Package leaflet: Information for the patient

Ritonavir Aurovitas, 100 mg, film-coated tablets
Ritonavirum
Please read all of this leaflet carefully before 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 further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
If you experience any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:
What Ritonavir Aurovitas is and what it is used for
What you need to know before taking Ritonavir Aurovitas
How to take Ritonavir Aurovitas
Possible side effects
How to store Ritonavir Aurovitas
Contents of the pack and other information

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

The active substance in Ritonavir Aurovitas is ritonavir. Ritonavir Aurovitas is a protease inhibitor used to help control human immunodeficiency virus (HIV) infection. Ritonavir Aurovitas is used in combination with other anti-HIV medicines (antiretroviral drugs) to help control HIV infection. Your doctor will decide which of these medicines should be used together with Ritonavir Aurovitas to achieve the best effect for you.
Ritonavir Aurovitas is used in children aged 2 years and older, adolescents, and adults infected with HIV, the virus that causes AIDS.

2. Important information before using Ritonavir Aurovitas

When not to use Ritonavir Aurovitas

If the patient is allergic to ritonavir or any of the other ingredients of this medicine (listed in section 6).
In case of severe liver disease.
When taking any of the following medicines:
Astemizole or terfenadine (commonly used to treat allergy symptoms – these medicines may be available without a prescription);
Amiodarone, bepridil, dronedarone, encainide, flecainide, propafenone, quinidine (used to treat irregular heart rhythms);
Dihydroergotamine, ergotamine (used for migraine headaches);
Ergonovine, methylergonovine (used to control severe bleeding that may occur after childbirth or miscarriage);
Chlordiazepoxide, diazepam, estazolam, flurazepam, triazolam or oral midazolam (used for insomnia and/or anxiety);
Clozapine, pimozide (used to treat thought or emotional disorders);
Quetiapine (used to treat schizophrenia, bipolar disorder and severe depression);
Lurasidone (used to treat depression);
Ranolazine (used to treat chronic chest pain [angina]);
Meperidine, propoxyphene (painkillers);
Cisapride (used for certain gastrointestinal disorders);
Rifabutin (used to prevent and treat certain infections)*;
Voriconazole (used to treat fungal infections)*;
Simvastatin, lovastatin (used to lower blood cholesterol levels);
Neratinib (used to treat breast cancer);
Lomitapide (used to lower blood cholesterol levels);
Alfuzosin (used to treat benign prostatic hyperplasia);
Fusidic acid (used to treat bacterial infections);
Sildenafil, if the patient has a lung condition called pulmonary hypertension causing breathing difficulties. Patients without this condition may use sildenafil to treat impotence (erectile dysfunction) under medical supervision (see section "Ritonavir Aurovitas with other medicines");
Avanafil or vardenafil (used to treat erectile dysfunction);
Colchicine (used to treat gout), if the patient has kidney and/or liver problems (see section "Ritonavir Aurovitas with other medicines");
Products containing St. John’s wort (Hypericum perforatum), as it may reduce the effectiveness of Ritonavir Aurovitas. St. John’s wort is commonly found in herbal remedies available without a prescription.

* The doctor will decide whether the patient can take rifabutin and/or voriconazole with Ritonavir Aurovitas at a boosting dose (lower dose). Ritonavir Aurovitas must not be used at full dose together with these two medicines.
Patients currently taking any of the medicines listed above should consult their doctor about whether a switch to another medicine is necessary during treatment with Ritonavir Aurovitas.
Please also refer to the list of medicines in section "Ritonavir Aurovitas with other medicines" for information about other medicines requiring special caution.

Warnings and precautions

Before starting Ritonavir Aurovitas, discuss this with your doctor.

Important information

If Ritonavir Aurovitas is used together with other antiretroviral medicines, carefully read the package leaflets of these other medicines. They may contain additional information about when Ritonavir Aurovitas should not be used. If you have any doubts about Ritonavir Aurovitas (ritonavir) or any other prescribed medicines, consult your doctor or pharmacist.
Ritonavir Aurovitas does not cure HIV infection or AIDS.
Patients taking Ritonavir Aurovitas may still develop infections or other illnesses related to HIV or AIDS. It is therefore important to remain under medical supervision while taking Ritonavir Aurovitas.

Tell your doctor if the patient has or has had:

Liver disease in the past.
Hepatitis B or C virus infection and is currently being treated with combination antiretroviral therapy, as there is an increased risk of severe and life-threatening liver-related adverse reactions. Additional blood tests may be required to monitor liver function in these patients.
Haemophilia, as increased bleeding has been reported in haemophilia patients taking this type of medicine (protease inhibitors). The cause is unknown. Additional treatment with a blood clotting agent (factor VIII) may be required to control bleeding.
Erectile dysfunction, as any of the medicines used for erectile dysfunction may cause hypotension and prolonged erection.
Diabetes, as worsening of diabetes symptoms or new-onset diabetes has been reported in some patients taking protease inhibitors.
Kidney disease, as the doctor may need to adjust the dosage of other medicines taken by the patient (such as protease inhibitors).

Tell your doctor if the patient experiences:

Diarrhoea or vomiting that does not resolve (persists), as this may reduce the effectiveness of the medicines taken.
Nausea, vomiting or abdominal pain, as these symptoms may indicate pancreatic problems (pancreatitis). Severe pancreatic problems may occur in some patients taking Ritonavir Aurovitas. If these symptoms occur, inform the doctor immediately.
Signs of infection – inform the doctor immediately. In some patients with advanced HIV infection (AIDS) who have started anti-HIV treatment, symptoms of past infections may appear, even if they were previously unaware of them. This is believed to be due to improved immune response, enabling the body to fight these infections. In addition to opportunistic infections, autoimmune disorders (where the immune system attacks healthy tissues) may also occur after starting anti-HIV medicines. Autoimmune disorders may develop several months after starting treatment. If the patient notices any signs of infection or other symptoms such as muscle weakness, weakness starting in the hands and feet and progressing to the trunk, palpitations, tremors or hyperexcitability, inform the doctor immediately, as appropriate treatment may be needed.
Joint stiffness, pain (especially in hips, knees and shoulders) and difficulty moving. Inform the doctor, as these may be symptoms of a condition causing bone tissue damage (osteonecrosis). This condition may develop in some patients taking multiple antiretroviral medicines.
Muscle pain, tenderness or weakness, particularly when occurring in association with antiretroviral protease inhibitors and nucleoside analogues. In rare cases, muscle disorders have been severe (see section 4. "Possible side effects").
Dizziness of varying severity, fainting or irregular heartbeat. Some patients taking Ritonavir Aurovitas may experience changes in the ECG recording. Inform the doctor if the patient has a heart defect or conduction disorders.
In case of any health problems, contact the doctor.

Children and adolescents
Ritonavir Aurovitas must not be used in children under 2 years of age.

Ritonavir Aurovitas with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription. There are medicines that must not be used together with Ritonavir Aurovitas. These have been listed earlier in section 2, under "When not to use Ritonavir Aurovitas". There are other medicines that can only be used under certain conditions, as described below.
The following warnings apply when Ritonavir Aurovitas is used at full dose. These warnings may also apply when Ritonavir Aurovitas is used at lower doses as a booster for other antiretroviral medicines.
Tell your doctor if the patient is taking any of the following medicines, as special caution is required.

Sildenafil or tadalafil used for impotence (erectile dysfunction). The dose and/or frequency of these medicines may need to be reduced to avoid hypotension and prolonged erection. Do not use Ritonavir Aurovitas with sildenafil if the patient has pulmonary hypertension (see section 2. "Important information before using Ritonavir Aurovitas"). If the patient with pulmonary hypertension is being treated with tadalafil, they should inform their doctor.
Colchicine (used for gout), as Ritonavir Aurovitas may increase the blood concentration of this medicine. Ritonavir must not be used with colchicine if the patient has kidney and/or liver problems (see also section "When not to use Ritonavir Aurovitas", above).
Digoxin (a medicine used for heart conditions). The doctor may adjust the digoxin dose and closely monitor the patient taking digoxin and Ritonavir Aurovitas to avoid cardiac complications.
Hormonal contraceptives containing ethinylestradiol, as Ritonavir Aurovitas may reduce their effectiveness. It is recommended to use a condom or a non-hormonal method of contraception instead. Irregular uterine bleeding may also be observed when using these hormonal contraceptives together with Ritonavir Aurovitas.
Atorvastatin or rosuvastatin (used when blood cholesterol levels are high), as Ritonavir Aurovitas may increase the blood levels of these medicines. Consult your doctor before using any cholesterol-lowering medicine with Ritonavir Aurovitas (see also "When not to use Ritonavir Aurovitas", above).
Steroids (e.g. dexamethasone, fluticasone propionate, prednisolone, triamcinolone), as Ritonavir Aurovitas may increase blood levels of these medicines, potentially leading to Cushing's syndrome (facial fat accumulation) and reduced cortisol production (hormone). The doctor may reduce the steroid dose or monitor for adverse effects more closely.
Trazodone (an antidepressant), as adverse effects such as nausea, dizziness, hypotension and fainting may occur when used with Ritonavir Aurovitas.
Rifampicin and saquinavir (used to treat tuberculosis and HIV, respectively), as their use with Ritonavir Aurovitas may cause severe liver damage.
Bosentan, riociguat (used for pulmonary hypertension), as Ritonavir Aurovitas may increase blood levels of these medicines.

Some medicines should not be used together with Ritonavir Aurovitas because their effects may be increased or decreased when taken simultaneously. In some cases, the doctor may recommend appropriate laboratory tests, dosage adjustments or periodic monitoring of the patient. Therefore, it is essential to inform the doctor about all medicines being taken, including those available without a prescription and herbal products. Be sure to tell the doctor if any of the following are being used:

Amphetamine or amphetamine derivatives;
Antibiotics (e.g. erythromycin, clarithromycin);
Anticancer medicines (e.g. abemaciclib, afatinib, apalutamide, ceritinib, encorafenib, dasatinib, ibrutinib, nilotinib, venetoclax, vincristine, vinblastine);
Medicines used to treat low platelet count (e.g. fostamatinib);
Anticoagulants (e.g. dabigatran etexilate, edoxaban, rivaroxaban, vorapaxar, warfarin);
Antidepressants (e.g. amitriptyline, desipramine, fluoxetine, imipramine, nefazodone, nortriptyline, paroxetine, sertraline, trazodone);
Antifungal medicines (e.g. ketoconazole, itraconazole);
Antihistamines (e.g. loratadine, fexofenadine);
Antiretroviral medicines, including HIV protease inhibitors (amprenavir, atazanavir, darunavir, fosamprenavir, indinavir, nelfinavir, saquinavir, tipranavir), non-nucleoside reverse transcriptase inhibitors (NNRTIs) (delavirdine, efavirenz, nevirapine) and others (didanosine, maraviroc, raltegravir, zidovudine);
Anti-tuberculosis medicines (bedaquiline, delamanid);
Antiviral medicines used to treat chronic hepatitis C virus (HCV) infection in adults (e.g. glecaprevir/pibrentasvir and simeprevir);
Sedatives, buspirone;
Asthma medicines, theophylline, salmeterol;
Atovaquone, a medicine used to treat certain types of pneumonia and malaria;
Buprenorphine, a medicine used to treat chronic pain;
Bupropion, a medicine used to help quit smoking;
Medicines for epilepsy (e.g. carbamazepine, divalproex, lamotrigine, phenytoin);
Heart medicines (e.g. disopyramide, mexiletine and calcium channel blockers such as amlodipine, diltiazem and nifedipine);
Medicines acting on the immune system (e.g. cyclosporine, tacrolimus, everolimus);
Levothyroxine (used to treat hypothyroidism);
Morphine and similar medicines used to treat severe pain (e.g. methadone, fentanyl);
Sleeping medicines (e.g. alprazolam, zolpidem) and injectable midazolam;
Neuroleptics (e.g. haloperidol, risperidone, thioridazine);
Colchicine, used for gout.

Some medicines must not be used at all with Ritonavir Aurovitas. These have been listed earlier in section 2, under "When not to use Ritonavir Aurovitas".

Ritonavir Aurovitas with food and drink
Ritonavir Aurovitas tablets should be taken with food.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
A large amount of information is available on the use of ritonavir (the active substance in Ritonavir Aurovitas) during pregnancy. Generally, ritonavir has been given to pregnant women after the first trimester, at a lower (boosting) dose in combination with other protease inhibitors. Ritonavir Aurovitas does not appear to increase the risk of congenital malformations compared to the expected rate in the general population.
Breastfeeding is not recommended for women who are HIV-positive, as HIV can be transmitted to the child through breast milk.
If the patient is breastfeeding or considering breastfeeding, she should consult her doctor as soon as possible.

Driving and operating machinery
Ritonavir Aurovitas may cause dizziness. If this adverse effect occurs, do not drive or operate machinery.

Ritonavir Aurovitas contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Ritonavir Aurovitas

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist. This medicine should be taken daily, once or twice a day, with food.
It is important to swallow the Ritonavir Aurovitas tablets whole, without chewing, breaking or
crushing them.
The recommended doses of Ritonavir Aurovitas are:

If Ritonavir Aurovitas is used to boost the effect of certain other anti-HIV medicines, the usual adult dose is 1 to 2 tablets once or twice daily. More detailed dosing recommendations, including dosing in children, are provided in the patient leaflet included with each package of the anti-HIV medicine with which Ritonavir Aurovitas is administered.
If your doctor prescribes a full dose, adults may start treatment with a dose of 3 tablets in the morning and 3 tablets 12 hours later, gradually increasing the dose over a period of up to 14 days to the full dose of 6 tablets twice daily (total 1200 mg per day). In children (aged 2 to 12 years), treatment should start at a lower dose, which is then gradually increased until the maximum dose based on body surface area is reached.

Your doctor will inform you which dose to take.
To suppress the development of HIV infection, Ritonavir Aurovitas must be taken daily, regardless of
any improvement in health status. If any side effect prevents the patient from taking Ritonavir Aurovitas as
recommended, this should be reported to the doctor immediately. During episodes of diarrhoea, the doctor
may decide to perform additional monitoring tests.
Always ensure you have an adequate supply of Ritonavir Aurovitas to avoid running out. When planning
travel or hospital admission, make sure you have enough Ritonavir Aurovitas to last until the next supply.
Taking more Ritonavir Aurovitas than recommended
If a patient takes too high a dose of Ritonavir Aurovitas, numbness or tingling sensations may occur.
If a patient has taken more Ritonavir Aurovitas than recommended, contact a doctor immediately or go to
the nearest hospital emergency department.
Missing a dose of Ritonavir Aurovitas
If a dose is missed, take it as soon as possible. If it is almost time for the next dose, take only the next
scheduled dose. Do not take a double dose to make up for a missed dose.
Stopping Ritonavir Aurovitas
Do not stop taking Ritonavir Aurovitas without consulting your doctor, even if you feel better. Taking
Ritonavir Aurovitas as prescribed offers the best chance of delaying the development of drug resistance.

4. Possible adverse effects

During treatment for HIV infection, increases in body weight, as well as blood lipid and glucose levels, 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 monitor these changes.

Like all medicines, Ritonavir Aurovitas may cause adverse effects, although not everyone experiences them. The adverse effects of Ritonavir Aurovitas when used in combination with other antiretroviral drugs also depend on these other drugs. Therefore, it is important to carefully read the package leaflet included with each of these other antiretroviral medicines.

Very common: may affect more than 1 in 10 people

abdominal pain in the upper or lower part of the abdomen
vomiting
diarrhoea (may be severe)
nausea
redness of the skin of the face or other parts of the body, sensation of warmth
tingling or numbness in hands, feet, or around lips and mouth
feeling of weakness or fatigue
unpleasant taste in the mouth
headache
dizziness
sore throat
cough
stomach discomfort or indigestion
nerve damage, which may cause weakness and pain
itching
rash
joint pain and back pain

Common: may affect less than 1 in 10 people

allergic reactions, including skin rashes (which may be red, raised above the surface of the surrounding skin, and itchy), severe swelling of the skin and other tissues
insomnia
anxiety
increased cholesterol levels
increased triglyceride levels
gout
gastrointestinal bleeding
hepatitis and yellowing of the skin or whites of the eyes
increased urination
impaired kidney function
seizures (epileptic fits)
decreased platelet count
sensation of thirst (dehydration)
abnormally heavy menstrual periods
bloating with gas release
loss of appetite
oral ulceration
muscle pain, tenderness, or weakness
fever
weight loss
laboratory findings: changes in blood test results (such as blood biochemistry and blood cell counts)
confusion
difficulty concentrating
fainting
blurred vision
swelling of hands and feet
high blood pressure
low blood pressure and feeling of impending fainting when standing up from a lying position
sensation of coldness in hands and feet
acne

Uncommon: may affect less than 1 in 100 people

heart attack
diabetes
kidney failure

Rare: may affect less than 1 in 1,000 people

severe or life-threatening skin reactions, including blistering (Stevens-Johnson syndrome, toxic epidermal necrolysis)
serious allergic reactions (anaphylactic reactions)
very high blood sugar levels

Frequency not known: cannot be estimated from available data

kidney stones

If nausea, vomiting, or abdominal pain occur, inform your doctor, as these symptoms may indicate pancreatitis. Also inform your doctor if joint stiffness, pain (especially in hips, knees, and shoulders), or difficulty moving develop, as these may be symptoms of bone necrosis. See also section 2. "Important information before using Ritonavir Aurovitas".

In patients with haemophilia A and B, increased bleeding has been reported during treatment with this medicine or other protease inhibitors. If this occurs, seek immediate medical advice.

Abnormal liver function test results, hepatitis, and rarely jaundice have been reported in patients treated with ritonavir. Some of these patients had pre-existing liver disease or were taking other medications. In patients with pre-existing liver disease or hepatitis, the condition may worsen.

Muscle pain, tenderness, and weakness have also been reported, particularly when cholesterol-lowering drugs are used concomitantly with antiretroviral drugs, including protease inhibitors and nucleoside analogues. In rare cases, these were serious muscle disorders (rhabdomyolysis). If unexplained or persistent muscle pain, tenderness, weakness, or cramps occur, discontinue the medicine and immediately contact your doctor or the nearest hospital emergency department.

Immediately inform your doctor if any symptoms suggesting an allergic reaction occur after taking Ritonavir Aurovitas, such as rash, urticaria (hives), or difficulty breathing.

If any of the adverse effects worsen or if any adverse effects not listed in this leaflet occur, consult a doctor, pharmacist, or go to the nearest hospital emergency department, or seek immediate medical help if the adverse effect requires urgent intervention.

Reporting of adverse effects

If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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

Adverse effects can also be reported to the marketing authorization holder.

Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Ritonavir Aurovitas

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, label, and carton after:
EXP. The expiry date refers to the last day of the stated month.
There are no special storage requirements for this medicine.
Use within 90 days after first opening the HDPE container.
Medicines must not be disposed of via wastewater 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 Ritonavir Aurovitas contains

The active substance is ritonavir. Each coated tablet contains 100 mg of ritonavir.
The other ingredients are: Tablet core: copovidone (K 25-30), sorbitan laurate, calcium hydrogen phosphate, calcium hydrogen phosphate dihydrate, cellulose, powdered cellulose, corn starch, mannitol, siliconized microcrystalline cellulose (Type-50 and Type-90), microcrystalline cellulose (PH-102), sodium stearyl fumarate. Tablet coating: hypromellose 2910 (6 cp), titanium dioxide (E 171), talc, macrogol 6000, macrogol 400, polysorbate 80.

What Ritonavir Aurovitas looks like and contents of the pack
Coated tablet.
White or almost white, coated, oval tablets, embossed with the letters "I" on one side and "100" on the other side.
Ritonavir Aurovitas coated tablets are available in blister packs and bottles containing 30 coated tablets per cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, local 27
01-909 Warsaw
e-mail: [email protected]

Manufacturer/Importer:
APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis 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 European Economic Area under the following names:
France: RITONAVIR ARROW 100 mg, comprimé pelliculé
Poland: Ritonavir Aurovitas
Portugal: Ritonavir Generis

Ritonavir aurovitas