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ISENTRESS 400 MG FILM-COATED TABLETS

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About the medicine

How to use ISENTRESS 400 MG FILM-COATED TABLETS

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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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.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

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.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

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:

Belgium/Belgique/Belgien

MSD Belgium

Tel: +32(0)27766211

[email protected]

Lithuania

UAB Merck Sharp & Dohme

Tel: +370 5 2780 247

[email protected]

Text in Bulgarian language with contact information of Merck Sharp and Dohme Bulgaria, including phone and email

Luxembourg/Luxemburg

MSD Belgium

Tel: +32(0)27766211

[email protected]

Czech Republic

Merck Sharp & Dohme s.r.o.

Tel: +420 233 010 111

[email protected]

Hungary

MSD Pharma Hungary Kft.

Tel: +36 1 888 5300

[email protected]

Denmark

MSD Danmark ApS

Tel: +45 4482 4000

[email protected]

Malta

Merck Sharp & Dohme Cyprus Limited

Tel: 8007 4433 (+356 99917558)

[email protected]

Germany

MSD Sharp & Dohme GmbH

Tel: +49 (0) 89 20 300 4500

[email protected]

Netherlands

Merck Sharp & Dohme B.V.

Tel: 0800 9999000

(+31 23 5153153)

[email protected]

Estonia

Merck Sharp & Dohme OÜ

Tel: +372 614 4200

[email protected]

Norway

MSD (Norge) AS

Tel: +47 32 20 73 00

[email protected]

Greece

MSD Α.Φ.Ε.Ε.

Tel: +30 210 98 97 300

[email protected]

Austria

Merck Sharp & Dohme Ges.m.b.H.

Tel: +43 (0) 1 26 044

[email protected]

Spain

Merck Sharp & Dohme de España, S.A.

Tel: +34 91 321 06 00

[email protected]

Poland

MSD Polska Sp. z o.o.

Tel: +48 22 549 51 00

[email protected]

France

MSD France

Tel: +33 (0) 1 80 46 40 40

Portugal

Merck Sharp & Dohme, Lda

Tel: +351 21 4465700

[email protected]

Croatia

Merck Sharp & Dohme d.o.o.

Tel: + 385 1 6611 333

[email protected]

Romania

Merck Sharp & Dohme Romania S.R.L.

Tel: +40 21 529 29 00

[email protected]

Ireland

Merck Sharp & Dohme Ireland (Human Health) Limited

Tel: +353 (0)1 2998700

[email protected]

Slovenia

Merck Sharp & Dohme, inovativna zdravila d.o.o.

Tel: +386 1 520 4201

[email protected]

Iceland

Vistor ehf.

Tel: + 354 535 7000

Slovak Republic

Merck Sharp & Dohme, s. r. o.

Tel: +421 2 58282010

[email protected]

Italy

MSD Italia S.r.l.

Tel: 800 23 99 89 (+39 06 361911)

[email protected]

Finland

MSD Finland Oy

Tel: +358 (0)9 804 650

[email protected]

Cyprus

Merck Sharp & Dohme Cyprus Limited

Tel: 800 00 673 (+357 22866700)

[email protected]

Sweden

Merck Sharp & Dohme (Sweden) AB

Tel: +46 77 5700488

[email protected]

Latvia

SIA Merck Sharp & Dohme Latvija

Tel: + 371 67025300

[email protected]

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.

Online doctors for ISENTRESS 400 MG FILM-COATED TABLETS

Discuss questions about ISENTRESS 400 MG FILM-COATED TABLETS, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Даниэль Чики

Family medicine 24 years exp.

Dr Daniel Cichi is a family medicine doctor with over 20 years of clinical experience. He provides online consultations for adults, supporting patients with acute symptoms, chronic conditions, and everyday health concerns that require timely medical guidance.

His background includes work in emergency care, ambulance services, and family medicine, which allows him to assess symptoms quickly, identify warning signs, and help patients choose the safest next steps – whether that means home care, treatment adjustment, or in-person evaluation.

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Dr Cichi’s consultations are structured and practical. He focuses on clear explanations, risk assessment, and actionable recommendations, helping patients understand their symptoms and make informed decisions about their health.
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Yevgen Yakovenko

General surgery 12 years exp.

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

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Lina Travkina

Family medicine 13 years exp.

Dr. Lina Travkina is a licensed family and preventive medicine doctor based in Italy. She provides online consultations for adults and children, supporting patients across all stages of care – from acute symptom management to long-term health monitoring and prevention.

Areas of medical care include:

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Dr. Travkina combines evidence-based medicine with an attentive, personalised approach. Her consultations focus not only on treatment, but also on prevention, recovery, and long-term wellbeing.

If during the consultation it becomes clear that your case requires in-person assessment or specialised care outside of her scope, the session will be terminated and the payment fully refunded.

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Alina Tsurkan

Family medicine 13 years exp.

Dr. Alina Tsurkan is a licensed family medicine physician based in Portugal, offering online consultations for adults and children. She provides professional primary care, with a focus on prevention, accurate diagnosis, and long-term management of acute and chronic conditions.

Dr. Tsurkan supports patients with a wide range of health issues, including:

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Anna Biriukova

General medicine 6 years exp.

Dr Anna Biriukova is an internal medicine doctor with clinical experience in cardiology, endocrinology, and gastroenterology. She provides online consultations for adults, offering expert medical support for heart health, hormonal balance, digestive issues, and general internal medicine.

Cardiology – Diagnosis and treatment of:

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General internal medicine and preventive care:
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Frequently Asked Questions

Is a prescription required for ISENTRESS 400 MG FILM-COATED TABLETS?
ISENTRESS 400 MG FILM-COATED TABLETS requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in ISENTRESS 400 MG FILM-COATED TABLETS?
The active ingredient in ISENTRESS 400 MG FILM-COATED TABLETS is raltegravir. This information helps identify medicines with the same composition but different brand names.
Who manufactures ISENTRESS 400 MG FILM-COATED TABLETS?
ISENTRESS 400 MG FILM-COATED TABLETS is manufactured by Merck Sharp & Dohme B.V.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of ISENTRESS 400 MG FILM-COATED TABLETS online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether ISENTRESS 400 MG FILM-COATED TABLETS is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to ISENTRESS 400 MG FILM-COATED TABLETS?
Other medicines with the same active substance (raltegravir) include ISENTRESS 100 MG CHEWABLE TABLETS, ISENTRESS 25 mg CHEWABLE TABLETS, ISENTRESS 600 MG FILM-COATED TABLETS. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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