Patient Information Leaflet

Ritonavir Sandoz 100 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you or your child start taking this medicine, as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you or your child only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Ritonavir Sandoz is and what it is used for
What you need to know before you or your child take Ritonavir Sandoz
How to take Ritonavir Sandoz
Possible side effects
How to store Ritonavir Sandoz
Contents of the pack and other information

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

Ritonavir Sandoz contains the active substance ritonavir. Ritonavir is a protease inhibitor enzyme used to control HIV infection. Ritonavir is used in combination with other anti-HIV medicines (antiretrovirals) to control HIV infection. Your doctor will discuss with you the optimal combination of medicines for your case.
Ritonavir Sandoz is used in children aged 2 years and older, adolescents, and adults who have been infected with HIV, the virus that causes AIDS.

2. What you should know before you or your child takes Ritonavir Sandoz

Do not take Ritonavir Sandoz

if you are allergic to ritonavir or to any of the other ingredients of this medicine (see section 6).
if you have severe liver disease.
if you are currently taking any of the following medicines:
astemizole or terfenadine (commonly used to treat allergic symptoms;
these medicines may be available without a prescription);
amiodarone, bepridil, dronedarone, encainide, flecainide, propafenone, quinidine (used to correct irregular heartbeat);
dihydroergotamine, ergotamine (used to treat migraine);
ergonovine, methylergonovine (used to stop excessive bleeding that may occur after childbirth or abortion);
clorazepate, diazepam, estazolam, flurazepam, triazolam or oral midazolam (taken by mouth) (used to help sleep and/or reduce anxiety);
clozapine, pimozide (used to treat abnormal thoughts or feelings);
quetiapine (used to treat schizophrenia, bipolar disorder and major depressive disorder);
lurasidone (used to treat depression);
ranolazine (used to treat chronic chest pain [angina]);
meperidine, piroxicam, propoxyphene (used for pain relief);
cisapride (used to relieve certain stomach problems);
rifabutin (used to prevent/treat certain infections)*;
voriconazole (used to treat fungal infections)*;
simvastatin, lovastatin (used to lower cholesterol levels in the blood);
neratinib (used to treat breast cancer);
lomitapide (used to lower cholesterol levels in the blood);
alfuzosin (used to treat benign prostatic hyperplasia);
fusidic acid (used to treat bacterial infections);
sildenafil if you have a lung disease called pulmonary arterial hypertension causing breathing difficulties. Patients without this condition may use sildenafil for impotence (erectile dysfunction) under medical supervision (see section Other medicines and Ritonavir Sandoz);
avanafil or vardenafil (used to treat erectile dysfunction);
colchicine (used to treat gout) if you have kidney and/or liver problems (see section Other medicines and Ritonavir Sandoz);
products containing St. John’s wort (Hypericum perforatum), as they may prevent Ritonavir Sandoz from working properly. St. John’s wort is often contained in herbal products that can be purchased over the counter.

* Your doctor may decide that you can take rifabutin and/or voriconazole with Ritonavir Sandoz at the boosting dose (the lower dose), but Ritonavir Sandoz at full dose must not be taken together with these two medicines.
If you are currently taking any of these medicines, ask your doctor whether you can use another medicine during the time you are taking Ritonavir Sandoz.
Also read the list of medicines under “Other medicines and Ritonavir Sandoz” for use with other medicines requiring special attention.

Warnings and precautions
Talk to your doctor or pharmacist before taking Ritonavir Sandoz.

Important information

If Ritonavir Sandoz is taken in combination with other antiretroviral medicines, it is important that you also read the patient information leaflet provided with these other medicines. These leaflets may contain additional information regarding situations in which the use of Ritonavir Sandoz should be avoided. If you have any further questions about Ritonavir Sandoz or the other medicines prescribed to you, consult your doctor or pharmacist.
Ritonavir Sandoz is not a cure for HIV infection or AIDS.
People taking Ritonavir Sandoz may still develop infections or other diseases associated with HIV infection or AIDS. Therefore, it is important that you remain under medical supervision during treatment with Ritonavir Sandoz.
You may still transmit HIV while taking this medicine, although the risk is reduced by effective antiretroviral therapy. Discuss with your doctor the precautions necessary to avoid transmitting the infection to others.

Tell your doctor if you or your child has/have had:

A history of liver disease.
Hepatitis B or C and are being treated with combination antiretroviral therapy, as you are at increased risk of serious and potentially life-threatening liver-related side effects. Regular blood tests may be needed to check that your liver is functioning properly.
Haemophilia, as increased episodes of bleeding have been reported in haemophiliac patients taking this type of medicine (protease inhibitors). The cause is not yet known. You may need a higher dose of the medicine that helps blood to clot (factor VIII) to control any bleeding episodes.
Erectile dysfunction, as medicines used to treat erectile dysfunction may cause hypotension and prolonged erection.
Diabetes, as worsening or onset of diabetes (diabetes mellitus) has been reported in some patients taking protease inhibitors.
Kidney problems, as your doctor may need to adjust the dose of other medicines (such as protease inhibitors).

Tell your doctor if you or your child experiences:

Diarrhoea or vomiting that does not improve (persistent), as this condition may reduce the effectiveness of the medicines you are taking.
Feeling unwell (nausea), vomiting or stomach pain, as these may be signs of inflammation of the pancreas (pancreatitis). Some patients taking Ritonavir Sandoz may develop serious problems affecting the pancreas. If these symptoms occur, inform your doctor as quickly as possible.
Signs of infection – inform your doctor immediately. Some patients with advanced HIV infection (AIDS) who start anti-HIV treatment may experience symptoms of past infections they were not even aware of. This is believed to occur due to an improved immune response helping the body fight such infections. In addition to opportunistic infections, autoimmune diseases (a condition occurring when the immune system attacks healthy body tissues) may also occur after starting treatment for HIV infection. Autoimmune diseases may appear many months after starting treatment. If you notice any signs of infection or any other symptoms such as muscle weakness, weakness starting in the hands and feet and spreading towards the trunk, palpitations, tremor or hyperactivity, inform your doctor immediately to receive necessary treatment.
Stiffness, tenderness and pain in the joints (especially in the hip, knee and shoulder) and difficulty moving, inform your doctor, as this may be a sign of a condition that can destroy bone tissue (osteonecrosis). Some patients taking multiple antiretroviral medicines may develop this condition.
Muscle pain, tenderness or weakness, particularly when associated with antiretroviral therapy including protease inhibitors and nucleoside analogues. In rare cases, these muscle disorders have been severe (see section 4 Possible side effects).
Dizziness, feeling of emptiness in the head, fainting or abnormal heartbeat. Some patients taking Ritonavir Sandoz may experience changes in the electrocardiogram (ECG). Inform your doctor if you have a heart defect or conduction disorder.
If you have any other health problems, discuss them with your doctor as soon as possible.

Children and adolescents
Ritonavir Sandoz is not recommended in children under 2 years of age.

Other medicines and Ritonavir Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those not requiring a prescription.

There are some medicines that must not be taken together with Ritonavir Sandoz. These medicines are listed above in section 2 under “Do not take Ritonavir Sandoz”. There are other medicines that can only be used under certain circumstances as described below.

The following precautions apply when Ritonavir Sandoz is taken at full dose. However, these precautions may also apply when Ritonavir Sandoz is taken at a lower dose (as a booster) with other medicines.

Inform your doctor or pharmacist if you or your child is taking, has recently taken or might take any of the medicines listed below, as special attention is required in these cases.

Sildenafil or tadalafil for impotence (erectile dysfunction). The dose and/or frequency of these medicines must be reduced to avoid low blood pressure and prolonged erection. You must not take ritonavir with sildenafil if you also have pulmonary arterial hypertension (see also section 2. What you should know before you or your child takes Ritonavir Sandoz). Inform your doctor if you are taking tadalafil for pulmonary arterial hypertension.
Colchicine (for gout), as ritonavir 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 ‘Do not take Ritonavir Sandoz’ above).
Digoxin (a heart medicine). Your doctor may need to adjust the digoxin dose and monitor you while taking digoxin and Ritonavir Sandoz to avoid heart problems.
Hormonal contraceptives containing ethinylestradiol, as Ritonavir Sandoz may reduce the effectiveness of these medicines. Use of condoms or other non-hormonal contraceptive methods is recommended. If you are taking this type of hormonal contraceptive together with Ritonavir Sandoz, you may experience irregular uterine bleeding.
Atorvastatin or rosuvastatin (for high cholesterol), as Ritonavir Sandoz may increase the levels of these medicines in the blood. Ask your doctor before taking any cholesterol-lowering medicine together with Ritonavir Sandoz (see also “Do not take Ritonavir Sandoz” above).
Steroids (e.g. dexamethasone, fluticasone propionate, prednisolone, triamcinolone), as Ritonavir Sandoz may increase the levels of these medicines in the blood, potentially leading to Cushing's syndrome (round face) and reduced cortisol hormone production. Your doctor may decide to reduce the steroid dose or monitor side effects more closely.
Trazodone (a medicine for depression), as increased side effects such as nausea, dizziness, low blood pressure and fainting may occur when taken together with Ritonavir Sandoz.
Rifampicin and saquinavir (used for tuberculosis and HIV, respectively), as they may cause severe liver damage when taken with Ritonavir Sandoz.
Bosentan, riociguat (used for pulmonary arterial hypertension), as ritonavir may increase the levels of this medicine in the blood.

There are other medicines that must not be taken together with Ritonavir Sandoz because their effects may increase or decrease when taken together. In some cases, your doctor may consider it necessary to perform tests, adjust doses or monitor you regularly. For this reason, you must inform your doctor if you are taking any other medicine, including those you have decided to purchase on your own or herbal products, but it is particularly important to mention the following medicines:

amphetamine or amphetamine derivatives;
antibiotics (e.g. erythromycin, clarithromycin);
anticancer treatments (e.g. abemaciclib, apalutamide, encorafenib, afatinib, ceritinib, dasatinib, ibrutinib, nilotinib, venetoclax, vincristine, vinblastine);
anticoagulants (e.g. rivaroxaban, vorapaxar, warfarin);
antidepressants (e.g. amitriptyline, desipramine, fluoxetine, imipramine, nefazodone, nortriptyline, paroxetine, sertraline, trazodone);
antifungals (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 and delamanid);
antiviral medicines used to treat chronic hepatitis C virus (HCV) infection in adults (e.g. glecaprevir/pibrentasvir and simeprevir);
anxiolytics, 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 stop smoking;
antiepileptic medicines (e.g. carbamazepine, divalproex, lamotrigine, phenytoin);
heart medicines (e.g. disopyramide, mexiletine, and calcium antagonists such as amlodipine, diltiazem and nifedipine);
medicines acting on the immune system (e.g. cyclosporine, tacrolimus, everolimus);
levothyroxine (used to treat thyroid problems);
morphine and morphine-like medicines used to treat severe pain (e.g. methadone, fentanyl);
sedatives (e.g. alprazolam, zolpidem) and also midazolam administered by injection;
tranquillisers (e.g. haloperidol, risperidone, thioridazine);
colchicine, a treatment for gout.

There are some medicines that must absolutely not be taken with Ritonavir Sandoz.
These have previously been listed in section 2 under “Do not take Ritonavir Sandoz”.

Ritonavir Sandoz with food and drink
Ritonavir Sandoz 100 mg film-coated tablets should be taken with food.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor for advice before taking this medicine.
There is extensive information regarding the use of ritonavir (the active substance in Ritonavir Sandoz) during pregnancy. In general, pregnant women have taken ritonavir after the first three months of pregnancy at a lower dose (as a booster) in combination with other protease inhibitors. Ritonavir Sandoz does not appear to increase the risk of birth defects compared to the general population.
Ritonavir Sandoz passes into breast milk. To avoid transmission of infection, HIV-positive mothers must not breastfeed their infants.

Driving and using machines
Ritonavir Sandoz may cause dizziness. If you experience these symptoms, do not drive or operate machinery.

Ritonavir Sandoz contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e. essentially 'sodium-free'.

3. How to take Ritonavir Sandoz

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. Take this medicine once or twice daily with food.
It is important that Ritonavir Sandoz tablets are swallowed whole and not chewed, split, or crushed.

The recommended doses of Ritonavir Sandoz are:

if Ritonavir Sandoz is used to boost the effects of other anti-HIV medicines, the standard adult dose is 1 to 2 tablets once or twice daily. For more detailed dosing recommendations, including those for children, please refer to the Package Leaflet of the anti-HIV medicines used in combination with Ritonavir Sandoz.
if your doctor prescribes a full-dose regimen, adults may start with a dose of 3 tablets in the morning and 3 tablets after 12 hours, gradually increasing over a 14-day period up to the full dose of 6 tablets twice daily (for a total of 1200 mg per day). Children (aged 2 to 12 years) will start with a lower dose and gradually increase until reaching the maximum dose allowed for their body size.

Your doctor will advise you on the correct dose to take.
Like all other anti-HIV medicines, Ritonavir Sandoz must be taken every day to help control HIV, regardless of how well you feel. If a side effect prevents you from taking Ritonavir Sandoz as prescribed, inform your doctor immediately. During episodes of diarrhoea, your doctor may decide whether additional monitoring is necessary.
Make sure you always have an adequate supply of Ritonavir Sandoz to avoid running out. When travelling or during hospital stays, ensure you have enough Ritonavir Sandoz to last until you can obtain more.

If you or your child takes more Ritonavir Sandoz than you should
If you take too much Ritonavir Sandoz, you may experience dizziness, tingling, or numbness. If you realize you have taken more than the prescribed dose, contact your doctor or the nearest hospital emergency department immediately.

If you or your child forgets to take Ritonavir Sandoz
If you miss a dose, take it as soon as possible. If it is almost time for your next dose, take only that next dose. Do not take a double dose to make up for the missed one.

If you or your child stops taking Ritonavir Sandoz
Even if you feel better, do not stop taking Ritonavir Sandoz without first talking to your doctor. Taking Ritonavir Sandoz as recommended gives you the best chance of delaying drug resistance.

If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

During therapy for HIV infection, an increase in weight as well as in blood lipid and glucose levels may occur. This is partly related to the recovery of health status and lifestyle, and in the case of blood lipids, sometimes also to the HIV medications themselves. Your doctor will monitor these changes.

Like all medicines, this medicine can cause side effects, although not everyone experiences them. In addition, the side effects of ritonavir when taken with other antiretroviral medicines depend on these other medicines. Therefore, it is important to carefully read the section on side effects in the package leaflets of these medicines.

Very common: may affect more than 1 in 10 people

upper or lower abdominal pain
vomiting
diarrhoea (may be severe)
feeling unwell (nausea)
flushing, sensation of warmth
headache
dizziness
sore throat
cough
stomach discomfort or indigestion
tingling or numbness in the hands, feet, or around the lips and mouth
feeling of weakness/tiredness
bad taste in the mouth
nerve damage that may 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 (may be red, raised, itchy), severe swelling of the skin and other tissues
increased cholesterol
inability to sleep (insomnia)
increased triglycerides
anxiety
gout
stomach bleeding
inflammation of the liver and yellowing of the skin or whites of the eyes
increased urination
reduced kidney function
seizures
low platelet levels in the blood
thirst (dehydration)
unusually heavy menstrual periods
flatulence
loss of appetite
mouth ulcers
muscle pain, tenderness, or weakness
fever
weight loss
laboratory results: changes in blood test results (such as blood chemistry and blood counts)
confusion
difficulty concentrating
fainting
blurred vision
sweating of hands and feet
high blood pressure
low blood pressure and feeling faint when standing up
cold 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 potentially life-threatening skin reactions including skin blistering (Stevens-Johnson syndrome, toxic epidermal necrolysis)
severe allergic reaction (anaphylaxis)
high blood sugar levels

Tell your doctor if you experience nausea, vomiting, or stomach pain, as these may be symptoms of pancreatitis. Also inform your doctor if you experience joint stiffness, tenderness, pain (especially in the hip, knee, or shoulder), or difficulty moving, as these may be signs of osteonecrosis.
See also section 2 What you should know before you or your child takes Ritonavir Sandoz.

In patients with haemophilia A and B, an increased frequency of bleeding episodes has been reported during treatment with this medicine or other protease inhibitors. If this occurs, contact your doctor immediately.

Abnormal liver function tests, hepatitis (inflammation of the liver), and rarely jaundice have been reported in patients treated with ritonavir. Some of these patients had other medical conditions or were taking other medicines. Patients with pre-existing liver disease or hepatitis may experience worsening of their condition.

Muscle pain, tenderness, or weakness have been reported, particularly when cholesterol-lowering medicines are taken in combination with antiretroviral therapy, including protease inhibitors and nucleoside analogues. In rare cases, these muscle disorders have been severe (rhabdomyolysis). If you experience unexplained or recurrent muscle pain, tenderness, weakness, or cramps, stop taking the medicine, contact your doctor as soon as possible, or go to the nearest hospital emergency department.

Inform your doctor as soon as possible if, after taking ritonavir, you develop any symptoms suggesting an allergic reaction, such as rash, itching, or breathing difficulties.

If any of the side effects become severe, or if you notice any side effects not listed in this leaflet, contact your doctor, pharmacist, emergency department, or, in case of emergency, seek immediate medical help.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ritonavir Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the bottle after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Once the bottle has been opened, use within 4 months.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ritonavir Sandoz contains

The active substance is ritonavir. Each film-coated tablet contains 100 mg of ritonavir.
The other components are: copovidone, sorbitan laurate (E 493), colloidal anhydrous silica (E 551), anhydrous calcium hydrogen phosphate, sodium stearyl fumarate.
hypromellose (E 464), titanium dioxide (E 171), macrogol 400 (E 1521), macrogol 3350 (E 1521), hydroxypropylcellulose (E 463), talc (E 553b), colloidal anhydrous silica (E 551), polysorbate 80 (E 433).

Description of the appearance of Ritonavir Sandoz and pack contents
Film-coated tablets, white to almost white in colour, capsule-shaped,
marked with 'H' on one side and 'R9' on the opposite side.
The film-coated tablets are available in white HDPE bottles with child-resistant
polypropylene caps.
Pack sizes:
30, 60 (2x30), 90 (3x30), 120 and 180 (2x[3x30]) film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A.
L.go U. Boccioni 1
21040 Origgio (VA)
Italy

Manufacturer
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1, Sachsen-Anhalt, 39179 Barleben
Germany
Pharmadox Healthcare, Ltd.
KW20A Kordin Industrial Park, Paola, PLA 3000
Malta

This medicinal product is authorized in the European Economic Area countries with the following names:
Austria Ritonavir Sandoz 100 mg - Filmtabletten
Belgium Ritonavir Sandoz 100 mg filmomhulde tabletten
Finland Ritonavir Sandoz 100 mg tabletti, kalvopäällysteinen
France RITONAVIR SANDOZ 100 mg, comprimé pelliculé
Germany Ritonavir HEXAL® 100 mg Filmtabletten
Italy Ritonavir Sandoz
Luxembourg Ritonavir Sandoz 100 mg comprimés pelliculés
Netherlands Ritonavir Sandoz 100 mg, filmomhulde tabletten
Poland Ritonavir Sandoz
Portugal Ritonavir Sandoz
Romania Ritonavir Sandoz 100 mg comprimate filmate
Slovenia Ritonavir Sandoz 100 mg filmsko obložene tablete
Spain Ritonavir Sandoz 100 mg cápsulas blandas EFG