If you are the parent of a child taking Isentress, please read this information carefully with your child.

• 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 or your child 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

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 600 mg film-coated tablets is used to treat adults and paediatric patients weighing at least 40 kg who are infected by HIV. 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, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.

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)
• 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
• atazanavir (an antiretroviral medication)
• rifampicin (a medicine used to treat some infections such as tuberculosis)
• tipranavir/ritonavir (antiretroviral medicines)

Keep a list of all your medicines to show your doctor and pharmacist.

• You can ask your doctor or pharmacist for a list of medicines that interact with Isentress.
• Do not start taking a new medicine without telling your doctor. Your doctor can tell you if it is safe to take Isentress with other medicines.

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 1,200 mg (two 600 mg tablets once daily)is not recommended in pregnancy because it has 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 lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Adults, children and adolescents weighing at least 40 kg

The recommended dose is 1,200 mg taken as two 600 mg tablets taken by mouth once a day.

Do not chew, crush or split the tablets because it may change the level of medicine in your body. This medicine can be taken with or without food or drink.

Isentress is also available in a 400 mg tablet, a chewable tablet and in granules for oral suspension.

Do not switch between the 600 mg tablet, 400 mg tablet, chewable tablet or granules for oral suspension without first talking with your doctor, pharmacist or nurse.

Do not take more tablets than the doctor recommends. If you do take too many tablets, 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 have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

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 film-coated tablet contains 600 mg of raltegravir (as potassium).

The other ingredients are: microcrystalline cellulose, hypromellose 2910, croscarmellose sodium and magnesium stearate. In addition, the film coating contains the following inactive ingredients: lactose monohydrate, hypromellose 2910, titanium dioxide, triacetin, iron oxide yellow and black iron oxide. The tablet may also contain trace amount of carnauba wax.

The 600 mg film-coated tablet is oval-shaped, yellow, marked with MSD corporate logo and "242" on one side and plain on the other side.

Two pack sizes are available: packs containing 1 bottle with 60 tablets, and multipacks comprising 3 bottles, each containing 60 tablets. The bottle contains desiccant.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Manufacturer

For any information about this medicine, please contact: