Active ingredient
- atazanavir sulfate
- cobicistat
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: EU/1/15/1025/001, EU/1/15/1025/002.
EVOTAZ 300 mg/150 mg film-coated tablets
Package leaflet: Information for the user
EVOTAZ 300 mg/150 mg film-coated tablets
atazanavir/cobicistat
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What EVOTAZ is and what it is used for
2. What you need to know before you take EVOTAZ
3. How to take EVOTAZ
4. Possible side effects
5. How to store EVOTAZ
6. Contents of the pack and other information
1. What EVOTAZ is and what it is used for
EVOTAZ contains two active substances:
EVOTAZ may be used by adults aged 18 years of age and older who are infected with HIV, the virus that causes acquired immunodeficiency syndrome (AIDS). It is used in combination with other anti-HIV medicines to help control your HIV infection. Your doctor will discuss with you which combination of these medicines with EVOTAZ is best for you.
2. What you need to know before you take EVOTAZ
Do not take EVOTAZ
Do not take sildenafil with EVOTAZ when sildenafil is used for the treatment of pulmonary arterial hypertension. Sildenafil is also used for the treatment of erectile dysfunction. Tell your doctor if you are using sildenafil for the treatment of erectile dysfunction.
Tell your doctor at once if any of these apply to you.
Warnings and precautions
Some people will need special care before or while taking EVOTAZ. Talk to your doctor or pharmacist before taking EVOTAZ.
EVOTAZ is not a cure for HIV infection. You may continue to develop infections or other illnesses linked to HIV infection. You can still pass on HIV to other people when taking this medicine, although the risk is lowered by effective antiretroviral therapy. Discuss with your doctor the precautions needed to avoid infecting other people.
Make sure your doctor knows:
In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is believed that these symptoms are due to an improvement in the body’s immune response, enabling the body to fight infections that may have been present with no obvious symptoms. If you notice any symptoms of infection, please inform your doctor immediately. In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection. Autoimmune disorders may occur many months after the start of treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment.
Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease. Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement. If you notice any of these symptoms please inform your doctor.
Hyperbilirubinaemia (an increase in the level of bilirubin in the blood) has occurred in patients receiving EVOTAZ. The signs may be a mild yellowing of the skin or eyes. If you notice any of these symptoms please inform your doctor.
Serious skin rash, including Stevens-Johnson syndrome, may develop in patients taking EVOTAZ. If you develop a rash inform your doctor immediately.
EVOTAZ may affect how well your kidneys work.
If you notice a change in the way your heart beats (heart rhythm changes), please inform your doctor.
Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age. The use of EVOTAZ in children and adolescents has not yet been studied.
Other medicines and EVOTAZ
You must not take EVOTAZ with certain medicines. These are listed under Do not take EVOTAZ, at the start of section 2.
There are other medicines that may not be taken together or may require a change in their mode of administration when taken with EVOTAZ. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. It is especially important to mention these:
It is important to tell your doctor if you are taking: Corticosteroids including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone. These medicines are used to treat allergies, asthma, inflammatory bowel diseases, inflammatory conditions of the eyes, joints and muscles and other inflammatory conditions. If alternatives cannot be used, its use should only take place after medical evaluation and under close monitoring by your doctor for corticosteroid side effects.
Pregnancy and breast-feeding
EVOTAZ should not be used during pregancy, because the drug levels in your blood may be lower during pregancy and may no longer be high enough to control HIV. Your doctor may prescribe different medicines if you become pregnant while taking EVOTAZ.
Atazanavir, a component of EVOTAZ is excreted in human milk. It is unknown if cobicistat, the other component of EVOTAZ, is excreted in human milk but it has been shown in animals that it is excreted in milk. Talk to your doctor about breast-feeding if you are taking EVOTAZ. Patients should not breast-feed while taking EVOTAZ. It is recommended that women infected with HIV do not breast-feed because the virus might be transmitted through the breast milk.
Driving and using machines
Some patients have reported dizziness when taking atazanavir or cobicistat, active substances of EVOTAZ. If you feel dizzy or lightheaded, do not drive, use any tools or use machines and contact your doctor immediately.
3. How to take EVOTAZ
Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. This way, you can be sure your medicine is fully effective and you reduce the risk of the HIV-virus developing resistance to the treatment.
The recommended adult dose of EVOTAZ is one tablet daily by mouth and with food, in combination with other anti-HIV medicines. The tablets have a poor taste, therefore swallow the tablet whole; do not crush or chew the tablets. This will help ensure you get the full dose.
If you take more EVOTAZ than you should
If you accidentally take more EVOTAZ than your doctor recommended, contact your doctor at once or contact the nearest hospital for advice.
If you forget to take EVOTAZ
If you miss a dose of EVOTAZ by 12 hours or less, take it right away with food and then take your next scheduled dose at the usual time. If you miss a dose and it is more than 12 hours from the time you should have taken EVOTAZ, do not take the missed dose. Wait and take the next dose at the usual time. Do not double the next dose. It is important that you do not miss any doses of EVOTAZ or your other anti-HIV medicines.
If you stop taking EVOTAZ
Do not stop taking EVOTAZ before talking to your doctor.
If you have any further questions on the use of this medicine, ask your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor if you notice anything unusual about your health.
The following side effects may occur when taking EVOTAZ
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves. Your doctor will test for these changes.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
Malta
United Kingdom
Yellow Card Scheme
Website: at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
5. How to store EVOTAZ
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 label and carton after EXP. The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What EVOTAZ contains
What EVOTAZ looks like and contents of the pack
EVOTAZ film-coated tablets are pink, oval, biconvex, of approximate dimensions of 19 mm x 10.4 mm, debossed on one side with "3641" and plain-faced on the other side of the tablet.
EVOTAZ film-coated tablets are supplied in bottles of 30 tablets. The following pack sizes are available: outer cartons containing 1 bottle of 30 film-coated tablets and outer cartons containing 90 (3 bottles of 30) film-coated tablets.
Not all packages may be marketed in your country.
Marketing Authorisation Holder
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in April 2020
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
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