Package Leaflet: Information for the User

Ritonavir Accord 100 mg Film-Coated Tablets EFG

Read this leaflet carefully before you start taking this medicine because it contains important information for you or your child.

• 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 only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isRitonavir Accordand what it is used for

2. What you need to know before you start taking or your child takesRitonavir Accord

3. How to takeRitonavir Accord

4. Possible side effects

5. Storage ofRitonavir Accord

6. Contents of the pack and additional information

Ritonavir Accord contains the active ingredient ritonavir. Ritonavir is a protease inhibitor used to control HIV infection. Ritonavir is used in combination with other anti-HIV (antiretroviral) medications to control HIV infection.Your doctor will discuss with you which is the best combination of medications for you.

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

Do not take Ritonavir Accord

- if you are allergic to ritonavir or any of the other ingredients of this medicine (see section6).

- if you have a serious liver disease.

- if you are currently taking any of the following medicines:

- astemizol or terfenadine (usually used to treat allergy symptoms – these medicines can be bought without a prescription);

- amiodarona, bepridil, dronedarona, encainida, flecainida, propafenona, quinidina (used to correct irregular heartbeats);

- dihidroergotamina, ergotamina (used to treat migraine headaches);

- ergonovina, metilergonovina (used to stop bleeding that may occur after childbirth or abortion);

- clorazepato, diazepam, estazolam, flurazepam, triazolam or midazolam oral (used to help you sleep and/or relieve anxiety);

- clozapina, pimozida (used to treat abnormal thoughts or feelings):

- quetiapina (used to treat schizophrenia, bipolar disorder, and major depressive disorder);

- petidina, propoxifeno (used to relieve pain);

- cisaprida (used to relieve certain stomach pain);

- rifabutina (used to prevent/treat certain infections)*;

- voriconazol (used to treat fungal infections)*;

- simvastatina, lovastatina, (used to reduce cholesterol in the blood);

- neratinib (used to treat breast cancer);

- lomitapida (used to lower cholesterol in the blood);

- alfuzosina (used to treat an enlarged prostate);

- ácido fucsídico (used to treat bacterial infections).

- sildenafilo if you have a lung disease called pulmonary hypertension that makes it hard to breathe. Patients without this disease may use sildenafilo to treat impotence (erectile dysfunction) under the supervision of their doctor (see sectionTaking Ritonavir Accord with other medicines);

- avanafilo or vardenafilo (used to treat impotence);

- colchicina (used to treat gout) if you have liver and/or kidney problems (see sectionTaking Ritonavir Accord with other medicines);

- products containing St. John's Wort (Hypericum perforatum) as it 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 take rifabutina and/or voriconazol with a booster (low) dose of ritonavir 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 you could change your medication while taking this medicine.

For the use of other medicines that require special care, see the list included in the section “Taking Ritonavir Accord with other medicines”

Warnings and precautions

Consult your doctor before starting to take this medicine

Important information

- If you take Ritonavir Accord with other antiretroviral medicines, it is important that you carefully read the leaflets of these other medicines. In these leaflets you may find additional important information about the situations in which you should avoid taking Ritonavir. If you have any questions about this medicine or the rest of the medicines that your doctor has prescribed for you, consult your doctor or pharmacist.

- Ritonavir is not a cure for HIV or AIDS infection

- People taking Ritonavir may still develop infections or other diseases related to HIV or AIDS infection. It is therefore important that you remain under the supervision of your doctor while taking this medicine.

Inform 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 they have a higher risk of suffering from severe and potentially fatal liver damage. You may need to have blood tests to monitor liver function.

- haemophilia, as there have been cases of patients with haemophilia taking this type of medicine (protease inhibitors) with increased bleeding. You may need to have additional medication administered to you to control any bleeding.

- erectile dysfunction: as medicines used to treat erectile dysfunction can 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 disease (renal): as your doctor may need to check the dose of other medicines you are taking (such as protease inhibitors)

Inform your doctor if you experience:

- persistent diarrhoea or vomiting, as this may reduce the effectiveness of the medicines you are taking.

- dizziness, vomiting, or stomach pain, as these may be signs of pancreatitis. Some patients taking Ritonavir Accord may develop pancreas problems. Inform your doctor as soon as possible if this is the case

- symptoms of infection – inform your doctor immediately. Some patients with advanced HIV (AIDS) infection who start antiretroviral treatment may develop symptoms they had in the past even if they do not know they had them. It is believed that this occurs because the body's immune response improves and helps the body fight these infections. In addition to opportunistic infections, you may also suffer from autoimmune disorders (a problem that occurs when the immune system attacks healthy body tissue) after starting antiretroviral treatment. Autoimmune disorders may appear 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 spreading to the trunk, palpitations, tremor, or hyperactivity, please inform your doctor immediately to seek necessary treatment.

- stiffness of joints, discomfort and pain (especially of the hip, knee, and shoulder) and difficulty moving, inform your doctor, as it may be a sign of a problem that can destroy bone (osteonecrosis). Some patients taking antiretroviral medicines may develop this disease.

- muscle pain, discomfort, or weakness, particularly in combination with antiretroviral therapy including protease inhibitors and nucleoside analogues. In rare cases, these muscle disorders have been severe (see section 4.Undesirable effects)

- dizziness, drowsiness, 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 heart conduction problems

- If you have any other health problems, consult your doctor as soon as possible.

Children and adolescents

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

Taking Ritonavir Accord with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take other medicines, even those bought without a prescription.There are some medicines that you cannot use if you are taking Ritonavir Accord. These medicines are listed in section 2 “Do not take Ritonavir Accord”. There are some medicines that can only be taken under certain circumstances as described below.

When this medicine is taken at full doses, the following precautions will be taken. However, these precautions may also be necessary when taking low doses (booster) of Ritonavir Accord with other medicines.

Inform your doctor if you are taking any of the medicines listed below, special precautions are necessary.

- Sildenafilo or tadalafilo for erectile dysfunction.

You must reduce the dose of these medicines to avoid hypotension and prolonged erection. Do not take Ritonavir Accord with sildenafilo if you also have pulmonary hypertension (see section 2.What you need to know before starting to take Ritonavir Accord).

- Colchicina (for gout) as ritonavir may increase the levels of this medicine in the blood. You should not take ritonavir with colchicina if you have liver and/or kidney problems (see also “Do not take Ritonavir Accord” above).

- Digoxina (heart medicine). Your doctor may need to adjust the dose of digoxina and monitor you while taking digoxina and Ritonavir Accord.

• Combined oral contraceptivescontaining etinil estradiol, as Ritonavir Accord may reduce the effectiveness of these medicines. It is recommended to use a condom or another non-hormonal contraceptive method. You may also experience irregular uterine bleeding if you take this type of contraceptive with Ritonavir Accord.

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

• Glucocorticoids(e.g. dexametasona, propionato de fluticasona, prednisolona, triamcinolona), as Ritonavir Accord may increase the levels of these medicines in the blood, which may lead to Cushing's syndrome (development of a rounded face) and reduce cortisol production. Your doctor may want to reduce the dose of glucocorticoids or monitor their side effects more closely.

• Trazodona(used to treat depression) as it may cause unwanted effects such as nausea, dizziness, low blood pressure, and drowsiness when taken with Ritonavir Accord.

• Rifampicina and saquinavir(used to treat tuberculosis and HIV respectively) as they may cause severe liver damage when taken with Ritonavir Accord.

• Bosentan, riociguat(used to treat pulmonary arterial hypertension) with Ritonavir Accord may increase the amount of this medicine in the blood (Bosentan).

There are some medicines that should not be taken with Ritonavir Accord because their effects may increase or decrease when taken together. In some cases, your doctor may need to perform certain tests, change the dose, or monitor you regularly. Therefore, you should inform your doctor if you are taking any medicine, even those you have bought yourself or herbal products, although it is essential to mention the following:

• amphetamine or amphetamine derivatives;
• antibiotics (e.g. eritromicina, claritromicina);
• chemotherapy for cancer (e.g. abemaciclib, afatinib, apalutamida, ceritinib, encorafenib, dasatinib, ibrutinib, nilotinib, vincristina, vinblastina)
• medicines used to treat low platelet count in the blood (e.g. fostamatinib)
• anticoagulants (e.g. dabigatran etexilato, edoxaban, rivaroxaban, vorapaxar, warfarina)
• antidepressants (e.g. amitriptilina, desipramina, fluoxetina, imipramina, nefazodone, nortriptilina, paroxetina, sertralina, trazodona);
• antifungals (e.g. ketoconazol, itraconazol);
• antihistamines (e.g. loratadina, fexofenadina);
• medicines that affect the immune system (e.g. ciclosporina, tacrólimus, everolimus);
• levotiroxina (used to treat thyroid problems);
• morphine and morphine derivatives used to treat severe pain (metadona, fentanilo);
• sleeping pills (e.g. alprazolam, zolpidem) and also midazolam administered by injection;
• tranquilizers (e.g. haloperidol, risperidona, tioridacina);
• colchicina, treatment for gout.

There are some medicines that you cannot take with Ritonavir Accord. These are listed above 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 are planning to become pregnant, it is very important that you consult your doctor before using this medicine.

There is very little information on the use of ritonavir (active ingredient of Ritonavir Accord) during pregnancy. In general, pregnant women received low doses (booster) of ritonavir 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.

It is not recommended that women living with HIV breastfeed as the HIV infection can be transmitted to the baby through breast milk.

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

Driving and operating machinery

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”.

Follow exactly the administration instructions for Ritonavir Accord as indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.Take this medicationonce or twice a day every day with food.

It is essential 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 potentiate the effect of other antiretroviral medications, the dose for adults is 1 to 2 tablets once or twice a day. For more information on dosage recommendations, including those for children, read the prospectus of the antiretroviral medications taken in combination with Ritonavir Accord.

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

Your doctor will indicate the appropriate dose that you should take.

You must take Ritonavir Accord every day to control HIV, regardless of how you feel. If any side effect prevents you from taking Ritonavir Accord as instructed, inform your doctor immediately. During diarrhea episodes, your doctor may decide that you need additional monitoring.

Always have a sufficient amount of Ritonavir Accord on hand so that you do not run out. When traveling or needing to stay in the hospital, check that 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 that you have taken more Ritonavir Accord than you should, contact your doctor or the nearest hospital's Emergency Service immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Ritonavir Accord

If you have forgotten to take a dose, take it as soon as possible. If the time for the next dose is near, take only one dose.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Ritonavir Accord

Although you may feel better, do not stop taking Ritonavir Accord without consulting your doctor.

If you take Ritonavir Accord as instructed, you will have a greater chance of delaying the development of resistance to this medication.

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

Like all medications, Ritonavir Accord can produce side effects, although not everyone will experience them.

When Ritonavir Accord is used with other antiretroviral medications, side effects also depend on those other medications. That's why it's very important to read carefully the adverse reactions section of the prospectus for these medications.

Inform your doctor if you feel dizzy (nausea), are vomiting, or have stomach pain, as these may be symptoms of pancreatitis. 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 section2. What you need to know before starting to take Ritonavir Accord.

There have been cases of increased bleeding in patients with hemophilia A and B during treatment with this or another protease inhibitor. If this happens to you, consult your doctor immediately.

There have been reports of patients taking Ritonavir Accord experiencing changes in liver function tests, hepatitis (liver inflammation), and rare cases of jaundice. Some people had another disease or were taking other medications. Some people with liver disease or hepatitis may have worsened.

There have been reports of muscle pain, discomfort, or weakness, particularly when taking cholesterol-lowering medications in combination with antiretroviral therapy, including protease inhibitors and nucleoside analogs. In rare cases, these muscle disorders were severe (rhabdomyolysis). In the case of muscle pain, discomfort, weakness, or cramps of unknown or continuous cause, stop taking the medication, contact your doctor as soon as possible, or go to the nearest hospital emergency room.

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 that any of the side effects you are experiencing is severe or if you notice any side effect not mentioned in this prospectus, inform your doctor, pharmacist, go to the emergency room, or, if urgent, seek immediate medical help.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it's a possible side effect that doesn't appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:

https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the box and on the bottle after CAD. The expiration date is the last day of the month indicated.

Once the bottle is opened, use within the next 4 months.

Store below 25°C

Medicines should not be thrown down the drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Ritonavir Accord

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

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

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

Appearance of the product and content of the container

The film-coated tablets of Ritonavir Accord are white or pale yellowish, in capsule shape, and marked with “H” on one face and “R9” on the other face.

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

Container sizes:

HDPE bottle: 30, 90, and 120 tablets.

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

Only some container 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 responsible:

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park, Paola

Malta

This leaflet has been revised in: January 2025

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS):http://www.aemps.gob.es/