Darunavir Aurovitas 600 mg film-coated tablets EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Darunavir Aurovitas 600 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. 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 must not be given to other people, 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.

Contents of the leaflet

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 side 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?

Darunavir is used to treat adults and children aged 3 years and older who weigh at least 15 kilograms and who have previously been treated with other antiretroviral medicines.

Darunavir must be taken together with a low dose of 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 Darunavir Aurovitas

Do not take Darunavir Aurovitas

If you are allergic to darunavir or to any of the other ingredients of this medicine (listed in section 6) or to 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.

Medicine	Purpose of the medicine
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 disorders
Ergot alkaloids such as ergotamine, dihydroergotamine, ergometrine and methylergonovine	treatment of migraine headaches
Amiodarone, bepridil, dronedarone, ivabradine, quinidine, ranolazine	treatment of certain heart conditions, for example, irregular heartbeats
Lovastatin, simvastatin and lomitapide	reduce cholesterol levels
Rifampicin	treatment of certain infections such as tuberculosis
The combination of lopinavir/ritonavir medicines	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 take darunavir with products containing St. John’s wort (Hypericum perforatum).

Warnings and precautions

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

Darunavir does not cure HIV infection.

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

People 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

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

Inform your doctor if you have had any liver disease, including hepatitis B or C infection. Your doctor will assess the severity of your liver disease before deciding whether you can take darunavir.
Inform your doctor if you have diabetes. Darunavir may cause an increase in 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 from 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 present without apparent symptoms.
In addition to opportunistic infections, autoimmune disorders (a condition occurring when the immune system attacks healthy body tissue) may also occur after you start 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, tremors, or hyperactivity, contact your doctor immediately to receive necessary treatment.
Inform your doctor if you have haemophilia. 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 contact your doctor.

Elderly population

Darunavir has only been used in a limited number of patients aged 65 years or older. If you belong to this age group, talk to your doctor to determine whether you can use darunavir.

Children

Darunavir must not be used in children under 3 years of age or weighing less than 15 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 anti-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 with ritonavir has not been tested 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 follow their instructions carefully 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), as the therapeutic or adverse effects of these medicines may be increased.
Apixaban, dabigatran etexilate, edoxaban, rivaroxaban, warfarin, clopidogrel (to reduce blood clotting), as the therapeutic or adverse effects of these medicines may be altered.
Hormonal contraceptives based on oestrogens 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 due to 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), as 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 for corticosteroid-related 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 for treating 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 combining them may affect their therapeutic or adverse effects or those of darunavir. Inform your doctor if you are taking:

Dabigatran etexilate, edoxaban, warfarin (to reduce blood clotting).
Alfentanil (a potent, short-acting injectable analgesic used during 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, intravenous midazolam, zolpidem (sedative agents).
Perphenazine, risperidone, thioridazine (for treating psychiatric conditions).

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 or breastfeeding women must not take darunavir with ritonavir unless specifically instructed by their doctor. Pregnant women must not take darunavir with cobicistat.

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

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, you should consult your doctor as soon as possible.

Driving and using machines

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

Darunavir Aurovitas contains propylene glycol

This medicine contains 83.34 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 instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again. Your doctor will tell you how much darunavir you should take.

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

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

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

You will require a different dose of darunavir that cannot be administered with these 600 milligram tablets. Other darunavir doses are available.

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

The dose is:

600 milligrams of darunavir together with 100 milligrams of ritonavir twice daily.

800 milligrams of darunavir (1 tablet containing 800 milligrams of darunavir) together with 100 milligrams of ritonavir once daily. The 800 milligram darunavir tablets are only used to achieve the 800 milligram once-daily dosing regimen.

Speak with your doctor about which dose is right for you.

Instructions for adults

Always take darunavir with ritonavir. Darunavir does not work properly without ritonavir.
In the morning, take one 600 milligram tablet of darunavir with 100 milligrams of ritonavir.
In the evening, take one 600 milligram tablet of darunavir with 100 milligrams of ritonavir.
Take darunavir with food. Darunavir does not work properly without food. The type of food is not important.
Swallow the tablets with a drink, which may be water or milk.

Dosage for children aged 3 years and older, weighing at least 15 kilograms, who have not previously taken antiretroviral medicines (to be determined by your child's doctor)

The doctor will calculate the correct daily dose according to the child's weight (see table below). This dose must not exceed the recommended adult dose, which is 800 milligrams of darunavir together with 100 milligrams of ritonavir once daily.

Your doctor will advise you on how much darunavir (tablets) and how much ritonavir (capsules, tablets, or solution) the child should take. Tablets of other strengths are available to achieve the appropriate dosing regimen.

Weight	A dose of darunavir is	A dose of ritonavir is
between 15 and 30 kilograms	600 milligrams	100 milligrams
between 30 and 40 kilograms	675 milligrams	100 milligrams
more than 40 kilograms	800 milligrams	100 milligrams

Ritonavir oral solution: 80 milligrams per milliliter

Dose for children aged 3 years and older, weighing at least 15 kilograms, who have previously received antiretroviral medications (your child's doctor will determine this)

The doctor will determine the correct dose based on the child's weight (see table below). The doctor will decide whether a once-daily or twice-daily dosing regimen is appropriate for the child. This dose must not exceed the recommended adult dose, which is 600 milligrams of darunavir together with 100 milligrams of ritonavir twice daily, or 800 milligrams of darunavir together with 100 milligrams of ritonavir once daily. Your child's doctor will inform you how many darunavir tablets and how much ritonavir (in capsules, tablets, or solution) the child should take. Lower-dose tablets are available to achieve the appropriate dosing regimen.

Your doctor will advise you whether darunavir tablets are suitable for the child.

Twice-daily dosing regimen

| Weight of child (kg) | Darunavir dose (twice daily) | Ritonavir dose (twice daily) | |----------------------|------------------------------|------------------------------| | 15 to <20 | 300 mg | 75 mg (0.94 ml) | | 20 to <25 | 375 mg | 75 mg (0.94 ml) | | 25 to <32 | 450 mg | 75 mg (0.94 ml) | | 32 to <40 | 525 mg | 75 mg (0.94 ml) | | ≥40 | 600 mg | 100 mg (1.25 ml) |

Note: The ritonavir dose should be rounded to the nearest 0.05 ml using an oral dosing syringe.

Weight	One dose is
between 15 and 30 kilograms	375 milligrams of darunavir + 50 milligrams of ritonavir twice daily
between 30 and 40 kilograms	450 milligrams of darunavir + 60 milligrams of ritonavir twice daily
over 40 kilograms*	600 milligrams of darunavir + 100 milligrams of ritonavir twice daily

Your child's doctor will determine whether the 800 mg dose of darunavir once daily can be used for children aged 12 years or older and weighing at least 40 kilograms. This dose cannot be administered with the 600 mg tablets. Other darunavir formulations are available.

Once-daily dosing

Weight	A dose of darunavir is	A dose of ritonavir is
between 15 and 30 kilograms	600 milligrams	100 milligrams
between 30 and 40 kilograms	675 milligrams	100 milligrams
over 40 kilograms	800 milligrams	100 milligrams

Ritonavir oral solution: 80 milligrams per milliliter

Instructions for children

The child must always take darunavir together with ritonavir. Darunavir cannot work properly without ritonavir.
The child must take the correct dose of darunavir and ritonavir twice a day or once a day. If darunavir has been prescribed twice a day, the child should take one dose in the morning and one in the evening. Your child's doctor will determine the appropriate dosing schedule for your child.
The child must take darunavir with food. Darunavir cannot work properly without food. The type of food does not matter.
The child should swallow the tablets with a drink such as water or milk.

Removing the child-resistant cap

Diagram showing two arrows indicating the movement of a hand pressing downward and rotating laterally around the neck

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, consult 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 6 hours, take the missed dose immediately. Always take the dose with ritonavir and with food. If you remember after 6 hours, skip the missed dose and take the next dose at the usual scheduled time. Do not take a double dose to make up for forgotten doses.

If you vomit after taking darunavir and ritonavir

If you vomit within 4 hours after taking the medicine, you should take another dose of darunavir and ritonavir together 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 ritonavir until the next scheduled administration time.

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

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

HIV medicines may make you feel better. However, even if you feel better, do not stop taking darunavir. Always 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, there may be an increase in weight and in blood glucose and lipid levels. This may be partly related to improved health, lifestyle, and, in the case of blood lipids, sometimes to the HIV medicines themselves. Your doctor will monitor you for these changes.

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

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

Cases of liver problems, which may occasionally be 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 the whites of the eyes, dark (tea-colored) urine, pale-colored stools (bowel movements), nausea, vomiting, loss of appetite, or pain, tenderness, or discomfort on the right side under the 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 talk to your doctor if you develop a rash. Your doctor will advise you on how to manage the symptoms or whether darunavir 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 sensitivity, tingling, attention disorder, memory loss, difficulty maintaining balance.
Difficulty breathing, cough, nosebleed, throat irritation.
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.
Urticaria, 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, cramps or weakness, limb pain, osteoporosis.
Reduced thyroid gland function. This may be seen 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, 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 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.
Confusion or disorientation, altered mood, agitation.
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 cell or biochemical values. These changes may 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 effect, consult your doctor or pharmacist, even if it is a possible adverse effect 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 sight and reach of children.

Do not use this medicine after the expiry date stated on the blister, 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 drains 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 600 mg of darunavir (as propylene glycolate).
The other components are:

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

Tablet coating: Ready-to-use white coating material: polyvinyl alcohol, macrogol 3350, titanium dioxide (E171) and talc.

Appearance of the product and contents of the pack

White or almost white, oval, biconvex, film-coated tablets, marked “D” on one side and “600” 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: 60 film-coated tablets.

Only some pack 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

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

This medicine is authorized in the European Economic Area member states under the following names:

Germany: Darunavir PUREN 600 mg Filmtabletten

Spain: Darunavir Aurovitas 600 mg film-coated tablets EFG

France: Darunavir Arrow 600 mg comprimé pelliculé

Netherlands: Darunavir Aurobindo 600 mg filmomhulde tabletten

Poland: Darunavir Aurovitas

Portugal: Darunavir Generis

Romania: Darunavir Aurobindo 600 mg comprimate filmate

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

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