Darunavir aurovitas

Package leaflet: Information for the patient

Darunavir Aurovitas, 800 mg, film-coated tablets
Darunavirum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

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

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

What Darunavir Aurovitas is
Darunavir Aurovitas contains the active substance darunavir. Darunavir Aurovitas 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 Aurovitas works by reducing the amount of HIV in the body. This helps the immune system and reduces the risk of developing HIV-related illnesses.

What it is used for
Darunavir Aurovitas 800 mg is used to treat adults and children (aged 3 years and older with a body weight of at least 40 kg) infected with HIV, including:

• those who have not previously been treated with other antiretroviral medicines;
• those who have previously been treated with other antiretroviral medicines (this will be determined by your doctor).

Darunavir Aurovitas must be taken in combination with a low dose of cobicistat or ritonavir and other anti-HIV medicines. Your doctor will decide the most appropriate combination of medicines for you.

2. Important information before using Darunavir Aurovitas

When not to use Darunavir Aurovitas

• if the patient is allergic to darunavir, or to any of the other ingredients of this medicine (listed in section 6), or to cobicistat or ritonavir;
• if the patient has severe liver function disorders. In case of uncertainty regarding liver disorders and their nature, a doctor should be consulted. Additional tests may be required.

Tell your doctor about all medicines you are taking, including those taken
orally, by inhalation, by injection, or applied to the skin.
Do not use Darunavir Aurovitas with the following medicines.
If you are taking any of the medicines listed below, consult your doctor about changing your treatment regimen.

Do not use herbal remedies containing St John's wort (Hypericum perforatum) during treatment with Darunavir Aurovitas.
Warnings and precautions
Before starting treatment with Darunavir Aurovitas, discuss this with your doctor, pharmacist, or nurse.
Darunavir Aurovitas is not a cure for HIV infection.
People taking Darunavir Aurovitas remain at risk of developing infections or other HIV-related illnesses and should therefore maintain regular contact with their doctor.
Skin rash may occur in patients treated with Darunavir Aurovitas. Rarely, it may be severe or potentially life-threatening. If a rash develops, contact your doctor.
Rash (usually mild or moderate) may occur more frequently in patients taking Darunavir Aurovitas and raltegravir (for the treatment of HIV infection) together than in patients taking either medicine alone.
When to inform your doctor about your health status BEFORE and DURING treatment
After reviewing the points below, the patient should inform the doctor if any of them apply.

• Inform your doctor if you have previously had liver disease, including hepatitis B or C virus infection. Your doctor will assess the severity of the condition before deciding whether Darunavir Aurovitas can be taken.
• Inform your doctor if you have diabetes. Darunavir Aurovitas may increase blood sugar levels.
• Inform your doctor immediately if you 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 past infections may occur soon after starting anti-HIV treatment. These symptoms are believed to result from an improved immune response, enabling the body to fight previously asymptomatic infections.
• In addition to opportunistic infections, autoimmune disorders (conditions arising when the immune system attacks healthy body tissues) may also occur after starting anti-HIV therapy. Autoimmune disorders may appear several months after starting treatment. If you experience symptoms of infection or other symptoms such as muscle weakness, weakness starting in the hands and feet and progressing towards the trunk, palpitations, tremor, or hyperactivity, contact your doctor immediately to initiate necessary treatment.
• Inform your doctor if you have haemophilia. Darunavir Aurovitas may increase the risk of bleeding.
• Inform your doctor if you are allergic to sulfonamides (e.g. used to treat certain infections).
• Inform your doctor if you have musculoskeletal disorders. Some patients receiving combination antiretroviral therapy may develop a bone disease called osteonecrosis (bone death caused by impaired blood supply to the bone). Risk factors for developing this condition include: duration of combination antiretroviral therapy, corticosteroid use, alcohol consumption, advanced immunosuppression, increased body mass index, and others. Symptoms of osteonecrosis include: joint pain and stiffness (especially in hips, knees, or shoulders) and difficulty moving. Inform your doctor if any of these symptoms occur.

Elderly patients
Darunavir Aurovitas has been used in only a small number of patients aged 65 years or older. If you belong to this age group, consult your doctor whether you can take Darunavir Aurovitas.
Children and adolescents
Do not use Darunavir Aurovitas in children under 3 years of age or weighing less than 40 kg.
Darunavir Aurovitas and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Some medicines must not be used together 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 used together with anti-HIV medicines from other classes [e.g.: NRTIs (nucleoside reverse transcriptase inhibitors), NNRTIs (non-nucleoside reverse transcriptase inhibitors), CCR5 antagonists, and IFs (fusion inhibitors)]. Combination of Darunavir Aurovitas and ritonavir with all PIs (protease inhibitors) has not been studied, and Darunavir Aurovitas must not be used in combination with other protease inhibitors. In some cases, dosage adjustments of other medicines may be necessary. Therefore, always inform your doctor about taking other anti-HIV medicines and strictly follow your doctor's instructions regarding concomitant use of other medicines.
The effectiveness of Darunavir Aurovitas may be reduced when taken together with any of the following products. Inform your doctor if you are taking:

• phenobarbital, phenytoin (anticonvulsants);
• dexamethasone (a 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 your doctor may recommend additional blood tests. Inform your doctor if you are taking:

• amlodipine, diltiazem, disopyramide, carvedilol, felodipine, flecainide, lidocaine, metoprolol, mexiletine, nifedipine, nicardipine, propafenone, timolol, verapamil (medicines used to treat heart conditions), due to the possibility of increased therapeutic effects and adverse reactions of these medicines;
• apixaban, edoxaban, dabigatran etexilate, rivaroxaban, warfarin, clopidogrel (anticoagulants), due to the possibility of increased therapeutic effects and adverse reactions of these medicines;
• hormonal contraceptives and hormone replacement therapy containing estrogens; Darunavir Aurovitas may reduce their effectiveness; if used to prevent pregnancy, non-hormonal contraceptive methods are recommended;
• ethinylestradiol/drospirenone. Darunavir Aurovitas may increase the risk of elevated potassium levels caused by drospirenone.
• atorvastatin, pravastatin, rosuvastatin (cholesterol-lowering medicines); there is an increased risk of muscle damage – your doctor will assess which cholesterol-lowering medicine is appropriate in your case;
• clarithromycin (an antibiotic);
• cyclosporine, everolimus, tacrolimus, sirolimus (immunosuppressive medicines), due to the possibility of increased therapeutic effects and adverse reactions of these medicines – your doctor may recommend additional tests;
• corticosteroids, including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone. These are medicines used to treat allergies, asthma, inflammatory bowel disease, skin, eye, joint, and muscle inflammation, and other inflammatory conditions. These medicines are usually taken orally, inhaled, injected, or applied to the skin. If no alternative treatment is possible, use of these medicines is permitted only after consultation with your doctor and under strict monitoring for corticosteroid-related adverse effects;
• buprenorphine/naloxone (medicines used to treat opioid dependence);
• salmeterol (a medicine used to treat asthma);
• artemether/lumefantrine (a combination medicine used to treat malaria);
• dasatinib, everolimus, irinotecan, nilotinib, vinblastine, vincristine (medicines used to treat cancer);
• sildenafil, tadalafil, vardenafil (for erectile dysfunction or for treating heart and lung disorders, so-called pulmonary arterial hypertension);
• glecaprevir/pibrentasvir (a medicine used to treat hepatitis C virus infection);
• fentanyl, oxycodone, tramadol (for pain relief);
• fesoterodine, solifenacin (for urological disorders).

Concomitant administration of other medicines with Darunavir Aurovitas may affect their therapeutic effects and adverse reactions. Therefore, your doctor may recommend additional blood tests, and dosage adjustments of other medicines may be required.
Inform your doctor if you are taking:

• dabigatran etexilate, edoxaban, warfarin (medicines that reduce blood clotting);
• alfentanil (injection, a potent, short-acting analgesic used in surgical procedures);
• digoxin (a medicine used to treat certain heart conditions);
• clarithromycin (an antibiotic);
• isavuconazole, itraconazole, posaconazole, ketoconazole (antifungal medicines). Voriconazole may be used only after consultation with your doctor;
• rifabutin (an antibacterial medicine);
• sildenafil, vardenafil, tadalafil (medicines for erectile dysfunction or pulmonary hypertension);
• amitriptyline, desipramine, imipramine, nortriptyline, paroxetine, sertraline, trazodone (antidepressants and anxiolytics);
• maraviroc (a medicine used to treat HIV infection);
• methadone (a medicine used to treat opioid dependence);
• carbamazepine, clonazepam (medicines to prevent seizures or used to treat certain types of nerve pain);
• colchicine (a medicine used to treat gout and familial Mediterranean fever);
• bosentan (a medicine used to treat pulmonary hypertension);
• buspirone, chlordiazepoxide, diazepam, estazolam, flurazepam, midazolam (when administered by injection), zolpidem (sedatives and hypnotics);
• perphenazine, risperidone, thioridazine (used to treat psychiatric disorders);
• metformin (a medicine used to treat type 2 diabetes).

This is not a complete list of medicines. Inform your doctor about all medicines you are taking.
Darunavir Aurovitas with food and drink
See section 3 “How to take Darunavir Aurovitas”.
Pregnancy and breastfeeding
Inform your doctor immediately if you are pregnant or planning to become pregnant. Women who are pregnant should not take Darunavir Aurovitas with ritonavir without specific medical advice.
Women who are pregnant should not take Darunavir Aurovitas with cobicistat.
Due to the potential for adverse effects in breastfed infants, women should not breastfeed while taking Darunavir Aurovitas.
Breastfeeding is not recommended for women infected with HIV, as HIV can be transmitted to the child through breast milk. If you are breastfeeding or considering breastfeeding, consult your doctor as soon as possible.
Driving and using machines
Do not drive or operate machinery if 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 this medicine to a child under 4 weeks of age, consult a 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 your doctor or pharmacist. If you have any doubts,
please consult your doctor or pharmacist.
Do not stop taking Darunavir Aurovitas together with cobicistat or ritonavir without consulting your doctor, even if you feel noticeably better.
Do not change the dose, formulation, or stop treatment without first discussing it with your doctor.
Darunavir Aurovitas 800 mg film-coated tablets are intended for once-daily use only.
This medicine is available only as film-coated tablets and is therefore not suitable for patients unable to swallow intact tablets, such as young children. For such patients, please check the availability of products containing darunavir in an appropriate pharmaceutical formulation.

Dose for adults who have not previously taken antiretroviral medicines (to be determined by the doctor)
The usual dose of Darunavir Aurovitas is 800 mg (1 tablet containing 800 mg) once daily.
Darunavir Aurovitas must be taken every day and always in combination with 150 mg cobicistat or 100 mg ritonavir, and with food. Darunavir Aurovitas will not work properly without cobicistat or ritonavir and food. A meal or snack should be consumed within 30 minutes before taking Darunavir Aurovitas and cobicistat or ritonavir. The type of food does not matter. Even if you feel better, do not stop taking Darunavir Aurovitas and cobicistat or ritonavir without consulting your doctor.

Instructions for adults

• Take one 800 mg tablet at the same time each day.
• Always take Darunavir Aurovitas together with 150 mg cobicistat or 100 mg ritonavir.
• Darunavir Aurovitas must be taken with food.
• Swallow the tablets whole with a drink such as water or milk.
• Take other HIV medicines in combination with Darunavir Aurovitas and cobicistat or ritonavir as directed by your doctor.

Dose for adults who have previously taken antiretroviral medicines (to be determined by the doctor)
You may require a different dose of Darunavir Aurovitas that cannot be administered using the 800 mg tablets. Other strengths of Darunavir Aurovitas are available.
The dose is:

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

Please discuss with your doctor which dose is appropriate for you.

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

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

Dose for children aged 3 years and older taking ritonavir, and aged 12 years and older taking cobicistat, weighing more than 40 kilograms, who have previously taken antiretroviral medicines (to be determined by the child's doctor)
The dose is:

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

Please discuss with your doctor which dose is appropriate for the patient.

Instructions for using Darunavir Aurovitas in children aged 3 years and older taking ritonavir, and aged 12 years and older taking cobicistat, weighing more than 40 kilograms

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

Child-resistant cap image

The plastic bottle is supplied with a child-resistant cap, which should be opened as follows:

• Press down on the plastic cap while turning it to the left.
• Remove the loosened cap.

Taking more Darunavir Aurovitas than prescribed
Contact your doctor, pharmacist, or nurse immediately.

If you miss a dose of Darunavir Aurovitas
If you notice you have missed a dose within 12 hours, take the missed tablets as soon as possible. Each dose must be taken with cobicistat or ritonavir and with a meal. If you notice the missed dose after 12 hours, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for a missed dose.

If you vomit after taking Darunavir Aurovitas and cobicistat or ritonavir
If you vomit within 4 hours of taking the medicine, take another dose of Darunavir Aurovitas and cobicistat or ritonavir as soon as possible, together with food. If you vomit more than 4 hours after taking the medicine, do not take another dose of Darunavir Aurovitas and cobicistat or ritonavir until your next scheduled dose.

If you are unsure about what to do in case of a missed dose or vomiting, contact your doctor.

Do not stop taking Darunavir Aurovitas without consulting your doctor
HIV medicines can improve your well-being, but even if you feel better, do not stop taking Darunavir Aurovitas without first discussing it with your doctor.
If you have any further questions about the use of this medicine, please consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

During treatment for HIV infection, increases in body weight and blood levels of lipids and
glucose may occur. This is partly related to improved health and lifestyle, and in the case of blood
lipid levels, sometimes to the use of antiretroviral drugs themselves. Your doctor will order tests to monitor these changes.
Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If any of the following symptoms occur, stop taking the tablets and contact your doctor immediately:
Liver complications have been reported, which in rare cases were severe. Your doctor will perform
blood tests before starting treatment with Darunavir Aurovitas. If you have chronic viral hepatitis B or C, your doctor should order blood tests more frequently, as there is an increased risk of liver complications. Discuss with your doctor symptoms of liver dysfunction, which may include: yellowing of the skin or eyes, dark urine (tea-colored), pale stools (faeces), nausea, vomiting, loss of appetite, or pain and discomfort under the ribs on the right side.
Skin rash (more frequent when used concomitantly with raltegravir), itching.
Skin rash is usually mild to moderate in severity. However, skin rash may also be a symptom of a rare, serious condition. Therefore, consult your doctor if a rash develops. Your doctor will recommend appropriate symptomatic treatment or decide whether to discontinue Darunavir Aurovitas.
Other clinically significant adverse reactions included: diabetes mellitus (frequent) and pancreatitis (uncommon).
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, flatulence;
• Headache, fatigue, dizziness, drowsiness, numbness, tingling or pain in hands or feet, weakness, difficulty falling asleep.

Uncommon (may affect up to 1 in 100 people)

• Chest pain, changes in ECG, rapid heart rate;
• Sensory disturbances or reduced skin sensation, tingling, difficulty concentrating, memory loss, balance disorders;
• Breathing difficulties, cough, nosebleeds, throat irritation;
• Inflammation of the stomach or oral cavity, heartburn, retching (without vomiting), dry mouth, abdominal discomfort, constipation, belching;
• Kidney failure, kidney stones, difficulty urinating, frequent or excessive urination, sometimes at night;
• Urticaria, severe swelling of the skin and other tissues (most commonly lips or eyes), rash, excessive sweating, night sweats, hair loss, acne, scaly skin, pigment deposition in nails;
• Muscle pain, muscle cramps or reduced muscle strength, limb pain, osteoporosis;
• Slowed thyroid activity, which may be detected in blood test results;
• Hypertension, sudden flushing of the face;
• Redness or dryness of the eyeballs;
• Fever, swelling of the lower limbs due to fluid retention, malaise, irritability, pain;
• Symptoms of infection, herpes;
• Erectile dysfunction, breast enlargement in men;
• Sleep disorders, somnolence, depression, anxiety, strange dreams, reduced libido.

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

• DRESS syndrome [severe rash accompanied by fever, fatigue, facial swelling or swollen lymph nodes, increased eosinophil count (a type of white blood cell), and liver, kidney, or lung involvement];
• Heart attack, slow heart rate, palpitations;
• Visual disturbances;
• Chills, feeling unwell;
• Feeling of disorientation or confusion, mood changes, restlessness;
• Fainting, seizures, changes or loss of taste;
• Mouth pain, bloody vomiting, inflammation of the lips, dry lips, coated tongue;
• Nasal congestion;
• Skin disorders, dry skin;
• Muscle or joint stiffness, joint pain with or without inflammation;
• Blood cell count and biochemical test abnormalities. Changes may be observed in blood or urine tests. Your doctor will provide detailed explanations. Examples include increased numbers of a certain type of white blood cells;
• Darunavir crystals in the kidneys causing kidney disease.

Adverse reactions typical for antiretroviral drugs belonging to the same class as Darunavir Aurovitas include:

• Muscle pain, tenderness, or weakness. In rare cases, such disorders have been severe.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps provide more information on the safety of the medicine.
Adverse reactions may 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 pack, label, carton or bottle after EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Do not use this medicine if you notice any changes in the appearance of the tablets.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack 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 tablets
Each 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), hydroxypropylcellulose, crospovidone (Type-B), colloidal anhydrous silica, magnesium stearate.
Coating:
Ready-to-use coating material (brown colour):
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 tablets
Dark red, oval, biconvex film-coated tablets, embossed with the code "D" on one side and "800" on the other side of the tablet.
Darunavir Aurovitas is available in blisters and in HDPE bottles with a child-resistant PP 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 Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warszawa
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 medicinal product is authorised in the Member States of the European Economic Area under the following names:
France: Darunavir Arrow 800 mg comprimé pelliculé
Germany: Darunavir PUREN 800 mg Filmtabletten
Netherlands: Darunavir Aurobindo 800 mg filmomhulde tabletten
Poland: Darunavir Aurovitas
Portugal: Darunavir Generis
Spain: Darunavir Aurovitas 800 mg comprimidos recubiertos con película EFG