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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 53095/0030.
Isentress 100 mg granules for oral suspension
Isentress® 100 mg granules for oral suspension
raltegravir
If you are the parent or carer of a child taking Isentress, please read this information carefully.
1. What Isentress is and what it is used for
2. What you need to know before you take Isentress
3. How to take Isentress
4. Possible side effects
5. How to store Isentress
6. Contents of the pack and other information
Note: Instructions for use - see user manual for how to prepare and give the medicine.
Isentress contains the active substance raltegravir. Isentress is an antiviral medicine that works against the Human Immunodeficiency Virus (HIV). This is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).
The virus produces an enzyme called HIV integrase. This helps the virus to multiply in the cells in your body. Isentress stops this enzyme from working. When used with other medicines, Isentress may reduce the amount of HIV in your blood (this is called your "viral load") and increase your CD4-cell count (a type of white blood cells that plays an important role in maintaining a healthy immune system to help fight infection). Reducing the amount of HIV in the blood may improve the functioning of your immune system. This means your body may fight infection better.
Isentress is used to treat adults, adolescents, children, toddlers and infants who are infected by HIV and to treat newborn babies exposed to HIV-1 infection from the mother. Your doctor has prescribed Isentress to help control your HIV infection.
Talk to your doctor, pharmacist or nurse before taking Isentress.
Remember that Isentress is not a cure for HIV infection. This means that you may keep getting infections or other illnesses associated with HIV. You should keep seeing your doctor regularly while taking this medicine.
Mental health problems
Tell your doctor if you have a history of depression or psychiatric illness. Depression, including suicidal thoughts and behaviours, has been reported in some patients taking this medicine, particularly in patients with a prior history of depression or psychiatric illness.
Bone problems
Some patients taking combination anti-retroviral 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 anti-retroviral therapy, corticosteroid use, alcohol consumption, severe reduction of the activity of the immune system, 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.
Liver problems
Tell your doctor, pharmacist or nurse if you have had problems with your liver before, including hepatitis B or C. Your doctor may evaluate how severe your liver disease is before deciding if you can take this medicine.
Infections
Tell your doctor, pharmacist or nurse immediately if you notice any symptoms of infection, such as fever, and/or feeling unwell. In some patients with advanced HIV infection 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.
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 the 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.
Muscle problems
Contact your doctor, pharmacist or nurse immediately if you experience unexplained muscle pain, tenderness, or weakness while taking this medicine.
Skin problems
Contact your doctor promptly if you develop a rash. Severe and life-threatening skin reactions and allergic reactions have been reported in some patients taking this medicine.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines with or without a prescription.
Isentress might interact with other medicines. Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take:
See section 3.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Ask your doctor, pharmacist or nurse for advice before taking any medicine if you are pregnant or breast-feeding.
Do not operate machines, drive or cycle if you feel dizzy after taking this medicine.
This medicine contains fructose up to 0.5 mg in each sachet.
Fructose may damage teeth.
This medicine contains sorbitol (E 420) up to 1.5 mg in each sachet.
This medicine contains up to 4.7 mg of sucrose in each sachet.
Sucrose may be harmful to the teeth.
If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per sachet, that is to say essentially ‘sodium-free’.
Always give this medicine to your child exactly as their doctor, pharmacist or nurse has told you. You should check with your child’s doctor, pharmacist or nurse if you are not sure. Isentress must be used in combination with other medicines for HIV.
The doctor will work out the right dose of granules for oral suspension based on the age and weight of the infant or toddler. The doctor will tell you how much of the oral suspension the infant or toddler must take.
Your child can take this medicine with or without food or drink.
Isentress is also available in a 400 mg tablet, a 600 mg tablet and in a chewable tablet.
Do not switch between the granules for oral suspension, chewable tablet, 600 mg tablet or 400 mg tablet without first talking to your child’s doctor, pharmacist or nurse.
Children should keep scheduled doctor’s visits because their Isentress dosage should be adjusted as they get older, grow or gain weight. Their doctor may also want to prescribe the chewable tablet when they are able to chew a tablet.
Do not take more Isentress than the doctor recommends. If you do take more than you should, contact your doctor.
It is important that you take Isentress exactly as your doctor has instructed. Do not change the dose or stop taking this medicine without first talking with your doctor, pharmacist or nurse. Do not stop taking it because:
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects – these are uncommon (may affect up to 1 in 100 people)
See a doctor immediately, if you notice any of the following:
See a doctor immediately, if you notice any of the side effects above.
Common: the following may affect up to 1 in 10 people
Uncommon: the following may affect up to 1 in 100 people
Additional side effects in children and adolescents
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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
See the instructions for use booklet for the right way to dispose of your leftover medicine.
The active substance is raltegravir. Each single-use sachet of granules for oral suspension contains 100 mg of raltegravir (as potassium).
The other ingredients are: hydroxypropyl cellulose, sucralose, mannitol (E 421), monoammonium glycyrrhizinate, sorbitol (E 420), fructose, banana flavour, sucrose, crospovidone Type A, magnesium stearate, ethylcellulose 20 cP, ammonium hydroxide, medium chain triglycerides, oleic acid, hypromellose 2910/6cP, macrogol/PEG 400, microcrystalline cellulose and carmellose sodium.
The banana flavoured granules for oral suspension is a white to off-white powder that may contain yellow or beige to tan particles in a single-use sachet.
One pack size is available: 1 carton with 60 sachets, two 10 mL syringes, two 3 mL syringes, two 1 mL syringes, two mixing cups, this package leaflet and booklet with instructions for use. Each single-use sachet contains 100 mg of raltegravir which is to be suspended in 10 mL of water giving a final concentration of 10 mg per mL.
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This leaflet was last revised in November 2022
© 2022 Merck & Co., Inc., Rahway, NJ, USA and its affiliates. All rights reserved.
PIL.IST.100mg-OG.22.GB.8297.IB-013.RCN024947