ISENTRESS 100 MG GRANULES FOR ORAL SOLUTION - patient leaflet, side effects, dosage

Patient leaflet - ISENTRESS 100 MG GRANULES FOR ORAL SOLUTION

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. Read all of this leaflet carefully before you start giving this medicine to your child because it contains important information.

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.

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
7

. Instructions for use

see the booklet for how to prepare and give the medicine

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 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.

2. what you need to know before you take isentress

Do not take Isentress

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

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:

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.

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.

Isentress granules for oral suspension are not recommended in pregnancy because they have not been studied in pregnant women.
Women with HIV should not breast-feed their infants because babies can be infected with HIV through their breast milk. Talk with your doctor about the best way to feed your baby.

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 100 mg granules for oral suspension contain fructose

This medicine contains fructose up to 0.5 mg in each sachet.

Fructose may damage teeth.

Isentress 100 mg granules for suspension contain sorbitol

This medicine contains sorbitol (E 420) up to 1.5 mg in each sachet.

Isentress 100 mg granules for suspension contain sucrose

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.

Isentress 100 mg granules for suspension contain sodium

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

3. how to take isentress

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.

See the instructions for use in the booklet for how to prepare and give a dose of Isentress. Keep the booklet and follow it each time you prepare the medicine. Bring this booklet to your child’s appointments.
Make sure the doctor, pharmacist or nurse explains how to mix and give the right dose to your child.
The granules need to be mixed with water before use. You must give to your child within 30 minutes of mixing.
The dose will change over time. Make sure to follow the instructions of your doctor. The doctor will tell you if and when to stop giving Isentress to your baby.

How much to take

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.

If you take more Isentress than you should

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 Isentress

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.

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:

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.

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: 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

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and sachet after EXP. The expiry date refers to the last day of that month.
Granules for oral suspension should be given to the patient within 30 minutes of mixing.
Store in the original package in order to protect from moisture.
This product does not require any special storage conditions. Do not open the Isentress sachets until ready to prepare a dose.

See the instructions for use booklet for the right way to dispose of your leftover medicine.

4. Possible side effects

6. contents of the pack and other information

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:

herpes infections including shingles
anaemia including due to low iron
signs and symptoms of infection or inflammation
mental disorder
suicide intention or attempt
stomach inflammation
inflammation of liver
liver failure
allergic rash
certain kinds of kidney problems
drug ingestion in quantities greater than recommended

See a doctor immediately, if you notice any of the side effects above.

Common: the following may affect up to 1 in 10 people

decreased appetite
trouble sleeping; abnormal dreams; nightmare; abnormal behaviour; feelings of deep sadness and unworthiness
feeling dizzy; headache
spinning sensation
bloating; abdominal pain; diarrhoea; excessive gas in the stomach or bowel; feeling sick; vomiting; indigestion; belching
certain kinds of rash (more often when used in combination with darunavir)
tiredness, unusual tiredness or weakness; fever
increased liver blood tests; abnormal white blood cells; increased fat levels in blood; increased level of enzyme from salivary glands or pancreas

Uncommon: the following may affect up to 1 in 100 people

infection of the hair roots; influenza; skin infection due to virus; vomiting or diarrhoea due to an infectious agent; upper respiratory tract infection; lymph node abscess
wart
lymph node pain; low count of white blood cells that fight infection; swollen glands in the neck, armpit and groin
allergic reaction
increased appetite; diabetes; increased blood cholesterol and lipids; high sugar levels in the blood; excessive thirst; severe weight loss; high levels of fat (such as cholesterol and triglycerides) in the blood; body fat disorder
feeling anxious; feeling of confusion; depressed mood; mood changes; panic attack
loss of memory; pain in the hand due to nerve compression; disturbance in attention; dizziness with rapid changes in posture; abnormal taste; increased sleepiness; lack of energy; forgetfulness; migraine headache; loss of feeling, numbness or weakness of the arms and/or legs; tingling; sleepiness; tension headache; tremors; poor quality sleep
visual disturbance
buzzing, hissing, whistling, ringing or other persistent noise in the ears
palpitations; slow heart rates; fast or irregular heart beats
hot flush; high blood pressure
harsh, raspy, or strained voice; nosebleed; nasal congestion
abdominal pain upper; rectal discomfort; constipation; dry mouth; heartburn; pain when swallowing; inflammation of the pancreas; ulcer or sore in stomach or upper intestine; bleeding at anus; stomach discomfort; inflammation of the gums; swollen, red sore tongue
accumulation of fat in the liver
acne; unusual hair loss or thinning; redness of skin; unusual distribution of fat on the body, this may include loss of fat from legs, arms, and face, and increase in abdomen fat; excessive sweating; night sweats; thickening and itching of the skin due to repeated scratching; skin lesion; dry skin
joint pain; painful joint disease; back pain; pain in bone/muscle; muscle tenderness or weakness; neck pain; pain in arms or legs; inflammation of the tendons; decrease in the amount of minerals in the bone
kidney stones; urination at night; kidney cyst
erectile dysfunction; breast enlargement in men; menopausal symptoms
chest discomfort; chills; swelling of face; feeling jittery; generally feeling unwell; neck mass; swelling of hands, ankles or feet; pain
decreased white blood cell count; decreased count of platelets in blood (a kind of cell that helps blood clot); blood test showing reduced kidney function; high blood sugar level; increased muscle enzyme in blood; sugar present in urine; red blood cells present in urine; weight gain; increase in waist size; decreased blood protein (albumin); increase in time for blood to clot

Additional side effects in children and adolescents

hyperactivity

What Isentress looks like and contents of the pack

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.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder in Great Britain: Merck Sharp & Dohme (UK) Limited, 120 Moorgate, London, EC2M 6UR, United Kingdom.

Marketing Authorisation Holder in UK (Northern Ireland): Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands.

Manufacturer: Merck Sharp & Dohme B. V., Waarderweg 39, 2031 BN Haarlem, The Netherlands.

For any information about this medicine, please contact:

Great Britain

Merck Sharp & Dohme (UK) Limited

United Kingdom (Northern Ireland)

Merck Sharp & Dohme Ireland (Human Health) Limited

Tel: +353 (0)1 2998700

This leaflet was last revised in October 2021

Detailed information on this medicine is available on the European Medicines Agency web site:.

PIL.IST.100mg-OG.21.GB-NI.7929.IB-006.RCN020459, RCN022001

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