200 mg and 300 mg hard capsules
atazanavir
Atazanavir Accord is an antiviral (or antiretroviral ) medicine. It belongs to a group called protease inhibitors, which control human immunodeficiency virus ( HIV)
-Infektionen by blocking a protein that HIV – virus et require to multiply. They work by reducing the number of HIV – the virus in the blood and this, in turn, strengthens your immune system. In this way, Atazanavir Accord reduces the risk of developing HIV-related diseases.
Atazanavir Accord capsules can be used by adults and children 6 years and older. Your doctor has prescribed Atazanavir Accord for you because you are infected with HIV which may cause Acquired Immune Deficiency Syndrome ( AIDS ). It is usually prescribed together
with other anti- HIV drugs. Your doctor will discuss with you which
combinations of these medicines which together with Atazanavir Accord are best for you.
Atazanavir contained in the Atazanavir Accord may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
- if you are allergic (hypersensitive) to atazanavir or any of the other ingredients in this medicine (listed in section 6).
- if you have moderate to severe liver problems. Your doctor will assess how severe your liver disease is before deciding if you can take the Atazanavir Accord.
- if you are taking any of these medicines: see also Other medicines and Atazanavir Accord
- rifampicin, (an antibiotic used to treat tuberculosis)
- astemizole or terfenadine (often used to treat allergic symptoms, these medications may be over-the-counter); cisapride (used to treat acid reflux [heartburn]); pimozide (used to treat schizophrenia); quinidine or bepridil (used to correct heart rhythm); ergotamine, dihydroergotamine, ergonovine, methylergonovine (used to treat headaches) and alfuzosin (used to treat prostate enlargement)
- quetiapine (used to treat schizophrenia, bipolar disorder, and severe Depression); lurasidone (used to treat schizophrenia)
- medicines containing St. John’s wort (Hypericum perforatum, a herbal medicine)
- triazolam and orally (taken by mouth) midazolam (used as a sleeping pill) and/or to reduce concerns).
- simvastatin and lovastatin (used to lower blood cholesterol)
- products containing grazoprevir, including a fixed-dose combination of elbasvir and grazoprevir, and the fixed-dose combination of glecaprevir and pibrentasvir (used to treat chronic hepatitis C infection )
Do not take sildenafil with Atazanavir Accord when sildenafil is used to treat pulmonary arterial hypertension. Sildenafil is also used to treat
erectile dysfunction. Tell your doctor if you are using sildenafil to treat erectile dysfunction.
Tell your doctor immediately if this applies to you.
Warnings and cautions
Talk to your doctor or pharmacist before taking Atazanavir Accord.
Atazanavir Accord is not a cure for HIV infection. You can continue to
develop infections or other diseases associated with HIV. You can
still transmit HIV infection when you take this medicine, although the risk is reduced with effective antiviral treatment. Discuss with your doctor the necessary steps to avoid infecting others.
For some people, special consideration may need to be given before or when taking Atazanavir Accord. Talk to your doctor or pharmacist before taking Atazanavir Accord and make sure your doctor knows the following:
- if you have hepatitis B or C
- if you develop signs or symptoms of gallstones (pain on the right side of your stomach)
- if you have hemophilia A or B
- if you need hemodialysis.
Atazanavir Accord may affect the way your kidneys function.
Kidney stones have been reported in patients taking atazanavir. Inform your doctor
immediately if you develop signs and symptoms of kidney stones (pain in the side,
blood in the urine, pain when urinating).
In some patients with advanced HIV – infection ( AIDS ) and a history of opportunistic infection, you ( the infection you incurred because the immune system is impaired), signs and symptoms of inflammation from previous infections may occur soon after anti- HIV started. These symptoms are probably due to an improvement in the body’s immune response, which enables the body to fight infections that may have been present without any obvious symptoms. Tell your doctor immediately if you notice any symptoms of infection. except for
opportunistic infection, you can autoimmune disorders (a condition in which the immune system attacks healthy body tissue) may also occur after you start taking medicines to treat your 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, weakness starting in the hands or
feet and moving towards the torso, palpitations, trembling or hyperactivity,
Inform your doctor immediately to get the necessary treatment.
Some patients taking combination antiretroviral therapy may develop one
a bone disease called osteonecrosis (bone tissue dies due to lost blood supply to the bone). Some of the many risk factors for developing the disease are long-term antiretroviral combination therapy, use of corticosteroids, alcohol consumption, a severe weakening of the immune system, and higher body mass index. Signs of osteonecrosis are stiffness in the joints and pain (especially in the hip, knee, and shoulders) and difficulty moving. Tell your doctor if you experience
some of these symptoms.
Increased levels of bile dye in the blood (hyperbilirubinemia) have occurred in patients receiving atazanavir. Signs of this may be a mild yellowing of the skin or eyes.
Tell your doctor if you experience any of these symptoms.
Severe rash including Stevens-Johnson syndrome has been reported in patients
who are taking atazanavir. Tell your doctor immediately if you develop a skin rash.
If you experience that your heart beats differently (changes in heart rhythm), talk about it
to your doctor. Children receiving atazanavir may need their heart monitored. This
determined by your child’s doctor.
Children
Do not give this medicine to children younger than 3 months and weighing less than 5 kg. The use of atazanavir in children less than 3 months of age and weighing
less than 5 kg have not been studied due to the risk of serious complications.
You must not take Atazanavir Accord with certain medicines. These stand
listed under the Do not take Atazanavir Accord, at the beginning of section 2.
There are other medicines that may not be taken with Atazanavir Accord. Tell your doctor or pharmacist if you are taking, have recently taken
or may take other medicines. It is especially important to mention these:
- other medicines to treat HIV infection (eg indinavir, nevirapine and efavirenz).
- boceprevir and sofosbuvir / velpatasvir / voxilaprevir (used to treat hepatitis C)
- sildenafil, vardenafil, or tadalafil (used by men to treat impotence[erectile dysfunction])
- if you are taking oral contraceptives ( p pills ) with atazanavir Accord to prevent pregnancy you should take it exactly as instructed by your doctor and not miss any dose
- medicines used to treat diseases related to the acid in the stomach (eg antacids to be taken 1 hour before or 2 hours after administration of Atazanavir Accord, H 2blockers such as famotidine and proton pump inhibitors such as for example omeprazole)
- medications that lower blood pressure, reduce heart rate, or affect the heart rhythm ( amiodarone, diltiazem, systemic lidocaine, verapamil)
- atorvastatin, pravastatin, and fluvastatin (used to lower cholesterol)in the blood)
- salmeterol (used to treat asthma)
- cyclosporine, tacrolimus, and sirolimus (medicines that reduce the effects of the body’s immune system)
- certain antibiotics (rifabutin, clarithromycin)
- ketoconazole, itraconazole, and voriconazole (antifungal)
- warfarin ( anticoagulants, used to prevent blood clots)
- carbamazepine, phenytoin, phenobarbital, lamotrigine (used to treat epilepsy)
- irinotecan (used to treat cancer)
- sedatives (eg midazolam given as an injection)
- buprenorphine (used to treat opioid abuse and pain).
Some medicines can be affected by ritonavir, a medicine that is taken with Atazanavir Accord. It is important to tell your doctor if you are taking fluticasone or
budesonide (given by the nose or inhaled to treat allergic symptoms or asthma).
It is important that you take Atazanavir Accord with food (a meal or a hearty one)
snack) as this helps the body absorb the medicine.
Pregnancy and breastfeeding
If you are pregnant, breast-feeding, think you may be pregnant, or are planning to have a baby,
consult a doctor before using this medicine. Atazanavir, the active substance in Atazanavir Accord, is excreted in human milk. Patients should not breast-feed while taking Atazanavir Accord. Women infected with HIV are advised not to breast-feed as the virus can be transmitted through breast milk.
Driving and using machines
Do not drive or use machines if you feel dizzy or faint and
contact your doctor immediately.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
If you have been told by your doctor that you have an intolerance to some sugars (eg lactose ), contact your doctor before taking this medicine.
Atazanavir Accord 200 mg hard capsules and Atazanavir Accord 300 mg hard capsules: para ‑ orange FCF (E110) may cause allergic reactions.
Always take this medicine exactly as your doctor has told you. Consult a doctor or
pharmacy staff if you are unsure. This way you can be sure that you get full effect
of your medicine and reduces the risk of the virus developing resistance to treatment.
The recommended dose of Atazanavir Accord for adults is 300 mg once
daily with 100 mg ritonavir and with food and in combination with other anti- HIV medicines. Your doctor may adjust the dose of Atazanavir Accord depending on the anti- HIV treatment you are taking.
For children (from 6 to less than 18 years of age), your child’s doctor will determine the dose based on your child’s weight. The dose of Atazanavir Accord capsules for children is calculated from the outside
body weight and taken once daily with food and 100 mg ritonavir as shown below:
| Bodyweight (kg) | Atazanavir Accord 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 can be used. |
Other forms of this medicine may be available for use in children
who are at least 3 months old and weigh at least 5 kg. Switching to capsules from other dosage forms is encouraged as soon as the patient is inclined to swallow capsules.
A dose change may be necessary when switching between oral powder and capsules.
Your doctor will decide the right dose based on your child’s weight.
There are no dose recommendations for atazanavir in children less than 3 months of age.
Take Atazanavir Accord capsules with food (a meal or a hearty snack).
Swallow the capsules whole. Do not open the capsules.
Yellowing of the skin and/or eyes (jaundice) and irregular heartbeat
(QTc prolongation) may occur if you or your child take too much Atazanavir Accord.
If you accidentally take more Atazanavir Accord capsules than recommended,
contact your HIV doctor immediately or contact your nearest hospital for advice.
If you forget to take a dose, take it with you as soon as possible
food and then take the next dose at the usual time. If it’s almost time for your next dose,
do not take the missed dose. Wait and take the next dose at the usual time. Do not take a double dose
to compensate for a missed dose.
Do not stop taking Atazanavir Accord before talking to your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Atazanavir Accord can cause side effects, although not everybody gets them. When treating HIV infection, it is difficult to know which ones
side effects caused by Atazanavir Accord, of the other medicines you are taking, or by the HIV – infection a. Tell your doctor if you notice anything unusual about your health.
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
In the case of blood lipids, there may sometimes be a link with HIV drugs. The doctor will perform tests to find such changes.
Talk to your doctor immediately if you develop any of the following serious side effects:
- Skin rash, itching that can sometimes be severe have been reported. The rash disappear usually within 2 weeks without any change in your Atazanavir Accord treatment. A severe rash can develop along with other symptoms that can be severe. Stop taking Atazanavir Accord and talk to your doctor immediately you get severe rash or rash with flu-like symptoms, blisters, fever, cold sores, muscle or joint pain, swelling of the face, inflammation of the eye that causes redness ( conjunctivitis ), pain, hot, or red bumps ( nodules).
- Yellowing of the skin or the white part of your eyes caused by high levels of bilirubin in the blood has been reported as common. This side effect is usually not dangerous in adults and children older than 3 months but could be a symptom of a serious problem. About your skin or the white part of your eyes turns yellow, talk to your doctor immediately.
- Changes in how your heart beats (changes in heart rate) can sometimes occur. Talk to your doctor immediately if you become dizzy, or if you suddenly faint. These can be symptoms of a serious heart problem.
- Liver problems are less common. Your doctor should do blood tests before you start taking Atazanavir Accord and during treatment. If you have liver problems including hepatitis B or C‑ infection, you may experience a worsening of your liver problems. Talk to your doctor immediately if you get dark (tea-colored) urine, itching, yellowing of the skin or the white part of your eyes, pain around the abdomen, pale stools, or nausea.
- Gallbladder problems are less common in people taking atazanavir. Symptoms of gallbladder problems may include pain in the right or middle of the upper abdomen, nausea, vomiting, fever, or yellowing of the skin or the white part of the eyes.
- Atazanavir Accord may affect the way your kidneys function.
- Kidney stones are less common in people taking atazanavir. Talk to your doctor immediately if you get symptoms of kidney stones which may include pain in the lower back or lower abdomen, blood in the urine, or pain when urinating.
Other side effects reported in patients treated with Atazanavir Accord:
Common (may affect up to 1 in 10 people):
- headache
- vomiting, diarrhea, stomach pain, nausea, dyspepsia (indigestion)
- extreme fatigue.
Uncommon (may affect up to 1 in 100 people):
- peripheral neuropathy (numbness, weakness, tingling or pain in the arms and legs)
- hypersensitivity (allergic reaction)
- asthenia (unusual tiredness or weakness)
- weight loss, weight gain, anorexia (loss of appetite), increase in appetite
- depression, anxiety, sleep disorders
- disorientation, memory loss, dizziness, drowsiness, abnormal dreams
- syncope (fainting), hypertension (high blood pressure)
- dyspnoea (shortness of breath)
- pancreatitis (inflammation of the pancreas), gastritis ( gastritis ), aphthous stomatitis (cold sores and colds), dysgeusia (change in taste), flatulence
- (weather stresses), dry mouth, distended abdomen
- angioedema (severe swelling of the skin and other tissues usually the lips
- or the eyes)
- alopecia (hair loss), itching
- muscle atrophy (muscle wasting), arthralgia (joint pain), myalgia (muscle pain)
- interstitial nephritis (inflammation of the kidneys), hematuria (blood in the urine), proteinuria (increased
- amount of protein in the urine), pollakiuria (increased urination)
- gynecomastia (breast augmentation in men)
- chest pain, malaise, fever
- insomnia.
Rare (may affect up to 1 in 1,000 people):
- abnormal gait
- edema (swelling)
- hepatosplenomegaly (enlargement of the liver and spleen)
- myopathy (muscle pain, muscle weakness, not caused by exercise)
- kidney pain.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
Keep this medicine out of the sight and reach of children.
No special storage instructions.
Do not use this medicine after the expiry date which is stated on the label, carton, or blister after EXP. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacy staff
how to discard drugs that are no longer used. These measures are to
protect the environment.
6. Contents of the packaging and other information
Content declaration
Atazanavir Accord 200 mg hard capsules
- The active substance is atazanavir. Each capsule contains 200 mg of atazanavir (as sulfate).
- Other ingredients are:
- Capsule content: lactose monohydrate, crospovidone (E1202), magnesium stearate (E441)
- Capsule shell: gelatin, brilliant blue FCF (E133), yellow iron oxide (E172), titanium dioxide (E171), para ‑ orange FCF (E110)
- Black ink: shellac (E904), black iron oxide (E172), potassium hydroxide (E525)
Atazanavir Accord 300 mg hard capsules
- The active substance is atazanavir. Each capsule contains 300 mg of atazanavir (as sulfate).
- Other ingredients are:
- Capsule content: lactose monohydrate, crospovidone (E1202), magnesium stearate (E441)
- Capsule shell: gelatin, brilliant blue FCF (E133), yellow iron oxide (E172), titanium dioxide (E171), erythrocin (E127), para ‑ orange FCF (E110)
- Black ink: shellac (E904), black iron oxide (E172), potassium hydroxide (E525)
What the medicine looks like and the contents of the pack
Atazanavir Accord 200 mg hard capsules are off-white to lightly yellow granular powder filled with hard gelatin capsules approximately 21.40 mm long and with a green opaque top embossed with “H” in black and a light green opaque bottom embossed with “A7” in black color.
There are OPA / aluminum / PVC aluminum blisters containing 30, 60, and 90 hard capsules. It is also available in an HDPE (high-density polyethylene) container with a polypropylene child-resistant cover with a “pulp liner”, containing 60 capsules.
Atazanavir Accord 300 mg hard capsules are off-white to lightly yellow granular powder filled in hard gelatin capsules approximately 23.50 mm long and with orange opaque top embossed with “H” in black and green opaque bottom embossed with “A8” in black color.
There are OPA / aluminum / PVC aluminum blisters containing 30, 60, and 90 hard capsules. There is also a container of HDPE (high-density polyethylene) with a child-resistant lid of polypropylene with a pad (“pulp liner”), containing 30 hard capsules.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare BV
Winthontlaan 200
3526 kV Utrecht
Netherlands
Manufacturer
Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow, Middlesex, HA1 4HF
UK
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta
Accord Healthcare Polska Sp.z oo
ul. Lutomierska 50, 95-200 Pabianice, Poland