RITONAVIR 100 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Ritonavir Aurovitas, 100 mg, Film-Coated Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for you.
   2. Contents of the Package Leaflet:
3. What Ritonavir Aurovitas is and what it is used for
4. Important information before taking Ritonavir Aurovitas
   1. When not to take Ritonavir Aurovitas
   2. Warnings and precautions
   3. Important information
   4. Tell your doctor if you have or have had:
   5. Tell your doctor if you experience:
   6. Children and adolescents
   7. Ritonavir Aurovitas and other medicines
   8. Tell your doctor if you are taking any of the following medicines, as special caution is required:
   9. Taking Ritonavir Aurovitas with food and drink
   10. Pregnancy and breastfeeding
   11. Driving and using machines
   12. Ritonavir Aurovitas contains sodium
5. How to take Ritonavir Aurovitas
   1. Taking more Ritonavir Aurovitas than prescribed
   2. Missing a dose of Ritonavir Aurovitas
   3. Stopping Ritonavir Aurovitas treatment
6. Possible side effects
   1. If any of your side effects get worse, or if you experience any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or the emergency room of your nearest hospital, or seek immediate medical attention.
   2. Reporting of side effects
7. How to store Ritonavir Aurovitas
8. Contents of the pack and other information
   1. What Ritonavir Aurovitas contains
   2. What Ritonavir Aurovitas looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder:
   5. Manufacturer/Importer:
   6. This medicine is authorized in the Member States of the European Economic Area under the following names:
   7. France:
   8. Poland:
   9. Portugal:
   10. Date of last revision of the leaflet: 02/2024

Package Leaflet: Information for the Patient

Ritonavir Aurovitas, 100 mg, Film-Coated Tablets

Ritonavir

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• You should keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects not mentioned in this leaflet, or if any of the side effects get serious, please tell your doctor or pharmacist. See section 4.

Contents of the Package Leaflet:

What Ritonavir Aurovitas is and what it is used for
Important information 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 of Ritonavir Aurovitas is ritonavir. Ritonavir Aurovitas is a protease inhibitor used to slow down the progression of HIV infection. Ritonavir Aurovitas is used in combination with other anti-HIV medicines to slow down the progression of HIV infection. Your doctor will decide which other medicines to use with Ritonavir Aurovitas to achieve the best effect for you.
Ritonavir Aurovitas is used in children aged 2 years and above, adolescents, and adults infected with HIV, which causes AIDS.

2. Important information before taking Ritonavir Aurovitas

When not to take Ritonavir Aurovitas

• if you are allergic to ritonavir or any of the other ingredients of this medicine (listed in section 6).
• if you have severe liver disease.
• if you are 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 heartbeats);
• Dihydroergotamine, ergotamine (used to treat migraine headaches);
• Ergonovine, methylergonovine (used to prevent excessive bleeding after childbirth or miscarriage);
• Chlordiazepoxide, diazepam, estazolam, flurazepam, triazolam, or oral midazolam (used to treat insomnia and/or anxiety);
• Clozapine, pimozide (used to treat thought or mood disorders);
• Quetiapine (used to treat schizophrenia, bipolar disorder, and severe depression);
• Lurasidone (used to treat depression);
• Ranolazine (used to treat chronic chest pain [angina]);
• Pethidine, propoxyphene (painkillers);
• Cisapride (used to treat certain stomach 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 you have pulmonary hypertension, which can cause difficulty breathing. Patients who do not have this condition may take sildenafil for erectile dysfunction under the supervision of a doctor (see section “Ritonavir Aurovitas and other medicines”);
• Avanafil or vardenafil (used to treat erectile dysfunction);
• Colchicine (used to treat gout), if you have kidney and/or liver problems (see section “Ritonavir Aurovitas and other medicines”);
• Products containing St. John's Wort (Hypericum perforatum), as it may decrease the effectiveness of Ritonavir Aurovitas. St. John's Wort is often used in herbal products available without a prescription.

*
Your doctor will decide whether you can take rifabutin and/or voriconazole with Ritonavir Aurovitas at a reduced dose (lower dose). You must not take Ritonavir Aurovitas at full dose with these two medicines.
If you are currently taking any of the above medicines, you should ask your doctor whether you need to change to a different medicine while taking Ritonavir Aurovitas.
You should also read the list of medicines in the section “Ritonavir Aurovitas and other medicines”to get information about other medicines that require special caution.

Warnings and precautions

You should discuss the use of Ritonavir Aurovitas with your doctor before starting treatment.

Important information

• If you are taking Ritonavir Aurovitas with other anti-retroviral medicines, you should carefully read the package leaflets of these other medicines. These package leaflets may contain additional information about when not to take Ritonavir Aurovitas. If you have any doubts about Ritonavir Aurovitas (ritonavir) or other prescribed medicines, you should consult your doctor or pharmacist.
• Ritonavir Aurovitas does not cure HIV infection or AIDS.
• People taking Ritonavir Aurovitas may still get infections or other illnesses associated with HIV or AIDS. It is therefore important to remain under the care of a doctor while taking Ritonavir Aurovitas.

Tell your doctor if you have or have had:

• Liver diseasein the past.
• Hepatitis B or C virus infectionand are currently being treated with combination anti-retroviral therapy, as there is an increased risk of severe and potentially life-threatening side effects from the liver. Patients with these conditions may require additional blood tests to monitor liver function.
• Hemophilia, as there have been reports of increased bleeding in patients with hemophilia taking this type of medicine (protease inhibitors). The reason is not known. Additional medication may be needed to increase blood clotting (factor VIII) and control any bleeding.
• Erectile dysfunction, as any of the medicines used to treat erectile dysfunction can cause low blood pressure and prolonged erection.
• Diabetes, as there have been reports of worsening diabetes symptoms or the development of diabetes in some patients taking protease inhibitors.
• Kidney problems, as your doctor may need to adjust the dose of other medicines you are taking (such as protease inhibitors).

Tell your doctor if you experience:

• Diarrhea or vomitingthat does not go away (persists), as this may reduce the effectiveness of your medicines.
• Nausea, vomiting, or abdominal pain, as these symptoms may indicate pancreatitis (inflammation of the pancreas). Some patients taking Ritonavir Aurovitas have developed serious pancreatitis. If you experience these symptoms, you should contact your doctor immediately.
• Infection symptoms- you should contact your doctor immediately. Some patients with advanced HIV infection (AIDS) who start anti-HIV treatment may develop symptoms of infections they have had in the past, even if they were not aware of them. It is believed that this is due to the improvement in the body's immune response, which allows it to fight off these infections. In addition to opportunistic infections, autoimmune disorders (where the immune system attacks healthy tissues) may also occur after starting anti-HIV treatment. Autoimmune disorders may occur several months after starting treatment.
• Joint stiffness, pain(especially in the hips, knees, and shoulders) and difficulty moving. You should tell your doctor, as these may be symptoms of a disease that causes bone destruction (osteonecrosis). See also section 2, “Important information before taking Ritonavir Aurovitas”.
• Pain, tenderness, or weakness of muscles, especially when taking protease inhibitors and nucleoside analogs. In rare cases, muscle disorders have been serious (see section 4, “Possible side effects”).
• Dizziness, fainting, or abnormal heartbeat. Some patients taking Ritonavir Aurovitas may experience changes in their EKG. You should tell your doctor if you have a heart condition or conduction problems.
• In case of any health problems, you should contact your doctor.

Children and adolescents

Ritonavir Aurovitas should not be used in children under 2 years of age.

Ritonavir Aurovitas and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about any medicines you plan to take, including those available without a prescription. There are medicines that must not be taken with Ritonavir Aurovitas, as listed earlier in section 2, under “When not to take Ritonavir Aurovitas”. There are other medicines that can only be taken under certain conditions, as described below.
The following warnings apply when Ritonavir Aurovitas is taken at full dose. These warnings may also apply when Ritonavir Aurovitas is taken at lower doses as a booster for other anti-retroviral medicines.

Tell your doctor if you are taking any of the following medicines, as special caution is required:

• Sildenafil or tadalafilused to treat erectile dysfunction. It may be necessary to reduce the dose and/or frequency of these medicines to avoid low blood pressure and prolonged erection. You must not take Ritonavir Aurovitas with sildenafil if you have pulmonary hypertension (see section 2, “Important information before taking Ritonavir Aurovitas”). If you have pulmonary hypertension and are being treated with tadalafil, you should tell your doctor.
• Colchicine(used to treat gout), as Ritonavir Aurovitas may increase the levels of this medicine in the blood. You must not take ritonavir with colchicine if you have kidney and/or liver problems (see also section “When not to take Ritonavir Aurovitas”above).
• Digoxin(a heart medicine). Your doctor may need to adjust the dose of digoxin and closely monitor you if you are taking digoxin and Ritonavir Aurovitas to avoid heart problems.
• Hormonal contraceptivescontaining ethinyl estradiol, as Ritonavir Aurovitas may reduce their effectiveness. Instead, a condom or other non-hormonal method of birth control is recommended. When taking these hormonal contraceptives and Ritonavir Aurovitas, you may also experience irregular vaginal bleeding.
• Atorvastatin or rosuvastatin(used to lower blood cholesterol levels), as Ritonavir Aurovitas may increase the levels of these medicines in the blood. You should consult your doctor before taking any cholesterol-lowering medicines with Ritonavir Aurovitas (see also “When not to take Ritonavir Aurovitas”above).
• Corticosteroids(e.g., dexamethasone, fluticasone propionate, prednisone, triamcinolone), as Ritonavir Aurovitas may increase the levels of these medicines in the blood, which may lead to Cushing's syndrome (moon face) and decreased cortisol production (a hormone). Your doctor may need to reduce the dose of the corticosteroid or closely monitor you for side effects.
• Trazodone(an antidepressant), as side effects such as nausea, dizziness, low blood pressure, and fainting may occur when taken with Ritonavir Aurovitas.
• Rifampicin and saquinavir(used to treat tuberculosis and HIV, respectively), as taking them with Ritonavir Aurovitas may increase the risk of severe liver damage.
• Bozentan, riociguat(used to treat pulmonary hypertension), as Ritonavir Aurovitas may increase the levels of these medicines in the blood.

There are medicines that should not be taken with Ritonavir Aurovitas, as their effects may increase or decrease when taken together. In some cases, your doctor may need to perform additional laboratory tests, adjust the dose, or monitor you regularly. Therefore, you should tell your doctor about all the medicines you are taking, including those available without a prescription, including herbal products. You should especially tell your doctor if you are taking:

• Amphetamine or amphetamine derivatives;
• Antibiotics (e.g., erythromycin, clarithromycin);
• Cancer medicines (e.g., abemaciclib, afatinib, apalutamide, ceritinib, encorafenib, dasatinib, ibrutinib, nilotinib, venetoclax, vincristine, vinblastine);
• Medicines used to treat low platelet count (e.g., fostamatinib);
• Anticoagulant medicines (e.g., dabigatran etexilate, edoxaban, rivaroxaban, vorapaxar, warfarin);
• Antidepressant medicines (e.g., amitriptyline, desipramine, fluoxetine, imipramine, nefazodone, nortriptyline, paroxetine, sertraline, trazodone);
• Antifungal medicines (e.g., ketoconazole, itraconazole);
• Antihistamine medicines (e.g., loratadine, fexofenadine);
• Anti-HIV medicines, including 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 and 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;
• Seizure medicines (e.g., carbamazepine, divalproex, lamotrigine, phenytoin);
• Heart medicines (e.g., disopyramide, mexiletine, and calcium channel blockers such as amlodipine, diltiazem, and nifedipine);
• Immunosuppressant medicines (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 midazolam given by injection;
• Neuroleptic medicines (e.g., haloperidol, risperidone, thioridazine);
• Colchicine, used to treat gout.

There are medicines that must not be taken with Ritonavir Aurovitas, as listed earlier in section 2, under “When not to take Ritonavir Aurovitas”.

Taking Ritonavir Aurovitas with food and drink

Ritonavir Aurovitas tablets should be taken with food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
There is a large amount of data on the use of ritonavir (the active substance of Ritonavir Aurovitas) in pregnancy. Generally, women who are pregnant have been given ritonavir after the first three months of pregnancy, at a lower dose (booster dose) in combination with other protease inhibitors. It does not appear that Ritonavir Aurovitas increases the risk of birth defects compared to the general population.
It is not recommended that HIV-infected women breastfeed their babies, as the HIV virus can be passed to the baby through breast milk.
If you are breastfeeding or thinking of breastfeeding, you should consult your doctor as soon as possible.

Driving and using machines

Ritonavir Aurovitas may cause dizziness. If you experience this side effect, you should not drive or operate machinery.

Ritonavir Aurovitas contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially sodium-free.

3. How to take Ritonavir Aurovitas

This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. This medicine should be taken every day, 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 other anti-HIV medicines, the typical dose for adults is 1 to 2 tablets once or twice a day. More detailed dosing recommendations, including dosing for children, can be found in the patient information leaflet of the anti-HIV medicine that is being taken with Ritonavir Aurovitas.
• If your doctor prescribes the full dose, adults can start treatment by taking 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 a day (a total of 1200 mg per day). In children (aged 2 to 12 years), treatment should be started with a lower dose, which is then gradually increased to the maximum dose based on body surface area.

Your doctor will tell you which dose to take.
To slow down the progression of HIV infection, Ritonavir Aurovitas should be taken every day, regardless of any improvement in your condition. If any side effect prevents you from taking Ritonavir Aurovitas as prescribed, you should immediately tell your doctor. During episodes of diarrhea, your doctor may decide to perform additional monitoring tests.
You should always have an adequate supply of Ritonavir Aurovitas to avoid running out. When planning a trip or hospital stay, make sure you have enough Ritonavir Aurovitas to last until your next supply.

Taking more Ritonavir Aurovitas than prescribed

If you take more Ritonavir Aurovitas than prescribed, you may experience numbness or tingling. If you realize you have taken more Ritonavir Aurovitas than prescribed, you should immediately contact your doctor or go to the emergency room of your nearest hospital.

Missing a dose of Ritonavir Aurovitas

If you miss a dose, you should take it as soon as possible. If it is almost time for your next dose, you should only take the next dose. Do not take a double dose to make up for a missed dose.

Stopping Ritonavir Aurovitas treatment

You should not stop taking Ritonavir Aurovitas without consulting your doctor, even if you feel better. Taking Ritonavir Aurovitas as prescribed gives you the best chance of delaying the development of resistance to the medicine.

4. Possible side effects

During HIV treatment, you may experience an increase in weight and levels of lipids and glucose in the blood. This is partly due to the improvement in your condition and lifestyle, and in the case of lipid levels, sometimes due to the HIV treatment itself. Your doctor will monitor these changes.
Like all medicines, Ritonavir Aurovitas can cause side effects, although not everybody gets them. The side effects of Ritonavir Aurovitas when taken with other anti-retroviral medicines also depend on the other medicines. Therefore, it is important to carefully read the package leaflet of each of the other anti-retroviral medicines you are taking.
Very common: may affect more than 1 in 10 people

• abdominal pain (upper or lower)
• vomiting
• diarrhea (may be severe)
• nausea
• flushing (redness of the face or other parts of the body) and feeling of warmth
• numbness or tingling of hands, feet, or around the lips and mouth
• feeling weak or tired
• unpleasant taste in the mouth
• headache
• dizziness
• sore throat
• cough
• stomach upset or indigestion
• nerve damage, which can cause weakness and pain
• itching
• rash
• joint pain and back pain

Common: may affect up to 1 in 10 people

• allergic reactions, including skin rash (which may be red, raised, and itchy), swelling of the skin and other tissues
• insomnia
• anxiety
• increased cholesterol levels
• increased triglyceride levels
• gout
• stomach bleeding
• liver inflammation and yellowing of the skin or whites of the eyes
• increased urination
• kidney problems
• seizures (fits)
• low platelet count
• feeling thirsty (dehydration)
• heavy or irregular menstrual periods
• bloating and gas
• loss of appetite
• mouth ulcers
• muscle pain, tenderness, or weakness
• fever
• weight loss
• abnormal laboratory test results (such as blood biochemistry and hematology tests)
• confusion
• difficulty concentrating
• fainting
• blurred vision
• swelling of hands and feet
• high blood pressure
• low blood pressure and feeling faint when standing up from a lying position
• feeling cold in hands and feet
• acne

Uncommon: may affect up to 1 in 100 people

• heart attack
• diabetes
• kidney failure

Rare: may affect up to 1 in 1,000 people

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

Frequency not known: cannot be estimated from the available data

• kidney stones

If you experience nausea, vomiting, or abdominal pain, you should tell your doctor, as these symptoms may indicate pancreatitis. You should also tell your doctor if you experience joint stiffness, pain (especially in the hips, knees, and shoulders), and difficulty moving, as these may be symptoms of a disease that causes bone destruction (osteonecrosis). See also section 2, “Important information before taking Ritonavir Aurovitas”.
Patients with hemophilia type A and B have reported increased bleeding when taking this medicine or other protease inhibitors. If this happens, you should immediately consult your doctor.
Patients treated with ritonavir have reported abnormal liver function tests, liver inflammation, and rare cases of yellowing of the skin or whites of the eyes. Some of these patients had other underlying conditions or were taking other medicines. In patients with pre-existing liver disease or liver inflammation, worsening of the condition may occur.
There have also been reports of muscle pain, tenderness, and weakness, especially when taking cholesterol-lowering medicines and anti-HIV medicines, including protease inhibitors and nucleoside analogs. In rare cases, these muscle disorders have been serious (rabdomyolysis). If you experience unexplained or persistent muscle pain, tenderness, weakness, or cramps, you should stop taking the medicine and immediately consult your doctor or go to the emergency room of your nearest hospital.
You should immediately tell your doctor if you experience any symptoms of an allergic reaction after taking Ritonavir Aurovitas, such as rash, hives, or difficulty breathing.

If any of your side effects get worse, or if you experience any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or the emergency room of your nearest hospital, or seek immediate medical attention.

if you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the https://smz.ezdrowie.gov.plwebsite. By reporting side effects, you can help 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 which is stated on the blister, label, and carton after EXP. The expiry date refers to the last day of that month.
There are no special storage instructions for this medicine.
Use within 90 days of first opening the HDPE container.
Medicines should 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 film-coated tablet contains 100 mg of ritonavir.
• The other ingredients are: Tablet core:copovidone (K 25-30), sorbitan laurate, calcium phosphate, calcium hydrogen phosphate dihydrate, cellulose, powder, corn starch, mannitol, microcrystalline cellulose (PH-102), siliconized microcrystalline cellulose (Type-50 and Type-90). Tablet coating:hypromellose 2910 (6cp), titanium dioxide (E 171), talc, macrogol 6000, macrogol 400, polysorbate 80.

What Ritonavir Aurovitas looks like and contents of the pack

Film-coated tablet.
White or almost white, film-coated, oval tablets, with the letters “I” embossed on one side and “100” on the other side.
Ritonavir Aurovitas film-coated tablets are available in blisters and containers of 30 film-coated tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warszawa
e-mail: [email protected]

Manufacturer/Importer:

APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
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 medicine is authorized in the Member States of the European Economic Area under the following names:

France:

RITONAVIR ARROW 100 mg, comprimé pelliculé

Poland:

Ritonavir Aurovitas

Portugal:

Ritonavir Generis

Date of last revision of the leaflet: 02/2024