100 mg film-coated tablets
ritonavir
Ritonavir Mylan contains the active substance ritonavir. Ritonavir is a protease inhibitor and is used to control HIV infection. Ritonavir Mylan 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 Mylan is used by children 2 years of age or older, adolescents, and adults infected with HIV, the virus that causes AIDS.
- 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 (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 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)
- quetiapine (used to treat schizophrenia, bipolar disorder, and major depression)
- lurasidone (used to treat depression)
- ranolazine (used to treat chronic chest pain [angina])
- pethidine, piroxicam, propoxyphene (used to relieve pain)
- 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 have a lung disease called pulmonary arterial hypertension which causes difficulty breathing. Patients who do not have this disease can use sildenafil for impotence ( erectile dysfunction ) under the supervision of a doctor (see section Other medicines and Ritonavir Mylan )
- avanafil or 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 Mylan )
- products containing St. John’s wort ( Hypericum perforatum ) as these may prevent ritonavir 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 ritonavir as a booster (lower dose ), but a full dose of ritonavir 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 Mylan.
Also, read the list of medicines under “Other medicines and Ritonavir Mylan” when using certain medicines that require special care.
Warnings and cautions
Talk to your doctor before taking Ritonavir Mylan.
Important information
- If you are taking Ritonavir Mylan in combination with other antiretroviral medicines, it is important that you also read the package leaflets that come with these medicines. There may be additional information on situations when Ritonavir Mylan should be avoided. If you have any further questions on the use of Ritonavir Mylan (ritonavir) or the other medicines, contact your doctor or pharmacist.
- Ritonavir Mylan does not cure HIV infection or AIDS.
- People taking Ritonavir Mylan may still develop infections or other illnesses associated with HIV or AIDS. It is therefore important that your doctor monitors you while you are taking Ritonavir Mylan.
- You can still transmit HIV infection while taking this medicine, even though the risk of effective antiretroviral therapy is reduced. Discuss the necessary steps to avoid infecting others with your doctor.
Tell your doctor if you have/had:
- Liver disease.
- Hepatitis B or C and treated with a combination of antiretroviral drugs, as 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 an increased tendency to bleed in patients with hemophilia taking this type of medicine ( protease inhibitor ). The reason for this is not known. You may need additional medicines to help the blood coagulate ( factor VIII ), 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 get better (permanent), as may reduce the effect of the medicines you are taking.
- Nausea, vomiting, or abdominal pain, as these may be signs of inflammation of the pancreas ( pancreatitis ). Some patients taking ritonavir may develop severe pancreatic problems. Tell your doctor as soon as possible if this applies to you.
- Symptoms of infection – contact a 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, autoimmune diseases (a condition that occurs when the immune system attacks healthy body tissue) can also occur after you start taking medicines to treat 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, a 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.
- Stiffness in joints, pain, and aches (especially in the hips, knees, and shoulders), and difficulty moving, tell a doctor as this may be a sign of a disease that can destroy bones ( osteonecrosis ). Some patients receiving multiple antiretroviral drugs may develop this disease.
- Muscle aches, soreness, or weakness, especially in combination with antiretroviral therapy that includes protease inhibitors and nucleoside analogs. In rare cases, these muscle problems have been severe. (See section 4. Possible side effects ) .
- Dizziness, fainting, fainting, or abnormal heartbeat. Some patients taking Ritonavir Mylan may experience electrocardiogram ( ECG ) changes. Tell your doctor if you have a heart defect or conduction defect in the heart.
- If you have any other questions concerning your health, discuss these with your doctor as soon as possible.
Children and young people
Ritonavir Mylan is not recommended for use in children below 2 years of age.
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 Mylan. These are listed earlier in section 2, under “Do not take Ritonavir Mylan”. Some other medicines can only be used in the specific circumstances described below.
The following warnings apply when Ritonavir Mylan is taken as a full dose. These warnings may also apply when Ritonavir Mylan is used at a lower dose (enhancer) than 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 must not take Ritonavir Mylan with sildenafil if you have pulmonary arterial hypertension (high blood pressure in the blood vessels of the lungs) (see also section 2, “ What you need to know before you or your child take Ritonavir Mylan” ). Tell your doctor if you are taking tadalafil for pulmonary arterial hypertension.
- Colchicine (for gout ) as ritonavir may increase the levels of this medicine in the blood. You must not take Ritonavir Mylan with colchicine if you have kidney and/or liver problems (see also “ Do not take Ritonavir Mylan” above).
- Digoxin (heart medicine). Your doctor may need to adjust your digoxin dose and monitor you while you are taking digoxin and Ritonavir Mylan to avoid heart problems.
- Hormonal contraceptives containing Ethinyl estradiol, such as ritonavir 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 Mylan.
- Atorvastatin or rosuvastatin (for high cholesterol ), as ritonavir may increase the levels of these medicines in the blood. Talk to your doctor before taking any cholesterol-lowering medicine with Ritonavir Mylan (see also ‘ Do not take Ritonavir Mylan’ above).
- Steroids (eg dexamethasone, fluticasone propionate, prednisolone, triamcinolone ), as ritonavir may increase the levels of these drugs in the blood, which may lead to Cushing’s syndrome (development of a round face) and decrease the production of the hormone et cortisol. Your doctor may reduce the steroid dose or monitor your side effects more closely.
- Trazodone (an antidepressant), as side effects such as nausea, dizziness, low blood pressure, and fainting may occur while taking Ritonavir Mylan at the same time.
- Rifampicin and saquinavir (used to treat tuberculosis and HIV, respectively ), as severe liver damage can occur if Ritonavir Mylan is taken at the same time.
- Bosentan, riociguat (used to treat pulmonary arterial hypertension ), and ritonavir may increase the levels of this medicine in the blood.
Some medicines may not be taken with ritonavir as their effects may increase or decrease when taken together. In some cases, your doctor may need to take some tests, change your dose 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. It is especially important to mention these:
- amphetamine or amphetamine derivative
- antibiotics (eg erythromycin, clarithromycin)
- cancer drugs (eg abemaciclib, afatinib, apalutamide, ceritinib, encorafenib, dasatinib, ibrutinib, nilotinib, venetoclax, vincristine, vinblastine)
- medicines to treat platelet deficiency (eg fostamatinib)
- anticoagulants (eg rivaroxaban, vorapaxar, warfarin )
- antidepressant drugs (eg amitriptyline, desipramine, fluoxetine, imipramine, nefazodone, nortriptyline, paroxetine, sertraline, trazodone)
- antifungals (eg ketoconazole , itraconazole)
- antihistamines are (eg loratadine , fexofenadine)
- antiretroviral drugs including HIV – protease inhibitors (amprenavir, atazanavir, darunavir, fosamprenavir, indinavir, nelfinavir, saquinavir, tipranavir), non-nucleoside reverse transcriptase inhibitors (NNRTIs) (delavirdine, never, aspirin, efavirenz, nevirapine,
- 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
- drugs for asthma, theophylline, salmeterol
- atovaquone, a drug used to treat 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 medicines (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 (for the treatment of 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 Mylan. These are listed earlier in section 2 under “Do not take Ritonavir Mylan”.
Ritonavir Mylan 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 Ritonavir Mylan) during pregnancy. After the first three months of pregnancy, pregnant women generally received a lower dose of ritonavir (as an enhancer) than other protease inhibitors. Ritonavir Mylan did not appear to increase the risk of malformations compared to the rest of the population.
Ritonavir passes into breast milk. To avoid transmitting the infection, women with HIV infection should not breast – feed their children.
Driving and using machines
Ritonavir Mylan may cause dizziness. If you are affected, do not drive or use machines.
This medicine contains 87.75 mg of sodium in each tablet. This corresponds to 4.4% of the maximum recommended sodium intake for an adult. Talk to your doctor or pharmacist if you need five or more tablets daily for an extended period, especially if you have been prescribed a low-salt diet (low in sodium).
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 Mylan tablets must be swallowed whole and not chewed, divided, or crushed.
The recommended dose of Ritonavir Mylan is:
- If Ritonavir Mylan is used to potentiate the effects of certain other medicines against HIV, the usual dose is one for 1-2 tablets for adults once or twice a day. For more detailed dosing recommendations, including those for children, see the package leaflets of the other anti- HIV medicines that Ritonavir Mylan is given.
- 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 and gradually increase the dose over 14 days to a full dose of 6 tablets twice daily (a total of 1,200 mg per day). Children (2-12 years) start with a smaller dose and continue up to the maximum allowable dose for their size.
Your doctor will tell you which dose to take.
Other forms of this medicine may be more suitable for children who have difficulty swallowing tablets.
Ritonavir Mylan should be taken every day to help keep your HIV infection under control, no matter how much better you feel. If a side effect prevents you from taking Ritonavir Mylan as directed, tell your doctor straight away. During periods of diarrhea, your doctor may decide that extra checks are needed.
Always have enough Ritonavir Mylan on hand so that it does not run out. When you travel or need to be hospitalized, make sure you have enough Ritonavir Mylan enough to take more.
Numbness, tingling, or ant crawling may occur if you take too much Ritonavir Mylan. If you find that you have taken more Ritonavir Mylan than you should, contact a doctor immediately or go to the nearest emergency department.
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.
Even if you feel better, do not stop taking Ritonavir Mylan without talking to your doctor. Taking Ritonavir Mylan as recommended gives 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 can sometimes be a connection 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 Mylan is used with other antiretroviral medicines, the side effects are also dependent on the other medicines. Therefore, it is important that you carefully read the side effects section of the package leaflets that come with these medicines.
Very common: may affect more than 1 user in 10
| pain in the upper or lower abdomenvomitingdiarrhea (may be severe)cause redness , feeling of heat tingling or numbness in the hands, feet, or around the lips and mouth weakness, feeling tired bad taste in the mouth | headachedizzinesssore throatcoughindigestionnerve damage that can cause weakness or painitchingrashjoint and back pain |
Common: may affect up to 1 in 10 users
| allergic reactions including rash (may be red, raised, itchy), severe swelling of the skin and other tissues difficulty sleeping (insomnia)concern elevated cholesterol elevated triglycerides _goutgastric haemorrhagehepatitis and yellowing of the skin or whites of the eyes more frequent urinationrenal impairmentcrampsdecreased platelet countthirst (dehydration)abnormally abundant menstruation | weather voltage loss of appetite could sore muscle pain, tenderness or weakness fever weight loss laboratory tests: changes in blood test results (eg chemical composition of substances in the blood and number of blood cells)confusion difficulty maintaining attentionfaintingdimsynswelling in hands and feet high blood pressure low blood pressure and fainting when getting up cold hands and feet ache |
Uncommon: may affect up to 1 in 100 people
| heart attack diabetes | kidney failure |
Rare: may affect up to 1 in 1,000 people
| severe or life-threatening skin reactions including blisters (Stevens-Johnson syndrome, toxic epidermal necrolysis ) | severe allergic reactions ( anaphylaxis )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 take Ritonavir Mylan”.
In patients with hemophilia type A and B, there have been reports of an increased tendency to bleed when taking this medicine or other protease inhibitors. If this happens to you, talk to your doctor straight away.
Abnormal liver function tests, hepatitis (hepatitis), and, in rare cases, jaundice has been reported in patients taking Ritonavir Mylan. Some people had other illnesses or took other medications. People who already have liver disease or hepatitis may get worse.
There have been reports of muscle pain, tenderness, or muscle weakness, especially with concomitant cholesterol-lowering drugs and 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 as soon as possible if you get any symptoms that indicate an allergic reaction after taking Ritonavir Mylan, such as itching, hives, 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, pharmacist, or emergency department or seek medical advice immediately.
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 or canister after EXP. The expiration date is the last day of the specified month.
For HDPE can: Opened packaging must be used within 45 days.
Do not store above 30 ° C. Store in the original package. Moisture sensitive.
Medicines should not be disposed of via wastewater. 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 in the tablet are copovidone, sorbitan laurate, anhydrous colloidal silica, sodium chloride, and sodium stearyl fumarate. See section 2 ‘Ritonavir Mylan contains sodium’.
- The coating of the tablet consists of hypromellose, titanium dioxide (E171), macrogols, hydroxypropylcellulose, talc, yellow iron oxide (E172), anhydrous colloidal silica, polysorbate 80.
What the medicine looks like and the contents of the pack
Ritonavir Mylan film-coated tablets are yellow, capsule-shaped, biconvex with beveled edges and marked with “M163” on one side and glossy on the other side.
Ritonavir Mylan film-coated tablets are supplied in plastic cans with screw caps and aluminum closures and wadding containing 30, 90, or 100 tablets and a multipack containing 90 tablets consisting of 3 cans of 30 tablets each. The jars also contain a desiccant. The desiccant must not be consumed.
Also available in blister packs containing 30 and 90 tablets and in perforated unit dose blisters containing 30×1 and 90×1 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan Pharmaceuticals Limited
Damastown Industrial Park,
Mulhuddart, Dublin 15,
DUBLIN
Ireland
Manufacturer
McDermott Laboratories Limited trading as Gerard Laboratories trading as Mylan Dublin,
Unit 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13,
Ireland
Mylan Hungary Kft,
Mylan utca 1, Komárom, H-2900
Hungary
Mylan Germany GmbH
Branch release Bad Homburg vd Hoehe
Benzstrasse 1
Bad Homburg vd Hoehe
Hessen, 61352
Germany