TELZIR 50 mg/mL ORAL SUSPENSION

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

• if you are allergicto fosamprenavir, amprenavir, or any of the other ingredients of this medicine (listed in section 6) or ritonavir
• if you are taking any of these medicines:

• alfuzosin (used to treat prostate problems)
• astemizole or terfenadine (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 cholesterollevels)
• 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 doctorif you are in any of these situations.

Be careful with Telzir

Consult your doctor or pharmacist before you start taking Telzir:

• If you are allergic to sulphonamide medicines, as you may also be allergic to Telzir.
• If you have liver disease. 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 getting worse.
• If you have haemophilia. You may experience increased bleeding while taking protease inhibitors (such as Telzir). The reason is unknown. You may need extra factor VIII to control bleeding.
• If you have diabetes. Some patients receiving antiretroviral medicines, including protease inhibitors, have experienced increased sugar in the blood and worsening of diabetes.

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

• If you are taking any other 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 check your blood sugar levels before and during treatment with Telzir.

Be aware of important symptoms

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

These can be:

• Return of previous infections
• Changes in body shape
• Problems with your bones.

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

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

Consult your doctor.

You may experience skin rash

However, if you develop a skin rash, you can continue taking Telzir. You can 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 medicines,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 increase or decrease the effect of other medicines. This can, in some cases, cause serious problems.

There are some medicines that must not be taken with Telzir.You must check 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 cholesterollevels)

• 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 cholesterollevels)
• carbamazepine, phenobarbital, phenytoin (used to treat epilepsy)
• cyclosporin, 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).

It may be necessary 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 performed on the use of Telzir/ritonavir with other hormonal therapies, such as hormone replacement therapy (HRT).

Taking Telzir with food and drinks

Adultsshould take Telzir oral suspension withoutfood and on an empty stomach.

Children and adolescentsshould take Telzir oral suspension withfood.

Pregnancy

If you are pregnant, think you may be pregnant, or are planning to have a baby:

Consult your doctor or pharmacistbefore using this medicine.

Breast-feeding

It is not recommendedthat HIV-infected women breast-feed their babies because HIV can be transmitted through breast milk. It is not known whether the components of Telzir can pass into breast milk. If you are breast-feeding or thinking of breast-feeding, consult your doctor as soon as possible.

Important information about some of the ingredients of Telzir oral suspension

Telzir oral suspension contains propyl hydroxybenzoate and methyl hydroxybenzoate. These ingredients may cause allergic reactions (which may be delayed).

Driving and using machines

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

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

Keep in regular contact with your doctor

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

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

3. How to take Telzir

Follow exactly the instructions for taking this medicine given by your doctor. It is very important that you take the complete daily dose of Telzir and ritonavir as your doctor has prescribed. Do not take morethan the recommended dose. If you are unsure, consult your doctor or pharmacist again.

Shake the bottle for 20 seconds before using it for the first time. Shake the bottle for 5 seconds before use on subsequent occasions.

A 10 ml graduated dosing syringe is included in the pack to measure the dose accurately.

Adults

Adultsshould take Telzir oral suspension withoutfood and on an empty stomach. The recommended dose is 14 ml of Telzir oral suspension(700 mg of fosamprenavir) twice a daywith 100 mg of ritonavir (in capsules or oral solution) twice a day.

Children over 6 years of age and weighing at least 25 kg

Childrenin this group should take Telzir oral suspension withfood.

Your doctor will tell you the correct dose based on weight.

The recommended dose is 0.36 ml/kgof Telzir oral suspension (which corresponds to 18 mg/kg of fosamprenavir) twice a daywith 3 mg/kg of ritonavir oral solution twice a day.

No dose recommendations can be made for children weighing less than 25 kg.

Children may take the adult dose of ritonavir capsules (100 mg twice a day) if they weigh at least 33 kg and can swallow the capsules whole.

As an alternative to Telzir oral suspension:

Children may take the adult dose of a 700 mg Telzir tablet twice a day(with 100 mg of ritonavir twice a day), if they weigh at least 39 kg and can swallow the tablets whole.

Children under 6 years of age

Telzir is not recommended for children under 6 years of age.

Adults with liver disease

If you have mild liver disease, the dose is 14 ml of Telzir oral suspension(700 mg of fosamprenavir) twice a daywith 100 mg of ritonavir only once a day. If you have moderate liver disease, the dose is 9 ml of Telzir oral suspension(450 mg of fosamprenavir) twice a day with 100 mg of ritonavir only once a day. If you have severe liver disease, the dose is 6 ml of Telzir oral suspension(300 mg of fosamprenavir) twice a day with 100 mg of ritonavir only once a day.

Step-by-step instructions

Do not mix Telzir with other medicines in the bottle or syringe.

1. Remove the plastic wrapperfrom the syringe/adapter.
2. Shake the bottlevigorously before use.
3. Remove the cap from the bottle. Keep the cap.
4. Remove the adapterfrom the syringe.
5. While holding the bottle firmly, insert the plastic adapter into the neck of the bottle.
6. Insert the syringefirmly into the adapter.
7. Turn the bottle upside down.
8. Pull the syringe plungeruntil you get the first part of the full dose.
9. Return the bottle to its normal positionand remove the syringe from the adapter.
10. Place the syringe in your mouth, with the syringe end towards the inside of your cheek. Push the plunger slowly, giving time to swallow the medicine. Do notintroduce the solution too quickly into the throat, as you may choke.
11. Repeatsteps 6to 10in the same way until you have taken the full dose.
12. After use, do not leave the syringe in the bottle. Remove the syringe and adapter and wash them well with clean water. Let them dry completely before using them again.
13. Close the bottle tightlywith the cap.

If you take more Telzir than you should

If you take more Telzir than your doctor prescribed:

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 taking 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.

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 levels of liver enzymes called transaminases, increased levels of 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 problems 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 prospectus.

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 that starts in the hands and feet and moves up to the torso, palpitations, tremors, or hyperactivity, inform 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 taking combined therapy 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 cautious if you notice:

• stiffness in the joints
• 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 prospectus. 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 freeze. Telzir does not require special storage conditions.

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

Discard the bottle 28 days after it was first opened, but do not throw the medication down the drain or in the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Telzir

• The active ingredient is fosamprenavir. Each ml of oral suspension contains 50 mg of fosamprenavir in the form of fosamprenavir calcium (equivalent to approximately 43 mg of amprenavir).

• The other ingredients are: hypromellose, sucralose, polysorbate 80, calcium chloride dihydrate, artificial grape flavor, natural mint flavor, purified water, propylene glycol, methylparaben (E218), and propylparaben (E216).

Appearance of the Product and Package Contents

Telzir is supplied in plastic bottles containing 225 ml of oral suspension. The package includes a 10 ml graduated syringe and an adapter. The suspension is white to off-white in color.

Telzir is also available in film-coated tablets with 700 mg.

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 prospectus:

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