Isentress 400 mg film-coated tablets

Package leaflet: Information for the user

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, as you may need to read it again.
• If you have any 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, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are side 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 functioning. 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 functioning 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 starting 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

Inform 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, especially 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). Duration of combination antiretroviral therapy, use of corticosteroids, alcohol consumption, severely weakened immune system, increased body mass index, among others, may be some of the many risk factors for developing this condition. Signs of osteonecrosis include 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

Inform 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 feeling unwell, inform your doctor, pharmacist, or nurse immediately. Some patients with advanced HIV infection who previously had opportunistic infections may develop signs and symptoms of inflammation from prior infections shortly after starting 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 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 toward the trunk, palpitations, tremors, 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 to pressure, 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

Inform 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.

Inform 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. Consult 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 taking Isentress, as these medicines may reduce the effectiveness of Isentress.
• rifampicin (a medicine used to treat certain infections such as tuberculosis), as it may lower 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

• Women living with HIV are not advised to breastfeed because HIV infection can be transmitted to the baby through breast milk.
• If you are breastfeeding or planning to breastfeed, 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 contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Isentress contains sodium

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

3. How to take Isentress

Follow exactly the instructions given by your doctor, pharmacist, or nurse for taking this medicine. If you are unsure, check with your doctor, pharmacist, or nurse again. Isentress must be used in combination with other medicines for HIV infection.

What dose to take

Adults

The recommended dose is 1 tablet (400 mg) taken orally twice daily.

Use in children and adolescents

The recommended dose of Isentress is 400 mg taken orally twice daily for adolescents and children weighing at least 25 kg.

Do not chew, crush, or split the tablets, as this may alter the amount of medicine in your body. You may 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, the 600 mg tablet, the chewable tablet, or the 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, 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 missed dose.

If you stop taking Isentress

It is important that you take Isentress exactly as directed 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 to take all 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 the medicines (also known as “drug resistance”).
• When you are running low on Isentress tablets, go to your doctor or pharmacy to get more. 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 everyone will experience them.

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

Seek medical advice immediately if you notice any of the following adverse effects:

• herpes infections including shingles (herpes zoster)
• anemia including iron deficiency anemia
• signs and symptoms of infection or inflammation
• mental disorder
• suicide attempt or suicidal thoughts
• stomach inflammation
• liver inflammation
• liver failure
• allergic-type rash
• certain types of kidney problems
• ingestion of the medicine in amounts higher than recommended

Seek medical advice immediately if you notice any of the adverse effects listed above.

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

• decreased appetite
• sleep problems; strange dreams; nightmares; abnormal behavior; feeling of deep sadness and lack of self-esteem
• dizziness; headache
• vertigo
• flatulence or gas; abdominal pain; diarrhea; 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 levels of blood fats; increased levels of enzymes from the 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 diarrhea due to an infectious agent; upper respiratory tract infection; pus accumulation in lymph node
• warts
• swollen lymph nodes; low count of white blood cells responsible for fighting infections; swelling of glands in neck, armpits, or groin
• allergic reaction
• increased appetite; diabetes; elevated cholesterol and blood 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; difficulty swallowing; pancreatitis; ulcer or sore in the stomach or upper intestine; bleeding from the anus; stomach discomfort; gum inflammation; swelling, red and ulcerated tongue
• fat accumulation in the liver
• 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; 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 aching or weakness; neck pain; pain in arms or legs; 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; lump in the neck; 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); reduced 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

Additional adverse effects in children and adolescents

• hyperactivity

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included 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 is the last day of the month indicated.
• No special storage conditions are required.
• Keep the bottle tightly closed, with the desiccant (drying agent) inside, to protect it from moisture. Do not swallow the desiccant.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Isentress

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

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

Appearance of the product and contents of the container

The 400 mg film-coated tablet is oval-shaped, pink in colour, and has the inscription “227” engraved on one side.

Two pack sizes are available: packs containing 1 bottle of 60 tablets and multiple packs 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

The Netherlands

For more information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent 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.