ISENTRESS. 400 mg. 60 tablets
Isentress raltegravir contains the active substance. Isentress is an antiviral medication that works against human immunodeficiency virus (HIV). This is the virus that causes acquired immunodeficiency syndrome disease (AIDS).
ISENTRESS. 400 mg. 60 tablets
What is Isentress and what it is used?
What is Isentress?
Isentress raltegravir contains the active substance . Isentress is an antiviral medication that works against human immunodeficiency virus (HIV). This is the virus that causes acquired immunodeficiency syndrome disease ( AIDS ) .
How does Isentress?
The virus produces an enzyme called HIV integrase . It helps the virus to multiply in the cells of your body. Isentress stops this enzyme. When used with other medicines , Isentress could reduce the amount of HIV in the blood (called " viral load" ) and increased the number of CD4 cells you ( a type of white blood cells that play an important role in maintaining a healthy immune system that helps to fight infection) . Reducing the amount of HIV in the blood can improve the functioning of the immune system . This means that your body can fight better with infection. Isentress may not have these effects in all patients. Isentress is not a cure for HIV infection.
When should I use Isentress?
Isentress is used to treat adults , adolescents and children aged 2 years who are infected with HIV. Your doctor has prescribed Isentress, to help control your HIV infection.
2 . What you should know before taking Isentress?
Do not take Isentress:
• if you are allergic (hypersensitive) to raltegravir or any of the other ingredients of this medicine (listed in Section 6 . " Content pack and other information").
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before taking Isentress. Remember that Isentress does not cure HIV infection. This means that you may continue to develop infections or other illnesses associated with HIV. Therefore , you must continue to regularly visit their doctor while taking this medicine.
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 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 tell your doctor.
Tell your doctor, pharmacist or nurse if you have liver problems , including hepatitis B or C. Your doctor can assess how severe your liver disease is before deciding whether you should take this medicine.
HIV infection is transmitted through blood or sexual contact with a person with HIV. There is no evidence that taking this drug reduces the risk of transmitting HIV to others through sexual contact or blood contamination.
Tell your doctor, pharmacist or nurse if you notice any symptoms of infection - such as fever and / or malaise . In some patients with advanced HIV infection and that had an opportunistic infection in the past, can be signs and symptoms of inflammation from previous infections soon after anti -HIV treatment . It is believed that these symptoms are due to an improvement in the immune response , enabling the body to fight infections that may have been present with no obvious symptoms.
In addition to opportunistic infections may also occur and autoimmune disorders (conditions that occur when the immune system attacks healthy tissue of the body) after taking drugs to treat HIV infection. Autoimmune diseases may occur many months after the start of treatment. If you notice any signs of infection or other symptoms such as muscle weakness , weakness beginning in the hands and feet and extending upward to the body , palpitations, tremor or hyperactivity , inform your doctor immediately to seek necessary treatment.
Tell your doctor, pharmacist or nurse immediately if you experience unexplained muscle pain , tension or muscle weakness while taking this medicine.
Contact your doctor immediately if you develop a rash. In some patients taking this drug reported severe and life-threatening skin reactions and allergic reactions. Tell your doctor if you have ever had depression or mental illness. In some patients receiving this drug were reported depression , including thoughts of suicide behavior , especially in patients who have ever had depression or mental illness.
Tell your doctor, pharmacist or nurse if you are taking antacids. Certain antacids ( containing aluminum and / or magnesium) are not recommended with Isentress.
Children and adolescents
Isentress is not intended for use in children under the age of 2 years . Other medicines and Isentress
Tell your doctor or pharmacist if you are taking , have recently taken or take any other prescription or not prescription.
Isentress may interact with other medicines.
Tell your doctor, pharmacist or nurse if you are taking , have recently taken or might take :
• antacids. It is not recommended to take Isentress certain antacids ( containing aluminum and / or magnesium) . Talk to your doctor about other antacids that you can take .
• rifampicin ( a drug used to treat certain infections, such as tuberculosis ) , as it may reduce your blood ISENTRESS. Your doctor may consider increasing your dose ISENTRESS, if you are taking rifampin.
Raltegravir is not known to have a significant effect on the blood levels of other agents used to treat HIV. Also, it is not known blood levels of raltegravir to be a major influence on other agents used to treat HIV. It is expected , however, the receipt of additional information , as experience with the use of raltegravir increases.
Pregnancy and lactation
If you are pregnant or breast-feeding, you may be pregnant or planning to become pregnant , ask your doctor or pharmacist before taking this medicine.
• Isentress is not recommended in pregnancy because it has not been studied in pregnant women.
• Women with HIV should not breast feed their babies as they can be infected with HIV through breast milk. Talk to your doctor about the best way to feed your baby .
Ask your doctor, pharmacist or nurse before taking any medicine if you are pregnant or breastfeeding.
Driving and using machines
Do not use machines, do not drive or ride a bike, if you feel dizzy after taking this medicine.
Isentress tablets contain lactose
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3 . How to take Isentress?
Always take this medicine exactly as your told your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist. Isentress should be used in combination with other drugs for HIV.
• It is very important to take this medication exactly as prescribed. Do not change your dose or stop taking this medication and do not replace tablets
400 mg of chewable tablets without first talking to your doctor, pharmacist or nurse.
How much to take ?
The recommended dose is 1 tablet (400 mg) twice daily by mouth .
Use in children and adolescents
The recommended dose of Isentress in adolescents aged 12 years and children aged 6 to 11 years and weighing at least 25 kg is 400 mg twice daily by mouth.
Isentress is available as a chewable tablet for children aged 2 to 11 years and weighing at least 12 kg.
Children should be kept on the designated check-ups because of Isentress dose should be adjusted according to the growth of the child .
It is recommended that the tablets should not be chewed, crushed or broken . This medicine may be taken with or without food or drink .
If you take more than the amount of Isentress
Do not take more tablets than your doctor has recommended . If you take too many tablets, contact your doctor.
If you forget to take Isentress
• If you miss a dose, take it as soon as you remember.
• However, if it is time for your next dose , skip the missed dose and go back to your regular schedule .
• Do not take a double dose of Isentress, to make up the missed dose.
If you stop taking Isentress
It is important to take Isentress exactly as your doctor tells you . Do not stop taking your medicine because:
• It is important to take all medications to treat HIV, as prescribed and at the time of day. This can help your medicines work better. Moreover, reducing the likelihood that drugs can no longer fight HIV ( also called " drug resistance " ) .
• When your supply of Isentress low, get more from your doctor or pharmacist. This is necessary because it is very important not to run out of drugs , even briefly. Over a short period in taking the medicine , the amount of virus in your blood may increase . This means that the HIV virus will develop resistance to the treatment and Isentress will become more difficult .
If you have any further questions on the use of this medicine , ask your doctor, pharmacist or nurse.
4 . Possible side effects
Like all medicines , Isentress can cause side effects, although not everybody gets them .
Serious side effects - they are uncommon ( may affect up to 1 in 100 people ) immediately go to the doctor if you notice any of the following:
• herpetic infections , including herpes zoster
• anemia , including that due to iron deficiency
• signs and symptoms of infection or inflammation • psychiatric disorders attempted suicide
• inflammation of the stomach liver inflammation liver failure allergic rash
• a certain type of kidney problems
• ingestion in quantities exceeding the recommended
If you notice any of these side effects occur, see a doctor.
Common: may affect up to 1 in 10 people decreased appetite
- Difficulty sleeping , strange dreams , nightmares , unusual behavior, a sense of deep sadness and sense of inferiority dizziness , headache feeling dizzy
- Bloating , abdominal pain , diarrhea , excessive gas in the stomach and intestines , nausea , vomiting, indigestion , belching certain types of rash (more often when used in combination with darunavir ) fatigue , unusual tiredness or weakness ; fever
- Elevated liver function tests in the blood increased number of white blood cells, elevated levels of fats in the blood, increased levels of enzymes from the salivary glands or pancreas.
Uncommon: may affect up to 1 in 100 people
- Infection of the hair follicles , influenza , skin infection caused by a virus , vomiting , or diarrhea caused by an infectious agent , infection of the upper respiratory tract , lymph node abscess warts
- Painful lymph node, low white blood cells that fight infection , swollen glands in the neck, armpits and groin allergic reaction
- Increased appetite , diabetes , elevated lipids and blood cholesterol , high blood sugar , excessive thirst , a large weight loss , high levels of fats ( such as cholesterol and triglycerides ) in the blood breach body fat feeling anxious , feeling confusion , depressed mood, mood swings , panic attacks
- Memory loss , pain in the hand due to nerve compression , disturbance in attention , dizziness with fast body position , altered taste , increased sleepiness , lack of energy, forgetfulness , migraine headaches , loss of sensation , numbness or weakness of the arms and / or feet , numbness , drowsiness , tension headache , tremor , poor quality of sleep disturbances in vision feeling of vertigo
- Noises in ears - buzzing, hissing , whistling , ringing or other persistent noise in the ears
- Palpitations, heart rate, rapid or abnormal heartbeat rhythm hot flashes , high blood pressure
- Hoarseness, rough or changed voice , nose bleeds , nasal congestion, pain in the upper abdomen , rectal discomfort , constipation, dry mouth , heartburn , pain on swallowing, inflammation of the pancreas , ulcers or inflammation of the stomach or upper bowel bleeding from the anus , stomach discomfort , gingivitis , swollen , painful red tongue fat accumulation in the liver
• Acne , unusual hair loss or thinning of hair , skin flushing , abnormal fat distribution in the body, this may include loss of fat from legs, arms and face, and fat accumulation in the abdomen , excessive sweating , night sweats , itching and thickening of the skin due to repeated scratching , skin lesion , dry skin
• joint pain , disease, painful joints , back pain , bone pain / myalgia, tenderness or muscle weakness , neck pain , pain in arms or legs ; inflammation of the tendons , decrease the amount of bone mineral
• kidney stones , urination at night , renal cyst
• erectile dysfunction , breast enlargement in men, symptoms of menopause
• chest discomfort , face edema , feeling jittery , fever , malaise , body in the neck , swelling of the hands , ankles , or feet ; pain
• low white blood cell count , low platelet count in the blood ( type cells that help blood to clot ) blood tests indicative of decreased kidney function , high blood sugar , elevated muscle enzymes in the blood sugar in the urine red blood cells in urine , weight gain , increase the size of the waist ; reduction of the protein in the blood ( albumin ), an increase in blood clotting time
Additional side effects in children and adolescents
There are reports of pain, or weakness in the muscles during treatment with Isentress.
In clinical studies, monitor the development of cancer in patients taking Isentress at a frequency similar to that observed in patients receiving other drugs against HIV.
Adverse event reporting
If you get any side effects, tell your doctor, pharmacist or nurse. This includes all listed in this leaflet . You can also report side effects directly through the national system of notification referred to in Annex V. As reported side effects , you can do your bit to get more information on the safety of this medicine.
5 How to store Isentress?
• Keep out of reach of children.
• Do not use this medicine after the expiry date stated on the bottle after " EXP" . The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required . These measures will help to protect the environment.
6 . Package Contents and more information
What does Isentress?
The active substance is raltegravir . Each tablet contains 400 mg of raltegravir (as potassium).
The other ingredients are lactose monohydrate, microcrystalline cellulose , calcium phosphate monobasic , hypromellose 2208 , poloxamer 407 , sodium stearyl fumarate and magnesium stearate. Furthermore , the film coating contains the following inactive ingredients : polyvinyl
alcohol , titanium dioxide (E171), polyethylene glycol 3350, talc , red iron oxide (E172) and black iron oxide (E172).
Isentress looks like and contents of the pack ?
Tablets is elliptical , pink , marked " 227" on one side. There are two types : 1 bottle with 60 tablets and 3 bottles of 60 tablets each.
Not all pack sizes may be marketed.