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 is: PLGB 15105/0138.
Reyataz 150 mg Hard Capsules
REYATAZ 150 mg hard capsules
1. What REYATAZ is and what it is used for
2. What you need to know before you take REYATAZ
3. How to take REYATAZ
4. Possible side effects
5. How to store REYATAZ
6. Contents of the pack and other information
REYATAZ is an antiviral (or antiretroviral) medicine. It is one of a group called protease inhibitors. These medicines control Human Immunodeficiency Virus (HIV) infection by stopping a protein that the HIV needs for its multiplication. They work by reducing the amount of HIV in your body and this in turn, strengthens your immune system. In this way REYATAZ reduces the risk of developing illnesses linked to HIV infection.
REYATAZ capsules may be used by adults and children 6 years of age and older. Your doctor has prescribed REYATAZ for you because you are infected by the HIV that causes Acquired Immunodeficiency Syndrome (AIDS). It is normally used in combination with other anti-HIV medicines. Your doctor will discuss with you which combination of these medicines with REYATAZ is best for you.
Do not take sildenafil with REYATAZ 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.
REYATAZ 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 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.
Some people will need special care before or while taking REYATAZ. Talk to your doctor or pharmacist before taking REYATAZ and make sure your doctor knows:
REYATAZ may affect how well your kidneys work.
Kidney stones have been reported in patients taking REYATAZ. If you develop signs or symptoms of kidney stones (pain in your side, blood in your urine, pain when you urinate), please inform your doctor immediately.
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 REYATAZ. 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, has been reported in patients taking REYATAZ. If you develop a rash inform your doctor immediately.
If you notice a change in the way your heart beats (heart rhythm changes), please inform your doctor. Children receiving REYATAZ may require their heart to be monitored. Your child's doctor will decide this.
Do not give this medicine to children younger than 3 months of age and weighing less than 5 kg. The use of REYATAZ in children less than 3 months of age and weighing less than 5 kg has not been studied due to the risk of serious complications.
You must not take REYATAZ with certain medicines. These are listed under Do not take REYATAZ, at the start of Section 2.
There are other medicines that may not mix with REYATAZ. Tell your doctor if you are taking, have recently taken, or might take any other medicines. It is especially important to mention these:
Some medicines may interact with ritonavir, a medicine that is taken with REYATAZ. It is important to tell your doctor if you are taking fluticasone or budesonide (given by nose or inhaled to treat allergic symptoms or asthma).
It is important that you take REYATAZ with food (a meal or a substantial snack) as this helps the body absorb the medicine.
If you are pregnant or breast-feeding, think that you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Atazanavir, the active substance of REYATAZ, is excreted in human milk. Patients should not breast-feed while taking REYATAZ. It is recommended that women infected with HIV do not breast-feed because the virus might be transmitted through the breast milk.
If you feel dizzy or lightheaded, do not drive or use machines and contact your doctor immediately.
If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicinal product.
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 virus developing resistance to the treatment.
The recommended adult dose of REYATAZ capsules is 300 mg once daily with 100 mg ritonavir once daily and with food, in combination with other anti-HIV medicines. Your doctor may adjust the dose of REYATAZ according to your anti-HIV therapy.
For children (6 to less than 18 years of age), your child's doctor will decide the right dose based on your child's weight. The dose of REYATAZ capsules for children is calculated by body weight and is taken once daily with food and 100 mg ritonavir as shown below:
Body Weight (kg) - REYATAZ Dose once daily (mg) - Ritonavir Dose* once daily (mg)
15 to less than 35 - 200 - 100
at least 35 - 300 - 100
*Ritonavir capsules, tablets or oral solution may be used.
REYATAZ is also available as an oral powder for use in children at least 3 months old and weighing at least 5 kg. Switching to REYATAZ capsules from REYATAZ oral powder is encouraged as soon as patients are able to consistently swallow capsules.
A change in dose may occur when switching between oral powder and capsules. Your doctor will decide the right dose based on your child’s weight.
There are no dosing recommendations for REYATAZ in paediatric patients less than 3 months of age.
Take REYATAZ capsules with food (a meal or a substantial snack). Swallow the capsules whole. Do not open the capsules.
Yellowing of the skin and/or eyes (jaundice) and irregular heart beat (QTc prolongation) may occur if you or your child take too much REYATAZ.
If you accidentally take more REYATAZ capsules than your doctor recommended, contact your HIV doctor at once or contact the nearest hospital for advice.
If you miss a dose, take the missed dose as soon as possible with food and then take your next scheduled dose at its regular time. If it is almost time for your next dose, do not take the missed dose. Wait and take the next dose at its regular time. Do not take a double dose to make up for a forgotten dose.
Do not stop taking REYATAZ before talking to your doctor.
If you have any further questions on the use of this medicine, ask your doctor.
Like all medicines, this medicine can cause side effects, although not everybody gets them. When treating HIV infection, it is not always easy to identify what side effects are caused by REYATAZ, by the other medicines you are taking, or by the HIV infection itself. Tell your doctor if you notice anything unusual about your health.
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.
Tell your doctor immediately if you develop any of the following serious side effects:
Other side effects reported for patients treated with REYATAZ are the following:
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):
If you get any side effects, talk to your doctor or nurse. 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.
or search for MHRA Yellow Card in the Google Play or Apple App Store
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, carton or blister. The expiry date refers to the last day of that month.
Do not store above 25°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.
Each capsule of REYATAZ 150 mg contains 150 mg atazanavir.
Opaque blue and powder blue capsule printed with white and blue inks, with "BMS 150 mg" on one half and with "3624" on the other half.
REYATAZ 150 mg hard capsules are supplied in bottles of 60 capsules.
REYATAZ 150 mg hard capsules are also supplied in blister strips in packs of 60 capsules.
Not all pack sizes may be marketed in all countries.
For any further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in August 2020
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.