Ritonavir Accord 100 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ritonavir Accord 100 mg film-coated tablets EFG

Read the entire leaflet carefully before you or your child starts taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Ritonavir Accord contains the active substance ritonavir. Ritonavir is a protease inhibitor used to control HIV infection. Ritonavir is used in combination with other anti-HIV medicines (antiretrovirals) to control HIV infection. Your doctor will discuss with you the most appropriate combination of medicines for your condition.

Ritonavir Accord is used in children aged 2 years and older, as well as in adolescents and adults infected with HIV, the virus that causes AIDS.

2. What you need to know before taking Ritonavir Accord

Do not take Ritonavir Accord

• if you are allergic to ritonavir or any of the other ingredients of this medicine (listed in section 6);
• if you have severe liver disease;
• if you are currently taking any of the following medicines:
  • astemizole or terfenadine (normally used to treat allergy symptoms – these medicines may be obtained without a prescription);
  • amiodarone, bepridil, dronedarone, encainide, flecainide, propafenone, quinidine (used to correct irregular heartbeats);
  • dihydroergotamine, ergotamine (used to treat migraine headaches);
  • ergonovine, methylergonovine (used to stop bleeding that may occur after childbirth or abortion);
  • clorazepate, diazepam, estazolam, flurazepam, triazolam, or oral midazolam (used to help you sleep and/or relieve anxiety);
  • clozapine, pimozide (used to treat abnormal thoughts or feelings);
  • quetiapine (used to treat schizophrenia, bipolar disorder, and major depressive disorder);
  • meperidine, propoxyphene (used to relieve pain);
  • cisapride (used to relieve certain stomach discomforts);
  • 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);
  • fusidic acid (used to treat bacterial infections);
  • sildenafil if you have a lung disease called pulmonary arterial hypertension that makes breathing difficult. Patients without this condition may use sildenafil for impotence (erectile dysfunction) under their doctor's supervision (see section "Taking Ritonavir Accord with other medicines");
  • avanafil or vardenafil (used to treat impotence);
  • colchicine (used to treat gout) if you have liver and/or kidney problems (see section "Taking Ritonavir Accord with other medicines");
  • products containing St. John’s wort (Hypericum perforatum), as they may cause Ritonavir Accord to stop working properly. St. John’s wort is often used in herbal medicines that you can buy yourself.

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

If you are currently taking any of these medicines, ask your doctor whether you could switch to another treatment while taking this medicine.

For other medicines requiring special care, refer to the list in section “Taking Ritonavir Accord with other medicines”.

Warnings and precautions

Talk to your doctor before starting this medicine.

Important information

• If you take Ritonavir Accord together with other antiretroviral medicines, it is important that you read carefully the package leaflets of these other medicines. They may contain additional important information about situations in which you should avoid taking Ritonavir. If you have further questions about this medicine or any other prescribed medicines, consult your doctor or pharmacist.
• Ritonavir is not a cure for HIV infection or AIDS.
• People taking Ritonavir may still develop infections or other diseases related to HIV infection or AIDS. It is therefore important that you remain under your doctor’s supervision while taking this medicine.

Tell your doctor if you have or have had:

• a history of liver disease;
• hepatitis B or C and are being treated with a combination of antiretroviral medicines, as you may have a higher risk of serious and potentially life-threatening side effects due to effects on the liver. Blood tests to monitor liver function may be necessary;
• haemophilia, as there have been cases of increased bleeding in haemophilia patients treated with this type of medicine (protease inhibitors). The reason for this is not known. You may need to receive additional medication to help blood clotting (Factor VIII) to manage any bleeding;
• erectile dysfunction: as medicines used to treat erectile dysfunction may cause hypotension and prolonged erection;
• diabetes, as there have been cases of worsening or development of diabetes (diabetes mellitus) in some patients taking protease inhibitors;
• kidney (renal) disease: as your doctor may need to adjust the dose of other medicines you are taking (such as protease inhibitors).

Tell your doctor if you experience:

• persistent diarrhoea or vomiting, as this may reduce the effectiveness of your medicines;
• nausea, vomiting, or stomach pain, as these may be signs of inflammation of the pancreas (pancreatitis). Some patients taking Ritonavir Accord may develop pancreatic problems. Inform your doctor as soon as possible if this applies to you;
• signs of infection – inform your doctor immediately. Some patients with advanced HIV infection (AIDS) who start anti-HIV treatment may develop symptoms of past infections even if they were unaware of having had them. This is believed to occur because the body's immune response improves and helps fight these infections. In addition to opportunistic infections, autoimmune disorders (a condition where the immune system attacks healthy body tissue) may also occur after starting treatment for HIV infection. Autoimmune disorders may appear several months after starting treatment. If you notice any signs of infection or other symptoms such as muscle weakness, ascending weakness starting in the hands and feet and moving up the trunk, palpitations, tremors, or hyperactivity, please inform your doctor immediately to receive necessary treatment;
• joint stiffness, discomfort, and pain (especially in the hip, knee, and shoulder) and difficulty moving, as this may be a sign of a condition that can destroy bone (osteonecrosis). Some patients taking antiretroviral medicines may develop this condition;
• muscle pain, tenderness, or weakness, particularly when combined with antiretroviral therapy including protease inhibitors and nucleoside analogues. In rare cases, these muscle disorders have been severe (see section 4. Possible side effects);
• dizziness, lightheadedness, fainting, or irregular heartbeat: Some patients taking Ritonavir Accord may experience changes in the electrocardiogram (ECG). Inform your doctor if you have any heart or electrical conduction problems;
• if you have any other health problems, consult your doctor as soon as possible.

Children and adolescents

The use of Ritonavir Accord is not recommended in children under 2 years of age.

Taking Ritonavir Accord with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription. There are some medicines that you must not take if you are using Ritonavir Accord. These are listed in section 2 “Do not take Ritonavir Accord”. Some medicines may only be taken under certain conditions, as described below.

The following precautions apply when this medicine is used at full dose. However, these precautions may also be necessary when low-dose (boosting) Ritonavir Accord is taken with other medicines.

Tell your doctor if you are taking any of the following medicines, as special precautions are required:

• sildenafil or tadalafil for impotence (erectile dysfunction).

The dose of these medicines should be reduced to avoid hypotension and prolonged erection. You must not take Ritonavir Accord with sildenafil if you also have pulmonary arterial hypertension (see section 2. What you need to know before taking Ritonavir Accord). Inform your doctor if you are taking tadalafil for the treatment of 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 liver and/or kidney problems (see also “Do not take Ritonavir Accord” above).

• digoxin (a heart medicine). To prevent heart problems, your doctor may need to adjust the dose of digoxin and monitor you while you are taking both digoxin and Ritonavir Accord.

• Hormonal contraceptives containing ethinylestradiol, as Ritonavir Accord may reduce the effectiveness of these medicines. It is recommended to use a condom or another non-hormonal contraceptive method instead. You may also experience irregular uterine bleeding if you take these hormonal contraceptives with Ritonavir Accord.

• Atorvastatin or rosuvastatin (for high cholesterol), as Ritonavir Accord may increase blood levels of these medicines. Inform your doctor before taking cholesterol-lowering medicines with Ritonavir Accord (see “Do not take Ritonavir Accord” above).

• Steroids (e.g. dexamethasone, fluticasone propionate, prednisolone, triamcinolone), as Ritonavir Accord may increase blood levels of these medicines, which could lead to Cushing's syndrome (development of a rounded face) and reduced cortisol hormone production. Your doctor may wish to reduce the steroid dose or monitor side effects more closely.

• Trazodone (a medicine for depression), as unwanted effects such as nausea, dizziness, low blood pressure, and fainting may occur when taken with Ritonavir Accord.

• Rifampicin and saquinavir (used for tuberculosis and HIV, respectively), as they may cause serious liver damage when taken with Ritonavir Accord.

• Bosentan, riociguat (used for pulmonary arterial hypertension) together with Ritonavir Accord may increase blood levels of bosentan.

Some medicines must not be combined with Ritonavir Accord because their effects may increase or decrease when taken together. In some cases, your doctor may need to perform certain tests, adjust doses, or monitor you regularly. Therefore, you must inform your doctor if you are taking any medicine, including those you have purchased yourself or herbal products, but especially the following:

• amphetamines or amphetamine derivatives;
• antibiotics (e.g. erythromycin, clarithromycin);
• cancer treatments (e.g. abemaciclib, afatinib, apalutamide, ceritinib, encorafenib, dasatinib, ibrutinib, nilotinib, vincristine, vinblastine);
• medicines used to treat low platelet count in blood (e.g. fostamatinib);
• anticoagulants (e.g. dabigatran etexilate, edoxaban, rivaroxaban, vorapaxar, warfarin);
• antidepressants (e.g. amitriptyline, desipramine, fluoxetine, imipramine, nefazodone, nortriptyline, paroxetine, sertraline, trazodone);
• antifungals (e.g. ketoconazole, itraconazole);
• antihistamines (e.g. loratadine, fexofenadine);
• antiretroviral medicines including HIV protease inhibitors (amprenavir, atazanavir, darunavir, fosamprenavir, indinavir, nelfinavir, saquinavir, tipranavir) and non-nucleoside reverse transcriptase inhibitors (NNRTIs) (delavirdine, efavirenz, nevirapine), and others (didanosine, maraviroc, raltegravir, zidovudine);
• tuberculosis medicines (bedaquiline and delamanid);
• antiviral medicines for the treatment of chronic hepatitis C virus (HCV) infection in adults (e.g. glecaprevir/pibrentasvir and simeprevir);
• medicines for anxiety, buspirone;
• medicines for asthma, theophylline, salmeterol;
• atovaquone, a medicine used to treat certain types of pneumonia and malaria;
• buprenorphine, a medicine used for chronic pain;
• bupropion, a medicine used to quit smoking;
• medicines for epilepsy (e.g. carbamazepine, divalproex, lamotrigine, phenytoin);
• medicines for the heart (e.g. disopyramide, mexiletine, and calcium channel blockers such as amlodipine, diltiazem, and nifedipine);
• medicines affecting the immune system (e.g. cyclosporine, tacrolimus, everolimus);
• levothyroxine (used to treat thyroid problems);
• morphine and morphine derivatives used to treat severe pain (methadone, fentanyl);
• sleeping pills (e.g. alprazolam, zolpidem) and also midazolam administered by injection;
• tranquilizers (e.g. haloperidol, risperidone, thioridazine);
• colchicine, a treatment for gout.

Some medicines must not be taken with Ritonavir Accord. These are listed earlier in section 2 “Do not take Ritonavir Accord”.

Taking Ritonavir Accord with food and drinks

Ritonavir Accord tablets should be taken with food.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to become pregnant, it is very important that you consult your doctor before using this medicine.

There is very limited information on the use of ritonavir (the active substance in Ritonavir Accord) during pregnancy. In general, pregnant women have received low-dose (boosting) ritonavir in combination with another protease inhibitor after the first three months of pregnancy. Ritonavir Accord does not appear to increase the risk of birth defects compared to the general population.

Breastfeeding is not recommended for women living with HIV because HIV infection can be transmitted to the baby through breast milk.

If you are breastfeeding or planning to breastfeed, you should consult your doctor as soon as possible.

Driving and using machines

Ritonavir Accord may cause dizziness. If you experience this effect, do not drive or operate machinery.

Ritonavir Accord contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet, which is essentially “sodium-free”.

3. How to take Ritonavir Accord

Follow exactly the instructions for taking Ritonavir Accord as given by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. Take this medicine once or twice daily with food.

It is important that Ritonavir Accord tablets are swallowed whole and not chewed, broken, or crushed.

The recommended doses of Ritonavir Accord are:

• If Ritonavir Accord is used to boost the effect of other antiretroviral medicines, the adult dose is 1 to 2 tablets once or twice daily. For further information on dosing recommendations, including those for children, please read the package leaflet of the anti-HIV medicines taken in combination with Ritonavir Accord.

• If your doctor prescribes a full dose, adults may start with a dose of 3 tablets in the morning and 3 tablets 12 hours later. This dose will be gradually increased over a period of up to 14 days to reach the full dose of 6 tablets twice daily (a total of 1200 mg per day). Children (2–12 years) will start at a lower dose than this and continue up to the maximum dose allowed for their body size.

Your doctor will tell you the correct dose you should take.

You should take Ritonavir Accord every day to control HIV, regardless of whether you feel better. If any side effect prevents you from taking Ritonavir Accord as directed, inform your doctor immediately. During episodes of diarrhoea, your doctor may decide that you need additional monitoring.

Always keep an adequate supply of Ritonavir Accord available so that you do not run out. When travelling or if you need to stay in hospital, make sure you have enough Ritonavir Accord until you can obtain more.

If you take more Ritonavir Accord than you should

If you take too much Ritonavir Accord, you may experience numbness, tingling, or a prickling sensation. If you realize you have taken more Ritonavir Accord than you should, contact your doctor or the nearest hospital emergency department immediately.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Ritonavir Accord

If you forget to take a dose, take it as soon as possible. If it is almost time for your next dose, take only one dose.

Do not take a double dose to make up for forgotten doses.

If you stop taking Ritonavir Accord

Even if you feel better, do not stop taking Ritonavir Accord without consulting your doctor.

If you take Ritonavir Accord exactly as directed, you are more likely to delay the development of resistance to this medicine.

4. Possible adverse effects

During HIV treatment, there may be an increase in weight and in blood glucose and lipid levels. This may be partly related to the recovery of health and to lifestyle, and in the case of blood lipids, sometimes to the HIV medicines themselves. Your doctor will monitor these changes.

Like all medicines, Ritonavir Accord can cause adverse effects, although not everyone experiences them.

When Ritonavir Accord is used in combination with other antiretroviral medicines, the adverse effects may also depend on those other medicines. For this reason, it is very important that you read carefully the adverse reactions section of the package leaflet for these medicines.

Inform your doctor if you feel dizzy (nausea), are vomiting, or have stomach pain, as these may be symptoms of pancreatitis (inflammation of the pancreas). Also inform your doctor if you experience joint stiffness, discomfort, and pain (especially in the hip, knee, and shoulder) and difficulty moving, as this may be a sign of osteonecrosis. See section 2. What you need to know before taking Ritonavir Accord.

Cases of increased bleeding have been reported in patients with haemophilia A and B during treatment with this or other protease inhibitors. If this occurs, consult your doctor immediately.

Abnormal liver function tests, hepatitis (liver inflammation), and, rarely, jaundice have been reported in patients taking Ritonavir Accord. Some patients had other illnesses or were taking other medications. Some patients with pre-existing liver disease or hepatitis may have worsened.

There have been reports of muscle pain, discomfort, or weakness, particularly when cholesterol-lowering medications are taken in combination with combination antiretroviral therapy, including protease inhibitors and nucleoside analogues. In rare cases, these muscle disorders were severe (rhabdomyolysis). If you experience unexplained or persistent muscle pain, discomfort, weakness, or cramps, stop taking the medication and contact your doctor as soon as possible or go to the nearest hospital emergency department.

Inform your doctor immediately if, after taking Ritonavir Accord, you experience any symptoms that may suggest an allergic reaction, such as skin rash, hives, or difficulty breathing.

If you consider any of the side effects you experience to be severe or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist, go to emergency care, or seek immediate medical help if urgent.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines:

https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ritonavir Accord

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

Do not use this medicine after the expiry date stated on the carton and on the bottle after EXP. The expiry date refers to the last day of the month indicated.

Once the bottle has been opened, use within the following 4 months.

Store below 25°C.

Medicines should not be disposed of via wastewater or household waste. Return unused medicines and their containers to your pharmacy’s SIGRE point. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ritonavir Accord

• The active substance is ritonavir. Each film-coated tablet contains 100 mg of ritonavir.

• The other components are: copovidone, sorbitan laurate (E493), colloidal anhydrous silica (E551), anhydrous calcium hydrogen phosphate, and sodium stearyl fumarate.

• The components of the film coating are: hypromellose (E464), titanium dioxide (E171), macrogol, hydroxypropyl cellulose (E463), talc (E553b), colloidal anhydrous silica (E551), and polysorbate 80 (E433).

Appearance of the product and contents of the pack

Ritonavir Accord film-coated tablets are white or pale white, capsule-shaped tablets, marked with “H” on one side and “R9” on the other.

Ritonavir Accord tablets are available in white HDPE bottles with child-resistant polypropylene caps containing 30, 90 and 120 film-coated tablets, and in Alu-Alu blisters.

Pack sizes:

HDPE bottle: 30, 90 and 120 tablets.

Carton containing pre-cut unit-dose blisters: 30, 90 and 120 tablets.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center

Moll de Barcelona s/n,

Edifici Est, 6th floor,

08039 Barcelona,

Spain

Manufacturers:

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park, Paola

Malta

This Patient Information Leaflet has been reviewed in: January 2025

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/