Prospect: Patient Information

Darunavir Aurovitas 800 mg Film-Coated Tablets

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any questions, consult your doctor, pharmacist, or nurse.

-This medicine has been prescribed only for you, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

1.What is Darunavir Aurovitas and how is it used

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

3.How to take Darunavir Aurovitas

4.Possible side effects

5.Storage of Darunavir Aurovitas

6.Contents of the pack and additional information

What is Darunavir Aurovitas?

Darunavir Aurovitas contains the active ingredient darunavir. Darunavir is an antiretroviral medication used in the treatment of Human Immunodeficiency Virus (HIV) infection. It belongs to a group of medications called protease inhibitors. Darunavir reduces the amount of HIV present in the body. This will improve the immune system and decrease the risk of developing diseases associated with HIV infection.

What is it used for?

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

•who have not used antiretroviral medications before.

•in certain patients who have used antiretroviral medications before (this will be determined by your doctor).

Darunavir must be taken with a low dose of cobicistat or ritonavir and other HIV medications. Your doctor will explain the most suitable combination of medications for you.

Do not takeDarunavir Aurovitas

•If you areallergicto darunavir or any of the other components of this medication (listed in section 6) or to cobicistat or ritonavir.

•If you havesevere liver problems. Ask your doctor if you are unsure of the severity of your liver disease. You may need to have some additional tests.

Inform your doctor aboutallthe medications you are taking, including those taken orally, inhaled, injected, or applied to the skin.

Do not combine darunavir with any of the following medications

If you are taking any of these medications, consult your doctor to change to another medication.

Do not combine darunavir with products containing St. John's Wort (Hypericum perforatum).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Darunavir Aurovitas.

Darunavir does not cure HIV infection.

People takingdarunavirmay develop other infections or diseases associated with HIV infection. You should maintain regular contact with your doctor.

People takingdarunavirmay develop a skin rash. It is not common for the rash to be severe or potentially fatal. Consult your doctor if you develop a rash.

Patients takingdarunavirand raltegravir (for HIV infection), may experience rashes (usually mild or moderate) more frequently than patients taking either medication separately.

Inform your doctor about your situation BEFORE and DURING treatment

Make sure to check the following points and inform your doctor if any of them apply to you.

•Inform your doctor if you have had anyliver disease, including hepatitis B or C infection. Your doctor will assess the severity of your liver disease before deciding if you can takedarunavir.

•Inform your doctor if you havediabetes. Darunavir may cause an increase in blood sugar levels.

•Inform your doctor immediately if you observe anysymptoms of infection(for example, 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 HIV treatment. It is believed that these symptoms are due to an improvement in the body's immune response, which allows the body to fight off infections that were present without any apparent symptoms.

•Additionally, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may appear after you have started taking medications for HIV treatment. Autoimmune disorders may appear many months after starting treatment. If you observe any symptoms of infection or other symptoms such as muscle weakness, weakness starting in the hands and feet and ascending to the trunk of the body, palpitations, tremors, or hyperactivity, inform your doctor immediately to receive necessary treatment.

•Inform your doctor if you havehemophilia. Darunavir may increase the risk of bleeding.

•Inform your doctor if you areallergic to sulfonamides(for example, used to treat certain infections).

•Inform your doctor if you notice anybone or muscle problems. Some patients using antiretroviral combination treatment may develop a bone disease called osteonecrosis (death of bone tissue due to lack of blood supply to the bone). Some of the many risk factors for developing this disease, among others, are the duration of antiretroviral combination treatment, the use of corticosteroids, alcohol consumption, severe immunodepression, and a higher body mass index. The signs of osteonecrosis are pain, discomfort, and stiffness of the joints (especially the hips, knees, and shoulders) and difficulty moving. If you notice any of these symptoms, please consult your doctor.

Geriatric population

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

Children and adolescents

Darunavir should not be used in children under 3 years of age or with a weight less than 40 kilograms.

Other medications andDarunavir Aurovitas

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

Some medicationsshould not be combinedwithdarunavir. The list can be consulted in the section “Do not combinedarunavirwith any of the following medications”.

In most cases,darunavircan be combined with HIV medications belonging to other classes [e.g. NRTIs (nucleoside reverse transcriptase inhibitors), NNRTIs (non-nucleoside reverse transcriptase inhibitors), CCR5 antagonists, and IFs (fusion inhibitors)]. Darunavir has not been tested with cobicistat or ritonavir with all protease inhibitors (PIs) and should not be used with other HIV protease inhibitors. In some cases, it may be necessary to change the dose of other medications. Therefore, if you are taking other HIV medications, inform your doctor and carefully follow their instructions on which medications can be combined.

The following products may reduce the effectiveness ofdarunavir. Inform your doctor if you take:

•Fenobarbital, phenytoin (to prevent seizures).

•Dexamethasone (corticosteroid).

•Efavirenz (for HIV infection).

•Rifapentine, rifabutin (medications to treat certain infections such as tuberculosis).

•Saquinavir (for HIV infection).

Darunavirmay also affect the effects of other medications and your doctor may want to perform additional blood tests. Inform your doctor if you take:

•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 medications may be increased.

•Apixaban, dabigatran etexilate, edoxaban, rivaroxaban, warfarin, clopidogrel(to reduce blood coagulation) because the therapeutic or adverse effects of these medications may be altered.

•Oral contraceptives based on estrogens and hormone replacement therapy. Darunavir may reduce their effectiveness. For birth control, non-hormonal methods are recommended.

•Etinilestradiol/drospirenona. Darunavir may increase the risk of elevated potassium levels due to the drospirenona effect.

•Atorvastatin, pravastatin, rosuvastatin (to reduce blood cholesterol). There may be an increased risk of muscle damage. Your doctor will determine which cholesterol-lowering treatment is best for you based on your individual circumstances.

•Clarithromycin (antibiotic).

•Ciclosporina, everolimus, tacrolimus, sirolimus (to inhibit the immune system) because the therapeutic or adverse effects of these medications may be increased. Your doctor may perform additional blood tests.

•Corticosteroids, including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone. These medications are used to treat allergies, asthma, inflammatory bowel disease, skin, eye, joint, and muscle inflammation, and other inflammatory conditions. These medications are usually taken orally, inhaled, injected, or applied to the skin. If alternatives cannot be used, their use should only be made after a clinical evaluation and with close monitoring by your doctor to assess the adverse effects of corticosteroids.

•Buprenorphine/naloxone (medications for opioid dependence treatment).

•Salmeterol (asthma medication).

•Artemether/lumefantrine (a combination of medications to treat malaria).

•Dasatinib, everolimus, irinotecan, nilotinib, vinblastine, vincristine (to treat cancer).

•Sildenafil, tadalafil, vardenafil (for erectile dysfunction or to treat a heart and lung disorder called pulmonary hypertension).

•Glecaprevir/pibrentasvir (to treat hepatitis C infection).

•Fentanyl, oxycodone, tramadol (to treat pain).

•Fesoterodine, solifenacin (to treat urological disorders).

Your doctor may want to perform additional blood tests and, in some cases, it may be necessary to modify the dose of some medications as they may be affected by the combination of these medications ordarunavir. Inform your doctor if you take:

•Dabigatran etexilate, edoxaban, warfarin (to reduce blood coagulation).

•Alfentanil (injected analgesic with strong and short action used in surgical procedures).

•Digoxin (to treat certain heart disorders).

•Clarithromycin (antibiotic).

•Itraconazole, isavuconazole, fluconazole, posaconazole, clotrimazole (to treat fungal infections). Voriconazole can only be administered after a medical evaluation.

•Rifabutin (to treat bacterial infections).

•Sildenafil, vardenafil, tadalafil (for erectile dysfunction or high blood pressure in the pulmonary circulation).

•Amitriptyline, desipramine, imipramine, nortriptyline, paroxetine, sertraline, trazodone (to treat depression and anxiety).

•Maraviroc (to treat HIV infection).

•Methadone (to treat opioid dependence).

•Carbamazepine, clonazepam (to prevent seizures or treat certain types of neuropathic pain).

•Colchicine (to treat gout or familial Mediterranean fever).

•Bosentan (to treat high blood pressure in the pulmonary circulation).

•Buspirone, chlorazepate, diazepam, estazolam, flurazepam, midazolam administered by injection, zolpidem (sedative agents).

•Perphenazine, risperidone, thioridazine (to treat psychiatric conditions).

•Metformin (to treat type 2 diabetes).

Thisis not a complete list of medications. Inform your doctor aboutallthe medications 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 should not takedarunavirwith ritonavir unless your doctor specifically indicates it. Pregnant women should not takedarunavirwith cobicistat.

Due to the possible adverse effects on the infant, women should not breastfeed their babies if they are receivingdarunavir.

It is not recommended that women living with HIV breastfeed because HIV infection can be transmitted to the baby through breast milk. If you are breastfeeding or plan to breastfeed, you should consult your doctor as soon as possible.

Driving and operating machinery

Do not operate tools or machines or drive if you experience dizziness after takingdarunavir.

Darunavir Aurovitas contains propylene glycol

This medication 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, especially if the baby has been given other medications containing propylene glycol or alcohol.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again.

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

Once treatment has started, do not change the dose or form of the dose or interrupt treatment without consulting your doctor.

The 800 mg darunavir tablets are only used for the 800 mg once-a-day regimen.

This product is only available in film-coated tablet form and is therefore not suitable for patients who cannot swallow whole tablets, such as young children. Check the availability of darunavir in a more suitable formulation for use in these patients.

Dosage for adults who have not taken antiretroviral medications before (will be determined by your doctor)

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

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

Instructions for adults

•Take one 800 mg darunavir tablet at the same time, once a day, every day.

•Take darunavir always with 150 mg of cobicistat or 100 mg of ritonavir.

•Take darunavir with food.

•Swallow the tablets with a liquid, such as water or milk.

•Take other HIV medications used in combination with darunavir and cobicistat or ritonavir as your doctor recommends.

Dosage for adults who have taken antiretroviral medications before (will be determined by your doctor)

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

The dose is:

•800 mg of darunavir (1 tablet containing 800 mg of darunavir) with 150 mg of cobicistat or 100 mg of ritonavir once a day.

Or

•600 mg of darunavir (1 tablet containing 600 mg of darunavir) with 100 mg of ritonavir twice a day.

Speak with your doctor about what dose is correct for you.

Dosage for children aged 3 years and older with ritonavir and aged 12 years and older with cobicistat, weighing more than 40 kg, who have not taken antiretroviral medications before (your child's doctor will determine the dose)

•The usual dose of darunavir is 800 mg (1 tablet containing 800 mg of darunavir) with 100 mg of ritonavir or 150 mg of cobicistat once a day.

Dosage for children aged 3 years and older with ritonavir and aged 12 years and older with cobicistat, weighing more than 40 kg, who have taken antiretroviral medications before (your child's doctor will determine the dose)

The dose is:

•800 mg of darunavir (1 tablet containing 800 mg of darunavir) with 100 mg of ritonavir or 150 mg of cobicistat once a day.

Or

•600 mg of darunavir (1 tablet containing 600 mg of darunavir) with 100 mg of ritonavir twice a day.

Speak with your doctor about what dose is correct for you.

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

•Take 800 mg of darunavir (1 tablet containing 800 mg of darunavir) at the same time, once a day, every day.

•Take darunavir always with 100 mg of ritonavir or 150 mg of cobicistat.

•Take darunavir with food.

•Swallow the tablets with a liquid, such as water or milk.

•Take other HIV medications used in combination with darunavir and ritonavir or cobicistat as your doctor recommends.

Removing the child-resistant cap

If you take more Darunavir Aurovitas than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or nurse immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Darunavir Aurovitas

If you realize within 12 hours, take the tablets immediately. Always take the dose with cobicistat or ritonavir and food. If you realize more than 12 hours later, omit that dose and take the next one as usual. Do not take a double dose to compensate for the missed doses.

If you vomit after taking darunavir and cobicistat or ritonavir

If you vomit within 4 hours of taking the medication, you must 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 medication, you do not need to take another dose of darunavir and cobicistat or ritonavir until the next scheduled dose.

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

Do not stop taking Darunavir Aurovitas without talking to your doctor

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

If you have any other questions about using this medication, ask your doctor, pharmacist, or nurse.

During HIV treatment, there may be an increase in weight and blood glucose and lipid levels. This may be partly related to health recovery and lifestyle, and in the case of blood lipids, sometimes to the HIV medications themselves. Your doctor will monitor these changes.

Like all medications, this medication can cause side effects, although not everyone will experience them.

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

There have been reports of liver problems that can occasionally be severe. Your doctor will perform a blood test before starting treatment withdarunavir. If you have a chronic infection caused by hepatitis B or C, your doctor will check your blood tests more frequently, as there is a higher probability of developing liver problems. Talk to your doctor about the signs and symptoms of liver problems. These may include yellowing of the skin and white of the eyes, darkening (tea color) of the urine, pale stools (intestinal movements), nausea, vomiting, loss of appetite, or pain, sensation of pain or discomfort in the right side below your ribs.

Skin rash (more frequent when used in combination with raltegravir), itching. The skin rash is usually mild to moderate. A skin rash can also be a symptom of a rare and severe condition. Therefore, it is essential to talk to your doctor if you experience a rash. Your doctor will advise you on how to control the symptoms or if you should discontinuedarunavir.

Other severe side effects were diabetes (frequent) and pancreatitis (infrequent).

Very frequent(may affect more than 1 in 10 people)

•Diarrhea.

Frequent(may affect up to 1 in 10 people)

•Vomiting, nausea, abdominal pain or distension, upper abdominal pain (dyspepsia), flatulence.

•Headache, fatigue, dizziness, drowsiness, numbness, tingling, or pain in the hands or feet, loss of strength, difficulty falling asleep.

Infrequent(may affect up to 1 in 100 people)

•Chest pain, changes in the electrocardiogram, rapid heart movements.

•Decreased or abnormal sensitivity in the skin, tingling, attention disorder, memory loss, difficulty maintaining balance.

•Respiratory difficulty, cough, nasal bleeding, throat irritation.

•Stomach or mouth inflammation, heartburn, nausea, dry mouth, abdominal discomfort, constipation, belching.

•Renal insufficiency, kidney stones, difficulty urinating, excessive or frequent urination, sometimes at night.

•Hives, severe skin swelling and other tissues (especially the lips or eyes), eczema, excessive sweating, night sweats, alopecia, acne, scaly skin, nail discoloration.

•Muscle pain, cramps, or weakness, limb pain, osteoporosis.

•Reduced thyroid function. This can be seen in a blood test.

•Hypertension (increased blood pressure), flushing.

•Red or dry eyes.

•Fever, swelling of the lower extremities due to fluid retention, discomfort, irritability, pain.

•Signs of infection, herpes simplex.

•Erectile dysfunction, breast enlargement.

•Difficulty falling asleep, drowsiness, depression, anxiety, abnormal dreams, decreased libido.

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

•A reaction called DRESS [severe rash, which can be accompanied by fever, fatigue, facial swelling or lymph node enlargement, increased eosinophils (a type of white blood cell), liver, kidney, or lung damage].

•Myocardial infarction, slow heart movements, palpitations.

•Visual disturbance.

•Chills, strange sensation.

•Confusion or disorientation, altered mood, agitation.

•Syncopal episode, seizure, changes or loss of taste.

•Oral ulcers, vomiting blood, lip inflammation, dry lips, tongue with plaque.

•Nasal secretion.

•Skin lesions, dry skin.

•Muscle stiffness or joint stiffness, joint pain with or without inflammation.

•Changes in some blood cell or biochemistry values. These changes can be seen in blood and/or urine tests. Your doctor will explain them to you. For example: increased in some white blood cells.

•Darunavir crystals in the kidney, which cause kidney disease.

Some side effects are typical of HIV medications that belong to the same family as darunavir. These are:

•Muscle pain, sensitivity, or weakness. In rare cases, these muscle disorders can be severe.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the blister, carton or bottle after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Do not use this medication if you observe any change in the appearance of the tablets.

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Darunavir Aurovitas Composition

• The active ingredient is darunavir (as propylenglycolate). Each film-coated tablet contains 800 mg of darunavir (as propylenglycolate).
• The other components are:

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

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

Product appearance and packaging contents

Dark red film-coated, oval, biconvex tablets with the mark “D” on one face and “800” on the other.

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

Packaging sizes:

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

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

Only some packaging sizes may 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

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Or

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Germany:Darunavir PUREN 800 mg Filmtabletten

Spain:Darunavir Aurovitas 800 mg film-coated tablets EFG

France:Darunavir Arrow 800 mg film-coated tablet

Netherlands:Darunavir Aurobindo 800 mg film-coated tablets

Poland:Darunavir Aurovitas

Portugal:Darunavir Generis

Last review date of this leaflet: September2023

More detailed information about this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).