TELZIR 700 mg FILM-COATED TABLETS

2. What you need to know before you take Telzir

Telzir is taken in combination with low doses of ritonavir and other antiretroviral agents.Therefore, it is important that you carefully read the package leaflet provided with this medicine. If you have any further questions about ritonavir or the other prescribed medicines, please consult your doctor or pharmacist.

Do not take Telzir

• to fosamprenavir, amprenavir, or any of the other ingredients of this medicine (listed in section 6) or to ritonavir
• :

• alfuzosin (used to treat prostate problems)
• astemizole or terfenadine (frequently used to treat allergy symptoms; these medicines may be available without a prescription)
• pimozide (used to treat schizophrenia)
• quetiapine (used to treat schizophrenia, bipolar disorder, and major depressive disorder)
• lurasidone (used to treat schizophreniaand bipolar disorder)
• cisapride (used to treat indigestion)
• ergotamine derivatives (used to treat headache)
• rifampicin (used to treat tuberculosis)
• amiodarone, quinidine, flecainide, and propafenone (heart medicines)
• bepridil (used to treat high blood pressure)
• midazolam oral and triazolam oral (used to treat anxiety)
• products containing St. John's Wort (Hypericum perforatum)
• lovastatin, simvastatin (used to lower cholesterol levels)
• sildenafil if used to treat pulmonary arterial hypertension(a disease affecting the blood vessels in the lungs)
• paritaprevir (used to treat hepatitis C virus infection)

Tell your doctor if you are in any of these situations.

Be careful with Telzir

Consult your doctor or pharmacist before starting to take Telzir:

• , as you may also be allergic to Telzir.
• . Your doctor may reduce the doses you receive of Telzir and ritonavir depending on the severity of your liver disease. You must be monitored by your doctor while taking Telzir. If your liver disease worsens, you may need to stop taking Telzir for a while or permanently. Patients with hepatitis B or C treated with combination antiretroviral therapy have a higher risk of their liver problems worsening.
• . There may be an increased risk of bleeding while taking protease inhibitors (such as Telzir). The reason is unknown. You may need additional factor VIII to control bleeding.
• . In some patients receiving antiretroviral medicines, including protease inhibitors, there have been cases of increased blood sugar levels and worsening of diabetes.

Some patients may also develop diabetes during treatment with these medicines.

• . See the section “Other medicines and Telzir”.

Tell your doctor if you are in any of these situations.While taking this medicine, you will require extra check-ups, including blood tests.

Your doctor will monitor your blood glucose levels before and during treatment with Telzir.

Be alert to important symptoms

Some patients taking HIV medicines develop other symptoms, which can be serious.

These may be:

• Reappearance of previous infections
• Changes in body shape
• Bone problems

It is essential that you know the signs and symptoms that may appear while taking Telzir.

Please read the information on “Other side effects of combination HIV therapy” in section 4 of this leaflet.If you have any questions about this information or the recommendations given:

Consult your doctor.

You may experience skin rashes

However, if you develop a skin rash, you can continue taking Telzir. You may be treated with antihistamines. Rarely, the skin rash can be severe and serious (Stevens-Johnson syndrome). If this happens, you must stop taking Telzir immediately and never take it again.

Other medicines and Telzir

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine, including herbal medicines or those bought without a prescription. Your doctor will decide if these medicines are suitable for you to take with Telzir and ritonavir. This is veryimportant, as taking certain types of medicines at the same time as Telzir and ritonavir can enhance or weaken the effect of other medicines. This can, in some cases, lead to serious situations.

There are some medicines that must not be taken with Telzir.You must review the list of medicines in the section “Do not take Telzir” at the beginning of section 2 of this leaflet.

The following medicines are not recommended to be taken with Telzir/ritonavir:

• ketoconazole and itraconazole doses above 200 mg per day (used to treat fungal infections)
• rifabutin doses above 150 mg every other day (an antibiotic)
• lidocaine injection
• halofantrine (used to treat malaria)
• sildenafil, vardenafil, or tadalafil (used to treat erectile dysfunction)
• atorvastatin doses above 20 mg per day (used to lower cholesterol levels)

• fluticasone propionate and similar medicines for the treatment of asthma, unless considered essential. In this case, close monitoring is required
• lopinavir/ritonavir combination (used to treat HIV infection)
• raltegravir (used to treat HIV infection)
• simeprevir, daclatasvir (used to treat hepatitis C virus infection)
• maraviroc (used to treat HIV infection)

You will require close monitoring if you are taking the following medicines with Telzir/ritonavir:

• atorvastatin up to 20 mg per day (used to lower cholesterol levels)
• carbamazepine, phenobarbital, phenytoin (used to treat epilepsy)
• cyclosporine, rapamycin, tacrolimus (used to reduce the activity of the immune system)
• dolutegravir (used to treat HIV infection)
• desipramine, nortriptyline, paroxetine, and similar medicines (used to treat depression)
• warfarin and other medicines that prevent blood clotting
• midazolam injection (used to treat anxiety)
• clarithromycin, erythromycin (an antibiotic)
• methadone (a heroin substitute)
• dasatinib, nilotinib, ibrutinib, vinblastine, and everolimus (used to treat various types of cancer)

You may need to change your dose of Telzir if you are taking

• etravirine (used to treat HIV infection)

Hormonal contraception

Taking Telzir and ritonavir while taking the contraceptive pill may damage your liver and may make the contraceptive less effective.

Use a non-hormonal contraceptive method, such as a condom.

No studies have been conducted on the use of Telzir/ritonavir with other hormonal therapies, such as hormone replacement therapy (HRT).

Pregnancy

If you are pregnant, think you may be pregnant, or plan to become pregnant:

Consult your doctor or pharmacistbefore using this medicine.

Breastfeeding

It is not recommendedthat HIV-infected women breastfeed their babies, as HIV infection can be transmitted to the baby through breast milk. It is not known if the components of Telzir can pass into breast milk. If you are breastfeeding or plan to breastfeed, consult your doctor as soon as possible.

Driving and using machines

Telzir may make you feel dizzy and cause other effects that reduce your attention.

Do not drive or operate machinery or toolsunless you feel well.

Keep regular contact with your doctor

Telzir helps control your disease, but it does not cure HIV infection. You must continue to take it every day to avoid your disease worsening. You may still develop other infections and diseases associated with HIV infection.

Keep in touch with your doctor and do not stop taking Telzirwithout your doctor's advice.

Telzir contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; this is essentially “sodium-free”.

3. How to take Telzir

Follow exactly the instructions for administration ofthis medicinegiven by your doctor.It is very important that you take the complete daily dose of Telzir and ritonavir as prescribed by your doctor. Do not take morethan the recommended dose. If in doubt, consult your doctor or pharmacist again.

Swallow the tablets whole with water or another drink. Telzir tablets can be taken with or without food. Telzir is also available in liquid form (oral suspension) for patients who are unable to swallow tablets. (Read the package leaflet of Telzir oral suspension for recommendations on how to take it with or without food).

Adults

The recommended dose is one 700 mg Telzir tablet twice a daywith 100 mg of ritonavir twice a day.

Children over 6 years and weighing at least39 kg

Children in this group can take the adult dose of one 700 mg Telzir tablet twice a daywith 100 mg of ritonavir twice a day, provided they can swallow the tablets whole.

Children over 6 years and weighing less than39 kg

Use the oral suspension of Telzir.

Adults with liver disease

If you have mild liver disease, the dose is one 700 mg Telzir tablet twice a daywith 100 mg of ritonavir only once a day. If you have moderate or severe liver disease, the dose of Telzir must be reduced. This dose adjustment cannot be made with Telzir tablets, so you must use the oral suspension of Telzir.

If you take more Telzir than you should

If you take more Telzir than the dose prescribed by your doctor:

Consult your doctor or pharmacist immediately.

If you forget to take Telzir

If you forget to take a dose of Telzir, take it as soon as you remember and then continue your treatment as before. Do not take a double dose to make up for forgotten doses.

Do not stop treatment with Telzir without your doctor's advice

Take Telzir for as long as your doctor recommends. Do not stop treatment unless your doctor advises you to do so.

4. Possible Adverse Effects

During HIV treatment, there may be an increase in weight and levels of glucose and lipids in the blood. This may be partly related to the recovery of health and lifestyle, and in the case of blood lipids, sometimes to HIV medications themselves. Your doctor will monitor these changes.

Like all medications, this medication may produce adverse effects, although not all people will experience them. When treating an HIV infection, it is not always possible to determine if some of the adverse effects that appear are caused by Telzir, by other medications taken at the same time, or by the HIV infection. For this reason, it is very important that you inform your doctor about any change that occurs in your health.

Very Common Adverse Effects

May affect more than 1 in 10 people treated:

• Diarrhea.
• Increased levels of cholesterol(a type of fat in the blood).

Common Adverse Effects

May affect up to 1 in 10 people treated:

• Increased levels of triglycerides(a type of fat in the blood).
• Discomfort (nausea or vomiting), abdominal pain, loose stools.
• Skin rashes (red, swollen, or itchy) – if the rash is severe, it may be necessary to interrupt treatment.
• Headache, dizziness.
• Fatigue.
• Increased liver enzymes, called transaminases, and an increase in a pancreatic enzyme called lipase.
• Numbness or tingling around the lips and mouth.

Uncommon Adverse Effects

May affect up to 1 in 100 people treated:

• Facial, lip, and tongue inflammation (angioedema).

Rare Adverse Effects

May affect up to 1 in 1,000 people treated:

• Severe or life-threatening skin reaction (Stevens-Johnson syndrome).

You may experience muscle problems

There have been reports of muscle pain, increased sensitivity, or weakness in the muscles, particularly with antiretroviral treatments that include protease inhibitors and nucleoside analogs. In rare cases, these muscle disorders have been severe (rhabdomyolysis). If you notice muscle problems:

?Tell your doctor.

Patients with hemophilia may bleed more

In patients with hemophilia A and B, increased bleeding has been observed while being treated with protease inhibitors. If this happens to you:

?Consult your doctor immediately.

If you experience adverse effects

?Consult your doctor or pharmacist, even if it's an adverse effect that is not listed in this leaflet.

Other Adverse Effects of HIV Treatment

Reappearance of previous infections

Patients with advanced HIV infection (AIDS) have a weakened immune system and are more prone to developing severe infections (opportunistic infections). When these patients start treatment, it may happen that previous infections recur, causing signs and symptoms of inflammation. These symptoms are likely caused by the immune system becoming more potent and starting to fight these infections.

In addition to opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also appear after you start taking medications for your HIV treatment. Autoimmune disorders can appear many months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness starting in the hands and feet and moving up to the torso, palpitations, tremors, or hyperactivity, tell your doctor immediately to receive the necessary treatment.

If you have any symptoms of infection or signs of inflammation while taking Telzir:

?Tell your doctor immediately. Do not take other medications for the infectionwithout consulting your doctor.

You may experience bone problems

Some patients on combined antiretroviral therapy for HIV develop osteonecrosis. In this condition, parts of the bone tissue die due to reduced blood supply to the bones.

Patients may be more likely to experience this condition:

• if they have been on combined treatment for a long time
• if they are also taking anti-inflammatory medications called corticosteroids
• if they drink alcohol
• if their immune system is severely weakened
• if they are overweight.

Be especially careful if you notice:

• joint stiffness
• pain(especially in the hip, knee, or shoulder)
• difficulty moving.

If you detect any of these symptoms:

?Tell your doctor.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it's a possible adverse effect that is not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Telzir

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date on the box and bottle.

Telzir does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Telzir Composition

• The active ingredient is fosamprenavir. Each tablet contains 700 mg of fosamprenavir as fosamprenavir calcium (equivalent to approximately 600 mg of amprenavir).

• The other ingredients are: microcrystalline cellulose, sodium croscarmellose, povidone K30, magnesium stearate, anhydrous colloidal silica, hypromellose, titanium dioxide (E171), glycerol triacetate, red iron oxide (E172).

Product Appearance and Package Contents

Telzir is supplied in plastic bottles containing 60 film-coated tablets. The tablets are capsule-shaped, biconvex, pink, and marked with "GXLL7" on one side.

Telzir is also available as an oral suspension for patients who cannot swallow tablets.

Marketing Authorization Holder and Manufacturer

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Date of the Last Revision of this Leaflet:

Detailed information about this medication is available on the European Medicines Agency website: http://www.ema.europa.eu.