ISENTRESS 600 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Isentress 600mg film-coated tablets

raltegravir

Read all of this 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, 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 or your child, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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. Storing 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 immune deficiency syndrome (AIDS).

How Isentress works

The virus produces an enzyme called HIV integrase, which helps the virus to enter the cells of the body 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 called your “viral load”) and increase the number of CD4 cells (a type of white blood cell that plays an important role in keeping the immune system healthy to help fight infection). By reducing the amount of HIV in the blood, it can improve the functioning of your immune system. This means your body can fight better against the infection.

When Isentress should be used

Isentress 600 mg film-coated tablets are used to treat adults and pediatric patients weighing at least 40 kg who are infected with HIV. Your doctor has prescribed Isentress to help control the HIV infection you have.

2. What you need to know before you take Isentress

Do not take Isentress:

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

Warnings and precautions

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

Remember that Isentress does not cure HIV infection. This means you can still get illnesses or infections related to HIV. You must keep seeing your doctor regularly while taking this medicine.

Mental health problems

Tell your doctor if you have a history of depression or mental health problems. Depression, including thoughts and behaviors of suicide, has been seen in some patients while taking this medicine, especially in patients with a previous history of depression or mental health problems.

Bone problems

Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). The duration of combination antiretroviral therapy, the use of corticosteroids, alcohol consumption, severe immune system suppression, increased body mass index, among others, may be some of the many risk factors for developing this disease. Signs of osteonecrosis are joint stiffness, discomfort, and pain (especially in the hip, knee, and 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 had liver problems in the past, including hepatitis B or C. Your doctor may assess the severity of your liver disease before deciding if you can take this medicine.

Infections

If you notice any symptoms of infection, such as fever and/or feeling unwell, tell your doctor, pharmacist, or nurse immediately. Some patients with advanced HIV infection who have previously had opportunistic infections may show signs and symptoms of inflammation due to previous infections soon after starting HIV treatment. It is believed that these symptoms are due to the improvement of the body's immune response, which allows the body to fight infections that it may have had but were not showing obvious symptoms.

In addition to opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also appear after you have started taking medicines for the treatment of your 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 up towards the trunk of the body, palpitations, tremors, or hyperactivity, tell your doctor immediately to receive the necessary treatment.

Muscle problems

Contact your doctor, pharmacist, or nurse immediately if you notice unexplained muscle pain, tenderness, or muscle weakness while taking 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, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.

Isentress may interact with other medicines. Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take:

• antacids (a medicine that counteracts or neutralizes stomach acid and relieves indigestion and heartburn)
• iron salts (to treat and prevent iron deficiency or anemia). You should wait at least 2 hours between taking iron salts and taking Isentress, as these medicines may reduce the effectiveness of Isentress.
• atazanavir (an antiretroviral medicine)
• rifampicin (a medicine used to treat some infections such as tuberculosis)
• tipranavir/ritonavir (antiretroviral medicines)

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

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

Taking Isentress with food and drinks

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 1,200 mg (two 600 mg tablets once daily) is not recommended during pregnancy, as it has not been studied in pregnant women.
• It is recommended that HIV-infected women do not breast-feed their babies to avoid transmitting the virus to them through breast milk.
• If you are breast-feeding or thinking of breast-feeding, consult your doctor as soon as possible.

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 any medicine.

Driving and using machines

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

Isentress contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

Isentress contains sodium

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

3. How to take Isentress

Always take this medicine exactly as your doctor, pharmacist, or nurse has told you. If you are not sure, check with your doctor, pharmacist, or nurse. Isentress should be used in combination with other medicines for HIV infection.

How much to take

Adults, children, and adolescents weighing at least 40 kg

The recommended dose is 1,200 mg taken as two 600 mg tablets by mouth once daily.

Do not chew, crush, or split the tablets as this may alter the amount of medicine in your body. You can take this medicine with or without food or drinks.

Isentress is also available as a 400 mg tablet, chewable tablet, and oral suspension.

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

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, talk to 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 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 missed dose.

If you stop taking Isentress

It is important that you take Isentress exactly as your doctor has told you. 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 they were prescribed and at the right times of the day. This makes the medicines work better and also reduces the chance of the medicines becoming unable to combat HIV (this is also called “drug resistance”).
• When you have only a few Isentress tablets left, go to your doctor or pharmacy to get more. The reason is that 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, and the disease may become harder to treat.

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

4. Possible side effects

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 side effects:

• herpes infections, including shingles
• anemia, including iron deficiency anemia
• signs and symptoms of infection or inflammation
• mental disorders
• suicidal thoughts or behaviors
• stomach inflammation
• liver inflammation
• liver failure
• allergic skin reactions
• certain types of kidney problems
• overdose

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

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

• decreased appetite
• sleep problems; unusual dreams; nightmares; abnormal behavior; feelings of 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
• certain types of skin rashes (more frequently when used in combination with darunavir)
• fatigue, unusual tiredness or weakness; fever
• elevated liver enzymes; abnormal white blood cell counts; increased fat levels in the blood; increased levels of pancreatic or salivary gland enzymes

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

• infection of the hair roots; flu; viral skin infection; vomiting or diarrhea due to an infectious agent; upper respiratory tract infection; accumulation of pus in lymph nodes
• warts
• lymph node pain; low count of white blood cells that fight infection; swelling of the lymph nodes in the neck, armpits, and groin
• allergic reactions
• increased appetite; diabetes; elevated cholesterol and lipid levels in the blood; increased blood sugar levels; excessive thirst; severe weight loss; high levels of fat in the blood (such as cholesterol and triglycerides); body fat disorders
• anxiety; confusion; depressed mood; mood changes; panic attacks
• memory loss; nerve compression pain in the hand; attention problems; dizziness when changing position quickly; unusual taste; increased drowsiness; lack of energy; forgetfulness; migraines; loss of sensation, numbness, or weakness in the arms and/or legs; tingling; drowsiness; tension headache; tremors
• vision problems
• ringing, high-pitched sounds, whistling, or other persistent noises in the ears
• palpitations; slow heartbeat; rapid or irregular heartbeat
• hot flashes; increased blood pressure
• hoarse, rough, or strained voice; nosebleeds; nasal congestion
• upper abdominal pain; rectal discomfort; constipation; dry mouth; heartburn; difficulty swallowing; pancreatitis; stomach or upper intestine ulcers; anal bleeding; stomach upset; gum inflammation; swelling, redness, and ulcers of the tongue
• fat accumulation in the liver
• acne; hair loss or thinning; skin redness; unusual fat distribution in the body, which may include loss of fat in the 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 lesions; dry skin
• joint pain; painful joints; back pain; bone or muscle pain; muscle weakness or pain; neck pain; pain in the arms or legs; tendon inflammation; decreased bone mineral density
• kidney stones; nocturia; kidney cyst
• erectile dysfunction; breast enlargement in men; menopausal symptoms
• chest discomfort; chills; facial swelling; feeling of nervousness; feeling of general discomfort; lump in the neck; swelling of the hands, ankles, or feet; pain
• low white blood cell count; low platelet count in the blood; decreased kidney 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 levels; increased blood clotting time

Other side effects in children and adolescents

• hyperactivity

Reporting of side effects

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

5. Storing 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 after EXP. The expiry date refers to the last day of that month.
• Keep the bottle tightly closed, with the desiccant (drying agent) to protect it from moisture. Do not swallow the desiccant.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Additional Information

Isentress Composition

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

The other ingredients are: microcrystalline cellulose, hypromellose 2910, sodium croscarmellose, and magnesium stearate. Additionally, the coating contains the following inactive ingredients: lactose monohydrate, hypromellose 2910, titanium dioxide, triacetin, yellow iron oxide, and black iron oxide. The tablet may also contain traces of carnauba wax.

Product Appearance and Package Contents

The 600 mg film-coated tablet is oval in shape, yellow in color, with the MSD corporate logo and the inscription "242" embossed on one side and the other side is smooth.

Two package sizes are available: packages of 1 bottle of 60 tablets and multiple packages containing 3 bottles of 60 tablets each. The bottle contains a desiccant.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

Netherlands

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

Date of Last Revision of this Leaflet:<{MM/AAAA}><{month AAAA}>.

Detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu.