Aptivus

Informazzjoni prinċipali

  • Isem kummerċjali:
  • Aptivus
  • Dominju tal-mediċina:
  • Bnedmin
  • Tip ta 'mediċina:
  • Droga allopatika

Dokumenti

Lokalizzazzjoni

  • Disponibbli fi:
  • Aptivus
    Unjoni Ewropea
  • Lingwa:
  • Ingliż

Informazzjoni terapewtika

  • Grupp terapewtiku:
  • Antivirals for systemic use,
  • Żona terapewtika:
  • HIV Infections
  • Indikazzjonijiet terapewtiċi:
  • Aptivus, co-administered with low-dose ritonavir, is indicated for combination antiretroviral treatment of HIV-1 infection in highly pretreated adults and adolescents 12 years of age or older with virus resistant to multiple protease inhibitors. Aptivus should only be used as part of an active combination antiretroviral regimen in patients with no other therapeutic options., This indication is based on the results of two phase-III studies, performed in highly pretreated adult patients (median number of 12 prior antiretroviral agents) with virus resistant to protease inhibitors and of one phase-II study investigating pharmacokinetics, safety and efficacy of Aptivus in mostly treatment-experienced adolescent patients aged 12 to 18 years. In deciding to initiate treatment with Aptivus, co-administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (wh
  • Sommarju tal-prodott:
  • Revision: 36

Status

  • Sors:
  • EMA - European Medicines Agency
  • L-istatus ta 'awtorizzazzjoni:
  • Authorised
  • Numru ta 'awtorizzazzjoni:
  • EMEA/H/C/000631
  • Data ta 'l-awtorizzazzjoni:
  • 24-10-2005
  • Kodiċi EMEA:
  • EMEA/H/C/000631
  • L-aħħar aġġornament:
  • 27-03-2019

Rapport ta 'Valutazzjoni Pubblika

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Send a question via our website

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© European Medicines Agency, 2014. Reproduction is authorised provided the source is acknowledged.

EMA/503056/2011

EMEA/H/C/000631

EPAR summary for the public

Aptivus

tipranavir

This document is a summary of the European public assessment report (EPAR) for Aptivus. It explains

how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its

opinion in favour of granting a marketing authorisation and its recommendations on the conditions of

use for Aptivus.

What is Aptivus?

Aptivus is a medicine that contains the active substance tipranavir. It is available as capsules (250 mg)

and as an oral solution.

What is Aptivus used for?

Aptivus is used to treat patients aged two years and above who have human immunodeficiency virus

type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). Aptivus is used in

combination with low-dose ritonavir (another HIV-medicine) and other HIV-medicines.

Aptivus should only be used in patients who have no other treatment options. It is used in patients

who have already been treated with other antiviral medicines for HIV infection, and in whom many

other medicines in the same class as Aptivus (protease inhibitors) do not work. Doctors should only

prescribe Aptivus once they have looked at the HIV-medicines that the patient has taken before and

the likelihood that the virus will respond to the medicine.

The medicine can only be obtained with a prescription.

How is Aptivus used?

Treatment with Aptivus should be started by a doctor who has experience in the treatment of HIV-1

infection.

Aptivus

EMA/401391/2014

Page 2/3

In patients aged 12 years and above, the recommended dose of Aptivus is 500 mg (two capsules)

twice a day. Children aged between two and 12 years should use the oral solution. The dose of the oral

solution depends on body surface area (calculated using the child’s height and weight). Each dose of

Aptivus must be taken with ritonavir and food. For more information, see the package leaflet.

How does Aptivus work?

The active substance in Aptivus, tipranavir, is a protease inhibitor. It blocks an enzyme called protease

that is involved in the reproduction of HIV. When the enzyme is blocked, the virus does not reproduce

normally, slowing down the spread of infection. Ritonavir is another protease inhibitor that is used as a

‘booster’. It slows down the rate at which tipranavir is broken down, increasing the levels of tipranavir

in the blood. This allows a lower dose of tipranavir to be used for the same antiviral effect.

Aptivus, taken in combination with other HIV medicines, reduces the amount of HIV in the blood and

keeps it at a low level. Aptivus does not cure HIV infection or AIDS, but it may delay the damage to

the immune system and the development of infections and diseases associated with AIDS.

How has Aptivus been studied?

Aptivus capsules have been studied in two main studies involving a total of 1,483 adults who had

received many different HIV-medicines in the past, and were not responding to their current treatment

combination including a protease inhibitor. Both studies compared the effects of Aptivus with those of

another protease inhibitor that was chosen on the basis of the patient’s previous treatments and

predicted response. The main measures of effectiveness were the number of patients who responded

to treatment, and how long it took before treatment stopped working, during the first 48 weeks of

treatment. A ‘response’ was defined as a fall in the levels of HIV in the blood (viral load) by 90% or

more that was maintained until the end of the 48 weeks.

Aptivus has also been studied in one study involving 63 children aged between two and 12 years, and

52 adolescents aged between 12 and 18 years, almost all of whom had taken HIV treatments in the

past. All of the patients started treatment with the oral solution, but adolescents taking the full adult

dose could switch to the capsules after four weeks. The study looked at the safety and effectiveness of

Aptivus, and at the levels of the medicine in the patients’ blood.

In all three studies, the patients also took ritonavir and a combination of other HIV-medicines that

were chosen as they had the best chances of reducing the levels of HIV in their blood.

What benefit has Aptivus shown during the studies?

Aptivus capsules, taken in combination with ritonavir, were more effective than the comparator

medicines in patients with few remaining options for successful HIV treatment. In the two adult studies

taken together, 34% of the patients taking Aptivus (251 out of 746) responded to treatment,

compared with 16% of the patients taking the comparator protease inhibitors (113 out of 737). On

average, it took 113 days for treatment to stop working in adults taking Aptivus. This was compared

with an average of zero days in those taking the comparator, meaning that most of the patients taking

the comparator did not respond to their treatment at all.

In the study of children and adolescents, 31% of the adolescents taking the capsules (9 out of 29) and

50% of the children taking the oral solution (31 out of 62) had reached and maintained viral loads

below 400 copies/ml after 48 weeks.

Aptivus

EMA/401391/2014

Page 3/3

What is the risk associated with Aptivus?

In adults, the most common side effects when taking Aptivus with ritonavir (seen in more than 1

patient in 10) are diarrhoea and nausea (feeling sick). Similar side effects were seen in children and

adolescents, although vomiting, rash and pyrexia (fever) were seen more commonly than in adults. For

the full list of all side effects reported with Aptivus, see the package leaflet.

Aptivus with ritonavir must not be used with colchicine (a medicine used to treat gout) in patients with

kidney or liver impairment. Aptivus with ritonavir must not be used in patients with moderate or

severe problems with their liver or who are taking any of the following medicines:

rifampicin (used to treat tuberculosis);

St John’s wort (a herbal preparation used to treat depression);

medicines that are broken down in the same way as Aptivus or ritonavir and are harmful at high

levels in the blood. See the package leaflet for the full list of these medicines.

Why has Aptivus been approved?

The CHMP noted that the studies supported the use of Aptivus capsules in adults. Although the

Committee had some concerns over how the study in children and adolescents was designed, the

Committee noted that its results supported the use of the capsules in adolescents and the oral solution

in children between the ages of two and 12 years. Therefore, the CHMP decided that the benefits of

Aptivus capsules are greater than their risks for the treatment of adults and adolescents 12 years of

age or older. The Committee also decided that the benefits of Aptivus oral solution are greater than its

risks for children from two to 12 years of age. However, the available information does not support the

use of the oral solution in patients aged 12 years or above.

The Committee recommended that Aptivus be given marketing authorisation. However, it concluded

that the medicine should only be considered for use as ‘last line’ therapy, when no other protease

inhibitors are predicted to work.

What measures are being taken to ensure the safe and effective use of

Aptivus?

A risk management plan has been developed to ensure that Aptivus is used as safely as possible.

Based on this plan, safety information has been included in the summary of product characteristics and

the package leaflet for Aptivus, including the appropriate precautions to be followed by healthcare

professionals and patients.

Other information about Aptivus:

The European Commission granted a marketing authorisation valid throughout the European Union for

Aptivus on 25 October 2005.

The full EPAR for Aptivus can be found on the Agency’s website: ema.europa.eu/Find medicine/Human

medicines/European Public Assessment Reports. For more information about treatment with Aptivus,

read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 07-2014.

Fuljett ta 'Informazzjoni għall-Pazjent: prodott - kompożizzjoni, indikazzjonijiet, effetti sekondarji, dożaġġ, interazzjonijiet, reazzjonijiet avversi, tqala, treddigħ

B. PACKAGE LEAFLET

Package leaflet: Information for the user

Aptivus 250 mg soft capsules

tipranavir

Read all of this leaflet carefully before you start taking this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, please ask your doctor or your pharmacist.

This medicine has been prescribed for you 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 or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

What Aptivus is and what it is used for

What you need to know before you take Aptivus

How to take Aptivus

Possible side effects

How to store Aptivus

Contents of the pack and other information

If Aptivus has been prescribed for your child, please note that all information in this leaflet is

addressed to your child (in this case please read “your child” instead of “you”).

1.

What Aptivus is and what it is used for

Aptivus contains the active substance tipranavir. It belongs to a group of medicines called protease

inhibitors and is used in the treatment of Human Immunodeficiency Virus (HIV) infection. It blocks

an enzyme called protease that is involved in the reproduction of HIV. When the enzyme is blocked,

the virus does not reproduce normally, slowing down the infection. You must take Aptivus together

with:

low dose ritonavir (this helps Aptivus to reach a high enough level in your blood)

other HIV medicines. Your doctor, together with you, will decide which other medicines you

should take. This will depend on, for example:

which other medicines you have already taken for HIV

which medicines your HIV is resistant to. If your HIV is resistant to some HIV

medicines, this means that the medicine will not work so well, or will not work at all.

Aptivus is specifically used for the treatment of HIV which is resistant to most other protease

inhibitors. Before starting treatment, your doctor will have taken blood samples to test the resistance

of your HIV. These tests will have confirmed that the HIV in your blood is resistant to most other

protease inhibitors. Aptivus treatment is therefore appropriate for you. You should not use Aptivus if

you have never received antiretroviral therapy or have other antiretroviral options available.

Aptivus soft capsules are indicated for:

adolescents 12 years of age or older

adults

2.

What you need to know before you take Aptivus

You must take Aptivus in combination with low dose ritonavir and other antiretroviral

medicines. It is therefore important that you know about these medicines too. You should

therefore carefully read the Package Leaflets of ritonavir and your other antiretroviral

medicines. If you have any further questions about ritonavir or the other medicines you are

prescribed, please ask your doctor or pharmacist.

Do not take Aptivus

if you are allergic to tipranavir or any of the other ingredients of this medicine (listed in section

if you have moderate to severe liver problems. Your doctor will take a blood sample to test how

well your liver is working (your liver function). Depending on your liver function you may have

to delay or stop Aptivus treatment

if you are currently taking products containing:

rifampicin (used to treat tuberculosis)

cisapride (used to treat stomach problems)

pimozide or sertindole (used to treat schizophrenia)

quetiapine (used to treat schizophrenia, bipolar disorder and major depressive

disorder)

lurasidone (used to treat schizophrenia)

triazolam or oral midazolam (taken by mouth). These medicines are used to treat

anxiety or sleep disorders

ergot derivatives (used to treat headaches)

astemizole or terfenadine (used to treat allergies or hay fever)

simvastatin or lovastatin (used to lower blood cholesterol)

amiodarone, bepridil, flecainide, propafenone or quinidine (used to treat heart

disorders)

metoprolol (used to treat heart failure)

alfuzosin and sildenafil (when used to treat a rare blood vessel disorder characterized

by increased pressure in the pulmonary artery)

colchicine (when used to treat gout flares in patients with kidney or liver disease).

Do not take products containing St John’s wort (a herbal remedy for depression). This may stop

Aptivus from working properly.

Warnings and precautions

Talk to your doctor or pharmacist before taking Aptivus.

Tell your doctor if you have:

type A or B haemophilia

diabetes

liver disease.

If you have:

high liver function test results

hepatitis B or C infection

you are at increased risk of severe and potentially fatal liver damage while taking Aptivus. Your

doctor will monitor your liver function by blood tests before and during Aptivus treatment. If you have

liver disease or hepatitis, your doctor will decide if you need additional testing. You should inform

your doctor as soon as possible if you notice the signs or symptoms of hepatitis:

fever

malaise (feeling generally unwell)

nausea (upset stomach)

vomiting

abdominal pain

tiredness

jaundice (yellowing of the skin or the eyeballs)

Aptivus is not a cure for HIV infection:

You should know that you may continue to develop infections and other illnesses associated with HIV

disease. You should therefore remain in regular contact with your doctor. You can still pass on HIV

when taking this medicine, although the risk is lowered by effective antiretroviral therapy. Discuss

with your doctor the precautions needed to avoid infecting other people.

Rash:

Mild to moderate rash, including:

hives

rash with flat or raised small red spots

sensitivity to the sun

have been reported in approximately 1 in 10 patients receiving Aptivus. Some patients who developed

rash also had:

joint pain or stiffness

throat tightness

generalized itching

In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs

and symptoms of inflammation from previous infections may occur soon after anti-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. If you

notice any symptoms of infection (for example fever, enlarged lymph nodes), please inform your

doctor immediately.

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. 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, please inform your doctor immediately to seek necessary treatment.

Tell your doctor if you experience fainting or a sensation of abnormal heart beats. Aptivus in

combination with low dose ritonavir may cause changes in your heart rhythm and the electrical

activity of your heart. These changes may be seen on an ECG (electrocardiogram).

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 length of

combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe

immunosuppression, higher body mass index, among others, may be some of the many risk factors for

developing this disease. Signs of osteonecrosis are joint stiffness, aches and pains (especially of the

hip, knee and shoulder) and difficulty in movement. If you notice any of these symptoms please

inform your doctor.

Children

Aptivus soft capsules should not be used by children under 12 years of age.

Older people

If you are older than 65 years your doctor will exercise caution when prescribing Aptivus soft capsules

to you and will closely monitor your therapy. Tipranavir has been used in limited number of patients

65 years or older.

Other medicines and Aptivus

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines, including medicines obtained without a prescription.

This is very important. If you take other medicines at the same time as Aptivus and ritonavir, this can

strengthen or weaken the effect of the medicines. These effects are called interactions, and can lead to

serious side effects, or prevent proper control of other conditions you may have.

Interactions with other HIV medicines:

etravirine belongs to a class of HIV medicines called non-nucleoside reverse transcriptase

inhibitors (NNRTIs). Taking Aptivus with etravirine is not recommended.

abacavir and zidovudine. These belong to a class of HIV medicines called nucleoside reverse

transcriptase inhibitors (NRTIs). Your doctor will only prescribe you abacavir and zidovudine if

you are unable to take other NRTIs.

didanosine: If you are taking didanosine enteric coated tablets, you should take them at least

two hours before or after Aptivus.

emtricitabine: If you are taking emtricitabine your kidney function should be checked before

initiation of Aptivus.

rilpivirine: If you are taking rilpivirine, your doctor will monitor you closely.

Protease Inhibitors (PIs): Taking Aptivus may cause large decreases in the blood levels of other

HIV protease inhibitors. For example the protease inhibitors amprenavir, atazanavir, lopinavir

and saquinavir will be decreased.

Taking Aptivus, with atazanavir, may cause the blood levels of Aptivus and ritonavir to increase

a lot.

Your doctor will carefully consider whether to treat you with combinations of Aptivus and

protease inhibitors.

Other medicines with which Aptivus may interact include:

oral contraceptives/hormone replacement therapy (HRT): If you are taking the contraceptive pill

to prevent pregnancy you should use an additional or different type of contraception (e.g. barrier

contraception like condoms). Generally, it is not recommended to take Aptivus, with ritonavir,

together with oral contraceptives or hormone replacement therapy (HRT). You should check

with your doctor if you do wish to continue taking oral contraceptives or HRT. If you use oral

contraceptives or HRT you have an increased chance of developing a skin rash while taking

Aptivus. If a rash occurs, it is usually mild to moderate. You should talk to your doctor as you

may need to temporarily stop taking either Aptivus or your oral contraceptives or HRT

carbamazepine, phenobarbital and phenytoin (used to treat epilepsy). These may decrease the

effectiveness of Aptivus.

sildenafil, vardenafil, tadalafil (medicines used to produce and maintain an erection). The effects

of sildenafil and vardenafil are likely to be increased if you take them with Aptivus. You should

not be prescribed tadalafil until you have been taking Aptivus for 7 days or more.

omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole (proton pump inhibitors

used to reduce the gastric acid production)

metronidazole (used to treat infections)

disulfiram (used to treat alcohol dependence)

buprenorphine/naloxone (medicines used to treat severe pain)

cyclosporin, tacrolimus, sirolimus (used to prevent organ rejection (to suppress the immune

system))

warfarin (used to treat and prevent thrombosis)

digoxin (used to treat heart arrhythmias and heart failure)

antifungal medications including fluconazole, itraconazole, ketoconazole or voriconazole

The following medicines are not recommended:

fluticasone (used to treat asthma)

atorvastatin (used to lower blood cholesterol)

salmeterol (used to achieve long-term asthma control, bronchospasm prevention with COPD)

bosentan (used to treat pulmonary artery hypertension)

halofantrine or lumefantrine (used to treat malaria)

tolterodine (used to treat overactive bladder (with symptoms of urinary frequency, urgency, or

urge incontinence))

boceprevir and telaprevir (used to treat hepatitis C)

cobicistat and products containing cobicistat (used to increase effectiveness of HIV medicines).

Aptivus may lead to a loss of effectiveness of some medicines including:

methadone, meperidine (pethidine), used as morphine substitutes

Your doctor may have to increase or decrease the dose of other medicines which you take together

with Aptivus. Examples include:

rifabutin and clarithromycin (antibiotics)

theophylline (used to treat asthma)

desipramine, trazodone and bupropion (used to treat depression; bupropion is also used for

smoking cessation)

midazolam (when given by injection); midazolam is a sedative used to treat anxiety and to help

you sleep

rosuvastatin or pravastatin (used to lower blood cholesterol)

colchicine (used to treat gout flares with normal kidney and liver function).

If you take aluminium- and magnesium-based antacid (used to treat dyspepsia/gastrooesophageal

reflux), the time interval between Aptivus and antacid should be at least two hours.

Tell your doctor if you receive medicines such as blood-thinning agents, or if you are taking vitamin

E. Your doctor may wish to consider certain precautionary measures in such circumstances.

Pregnancy, breast-feeding and fertility

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 not known whether Aptivus may

be used safely during pregnancy. You must not breast-feed your baby because it is possible that the

baby can become HIV-infected through the breast milk. See also Section 2, under “Oral

contraceptives/hormone replacement therapy (HRT)”.

Aptivus contains very small amounts of alcohol (see Aptivus capsules contain ethanol).

Driving and using machines

Some of the side effects of Aptivus may affect your ability to drive or operate machinery (e.g.

dizziness and sleepiness). If affected, you should not drive or operate machinery.

Aptivus capsules contain ethanol, macrogolglycerol ricinoleate and sorbitol (E420)

Aptivus contains 7 % ethanol (alcohol), i.e. up to 400 mg per daily dose, equivalent to 8 ml of beer, or

less than 4 ml of wine. Harmful for those suffering from alcoholism. To be taken into account in

pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or

epilepsy.

Aptivus also contains macrogolglycerol ricinoleate which may cause stomach upset and diarrhoea.

This medicine contains sorbitol. If you have been told by your doctor that you have an intolerance to

some sugars, contact your doctor before taking this medicine.

3.

How to take Aptivus

Always take this medicine exactly as your doctor has told you. You should check with your doctor or

pharmacist if you are not sure. You must take Aptivus together with ritonavir.

The recommended dose for an adult or an adolescent 12 years and above is:

500 mg (two 250 mg capsules) Aptivus together with

200 mg (two 100 mg capsules) ritonavir

twice per day with food.

Oral use.

Aptivus capsules should be taken with food.

Always take this medicine in combination with other antiretroviral medicines. You should follow the

instructions for these medicines within the supplied Package Leaflets.

You should continue to take Aptivus for as long as your doctor tells you.

If you take more Aptivus than you should

Inform your doctor as soon as possible if you take more than the prescribed dose of Aptivus.

If you forget to take Aptivus

If you miss a dose of Aptivus or ritonavir by more than 5 hours, wait and then take the next dose of

Aptivus and ritonavir at the regularly scheduled time. If you miss a dose of Aptivus and/or ritonavir by

less than 5 hours, take your missed dose immediately. Then take your next dose of Aptivus and

ritonavir at the regularly scheduled time.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Aptivus

It has been shown that taking all doses at the appropriate times:

greatly increases the effectiveness of your combination antiretroviral medicines

reduces the chances of your HIV becoming resistant to your antiretroviral medicines

Therefore, it is important that you continue taking Aptivus correctly, as described above. Do NOT stop

taking Aptivus unless your doctor instructs you to do so.

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

4.

Possible side effects

During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This

is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV

medicines themselves. Your doctor will test for these changes.

Like all medicines, this medicine can cause side effects, although not everybody gets them. It may be

difficult to tell the difference between:

side effects caused by Aptivus

side effects caused by the other medicines you are also taking

complications of HIV infection.

For this reason it is very important that you tell your doctor about any changes in your health.

Serious side effects associated with Aptivus:

Abnormal liver function

Hepatitis and fatty liver

Liver failure. This can lead to death

Increased blood levels of bilirubin (a breakdown product of haemoglobin)

You should inform your doctor if you experience:

Loss of appetite

Nausea (upset stomach)

Vomiting and/or jaundice

which may be symptoms of abnormal liver function

Bleeding

*Bleeding in the brain. This can lead to permanent disability or death, and has

occurred in some patients treated with Aptivus in clinical trials. In the majority of

these patients the bleeding may have had other causes. For example they had other

medical conditions or were receiving other medicine that may have caused the

bleeding.

Possible side effects:

Very common: may affect more than 1 in 10 people

Diarrhoea

Nausea (upset stomach)

Common: may affect up to 1 in 10 people

Vomiting

Abdominal pain (tummy pain)

Flatulence (when you break wind more often)

Tiredness

Headache

Mild rashes e.g. with hives or with flat or raised small red spots

Increases in blood lipid (fat) levels

Dyspepsia

Uncommon: may affect up to 1 in 100 people

Reduction in red and white blood cells

Reduction in blood platelets

Allergic (hypersensitivity) reactions

Decreased appetite

Diabetes

Increased blood sugar

Increased blood levels of cholesterol

Sleeplessness and other sleep disorders

Sleepiness

Dizziness

Numbness and/or tingling and/or pain in the feet or hands

Breathing difficulties

Heartburn

Inflammation of the pancreas

Skin inflammation

Itching

Muscle cramp

Muscle pain

Kidney disease

Flu like symptoms (feeling unwell)

Fever

Weight loss

Increased blood levels of the pancreas enzyme amylase

Increases in liver enzyme activity

Hepatitis with liver cell damage due to influence of a toxin

Rare: may affect up to 1 in 1,000 people

Liver failure (including fatal outcome)

Hepatitis

Fatty liver

Increased blood levels of bilirubin (a breakdown product of haemoglobin)

Dehydration (when your body does not have enough water)

Thinning of the face

Bleeding in the brain* (see above)

Increased blood levels of the pancreas enzyme lipase

Further information on possible side effects related to combination antiretroviral treatment:

Bleeding

Increased bleeding. If you have haemophilia type A and B, you may experience

increased bleeding. This may be in the skin or joints. If you suffer increased bleeding

you should see your doctor immediately.

Muscle disorders

There have been reports of muscle pain, tenderness or weakness. These occur particularly when

Aptivus or other protease inhibitors are taken together with nucleoside analogues. Rarely these muscle

disorders have been serious, involving breakdown of muscle tissue (rhabdomyolysis).

Additional side effects in children and adolescents

The most common side effects were generally similar to those described in adults. Vomiting, rash and

fever were observed more frequently in children than in adults.

Reporting of side effects

If you get any side effects, please talk to your doctor or pharmacist. 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.

How to store Aptivus

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 bottle after EXP. The expiry date

refers to the last day of that month.

Store in a refrigerator (2°C to 8°C). Once the bottle is opened the contents must be used within 60

days (stored below 25°C). You should write the date of opening the bottle on the label and/or outer

carton.

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.

6.

Contents of the pack and other information

What Aptivus contains

The active substance is tipranavir. Each capsule contains 250 mg tipranavir.

The other ingredients are macrogolglycerol ricinoleate, ethanol (alcohol), mono/diglycerides

of caprylic/capric acid, propylene glycol, purified water, trometamol and propyl gallate. The

capsule shell contains gelatin, red iron oxide, propylene glycol, purified water, ‘sorbitol

special-glycerin blend’ (d-sorbitol, 1,4 sorbitan, mannitol and glycerin) and titanium dioxide.

The black printing ink contains propylene glycol, black iron oxide, polyvinyl acetate

phthalate, macrogol and ammonium hydroxide.

What Aptivus looks like and contents of the pack

Aptivus soft capsules are pink coloured, oblong soft gelatin capsules with a black print imprint of

‘TPV 250’. Each Aptivus capsule contains 250 mg of the active substance tipranavir. Aptivus is

supplied in bottles containing 120 capsules.

Marketing Authorisation Holder

Boehringer Ingelheim International GmbH

Binger Strasse 173

D-55216 Ingelheim am Rhein

Germany

Manufacturer

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Strasse 173

D-55216 Ingelheim am Rhein

Germany

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

België/Belgique/Belgien

SCS Boehringer Ingelheim Comm.V

Tél/Tel: +32 2 773 33 11

Lietuva

Boehringer Ingelheim RCV GmbH & Co KG

Lietuvos filialas

Tel.: +370 37 473922

България

Бьорингер Ингелхайм РЦВ ГмбХ и Ко КГ -

клон България

Тел: +359 2 958 79 98

Luxembourg/Luxemburg

SCS Boehringer Ingelheim Comm.V

Tél/Tel: +32 2 773 33 11

Česká republika

Boehringer Ingelheim spol. s r.o.

Tel: +420 234 655 111

Magyarország

Boehringer Ingelheim RCV GmbH & Co KG

Magyarországi Fióktelepe

Tel.: +36 1 299 89 00

Danmark

Boehringer Ingelheim Danmark A/S

Tlf: +45 39 15 88 88

Malta

Boehringer Ingelheim Ireland Ltd.

Tel: +353 1 295 9620

Deutschland

Boehringer Ingelheim Pharma GmbH & Co. KG

Tel: +49 (0) 800 77 90 900

Nederland

Boehringer Ingelheim b.v.

Tel: +31 (0) 800 22 55 889

Eesti

Boehringer Ingelheim RCV GmbH & Co KG

Eesti filiaal

Tel: +372 612 8000

Norge

Boehringer Ingelheim Norway KS

Tlf: +47 66 76 13 00

Ελλάδα

Boehringer Ingelheim Ellas A.E.

Tηλ: +30 2 10 89 06 300

Österreich

Boehringer Ingelheim RCV GmbH & Co KG

Tel: +43 1 80 105-0

España

Boehringer Ingelheim España, S.A.

Tel: +34 93 404 51 00

Polska

Boehringer Ingelheim Sp.zo.o.

Tel.: +48 22 699 0 699

France

Boehringer Ingelheim France S.A.S.

Tél: +33 3 26 50 45 33

Portugal

Boehringer Ingelheim, Unipessoal, Lda.

Tel: +351 21 313 53 00

Hrvatska

Boehringer Ingelheim Zagreb d.o.o.

Tel: +385 1 2444 600

România

Boehringer Ingelheim RCV GmbH & Co KG

Viena - Sucursala Bucuresti

Tel: +40 21 302 2800

Ireland

Boehringer Ingelheim Ireland Ltd.

Tel: +353 1 295 9620

Slovenija

Boehringer Ingelheim RCV GmbH & Co KG,

Podružnica Ljubljana

Tel: +386 1 586 40 00

Ísland

Vistor hf.

Sími: +354 535 7000

Slovenská republika

Boehringer Ingelheim RCV GmbH & Co KG,

organizačná zložka

Tel: +421 2 5810 1211

Italia

Boehringer Ingelheim Italia S.p.A.

Tel: +39 02 5355 1

Suomi/Finland

Boehringer Ingelheim Finland Ky

Puh/Tel: +358 10 3102 800

Κύπρος

Boehringer Ingelheim Ellas A.E.

Tηλ: +30 2 10 89 06 300

Sverige

Boehringer Ingelheim AB

Tel: +46 8 721 21 00

Latvija

Boehringer Ingelheim RCV GmbH & Co KG

Latvijas filiāle

Tel: +371 67 240 011

United Kingdom

Boehringer Ingelheim Ltd.

Tel: +44 1344 424 600

This leaflet was last approved in {MM/YYYY}

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu.

Package leaflet: Information for the user

Aptivus 100 mg/ml oral solution

tipranavir

Read all of this leaflet carefully before your child starts taking this medicine because it contains

important information for your child.

Keep this leaflet. You may need to read it again.

If you have any further questions, please ask your child’s doctor or pharmacist.

This medicine has been prescribed for your child only. Do not pass it on to others. It may harm

them, even if their signs of illness are the same as your child’s.

If your child gets any side effects, talk to your child’s doctor or pharmacist. This includes any

possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

What Aptivus is and what it is used for

What you need to know before your child takes Aptivus

How to take Aptivus

Possible side effects

How to store Aptivus

Contents of the pack and other information

1.

What Aptivus is and what it is used for

Aptivus contains the active substance tipranavir. It belongs to a group of medicines called protease

inhibitors and is used in the treatment of Human Immunodeficiency Virus (HIV) infection. It blocks

an enzyme called protease that is involved in the reproduction of HIV. When the enzyme is blocked,

the virus does not reproduce normally, slowing down the infection. Your child must take Aptivus

together with:

low dose ritonavir (this helps Aptivus to reach a high enough level in your child’s blood)

other HIV medicines. Your child’s doctor, together with you, will decide which other medicines

your child should take. This will depend on, for example:

which other medicines your child has already taken for HIV

which medicines your child’s HIV is resistant to. If your child’s HIV is resistant to

some HIV medicines, this means that the medicine will not work so well, or will not

work at all.

Aptivus is specifically used for the treatment of HIV which is resistant to most other protease

inhibitors. Before starting treatment, your child’s doctor will have taken blood samples to test the

resistance of your child’s HIV. These tests will have confirmed that the HIV in your child’s blood is

resistant to most other protease inhibitors. Aptivus treatment is therefore appropriate for your child.

Your child should not use Aptivus if they have never received antiretroviral therapy or have other

antiretroviral options available.

Aptivus oral solution is indicated for:

children from 2 to 12 years of age

2.

What you need to know before your child takes Aptivus

Your child must take Aptivus in combination with low dose ritonavir and other antiretroviral

medicines. It is therefore important that you know about these medicines too. You should

therefore carefully read the Package Leaflets of ritonavir and your child’s other antiretroviral

medicines. If you have any further questions about ritonavir or the other medicines your child is

prescribed, please ask your child’s doctor or pharmacist.

Do not give Aptivus

if your child is allergic to tipranavir or any of the other ingredients of this medicine (listed in

section 6)

if your child has moderate to severe liver problems. Your child’s doctor will take a blood

sample to test how well your child’s liver is working (your child’s liver function). Depending on

your child’s liver function they may have to delay or stop Aptivus treatment

if your child is currently taking products containing:

rifampicin (used to treat tuberculosis)

cisapride (used to treat stomach problems)

pimozide or sertindole (used to treat schizophrenia)

quetiapine (used to treat schizophrenia, bipolar disorder and major depressive

disorder)

lurasidone (used to treat schizophrenia)

triazolam or oral midazolam (taken by mouth). These medicines are used to treat

anxiety or sleep disorders

ergot derivatives (used to treat headaches)

astemizole or terfenadine (used to treat allergies or hay fever)

simvastatin or lovastatin (used to lower blood cholesterol)

amiodarone, bepridil, flecainide, propafenone or quinidine (used to treat heart

disorders)

metoprolol (used to treat heart failure)

alfuzosin and sildenafil (when used to treat a rare blood vessel disorder characterized

by increased pressure in the pulmonary artery)

colchicine (when used to treat gout flares in patients with kidney or liver disease).

Your child must not take products containing St John’s wort (a herbal remedy for depression). This

may stop Aptivus from working properly.

Warnings and precautions

Talk to your child’s doctor or pharmacist before giving Aptivus to your child.

Tell your child’s doctor if they have:

type A or B haemophilia

diabetes

liver disease.

If your child has:

high liver function tests results

hepatitis B or C infection

your child is at increased risk of severe and potentially fatal liver damage while taking Aptivus. Your

child’s doctor will monitor their liver function by blood tests before and during Aptivus treatment. If

your child has liver disease or hepatitis, their doctor will decide if they need additional testing. You

should inform your child’s doctor as soon as possible if you notice your child has the signs or

symptoms of hepatitis:

fever

malaise (feeling generally unwell)

nausea (upset stomach)

vomiting

abdominal pain

tiredness

jaundice (yellowing of the skin or the eyeballs)

Aptivus is not a cure for HIV infection:

You should know that your child may continue to develop infections and other illnesses associated

with HIV disease. You should therefore remain in regular contact with your child’s doctor. Your child

can still pass on HIV when taking this medicine, although the risk is lowered by effective

antiretroviral therapy. Discuss with your child’s doctor the precautions needed to avoid infecting other

people.

Rash:

Mild to moderate rash, including:

hives

rash with flat or raised small red spots

sensitivity to the sun

have been reported in approximately 1 in 10 patients receiving Aptivus. Some patients who developed

rash also had:

joint pain or stiffness

throat tightness

generalized itching

In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs

and symptoms of inflammation from previous infections may occur soon after anti-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. If you

notice any symptoms of infection (for example fever, enlarged lymph nodes), please inform your

child’s doctor immediately.

In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the

immune system attacks healthy body tissue) may also occur after your child starts taking medicines for

the treatment of your child’s HIV infection. Autoimmune disorders may occur many months after the

start of treatment. 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, please inform your child’s doctor immediately to seek necessary

treatment.

Tell your child’s doctor if your child experiences fainting or a sensation of abnormal heart beats.

Aptivus in combination with low dose ritonavir may cause changes in your child’s heart rhythm and

the electrical activity of your child’s heart. These changes may be seen on an ECG

(electrocardiogram).

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 length of

combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe

immunosuppression, higher body mass index, among others, may be some of the many risk factors for

developing this disease. Signs of osteonecrosis are joint stiffness, aches and pains (especially of the

hip, knee and shoulder) and difficulty in movement. If you notice any of these symptoms please

inform your child’s doctor.

Children and adolescents

Aptivus should neither be used by children under 2 years of age nor by adolescents 12 years of age or

older.

Aptivus oral solution contains vitamin E. Your child should not take any additional vitamin E

supplements.

Other medicines and Aptivus

Tell your child’s doctor or pharmacist if your child is taking, has recently taken or might take any

other medicines, including medicines obtained without a prescription.

This is very important. If your child takes other medicines at the same time as Aptivus and ritonavir,

this can strengthen or weaken the effect of the medicines. These effects are called interactions, and can

lead to serious side effects, or prevent proper control of other conditions your child may have.

Interactions with other HIV medicines:

etravirine belongs to a class of HIV medicines called non-nucleoside reverse transcriptase

inhibitors (NNRTIs). Taking Aptivus with etravirine is not recommended.

abacavir and zidovudine. These belong to a class of HIV medicines called nucleoside reverse

transcriptase inhibitors (NRTIs). Your child’s doctor will only prescribe them abacavir and

zidovudine if they are unable to take other NRTIs.

didanosine: If your child is taking didanosine enteric coated tablets, they should take them at

least two hours before or after Aptivus.

emtricitabine: If your child is taking emtricitabine your child’s kidney function should be

checked before initiation of Aptivus.

rilpivirine: If your child is taking rilpivirine, your child’s doctor will monitor your child closely.

Protease Inhibitors (PIs): Taking Aptivus may cause large decreases in the blood levels of other

HIV protease inhibitors. For example the protease inhibitors amprenavir, atazanavir, lopinavir

and saquinavir will be decreased.

Taking Aptivus, with atazanavir, may cause the blood levels of Aptivus and ritonavir to increase

a lot.

Your child’s doctor will carefully consider whether to treat them with combinations of Aptivus

and protease inhibitors.

Other medicines with which Aptivus may interact include:

oral contraceptives/hormone replacement therapy (HRT): If your child is taking the

contraceptive pill to prevent pregnancy they should use an additional or different type of

contraception (e.g. barrier contraception like condoms). Generally, it is not recommended to

take Aptivus, with ritonavir, together with oral contraceptives or hormone replacement therapy

(HRT). You should check with your child’s doctor if they do wish to continue taking oral

contraceptives or HRT. If your child uses oral contraceptives or HRT they have an increased

chance of developing a skin rash while taking Aptivus. If a rash occurs, it is usually mild to

moderate. You should talk to your child’s doctor as they may need to temporarily stop taking

either Aptivus or their oral contraceptives or HRT

carbamazepine, phenobarbital and phenytoin (used to treat epilepsy). These may decrease the

effectiveness of Aptivus.

sildenafil, vardenafil, tadalafil (medicines used to produce and maintain an erection). The effects

of sildenafil and vardenafil are likely to be increased if taken with Aptivus. Tadalafil should not

be prescribed until Aptivus has been taken for 7 days or more.

omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole (proton pump inhibitors

used to reduce the gastric acid production)

metronidazole (used to treat infections)

disulfiram (used to treat alcohol dependence)

buprenorphine/naloxone (medicines used to treat severe pain)

cyclosporin, tacrolimus, sirolimus (used to prevent organ rejection (to suppress the immune

system))

warfarin (used to treat and prevent thrombosis)

digoxin (used to treat heart arrhythmias and heart failure)

antifungal medications including fluconazole, itraconazole, ketoconazole or voriconazole

The following medicines are not recommended:

fluticasone (used to treat asthma)

atorvastatin (used to lower blood cholesterol)

salmeterol (used to achieve long-term asthma control, bronchospasm prevention with COPD)

bosentan (used to treat pulmonary artery hypertension)

halofantrine or lumefantrine (used to treat malaria)

tolterodine (used to treat overactive bladder (with symptoms of urinary frequency, urgency, or

urge incontinence))

boceprevir and telaprevir (used to treat hepatitis C)

cobicistat and products containing cobicistat (used to increase effectiveness of HIV medicines).

Aptivus may lead to a loss of effectiveness of some medicines including:

methadone, meperidine (pethidine), used as morphine substitutes

Your child’s doctor may have to increase or decrease the dose of other medicines which they take

together with Aptivus. Examples include:

rifabutin and clarithromycin (antibiotics)

theophylline (used to treat asthma)

desipramine, trazodone and bupropion (used to treat depression; bupropion is also used for

smoking cessation)

midazolam (when given by injection); midazolam is a sedative used to treat anxiety and to help

your child sleep

rosuvastatin or pravastatin (used to lower blood cholesterol)

colchicine (used to treat gout flares with normal kidney and liver function).

If your child takes aluminium- and magnesium-based antacid (used to treat dyspepsia/

gastrooesophageal reflux), the time interval between Aptivus and antacid should be at least two hours.

Tell your child’s doctor if your child receives medicines such as blood-thinning agents, or if your child

is taking vitamin E. Your child’s doctor may wish to consider certain precautionary measures in such

circumstances.

Pregnancy, breast-feeding and fertility

If your child is pregnant or breast-feeding, you think your child may be pregnant or is planning to have

a baby, ask your child’s doctor or pharmacist for advice before giving this medicine. It is not known

whether Aptivus may be used safely during pregnancy. Your child must not breast-feed the baby

because it is possible that the baby can become HIV-infected through the breast milk. See also Section

2, under “Oral contraceptives/hormone replacement therapy (HRT)”.

Driving and using machines

Some of the side effects of Aptivus may affect your child’s ability to drive or operate machinery (e.g.

dizziness and sleepiness). If affected, your child should not drive or operate machinery.

3.

How to take Aptivus

Always give your child this medicine exactly as the doctor has advised. Check with your child’s

doctor or pharmacist if you are not sure. Your child must take Aptivus together with ritonavir.

Aptivus oral solution should be taken with food.

The dose for children, aged 2 to 12 years, will be calculated by the doctor. This will be based on the

child’s body surface area in metres squared. The dose for children should not exceed 5 ml (500 mg)

twice a day. Be sure your child’s doctor clearly informs you what the correct dose for your child

should be. You should measure the exact dose using the supplied measuring syringe and adapter, as

follows:

Check that the oral solution is clear (see below).

Open the bottle by pressing down on the cap and turning it in an anti-clockwise direction.

Remove the syringe cap covering the tip of the oral syringe (the cap will not be attached if this

is the first time you are using the syringe).

Insert the oral syringe into the adapter located in the neck of the bottle. Make sure the oral

syringe is tightly inserted. The maximum volume you can withdraw at one time is 5 ml

(equivalent to 500 mg tipranavir), which is the maximum single dose for a child with BSA

(Calculated body surface area) > 1.33 m

Turn the bottle upside down and gently withdraw the required amount of Aptivus oral solution.

Gently empty Aptivus oral solution from the syringe into your child’s mouth.

After use of the oral syringe, replace the syringe cap.

Before giving Aptivus you should check that the oral solution is clear. Crystals may be seen as a

paper-thin layer at the bottom of the bottle when it is stored upright. There may be other particles at

the bottom of the bottle. A small amount of crystals does not affect the strength or safety of your

child’s medicine.

You should return the bottle to your child’s pharmacist or doctor for a replacement as soon as possible

there is more than a thin layer of crystals at the bottom of the bottle, or

you are uncertain about the amount of crystals you see or

any other particles are visible.

Until you exchange the bottle, please continue to give your child their usual doses of Aptivus oral

solution.

Your child will always have to take Aptivus in combination with other antiretroviral medicines. You

should follow the instructions for these medicines within the supplied Package Leaflets.

Your child should continue to take Aptivus for as long as your child’s doctor tells him/her. At the age

of 12 years, children treated with Aptivus should be switched from the oral solution to the capsules.

If your child takes more Aptivus than he/she should

Inform your child’s doctor as soon as possible if they take more than the prescribed dose of Aptivus.

If your child forgets to take Aptivus

If your child misses a dose of Aptivus or ritonavir by more than 5 hours, wait and then give the next

dose of Aptivus and ritonavir at the regularly scheduled time. If your child misses a dose of Aptivus

and/or ritonavir by less than 5 hours, give the missed dose immediately. Then give the next dose of

Aptivus and ritonavir at the regularly scheduled time.

Do not give a double dose to make up for a forgotten dose.

If your child stops taking Aptivus

It has been shown that taking all doses at the appropriate times:

greatly increases the effectiveness of your child’s combination antiretroviral medicines

reduces the chances of your child’s HIV becoming resistant to his/her antiretroviral medicines.

Therefore, it is important that your child continues taking Aptivus correctly, as described above. Your

child must NOT stop taking Aptivus unless your child’s doctor instructs to do so.

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

4.

Possible side effects

During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This

is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV

medicines themselves. Your child’s doctor will test for these changes.

Like all medicines, this medicine can cause side effects, although not everybody gets them. It may be

difficult to tell the difference between:

side effects caused by Aptivus

side effects caused by the other medicines your child is also taking

complications of HIV infection.

For this reason it is very important that you tell your child’s doctor about any changes in their health.

Serious side effects associated with Aptivus:

Abnormal liver function

Hepatitis and fatty liver

Liver failure. This can lead to death

Increased blood levels of bilirubin (a breakdown product of haemoglobin)

You should inform your child’s doctor if they experience:

Loss of appetite

Nausea (upset stomach)

Vomiting and/or jaundice

which may be symptoms of abnormal liver function

Bleeding

* Bleeding in the brain. This can lead to permanent disability or death, and has

occurred in some patients treated with Aptivus in clinical trials. In the majority of

these patients the bleeding may have had other causes. For example they had other

medical conditions or were receiving other medicine that may have caused the

bleeding.

Possible side effects:

Very common: may affect more than 1 in 10 people

Diarrhoea

Nausea (upset stomach)

Common: may affect up to 1 in 10 people

Vomiting

Abdominal pain (tummy pain)

Flatulence (breaking wind more often)

Tiredness

Headache

Mild rashes e.g. with hives or with flat or raised small red spots

Increases in blood lipid (fat) levels

Dyspepsia

Uncommon: may affect up to 1 in 100 people

Reduction in red and white blood cells

Reduction in blood platelets

Allergic (hypersensitivity) reactions

Decreased appetite

Diabetes

Increased blood sugar

Increased blood levels of cholesterol

Sleeplessness and other sleep disorders

Sleepiness

Dizziness

Numbness and/or tingling and/or pain in the feet or hands

Breathing difficulties

Heartburn

Inflammation of the pancreas

Skin inflammation

Itching

Muscle cramp

Muscle pain

Kidney disease

Flu like symptoms (feeling unwell)

Fever

Weight loss

Increased blood levels of the pancreas enzyme amylase

Increases in liver enzyme activity

Hepatitis with liver cell damage due to influence of a toxin

Rare: may affect up to 1 in 1,000 people

Liver failure (including fatal outcome)

Hepatitis

Fatty liver

Increased blood levels of bilirubin (a breakdown product of haemoglobin)

Dehydration (when the body does not have enough water)

Thinning of the face

Bleeding in the brain* (see above)

Increased blood levels of the pancreas enzyme lipase

Further information on possible side effects related to combination antiretroviral treatment:

Bleeding

Increased bleeding. If your child has haemophilia type A and B, they may experience

increased bleeding. This may be in the skin or joints. If your child suffers increased

bleeding you should see your child’s doctor immediately.

Muscle disorders

There have been reports of muscle pain, tenderness or weakness. These occur particularly when

Aptivus or other protease inhibitors are taken together with nucleoside analogues. Rarely these muscle

disorders have been serious, involving breakdown of muscle tissue (rhabdomyolysis).

Additional side effects in children and adolescents

The most common side effects were generally similar to those described in adults. Vomiting, rash and

fever were observed more frequently in children than in adults.

Reporting of side effects

If your child gets any side effects, please talk to your child’s doctor or pharmacist. 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.

How to store Aptivus

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 bottle after EXP. The expiry date

refers to the last day of that month.

Do not store below 15°C. Do not refrigerate or freeze. Once the bottle is opened your child should use

the medicine within 60 days. You should write the date of opening the bottle on the label and/or outer

carton. Keep the container in the outer carton.

If you notice more than a thin layer of crystals at the bottom of the bottle you should:

give the next dose

return the bottle to the pharmacist or doctor as soon as possible for a fresh supply.

Do not throw away any medicines via wastewater or household waste. Ask your child’s pharmacist

how to throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Aptivus contains

The active substance is tipranavir. Each ml contains 100 mg tipranavir.

The other ingredients are macrogol, vitamin E polyethylene glycol succinate, purified water,

propylene glycol, mono/diglycerides of caprylic/capric acid, sucralose, ascorbic acid, Butter

Mint and Butter Toffee flavourings.

What Aptivus looks like and contents of the pack

Aptivus oral solution is a clear yellow liquid.

Aptivus oral solution is supplied in amber glass bottles containing 95 ml of oral solution. A 5 ml oral

syringe and adapter is supplied for dosing.

Marketing Authorisation Holder

Boehringer Ingelheim International GmbH

Binger Strasse 173

D-55216 Ingelheim am Rhein

Germany

Manufacturer

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Strasse 173

D-55216 Ingelheim am Rhein

Germany

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

België/Belgique/Belgien

SCS Boehringer Ingelheim Comm.V

Tél/Tel: +32 2 773 33 11

Lietuva

Boehringer Ingelheim RCV GmbH & Co KG

Lietuvos filialas

Tel.: +370 37 473922

България

Бьорингер Ингелхайм РЦВ ГмбХ и Ко КГ -

клон България

Тел: +359 2 958 79 98

Luxembourg/Luxemburg

SCS Boehringer Ingelheim Comm.V

Tél/Tel: +32 2 773 33 11

Česká republika

Boehringer Ingelheim spol. s r.o.

Tel: +420 234 655 111

Magyarország

Boehringer Ingelheim RCV GmbH & Co KG

Magyarországi Fióktelepe

Tel.: +36 1 299 89 00

Danmark

Boehringer Ingelheim Danmark A/S

Tlf: +45 39 15 88 88

Malta

Boehringer Ingelheim Ireland Ltd.

Tel: +353 1 295 9620

Deutschland

Boehringer Ingelheim Pharma GmbH & Co. KG

Tel: +49 (0) 800 77 90 900

Nederland

Boehringer Ingelheim b.v.

Tel: +31 (0) 800 22 55 889

Eesti

Boehringer Ingelheim RCV GmbH & Co KG

Eesti filiaal

Tel: +372 612 8000

Norge

Boehringer Ingelheim Norway KS

Tlf: +47 66 76 13 00

Ελλάδα

Boehringer Ingelheim Ellas A.E.

Tηλ: +30 2 10 89 06 300

Österreich

Boehringer Ingelheim RCV GmbH & Co KG

Tel: +43 1 80 105-0

España

Boehringer Ingelheim España, S.A.

Tel: +34 93 404 51 00

Polska

Boehringer Ingelheim Sp.zo.o.

Tel.: +48 22 699 0 699

France

Boehringer Ingelheim France S.A.S.

Tél: +33 3 26 50 45 33

Portugal

Boehringer Ingelheim, Unipessoal, Lda.

Tel: +351 21 313 53 00

Hrvatska

Boehringer Ingelheim Zagreb d.o.o.

Tel: +385 1 2444 600

România

Boehringer Ingelheim RCV GmbH & Co KG

Viena - Sucursala Bucuresti

Tel: +40 21 302 2800

Ireland

Boehringer Ingelheim Ireland Ltd.

Tel: +353 1 295 9620

Slovenija

Boehringer Ingelheim RCV GmbH & Co KG,

Podružnica Ljubljana

Tel: +386 1 586 40 00

Ísland

Vistor hf.

Sími: +354 535 7000

Slovenská republika

Boehringer Ingelheim RCV GmbH & Co KG,

organizačná zložka

Tel: +421 2 5810 1211

Italia

Boehringer Ingelheim Italia S.p.A.

Tel: +39 02 5355 1

Suomi/Finland

Boehringer Ingelheim Finland Ky

Puh/Tel: +358 10 3102 800

Κύπρος

Boehringer Ingelheim Ellas A.E.

Tηλ: +30 2 10 89 06 300

Sverige

Boehringer Ingelheim AB

Tel: +46 8 721 21 00

Latvija

Boehringer Ingelheim RCV GmbH & Co KG

Latvijas filiāle

Tel: +371 67 240 011

United Kingdom

Boehringer Ingelheim Ltd.

Tel: +44 1344 424 600

This leaflet was last approved in {MM/YYYY}

Detailed information on this medicine is available on the European Medicines Agency (EMA) web

site: http://www.ema.europa.eu.