Dutrebis
lamivudine, raltegravir potassium
lamivudine/raltegravir
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 get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What DUTREBIS is and what it is used for
What you need to know before you take DUTREBIS
How to take DUTREBIS
Possible side effects
How to store DUTREBIS
Contents of the pack and other information
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DUTREBIS is an antiretroviral medicine used to treat infection with human immunodeficiency virus (HIV). It contains the active substances lamivudine and raltegravir:
Lamivudine belongs to a group of medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs)
Raltegravir belongs to a group of medicines called HIV integrase strand transfer inhibitors
DUTREBIS is used to treat HIV (Human Immunodeficiency Virus). HIV is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).
DUTREBIS is used in combination with other medicines to treat adults, adolescents, and children 6 years of age and older and weighing at least 30 kg who are infected by HIV. Your doctor has prescribed DUTREBIS to help control your HIV infection.
When used with other medicines, DUTREBIS may:
reduce the amount of HIV in your blood (this is called your "viral load")
increase your CD4-cell count (a type of white blood cell that plays an important role in maintaining a healthy immune system to help fight infection).
Reducing the amount of HIV in the blood may improve the functioning of your immune system. This means your body may fight infection better.
DUTREBIS also helps stop the production of an enzyme called “HIV integrase”. This enzyme is needed for HIV to make more virus.
DUTREBIS is not a cure for HIV infection.
If you are allergic to lamivudine, raltegravir or any of the other ingredients in this medicine listed in section 6.
If you are not sure, talk to your doctor, pharmacist or nurse before taking DUTREBIS.
Remember that DUTREBIS is not a cure for HIV infection. This means that you may keep getting
infections or other illnesses associated with HIV, if you don’t take DUTREBIS as your doctor has instructed you.
Talk to your doctor, pharmacist or nurse before taking DUTREBIS if:
you have a history of depression or psychiatric illness. Depression, including suicidal thoughts and behaviours, has been reported in some patients taking raltegravir (one of the medicines in DUTREBIS), particularly in patients with a prior history of depression or psychiatric illness.
you have kidney problems - Your doctor may decide to change your dose by using the medicines in DUTREBIS separately.
you have had problems with your liver before, including hepatitis B or C. Your doctor may evaluate how severe your liver disease is before deciding if you can take this medicine. Do not
stop taking DUTREBIS without your doctor’s advice.
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking DUTREBIS.
HIV infection is spread by contact with blood or sexual contact with a person with HIV. You can still
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pass on HIV when taking this medicine, although the risk is lowered by effective therapy. Discuss with your doctor the precautions needed to avoid infecting other people.
DUTREBIS can cause some side effects that you need to talk to your doctor, pharmacist or nurse
about. See section 4 for more information about side effects.
Talk to your doctor immediately if you develop a rash. Severe and life-threatening skin reactions and allergic reactions have been reported in some patients taking raltegravir (one of the medicines in DUTREBIS).
Talk to your doctor, pharmacist or nurse immediately if you experience unexplained muscle pain, tenderness or weakness while taking this medicine.
Tell your doctor, pharmacist or nurse immediately if you notice any symptoms of infection, such
as:
fever, and/or feeling unwell.
In some patients with advanced HIV infection and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after HIV treatment is started. It is believed that these symptoms are due to an improvement in the body’s immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for
the treatment of your HIV infection. Autoimmune disorders may occur many months after the start
of treatment.
Tell your doctor, pharmacist or nurse immediately if you notice any symptoms of infection or other symptoms such as:
muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity.
Some people taking DUTREBIS, or similar medicines, may get a side effect called “lactic acidosis” and a swollen liver. Lactic acidosis is caused by a build-up of lactic acid in the body. It is rare (may affect up to 1 in 1,000 people) and if it does happen, it usually happens after a few
months of treatment. It can be life-threatening, and cause internal organs to fail.
Lactic acidosis is more likely to happen in people who have liver problems, or in people who are very overweight, especially women.
During your treatment, your doctor will check you for signs of lactic acidosis.
Tell your doctor immediately if you have any of the following signs of lactic acidosis, or any other symptoms that worry you:
deep, fast, difficult breathing, feeling drowsy, numb or weak arms or legs, feeling or being sick (nausea or vomiting), stomach pain.
Some patients taking combination treatment for HIV may develop a bone disease called
osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). This may be more likely with long-term HIV treatment, more severe damage to the immune system, overweight, or
the use of alcohol or other medicines called corticosteroids.
Tell your doctor if you notice any of the following signs of osteonecrosis:
joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty moving.
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Talk to your doctor if you notice changes in your body shape. People taking anti-retroviral medicines may find that their body shape changes. This is because of changes in fat distribution:
fat may be lost from the legs, arms or face; extra fat may build up around the tummy, breasts or internal organs; fatty lumps (sometimes called buffalo hump) may appear on the back of the neck.
It is not yet known what causes these changes, or whether they have any long-term effects.
Some people taking DUTREBIS or other antiretroviral medicines may have other effects show up in their blood tests:
increased levels of lactic acid in the blood, which on rare occasions can lead to lactic acidosis; increased levels of sugar and fats (triglycerides and cholesterol) in the blood; resistance to insulin
(so if you are diabetic, you may have to change your insulin dose to control your blood sugar).
DUTREBIS is not for use in children below 6 years of age.
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This is because DUTREBIS might interact with other medicines.
DUTREBIS must not be used with the following medicines. Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take:
medicines containing lamivudine – used to treat HIV or hepatitis B.
medicines containing raltegravair or emtricitabine – used to treat HIV.
high doses of co-trimoxazole – used to treat infections.
trimethoprim – used to treat infections.
interferons taken with or without ribavirin – used to treat hepatitis.
cladribine – used to treat hairy cell leukaemia.
antacids containing aluminium and/or magnesium – used for heartburn. Talk to your doctor about other medicines you can take.
rifampicin – used to treat some infections such as tuberculosis. Rifampicin may decrease your levels of raltegravir (one of the medicines in DUTREBIS). Your doctor may decide to change your dose by using the medicines in DUTREBIS separately, if you are taking rifampicin.
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.
DUTREBIS is not recommended in pregnancy.
Women with HIV should not breast-feed their infants because babies can be infected with HIV through their breast milk. Talk with your doctor about the best way to feed your baby.
Ask your doctor, pharmacist or nurse for advice before taking any medicine if you are pregnant or breast-feeding.
Do not operate machines, drive or cycle if you feel dizzy after taking this medicine.
If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
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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. DUTREBIS must be used in combination with other medicines for HIV.
The recommended dose is 1 tablet twice a day.
Swallow the tablet whole (do not crush or chew).
This medicine can be taken with or without food or drink.
Do not take more tablets than the doctor recommends. If you do take too many tablets, contact your
doctor.
If you forget to take a dose, take it as soon as you remember it. If you notice within 6 hours, you must
take the tablet immediately. If you notice after 6 hours, then skip the intake and take the next doses as usual.
It is important that you take DUTREBIS exactly as your doctor has instructed. Do not stop taking it
because:
It is very important to take all your HIV medicines as prescribed and at the right times of day.
This can help your medicines work better. It also lowers the chance that your medicines will stop being able to fight HIV (also called "drug resistance").
When your supply of DUTREBIS starts to run low, get more from your doctor or pharmacy.
This is because it is very important not to be without the medicine, even for a short time. During a short break in taking the medicine, the amount of virus in your blood may increase. This may mean that the HIV virus will develop resistance to DUTREBIS and become harder to treat.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them. DUTREBIS contains two medicines: lamivudine and raltegravir. The side effects for the two
individual medicines contained in DUTREBIS are presented below.
These are uncommon (may affect up to 1 in 100 people)
herpes infections including shingles
anaemia including due to low iron
signs and symptoms of infection or inflammation
mental disorder
suicide intention or attempt
stomach inflammation
inflammation of liver (hepatitis); When hepatitis causes symptoms, they can include: belly pain; nausea and vomiting; not feeling hungry; jaundice, which is when the skin or white part of the eye turns yellow
liver failure (the liver stops working , which may cause heavy bleeding, swelling, and breathing problems)
allergic rash (including red spots or blotches sometimes with blistering and swelling of the skin)
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certain kinds of kidney problems, including conditions in which the kidneys lose the ability to remove waste and excess water from the bloodstream. As waste and fluids
accumulate, other body systems are affected, potentially leading to complications
taking drug in quantities greater than recommended These are rare (may affect up to 1 in 1,000 people)
lactic acidosis – signs include deep, fast, difficult breathing, feeling drowsy, numb or weak arms or legs, feeling or being sick (nausea or vomiting), stomach pain
See a doctor immediately, if you notice any of the side effects above.
headache; feeling dizzy
feeling or being sick (nausea or vomiting), diarrhoea, stomach pain
feeling tired, lack of energy, difficulty in sleeping (insomnia)
fever, general feeling of being unwell
muscle pain and discomfort, joint pain
cough, irritated or runny nose
rash, hair loss (alopecia)
decreased appetite
abnormal dreams; nightmare; abnormal behaviour; feelings of deep sadness and unworthiness
spinning sensation
bloating; excessive gas in the stomach or bowel; indigestion; belching
rash (more often when used in combination with darunavir)
increased liver blood tests; abnormal white blood cells; increased fat levels in blood (such as cholesterol and triglycerides); increased level of enzyme from salivary glands or pancreas
infection of the hair roots; influenza; skin infection due to virus; upper respiratory tract infection(such as inflammation of the nasal cavity or sinuses located around the nose; common cold); infection in the lymph node (gland in the neck, armpit, or groin)
wart
low count of white blood cells that fight infection; pain or swollen glands (lymph nodes) in the neck, armpit and groin
allergic reaction
increased appetite; diabetes; high sugar levels in the blood; excessive thirst; severe weight loss; body fat disorder
feeling anxious; feeling of confusion; depressed mood; mood changes; panic attack
loss of memory; pain in the hand due to nerve compression; disturbance in attention; dizziness with rapid changes in posture; abnormal taste; increased sleepiness; lack of energy; forgetfulness; migraine headache; reduced sense of touch, numbness or weakness of the arms and/or legs; tingling; sleepiness; tension headache; tremors; poor quality sleep
visual disturbance
buzzing, hissing, whistling, ringing or other persistent noise in the ears
palpitations; slow heart rate; fast or irregular heart beats
hot flush; high blood pressure
harsh, raspy, or strained voice; nosebleed; nasal congestion
pain in the upper part of the belly; rectal discomfort; constipation; dry mouth; heartburn; pain when swallowing; inflammation of the pancreas (pancreatitis); ulcer or sore in stomach or upper intestine; bleeding from anus; stomach discomfort; inflammation of the gums; swollen, red sore tongue
accumulation of fat in the liver
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acne; unusual hair loss or thinning; redness of skin; unusual distribution of fat on the body, this may include loss of fat from legs, arms, and face, and increase in abdomen fat; excessive sweating; night sweats; thickening and itching of the skin due to repeated scratching; skin lesion; dry skin
back pain; pain in bone/muscle; muscle tenderness or weakness; neck pain; pain in arms or legs; inflammation of the tendons; decrease in the amount of minerals in the bone
kidney stones; urination at night; kidney cyst
erectile dysfunction; breast enlargement in men; menopausal symptoms
chest discomfort; chills; swelling of face; feeling jittery; lump in the neck; swelling of hands, ankles or feet; pain
blood test showing decreased count of platelets in blood (a kind of cell that helps blood clot); blood test showing reduced kidney function; increased muscle enzyme in blood; sugar present in urine; red blood cells present in urine; weight gain; increase in waist size; decreased blood protein (albumin); increase in time for blood to clot; blood test showing low red blood cell count (anaemia)
serious allergic reaction causing swelling of the face, tongue or throat which may cause difficulty in swallowing or breathing
breakdown of muscle tissue
liver problems, such as yellowing of the skin or whites of the eyes, swollen or fatty liver
blood test showing an increase in an enzyme called amylase
blood test showing failure of the bone marrow to produce new red blood cells (pure red cell aplasia)
hyperactivity
Muscle pain, tenderness, or weakness have been reported during treatment with raltegravir.
Patients with HIV are at higher risk of developing cancer than patients without the disease. In clinical studies, the number of HIV patients taking raltegravir who developed cancer was similar to that of patients taking other HIV medicines.
Tell your doctor, pharmacist or nurse if you notice any of the side effects above.
If you get 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 thenationalreporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not take this medicine after the expiry date which is stated on the bottle after EXP. The expiry date refers to the last day of that month.
Store in the original package in order to protect from moisture.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
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The active substances are lamivudine and raltegravir. Each film-coated tablet contains 150 mg of lamivudine and 300 mg of raltegravir (as potassium).
The other ingredients are: hypromellose (2910), croscarmellose sodium, lactose monohydrate, silicon dioxide (colloidal), magnesium stearate, and microcrystalline cellulose. In addition, the film coating contains the following inactive ingredients: hypromellose, lactose monohydrate,
triacetin, yellow iron oxide, Indigo Carmine (E132) Aluminium Lake, and titanium dioxide.
The film-coated tablet is oval-shaped, green, marked with "144" on one side. One pack size is
available: 1 bottle with 60 tablets.
Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon Hertfordshire EN11 9BU United Kingdom
Merck Sharp & Dohme B. V. Waarderweg 39
2031 BN Haarlem
The Netherlands
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
MSD Belgium BVBA/SPRL
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medicalinformationuk@merck.com
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Tel: +371 67364 224
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