Label: information for the user

Isentress 25mgchewable tablets

Isentress 100mg chewable tablets

raltegravir

Read this label carefully before starting to take this medication, as 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 label, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you or your child, and should not be given to

other people, even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor, pharmacist, or nurse,

Even if they are not listed in this label. See section4.

What is Isentress

Isentress contains the active ingredient raltegravir. Isentress is an antiviral medication 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 to enter the body's cells and multiply. Isentress prevents this enzyme from functioning. When used with other medications, Isentress can reduce the amount of HIV in the blood (this is known as its "viral load") and increase the count of CD4 cells (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, it may improve the functioning of the immune system. This means that the body can fight better against infection.

When to use Isentress

Isentress is used to treat patients who are infected with HIV. Your doctor has prescribed Isentress to help you control the HIV infection you have.

Do not take Isentress:

• if you are allergic to raltegravir or any of the other ingredients in this medication (listed in section6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Isentress.

Remember that Isentress does not cure HIV infection. This means that you may still experience infections or other HIV-related illnesses. You should continue to see your doctor regularly while taking this medication.

Mental health problems

Inform your doctor if you have a history of depression or mental illness. Depression, including suicidal thoughts and behaviors, has been observed in some patients taking this medication, especially those with a prior history of depression or mental illness.

Bone problems

Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (bone tissue death caused by loss of blood supply to the bone). Factors that may increase the risk of developing this disease include the duration of antiretroviral therapy, use of corticosteroids, alcohol consumption, severe immunosuppression, increased body mass index, and others. Signs of osteonecrosis include joint stiffness, pain, and difficulty moving, especially in the hip, knee, and shoulder. If you experience any of these symptoms, see your doctor.

Liver problems

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

Infections

If you notice any symptoms of infection, such as fever and/or feeling unwell, inform your doctor, pharmacist, or nurse immediately. Some patients with advanced HIV infection and a history of opportunistic infections may experience signs and symptoms of inflammation due to previous infections shortly after starting HIV treatment. These symptoms are believed to result from the improvement of the body's immune response, allowing the body to fight off infections that may have been present but not causing obvious symptoms.

In addition to opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after starting HIV treatment. These disorders can occur 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 ascending to the body trunk, palpitations, tremors, or hyperactivity, inform your doctor immediately to receive necessary treatment.

Muscle problems

Contact your doctor, pharmacist, or nurse immediately if you notice unexplained muscle pain, sensitivity to pressure, or muscle weakness during treatment with this medication.

Skin problems

Contact your doctor immediately if you experience a rash. Severe and potentially life-threatening skin reactions and allergic reactions have been reported in some patients taking this medication.

Other medications and Isentress

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication with or without a prescription.

Isentress may interact with other medications.

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

• antacids (a medication that counteracts or neutralizes stomach acid and relieves indigestion and heartburn). Do not take Isentress with some antacids (those containing aluminum and/or magnesium). Consult your doctor about other antacids you may take.
• iron supplements (to treat and prevent iron deficiency or anemia). Wait at least two hours between taking iron supplements and taking Isentress, as these medications may reduce the effectiveness of Isentress.
• rifampicin (a medication used to treat some infections such as tuberculosis), as it may lower your Isentress levels. If you are taking rifampicin, your doctor may consider increasing your Isentress dose.

Taking Isentress with food and drinks

See section3.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

• The chewable tablets of Isentress are not recommended during pregnancy, as they have not been studied in pregnant women.
• It is not recommended that HIV-positive women breastfeed, as HIV infection can be transmitted to the baby through breast milk.
• If you are breastfeeding or plan to breastfeed, consult your doctor as soon as possible.

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

Driving and operating machinery

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

Isentress 25mg chewable tablet

Isentress 25mg chewable tablet contains fructose

This medication contains up to 0.54mg of fructose in each tablet.

Fructose may damage teeth.

Isentress 25mg chewable tablet contains sorbitol

This medication contains up to 1.5mg of sorbitol (E420) in each tablet.

Isentress 25mg chewable tablet contains sucrose

This medication contains up to 3.5mg of sucrose in each 25mg chewable tablet.

Sucrose may harm teeth.

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Isentress 25mg chewable tablet contains aspartame

This medication contains up to 0.47mg of aspartame (E951) in each 25mg chewable tablet, equivalent to up to 0.05mg of phenylalanine.Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU),a rare genetic disorder in which phenylalanine accumulates due to the body's inability to eliminate it correctly.

Isentress 25mg chewable tablet contains sodium

This medication contains less than 1mmol of sodium (23mg) per tablet; essentially "sodium-free".

Isentress 100mg chewable tablet

Isentress 100mg chewable tablet contains fructose

This medication contains up to 1.07mg of fructose in each tablet.

Fructose may damage teeth.

Isentress 100mg chewable tablet contains sorbitol

This medication contains up to 2.9mg of sorbitol (E420) in each tablet.

Isentress 100mg chewable tablet contains sucrose

This medication contains up to 7mg of sucrose in each 100mg chewable tablet.

Sucrose may harm teeth.

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Isentress 100mg chewable tablet contains aspartame

This medication contains up to 0.93mg of aspartame (E951) in each 100mg chewable tablet, equivalent to up to 0.10mg of phenylalanine.Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU),a rare genetic disorder in which phenylalanine accumulates due to the body's inability to eliminate it correctly.

Isentress 100mg chewable tablet contains sodium

This medication contains less than 1mmol of sodium (23mg) per tablet; essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor, pharmacist, or nurse. In case of doubt, consult your doctor, pharmacist, or nurse again. Isentress should be used in combination with other medications for HIV infection.

The 100 mg chewable tablet can be divided into two equal halves. However, it should be avoided breaking the tablets whenever possible.

How much to take

Dose for children between 2 and 11 years of age

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

Isentress is also available in 400 mg tablets, 600 mg tablets, and oral granules for suspension.

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

Children should attend scheduled visits with their doctor as their Isentress dose should be adjusted as they grow, gain weight, or become older. Your doctor may also want to prescribe the 400 mg tablet when they are able to swallow a tablet.

This medication can be taken with or without food or beverages.

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 that you have not taken it.
• However, if it is time to take the next dose, do not take the missed dose and follow your usual dosing schedule.
• Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Isentress

It is essential that you take Isentress exactly as your doctor has told you.Do not change the dose or stop taking this medication without consulting your doctor, pharmacist, or nurse first.Do not stop taking it, because:

• It is very important that you take all HIV medications as prescribed and at the correct times of the day. This makes the medications work better and also reduces the possibility of them becoming unable to combat HIV (also known as "drug resistance").
• When you have few tablets of Isentress left, go to your doctor or pharmacy to get more. The reason is that it is very important not to run out of medication, not even for a few days. If you stop taking the medication for a few days, the amount of virus in the blood may increase, and as a result, HIV may develop resistance to Isentress, making the disease more difficult to treat.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Severe side effects–these are rare (may affect up to 1 in 100people)

Seek medical attention immediately if you notice any of the following side effects:

• herpes infections, including shingles
• anemia, including iron deficiency anemia
• signs and symptoms of infection or inflammation
• mental disorder
• suicidal attempt or intention
• inflammation of the stomach
• inflammation of the liver
• hepatic failure
• allergic-type rash
• specific types of kidney problems
• ingestion of the medicine in quantities greater than those recommended

Seek medical attention immediately if you notice any of the side effects mentioned above.

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

• loss of appetite
• difficulty sleeping; strange dreams; nightmares; abnormal behavior; deep sadness and low self-esteem
• dizziness; headache
• vertigo
• flatulence or gas; abdominal pain; diarrhea; excessive gas in the stomach or intestines; nausea; vomiting; indigestion; belching
• specific types of rash (more frequently when used in combination with darunavir)
• unusual fatigue, weakness, or tiredness; fever
• high levels of liver parameters; abnormal white blood cell counts; high levels of blood fat; high levels of salivary gland or pancreatic enzymes

Poorly frequent: the following side effects may affect up to 1 in 100people

• infection of the hair follicles; flu; skin infection due to a virus; vomiting or diarrhea due to an infectious agent; upper respiratory tract infection; accumulation of pus in lymph nodes
• warts
• swollen lymph nodes; low white blood cell count responsible for fighting infections; swelling of the thyroid gland, axillary, and inguinal glands
• allergic reaction
• increased appetite; diabetes; high cholesterol and blood lipids; high blood sugar levels; excessive thirst; severe weight loss; high levels of blood fat (such as cholesterol and triglycerides); body fat disorders
• feeling of anxiety; feeling of confusion; depressed mood; changes in mood; panic attack
• memory loss; hand pain due to nerve compression; altered attention; dizziness when changing position quickly; abnormal taste; increased somnolence; lack of energy; forgetfulness; migraines; loss of sensation, numbness, or weakness in the arms and/or legs; paresthesia; somnolence; tension headache; tremors; poor sleep
• vision alteration
• tinnitus, high-pitched sounds, buzzing, or other persistent sounds in the ears
• palpitations; slow heartbeats; irregular heartbeats
• angina; increased blood pressure
• hoarse, rough, or forced voice; nasal bleeding; nasal congestion
• upper abdominal pain; rectal discomfort; constipation; dry mouth; stomach burning; difficulty swallowing; pancreatitis; stomach or intestinal ulcer; rectal bleeding; stomach discomfort; gum inflammation; swollen tongue and ulcerated
• accumulation of fat in the liver
• acne; hair loss or thinning; skin redness; unusual distribution of body fat, which may include loss of fat in legs, arms, and face, and increased fat in the abdomen; excessive sweating; night sweats; skin thickening and itching due to repeated scratching; skin lesions; dry skin
• joint pain; painful joints; back pain; bone or muscle pain; muscle weakness or pain; neck pain; arm or leg pain; tendon inflammation; decreased mineral levels in the bone
• kidney stones; nocturia; renal cyst
• erectile dysfunction; breast enlargement in men; menopausal symptoms
• chest discomfort; chills; facial swelling; feeling of nervousness; general feeling of discomfort; neck lump; hand, ankle, or foot swelling; pain
• low white blood cell count; low platelet count in the blood (a type of cell involved in blood clotting); decreased renal function in blood tests; high blood sugar levels; elevated muscle enzymes in the blood; sugar in the urine; red blood cells in the urine; weight gain; increased waist circumference; decreased blood protein (albumin); prolonged blood clotting time

Other side effects in children and adolescents

• hyperactivity

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus.You can also report them directly through thenational notification system included in theAppendixV. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

• Do not use this medication after the expiration date that appears on the bottle after CAD. The expiration date is the last day of the month indicated.
• Keep the bottle perfectly closed, with the desiccant (drying agent) to protect it from moisture. Do not ingest the desiccant.
• Before breaking the seal, it does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Isentress Composition

The active ingredient is raltegravir.

25 mg chewable tablets:

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, glycirricinamide, sorbitol (E 420), fructose, natural and artificial flavors (orange, banana, and masking), aspartame (E 951), sucrose, crospovidone Type A, magnesium stearate, sodium stearate fumarate, ethylcellulose 20 cP, ammonium hydroxide, medium-chain triglycerides, oleic acid, hypromellose 2910/6 cP, and macrogol/PEG 400.

100 mg chewable tablets:

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, glycirricinamide, sorbitol (E 420), fructose, natural and artificial flavors (orange, banana, and masking), aspartame (E 951), sucrose, crospovidone Type A, magnesium stearate, sodium stearate fumarate, ethylcellulose 20 cP, ammonium hydroxide, medium-chain triglycerides, oleic acid, hypromellose 2910/6 cP, and macrogol/PEG 400.

Appearance of the product and contents of the package

Isentress 25 mg chewable tablets:

Chewable tablet of yellowish color, with orange and banana flavor, round, with the MSD corporate logo on one face and "473" on the other face.

Available in one package size: 1 bottle with 60 tablets. The bottle contains a desiccant.

Isentress 100 mg chewable tablets:

Chewable tablet of orange-yellowish color, with orange and banana flavor, oval, scored on both faces, engraved on one face with the MSD corporate logo and the inscription "477" and without inscription on the other face.

Available in one package size: 1 bottle with 60 tablets. The bottle contains a desiccant.

Holder of the marketing authorization and responsible for manufacturing

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

Netherlands

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last revision date of this leaflet:<{MM/AAAA}><{mes AAAA}>.

For detailed information about this medicine, please visit the European Medicines Agency website:http://www.ema.europa.eu.