ISENTRESS 400 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Isentress 400mg 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 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 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. Package contents and further 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 your 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 better fight off infections.

When Isentress should be used

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.

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 and 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 of suicide and suicidal behaviour, has been reported in some patients taking this medicine, especially in patients with a 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 immunosuppression, high body mass index, among others, can be some of the many risk factors for developing this disease. The signs of osteonecrosis are joint stiffness, pain and difficulty moving. If you experience any of these symptoms, contact 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 and who have had previous opportunistic infections may experience signs and symptoms of inflammation from previous infections when they start taking HIV treatment. These symptoms are thought to be due to the improvement in the body’s immune response, enabling the body to fight infections that may have been present without causing symptoms.

In addition to opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you have started taking medicines for the treatment of your HIV infection. Autoimmune disorders may occur many months after the start of treatment. If you observe 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 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 take any other medicines, including those obtained without a prescription.

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 neutralises stomach acid and relieves indigestion and heartburn). It is not recommended to take Isentress with some antacids (those containing aluminium and/or magnesium). Ask your doctor about other antacids that you can take.
• iron salts (to treat and prevent iron deficiency or anaemia). You should wait at least 2 hours between taking iron salts and taking Isentress, as these medicines can reduce the effectiveness of Isentress.
• rifampicin (a medicine used to treat some infections such as tuberculosis), as they may decrease Isentress levels. If you are taking rifampicin, your doctor may consider increasing your dose of Isentress.

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.

• It is recommended that HIV-infected women do not breast-feed their babies because HIV can be transmitted to the baby through breast milk.
• If you are breast-feeding or thinking of breast-feeding, you should 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 or operate machinery 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 sodium (23 mg) per tablet, i.e. essentially “sodium-free”.

3. How to take Isentress

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

How much to take

Adults

The recommended dose is 1 tablet (400 mg) taken by mouth twice a day.

Use in children and adolescents

The recommended dose of Isentress is 400 mg taken by mouth twice a day for adolescents and children weighing at least 25 kg.

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

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

Do not switch between the 400 mg tablet, 600 mg tablet, chewable tablet or granules for 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, contact 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 forgotten 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 as prescribed and at the right time of day. This will help the medicines work better and reduce the chance of the medicines not being able to fight HIV (this is called “drug resistance”).
• When you are running low on Isentress, go to your doctor or pharmacy to get more. The reason is that it is very important not to be without your medicine, even for a few days. If you stop taking your 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 be 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 serious side effects:

• herpes infections including shingles
• anaemia including that caused by low iron
• signs and symptoms of infection or inflammation
• mental disorders
• suicidal thoughts or attempts
• stomach inflammation
• liver inflammation
• liver failure
• allergic reactions
• certain types of kidney problems
• overdose

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

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

• loss of appetite
• sleep problems; unusual dreams; nightmares; abnormal behaviour; feeling sad
• dizziness; headache
• vertigo
• wind or gas; stomach pain; diarrhoea; excessive gas in the stomach or intestines; nausea; vomiting; indigestion; belching
• certain types of rash (more frequently when used in combination with darunavir)
• fatigue, tiredness or unusual weakness; fever
• high liver enzymes; abnormal white blood cell counts; high blood fat levels; high 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 diarrhoea due to an infectious agent; upper respiratory tract infection; collection of pus in lymph node
• 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 reaction
• increased appetite; diabetes; high blood cholesterol and fat levels; high 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 attack
• memory loss; nerve damage causing pain in the hand; attention disturbance; dizziness when changing posture quickly; unusual taste; increased sleepiness; lack of energy; forgetfulness; migraine; loss of sensation, numbness or weakness in the arms and/or legs; tingling; sleepiness; tension headache; tremors
• vision disturbances
• ringing, buzzing, whistling, hissing or other persistent noises in the ears
• palpitations; slow heartbeat; fast or irregular heartbeat
• hot flushes; high blood pressure
• hoarse, rough or strained voice; nosebleeds; nasal congestion
• upper stomach pain; rectal discomfort; constipation; dry mouth; heartburn; difficulty swallowing; pancreatitis; stomach or duodenal ulcer; bleeding from the anus; stomach upset; gum inflammation; swelling, redness and ulcers of the tongue
• fat accumulation in the liver
• acne; hair loss or thinning; skin redness; unusual distribution of body fat, this may include loss of fat from the legs, arms and face and increase in 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 joints; back pain; muscle pain or weakness; neck pain; pain in the arms or legs; tendon inflammation; decrease in bone mineral density
• kidney stones; nocturia; kidney cyst
• erectile dysfunction; breast enlargement in men; menopausal symptoms
• chest discomfort; chills; facial swelling; feeling anxious; feeling unwell; lump in the neck; swelling of the hands, ankles or feet; pain
• low white blood cell count; low platelet count; decreased kidney function in blood tests; high blood sugar levels; high 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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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.
• No special storage conditions are required.
• 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. These measures will help protect the environment.

6. Container contents and additional information

Isentress composition

The active ingredient is raltegravir. Each film-coated tablet contains 400 mg of raltegravir (potassium).

The other ingredients are: lactose monohydrate, microcrystalline cellulose, anhydrous dibasic calcium phosphate, hypromellose 2208, poloxamer 407, sodium stearyl fumarate, and magnesium stearate. In addition, the coating contains the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350, talc, red iron oxide, and black iron oxide.

Product appearance and container contents

The 400 mg film-coated tablet is oval in shape, pink in color, and has "227" engraved on one side.

Two pack sizes are available: packs of 1 bottle of 60 tablets and multipacks containing 3 bottles of 60 tablets each. The bottle contains a desiccant.

Only some pack 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, 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.