200 mg / 50 mg film-coated tablets
lopinavir / ritonavir
- Your doctor has prescribed Lopinavir / Ritonavir Accord to help keep your human immunodeficiency virus ( HIV ) infection under control. Lopinavir / Ritonavir Accord does this by slowing down the spread of infection in your body.
- Lopinavir / Ritonavir Accord not a cure for HIV – infection or AIDS .
- Lopinavir / Ritonavir Accord is used by children 2 years of age and older, adolescents and adults infected with HIV , the virus that causes AIDS .
- Lopinavir / Ritonavir Accord contains the active substances lopinavir and ritonavir. Lopinavir / Ritonavir Accord is an antiretroviral medicine. It belongs to a group of medicines called protease inhibitors .
- Lopinavir / Ritonavir Accord is prescribed for use in combination with other antiviral medicines. Your doctor will discuss with you and decide which drugs are best for you.
Lopinavir and ritonavir contained in Lopinavir / Ritonavir Accord may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
- if you are allergic to lopinavir, ritonavir or any of the other ingredients of this medicine (listed in section 6).
- if you have severe liver problems.
Do not take Lopinavir / Ritonavir Accord with any of the following medicines:
- astemizole or terfenadine (often used to treat allergic symptoms – these medicines may be over-the-counter);
- oral midazolam, triazolam (used to relieve anxiety and / or sleep problems);
- pimozide (used to treat schizophrenia);
- quetiapine (used to treat schizophrenia, bipolar disorder and major depression);
- 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 heartbeats);
- lovastatin, simvastatin (used to lower blood cholesterol);
- lomitapide (used to lower blood cholesterol);
- alfuzosin (used in men to treat symptoms of prostate enlargement ( 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 bone and joint infections can be taken under medical supervision (see section Other medicines and Lopinavir / Ritonavir Accord);
- colchicine (used to treat gout ) if you have kidney and / or liver problems (see section Other medicines and Lopinavir / Ritonavir Accord );
- elbasvir / grazoprevir (used to treat hepatitis C virus [HCV]);
- ombitasvir / paritaprevir / ritonavir with or without dasabuvir (used to treat hepatitis C virus [HCV]);
- neratinib (used to treat breast cancer);
- avanafil and vardenafil (used to treat erectile dysfunction );
- sildenafil (used to treat pulmonary arterial hypertension (high blood pressure in the pulmonary artery)).For the treatment of erectile dysfunction , sildenafil can be taken in consultation with a doctor (see section Other medicines and Lopinavir / Ritonavir Accord );
- products containing St. John’s wort ( Hypericum perforatum ).
Read the list of medicines below under the section “Other medicines and Lopinavir / Ritonavir Accord” for information on other medicines that require special attention.
If you are currently taking any of these medicines, ask your doctor to make the necessary changes either in the treatment of your other ailments or in your antiretroviral treatment.
Warnings and cautions
Talk to your doctor or pharmacist before taking Lopinavir / Ritonavir Accord.
Important information
- People taking Lopinavir / Ritonavir Accord may still develop infections or other diseases associated with HIV or AIDS . It is therefore important that you remain under the supervision of your doctor while taking Lopinavir / Ritonavir Accord.
- You can still transmit HIV infection while taking this medicine , even though the risk of effective antiviral therapy is reduced . Discuss with your doctor the necessary steps to avoid infecting others.
Tell your doctor if you or your child have/have had
- Hemophilia type A or B as Lopinavir / Ritonavir Accord may increase the risk of bleeding.
- Diabetes because high blood sugar has been reported in patients receiving lopinavir / ritonavir.
- Previous liver problems when patients with previous liver diseases, including chronic hepatitis B or C, have an increased risk of severe and potentially life-threatening liver side effects.
Tell your doctor if you or your child are experiencing
- Nausea, vomiting, abdominal pain, breathing problems and pronounced weakness in the muscles of the legs and arms as these symptoms may indicate elevated lactic acid levels.
- Thirst, frequent urination, blurred vision or weight loss as this may indicate an elevated blood sugar level.
- Nausea, vomiting, abdominal pain because a sharp increase in triglycerides (fats in the blood) has been judged to be a risk factor for pancreatitis ( inflammation of the pancreas) and these symptoms may indicate this condition.
- In some patients with advanced HIV – infection and the background of opportunistic infection s, signs and symptoms of previous infection you occur soon after a treatment for HIV begins. It is believed that these symptoms are due to an improvement in the body’s immune response , which allows the body to fight infections that may have existed without noticeable symptoms. In addition to the opportunistic infections are also autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may occur after you start taking medicines to treat your HIV – infection. Autoimmune diseases can occur several months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness that starts in the hands and feet and goes up in the body, palpitations, tremors or hyperactivity, inform your doctor immediately for the necessary treatment.
- Joint stiffness, aches and pains (especially hip, knee and shoulder) and difficulty moving as some of the patients taking these drugs may develop a bone disease called osteonecrosis (bone tissue dies due to lost blood supply to the bone). The duration of the combination antiretroviral therapy, the use of corticosteroids , alcohol consumption, severe weakening of the immune system (decrease in the activity of the immune system), higher body mass index, among others, can be some of the many risk factors for developing this disease.
- Muscle pain , tenderness or weakness, especially in combination with these drugs. On rare occasions, these muscle problems have been serious.
- Symptoms of dizziness, fainting or feeling of abnormal heartbeat. Lopinavir / Ritonavir Accord may cause changes in your heart rhythm and the electrical activity of your heart. These changes can be seen on the ECG ( electrocardiogram ).
Tell your doctor or pharmacist if you or your child are taking, have recently taken, or might take any other medicines.
- antibiotics (eg rifabutin, rifampicin, clarithromycin);
- cancer drugs (eg abemaciclib, afatinib, apalutamide, ceritinib, encorafenib, ibrutinib, venetoclax, most tyrosine kinase inhibitors such as dasatinib and nilotinib, including vincristine and vinblastine);
- anticoagulants (eg warfarin , rivaroxaban, vorapaxar);
- antidepressants (eg trazodone, bupropion);
- antiepileptic drugs (eg carbamazepine, phenytoin , phenobarbital, lamotrigine and valproate );
- antifungal drugs (eg ketoconazole , itraconazole, voriconazole);
- medicines for gout (eg colchicine). You must not take Lopinavir / Ritonavir Accord with colchicine if you have kidney and / or liver problems (see also Do not take Lopinavir / Ritonavir Accord above);
- drugs against tuberculosis (bedakilin, delamanide);
- antiviral drugs used to treat chronic hepatitis C virus ( HCV ) infection in adults (eg glekaprevir / pibrentasvir, simeprevir and sofosbuvir / velpatasvir / voxilaprevir);
- drugs for impaired erection (eg sildenafil and tadalafil);
- fusidic acid used to treat long-term infections in bone and joints (eg osteomyelitis);
- heart medications including:
- digoxin;
- calcium channel antagonists (eg felodipine, nifedipine, nicardipine);
- drugs used to correct the heart rhythm (eg bepridil, systemic lidocaine , quinidine );
- HIV CCR5 antagonist s (e.g. maraviroc);
- HIV- 1 integrase inhibitors (eg raltegravir);
- drugs for the treatment of platelet deficiency (eg fostamatinib);
- drugs used to lower blood cholesterol (eg atorvastatin, lovastatin, rosuvastatin or simvastatin );
- drugs used to treat asthma and other lung problems such as chronic obstructive pulmonary disease (COPD) (eg salmeterol );
- drugs used to treat high blood pressure in the pulmonary artery ( pulmonary arterial hypertension ) (eg bosentan , riociguat, sildenafil, tadalafil);
- drugs that affect the immune system (eg cyclosporine, sirolimus (rapamycin), tacrolimus);
- smoking cessation drugs (eg bupropion);
- painkillers (eg fentanyl );
- morphine-like drugs (eg methadone );
- non- nucleoside reverse transcriptase inhibitor (NNRTI) (eg efavirenz, nevirapine);
- oral contraceptives or the use of contraceptive patches to prevent pregnancy (see section below entitled Contraceptives );
- protease inhibitors (eg fosamprenavir, indinavir, ritonavir, saquinavir, tipranavir);
- sedatives (eg midazolam given by injection );
- steroid preparations (eg budesonide, dexamethasone, fluticasone propionate, ethinyl estradiol, triamcinolone);
- levothyroxine (used to treat thyroid problems).
Read the list of medicines above “Do not take Lopinavir / Ritonavir Accord with any of the following medicines” for information on medicines that you must not take with Lopinavir / Ritonavir Accord.
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 a prescription.
Drugs for reduced ability to get an erection (avanafil, vardenafil, sildenafil, tadalafil)
- Do not take Lopinavir / Ritonavir Accord if you are taking avanafil or vardenafil.
- You must not take Lopinavir / Ritonavir Accord with sildenafil for the treatment of pulmonary arterial hypertension (high blood pressure in the pulmonary artery) (see also section Do not take Lopinavir / Ritonavir Accord above).
- If you take sildenafil or tadalafil with Lopinavir / Ritonavir Accord, you may experience side effects such as low blood pressure , fainting, changes in vision and penile erection lasting longer than 4 hours. If an erection lasts longer than 4 hours, you should seek medical attention immediately to avoid permanent damage to your penis. Your doctor can explain these symptoms to you.
Contraceptive
- If you are currently using the contraceptive pill or a contraceptive patch to prevent getting pregnant, you should use an additional contraceptive or other type of contraceptive (eg a condom) as Lopinavir / Ritonavir Accord may reduce the effect of the contraceptive pill and contraceptive patches.
- Lopinavir / Ritonavir Accord does not reduce the risk of transmitting HIV to others. Take appropriate precautions (eg by using a condom) to prevent the disease from being transmitted through sexual contact.
Pregnancy and breastfeeding
- Tell your doctor immediately if you are planning to have a baby, if you are or think you may be pregnant or if you are breast-feeding.
- Nursing mothers should not take Lopinavir / Ritonavir Accord without special prescription by doctors.
- It is recommended that women with HIV – infection do not breast feed their infants because there is a risk that the baby can be infected by HIV through your breast milk.
Driving and using machines
Lopinavir / Ritonavir Accord has not been specifically studied for its possible effect on the ability to drive or use machines. Do not drive or use machines if you experience any side effects (eg nausea) that affect your ability to do so safely. Contact your doctor instead.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
How to take Lopinavir / Ritonavir Accord?
| Lopinavir / Ritonavir Accord tablets must be swallowed whole and not chewed, divided, or crushed. |
|---|
Always take this medicine exactly as your doctor has told you. If you are not sure how to take this medicine, talk to your doctor or pharmacist.
How much Lopinavir / Ritonavir Accord should I take and when?
Use for adults
- The usual dose for adults is 400 mg / 100 mg twice daily, ie every 12 hours, in combination with other HIV medicines. Adult patients who have not previously taken antiretroviral medicines may also take Lopinavir / Ritonavir Accord tablets once daily as an 800 mg / 200 mg dose . Your doctor will decide how many tablets to take. Adult patients who have previously used antiviral drugs may take Lopinavir / Ritonavir Accord tablets once daily as an 800 mg / 200 mg dose if their doctor deems it appropriate.
- Lopinavir / Ritonavir Accord must not be taken once daily with efavirenz, nevirapine, carbamazepine, phenobarbital or phenytoin .
- Lopinavir / Ritonavir Accord can be taken with or without food.
Use for children
- For children, your doctor will determine the correct dose (number of tablets) based on the child’s height and weight.
- Lopinavir / Ritonavir Accord can be taken with or without food.
- If you find that you have taken more Lopinavir / Ritonavir Accord than you should, contact your doctor immediately.
- If you can not contact your doctor, go to the hospital.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. It can be difficult to distinguish between the side effects are caused by Lopinavir / Ritonavir Accord and those that may be due to other medicines you take at the same time or by the complications of HIV – infection a.
During HIV treatment, weight gain and increased levels of lipids and glucose in the blood may occur. This is partly related to restored health and lifestyle, but when it comes to blood lipids, there can sometimes be a connection with HIV drugs. The doctor will perform tests to find such
changes.
The following side effects have been reported in patients taking this medicine. You should tell your doctor immediately about these or other symptoms. If the condition persists or worsens, seek medical attention.
Very common (may affect more than 1 user in 10):
- diarrhea;
- nausea;
- upper respiratory tract infection.
Common (may affect up to 1 in 10 people):
- inflammation of the pancreas;
- vomiting, enlarged abdomen, lower and upper abdominal pain, gas, indigestion, decreased appetite, abdominal to esophageal regurgitation that may cause pain;
- Tell your doctor if you experience nausea, vomiting or abdominal pain as this may indicate pancreatitis ( inflammation of the pancreas).
- swelling or inflammation of the stomach, small intestine and large intestine;
- elevated blood cholesterol , elevated triglycerides (a type of fat) in the blood, high blood pressure;
- decreased ability of the body to handle sugar including diabetes mellitus and weight loss;
- low red blood cell count , low white blood cell count usually needed to fight infection;
- rash, eczema , accumulation of flaky oily skin;
- dizziness, anxiety, sleep problems;
- fatigue, lack of strength and energy, headache including migraine;
- hemorrhoids;
- inflammation of the liver including elevated liver enzymes;
- allergic reactions including hives and inflammation of the mouth;
- lower respiratory tract infection;
- enlarged lymph nodes;
- impotence , abnormally heavy or prolonged menstrual bleeding or lack of menstruation;
- muscle disorders such as weakness and cramps, pain in joints, muscles and back;
- damage to the peripheral nerves (nerve fibers outside the brain and spinal cord);
- nocturnal sweating, itching , rash including raised lumps on the skin, infection of the skin, inflammation of the skin or hair pores, accumulation of fluid in cells or tissue .
Uncommon (may affect up to 1 in 100 people):
- abnormal dreams;
- loss of or altered sense of taste;
- hair loss;
- changes in your electrocardiogram ( ECG ) called atrioventricular block ( AV block );
- the formation of plaque in your arteries which can lead to heart attack and stroke;
- inflammation of blood vessels and capillaries;
- inflammation of the bile ducts;
- involuntary body movements;
- constipation;
- deep inflammation in a blood vessel (vein) due to a blood clot;
- dry mouth;
- inability to control your bowel function;
- 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 the urine;
- yellow skin or whites of the eyes (jaundice)
- fatty deposits in the liver, enlarged liver;
- dysfunction of the testicles;
- bloating symptoms related to an inactive infection in your body (immune reactivation);
- increased appetite;
- abnormally high levels of bilirubin (a pigment produced by the breakdown of red blood cells ) in the blood;
- decreased sex drive;
- inflammation of the kidney;
- bone tissue death caused by poor blood supply to the area;
- cold sores or ulceration (ulcers), inflammation of the stomach and intestines;
- kidney failure;
- degradation of muscle fibers leading to the release of muscle fiber content (myoglobin) into the blood;
- a sound in one or both ears, such as hissing, ringing or howling;
- tremor (tremors);
- abnormal closure of one of the valves (the tricuspid valve in your heart);
- vertigo (feeling dizzy);
- eye problems, visual disturbances;
- weight gain.
Rare (may affect up to 1 in 1,000 people):
- severe or life-threatening skin rash and blisters ( Stevens-Johnson syndrome and erythema multiforme).
No known frequency (can not be calculated from the available data):
- kidney stones ar.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.
- No special storage instructions.
- Do not use this medicine if it is discolored.
How to dispose of unused Lopinavir / Ritonavir Accord?
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
The active substances are lopinavir and ritonavir.
Each tablet of Lopinavir / Ritonavir Accord contains 200 mg lopinavir and 50 mg ritonavir.
Other ingredients are:
Tablet: copovidone, sorbitan laurate, colloidal anhydrous silica, sodium stearyl fumarate.
Tablet coating: Hypromellose (E464), titanium dioxide (E171), macrogol (polyethylene glycol 400), hydroxypropyl cellulose (E463), talc (E553b), colloidal anhydrous silica (E551), macrogol (polyethylene glycol 3350), yellow iron oxide (E172), polysorbate (E172) E433).
What the medicine looks like and contents of the pack
Lopinavir / Ritonavir Accord are yellow, oval, biconvex film-coated tablets, debossed with “H” on one side and “L3” on the other.
Lopinavir / Ritonavir Accord film-coated tablets are supplied in packs of 120 tablets (1 plastic jar of 120 tablets) and 360 tablets (3 plastic jars of 120 tablets).
Multi-blister packs of 60 and 120 tablets (1 pack of 120 tablets or 3 packs of 40 tablets) are also available.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare BV
Winthontlaan 200
3526 KV Utrecht, The Netherlands
Manufacturer
Accord Healthcare Limited
Sage House, 319, Pinner Road, North Harrow
Middlesex HA1 4HF, UK
Paradox Healthcare, Ltd.
KW20A Kordin Industrial Park,
Paola, PLA 3000, Malta