Label: information for the user

Isentress 600mg film-coated 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 refer to 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 others 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.

1.What Isentress is and for what it is used

2.What you need to know before starting to take Isentress

3.How to take Isentress

4.Possible adverse effects

5.Storage of Isentress

6.Contents of the package and additional information

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 can improve the functioning of the immune system. This means that the body can fight better against infection.

When to use Isentress

Isentress 600 mg film-coated tablets are used to treat adults and pediatric patients with a weight of at least 40 kg 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 components of 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 in patients with a previous 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, significant weight gain, 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 hepatitisB or C. Your doctor may evaluate the severity of your liver disease before deciding if 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 be caused by the improvement of the body's immune response, which allows the body to fight off infections that may have been present but not producing 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, pharmacist, or nurse if you are taking, have taken recently, or may need to take any other medication.

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)
• iron supplements (to treat and prevent iron deficiency or anemia). Wait at least twohours between taking iron supplements and taking Isentress, as these medications may reduce the effectiveness of Isentress.
• atazanavir (an antiretroviral medication)
• rifampicin (a medication used to treat certain infections such as tuberculosis)
• tipranavir/ritonavir (antiretroviral medications)

Carry a list of all your medications to show your doctor and pharmacist.

• You can ask your doctor or pharmacist to give you a list of medications that interact with Isentress.
• Do not start taking a new medication without informing your doctor. Your doctor may tell you if it is safe to take Isentress with other medications.

Isentress with food and beverages

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.

• Isentress 1.200mg (two 600mg tablets once a day) is not recommended during pregnancy, as it has not been studied in pregnant women.
• It is not recommended that women with HIV infection breastfeed, as the 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 contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Isentress contains sodium

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

Follow exactly the administration instructions of this medication 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.

How muchto take

Adults, children and adolescents who weigh at least 40kg

The recommended dose is 1,200mg taken as two 600mg tablets orally once a day.

Do not crush, chew or break the tablets because it may alter the amount of medication in your body. You can take this medication with or without food or drinks.

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

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

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 the 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 hours of the day. This makes the medications work better and also reduces the possibility that they will no longer be able 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 consequence, HIV may develop resistance to Isentress and the disease may be more difficult to treat.

If you have any other doubts 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
• gastritis inflammation
• liver inflammation
• hepatic failure
• allergic 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
• sleep problems; 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

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

• hair follicle infection; flu; skin infection due to virus; vomiting or diarrhea due to an infectious agent; upper respiratory tract infection; lymph node abscess
• warts
• lymph node pain; low white blood cell count; swelling of the neck, armpit, and groin 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
• anxiety sensation; confusion sensation; depressed mood; mood changes; panic attack
• memory loss; hand pain due to nerve compression; altered attention; dizziness upon rapid change of posture; abnormal taste; increased somnolence; lack of energy; forgetfulness; migraines; numbness, tingling, or weakness of the arms and/or legs; paresthesia; somnolence; tension headache; tremors; poor sleep
• vision alteration
• tinnitus, high-pitched sounds, buzzing, or other persistent noises in the ears
• palpitations; slow heart rate; irregular heartbeats
• angina; high blood pressure
• hoarse, rough, or forced voice; nasal bleeding; nasal congestion
• upper abdominal pain; rectal discomfort; constipation; dry mouth; stomach burning; difficulty swallowing; pancreatitis inflammation; stomach or intestinal ulcer or wound; rectal bleeding; stomach discomfort; gum inflammation; swollen tongue and ulceration
• liver fat accumulation
• acne; hair loss or thinning; skin redness; unusual body fat distribution, 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; gynecomastia 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 blood (a type of cell involved in blood clotting); decreased renal function in blood test; high blood sugar levels; elevated muscle enzymes in blood; sugar in urine; red blood cells in 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.

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

Composition of Isentress

The active ingredient is raltegravir. Each film-coated tablet contains 600mg of raltegravir (potassium).

The other components are: microcrystalline cellulose, hypromellose2910, croscarmellose sodium, and magnesium stearate. Additionally, the coating contains the following inactive components: lactose monohydrate, hypromellose2910, titanium dioxide, triacetin, yellow iron oxide, and black iron oxide. The tablet may also contain traces of carnauba wax.

Appearance of the product and contents of the pack

The 600mg film-coated tablet is oval in shape, yellow in color, with the MSD corporate logo and the inscription “242” engraved on one face and the other face is smooth.

Two pack sizes are available: a pack of 60film-coated tablets in a bottle and a pack containing 3bottles of 60film-coated tablets each. The bottle contains a desiccant.

Only some pack sizes may be marketed.

Marketing authorization holder and responsible person for manufacturing

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

Netherlands

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

Last update of the summary of product characteristics:<{MM/AAAA}><{mes AAAA}>.

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