Patient Leaflet Updated 18-Oct-2024 | Dr. Reddy's Laboratories (UK) Ltd
Raltegravir 600 mg film-coated tablets
Raltegravir 600 mg film-coated tablets
raltegravir
If you are the parent of a child taking Raltegravir, please read this information carefully with your child.
1. What Raltegravir is and what it is used for
2. What you need to know before you take Raltegravir
3. How to take Raltegravir
4. Possible side effects
5. How to store Raltegravir
6. Contents of the pack and other information
Raltegravir contains the active substance raltegravir. Raltegravir 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. Raltegravir stops this enzyme from working. When used with other medicines, Raltegravir 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.
Raltegravir 600 mg film-coated tablets are used to treat adults and paediatric patients weighing at least 40 kg who are infected by HIV. Your doctor has prescribed Raltegravir 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 Raltegravir. Remember that Raltegravir 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.
Raltegravir might interact with other medicines.
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take:
Keep a list of all your medicines to show your doctor and pharmacist.
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 less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
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. Raltegravir must be used in combination with other medicines for HIV.
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.
Raltegravir is only available as 600 mg tablets. Other formulations and strengths of raltegravir might be available, please talk to your doctor, pharmacist or nurse for further information.
Do not take more tablets than the doctor recommends. If you do take too many tablets, contact your doctor.
It is important that you take Raltegravir 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:
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.
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.
The active substance is raltegravir. Each film-coated tablet contains 600 mg raltegravir (as potassium)
The other ingredients are: microcrystalline cellulose, croscarmellose sodium, carbomers, magnesium stearate. In addition, the film coating contains the following inactive ingredients: macrogols, talc, titanium dioxide (E171), glycerol monocaprylocaprate (type I), poly(vinyl alcohol) and iron oxide yellow (E172).
The 600 mg film-coated tablet is oval-shaped, yellow, debossed with "C30" on one side and „600“on the other side.
Pack sizes: packs containing 1 bottle with 60 tablets and multipacks comprising 3 bottles, each containing 60 tablets.
Not all pack sizes may be marketed
This leaflet was last revised in July 2024.
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