Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Aptivus. If you are concerned about side effects, discuss the risks and benefits of Aptivus with your doctor.

The following side effects have been reported by at least 1% of people taking Aptivus. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• Diarrhea
• difficulty swallowing
• fatigue or tiredness
• headache
• heartburn
• increased sensitivity to the sun
• loss of appetite
• nausea
• vomiting
• weight loss

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• abdominal pain
• changes in body fat distribution
• chest pain
• flu-like symptoms (e.g., sudden lack of energy, Fever, cough, sore throat)
• mental or mood changes (e.g., agitation, Depression, confusion, hallucinations, or thoughts of suicide)
• shortness of breath
• signs of bleeding (e.g., bloody nose, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
• signs of infection (e.g., fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
• skin rash
• symptoms of Anemia (e.g., paleness, weakness, or fatigue)
• symptoms of liver damage (e.g., yellow skin or eyes, abdominal pain, dark urine, pale stools, loss of appetite, nausea and vomiting, or itching)
• symptoms of nerve damage (e.g., numbness, burning, prickling, shock-like, or painful sensations in the hands or feet that are felt on both sides and may be worse at night)

Seek immediate medical attention if any of the following occur:

• signs of an allergic reaction (e.g., shortness of breath or difficulty breathing; Hives; swelling of the eyes, mouth, lips, or throat)
• signs of bleeding into the brain (e.g., a sudden severe headache, muscle weakness, loss of coordination or balance, vision changes, unusual fatigue)
• signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Aptivus.

Each pink, oblong soft gelatin capsule, imprinted in black with "TPV 250" contains tipranavir 250 mg. Nonmedicinal ingredients: Cremophor EL, ethanol, mono/diglycerides of caprylic/capric acid, propyl gallate, propylene glycol, purified water, and trometamol; shell: gelatin, iron oxide red, propylene glycol, purified water, "sorbitol special glycerin blend" (d-sorbitol, 1,4-sorbitan, mannitol, and glycerin), and titanium dioxide; black printing ink: ammonium hydroxide, ethylacetate, iron oxide black, isopropyl alcohol, Macrogol, polyvinyl acetate phthalate, propylene glycol, purified water, and SDA 35 alcohol.

Do not take Aptivus if you:

• are allergic to tipranavir or any ingredients of the medication
• are taking any of the following medications:
• Alfuzosin
• Amiodarone
• astemizole
• bepridil
• cisapride
• ergot-type medications (e.g., Dihydroergotamine, ergonovine, ergotamine, methylergonovine)
• Flecainide
• Lovastatin
• midazolam
• Pimozide
• Propafenone
• quinidine
• rifampin
• Sildenafil
• Simvastatin
• St. John's wort
• terfenadine
• Triazolam
• Vardenafil
• have moderate-to-severe liver disease

There may be an interaction between tipranavir and any of the following:

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Aptivus. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Aptivus.

Allergy to sulfa medications: Some people who are allergic to sulfa medications also experience allergic reactions to tipranavir. Before you take tipranavir, inform your doctor about any previous adverse reactions you have had to medications, especially sulfonamide antibiotics, Sumatriptan, Celecoxib, and certain diuretics. Contact your doctor at once if you experience signs of an allergic reaction, such as skin rash, itching, difficulty breathing or swelling of the face and throat.

Bleeding problems: People taking tipranavir have experienced intracranial hemorrhage (bleeding into the brain). If you experience symptoms of this condition, including severe headache, nausea or vomiting, unusual weakness or tiredness, changes in vision, or loss of balance, stop taking the medication and seek immediate medical attention.

If you are at increased risk of bleeding (e.g., taking certain medications, have had recent surgery), discuss with your doctor how Aptivus may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Aptivus, and whether any special monitoring is needed.

Body fat changes: People using tipranavir may notice the accumulation and redistribution of fat in their body. For example, less body fat on their arms, legs, and face, and more around the center of their body (e.g., enlarged breasts, abdominal or central Obesity, and a "buffalo hump" [a pad of fat on the back]). The cause or long-term health effects of these conditions are not known at this time.

Cholesterol: Tipranavir can cause increased blood cholesterol levels. This may happen to people with normal cholesterol levels and High Cholesterol levels at the beginning of treatment.

If you are at risk of developing high cholesterol or you have high cholesterol levels before starting tipranavir, discuss with your doctor how Aptivus may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Aptivus, and whether any special monitoring is needed.

Your doctor will monitor your cholesterol levels regularly while you are taking Aptivus.

Diabetes: Some people taking protease inhibitor medications such as tipranavir have developed diabetes during treatment, and people with diabetes have noticed that their diabetes became worse during treatment.

If you have diabetes before starting tipranavir, discuss with your doctor how Aptivus may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Aptivus, and whether any special monitoring is needed.

If you notice signs of reduced blood glucose control, such as a fruity odour to the breath, increased urination at night and thirst, or problems with wound healing talk to your doctor as soon as possible.

Hemophilia: People with hemophilia A or B may be at an increased risk of bleeding while taking tipranavir. If you have hemophilia A or B, discuss with your doctor how Aptivus may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Aptivus, and whether any special monitoring is needed.

Immune reconstitution syndrome: Aptivus may cause immune reconstitution syndrome, where signs and symptoms of inflammation from previous infections appear. These symptoms occur soon after starting anti-HIV medication and can vary. They are thought to occur as a result of the immune system improving and being able to fight infections that have been present without symptoms (such as pneumonia, herpes, or Tuberculosis). Report any new symptoms to your doctor as soon as possible.

Liver function: Aptivus can cause severe and sometimes fatal liver problems. People with hepatitis B or C, or liver disease, may experience worsening of their liver disease symptoms while taking Aptivus. Your doctor will perform liver function tests at the start of treatment and at regular intervals while you are taking Aptivus.

If you have reduced liver function or liver disease such as hepatitis, discuss with your doctor how Aptivus may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Aptivus, and whether any special monitoring is needed.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

People with moderate-to-severe liver disease should not use tipranavir.

Other medications: Tipranavir may interact with a number of medications, which may mean a change in how you take Aptivus (see "What medications can interact with Aptivus?"). Tell your doctor of all medications that you are taking. Certain medications should not be taken with tipranavir at all (see "Who should NOT take Aptivus?").

Stopping the medication: If you stop taking Aptivus, your HIV infection could get worse. Take the medication exactly as prescribed by your doctor, and do not stop taking the medication without checking with your doctor first.

Pregnancy: Aptivus should not be used during pregnancy unless the potential benefits outweigh the risks. If you become pregnant while taking Aptivus, contact your doctor immediately.

Breast-feeding: It is not known if tipranavir passes into breast milk. Breast-feeding is not recommended HIV-positive women since the virus can be transmitted through the breast milk.

Children: The safety and effectiveness of using Aptivus have not been established for children and adolescents up to 18 years of age.