurs. The doctor will recommend appropriate treatment for the symptoms or decide to stop Darunavir Aurovitas. Other clinically significant side effects were: diabetes (often) and pancreatitis (not very often). Very common(may affect more than 1 in 10 people)

• diarrhea.

Common(may affect up to 1 in 10 people)

• vomiting, nausea, abdominal pain or bloating, indigestion, bloating;
• headache, fatigue, dizziness, drowsiness, numbness, tingling, or pain in the hands or feet, weakness, difficulty sleeping.

Uncommon(may affect up to 1 in 100 people)

• chest pain, changes in ECG, rapid heart rate;
• disorders or weakening of skin sensation, numbness, tingling, or pain in the hands or feet, difficulty concentrating, memory loss, balance disorders;
• breathing difficulties, cough, nosebleeds, throat irritation;
• gastritis or oral inflammation, heartburn, belching, dry mouth, abdominal discomfort, constipation, bloating;

renal failure, kidney stones, difficulty urinating, frequent or excessive urination, sometimes at night;

• hives, severe skin and tissue swelling (most often around the lips or eyes), rash, excessive sweating, night sweats, hair loss, acne, scaly skin, nail discoloration;
• muscle pain, muscle cramps or weakness, muscle pain, osteoporosis;
• slowed thyroid activity, which can be detected by blood tests;
• high blood pressure, sudden flushing of the face;
• redness or dryness of the eyes;
• fever, swelling of the lower limbs due to fluid retention, feeling unwell, irritability, pain;
• infection symptoms, herpes;
• erectile dysfunction, breast enlargement in men;
• sleep disorders, drowsiness, depression, anxiety, strange dreams, decreased libido.

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

• DRESS syndrome [severe rash, which may be accompanied by fever, fatigue, face or lymph node swelling, increased eosinophil count (a type of white blood cell), liver, kidney, or lung symptoms];
• heart attack, slow heart rate, palpitations;
• vision disorders;
• chills, malaise;
• feeling disoriented or lost, mood changes, restlessness;
• fainting, seizures, changes in or loss of taste;
• mouth pain, bloody vomiting, mouth inflammation, dry mouth, unpleasant sensations in the abdomen, constipation, bloating;

Side effects typical of HIV medicines in the same class as Darunavir Aurovitas include:

• muscle pain, pain, or weakness. In rare cases, these disorders have been severe.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, more information can be collected on the safety of this medicine. Side effects can also be reported to the marketing authorization holder.

5. How to store Darunavir Aurovitas

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the blister, label, carton, or bottle after EXP. The expiry date refers to the last day of the month stated. There are no special precautions for storing the medicine. Do not use this medicine if the patient notices any changes in the appearance of the tablets. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Darunavir Aurovitas contains

• The active substance is darunavir (in the form of darunavir with propylene glycol).

Darunavir Aurovitas, 800 mg, film-coated tabletsEach film-coated tablet contains 800 mg of darunavir (in the form of darunavir with propylene glycol).

• Other ingredients are:

Tablet core: Microcrystalline cellulose (Type-101), hydroxypropyl cellulose, crospovidone (Type-B), silicon dioxide, magnesium stearate. Coating: Ready-to-use coating material (brown color): Polyvinyl alcohol, macrogol 3350, iron oxide red (E 172), titanium dioxide (E 171), talc.

What Darunavir Aurovitas looks like and contents of the pack

Darunavir Aurovitas, 800 mg, film-coated tabletsDark red, oval, biconvex film-coated tablets with "D" embossed on one side and "800" on the other side. Darunavir Aurovitas is available in blisters and HDPE bottles with a PP child-resistant closure.

Pack sizes:

Blisters: 30, 50, 60, 90, 100, or 120 film-coated tablets. HDPE bottle: 30 or 90 (3 x 30) film-coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o. ul. Sokratesa 13D lokal 27 01-909 Warsaw e-mail: [email protected]

Manufacturer/Importer:

APL Swift Services (Malta) Ltd. HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta Generics Farmacêutica, S.A. Rua João de Deus 19, Venda Nova 2700-487 Amadora Portugal Arrow Génériques 26 Avenue Tony Garnier 69007 Lyon France

This medicine is authorized in the Member States of the European Economic Area under the following names:

France: Darunavir Arrow 800 mg film-coated tablet Germany: Darunavir PUREN 800 mg film-coated tablets Netherlands: Darunavir Aurobindo 800 mg film-coated tablets Poland: Darunavir Aurovitas Portugal: Darunavir Generis Spain: Darunavir Aurovitas 800 mg film-coated tablets EFG

Date of last revision of the leaflet: 09/2023