Ritonavir Viatris

Package leaflet: Information for the user

Ritonavir Viatris 100 mg film-coated tablets

ritonavir
Read this leaflet carefully before taking this medicine because it contains
important information for you or your child.

• 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 only. Do not give it to other people, 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

1. What Ritonavir Viatris is and what it is used for
2. What you need to know before you or your child take Ritonavir Viatris
3. How to take Ritonavir Viatris
4. Possible side effects
5. How to store Ritonavir Viatris
6. Contents of the pack and other information

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

Ritonavir Viatris contains the active substance ritonavir. Ritonavir is a protease inhibitor used in combination with other anti-HIV medicines (antiretrovirals) as a pharmacokinetic enhancer to control HIV infection. As an enhancer, ritonavir does not treat HIV directly, but increases the blood levels of other protease inhibitors to improve their effect in controlling HIV infection. Your doctor will discuss with you the optimal combination of medicines for your case.
Ritonavir Viatris is used in children from 2 years of age, adolescents, and adults who have been infected with HIV, the virus that causes AIDS.

2. What you need to know before you or the child takes Ritonavir Viatris

Do not take Ritonavir Viatris

• if you are allergic to ritonavir or to any of the other ingredients of this medicine (listed in 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 and headache);
  • ergonovine, methylergonovine (used to stop excessive bleeding that may occur during childbirth or abortion);
  • chlordiazepoxide, diazepam, estazolam, flurazepam, triazolam or oral midazolam (administered orally) (used to relieve sleep and/or anxiety disorders);
  • 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, propoxyphene (used for pain relief);
  • cisapride (used to relieve certain stomach problems);
  • 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 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 Viatris);
  • avanafil or vardenafil (used to treat erectile dysfunction);
  • colchicine (used to treat gout) if you have kidney or liver problems (see section Other medicines and Ritonavir Viatris);
  • products containing St. John’s wort (Hypericum perforatum), as they may reduce the effectiveness of ritonavir. St. John’s wort is often found in herbal products that may be purchased without a prescription.

If you are currently taking any of these medicines, ask your doctor whether you can use an alternative medicine during treatment with Ritonavir Viatris.
Also read the list of medicines under “Other medicines and Ritonavir Viatris” for use with some of these medicines that require special care.

Warnings and precautions

Talk to your doctor before taking Ritonavir Viatris.

Important information

• If Ritonavir Viatris is taken in combination with other antiretroviral medicines, it is important that you also read carefully the package leaflet supplied with those medicines. Additional information regarding situations in which it is better to avoid using ritonavir may be included in these leaflets. If you have any further questions about Ritonavir Viatris (ritonavir) or other medicines prescribed to you, ask your doctor or pharmacist.
• Ritonavir is not a cure for HIV infection or acquired immunodeficiency syndrome (AIDS).
• People taking ritonavir may still develop infections or other diseases associated with HIV or AIDS. Therefore, it is important that you remain under medical supervision while taking Ritonavir Viatris.

Tell your doctor if you have/have had:

• A history of liver disease.
• Hepatitis B or C and are receiving combination antiretroviral therapy, as you are at increased risk of serious, potentially life-threatening liver-related side effects. More frequent blood tests may be needed to monitor liver function.
• Haemophilia, as increased bleeding episodes have been reported in haemophilia patients receiving this type of medicine (protease inhibitors). The reason for this 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 low blood pressure and prolonged erection.
• Diabetes, as worsening or new-onset diabetes (diabetes mellitus) has been reported in some patients receiving protease inhibitors.
• Kidney (renal) diseases, as your doctor may need to adjust the dose of other medicines (such as protease inhibitors).

Tell your doctor if you experience:

• 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 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. In some patients with advanced HIV infection (AIDS), shortly after starting anti-HIV treatment, signs and symptoms of past infections may appear, even if previously unknown. These symptoms are believed to result from an improved immune response enabling the body to 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 taking medicines to treat HIV infection. Autoimmune diseases may appear many months after starting treatment. If you notice any signs of infection or 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 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 certain types and numbers of antiretroviral medicines may develop this disease.
• 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 may experience changes in the electrocardiogram (ECG). Inform your doctor if you have a heart defect or conduction disorder.
• If you have any other doubts about your health, discuss them with your doctor as soon as possible.

Children and adolescents
Ritonavir Viatris is not recommended for children under 2 years of age.

Other medicines and Ritonavir Viatris
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine, including those not requiring a prescription. There are some medicines that must absolutely not be taken with ritonavir. These medicines are listed above in section 2 under “Do not take Ritonavir Viatris”. There are some medicines that may only be used under certain circumstances as described below.
The following precautions may apply when Ritonavir Viatris is used as a pharmacokinetic enhancer with other medicines.
Tell your doctor if you are taking any of the following medicines, as special attention is required in these cases.

• Sildenafil or tadalafil for impotence (erectile dysfunction). The dose of these medicines must be reduced to avoid low blood pressure and prolonged erection. You must not take Ritonavir Viatris with sildenafil if you also have pulmonary arterial hypertension (see also section 2 “What you need to know before you or the child takes Ritonavir Viatris”). 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 or liver problems (see also “Do not take Ritonavir Viatris” above).
• Digoxin (a heart medicine). Your doctor may need to adjust the digoxin dose and monitor you while taking digoxin and ritonavir to avoid heart problems.
• Hormonal contraceptives containing ethinylestradiol, as ritonavir may reduce the effectiveness of these medicines. Use of condoms or other non-hormonal contraceptive methods is recommended. If you take this type of hormonal contraceptive with ritonavir, you may experience irregular uterine bleeding (spotting).
• Atorvastatin or rosuvastatin (for high cholesterol). Ritonavir may increase the levels of these medicines in the blood. Ask your doctor before taking any cholesterol-lowering medicine with ritonavir (see also “Do not take Ritonavir Viatris” above).
• Steroids (e.g. dexamethasone, fluticasone propionate, prednisolone, triamcinolone), as ritonavir 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 (for depression). Undesirable effects such as nausea, dizziness, low blood pressure and weakness may occur when administered with ritonavir.
• Rifampicin (for tuberculosis), as it may cause severe liver damage when taken with ritonavir.
• Bosentan, riociguat (used for pulmonary arterial hypertension), as ritonavir may increase the levels of these medicines in the blood.

There are other medicines that must not be taken together with ritonavir because their effects may increase or decrease when taken together. In some cases, your doctor may need to perform tests, adjust doses or monitor your condition regularly. Inform your doctor if you are taking any other medicine, whether prescription or over-the-counter, including herbal products, but it is particularly important to mention the following medicines:

• amphetamine or amphetamine derivatives;
• antibiotics (e.g. erythromycin, clarithromycin, rifabutin);
• antineoplastics (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);
• antifungals (e.g. ketoconazole, itraconazole, voriconazole);
• antihistamines (e.g. loratadine, fexofenadine);
• antiretrovirals including HIV protease inhibitors (atazanavir, darunavir, fosamprenavir, indinavir, nelfinavir, tipranavir), non-nucleoside reverse transcriptase inhibitors (NNRTIs) and others (maraviroc, raltegravir);
• anti-tuberculosis medicines (bedaquiline and delamanid);
• antivirals 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;
• antiepileptics (e.g. carbamazepine, valproate, lamotrigine, phenytoin);
• heart medicines (e.g. disopyramide, mexiletine, and calcium antagonists such as amlodine, 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);
• oral sedatives (e.g. alprazolam, zolpidem) and also injectable midazolam;
• tranquillisers (e.g. haloperidol, risperidone, thioridazine);
• colchicine, a medicine used to treat gout.

Some medicines must not be taken under any circumstances with ritonavir. These are briefly listed in section 2 under “Do not take Ritonavir Viatris”.

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

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, it is very important to consult your doctor before taking this medicine.
There is extensive information on the use of ritonavir (the active substance in Ritonavir Viatris) during pregnancy. In general, pregnant women have taken ritonavir as a pharmacokinetic booster after the first three months of pregnancy in combination with other protease inhibitors. There is no evidence that ritonavir increases the risk of birth defects compared to the general population.

Breastfeeding is not recommended for women living with HIV, as the virus may be transmitted to the infant through breast milk.
If you are breastfeeding or considering breastfeeding, discuss this with your doctor as soon as possible.

Driving and using machines
Ritonavir Viatris may cause dizziness. If this occurs, do not drive or operate machinery.

Ritonavir Viatris contains sodium
This medicine contains 87.75 mg of sodium per tablet. This corresponds to 4.4% of the maximum daily dietary intake recommended for an adult. Consult your doctor or pharmacist if you need to take five or more tablets daily for a prolonged period, especially if you have been advised to follow a low-salt (sodium) diet.

3. How to take Ritonavir Viatris

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist. This medicine must be taken once or twice
daily, every day, with food.
It is important that Ritonavir Viatris tablets are swallowed whole and not chewed, divided, or
crushed.
The recommended dose of Ritonavir Viatris is: Ritonavir Viatris is used to boost the effects of
other anti-HIV medicines. The usual dosage for adults is 1 or 2 tablets once or twice daily. For more detailed dosing recommendations, including those for children, refer to the Patient Information Leaflet of the anti-HIV medicines with which Ritonavir Viatris is used in combination.
Your doctor will determine the dose you should take.
Other formulations of this medicine may be more suitable for children who have difficulty swallowing tablets.
Ritonavir Viatris must be taken every day to help control HIV infection, regardless of how well you may feel. If an adverse effect prevents you from taking Ritonavir Viatris as prescribed, inform your doctor immediately. In cases of diarrhoea, your doctor may decide whether further monitoring is needed.
Make sure you always have an adequate supply of Ritonavir Viatris to avoid running out. When travelling or during hospital stays, ensure you have enough Ritonavir Viatris to last until you can obtain more.
If you take more Ritonavir Viatris than you should
If you take too much ritonavir, you may experience dizziness, tingling, and prickling or stinging sensations. If you realize you have taken more Ritonavir Viatris than the correct dose, contact your doctor or the nearest hospital emergency department immediately.
If you forget to take Ritonavir Viatris
If you miss a dose of medicine, take it as soon as possible. If it is almost time for your next dose, take only the next scheduled dose. Do not take a double dose to make up for a missed dose.
If you stop taking Ritonavir Viatris
Even if you feel better, do not stop taking Ritonavir Viatris without speaking to your doctor.
Taking Ritonavir Viatris as recommended may give you the best chance of delaying resistance to medicines.

4. Possible side effects

During therapy for HIV infection, an increase in weight and 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 medicines themselves. Your doctor will monitor these changes.
Like all medicines, this medicine can cause side effects, although not everybody gets them. In addition, the side effects of ritonavir taken with other antiretroviral medicines depend on those other medicines.
Therefore, it is important to carefully read the section on side effects of the

Patient Information Leaflet for these Medicines

Very common: may affect more than 1 in 10 people

• Stomach ache (upper or lower) • Tingling or numbness sensation
• Vomiting • Warmth or flushing sensation
• Diarrhoea (may be severe) • Numbness in hands, feet or around the lips and mouth
• Feeling unwell (nausea) • Weakness/tiredness
• Headache • Nerve damage which may cause weakness and pain
• Dizziness • Itching
• Sore throat • Skin rash
• Cough • Joint pain and back pain
• Stomach pain or indigestion • Bad taste in mouth

Common: may affect up to 1 in 10 people

• Allergic reactions including skin rash (skin may be red, raised, itchy), swelling of skin and other tissues • Mouth ulcers
• Loss of appetite • Muscle pain, tenderness or weakness
• Insomnia • Fever
• Anxiety • Weight loss
• Increased cholesterol • Blood tests: changes in blood cell counts and chemical parameters
• Gout • Confusion
• Stomach bleeding • Difficulty concentrating
• Liver inflammation and yellowing of the skin or whites of the eyes • Fainting
• Increased frequency of urination • Swelling of hands and feet
• Reduced kidney function • High blood pressure
• Seizures • Low blood pressure and feeling faint when standing up
• Low platelet levels in blood • Coldness in hands and feet
• Abnormally heavy menstrual cycle • Acne
• Flatulence

Uncommon: may affect up to 1 in 100 people

• Heart attack • Kidney impairment
• Diabetes

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

• Severe reactions or those that may lead to death, including blistering skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) • Severe allergic reactions (anaphylaxis)
• High blood glucose levels

Not known: frequency cannot be estimated from available data

• Kidney stones

Inform your doctor if you experience feelings of discomfort (nausea), vomiting or stomach pain, as these may be symptoms of pancreatitis. Also inform your doctor if you experience joint stiffness, tenderness and pain (especially in the hips, knees and shoulders) and difficulty moving, as these may be signs of osteonecrosis. See also section 2 What you need to know before you or your child take Ritonavir Viatris.

In patients with haemophilia A or B receiving treatment with this medicine or other protease inhibitors, an increase in bleeding episodes (bleeding) has been reported. If this occurs, contact your doctor immediately.

Cases of impaired liver function, hepatitis and, rarely, jaundice have been reported in patients treated with ritonavir. Some of these patients had other underlying diseases or were taking other medicines. Patients with pre-existing liver disease may experience worsening of their condition.

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

Inform your doctor immediately if, after taking Ritonavir Viatris, you notice symptoms that may indicate an allergic reaction, such as skin rash, itching or difficulty breathing.

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

5. How to store Ritonavir Viatris

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box or HDPE bottle after "Exp.". The expiry date refers to the last day of that month.
For the HDPE bottle: after first opening, use within 45 days. Do not store above 30 °C. Keep in the original packaging to protect the medicine from moisture.
Do not dispose of medicines via wastewater. 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 Viatris contains

• The active substance is ritonavir. Each film-coated tablet contains 100 mg of ritonavir.
• The other components of the tablet are: copovidone, sorbitan laurate, anhydrous colloidal silica, sodium chloride, sodium stearate fumarate (see section 2, “Ritonavir Viatris contains sodium”).
• The tablet coating consists of: hypromellose, titanium dioxide (E171), macrogol, hydroxypropylcellulose, talc, yellow iron oxide (E172), anhydrous colloidal silica, polysorbate 80.

What Ritonavir Viatris looks like and contents of the pack
Ritonavir Viatris film-coated tablets are yellow, capsule-shaped, biconvex, with a bevelled edge, marked “M163” on one side and white on the other.
Ritonavir Viatris film-coated tablets are available in plastic bottles with screw caps, inner sealing gasket and aluminium seal containing 30, 90 or 100 tablets, and in multiple packs of 90 tablets comprising 3 bottles of 30 tablets each. The bottles also contain a desiccant. Do not ingest the desiccant.
Also available in blisters containing 30 and 90 tablets, and in unit-dose divisible blisters containing 30 x 1 and 90 x 1 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Mylan Pharmaceuticals Limited
Damastown Industrial Park,
Mulhuddart, Dublin 15,
DUBLIN
Ireland

Manufacturer
Mylan Hungary Kft,
Mylan utca 1, Komárom, H-2900
Hungary
Mylan Germany GmbH
Zweigniederlassung Bad Homburg v. d. Hoehe,
Benzstrasse 1, Bad Homburg v. d. Hoehe
Hessen, 61352
Germany

For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Viatris Viatris UAB
Tél/Tel.: + 32 (0)2 658 61 00 Tel: +370 5 205 1288

България Luxembourg/Luxemburg
Майлан ЕООД Viatris
Тел.: +359 2 44 55 400 Tél/Tel: + 32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika Magyarország
Viatris CZ s.r.o. Viatris Healthcare Kft.
Tel: + 420 222 004 400 Tel.: + 36 1 465 2100

Danmark Malta
Viatris ApS V.J. Salomone Pharma Ltd
Tlf.: + 45 28 11 69 32 Tel: + 356 21 22 01 74

Deutschland Nederland
Viatris Healthcare GmbH Mylan BV
Tel: + 49 800 0700 800 Tel: +31 (0)20 426 3300

Eesti Norge
Viatris OÜ Viatris AS
Tel: + 372 6363 052 Tlf: + 47 66 75 33 00

Ελλάδα Österreich
Viatris Hellas Ltd Arcana Arzneimittel GmbH
Τηλ: + 30 2100 100 002 Tel: + 43 1 416 2418

España Polska
Viatris Pharmaceuticals, S.L.U. Mylan Healthcare Sp. z o.o.
Tel: + 34 900 102 712 Tel.: + 48 22 546 64 00

France Portugal
Viatris Santé Mylan, Lda.
Tél: + 33 4 37 25 75 00 Tel: + 351 214 127200

Hrvatska România
Viatris Hrvatska d.o.o. BGP Products SRL
Tel: + 385 1 23 50 599 Tel: + 40 372 579 000

Ireland Slovenija
Mylan Ireland Limited Viatris d.o.o.
Tel: +353 1 8711600 Tel: + 386 1 23 6 31 80

Ísland Slovenská republika
Icepharma hf. Viatris Slovakia s.r.o.
Sími: + 354 540 8000 Tel: + 421 2 32 199 100

Italia Suomi/Finland
Viatris Italia S.r.l. Viatris Oy
Tel: + 39 (0) 2 612 46921 Puh/Tel: + 358 20 720 9555

Κύπρος Sverige
CPO Pharmaceuticals Limited Viatris AB
Τηλ: + 357 2220 7700 Tel: +46 (0)8 630 19 00

Latvija
Viatris SIA
Tel: +371 676 055 80

More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu/ .