Active ingredient
- raltegravir potassium
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
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 53095/0032.
Isentress 400 mg Film-coated Tablets
Package leaflet: Information for the user
Isentress® 400 mg film-coated tablets
raltegravir
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
If you are the parent of a child taking Isentress, please read this information carefully with your child.
What is in this leaflet
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
1. What Isentress is and what it is used for
What Isentress is
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).
How Isentress works
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.
When Isentress should be used
Isentress is used to treat those who are infected by HIV. Your doctor has prescribed Isentress to help control your HIV infection.
2. What you need to know before you take Isentress
Do not take Isentress:
Warnings and precautions
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.
Passing HIV to others
HIV infection is spread by contact with blood or sexual contact with a person with HIV. You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy. Discuss with your doctor the precautions needed to avoid infecting other people.
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.
Other medicines and Isentress
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:
Taking Isentress with food and drink
See section 3.
Pregnancy and breast-feeding
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.
Driving and using machines
Do not operate machines, drive or cycle if you feel dizzy after taking this medicine.
Isentress contains lactose
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.
Isentress contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
3. How to take Isentress
Always take this medicine exactly as your doctor, pharmacist or nurse has told you. You should check with your doctor, pharmacist or nurse if you are not sure. Isentress must be used in combination with other medicines for HIV.
How much to take
Adults
The recommended dose is 1 tablet (400 mg) by mouth twice a day.
Use in children and adolescents
The recommended dose of Isentress is 400 mg by mouth, twice a day for adolescents and children weighing at least 25 kg.
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 600 mg tablet, a chewable tablet and in granules for oral suspension.
Do not switch between the 400 mg tablet, the 600 mg tablet, chewable tablet or granules for oral suspension without first talking with your doctor, pharmacist or nurse.
If you take more Isentress than you should
Do not take more tablets than the doctor recommends. If you do take too many tablets, contact your doctor.
If you forget to take Isentress
If you stop taking Isentress
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.
4. Possible side effects
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
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 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.
5. How to store Isentress
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Isentress contains
The active substance is raltegravir. Each film-coated tablet contains 400 mg of raltegravir (as potassium).
The other ingredients are: lactose monohydrate, microcrystalline cellulose, calcium phosphate dibasic anhydrous, hypromellose 2208, poloxamer 407, sodium stearyl fumarate, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350, talc, red iron oxide and black iron oxide.
What Isentress looks like and contents of the pack
The film-coated tablet is oval-shaped, pink, marked with "227" on one side.
Two pack sizes are available: packs containing1 bottle with 60 tablets, and multipacks comprising 3 bottles, each containing 60 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
This leaflet was last revised in October 2020
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
© Merck Sharp & Dohme Limited, 2020. All rights reserved.
PIL.IST.400mg.20.UK.7375.IB-0092.RCN016409
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