250 mg soft capsules 
tipranavir

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

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

– This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

If Aptivus has been prescribed for your child, please note that all information in this pack is addressed to your child (in this case, read “your child” instead of “you”).

In this leaflet you will find information about: 
1. What Aptivus is and what it is used for 
2. What you need to know before using Aptivus 
3. How to use Aptivus 
4. Possible side effects 
5. How to store Aptivus 
6. Contents of the packaging 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 infections caused by the Human Immunodeficiency Virus ( HIV ). It inhibits an enzyme called protease that is involved in the multiplication of HIV. When the enzyme is inhibited, the virus does not multiply as normal, which slows down the infection. You must take Aptivus with:

– low dose ritonavir (this helps Aptivus to reach a sufficiently high level in the blood)

– other HIV medicines. Your doctor, together with you, will decide which medicines to use. This depends on, for example:

– what other medicines you are already taking for HIV

– which drugs your HIV is resistant to. If your HIV is resistant to any HIV drugs, it means that those drugs will not work so well, or will not work at all.

Aptivus is especially used for the treatment of HIV which is resistant to most other protease inhibitors. Before starting treatment, your doctor will take a blood test to check the resistance of your HIV. These tests will have confirmed that HIV in your blood is resistant to most other protease inhibitors. Aptivus treatment is, therefore, suitable for you. You should not use Aptivus if you have never received antiretroviral therapy or have other treatment options.

Aptivus soft capsules are intended for:

– young people 12 years or older

– adults

2. What you need to know before using Aptivus

Do not use Aptivus

You must take Aptivus with low dose ritonavir and other antiviral medicines. It is therefore important to also know about these drugs. You should therefore carefully read the package leaflet for ritonavir and other antiviral medicines. Ask your doctor or pharmacist if you have any questions about ritonavir or the other medicines you have been prescribed.

Do not take Aptivus :

– if you are allergic to tipranavir or any of the other ingredients of this medicine (listed in section 6).

– if you have moderate to severe liver disease. Your doctor will take blood samples to examine your liver function. Depending on your liver function, you may need to wait or discontinue treatment with Aptivus.

– if you are currently taking medicines containing:

  • rifampicin (used to treat tuberculosis )
  • cisapride (medicine for stomach upset)
  • pimozide or sertindole (medicine for schizophrenia)
  • quetiapine (medicine for schizophrenia, bipolar disorder, and major depression)
  • lurasidone (used to treat schizophrenia)
  • triazolam or oral midazolam (which is swallowed). These drugs are used to treat anxiety or sleep disorders
  • ergot derivatives (for the treatment of headaches)
  • astemizole or terfenadine (to treat allergies or hay fever)
  • simvastatin or lovastatin (lowers blood cholesterol)
  • amiodarone, bepridil, flecainide, propafenone, or quinidine (used in heart disease)
  • metoprolol (used for heart failure )
  • alfuzosin or sildenafil (when used to treat a rare blood vessel disease with high blood pressure in the pulmonary artery)
  • colchicine (when used to treat gout in patients with kidney or liver disease).

Do not use products that contain St. John’s wort (a natural remedy for mild depression and mild anxiety). This may prevent Aptivus from working properly.

Warnings and cautions

Talk to your doctor or pharmacist before taking Aptivus.

Tell your doctor if you have:

type A or B hemophilia

– diabetes

– liver disease

If you have:

  • high results in liver function tests
  • infection with hepatitis B or C

you have an increased risk of serious and potentially fatal liver damage when using Aptivus. Your doctor will monitor your liver function through blood tests before and during treatment with Aptivus. If you have liver disease or hepatitis, your doctor will decide if you need extended sampling. You should tell your doctor as soon as possible if you notice any signs or symptoms of hepatitis:

  • fever
  • feeling sick
  • nausea
  • vomiting
  • abdominal pain
  • fatigue
  • jaundice (yellowing of the skin and whites of the eyes)

Aptivus does not lead to HIV – infection, a cure:

You should know that you can constantly develop new infections or other diseases related to HIV. You should therefore keep in regular contact with your doctor. You can still transmit HIV infection when you take this medicine, even though the risk of effective antiviral therapy is reduced. Discuss with your doctor the necessary steps to avoid infecting others.

Skin rash :

Mild to moderate skin rashes, including:

  • blisters
  • rash with flat or raised small red spots
  • hypersensitivity to the sun

has been reported in approximately 1 patient in 10 treated with Aptivus. Some patients who developed rash also had:

  • joint pain or stiffness
  • tightness in the throat
  • general itching

In some patients with advanced HIV – infection ( AIDS ) and a history of HIV -related infection, may be symptoms of inflammation occur soon after anti- HIV has begun. It is believed that these symptoms are due to the improvement of the body’s immune response, which allows the body to fight infection, which may have previously been hidden without obvious symptoms. Tell your doctor immediately if you notice any symptoms of infection (such as fever, enlarged lymph nodes ).

In addition to opportunistic infections, autoimmune disorders (conditions in which the immune system attacks healthy body tissue) can also occur after you start taking medicines to treat your HIV infection. Autoimmune disorders can occur several months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, the weakness that starts in the hands or feet and moves to the torso, palpitations, tremors, or hyperactivity, informs your doctor immediately for the necessary treatment.

Tell your doctor if you have fainted or experienced abnormal heartbeats. Aptivus with low dose ritonavir can cause changes in your heart rhythm and the electrical activity of your heart. These changes can be seen on an ECG ( electrocardiogram ).

Bone problems: Some patients receiving combination antiretroviral therapy may develop a bone disease called osteonecrosis (bone tissue dies due to lost blood supply to the bone). Some of the many risk factors for developing the disease are long-term antiretroviral combination therapy, use of corticosteroids, alcohol consumption, a severe weakening of the immune system, and higher body mass index. Signs of osteonecrosis are stiffness in the joints and pain (especially in the hip, knee, and shoulders) and difficulty moving. Tell your doctor if you experience any of these symptoms.

Elderly: If you are older than 65 years, your doctor will exercise caution when prescribing Aptivus soft capsules to you and will closely monitor your treatment. Tipranavir has been used in a limited number of patients aged 65 years or older.

Children and young people

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

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 are taking other medicines at the same time as Aptivus and ritonavir, this may increase or decrease the effectiveness of the treatment. These effects are called interactions and can lead to serious side effects or prevent adequate control of other conditions you may have.

Interaction 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 drugs called nucleoside reverse transcriptase inhibitors (NRTIs). Your doctor will only prescribe abacavir and zidovudine if you can not use other reverse transcriptase inhibitors.

– didanosine: If you use didanosine tablets with gastric juice-resistant coating, take them at least 2 hours before or after Aptivus.

– emtricitabine: If you are taking emtricitabine, your kidney function should be checked before starting treatment with Aptivus.

– rilpivirine: If you are using rilpivirine, your doctor will monitor your treatment closely.

– Protease inhibitors (PIs): Treatment with Aptivus can lead to large reductions in the blood levels of other HIV protease inhibitors. For example, the levels of the protease inhibitors amprenavir, atazanavir, lopinavir, and saquinavir are reduced.

If Aptivus is used in combination with atazanavir, the blood levels of Aptivus and ritonavir may increase significantly.

Your doctor will carefully consider whether you should be treated with a combination of Aptivus and protease inhibitors.

Other medicines that Aptivus may interact with include:

  • Birth control pills/hormone replacement therapy ( HRT ): If you are using birth control pills to avoid pregnancy, you should use additional or alternative contraceptives (eg barrier contraceptives such as condoms). In general, the use of Aptivus with ritonavir, in combination with oral contraceptives or hormone replacement therapy ( HRT ) is not recommended. You should talk to your doctor if you want to continue taking birth control pills or HRT. If you are taking birth control pills or HRTThere is an increased risk of skin rash when you use Aptivus. If skin rashes occur, they are usually mild or moderate. You should talk to your doctor as you may need to take a temporary break from treatment with Aptivus or your birth control pills or HRT.
  • carbamazepine, phenobarbital, and phenytoin (for the treatment of epilepsy ). These medicines may reduce the effect of Aptivus.
  • sildenafil, vardenafil, tadalafil (medicines used to induce and maintain an erection). The effects of sildenafil and vardenafil are likely to increase if you take them with Aptivus. You should not receive a prescription for tadalafil until you have used Aptivus for 7 days or more.
  • omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole ( proton pump inhibitors used to reduce gastric acid production)
  • metronidazole (for the treatment of infections )
  • disulfiram (to treat alcohol dependence)
  • buprenorphine/naloxone (medicine to treat severe pain)
  • ciclosporin, tacrolimus, sirolimus (used to prevent organ rejection (immunosuppressive)
  • warfarin (used to treat and prevent thrombosis )
  • digoxin (used to treat heart rhythms and heart failure )
  • antifungal drugs including fluconazole, itraconazole, ketoconazole, or voriconazole

The following medicines are not recommended:

  • fluticasone (for the treatment of asthma )
  • atorvastatin (to lower blood cholesterol)
  • salmeterol (for long-term treatment of asthma, prevention of bronchospasm in COPD)
  • bosentan (for the treatment of high blood pressure in the pulmonary artery)
  • halofantrine or lumefantrine (used to treat malaria )
  • tolterodine (used to treat overactive bladder (with symptoms such as urination frequency, urination or urge incontinence))
  • boceprevir and telaprevir (used to treat hepatitis C)
  • cobicistat and products containing cobicistat (used to increase the effect of HIV medicines).

Aptivus may reduce the effectiveness of certain medicines, including:

  • methadone, pethidine (used as a morphine substitute)

Your doctor may need to increase or decrease the dose of one of the other medicines you are taking with Aptivus. For example:

  • rifabutin and clarithromycin ( antibiotics )
  • theophylline (for the treatment of asthma )
  • desipramine, trade zone, and bupropion (for the treatment of depression; bupropion is also used as a smoking cessation agent)
  • midazolam (when given as an injection ); Midazolam is sedative and is used to treat anxiety and to help you fall asleep
  • rosuvastatin or pravastatin (used to lower blood cholesterol)
  • colchicine (used to treat gout in patients with normal kidney and liver function)
  • raltegravir (used to treat HIV – infection )
  • dolutegravir (used to treat HIV – infection )

If you are using aluminum-magnesium-based antacids (to treat dyspepsia / gastroesophageal reflux disease ), the time interval between Aptivus and antacids should be at least 2 hours.

Tell your doctor if you are taking blood-thinning medicines, or if you are taking vitamin E. Your doctor may wish to take certain safety precautions in such cases.

Aptivus with food, drink, and alcohol

Aptivus capsules should be taken with food.

Pregnancy, breastfeeding, 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 if Aptivus is safe to use during pregnancy. You should not breast-feed your baby as it is possible that the baby may become HIV- infected through breast milk. See also section 2, under “Pills/hormone replacement therapy ( HRT )”.

Aptivus contains a very small amount of alcohol (see Important information about some of the excipients in Aptivus).

Driving and using machines

Some side effects of Aptivus may affect the ability to drive and use machines (eg dizziness and drowsiness). If you are affected, do not drive or use machines.

Aptivus contains ethanol, macrogol glycerol ricinoleate, and sorbitol (E420)

Aptivus contains 100 mg of alcohol ( ethanol ) per capsule. The amount in 250 mg of this medicine (ie one capsule) corresponds to less than 3 ml of beer or 1 ml of wine. The low amount of alcohol in this medicine does not produce any noticeable effects.

Aptivus also contains macrogol glycerol ricinoleate, which may cause an upset stomach and diarrhea.

This medicine contains 12.6 mg sorbitol per capsule.

3. How to use Aptivus

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. You must take Aptivus with ritonavir.

The recommended dose for adults or adolescents over 12 years of age is:

500 mg (two 250 mg capsules) Aptivus together with

– 200 mg (two 100 mg capsules) ritonavir

twice daily with food.

Oral use.

Aptivus capsules should be taken with food, swallowed whole, and must not be opened or chewed.

Always use this medicine in combination with other antiretroviral medicines. You must follow the instructions for these medicines, which are included in the package leaflets that come with the packs.

You should continue to use Aptivus for as long as your doctor recommends it.

Use for children and adolescents

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

If you use more Aptivus than you should  

Tell your doctor as soon as possible if you are taking more than the prescribed dose of Aptivus.

If you forget to use Aptivus

If you miss a dose of Aptivus or ritonavir by more than 5 hours, skip it and take the next dose of Aptivus and ritonavir at the next regular time. If a dose of Aptivus and/or ritonavir is less than 5 hours late, take it at once. Then take the next scheduled dose of Aptivus and ritonavir as usual at the next regular time.

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

If you stop using Aptivus

It has been shown that taking all doses at the right time:

  • greatly increases the effectiveness of your combination of antiretroviral drugs
  • reduces the risk of your HIV becoming resistant to your antiretroviral medicines

Therefore, it is important that you continue to use Aptivus correctly, as described above. DO NOT STOP using Aptivus unless instructed to do so by your doctor.

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

4. Possible side effects

During HIV treatment, weight gain and increased levels of blood fats and blood sugar may occur. This is partly related to restored health and lifestyle, but when it comes to blood fats, there can sometimes be a connection with HIV drugs. The doctor will perform tests to find such changes.

Like all medicines, this medicine can cause side effects, although not everybody gets them. It can be difficult to distinguish between:

  • side effects are caused by Aptivus
  • side effects are caused by the other medications you are also using
  • complications of HIV – infection a

For this reason, it is important that you tell your doctor about changes in your state of health.

Serious side effects associated with Aptivus:

Abnormal liver function:

  • hepatitis and hepatic obesity
  • liver failure. This can lead to death.
  • elevated levels of bilirubin in the blood (formed by the breakdown of hemoglobin)

You should contact your doctor if you experience:

  • reduced appetite
  • nausea
  • vomiting and/or jaundice

which may be a sign of abnormal liver function.

Bleeding

  • bleeding in the brain. This can lead to permanent disability or death and has been reported by 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 given other medicines that may have caused the bleeding.

Possible side effects:

Very common: may affect more than 1 in 10 people

  • diarrhea
  • nausea

Common: may affect up to 1 in 10 people

  • vomiting
  • abdominal pain
  • weather stresses
  • fatigue
  • headache
  • mild skin rash, for example with hives or flat or raised small red spots
  • increased blood fats
  • dyspepsia

Uncommon: may affect up to 1 in 100 people

  • fewer red and white blood cells
  • fewer platelets
  • allergic reactions ( hypersensitivity reactions )
  • reduced appetite
  • diabetes
  • increased blood sugar
  • increased level of cholesterol in the blood
  • insomnia and other sleep disorders
  • somnolence
  • dizziness
  • numbness and/or pain in feet or hands
  • breathing difficulties
  • heartburn
  • inflammation of the pancreas
  • dermatitis
  • itching
  • muscle cramps
  • muscle pain
  • kidney disease
  • flu-like symptoms (feeling sick)
  • fever
  • weight loss
  • increased levels in the blood of the pancreatic enzyme amylase
  • increased liver enzyme activity
  • hepatitis with liver cell damage, caused by a toxin

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

  • liver failure (including fatal outcome)
  • hepatitis
  • hepatic obesity
  • increased levels of bilirubin in the blood (a breakdown product of hemoglobin )
  • dehydration
  • emaciation of the face
  • bleeding in the brain * (see above)
  • an increased level in the blood of the pancreatic enzyme lipase

Additional information on possible side effects is related to combined antiretroviral therapy:

Bleeding

  • Increased bleeding. If you have type A or B hemophilia, you may experience increased bleeding. Bleeding may occur in the skin or joints. If you suffer from increased bleeding, seek medical attention immediately.

Muscle diseases

Muscle pain, tenderness, and weakness have been reported, especially when Aptivus or other protease inhibitors are taken with and nucleoside analogs. In rare cases, these muscle changes have been severe and have involved the breakdown of muscle tissue ( rhabdomyolysis ).

Additional side effects are in children and adolescents

Most common side effects were generally similar to those described in adults. Vomiting, rash, and fever were observed more often in children than in adults.

Reporting of side effects

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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

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 expiration date is the last day of the specified month.

Store in a refrigerator (2 o C to 8 o C). Once opened, the contents must be used within 60 days (do not store above 25 ° C). Write the date when the bottle was opened on the label and/or the outer carton.

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 to protect the environment…

6. Contents of the packaging and other information

Content declaration

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

The other ingredients are macrogol glycerol ricinoleate, ethanol (alcohol), mono/diglycerides of caprylic acid / 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 mixture (d-sorbitol, 1,4 sorbitan, mannitol, and glycerin), and titanium dioxide.

The black label contains propylene glycol, black iron oxide, polyvinyl acetate phthalate, macrogol, and ammonium hydroxide.

What the medicine looks like and the contents of the pack

Aptivus soft capsules are pink, oblong soft gelatin capsules marked TPV 250 in black. Each Aptivus capsule contains 250 mg of the active substance tipranavir. Aptivus is supplied in bottles containing 120 capsules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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

or

Boehringer Ingelheim France

100-104 avenue de France

75013 Paris

France

Contact the representative of the marketing authorization holder to find out more about this medicine:
Belgium / Belgique / BelgienSCS Boehringer Ingelheim Comm.VTel: +32 2 773 33 11 LithuaniaBoehringer Ingelheim RCV GmbH & Co KGLithuanian branchesTel: +370 5 2595942
BulgariaБьорингер Ингелхайм РЦВ ГмбХ и Ко КГ – clone of BulgariaTel: +359 2 958 79 98 Luxembourg / LuxemburgSCS Boehringer Ingelheim Comm.VTel: +32 2 773 33 11
Czech RepublicBoehringer Ingelheim spol. s roTel: +420 234 655 111 HungaryBoehringer Ingelheim RCV GmbH & Co KG Magyarországi FióktelepeTel: +36 1 299 8900
DenmarkBoehringer Ingelheim Danmark A / STel: +45 39 15 88 88 MaltaBoehringer Ingelheim Ltd.Tel: +44 1344 424 600
GermanyBoehringer Ingelheim Pharma GmbH & Co. KGTel: +49 800 77 90 900 The NetherlandsBoehringer Ingelheim bvTel: +31 (0) 800 22 55 88 9
EestiBoehringer Ingelheim RCV GmbH & Co. KGEesti subsidiaryTel: +372 61 28 000 NorwayBoehringer Ingelheim Norway KSTel: +47 66 76 13 00
GreeceBoehringer Ingelheim Ellas AETηλ: +30 2 10 89 06 300 AustriaBoehringer Ingelheim RCV GmbH & Co KGTel: +43 1 80 105 7870
SpainBoehringer Ingelheim España, SATel: +34 93 404 51 00 PolandBoehringer Ingelheim Sp.zo.o.Tel: +48 22 699 0 699
FranceBoehringer Ingelheim France SASTel: +33 3 26 50 45 33 PortugalBoehringer Ingelheim, Unipessoal. Lda.Tel: +351 21 313 53 00
CroatiaBoehringer Ingelheim Zagreb dooTel: +385 1 2444 600 RomaniaBoehringer Ingelheim RCV GmbH & Co KGVienna – Sucursala BucharestTel: +40 21 302 28 00
IrelandBoehringer Ingelheim Ireland Ltd.Tel: +353 1 295 9620 SloveniaBoehringer Ingelheim RCV GmbH & Co KGPodružnica LjubljanaTel: +386 1 586 40 00
IcelandVistor hf.Phone: +354 535 7000 Slovak RepublicBoehringer Ingelheim RCV GmbH & Co KGorganizing serviceTel: +421 2 5810 1211
ItalyBoehringer Ingelheim Italia SpATel: +39 02 5355 1 Finland / FinlandBoehringer Ingelheim Finland KyPuh / Tel: +358 10 3102 800
ΚύπροςBoehringer Ingelheim Ellas AETηλ: +30 2 10 89 06 300
LatviaBoehringer Ingelheim RCV GmbH & Co KGLatvian branchTel: +371 67 240 011 United KingdomBoehringer Ingelheim Ltd.Tel: +44 1344 424 600

Muhammad Nadeem

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