Isentress 100 mg Granules for Oral Suspension

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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.

• If you are allergic to raltegravir or to any of the other ingredients in this medicine (listed in section 6.).

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:

• antacids (an agent that counteracts or neutralises the acid in the stomach to relieve indigestion and heartburn). It is not recommended to take Isentress with certain antacids (those containing aluminium and/or magnesium). Talk to your doctor about other antacids you can take.
• iron salts (to treat and prevent iron deficiency or anaemia). You should wait at least two hours between taking iron salts and taking Isentress, as these medicines may reduce Isentress efficacy.
• rifampicin (a medicine used to treat some infections such as tuberculosis), as it may decrease your levels of Isentress. Your doctor may consider increasing your dose of Isentress if you are taking rifampicin.

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.

• Isentress granules for oral suspension are not recommended in pregnancy because they have not been studied in pregnant women.
• Breast-feeding is not recommended in women living with HIV because HIV infection can be passed on to the baby in breast milk.
• If you are breast-feeding, or thinking about breast-feeding, you should discuss it with your doctor as soon as possible.

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’.

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.

• If you forget to take a dose, take it as soon as you remember it.
• 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 to make up for a forgotten dose.

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:

• It is very important to take all your HIV medicines as prescribed and at the right times of day. This can help your medicines work better. It also lowers the chance that your medicines will stop being able to fight HIV (also called "drug resistance").
• When your supply of Isentress starts to run low, get more from your doctor or pharmacy. This is because it is very important not to be without the medicine, even for a short time. During a short break in taking the medicine the amount of virus in your blood may increase. This may mean that the HIV virus will develop resistance to Isentress and become harder to treat.

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.

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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