Isentress 100 mg chewable tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Isentress 25 mg chewable tablets

Isentress 100 mg chewable tablets

raltegravir

Read the entire 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.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you or your child only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Isentress is and what it is used for
2. What you need to know before taking 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 acts against the human immunodeficiency virus (HIV). This is the virus that causes acquired immunodeficiency syndrome (AIDS).

How Isentress works

The virus produces an enzyme called HIV integrase, which helps the virus enter the body's cells and multiply. Isentress prevents this enzyme from working. When used with other medicines, Isentress can reduce the amount of HIV in the blood (this is known as your "viral load") and increase the CD4 cell count (a type of white blood cell that plays an important role in maintaining a healthy immune system to help fight infection). By reducing the amount of HIV in the blood, Isentress may improve the function of your immune system. This means your body can fight the infection more effectively.

When Isentress should be used

Isentress is used to treat patients infected with HIV. Your doctor has prescribed Isentress to help you control your HIV infection.

2. What you need to know before taking Isentress

Do not take Isentress:

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

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Isentress.

Remember that Isentress does not cure HIV infection. This means you may still develop HIV-related infections or other illnesses. You must continue to visit your doctor regularly while taking this medicine.

Mental health problems

Tell your doctor if you have a history of depression or mental illness. Depression, including suicidal thoughts and behaviour, has been observed in some patients taking this medicine, particularly in those with a prior history of depression or mental illness.

Bone problems

Some patients receiving combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by reduced blood supply to the bone). Factors that may increase the risk of developing this condition include long-term combination antiretroviral therapy, use of corticosteroids, alcohol consumption, severely weakened immune system, and increased body mass index, among others. Signs of osteonecrosis include joint stiffness, discomfort, and pain (especially in the hip, knee, or shoulder) and difficulty moving. If you experience any of these symptoms, see your doctor.

Liver problems

Tell your doctor, pharmacist or nurse if you have previously had liver problems, including hepatitis B or C. Your doctor may assess the severity of your liver disease before deciding whether you can take this medicine.

Infections

If you notice any symptoms of infection, such as fever and/or feel unwell, tell your doctor, pharmacist or nurse immediately. Some patients with advanced HIV infection and a history of opportunistic infections may develop signs and symptoms of inflammation from previous infections shortly after starting anti-HIV treatment. These symptoms are believed to result from improved immune response, which enables the body to fight infections that may have been present but not causing obvious symptoms.

In addition to opportunistic infections, autoimmune disorders (a condition in which the immune system attacks healthy body tissue) may also occur after you start taking medicines for HIV infection. Autoimmune disorders may appear many months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness starting in the hands and feet and moving upwards towards the trunk, palpitations, tremor, or hyperactivity, inform your doctor immediately to receive appropriate treatment.

Muscle problems

Contact your doctor, pharmacist or nurse immediately if you experience unexplained muscle pain, tenderness, or muscle weakness during treatment with this medicine.

Skin problems

Contact your doctor immediately if you develop a rash. Serious and potentially 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 need to take any other medicines, with or without a prescription.

Isentress may interact with other medicines.

Tell your doctor, pharmacist or nurse if you are taking, have recently taken, or might need to take:

• antacids (a medicine that counteracts or neutralizes stomach acid and relieves indigestion and heartburn). Taking Isentress with certain antacids (those containing aluminium and/or magnesium) is not recommended. Ask your doctor about other antacids you may take.
• iron salts (to treat or prevent iron deficiency or anaemia). You should wait at least two hours between taking iron salts and Isentress, as these medicines may reduce the effectiveness of Isentress.
• rifampicin (a medicine used to treat certain infections such as tuberculosis), as it may reduce your levels of Isentress. If you are taking rifampicin, your doctor may consider increasing your dose of Isentress.

Taking Isentress with food and drink

See section 3.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

• Isentress chewable tablets are not recommended during pregnancy, as they have not been studied in pregnant women.
• Women living with HIV should not breastfeed because HIV infection can be transmitted to the baby through breast milk.
• If you are breastfeeding or considering breastfeeding, you should consult your doctor as soon as possible.

If you are pregnant or breastfeeding, consult your doctor, pharmacist or nurse before using any medicine.

Driving and using machines

Do not operate machinery, drive or ride a bicycle if you feel dizzy after taking this medicine.

Isentress 25 mg chewable tablet

Isentress 25mg chewable tablet contains fructose

This medicine contains up to 0.54 mg of fructose per tablet.

Fructose may damage the teeth.

Isentress 25mg chewable tablet contains sorbitol

This medicine contains up to 1.5 mg of sorbitol (E 420) per tablet.

Isentress 25mg chewable tablet contains sucrose

This medicine contains up to 3.5 mg of sucrose per 25 mg chewable tablet.

Sucrose may damage the teeth.

If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

Isentress 25mg chewable tablet contains aspartame

This medicine contains up to 0.47 mg of aspartame (E 951) per 25 mg chewable tablet, equivalent to up to 0.05 mg of phenylalanine. Aspartame contains a source of phenylalanine which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

Isentress 25mg chewable tablet contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; i.e., essentially “sodium-free”.

Isentress 100 mg chewable tablet

Isentress 100mg chewable tablet contains fructose

This medicine contains up to 1.07 mg of fructose per tablet.

Fructose may damage the teeth.

Isentress 100mg chewable tablet contains sorbitol

This medicine contains up to 2.9 mg of sorbitol (E 420) per tablet.

Isentress 100mg chewable tablet contains sucrose

This medicine contains up to 7 mg of sucrose per 100 mg chewable tablet.

Sucrose may damage the teeth.

If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

Isentress 100mg chewable tablet contains aspartame

This medicine contains up to 0.93 mg of aspartame (E 951) per 100 mg chewable tablet, equivalent to up to 0.10 mg of phenylalanine. Aspartame contains a source of phenylalanine which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

Isentress 100mg chewable tablet contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; i.e., essentially “sodium-free”.

3. How to take Isentress

Follow exactly the instructions for using this medicine as given by your doctor, pharmacist, or nurse. If in doubt, check with your doctor, pharmacist, or nurse again. Isentress should be used in combination with other medicines for HIV infection.

The 100 mg chewable tablet may be divided into equal halves. However, splitting tablets should be avoided whenever possible.

What dose to take

Dosage for children between 2 and 11 years of age

Your doctor will recommend the appropriate number of chewable tablets depending on the child's age and weight. This dose should not exceed 300 mg twice daily. Your doctor will tell you how many chewable tablets the child should take.

Isentress is also available as a 400 mg tablet, a 600 mg tablet, and as granules for oral suspension.

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

Children should attend their scheduled visits with their doctor, as their dose of Isentress needs to be adjusted as they grow older, grow taller, or gain weight. Your doctor may also wish to prescribe the 400 mg tablet when the child is able to swallow a whole tablet.

This medicine can be taken with or without food or drink.

If you take more Isentress than you should

Do not take more tablets than your doctor has recommended. If you take more tablets than recommended, consult your doctor.

If you forget to take Isentress

• If you forget to take a dose, take it as soon as you remember.
• However, if it is almost time for your next dose, do not take the missed dose and continue with your regular dosing 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 prescribed by your doctor. Do not change the dose or stop taking this medicine without first consulting your doctor, pharmacist, or nurse. Do not stop taking it because:

• It is very important that you take all your HIV medicines exactly as prescribed and at the correct times of day. This helps the medicines work better and also reduces the chance that the virus becomes resistant to them (this is also known as “drug resistance”).
• When you are running low on Isentress tablets, go to your doctor or pharmacy to get more. This is because it is very important not to run out of medicine, even for a few days. If you stop taking the medicine for a few days, the amount of virus in your blood may increase, and as a result, HIV may develop resistance to Isentress, making the disease harder to treat.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody gets them.

Serious adverse effects – these are uncommon (may affect up to 1 in 100 people)

Seek immediate medical advice if you experience any of the following adverse effects:

• herpes infections including herpes zoster
• anaemia including iron deficiency anaemia
• signs and symptoms of infection or inflammation
• mental disorder
• suicide attempt or suicidal ideation
• stomach inflammation
• liver inflammation
• liver failure
• allergic-type rash
• certain types of kidney problems
• ingestion of the medicine in quantities exceeding the recommended dose

Seek immediate medical advice if you experience any of the adverse effects listed above.

Frequent: the following adverse effects may affect up to 1 in 10 people

• decreased appetite
• difficulty sleeping; strange dreams; nightmares; abnormal behaviour; feeling of deep sadness and low self-esteem
• dizziness; headache
• vertigo
• flatulence or gas; abdominal pain; diarrhoea; excessive gas in the stomach or intestine; nausea; vomiting; indigestion; burping
• certain types of rash (more frequently when used in combination with darunavir)
• fatigue, unusual tiredness or weakness; fever
• elevated liver parameters; abnormal white blood cell counts; increased blood fat levels; increased levels of enzymes from salivary glands or pancreas

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

• hair follicle infection; flu; viral skin infection; vomiting or diarrhoea due to an infectious agent; upper respiratory tract infection; pus accumulation in lymph node
• warts
• lymph node pain; low count of white blood cells responsible for fighting infections; swelling of glands in neck, armpits, and groin
• allergic reaction
• increased appetite; diabetes; elevated blood cholesterol and lipids; increased blood sugar levels; excessive thirst; severe weight loss; high levels of blood fats (such as cholesterol and triglycerides); body fat disorders
• feeling of distress; feeling confused; depressed mood; mood changes; panic attack
• memory loss; hand pain due to nerve compression; attention disturbance; dizziness upon rapid postural change; abnormal taste; increased drowsiness; lack of energy; forgetfulness; migraine headache; loss of sensation, numbness or weakness in arms and/or legs; tingling; drowsiness; tension headache; tremors; poor sleep
• vision disturbance
• tinnitus, high-pitched sounds, ringing, buzzing, or other persistent noises in the ears
• palpitations; slow pulse; rapid or irregular heartbeat
• hot flushes; increased blood pressure
• hoarse, rough, or strained voice; nosebleed; nasal congestion
• upper abdominal pain; rectal discomfort; constipation; dry mouth; heartburn; pain when swallowing; pancreatitis; ulcer or sore in the stomach or upper intestine; bleeding from the anus; stomach discomfort; gum inflammation; swelling, redness and ulceration of the tongue
• fat accumulation in the liver
• acne; hair loss or thinning; skin redness; unusual body fat redistribution, which may include loss of fat in legs, arms, and face and increased fat in the abdomen; 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; bone/muscle pain; muscle aches or weakness; neck pain; arm or leg pain; tendon inflammation; decreased bone mineral content
• kidney stones; nocturnal urination; renal cyst
• erectile dysfunction; breast enlargement in men; menopausal symptoms
• chest discomfort; chills; facial swelling; feeling of nervousness; feeling of general malaise; neck lump; swelling of hands, ankles, or feet; pain
• low white blood cell count; low platelet count in blood (a type of cell involved in blood clotting); decreased kidney function in blood tests; high blood sugar levels; elevated muscle enzymes in blood; sugar in urine; red blood cells in urine; weight gain; increased waist circumference; decreased blood proteins (albumin); prolonged blood clotting time

Other adverse effects in children and adolescents

• hyperactivity

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Isentress

• Keep this medicine out of the sight and reach of children.

• Do not use this medicine after the expiry date stated on the bottle after EXP. The expiry date refers to the last day of the month indicated.

• Keep the bottle tightly closed, with the desiccant (drying agent) inside, to protect it from moisture. Do not swallow the desiccant.

• Before breaking the seal, no special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Isentress

The active substance is raltegravir.

Chewable tablets 25 mg:

Each chewable tablet contains 25 mg of raltegravir (potassium).

The other components are: hydroxypropylcellulose, sucralose, sodium saccharin, sodium citrate dihydrate, mannitol (E 421), yellow iron oxide, monoammonium glycyrrhizinate, sorbitol (E 420), fructose, natural and artificial flavours (orange, banana and flavour-masking), aspartame (E 951), sucrose, crospovidone Type A, magnesium stearate, sodium stearyl fumarate, ethylcellulose 20 cP, ammonium hydroxide, medium-chain triglycerides, oleic acid, hypromellose 2910/6cP and macrogol/PEG 400.

Chewable tablets 100 mg:

Each chewable tablet contains 100 mg of raltegravir (potassium).

The other components are: hydroxypropylcellulose, sucralose, sodium saccharin, sodium citrate dihydrate, mannitol (E 421), red iron oxide, yellow iron oxide, monoammonium glycyrrhizinate, sorbitol (E 420), fructose, natural and artificial flavours (orange, banana and flavour-masking), aspartame (E 951), sucrose, crospovidone Type A, magnesium stearate, sodium stearyl fumarate, ethylcellulose 20 cP, ammonium hydroxide, medium-chain triglycerides, oleic acid, hypromellose 2910/6cP and macrogol/PEG 400.

Nature of the product and contents of the pack

Isentress 25 mg chewable tablets:

Light yellow chewable tablet, flavoured with orange and banana, round, with the MSD corporate logo on one side and "473" on the other side.

One pack size is available: 1 bottle containing 60 tablets. The bottle contains a desiccant.

Isentress 100 mg chewable tablets:

Light orange chewable tablet, flavoured with orange and banana, oval, scored on both sides, engraved on one side with the MSD corporate logo and the inscription "477", and without inscription on the other side.

One pack size is available: 1 bottle containing 60 tablets. The bottle contains a desiccant.

Marketing Authorisation Holder and Manufacturer

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

The Netherlands

More information about this medicinal product is available upon request by contacting the local representative of the Marketing Authorisation Holder:

Date of the latest review of this leaflet: <{MM/YYYY}><{month YYYY}>.

Detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.euopa.eu.