Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - lopinavir

Document Subject

Generated Narrative: MedicinalProductDefinition mpa0f6051c039253e4a1c573c85f53f945

identifier: http://ema.europa.eu/identifier/EU/1/15/1067/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Lopinavir/Ritonavir Mylan 100 mg/25 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-a0f6051c039253e4a1c573c85f53f945

identifier: http://ema.europa.eu/identifier/EU/1/15/1067/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - lopinavir

Attesters

What is in this leaflet

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

• Your doctor has prescribed lopinavir/ritonavir to help to control your Human Immunodeficiency Virus (HIV) infection. Lopinavir/ritonavir does this by slowing down the spread of the infection in your body.
• Lopinavir/Ritonavir Mylan is not a cure for HIV infection or AIDS
• Lopinavir/ritonavir is used by children 2 years of age or older, adolescents and adults who are infected with HIV, the virus which causes AIDS.
• Lopinavir/Ritonavir Mylan contains the active substances lopinavir and ritonavir. Lopinavir/ritonavir is an antiretroviral medicine. It belongs to a group of medicines called protease inhibitors.
• Lopinavir/ritonavir is prescribed for use in combination with other antiviral medicines. Your doctor will discuss with you and determine which medicines are best for you.

Do not take Lopinavir/Ritonavir Mylan if:

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

Do not take Lopinavir/Ritonavir Mylan with any of the following medicines:

astemizole or terfenadine (commonly used to treat allergy symptoms these medicines may be available without prescription);

midazolam taken orally (taken by mouth), triazolam (used to relieve anxiety and/or trouble sleeping);

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 stomach problems);

ergotamine, dihydroergotamine, ergonovine, methylergonovine (used to treat headaches);

amiodarone, dronedarone (used to treat abnormal heart beat);

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 Staphylococcus bacteria such as impetigo and infected dermatitis. Fusidic acid used to treat long-term infections of the bones and joints may be taken under doctor s supervision (see Other medicines and Lopinavir/Ritonavir Mylan section);

colchicine (used to treat gout) if you have kidney and/or liver problems (see the section on Other medicines and Lopinavir/Ritonavir Mylan);

elbasvir/grazoprevir (used to treat chronic hepatitis C virus [HCV]);

ombitasvir/paritaprevir/ritonavir with or without dasabuvir (used to treat chronic hepatitis C virus [HCV]);

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 doctor s supervision (see Other medicines and Lopinavir/ritonavir Mylan section);

products that contain St John s wort (Hypericum perforatum).

Read the list of medicines below under Other medicines and Lopinavir/Ritonavir Mylan for information on certain other medicines which require special care.

If you are currently taking any of these medicines, ask your doctor about making necessary changes either in the treatment for your other condition(s) or in your antiretroviral treatment.

Warnings and precautions

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

Important information

People taking lopinavir/ritonavir may still develop infections or other illnesses associated with HIV disease and AIDS. It is therefore important that you remain under the supervision of your doctor while taking lopinavir/ritonavir.

Tell your doctor if you or your child have/had

Haemophilia type A and B as lopinavir/ritonavir might increase the risk of bleeding.

Diabetes as increased blood sugars has been reported in patients receiving lopinavir/ritonavir.

A history of liver problems as patients with a history of liver disease, including chronic hepatitis B or C are at increased risk of severe and potentially fatal liver side effects.

Tell your doctor if you or your child experience

Nausea, vomiting, abdominal pain, difficulty breathing and severe weakness of the muscles in the legs and arms as these symptoms may indicate raised lactic acid levels.

Thirst, frequent urination, blurred vision or weight loss as this may indicate raised sugar levels in the blood.

Nausea, vomiting, abdominal pain as large increases in the amount of triglycerides (fats in the blood) have been considered a risk factor for pancreatitis (inflammation of the pancreas) and these symptoms may suggest this condition.
In some patients with advanced HIV infection and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is believed that these symptoms are due to an improvement in the body s immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection. Autoimmune disorders may occur many months after the start of treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness,

weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment.

Joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement as some patients taking these medicines may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression (reduction in the activity of the immune system), higher body mass index, among others, may be some of the many risk factors for developing this disease.

Muscle pain, tenderness or weakness, particularly in combination with these medicines. On rare occasions these muscle disorders have been serious.

Symptoms of dizziness, lightheadedness, fainting or sensation of abnormal heartbeats. Lopinavir/ritonavir may cause changes in your heart rhythm and the electrical activity of your heart. These changes may be seen on an ECG (electrocardiogram).

Other medicines and Lopinavir/Ritonavir Mylan

Tell your doctor or pharmacist if you or your child are taking, have 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 kinases inhibitors such as dasatinib and nilotinib, also vincristine and vinblastine);

anticoagulants (e.g. dabigatran etexilate, edoxaban, rivaroxaban, vorapaxar and warfarin);

antidepressants (e.g. trazodone, bupropion);

anti-epilepsy medicines (e.g. carbamazepine, phenytoin, phenobarbital, lamotrigine and valproate);

antifungals (e.g. ketoconazole, itraconazole, voriconazole);

anti-gout medicines (e.g. colchicine). You must not take Lopinavir/Ritonavir Mylan with colchicine if you have kidney and/or liver problems (see also Do not take Lopinavir/Ritonavir Mylan above);

anti tuberculosis medicine (bedaquiline, delamanid);

antiviral medicine used to treat chronic hepatitis C virus (HCV) infection in adults (e.g. glecaprevir/pibrentasvir and sofosbuvir/velpatasvir/voxilaprevir);

erectile dysfunction medicines (e.g. sildenafil and tadalafil);

fusidic acid used to treat long-term infections of the bones and joints (e.g. osteomyelitis);

heart medicines including:

digoxin;

calcium channel antagonists (e.g. felodipine, nifedipine, nicardipine);

medicines used to correct heart rhythm (e.g. bepridil, systemic lidocaine, quinidine);

HIV CCR5-antagonist (e.g. maraviroc);

HIV-1 integrase inhibitor (e.g. raltegravir);

medicines used to treat low blood platelet count (e.g. fostamatinib);

levothyroxine (used to treat thyroid problems);

medicines used to lower blood cholesterol (e.g. atorvastatin, lovastatin, rosuvastatin or simvastatin);

medicines used to treat asthma and other lung-related problems 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 affecting the immune system (e.g. cyclosporin, sirolimus (rapamycin), tacrolimus);

medicines used for smoking cessation (e.g. bupropion);

pain-relieving medicines (e.g. fentanyl);

morphine-like medicines (e.g. methadone);

non-nucleoside reverse transcriptase inhibitors (NNRTIs) (e.g. efavirenz, nevirapine);

oral contraceptive or using a patch contraceptive to prevent pregnancy (see section below titled Contraceptives);

protease inhibitors (e.g. fosamprenavir, indinavir, ritonavir, saquinavir, tipranavir);

sedatives (e.g. midazolam administered by injection);

steroids (e.g. budesonide, dexamethasone, fluticasone propionate, ethinyl oestradiol, triamcinolone).

Read the list of medicines above Do not take Lopinavir/Ritonavir Mylan with any of the following medicines for information on medicines that you must not take with lopinavir/ritonavir.

Tell your doctor or pharmacist if you or your child are taking, have recently taken or might take any other medicines, including medicines obtained without prescription.

Erectile dysfunction medicines (avanafil, vardenafil, sildenafil, tadalafil)

Do not take lopinavir/ritonavir if you are currently taking avanafil or vardenafil.

You must not take lopinavir/ritonavir with sildenafil used to treat pulmonary arterial hypertension (high blood pressure in the pulmonary artery) (see also Do not take Lopinavir/Ritonavir Mylan section above).

If you take sildenafil or tadalafil and lopinavir/ritonavir together, you may be at risk of side effects such as low blood pressure, passing out, visual changes and penile erection lasting more than 4 hours. If an erection lasts longer than 4 hours, you should get medical help immediately to avoid permanent damage to your penis. Your doctor can explain these symptoms to you.

Contraceptives

If you are currently using an oral contraceptive or using a patch contraceptive to prevent pregnancy, you should use an additional or different type of contraception (e.g. condom) as lopinavir/ritonavir may reduce the effectiveness of oral and patch contraceptives.

Pregnancy and breast-feeding

Tell your doctor immediately if you are planning to have a baby, you are pregnant, think you may be pregnant or if you are breast-feeding.

If you are breast-feeding or thinking about breast-feeding, you should discuss it with your doctor as soon as possible.

Breast-feeding is not recommended in women living with HIV because HIV infection can be passed on to the baby in breast milk.

Driving and using machines

Lopinavir/ritonavir has not specifically been tested for its possible effects on the ability to drive a car or operate machines. Do not drive a car or operate machinery if you experience any side effects (e.g. nausea) that impact your ability to do so safely. Instead, contact your doctor.

Lopinavir/Ritonavir Mylan contains sodium

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

It is important that Lopinavir/Ritonavir Mylan tablets are swallowed whole and not chewed, broken or crushed. Patients who have difficulty in swallowing the tablets, should should check for the availabity of more suitable formulations.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure how you should take your medicine.

How much Lopinavir/Ritonavir Mylan should be taken and when?

Use in adults

The usual adult dose is 400 mg/100 mg twice a day i.e. every 12 hours, in combination with other anti- HIV medicines. Adult patients who have not previously taken other antiviral medicines can also take

lopinavir/ritonavir tablets once daily as an 800 mg/200 mg dose. Your doctor will advise on the number of tablets to be taken. Adult patients who have previously taken other antiviral medicines can take lopinavir/ritonavir tablets once daily as an 800 mg/200 mg dose if their doctor decides it is appropriate.

Lopinavir/ritonavir must not be taken once daily with efavirenz, nevirapine, carbamazepine, phenobarbital and phenytoin.

Lopinavir/ritonavir tablets can be taken with or without food.

Use in children

For children, your doctor will decide the right dose (number of tablets) based on the child s height and weight.

Lopinavir/ritonavir tablets can be taken with or without food.

Lopinavir/ritonavir is also supplied as 100 mg/25 mg film-coated tablets.

If you or your child take more Lopinavir/Ritonavir Mylan than you should

If you realise you have taken more lopinavir/ritonavir than you were supposed to, contact your doctor right away.

If you cannot contact your doctor, go to the hospital.

If you or your child forget to take Lopinavir/Ritonavir Mylan

If you are taking lopinavir/ritonavir twice a day

If you notice you miss a dose within 6 hours of your normal dosing time, take your missed dose as soon as possible, and then continue with your normal dose at the regular time as prescribed by your doctor.

If you notice you miss a dose by more than 6 hours after your normal dosing time, do not take the missed dose. Take the next dose as usual. Do not take a double dose to make up for a forgotten dose.

If you are taking lopinavir/ritonavir once a day

If you notice you miss a dose within 12 hours of your normal dosing time, take your missed dose as soon as possible, and then continue with your normal dose at the regular time as prescribed by your doctor.

If you notice you miss a dose by more than 12 hours after your normal dosing time, do not take the missed dose. Take the next dose as usual. Do not take a double dose to make up for a forgotten dose.

If you or your child stop taking Lopinavir/Ritonavir Mylan

Do not stop or change the daily dose of lopinavir/ritonavir without first consulting with your doctor.

Lopinavir/ritonavir should always be taken every day to help control your HIV infection, no matter how much better you feel.

Taking lopinavir/ritonavir as recommended should give you the best chance of delaying the development of resistance to the product.

If a side effect is preventing you from taking lopinavir/ritonavir as directed tell your doctor right away.

Always keep enough lopinavir/ritonavir on hand so you don t run out. When you travel or need to stay in the hospital make sure you will have enough lopinavir/ritonavir to last until you can get a new supply.

Continue to take this medicine until your doctor tells you otherwise.

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

Like all medicines, lopinavir/ritonavir can cause side effects, although not everybody gets them. It may be difficult to tell which side effects have been caused by lopinavir/ritonavir and which may occur due to other medicines you take at the same time or by the complications of the HIV infection.

During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves. Your doctor will test for these changes.

The following side effects have been reported by patients who took this medicine. You should tell your doctor promptly about these or any other symptoms. If the condition persists or worsens, seek 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, enlarged abdomen, pain in the lower and upper stomach area, passing wind, indigestion, decreased appetite, reflux from your stomach to your oesophagus which may cause pain;

Tell your doctor if you experience nausea, vomiting or abdominal pain as these may be suggestive of pancreatitis (inflammation of the pancreas).

swelling or inflammation of the stomach, intestines and colon;

increased cholesterol levels in your blood, increased triglycerides (a form of fat) levels in your blood, high blood pressure;

decreased ability of the body to handle sugar including diabetes mellitus, weight loss;

low number of red blood cells, low number of white blood cells which are usually used to fight infection;

rash, eczema, accumulation of scales of greasy skin;

dizziness, anxiety, difficulty in sleeping;

feeling tired, lack of strength and energy, headache including migraine;

haemorrhoids;

inflammation of the liver including increased liver enzymes;

allergic reactions including hives and inflammation in the mouth;

lower respiratory tract infection;

enlargement of the lymph nodes;

impotence, abnormally heavy or extended menstrual flow or a lack of menstruation;

muscle disorders such as weakness and spasms, pain in the joints, muscles and back;

damage to nerves of the peripheral nervous system;

night sweats, itching, rash including raised bumps on the skin, infection of the skin, inflammation of skin or hair pores, accumulation of fluid in the cells or tissues.

Uncommon: may affect up to 1 in 100 people

abnormal dreams;

loss or changed sense of taste;

hair loss;

an abnormality in your electrocardiogram (ECG) called atrioventricular block;

plaque building up inside your arteries which could lead to heart attack and stroke;

inflammation of blood vessels and capillaries;

inflammation of the bile duct;

uncontrolled shaking of the body;

constipation;

deep vein inflammation related to a blood clot;

dry mouth;

inability to control your bowels;

inflammation of the first section of the small intestine just after the stomach, wound or ulcer in the digestive tract, bleeding from the intestinal tract or rectum;

red blood cells in the urine;

yellowing of the skin or whites of eyes (jaundice);

fatty deposits in the liver, enlarged liver;

lack of functioning of the testes;

a flare-up of symptoms related to an inactive infection in your body (immune reconstitution);

increased appetite;

abnormally high level of bilirubin (a pigment produced from the breakdown of red blood cells) in the blood;

decreased sexual desire;

inflammation of the kidney;

bone death caused by poor blood supply to the area;

mouth sores or ulcerations, inflammation of the stomach and intestine;

kidney failure;

breakdown of muscle fibres resulting in the release of muscle fibre contents (myoglobin) into the bloodstream;

a sound in one ear or both ears, such as buzzing, ringing or whistling;

tremor;

abnormal closure of one of the valves (tricuspid valve in your heart);

vertigo (spinning feeling);

eye disorder, 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.

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

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

This medicinal product does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

For plastic containers, use within 120 days after first opening.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Lopinavir/Ritonavir Mylan contains

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

80. What Lopinavir/Ritonavir Mylan looks like and contents of the pack

Lopinavir/Ritonavir Mylan 200 mg/50 mg film-coated tablets are white, film coated, ovaloid, biconvex beveled edge tablets debossed with 'MLR3' on one side of the tablet and plain on the other side.

They are available in blister multipacks of 120, 120x1 (4 cartons of 30 or 30x1) or 360 (12 cartons of 30) film-coated tablets and in plastic bottles (containing a desiccant, which should not be eaten) of 120 film- coated tablets and a multipack containing 360 (3 bottles of 120) film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

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

Manufacturer

Mylan Hungary Kft H-2900 Kom rom, Mylan utca 1 Hungary

McDermott Laboratories Limited trading as Gerard Laboratories 35/36 Baldoyle Industrial Estate, Grange Road, Dublin Ireland

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Viatris
T l/Tel: + 32 (0)2 658 61 Lietuva Viatris UAB
Tel: +370 5 205 1

: +359 2 44 55 Luxembourg/Luxemburg Viatris

T l/Tel: + 32 (0)2 658 61 (Belgique/Belgien)

esk republika Viatris CZ s.r.o. Tel: +420 222 004 Magyarorsz g Viatris Healthcare Kft. Tel.: + 36 1 465 2Danmark Viatris ApS Tlf: +45 28 11 69 Malta V.J. Salomone Pharma Ltd Tel: + 356 21 22 01 Deutschland Viatris Healthcare GmbH Tel: +49 800 0700 Nederland Mylan BV Tel: + 31 (0)20 426 3Eesti Viatris O
Tel: + 372 6363 Norge Viatris AS Tlf: + 47 66 75 33
Viatris Hellas Ltd : +30 2100 100 sterreich Arcana Arzneimittel GmbH Tel: +43 1 416 2Espa a Viatris Pharmaceuticals, S.L.U. Tel: + 34 900 102 Polska Mylan Healthcare Sp. z o.o. Tel: + 48 22 546 64 France Viatris Sant
T l: +33 4 37 25 75 Portugal Mylan, Lda. Tel: + 351 214 127 Hrvatska Viatris Hrvatska d.o.o. Tel: +385 1 23 50 Rom nia BGP Products SRL Tel: + 40 372 579 Ireland Mylan Ireland Limited Tel: +353 1 8711Slovenija Viatris d.o.o. Tel: + 386 1 23 63 sland Icepharma hf. S mi: +354 540 8Slovensk republika Viatris Slovakia s.r.o. Tel: +421 2 32 199 Italia Viatris Italia S.r.l. Tel: + 39 (0) 2 612 46Suomi/Finland Viatris Oy Puh/Tel: + 358 20 720 9
Varnavas Hadjipanayis Ltd Sverige Viatris AB

: +357 2220 7Tel: + 46 (0)8 630 19 Latvija Viatris SIA Tel: +371 676 055 United Kingdom (Northern Ireland) Mylan IRE Healthcare Limited Tel: +353 18711This leaflet was last revised in .

Detailed information on this medicine is available on the European Medicines Agency web site: