Lopinavir and ritonavir Viatri: detailed information

Package leaflet: Information for the user

Lopinavir and Ritonavir Viatris 200 mg/50 mg film-coated tablets

lopinavir and ritonavir
Please read all of 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 or your child only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Your doctor has prescribed lopinavir and ritonavir to help you control Human Immunodeficiency Virus (HIV) infection. Lopinavir and ritonavir works by slowing down the spread of the infection in your body.
Lopinavir/Ritonavir Viatris is not a cure for HIV infection or AIDS.
Lopinavir and ritonavir is used in children aged 2 years and older, adolescents, and adults infected with HIV, the virus that causes AIDS.
Lopinavir and Ritonavir Viatris contains the active substances lopinavir and ritonavir. Lopinavir and ritonavir is an antiretroviral medicine. It belongs to a group of medicines known as protease inhibitors.
Lopinavir and ritonavir is prescribed to be used in combination with other antiviral medicines. Your doctor will discuss this with you and decide which medicines are most appropriate for your specific condition.

2. What you need to know before you or your child takes Lopinavir and Ritonavir Viatris

Do not take Lopinavir and Ritonavir Viatris if you:

are allergic to lopinavir, ritonavir, or any of the other ingredients of this medicine (listed in section 6).
have severe liver problems.

Do not take Lopinavir and Ritonavir Viatris together with any of the following medicines:

astemizole or terfenadine (commonly used to treat allergic symptoms – these medicines may be available without a prescription);
midazolam taken orally (by mouth), triazolam (used to relieve anxiety and/or sleep disorders);
pimozide (used to treat schizophrenia);
quetiapine (used to treat schizophrenia, bipolar disorder, and major depressive disorder);
lurasidone (used to treat depression);
ranolazine [used to treat chronic chest pain (angina)];
cisapride (used to relieve certain digestive problems);
ergotamine, dihydroergotamine, ergonovine, methylergonovine (used to treat migraine headaches);
amiodarone, dronedarone (used to treat heart rhythm disorders);
lovastatin, simvastatin (used to lower blood cholesterol);
lomitapide (used to lower blood cholesterol);
alfuzosin (used in men to treat symptoms of an enlarged prostate (benign prostatic hyperplasia, BPH));
fusidic acid (used to treat skin infections caused by the bacterium Staphylococcus, such as impetigo and infected dermatitis. Fusidic acid used for long-term treatment of bone and joint infections should be taken under medical supervision (see section Other medicines and Lopinavir and Ritonavir Viatris);
colchicine (used to treat gout) if you have kidney or liver problems (see section Other medicines and Lopinavir and Ritonavir Viatris);
elbasvir/grazoprevir (used to treat chronic hepatitis C virus [HCV] infection);
ombitasvir/paritaprevir/ritonavir with or without dasabuvir (used to treat chronic hepatitis C virus [HCV] infection);
neratinib (used to treat breast cancer);
avanafil or vardenafil (used to treat erectile dysfunction);
sildenafil used to treat pulmonary arterial hypertension (high blood pressure in the pulmonary artery). Sildenafil used for the treatment of erectile dysfunction may be taken under medical supervision (see section Other medicines and Lopinavir and Ritonavir Viatris);
products containing St. John’s wort (Hypericum perforatum).

Read the list of medicines below in the section “Other medicines and Lopinavir and Ritonavir Viatris” for more specific information about other medicines that require special attention.
If you are currently taking any of these medicines, ask your doctor whether adjustments are needed either to your treatment for another condition(s) or to your antiretroviral therapy.

Warnings and precautions

Talk to your doctor or pharmacist before taking Lopinavir/Ritonavir Viatris.

Important information

In patients taking lopinavir and ritonavir, infections or other diseases associated with HIV or AIDS may still occur. For this reason, regular medical check-ups are important during treatment with lopinavir and ritonavir. Inform your doctor if you or your child has/have had
Haemophilia type A or B, as lopinavir and ritonavir may increase the risk of bleeding.
Diabetes, as increased blood sugar levels have been reported in patients taking lopinavir and ritonavir.
Liver problems, as patients with liver problems, including chronic hepatitis B or C, may have an increased risk of potentially fatal or serious liver-related side effects.

Inform your doctor if you or your child experiences any of the following:

Nausea, vomiting, abdominal pain, difficulty breathing, and severe muscle weakness in the legs and arms, as these symptoms may indicate elevated levels of lactic acid.
Thirst, frequent urination, blurred vision, or weight loss, as these may indicate high blood sugar levels.
Nausea, vomiting, abdominal pain, and marked increases in triglyceride levels (fats in the blood) are considered risk factors for pancreatitis (inflammation of the pancreas), and these symptoms may indicate this condition.
In some patients with advanced HIV infection and a history of opportunistic infections, signs and symptoms of inflammation from previous infections may appear shortly after starting anti-HIV treatment. These symptoms are believed to result from an improved immune response, allowing the body to fight latent infections that were previously present but asymptomatic. In addition to opportunistic infections, autoimmune diseases (a condition where the immune system attacks healthy body tissue) may also occur after starting medicines 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 toward the trunk, palpitations, tremors, or hyperactivity, inform your doctor immediately to receive appropriate treatment.
Joint stiffness, discomfort, and pain (especially in the hips, knees, and shoulders) and difficulty moving, as in some patients receiving these medicines, a bone disease called osteonecrosis (bone tissue death due to reduced blood supply) may develop. Duration of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression (reduced immune system activity), higher body mass index, among others, may be some of the many risk factors for developing this condition.
Muscle pain, tenderness, or weakness, especially if associated with taking these medicines. In rare cases, these conditions have been severe.
Symptoms of dizziness, lightheadedness, fainting, or abnormal heartbeats. Lopinavir and ritonavir may cause changes in heart rhythm and electrical activity of the heart. These changes can be seen on an ECG (electrocardiogram).

Other medicines and Lopinavir and Ritonavir Viatris

Tell your doctor or pharmacist if you or your child is taking, has recently taken, or might take any other medicine.

antibiotics (e.g., rifabutin, rifampicin, clarithromycin);
anticancer medicines (e.g., abemaciclib, afatinib, apalutamide, ceritinib, encorafenib, ibrutinib, venetoclax, most tyrosine kinase inhibitors such as dasatinib and nilotinib, vincristine, and vinblastine);
anticoagulants (e.g., dabigatran etexilate, edoxaban, rivaroxaban, vorapaxar, warfarin);
antidepressants (e.g., trazodone, bupropion);
antiepileptics (e.g., carbamazepine, phenytoin, phenobarbital, lamotrigine, valproate);
antifungal medicines (e.g., ketoconazole, itraconazole, voriconazole);
medicines for gout (e.g., colchicine). You must not take Lopinavir and Ritonavir Viatris with colchicine if you have kidney or liver problems (see also ‘Do not take Lopinavir and Ritonavir Viatris’ above);
anti-tuberculosis medicines (bedaquiline, delamanid);
antiviral medicines used to treat chronic hepatitis C virus (HCV) infection in adults (e.g., glecaprevir/pibrentasvir, sofosbuvir/velpatasvir/voxilaprevir);
medicines used to treat erectile dysfunction (e.g., sildenafil, tadalafil);
fusidic acid used for long-term treatment of bone and joint infections (e.g., osteomyelitis);
medicines used to treat heart problems:
- digoxin;
- calcium channel blockers (e.g., felodipine, nifedipine, nicardipine);
- medicines used to stabilize heart rhythm (e.g., bepridil, systemic lidocaine, quinidine);
HIV CCR5 antagonists (e.g., maraviroc);
HIV-1 integrase inhibitors (e.g., raltegravir);
medicines used to treat low platelet count in the blood (e.g., fostamatinib);
levothyroxine (used to treat thyroid problems);
medicines used to lower blood cholesterol (e.g., atorvastatin, lovastatin, rosuvastatin, simvastatin);
medicines used to treat asthma and other lung conditions such as chronic obstructive pulmonary disease (COPD) (e.g., salmeterol);
medicines used to treat pulmonary arterial hypertension (high blood pressure in the pulmonary artery) (e.g., bosentan, riociguat, sildenafil, tadalafil);
medicines that affect the immune system (e.g., cyclosporine, sirolimus [rapamycin], tacrolimus);
medicines used to stop smoking (e.g., bupropion);
painkillers (e.g., fentanyl);
opioid-like medicines (e.g., methadone);
non-nucleoside reverse transcriptase inhibitors (NNRTIs) (e.g., efavirenz, nevirapine);
oral contraceptives or contraceptive patches used to prevent pregnancy (see the section titled “Contraceptives” below);
protease inhibitors (e.g., fosamprenavir, indinavir, ritonavir, saquinavir, tipranavir);
sedatives (e.g., midazolam administered by injection);
steroid medicines (e.g., budesonide, dexamethasone, fluticasone propionate, ethinylestradiol, triamcinolone).

Read the list of medicines above in the section “Do not take Lopinavir and Ritonavir Viatris together with any of the following medicines” for information on medicines that must not be taken with lopinavir and ritonavir.
Inform your doctor or pharmacist if you or your child is taking, has recently taken, or might take any other medicine, including those available without a prescription.

Medicines for erectile dysfunction (avanafil, vardenafil, sildenafil, tadalafil)

Do not take lopinavir and ritonavir if you are taking avanafil or vardenafil.
You must not take lopinavir and ritonavir with sildenafil used to treat pulmonary arterial hypertension (high blood pressure in the pulmonary artery) (see also the section above Do not take Lopinavir and Ritonavir Viatris).
If you are taking sildenafil or tadalafil together with Lopinavir and Ritonavir, you may be at risk of developing side effects such as low blood pressure, fainting, vision changes, and prolonged erection lasting more than 4 hours. If an erection lasts longer than 4 hours, you must immediately contact your doctor and seek medical help to prevent permanent damage to the penis. Your doctor can explain these symptoms to you.

Contraceptives

If you are using an oral contraceptive or a contraceptive patch to prevent pregnancy, you should use additional contraceptive methods or alternative methods (e.g., condoms), as lopinavir and ritonavir may reduce the effectiveness of oral contraceptives or contraceptive patches.

Pregnancy and breastfeeding

Inform your doctor immediately if you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding.
If you are breastfeeding or planning to breastfeed, discuss this with your doctor as soon as possible.
Breastfeeding is not recommended for HIV-positive women, as HIV infection can be transmitted to the child through breast milk.

Driving and using machines

Lopinavir and ritonavir has not been specifically tested for its possible effects on the ability to drive vehicles or operate machinery. Do not drive or operate machinery if you experience side effects (e.g., nausea) that could negatively affect your ability to perform these activities safely. In such cases, consult your doctor.

Lopinavir and Ritonavir Viatris contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially ‘sodium-free’.

3. How to take Lopinavir and Ritonavir Viatris

It is important to take the Lopinavir and Ritonavir Viatris tablets by swallowing them whole, without chewing, dividing or crushing them. Patients who have difficulty swallowing tablets should check whether more suitable formulations are available.
Take this medicine exactly as directed by your doctor. If you have any doubts about how to take the medicine, consult your doctor or pharmacist.

What dose of Lopinavir and Ritonavir Viatris should you take and when?

Use in adults

The usual dose for adult patients is 400 mg/100 mg twice daily, i.e. every 12 hours, in combination with other anti-HIV medicines. Adult patients who have not previously taken other antivirals may take lopinavir and ritonavir tablets once daily at a dose of 800 mg/200 mg. Your doctor will tell you how many tablets to take. Adult patients who have previously taken other antiviral medicines may take lopinavir and ritonavir tablets once daily at a dose of 800 mg/200 mg, if your doctor considers this appropriate.
Lopinavir and ritonavir must not be taken once daily with efavirenz, nevirapine, carbamazepine, phenobarbital or phenytoin.
Lopinavir and ritonavir tablets may be taken with or without food.

Use in children

For children, the doctor will determine the exact dose (number of tablets) based on the child's height and weight.
Lopinavir and ritonavir tablets may be taken with or without food.

Lopinavir and ritonavir is also available as film-coated tablets of 100 mg/25 mg.

If you or your child takes more Lopinavir and Ritonavir Viatris than you should

If you realize you have taken more lopinavir and ritonavir than prescribed, contact your doctor immediately.
If you are unable to contact your doctor, go to hospital.

If you or your child forgets to take Lopinavir and Ritonavir Viatris

If you take lopinavir and ritonavir twice daily

If you realize you have missed a dose within 6 hours of your usual dosing time, take the missed dose as soon as possible, then continue treatment as directed by your doctor.
If you realize you have missed a dose more than 6 hours after your usual dosing time, do not take the missed dose. Do not take a double dose to make up for the missed dose.

If you take lopinavir and ritonavir once daily

If you realize you have missed a dose within 12 hours of your usual dosing time, take the missed dose as soon as possible, then continue treatment as directed by your doctor.
If you realize you have missed a dose more than 12 hours after your usual dosing time, do not take the missed dose. Do not take a double dose to make up for the missed dose.

If you or your child stops treatment with Lopinavir and Ritonavir Viatris

Do not stop or change your daily dose of lopinavir and ritonavir without first consulting your doctor.
Lopinavir and ritonavir must be taken every day to keep HIV infection under control. You must continue taking lopinavir and ritonavir even if you feel better.
Taking lopinavir and ritonavir as recommended by your doctor will help delay the development of resistance to the medicine for as long as possible.
If any side effect prevents you from taking lopinavir and ritonavir as prescribed, inform your doctor immediately.
Make sure you always have an adequate supply of medicine available so that you do not run out. When travelling or during a hospital stay, ensure you have enough lopinavir and ritonavir to cover the period until you can obtain more.
Continue taking this medicine until your doctor tells you otherwise.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. It may be difficult to distinguish between side effects caused by lopinavir and ritonavir, those caused by other medicines taken concomitantly with lopinavir and ritonavir, and those related to complications of HIV infection.

During HIV therapy, weight gain and increases in blood lipid and glucose levels may occur. This is partly due to the recovery of health status and lifestyle, and in the case of blood lipids, sometimes to the HIV medicines themselves. Your doctor will monitor these changes.

The following side effects have been reported in patients taking this medicine.
Inform your doctor immediately if you experience any of these symptoms or any other symptoms. If any condition persists or worsens, seek prompt medical attention.

Very common: may affect more than 1 in 10 people

diarrhoea;
nausea;
upper respiratory tract infection.

Common: may affect up to 1 in 10 people

inflammation of the pancreas;
vomiting, abdominal swelling, pain in the upper and lower stomach area, flatulence, indigestion, decreased appetite, gastroesophageal reflux that may cause pain;
Inform your doctor if you experience nausea, vomiting, or abdominal pain, as these may indicate pancreatitis (inflammation of the pancreas).
swelling or inflammation of the stomach, intestine, and colon;
increased blood cholesterol, increased levels of triglycerides (a type of fat) in the blood, increased blood pressure;
reduced ability of the body to metabolise sugar including diabetes mellitus, weight loss;
low red blood cell count, low white blood cell count (usually used to fight infections);
rash, eczema, accumulation of greasy skin scales;
dizziness, anxiety, difficulty sleeping;
feeling of tiredness, lack of strength and energy, headache including migraine;
haemorrhoids;
inflammation of the liver including increased liver enzymes;
allergic reactions including urticaria and inflammation of the mouth;
lower respiratory tract infection;
enlargement of lymph nodes;
impotence, heavy or prolonged menstrual flow, or absence of menstruation;
muscle disorders such as weakness and spasms, joint, muscle and back pain;
damage to nerves of the peripheral nervous system;
night sweats, itching, rash including skin swellings, skin infections, inflammation of the skin or hair pores, fluid accumulation in cells or tissues.

Uncommon: may affect up to 1 in 100 people

abnormal dreams;
loss or change in taste sensation;
hair loss;
abnormalities in the electrocardiogram (ECG) called atrioventricular block;
formation of plaques inside the arteries which may lead to heart attack and stroke;
inflammation of blood vessels and capillaries;
inflammation of the bile duct;
uncontrolled body tremor;
constipation;
deep vein thrombosis due to blood clot;
dry mouth;
inability to control bowel;
inflammation of the first part of the small intestine just after the stomach, injury or ulcer in the digestive tract, bleeding from the intestinal tract or rectum;
red blood cells in urine;
yellowing of the skin or whites of the eyes (jaundice);
fat deposits in the liver, liver enlargement;
testicular dysfunction;
a set of symptoms related to inactive infections in the body (immune reconstitution syndrome);
increased appetite;
abnormally high levels of bilirubin (a pigment produced by the breakdown of red blood cells) in the blood;
decreased sexual desire;
inflammation of the kidneys;
bone necrosis due to poor blood supply to the area;
mouth ulcers or sores, inflammation of the stomach and intestine;
impaired kidney function;
breakdown of muscle fibres resulting in the release of muscle fibre contents (myoglobin) into the bloodstream;
a sound in one or both ears, such as ringing, buzzing, or whistling (tinnitus);
tremor;
abnormal closure of one of the heart valves (tricuspid valve);
vertigo (sensation of spinning);
eye disorders, abnormal vision;
weight gain.

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

severe or life-threatening skin rashes and blisters (Stevens-Johnson syndrome and erythema multiforme).

Not known: frequency cannot be estimated from the available data

kidney stones.

Side effects for which frequency is not known:
Other side effects reported with lopinavir and ritonavir: yellowing of the skin or whites of the eyes (jaundice), severe or life-threatening skin rashes and blisters (Stevens-Johnson syndrome and erythema multiforme).

If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of side effects
If you get 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 referred to in Annex V.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Lopinavir and Ritonavir Viatris

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use Lopinavir and Ritonavir Viatris after the expiry date stated on the pack after
EXP. The expiry date refers to the last day of that month.
For plastic bottles: use within 120 days after first opening.
Do not dispose of any medicine 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 Lopinavir and Ritonavir Viatris contains

The active substances are lopinavir and ritonavir.
The other components are: sorbitan laurate, anhydrous colloidal silica, copovidone, sodium stearyl fumarate, hypromellose, titanium dioxide (E171), macrogol, hydroxypropylcellulose, talc, polysorbate 80.

Description of the appearance of Lopinavir and Ritonavir Viatis and pack sizes
Lopinavir and Ritonavir Viatris 200 mg/50 mg film-coated tablets are white, ovaloid, biconvex, with a bevelled edge, marked “MLR3” on one side and smooth on the other side.
The tablets are available in blisters within multiple packs containing 120 or 120x1 film-coated tablets (4 cartons of 30 or 30x1) or 360 film-coated tablets (12 cartons of 30), and in plastic bottles (containing a desiccant which must not be ingested) with 120 film-coated tablets, and in multiple packs containing 360 film-coated tablets (3 plastic bottles of 120).
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Viatris Limited
Damastown Industrial Park,
Mulhuddart, Dublin 15,
DUBLIN
Ireland

Manufacturer
Mylan Hungary Kft.,
Mylan utca 1, Komárom 2900,
Hungary
McDermott Laboratories Limited t/a Gerard Laboratories t/a Mylan Dublin, Unit 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Mylan BV, Dieselweg 25, 3752 LB Bunschoten, Netherlands

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation 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 02 658 61 00
(Belgique/Belgien)

Česká republika Magyarország
Mylan Healthcare 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
Mylan Healthcare GmbH Mylan BV
Tel: + 49 800 0700 800 Tel: +31 (0)20 426 3300

Eesti Norge
Viatris OÜ Mylan Healthcare Norge 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
Mylan Pharmaceuticals, S.L. Viatris 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: + 351 214 127 200

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

Ireland Slovenija
Viatris Limited Viatris d.o.o.
Tel: +353 1 8711600 Tel: + 386 1 23 63 180

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

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

Κύπρος Sverige
Varnavas Hadjipanayis Ltd Mylan AB
Τηλ: +357 2220 7700 Tel: + 46 855 522 750

Latvija United Kingdom (Northern Ireland)
Viatris SIA Mylan IRE Healthcare Limited
Tel: + 371 676 055 80 Tel: +353 18711600

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

Package leaflet: information for the user

Lopinavir and Ritonavir Viatris 100 mg/25 mg film-coated tablets

lopinavir and ritonavir
Please 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, consult your doctor or pharmacist.
This medicine has been prescribed for you or your child only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Your doctor has prescribed lopinavir and ritonavir to help you control Human Immunodeficiency Virus (HIV) infection. Lopinavir and ritonavir works by slowing down the spread of the infection in your body.
Lopinavir/ritonavir Viatris is not a cure for HIV infection or AIDS.
Lopinavir and ritonavir is used in children aged 2 years and older, adolescents, and adults infected with HIV, the virus that causes AIDS.
Lopinavir and Ritonavir Viatris contains the active substances lopinavir and ritonavir. Lopinavir and ritonavir is an antiretroviral medicine. It belongs to a group of medicines known as protease inhibitors.
Lopinavir and ritonavir is prescribed to be used in combination with other antiviral medicines. Your doctor will discuss this with you and decide which medicines are most appropriate for your specific condition.

2. What you should know before you or the child takes Lopinavir and Ritonavir Viatris

Do not take Lopinavir and Ritonavir Viatris if you:

are allergic to lopinavir, ritonavir, or any of the other ingredients of this medicine (listed in section 6).
have severe liver problems.

Do not take Lopinavir and Ritonavir Viatris together with any of the following medicines:

astemizole or terfenadine (commonly used to treat allergic symptoms – these medicines may be available without a prescription);
midazolam administered orally (taken by mouth), triazolam (used to relieve anxiety and/or sleep disorders);
pimozide (used to treat schizophrenia);
quetiapine (used to treat schizophrenia, bipolar disorders, and major depressive disorder); lurasidone (used to treat depression).
ranolazine [used to treat chronic chest pain (angina)];
cisapride (used to relieve certain digestive problems);
ergotamine, dihydroergotamine, ergonovine, methylergonovine (used to treat migraine headaches);
amiodarone, dronedarone (used to treat heart rhythm disorders);
lovastatin, simvastatin (used to lower blood cholesterol);
lomitapide (used to lower blood cholesterol);
alfuzosin (used in men to treat symptoms of an enlarged prostate (benign prostatic hyperplasia (BPH));
fusidic acid (used to treat skin infections caused by the bacterium Staphylococcus, such as impetigo and infected dermatitis. Fusidic acid used for long-term treatment of bone and joint infections must be taken under medical supervision (see section Other medicines and Lopinavir and Ritonavir Viatris);
colchicine (used to treat gout) if you have kidney or liver problems (see section Other medicines and Lopinavir and Ritonavir Viatris);
elbasvir/grazoprevir (used to treat chronic hepatitis C virus [HCV] infection);
ombitasvir/paritaprevir/ritonavir with or without dasabuvir (used to treat chronic hepatitis C virus [HCV] infection);
neratinib (used to treat breast cancer);
avanafil or vardenafil (used to treat erectile dysfunction);
sildenafil used to treat pulmonary arterial hypertension (high blood pressure in the pulmonary artery). Sildenafil used to treat erectile dysfunction may be taken under medical supervision (see section Other medicines and Lopinavir and Ritonavir Viatris);
products containing St. John’s wort (Hypericum perforatum).

Read the list of medicines provided below in the section “Other medicines and Lopinavir and Ritonavir Viatris” for more specific information about other medicines that require special attention.
If you are currently taking any of these medicines, ask your doctor whether adjustments are needed either to your treatment for other conditions or to your antiretroviral therapy.

Warnings and precautions

Talk to your doctor or pharmacist before taking Lopinavir and Ritonavir Viatris.

Important information

Infections or other HIV- or AIDS-related illnesses may still occur in patients taking lopinavir and ritonavir. For this reason, regular medical check-ups during treatment with lopinavir and ritonavir are important. Inform your doctor if you or your child has/have had
Haemophilia type A or B, as lopinavir and ritonavir may increase the risk of bleeding.
Diabetes, as increased blood sugar levels have been reported in patients taking lopinavir and ritonavir.
Liver problems, as patients with liver disease, including chronic hepatitis B or C, may have an increased risk of potentially fatal or serious liver-related side effects.

Inform your doctor immediately if you or your child notice the appearance of

Nausea, vomiting, abdominal pain, difficulty breathing, and severe muscle weakness in the arms and legs, as these symptoms may indicate elevated lactate levels.
Thirst, frequent urination, blurred vision, or weight loss, as these conditions may indicate high blood sugar levels.
Nausea, vomiting, abdominal pain, and marked increases in triglyceride levels (fats in the blood) are considered risk factors for pancreatitis (inflammation of the pancreas), and these symptoms may indicate this condition.

In some patients with advanced HIV infection and a history of opportunistic infections, signs and symptoms of inflammation from previous infections may appear shortly after starting anti-HIV treatment. These symptoms are believed to result from an improved immune response, allowing the body to fight latent infections that were previously asymptomatic. In addition to opportunistic infections, autoimmune diseases (a condition in which the immune system attacks healthy body tissue) may also occur after starting medicines for HIV infection. Autoimmune disorders 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 toward the trunk, palpitations, tremors, or hyperactivity, inform your doctor immediately to receive appropriate treatment.

Joint stiffness, discomfort, and pain (especially in the hips, knees, and shoulders) and difficulty moving, as in some patients receiving these medicines, a bone disease called osteonecrosis (bone tissue death due to reduced blood supply to the bone) may develop. Duration of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression (reduced immune system activity), higher body mass index, among others, are among the many risk factors for developing this condition.
Muscle pain, tenderness, or weakness, especially if associated with taking these medicines. In rare cases, these conditions have been severe.
Symptoms of dizziness, feeling faint, fainting, or sensations of abnormal heartbeats. Lopinavir and ritonavir may cause changes in heart rhythm and electrical activity of the heart. These changes can be seen on an ECG (electrocardiogram).

Other medicines and Lopinavir and Ritonavir Viatris
Tell your doctor or pharmacist if you or your child is taking, has recently taken, or might take any other medicines.

antibiotics (e.g. rifabutin, rifampicin, clarithromycin);
anticancer medicines (e.g. abemaciclib, afatinib, apalutamide, ceritinib, encorafenib, ibrutinib, venetoclax, most tyrosine kinase inhibitors such as dasatinib and nilotinib, vincristine, and vinblastine);
anticoagulants (e.g. dabigatran etexilate, edoxaban, rivaroxaban, vorapaxar, and warfarin);
antidepressants (e.g. trazodone, bupropion);
antiepileptics (e.g. carbamazepine, phenytoin, phenobarbital, lamotrigine, and valproate);
antifungals (e.g. ketoconazole, itraconazole, voriconazole);
gout medicines (e.g. colchicine). Do not take Lopinavir and Ritonavir Viatris with colchicine if you have kidney or liver problems (see also ‘Do not take Lopinavir and Ritonavir Viatris’ above);
anti-tuberculosis medicines (bedaquiline, delamanid);
antiviral medicines used to treat chronic hepatitis C virus (HCV) infection in adults (e.g. glecaprevir/pibrentasvir and sofosbuvir/velpatasvir/voxilaprevir);
medicines used to treat erectile dysfunction (e.g. sildenafil and tadalafil);
fusidic acid used for long-term treatment of bone and joint infections (e.g. osteomyelitis);
medicines used to treat heart problems:
digoxin;
calcium channel blockers (e.g. felodipine, nifedipine, nicardipine);
medicines used to stabilize heart rhythm (e.g. bepridil, systemic lidocaine, quinidine);
HIV CCR5 antagonists (e.g. maraviroc);
HIV-1 integrase inhibitors (e.g. raltegravir);
medicines used to treat low platelet count in the blood (e.g. fostamatinib);
levothyroxine (used to treat thyroid problems);
medicines used to lower blood cholesterol (e.g. atorvastatin, lovastatin, rosuvastatin, and simvastatin);
medicines used to treat asthma and other lung-related conditions such as chronic obstructive pulmonary disease (COPD) (e.g. salmeterol);
medicines used to treat pulmonary arterial hypertension (high blood pressure in the pulmonary artery) (e.g. bosentan, riociguat, sildenafil, tadalafil);
medicines that affect the immune system (e.g. ciclosporin, sirolimus (rapamycin), tacrolimus);
medicines used to stop smoking (e.g. bupropion);
painkillers (e.g. fentanyl);
morphine-like medicines (e.g. methadone);
non-nucleoside reverse transcriptase inhibitors (NNRTIs) (e.g. efavirenz, nevirapine);
oral contraceptives or contraceptive patches used to prevent pregnancy (see the section titled “Contraceptives” below);
protease inhibitors (e.g. fosamprenavir, indinavir, ritonavir, saquinavir, tipranavir);
sedatives (e.g. midazolam administered by injection);
steroid medicines (e.g. budesonide, dexamethasone, fluticasone propionate, ethinylestradiol, triamcinolone).

Read the list of medicines provided above in the section “Do not take Lopinavir and Ritonavir Viatris together with any of the following medicines” for information on medicines that must not be taken with lopinavir and ritonavir.
Inform your doctor or pharmacist if you or your child is taking, has recently taken, or might take any other medicine, including those available without a prescription.

Medicines for the treatment of erectile dysfunction (avanafil, vardenafil, sildenafil, tadalafil)

Do not take lopinavir and ritonavir if you are taking avanafil or vardenafil.
Do not take lopinavir and ritonavir with sildenafil used to treat pulmonary arterial hypertension (high blood pressure in the pulmonary artery) (see also the section above Do not take Lopinavir and Ritonavir Viatris).
If you are taking sildenafil or tadalafil together with Lopinavir and Ritonavir, you may be at risk of developing side effects such as low blood pressure, loss of consciousness, vision disturbances, and prolonged erection lasting more than 4 hours. If an erection lasts longer than 4 hours, you must immediately contact your doctor and seek medical help to prevent permanent damage to the penis. Your doctor can explain these symptoms to you.

Contraceptives

If you are using an oral contraceptive or a contraceptive patch to prevent pregnancy, you must use additional contraceptive methods or different contraceptive methods (e.g. condoms), as lopinavir and ritonavir may reduce the effectiveness of oral contraceptives or contraceptive patches.

Pregnancy and breastfeeding

Inform your doctor immediately if you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding.
If you are breastfeeding or considering breastfeeding, discuss this with your doctor as soon as possible.
Breastfeeding is not recommended for HIV-positive women, as HIV infection can be transmitted to the child through breast milk.

Driving and using machines
Lopinavir and ritonavir has not been specifically tested for its possible effects on the ability to drive or use machines. Do not drive or operate machinery if you experience side effects (e.g. nausea) that could negatively affect your ability to perform these activities safely. In such cases, consult your doctor.

Lopinavir and Ritonavir Viatris contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., it is essentially ‘sodium-free’.

3. How to take Lopinavir and Ritonavir Viatris

It is important to take the Lopinavir and Ritonavir Viatris tablets by swallowing them whole, without chewing, dividing or crushing them. Patients who have difficulty swallowing tablets should check whether more suitable formulations are available.
Take this medicine exactly as prescribed by your doctor. If you have any doubts about how to take the medicine, consult your doctor or pharmacist.

What is the dose of Lopinavir and Ritonavir Viatris that you should take and when?

Use in adults

The usual dose for adult patients is 400 mg/100 mg twice daily, i.e. every 12 hours, in combination with other anti-HIV medicines. Adult patients who have not previously taken other antivirals may take lopinavir and ritonavir tablets once daily at a dose of 800 mg/200 mg. Your doctor will tell you how many tablets to take. Adult patients who have previously taken other antiviral medicines may take lopinavir and ritonavir tablets once daily at a dose of 800 mg/200 mg if their doctor considers this appropriate.
Lopinavir and ritonavir must not be taken once daily with efavirenz, nevirapine, carbamazepine, phenobarbital or phenytoin.
Lopinavir and ritonavir tablets may be taken with or without food.

Use in children aged 2 years and older

For children, the doctor will determine the most appropriate exact dose (number of tablets) based on the child's height and weight.
Lopinavir and ritonavir tablets may be taken with or without food.

Lopinavir and Ritonavir Viatris is also available as film-coated tablets containing 200 mg/50 mg.
Other formulations of this medicine may be more suitable for children; please ask your doctor or pharmacist.

If you or your child takes more Lopinavir and Ritonavir Viatris than you should

If you realize that you have taken more lopinavir and ritonavir than prescribed, contact your doctor immediately.
If you are unable to contact your doctor, go to hospital.

If you or your child forgets to take Lopinavir and Ritonavir Viatris

If you take lopinavir and ritonavir twice daily

If you remember you have missed a dose within 6 hours of the usual time, take the missed dose as soon as possible, then continue taking the medicine as directed by your doctor.
If you remember you have missed a dose more than 6 hours after the usual time, do not take the missed dose. Do not take a double dose to make up for the missed dose.

If you take lopinavir and ritonavir once daily

If you remember you have missed a dose within 12 hours of the usual time, take the missed dose as soon as possible, then continue taking the medicine as directed by your doctor.
If you remember you have missed a dose more than 12 hours after the usual time, do not take the missed dose. Do not take a double dose to make up for the missed dose.

If you or your child stops treatment with Lopinavir and Ritonavir Viatris

Do not stop or change the daily dose of lopinavir and ritonavir without first consulting your doctor.
Lopinavir and ritonavir must be taken every day to keep HIV infection under control. You must continue taking lopinavir and ritonavir even if you feel better.
Taking Lopinavir and Ritonavir Viatris as recommended by your doctor will help delay the development of resistance to the medicine for as long as possible.
If a side effect prevents you from taking lopinavir and ritonavir as prescribed, inform your doctor immediately.
Make sure you always have an adequate supply of medicine available so that you do not run out. When travelling or during a hospital stay, ensure you have enough lopinavir and ritonavir to cover the period until you can obtain more.
Continue taking the medicine until your doctor gives you different instructions.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

During HIV treatment, an increase in weight, as well as increases in blood lipid and glucose levels, may occur. This is partly related to the improvement in health status and lifestyle, and in the case of blood lipids, sometimes to the HIV medicines themselves. Your doctor will monitor these changes.

The following side effects have been reported in patients taking this medicine.
Inform your doctor immediately if you experience any of these symptoms or any other unusual symptoms. If any condition persists or worsens, seek prompt medical attention.

Very common: may affect more than 1 in 10 people

diarrhoea;
nausea;
upper respiratory tract infection.

Common: may affect up to 1 in 10 people

inflammation of the pancreas;
vomiting, abdominal bloating, pain in the upper and lower stomach area, flatulence, indigestion, decreased appetite, gastroesophageal reflux that may cause discomfort;
Inform your doctor if you experience nausea, vomiting, or abdominal pain, as these may indicate pancreatitis (inflammation of the pancreas);
swelling or inflammation of the stomach, intestine, and colon;
increased blood cholesterol, increased blood triglyceride levels (a type of fat), increased blood pressure;
reduced ability of the body to metabolise sugar, including diabetes mellitus, weight loss;
low red blood cell count, low white blood cell count usually used to fight infections;
skin rash, eczema, accumulation of greasy skin scales;
dizziness, anxiety, difficulty sleeping;
feeling of tiredness, lack of strength and energy, headache including migraine;
haemorrhoids;
liver inflammation including increased liver enzymes;
allergic reactions including urticaria and mouth inflammation;
lower respiratory tract infection;
enlarged lymph nodes;
impotence, heavy or prolonged menstrual flow, or absence of menstruation;
muscle disorders such as weakness and spasms, joint, muscle, and back pain;
nerve damage in the peripheral nervous system;
night sweats, itching, skin rash including skin swellings, skin infections, skin or hair pore inflammation, fluid accumulation in cells or tissues.

Uncommon: may affect up to 1 in 100 people

abnormal dreams;
loss or change in taste sensation;
hair loss;
electrocardiogram (ECG) abnormalities called atrioventricular block;
formation of plaques inside arteries that may lead to heart attack and stroke;
inflammation of blood vessels and capillaries;
inflammation of the bile duct;
uncontrolled body tremor;
constipation;
deep vein thrombosis (venous inflammation due to blood clot);
dry mouth;
inability to control bowel movements;
inflammation of the first part of the small intestine immediately after the stomach, injury or ulcer in the digestive tract, bleeding from the intestinal tract or rectum;
red blood cells in urine;
yellowing of the skin or whites of the eyes (jaundice);
fat deposits in the liver, liver enlargement;
testicular dysfunction;
a group of symptoms related to previously dormant infections in the body (immune reconstitution syndrome);
increased appetite;
abnormally high levels of bilirubin (a pigment produced by the breakdown of red blood cells) in the blood;
decreased sexual desire;
kidney inflammation;
bone necrosis due to poor blood supply to the area;
mouth sores or ulcers, stomach and intestinal inflammation;
kidney impairment;
breakdown of muscle fibres leading to the release of muscle fibre contents (myoglobin) into the bloodstream;
ringing, buzzing, or whistling sound in one or both ears (tinnitus);
tremor;
abnormal closure of one of the heart valves (tricuspid valve);
vertigo (sensation of spinning);
eye disorders, abnormal vision;
weight gain.

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

severe or life-threatening skin rashes and blisters (Stevens-Johnson syndrome and erythema multiforme).

Not known: frequency cannot be estimated from available data

kidney stones.

Side effects with unknown frequency:
Other side effects reported with lopinavir and ritonavir include: yellowing of the skin or whites of the eyes (jaundice), severe or life-threatening skin rashes and blisters (Stevens-Johnson syndrome and erythema multiforme).

If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through 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 Lopinavir and Ritonavir Viatris

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use Lopinavir and Ritonavir Viatris after the expiry date stated on the packaging after
EXP. The expiry date refers to the last day of that month.
For plastic bottles: use within 120 days of first opening.
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 Lopinavir and Ritonavir Viatris contains

The active substances are lopinavir and ritonavir.
The other components are: sorbitan laurate, anhydrous colloidal silica, copovidone, sodium stearoyl fumarate, hypromellose, titanium dioxide (E171), macrogol, hydroxypropylcellulose, talc, polysorbate 80.

Description of the appearance of Lopinavir and Ritonavir Viatris and package contents
Lopinavir and Ritonavir Viatris 100 mg/25 mg film-coated tablets are white,
ovaloid, biconvex, with bevelled edges, marked with "MLR4" on one side and plain on the other.
The tablets are available in blisters within multi-pack containers containing 60 or 60x1 film-coated tablets (2 cartons of 30 or 30x1) and in plastic bottles (containing a desiccant which must not be ingested) containing 60 film-coated tablets.
Not all pack sizes may be marketed.

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

Manufacturers
Mylan Hungary Kft.,
Mylan utca 1, Komárom 2900,
Hungary
McDermott Laboratories Limited t/a Gerard Laboratories t/a Viatris Dublin, Unit 35/36 Baldoyle
Industrial Estate, Grange Road, Dublin 13, Ireland
Mylan BV, Dieselweg 25, 3752 LB Bunschoten, Netherlands

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