100 mg film-coated tablets
ritonavir

What Ritonavir Accord is and what it is used for

Ritonavir Accord contains the active substance ritonavir. Ritonavir Accord is a protease inhibitor and is used to control HIV infection. Ritonavir Accord is used with other anti – HIV medicines (antiretroviral medicines) to control your HIV infection. Your doctor will discuss with you which combination of drugs is best for you.

Ritonavir Accord is used by children 2 years of age and older, adolescents, and adults 

infected with HIV, the virus that causes AIDS.

Ritonavir contained in Ritonavir Accord may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you or your child take Ritonavir Accord

Do not take Ritonavir Accord

  • if you are allergic to ritonavir or any of the other ingredients of this medicine (see section 6).
  • if you have severe liver disease.
  • if you are currently taking any of the following medicines:
    • astemizole or terfenadine (commonly used to treat allergy symptoms – these medicines may be over-the-counter);
    • amiodarone , bepridil, dronedarone, encainide, flecainide , propafenone , quinidine (used to correct irregular heartbeat);
    • dihydroergotamine, ergotamine (used to treat migraines );
    • ergonovine, methylergonovine (used to stop heavy bleeding that may occur after childbirth or an abortion);
    • clorazepate, diazepam, estazolam, flurazepam, triazolam, or oral (swallowed) midazolam (used to help you sleep and/or to relieve anxiety);
    • clozapine, pimozide (used to treat abnormal thoughts and feelings);
    • pethidine, piroxicam, propoxyphene (used to relieve pain);
    • 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 ailments);
    • rifabutin (used to prevent/treat certain infections ) *;
    • voriconazole (used to treat fungal infections) *;
    • simvastatin, lovastatin (used to lower blood cholesterol );
    • neratinib (used to treat breast cancer);
    • lomitapide (used to lower blood cholesterol);
    • alfuzosin (used to treat enlarged prostate gland);
    • fusidic acid (used to treat bacterial infections);
    • sildenafil if you also have a lung disease called pulmonary arterial hypertension that causes difficulty breathing. Patients without this disease may use sildenafil for impotence ( erectile dysfunction ) under the supervision of a physician (see section Other medicines and Ritonavir Accord);
    • avanafil and vardenafil (used to treat erectile dysfunction );
    • colchicine (used to treat gout ) if you have kidney and/or liver problems (see the section on Other medicines and Ritonavir Accord);
    • products containing St. John’s wort (Hypericum perforatum) as these may prevent Ritonavir Accord from working properly. St. John’s wort is often used in herbal remedies that you can buy yourself.

* Your doctor may decide that you can take rifabutin and/or voriconazole with a booster (lower dose ) of Ritonavir Accord, but a full dose of Ritonavir Accord should not be taken with these two medicines.

If you are currently taking any of these medicines, ask your doctor if it is possible to switch to another medicine while you are taking Ritonavir Accord.

Also, read the list of medicines in the section “Other medicines and Ritonavir Accord” when using certain medicines that require special care.

Warnings and cautions

Talk to your doctor before taking Ritonavir Accord.

Important information

  • If you are taking Ritonavir Accord in combination with other antiretroviral medicines, it is important that you also carefully read the package leaflet that comes with these medicines. There may be additional information on situations when Ritonavir Accord should be avoided. If you have any further questions on the use of Ritonavir Accord or any of the other medicines, contact your doctor or pharmacist.
  • Ritonavir Accord does not cure HIV infection or AIDS.
  • Those taking Ritonavir Accord may still develop infections or other conditions associated with HIV infection or AIDS. It is therefore important that your doctor monitors you while you are taking Ritonavir Accord.
  • You can still transmit HIV infection while taking this medicine, even though the risk of effective antiretroviral therapy is reduced. Discuss with your doctor the necessary steps to avoid infecting others.

Tell your doctor if you have/had:

  • Previous liver disease.
  • Hepatitis B or C is treated with a combination of antiretroviral drugs because you then have an increased risk of severe and potentially life-threatening reactions due to the effect on the liver. Regular blood tests may be required to check that the liver is functioning properly.
  • Hemophilia, as there are reports of increased bleeding in patients with hemophilia taking this type of medicine ( protease inhibitor ). The reason for this is not known. You may need more medication to help the blood clot ( factor VIII ), to be able to control any bleeding.
  • Impotence (erectile dysfunction), as drugs used to treat erectile dysfunction, can cause low blood pressure and prolonged erection.
  • Diabetes, as there are reports of worsening or development of diabetes (diabetes mellitus) in some patients taking protease inhibitors.
  • Kidney disease, as your doctor may need to check the dose of one of your other medicines (such as protease inhibitors ).

Tell your doctor if you experience:

  • Diarrhea or vomiting that does not improve (lasting), as this may reduce the effect of the medicines you are taking.
  • Nausea, vomiting, or abdominal pain, as this may be a sign of inflammation of the pancreas ( pancreatitis ). Some patients taking Ritonavir Accord may develop serious problems with their pancreas. Tell your doctor as soon as possible if this applies to you. Symptoms of infection –  contact your doctor immediately. Some patients with advanced HIV infection (AIDS) who are starting treatment for HIV may have symptoms from previous infections that they did not know they had. This is probably due to the body’s improved immune response which enables the body to fight these infections.
    In addition to the opportunistic infections, so can autoimmune diseases (a condition that occurs when the immune system attacks healthy body tissue) occur after you start taking medication 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 starting in the hands and feet and going upwards in the body, palpitations, tremors, or hyperactivity, inform your doctor immediately to get the necessary treatment.
  • Stiffness in joints, pain, and aches (especially hips, knees, and shoulders), and difficulty moving, tell your doctor as this may be a sign of a disease that can destroy bones ( osteonecrosis ). Some patients receiving combination antiretroviral therapy may develop this disease.
  • Muscle aches, soreness, and weakness, especially in combination with antiretroviral therapy that includes protease inhibitors and nucleoside analogs. On rare occasions, these muscle problems have been severe. (See section 4.  Possible side effects ) .
  • Dizziness, fainting, or abnormal heartbeat. Some patients taking Ritonavir Accord may experience electrocardiogram ( ECG ) changes. Tell your doctor if you have a heart defect or conduction disturbances in your heart.
  • If you have any other questions concerning your health, discuss these with your doctor as soon as possible.

Children and young people

Ritonavir Accord is not recommended for use in children below 2 years of age.

Other medicines and Ritonavir Accord

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. There are medicines that you can not take at all with Ritonavir Accord. They are listed earlier in section 2, 

under “Do not take Ritonavir Accord”. Other medicines can only be used in special circumstances described below.

The following warnings apply when Ritonavir Accord is taken as a full dose. These warnings may also apply when Ritonavir Accord is used at a lower dose (booster) with other medicines.

Tell your doctor if you are taking any of the medicines listed below, as special care should be taken.

  • Sildenafil or tadalafil for impotence ( erectile dysfunction ). The dose and/or frequency of use of these drugs may need to be reduced to avoid low blood pressure and prolonged erection. You should not take Ritonavir Accord with sildenafil if you have pulmonary arterial hypertension (see also section 2. What you need to know before you or your child take Ritonavir Accord ). Tell your doctor if you are taking tadalafil for pulmonary arterial hypertension.
  • Colchicine (for gout ) as ritonavir may increase blood levels of this medicine. You must not take ritonavir with colchicine if you have kidney and/or liver problems (see also Do not take Ritonavir Accord above).
  • Digoxin (heart medicine). Your doctor may need to adjust your digoxin dose and you should check if you are taking digoxin and Ritonavir Accord to avoid heart problems.
  • Hormonal contraceptives containing Ethinyl estradiol as Ritonavir Accord may reduce the effect of these medicines. It is recommended that condoms or other non-hormonal contraceptive methods be used instead. You may also experience irregular bleeding if you take this type of hormonal contraceptive with Ritonavir Accord.
  • Atorvastatin or rosuvastatin (for high cholesterol) as Ritonavir Accord may increase the levels of these medicines in the blood. Talk to your doctor before taking any cholesterol-lowering medicine with Ritonavir Accord (see Do not take Ritonavir Accord above).
  • Steroids (eg dexamethasone, fluticasone propionate, prednisolone, triamcinolone) such as Ritonavir Accord may increase blood levels of these medicines which may lead to Cushing’s syndrome (development of a round face) and decrease the production of the hormone cortisol. Your doctor may lower your dose of steroids and monitor your side effects closely.
  • Trazodone (antidepressant) because side effects such as nausea, dizziness, low blood pressure, and fainting may occur when taking Ritonavir Accord at the same time.
  • Rifampicin and saquinavir (used to treat tuberculosis and HIV respectively) Severe liver damage may occur if Ritonavir Accord is taken at the same time.
  • Bosentan, riociguat (used to treat pulmonary arterial hypertension ) as ritonavir may increase blood levels of this medicine.

Some medicines may not be taken with Ritonavir Accord as their effects may increase or decrease when taken together. In some cases, your doctor may need to take some tests, change the dosage or check you regularly. Therefore, you should tell your doctor if you are taking other medicines, including those you have bought yourself or herbal medicines, but it is especially important to mention these:

  • amphetamine or amphetamine derivative;
  • antibiotics (eg erythromycin, clarithromycin);
  • chemotherapy (eg abemaciclib, afatinib, apalutamide, ceritinib,encorafenib, dasatinib, ibrutinib, nilotinib, venetoclax, vincristine, vinblastine);
  • drugs used to treat platelet deficiency (eg fostamatinib);
  • anticoagulants (eg rivaroxaban, vorapaxar, warfarin );
  • antidepressants (eg amitriptyline, desipramine, fluoxetine, imipramine, nefazodone, nortriptyline, paroxetine, sertraline, trazodone);
  • antifungals (eg ketoconazole , itraconazole);
  • antihistamines are (eg loratadine , fexofenadine);
  • antiretroviral medicinal products including HIV protease inhibitors ( amprenavir, atazanavir, darunavir, fosamprenavir, indinavir, nelfinavir, saquinavir, tipranavir), non-nucleoside reverse transcriptase inhibitors (NNRTIs) (delavirdine, ribavirin, papaverine, zavapyrin, efavirenz, ;
  • drugs against tuberculosis (bedacillin and delaminate);
  • antiviral drugs used to treat chronic hepatitis C ( HCV ) infection in adults (eg glekaprevir / pibrentasvir and simeprevir);
  • antianxiety drugs, buspirone;
  • asthma medication, theophylline, salmeterol;
  • atovaquone, a medicine for the treatment of a specific type of pneumonia and malaria;
  • buprenorphine, a drug used in the treatment of chronic pain;
  • bupropion, a drug used for smoking cessation;
  • epilepsy drugs (eg, carbamazepine, divalproex, lamotrigine, phenytoin );
  • cardiac drugs (eg disopyramide, mexiletine, and calcium channel antagonists such as amlodipine, diltiazem, and nifedipine);
  • immune system (eg cyclosporine, tacrolimus, everolimus);
  • levothyroxine (used to treat thyroid problems);
  • morphine and morphine-like drugs used in the treatment of severe pain (eg methadone, fentanyl );
  • hypnotics (eg alprazolam, zolpidem) and also midazolam are given as an injection;
  • sedatives (eg haloperidol , risperidone , thioridazine);
  • colchicine, a gout treatment.

There are certain medicines that you can not take at all with Ritonavir Accord. These are listed earlier in section 2, under ‘Do not take Ritonavir Accord’.

Taking Ritonavir Accord with food and drink

Ritonavir Accord 100 mg film-coated tablets should be taken with food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you must consult your doctor before taking this medicine.

There is a lot of information about the use of ritonavir (the active substance in the Ritonavir Accord) during pregnancy. After the first three months, in most cases, pregnant women received ritonavir at lower doses (booster) with other protease inhibitors. Ritonavir Accord does not appear to increase the risk of malformations compared to the rest of the population.

Ritonavir Accord may pass into breast milk. To avoid transmission of 

infection, women with HIV infection should not breastfeed their children.

Driving and using machines

Ritonavir Accord may cause dizziness. If you are affected, do not drive or use machines.

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.

Ritonavir Accord contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, ie essentially ‘sodium-free’. is next to “sodium-free”.

How to take Ritonavir Accord

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure. Take this medicine once or twice a day with food.

Ritonavir Accord tablets must be swallowed whole and not chewed, divided, or crushed.

The recommended dose of Ritonavir Accord is:

  • If Ritonavir Accord is used to enhance the effect of certain another anti – HIV medicines, the most common dose is one to 1 to 2 tablets for adults once or twice daily. For more detailed dosing recommendations, including those for children, read the package leaflet for the other anti- HIV medicines that Ritonavir Accord is given with.
  • If your doctor prescribes a full dose, adults can start with 3 tablets in the morning and 3 tablets 12 hours later, gradually increasing the dose one over 14 days to achieve the full dose of 6 tablets twice daily (total 1200 mg per day). Children (2 – 12 years) start with a smaller dose and continue up to the dose that is maximum allowed for their size.

Your doctor will tell you which dose to use.

Ritonavir Accord is taken daily to help keep your HIV infection under control no matter how much better you feel. If a side effect prevents you from taking Ritonavir Accord as prescribed, you must tell your doctor immediately. During periods of diarrhea, your doctor may decide that extra checks are needed.

Always have enough Ritonavir Accord on hand so that it does not run out. When you

If you are traveling or need to be hospitalized, make sure you have enough Ritonavir Accord enough to get more.

If you take more Ritonavir Accord than you should

Numbness, tingling, or an ant crawling may occur if you take too much Ritonavir Accord. If you find that you have taken more Ritonavir Accord than you should, contact your doctor immediately or go to the emergency room at the nearest hospital.

If you have ingested too much medicine or if e.g. If a child has ingested the medicine, contact a doctor or hospital for an assessment of the risk and advice.

If you forget to take Ritonavir Accord

If you miss a dose, take the missed dose as soon as possible. If it is soon time for your next dose, just take it. Do not take a double dose to make up for a forgotten dose.

If you stop taking Ritonavir Accord

Even if you feel better, do not stop taking Ritonavir Accord without talking to your doctor. Using Ritonavir Accord as prescribed, should give you the best opportunity to delay the development of drug resistance.

Possible side effects

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 may sometimes be a link with HIV drugs. The doctor will perform tests to find such changes.

Like all medicines, this medicine can cause side effects, although not everybody gets them. When ritonavir is used with other antiretroviral medicines, the side effects are dependent on the other medicines. Therefore, it is important that you carefully read the side effects section of the package leaflet that comes with these medicines.

Very common: may affect more than 1 user in 10

  • pain in the upper or lower abdomen
  • vomiting
  • diarrhea (may be severe)
  • nausea
  • redness of the skin, the feeling of heat
  • headache
  • dizziness
  • sore throat
  • tingling or numbness in the hands, feet, or around the lips and mouth
  • the feeling of weakness/tiredness
  • bad taste in the mouth
  • nerve damage that can cause weakness or pain
  • itching
  • rash
  • joint and back pain

Common: may affect up to 1 in 10 users

  • allergic reactions including rash (may be red, increased, itchy), severe swelling of the skin and other tissues
  • difficulty sleeping
  • increased cholesterol levels
  • increased levels of triglycerides
  • concern
  • gout
  • gastric hemorrhage
  • hepatitis and yellowish color of skin and whites of the eyes
  • denser hydration
  • renal impairment
  • cramps
  • decreased platelet count
  • thirst (dehydration)
  • abnormally abundant menstruation
  • inflated stomach
  • loss of appetite
  • cold sores
  • muscle pain, tenderness, or weakness
  • fever
  • weight loss
  • laboratory tests: changes in the results of blood tests (eg composition of substances in the blood and number of blood cells)
  • confusion
  • difficulty retaining attention
  • fainting
  • dimsyn
  • swelling in hands and feet
  • high blood pressure
  • low blood pressure and fainting when getting up
  • cold hands and feet
  • acne

Uncommon: may affect up to 1 in 100 people

  • myocardial infarction
  • diabetes
  • kidney failure

Rare: may affect up to 1 in 1000 people

  • severe or life-threatening skin reactions including blisters (Stevens-Johnson syndrome, toxic epidermal necrolysis )
  • severe allergic reactions
  • elevated blood sugar levels

No known frequency: can not be calculated from the available data

  • kidney stones are

Tell your doctor if you feel nauseous, vomit or have abdominal pain as these may be signs of an inflamed pancreas. Also tell your doctor if you have joint stiffness, aches, pains (especially in the hip, knee, and shoulder), and difficulty moving, as this may be a sign of osteonecrosis. See also section 2. What you need to know before you or your child takes Ritonavir Accord.

In patients with hemophilia type A and B, there have been reports of an increased tendency to bleed when taking this or another protease inhibitor. If this happens to you, talk to your doctor straight away.

There are reports of abnormal liver values, hepatitis ( inflammation of the liver), and, in rare cases, jaundice in patients taking ritonavir. Some people had other illnesses or were on other medications. People who already have liver disease or hepatitis may get worse.

There are reports of muscle pain, soreness, or weakness in the muscles, especially with the concomitant use of cholesterol-lowering drugs in combination with antiretroviral therapy including protease inhibitors and nucleoside analogs. In rare cases, these muscle problems have been severe ( rhabdomyolysis ). In case of unexplained or persistent muscle pain, soreness, weakness, or cramps, stop taking the medicine, contact your doctor as soon as possible or go to the emergency room at the nearest hospital.

Tell your doctor immediately if you get any symptoms that indicate an allergic reaction after taking ritonavir, such as itching, rash, or difficulty breathing.

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, or emergency department or if you have an emergency, seek medical advice immediately.

How to store Ritonavir Accord

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 and can. The expiration date is the last day of the specified month.

Once the jar has been opened, it should be used within 4 months.

Do not store above 25 ° C.

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 package and other information

Content declaration

  • The active substance is ritonavir. Each film-coated tablet contains 100 mg of ritonavir.
  • The other ingredients of the tablet are copovidone, sorbitan laurate (E493), anhydrous colloidal silica (E551), anhydrous calcium hydrogen state, and sodium stearyl fumarate.
  • The coating of the tablet consists of hypromellose (E464), titanium dioxide (E171), macrogol, hydroxypropylcellulose (E463), talc (E553b), colloidal anhydrous silica (E551), polysorbate 80 (E433).

What the medicine looks like and the contents of the pack

Ritonavir Accord 100 mg tablets are white to off-white, capsule-shaped film-coated tablets debossed with “H” on one side and “R9” on the other side.

Ritonavir Accord 100 mg film-coated tablets are supplied in HDPE cans with child-resistant polypropylene caps and Alu-Alu blister packs.

Pack sizes:

HDPE jar: 30, 90, and 120 tablets.

Cross-perforated blister packs for unit dose: 30×1, 90×1 and 120×1 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Accord Healthcare BV

Winthontlaan 200

3526 VK Utrecht

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

Muhammad Nadeem

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