Darunavir Aurovitas 800 mg film-coated tablets EFG: detailed information

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Darunavir Aurovitas 800 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

What Darunavir Aurovitas is and what it is used for
What you need to know before taking Darunavir Aurovitas
How to take Darunavir Aurovitas
Possible adverse effects
How to store Darunavir Aurovitas
Contents of the pack and other information

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

What is Darunavir Aurovitas?

Darunavir Aurovitas 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 reduces the amount of HIV in your body. As a result, your immune system will improve and the risk of developing HIV-related illnesses will decrease.

What is it used for?

The 800 milligram darunavir tablet is used to treat adults and children (aged 3 years and older, weighing at least 40 kilograms) infected with HIV and:

who have not previously used antiretroviral medicines.
in certain patients who have previously used antiretroviral medicines (as determined by your doctor).

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

2. What you need to know before starting to take Darunavir Aurovitas

Do not take Darunavir Aurovitas

If you are allergic to darunavir or to any of the other components of this medicine (listed in section 6), or to cobicistat or ritonavir.
If you have severe liver problems. Ask your doctor if you are unsure about the severity of your liver disease. Additional tests may be required.

Inform your doctor about all the medicines you are taking, including those taken orally, inhaled, injected, or applied to the skin.

Do not combine darunavir with any of the following medicines

If you are taking any of these drugs, consult your doctor to switch to another medicine.

Medication	Purpose of the medication
Avanafil	treatment of erectile dysfunction
Astemizole or terfenadine	treatment of allergy symptoms
Triazolam and midazolam (oral)	to help you sleep and/or relieve anxiety
Cisapride	treatment of stomach problems
Colchicine (if you have kidney and/or liver problems)	treatment of gout or familial Mediterranean fever
Lurasidone, pimozide, quetiapine, or sertindole	treatment of psychiatric conditions
Ergot alkaloids such as ergotamine, dihydroergotamine, ergometrine, and methylergonovine	treatment of migraine-type headaches
Amiodarone, bepridil, dronedarone, ivabradine, quinidine, ranolazine	treatment of certain heart conditions, for example, irregular heartbeats
Lovastatin, simvastatin, and lomitapide	to reduce cholesterol levels
Rifampicin	treatment of certain infections such as tuberculosis
Combination of lopinavir/ritonavir medications	this HIV medicine belongs to the same class as darunavir
Elbasvir/grazoprevir	to treat hepatitis C infection
Alfuzosin	treatment of enlarged prostate
Sildenafil	treatment of high blood pressure in the pulmonary circulation
Ticagrelor	to help prevent platelet aggregation in patients with a history of heart attack
Naloxegol	to treat opioid-induced constipation
Dapoxetine	to treat premature ejaculation
Domperidone	to treat nausea and vomiting

Do not combine darunavir with products containing St. John’s wort (Hypericum perforatum).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting treatment with Darunavir Aurovitas.

Darunavir does not cure HIV infection.

Patients taking darunavir may develop other infections or diseases associated with HIV infection. You must maintain regular contact with your doctor.

Patients taking darunavir may develop a skin rash. It is uncommon for the rash to be severe or potentially life-threatening. Contact your doctor if you develop a rash.

Patients taking darunavir and raltegravir (for HIV infection) may experience rashes (usually mild or moderate) more frequently than patients taking either of these medicines separately.

Inform your doctor about your condition BEFORE and DURING treatment

Ensure you check the following points and inform your doctor if any apply to you.

Inform your doctor if you have ever had liver disease, including hepatitis B or C infection. Your doctor will assess the severity of liver disease before deciding whether you can take darunavir.
Inform your doctor if you have diabetes. Darunavir may increase blood sugar levels.
Inform your doctor immediately if you notice any symptoms of infection (e.g., swollen lymph nodes and fever). In some patients with advanced HIV infection and a history of opportunistic infections, signs and symptoms of inflammation due to previous infections may appear shortly after starting anti-HIV treatment. These symptoms are believed to result from improved immune response, enabling the body to fight infections that were previously asymptomatic.
In addition to opportunistic infections, autoimmune disorders (a condition in which the immune system attacks healthy body tissue) may also occur after you begin taking medicines for your HIV infection. Autoimmune disorders may appear many months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness starting in the hands and feet and moving upward toward the trunk, palpitations, tremor, or hyperactivity, contact your doctor immediately to receive necessary treatment.
Inform your doctor if you have hemophilia. Darunavir 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 notice any bone or muscle problems. Some patients receiving combination antiretroviral therapy may develop a bone disorder called osteonecrosis (bone tissue death caused by reduced blood supply to the bone). Among the many risk factors for this condition are duration of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, and higher body mass index. Signs of osteonecrosis include joint pain, discomfort, and stiffness (especially in the hips, knees, and shoulders) and difficulty moving. If you notice any of these symptoms, please consult your doctor.
Inform your doctor if you are elderly.

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 whether darunavir is suitable for you.

Children and adolescents

Darunavir must not be used in children under 3 years of age or weighing less than 40 kilograms.

Other medicines and Darunavir Aurovitas

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

Some medicines must not be combined with darunavir. The list can be found in the section “Do not combine darunavir with any of the following medicines.”

In most cases, darunavir can be combined with HIV medicines belonging to other classes [e.g., NRTIs (nucleoside reverse transcriptase inhibitors), NNRTIs (non-nucleoside reverse transcriptase inhibitors), CCR5 antagonists, and FIs (fusion inhibitors)]. Darunavir has not been studied with cobicistat or ritonavir in combination with all protease inhibitors (PIs) and must not be used with other HIV protease inhibitors. In some cases, the dose of other medicines may need to be adjusted. Therefore, if you are taking other anti-HIV medicines, always inform your doctor and carefully follow their instructions regarding which medicines can be combined.

The following products may reduce the effectiveness of darunavir. Inform your doctor if you are taking:

Phenobarbital, phenytoin (to prevent seizures).
Dexamethasone (a corticosteroid).
Efavirenz (for HIV infection).
Rifapentine, rifabutin (medicines to treat certain infections such as tuberculosis).
Saquinavir (for HIV infection).

Darunavir may also affect the effects of other medicines, and your doctor may wish to perform additional blood tests. Inform your doctor if you are taking:

Amlodipine, diltiazem, disopyramide, carvedilol, felodipine, flecainide, lidocaine, metoprolol, mexiletine, nifedipine, nicardipine, propafenone, timolol, verapamil (for heart disorders), because the therapeutic or adverse effects of these medicines may be increased.
Apixaban, dabigatran etexilate, edoxaban, rivaroxaban, warfarin, clopidogrel (to reduce blood clotting), because the therapeutic or adverse effects of these medicines may be altered.
Hormonal contraceptives based on estrogens and hormone replacement therapies. Darunavir may reduce their effectiveness. For contraception, non-hormonal alternative methods are recommended.
Ethinylestradiol/drospirenone. Darunavir may increase the risk of elevated potassium levels caused by drospirenone.
Atorvastatin, pravastatin, rosuvastatin (to reduce blood cholesterol). There may be an increased risk of muscle damage. Your doctor will determine the most appropriate cholesterol-lowering treatment based on your individual circumstances.
Clarithromycin (an antibiotic).
Cyclosporine, everolimus, tacrolimus, sirolimus (to suppress the immune system), because the therapeutic or adverse effects of these medicines may be increased. Your doctor may perform additional tests.
Corticosteroids, including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone. These medicines are used to treat allergies, asthma, inflammatory bowel diseases, inflammatory skin, eye, joint, and muscle conditions, and other inflammatory disorders. These medicines are usually taken orally, inhaled, injected, or applied to the skin. If alternatives cannot be used, their use should only occur after clinical evaluation and with close monitoring by your doctor to assess corticosteroid adverse effects.
Buprenorphine/naloxone (medicines for opioid dependence treatment).
Salmeterol (a medicine for asthma treatment).
Artemether/lumefantrine (a combination of medicines for treating malaria).
Dasatinib, everolimus, irinotecan, nilotinib, vinblastine, vincristine (for cancer treatment).
Sildenafil, tadalafil, vardenafil (for erectile dysfunction or to treat a heart and lung disorder called pulmonary arterial hypertension).
Glecaprevir/pibrentasvir (for treating hepatitis C infection).
Fentanyl, oxycodone, tramadol (for pain treatment).
Fesoterodine, solifenacin (for treating urological disorders).

Your doctor may wish to perform additional blood tests and, in certain cases, may need to adjust the dose of some medicines, as their therapeutic or adverse effects (or those of darunavir) may be affected when combined. Inform your doctor if you are taking:

Dabigatran etexilate, edoxaban, warfarin (to reduce blood clotting).
Alfentanil (a potent, short-acting injectable analgesic used in surgical procedures).
Digoxin (for treating certain heart disorders).
Clarithromycin (an antibiotic).
Itraconazole, isavuconazole, fluconazole, posaconazole, clotrimazole (to treat fungal infections). Voriconazole may only be administered after medical evaluation.
Rifabutin (for bacterial infections).
Sildenafil, vardenafil, tadalafil (for erectile dysfunction or high blood pressure in the pulmonary circulation).
Amitriptyline, desipramine, imipramine, nortriptyline, paroxetine, sertraline, trazodone (for treating depression and anxiety).
Maraviroc (for treating HIV infection).
Methadone (for treating opioid dependence).
Carbamazepine, clonazepam (to prevent epileptic seizures or to treat certain types of neuropathic pain).
Colchicine (for treating gout or familial Mediterranean fever).
Bosentan (for treating high blood pressure in the pulmonary circulation).
Buspirone, chlordiazepoxide, diazepam, estazolam, flurazepam, midazolam administered by injection, zolpidem (sedative agents).
Perphenazine, risperidone, thioridazine (for treating psychiatric conditions).
Metformin (for treating type 2 diabetes).

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

Taking Darunavir Aurovitas with food and drinks

See section 3 “How to take Darunavir Aurovitas”.

Pregnancy and breastfeeding

Inform your doctor immediately if you are pregnant, planning to become pregnant, or breastfeeding. Pregnant women must not take darunavir with ritonavir unless specifically instructed by their doctor. Pregnant women must not take darunavir with cobicistat.

Due to potential adverse effects on the infant, women receiving darunavir must not breastfeed.

Women living with HIV are not recommended to breastfeed because HIV infection can be transmitted to the baby through breast milk. If you are breastfeeding or considering breastfeeding, consult your doctor as soon as possible.

Driving and using machines

Do not operate tools or machinery or drive if you experience dizziness after taking darunavir.

Darunavir Aurovitas contains propylene glycol

This medicine contains 111.12 mg of propylene glycol in each film-coated tablet. If the baby is less than 4 weeks old, consult your doctor or pharmacist, particularly if the baby has been given other medicines containing propylene glycol or alcohol.

3. How to take Darunavir Aurovitas

Follow exactly the dosing instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Do not stop taking darunavir, cobicistat, or ritonavir without first consulting your doctor, even if you feel well.

Once treatment has been started, the dose or dosing regimen must not be changed or treatment interrupted without consulting your doctor.

The 800 milligram darunavir tablets are only used for the 800 milligram once-daily regimen.

This product is only available as film-coated tablets and is therefore not suitable for patients who cannot swallow whole tablets, for example young children. For use in such patients, the availability of darunavir in a more suitable formulation should be checked.

Dosage for adults who have not previously taken antiretroviral medicines (to be determined by your doctor)

The usual dose of darunavir is 800 milligrams (1 tablet containing 800 milligrams of darunavir) once daily.

You must take darunavir every day and always in combination with 150 milligrams of cobicistat or 100 milligrams of ritonavir and with food. Darunavir does not work properly without cobicistat or ritonavir and food. You must eat a meal 30 minutes before taking darunavir and cobicistat or ritonavir. The type of food is not important. Do not interrupt treatment with darunavir or with cobicistat or ritonavir without first consulting your doctor, even if you feel well.

Instructions for adults

Take one 800 milligram tablet of darunavir at the same time each day.
Take darunavir always together with 150 milligrams of cobicistat or 100 milligrams of ritonavir.
Take darunavir with food.
Swallow the tablets with a drink, which can be water or milk.
Take the other HIV medicines used in combination with darunavir and cobicistat or ritonavir as recommended by your doctor.

Dosage for adults who have previously taken antiretroviral medicines (to be determined by your doctor)

You may require a different dose of darunavir that cannot be administered with these 800 milligram tablets. Other darunavir doses are available.

The dose is:

800 milligrams of darunavir (1 tablet containing 800 milligrams of darunavir) together with 150 milligrams of cobicistat or 100 milligrams of ritonavir once daily.

600 milligrams of darunavir (1 tablet containing 600 milligrams of darunavir) together with 100 milligrams of ritonavir twice daily.

Talk to your doctor about which dose is right for you.

Dosage 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 your child’s doctor)

The usual dose of darunavir is 800 milligrams (1 tablet containing 800 milligrams of darunavir) together with 100 milligrams of ritonavir or 150 milligrams of cobicistat once daily.

Dosage 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 your child’s doctor)

The dose is:

800 milligrams of darunavir (1 tablet containing 800 milligrams of darunavir) together with 100 milligrams of ritonavir or 150 milligrams of cobicistat once daily.

600 milligrams of darunavir (1 tablet containing 600 milligrams of darunavir) together with 100 milligrams of ritonavir twice daily.

Talk to your doctor about which dose is right for you.

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

Take 800 milligrams of darunavir (1 tablet containing 800 milligrams of darunavir) at the same time each day.
Take darunavir always together with 100 milligrams of ritonavir or 150 milligrams of cobicistat.
Take darunavir with food.
Swallow the tablets with a liquid such as water or milk.
Take the other HIV medicines used in combination with darunavir and ritonavir or cobicistat as recommended by your doctor.

Removing the child-resistant cap

Diagram showing two arrows indicating movement: the first arrow points downward at the top, and the second rotates laterally

The plastic bottle has a child-resistant safety closure and opens as follows:

Push down on the plastic cap while turning it counterclockwise.
Remove the cap by unscrewing it.

If you take more Darunavir Aurovitas than you should

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or nurse immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Darunavir Aurovitas

If you remember within 12 hours , take the tablets immediately. Always take the dose with cobicistat or ritonavir and with food. If you remember after 12 hours , skip that dose and take the next one at your usual time. Do not take a double dose to make up for a missed dose.

If you vomit after taking darunavir and cobicistat or ritonavir

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

Contact your doctor if you have any questions about what to do if you miss a dose or vomit.

Do not stop taking Darunavir Aurovitas without first talking to your doctor

HIV medications can help you feel better. Even if you feel well, do not stop taking darunavir. Consult your doctor first.

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

4. Possible adverse effects

During HIV treatment, increases in body weight and in blood glucose and lipid levels may occur. This may be partly related to improved health and lifestyle, and in the case of blood lipids, sometimes to the HIV medicines themselves. Your doctor will monitor these changes.

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Inform your doctor if you develop any of the following adverse effects:

Cases of liver problems, occasionally serious, have been reported. Your doctor will perform a blood test before you start treatment with darunavir. If you have a chronic infection caused by hepatitis B or C, your doctor will check your blood tests more frequently, as you have a higher risk of developing liver problems. Talk to your doctor about the 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, tenderness, or discomfort on the right side under your ribs.

Skin rash (more frequent when used in combination with raltegravir), itching. Skin rash is usually mild to moderate. However, a skin rash may also be a symptom of a rare but serious condition. Therefore, it is important to speak with your doctor if you develop a rash. Your doctor will advise you on how to manage symptoms or whether darunavir treatment should be discontinued.

Other serious adverse effects include diabetes (frequent) and inflammation of the pancreas (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, upper abdominal pain (dyspepsia), flatulence.
Headache, fatigue, dizziness, drowsiness, numbness, tingling, or pain in the hands or feet, loss of strength, difficulty falling asleep.

Uncommon (may affect up to 1 in 100 people)

Chest pain, changes in electrocardiogram, rapid heartbeat.
Decreased or abnormal skin sensation, tingling, attention disorder, memory loss, difficulty maintaining balance.
Breathing difficulty, cough, nosebleed, sore throat.
Inflammation of the stomach or mouth, heartburn, retching, dry mouth, abdominal discomfort, constipation, belching.
Kidney failure, kidney stones, difficulty urinating, excessive or frequent urination, sometimes at night.
Hives, severe swelling of the skin and other tissues (especially lips or eyes), eczema, excessive sweating, night sweats, alopecia, acne, scaly skin, nail discoloration.
Muscle pain, muscle cramps or weakness, limb pain, osteoporosis.
Reduced thyroid gland function. This can be detected in a blood test.
Hypertension (increased blood pressure), flushing.
Red or dry eyes.
Fever, swelling of the lower limbs due to fluid retention, malaise, irritability, pain.
Symptoms of infection, simple herpes.
Erectile dysfunction, breast enlargement.
Difficulty falling asleep, drowsiness, depression, anxiety, abnormal dreams, decreased sexual desire.

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

A reaction called DRESS [severe rash, which may be accompanied by fever, fatigue, facial swelling or swollen lymph nodes, increased eosinophils (a type of white blood cell), liver, kidney, or lung damage].
Myocardial infarction, slow heartbeat, palpitations.
Visual disturbance.
Chills, unusual sensation.
Feeling confused or disoriented, altered mood, restlessness.
Fainting, epileptic seizure, changes or loss of taste.
Mouth ulcers, vomiting blood, lip inflammation, dry lips, coated tongue.
Nasal discharge.
Skin lesions, dry skin.
Muscle or joint stiffness, joint pain with or without inflammation.
Changes in certain blood or biochemical values. These changes can be seen in blood and/or urine tests. Your doctor will explain them to you. For example: increase in certain white blood cells.
Darunavir crystals in the kidney, leading to kidney disease.

Some adverse effects are typical of HIV medicines belonging to the same class as darunavir. These include:

Muscle pain, tenderness, or weakness. In rare cases, these muscle disorders may be severe.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Darunavir Aurovitas Storage

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, outer packaging, or bottle after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Do not use this medicine if you notice any changes in the appearance of the tablets.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Darunavir Aurovitas

The active substance is darunavir (as propylene glycolate). Each film-coated tablet contains 800 mg of darunavir (as propylene glycolate).
The other components are:

Tablet core: microcrystalline cellulose (Grade 101), hydroxypropylcellulose, crospovidone (Type B), colloidal anhydrous silica and magnesium stearate.

Tablet coating: Ready-to-use brown coating material: polyvinyl alcohol, macrogol 3350, iron oxide red (E172), titanium dioxide (E171) and talc.

Appearance of the product and contents of the pack

Film-coated, dark red, oval-shaped, biconvex tablets marked with “D” on one side and “800” on the other.

Darunavir Aurovitas film-coated tablets are available in blister packs and in high-density polyethylene (HDPE) bottles with child-resistant polypropylene caps.

Pack sizes:

Blister packs: 30, 50, 60, 90, 100 and 120 film-coated tablets.

HDPE bottles: 30 and 90 (3×30) film-coated tablets.

Some pack sizes may not be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

This medicinal product is authorized in the Member States of the European Economic Area (EEA) under the following names:

Germany: Darunavir PUREN 800 mg Filmtabletten

Spain: Darunavir Aurovitas 800 mg film-coated tablets EFG

France: Darunavir Arrow 800 mg comprimé pelliculé

Netherlands: Darunavir Aurobindo 800 mg filmomhulde tabletten

Poland: Darunavir Aurovitas

Portugal: Darunavir Generis

Date of the most recent revision of this leaflet: September 2023

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).