Telzir 50 mg/ml oral suspension

Telzir is to be taken in combination with low doses of ritonavir and other antiretroviral medicines. It is therefore important that you carefully read the package leaflet provided with these medicines. If you have any further questions about ritonavir or the other medicines prescribed, please ask your doctor or pharmacist.

Don?t take Telzir:

• if you are allergic ( hypersensitive) to fosamprenavir, amprenavir or any of the other ingredients in Telzir (listed in section 6), or to ritonavir.
• if you are taking any of these medicines:
• astemizole or terfenadine (commonly used to treat allergy symptoms ? these medicines may be available without prescription)
• pimozid e (used to treat schizophrenia)
• cisapride (used to relieve indigestion)
• ergot derivatives (used to treat headaches)
• rifampicin (used to treat tuberculosis)
• amiodarone, quinidine, flecainide and propafenone ( heart medicines)
• bepridil (used to treat high blood pressure).
• oral midazolam or oral triazolam (used to treat anxiety)
• products containing St John?s wort ( Hypericum perforatum).

? Tell your doctor if any of these applies to you.

Take special care with Telzir
Before you take Telzir your doctor needs to know :

• If you have a known allergy to medicines containingsulphonamide. You may also be allergic to Telzir.
• If you have liver disease. Your doctor may lower your dose of Telzir and ritonavir depending on the amount of liver damage. You will be monitored while you are taking Telzir. If your liver disease gets worse, you may need to stop taking Telzir for a while, or permanently. People with hepatitis B or C taking combination therapy are at increased risk of getting severe liver problems.
• If you have haemophilia. Increased bleeding may occur while taking protease inhibitors (such as Telzir). The reason for this is not known. You may need additional factor VIII to control any bleeding.
• If you have diabetes. In some patients taking antiretroviral medicines including protease inhibitors, there have been reports of increased sugar in the blood and diabetes getting worse. Also, some people have become diabetic while taking these medicines.
• If you are taking any other medicines. See section ?Other medicines and Telzir? below.

? Tell your doctor if any of these applies to you. You will need extra check-ups, including blood tests, while you?re taking your medication.

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

Look out for important symptoms

Some people taking medicines for HIV infection develop other conditions, which can be serious. These include:

• Flare up of old infections
• Change in your body shape
• Problems with your bones. You need to know about important signs and symptoms to look out for while you?re 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: ? Talk to your doctor.

You may get a skin rash.

However you can still continue to take Telzir.It can be treated with antihistamines. Rarely, the skin rash can be severe and serious ( Stevens Johnson syndrome). If this happens, Telzir must be stopped immediately and you must never take it again.

Protect other people

Telzir will not stop you passing HIV infection on to other people, by having sex or by blood transfer. To protect other people from becoming infected with HIV:
? Use a condom when you have oral or penetrative sex.
? Don?t risk blood transfer ? for example, don?t share needles.

Other medicines and Telzir
Tell your doctor or pharmacist if you?re taking any other medicines, if you?ve taken any recently, or if you start taking new ones ? these include herbal medicines or other medicines you bought without a prescription.
Your doctor will decide if these medicines are suitable for you to take with Telzir and ritonavir. This is very important, as Telzir or ritonavir can strengthen or weaken the effects of other medicines. This can sometimes lead to serious medical conditions.

There are some medicines that must not be taken with Telzir. You must check the list of medicines under 'Don't take Telzir' at the beginning of section 2 of this leaflet.

These medicines are not recommended with Telzir/ritonavir:

• doses of ketoconazole and itraconazole greater than 200 mg per day (used to treat fungal infections)
• doses of rifabutin greater than 150 mg every other day (an antibiotic)
• lidocaine given by injection (an anaesthetic)
• halofantrine (used to treat malaria)
• sildenafil and vardenafil (used to treat erectile dysfunction)
• lovastatin, simvastatin and doses of atorvastatin greater than 20 mg per day (used tolower cholesterol)
• fluticasone propionate and similar medicines used to treat asthma, unless considered essential. In this case close monitoring is required.
• lopinavir/ritonavir combination (used to treat HIV infection)

You will be closely monitored if you are taking these medicines with Telzir/ritonavir:

• atorvastatinup to 20 mg per day (used to lower cholesterol)
• carbamazepine, phenobarbital(used to treat epilepsy)
• cyclosporin, rapamycin, tacrolimus (used to suppress the immune system)
• desipramine, nortriptyline, paroxetine and similar medicines (used to treat depression)
• warfarin and other medicines that stop blood clotting
• injectable midazolam (used to treat anxiety) .

Your dose of Telzir may need to be changed if you are taking

• etravirine (used to treat HIV infection)

Hormonal contraception

Taking Telzir and ritonavir while taking the contraceptive pill may harm your liver and may stop the contraceptive from working properly.
? Use an alternative non-hormonal type of contraception such as a condom.
No studies have been done on the use of Telzir/ritonavir with other hormonal therapies, such as hormone replacement therapy (HRT).

Taking Telzir and food
Adults should take the Telzir oral suspension withoutfood and on an empty stomach. Children and adolescents should take the Telzir oral suspension with food.

Pregnancy and breast feeding

If you are pregnant, if you become pregnant, or if you are planning to become pregnant: ? Talk to your doctor about the risks and benefits of taking Telzir.

Women who are HIV-positive must not breast feed because HIV infection can be passed on to the baby in breast milk. If you?re breast feeding, or thinking about breast feeding:
? Talk to your doctor.

Important information about ingredients of Telzir oral suspension

Telzir oral suspension contains propyl and methyl parahydroxybenzoate. These ingredients may cause allergic reactions (sometimes delayed).

Driving and using machines

Telzir can make you feel dizzy and have other side effects that make you less alert. ? Don?t drive or operate machinery unless you?re feeling well.

Stay in regular contact with your doctor

Telzir helps to control your condition, but it is not a cure for HIV infection. You need to keep taking it every day to stop your illness getting worse. You may still develop other infections and illnesses linked to HIV infection.
? Keep in touch with your doctor, and don?t stop taking Telzir without your doctor?s advice.

Always take Telzir exactly as your doctor has told you. It is very important that you take the full daily dose of Telzir and ritonavir as prescribed by your doctor. Do not takemore than the recommended dose. Check with your doctor or pharmacist if you are not sure.

Shake the bottle for 20 seconds before the first use. Shake the bottle for 5 seconds before subsequent uses.

A dosing syringe with a 10 ml graduation is supplied with the pack so you can measure your dose accurately.

How much to take

AdultsAdults should take the Telzir oral suspension without food and on an empty stomach. The recommended dose is 14 ml Telzir oral suspension (700 mg fosamprenavir) twice daily with 100 mg ritonavir (as capsule or oral solution) twice daily.

Children from 6 years of age and weighing at least 25 kg
Children should take the Telzir oral suspension with food.

Your doctor will work out the right dose based on your weight.

The recommended dose is 0.36 ml/kg of Telzir oral suspension (18 mg per kg fosamprenav ir) twice daily with 3 mg/kg ritonavir oral solution twice daily.

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

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

As an alternative to taking Telzir oral suspension:

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

Children less than 6 years of age

Telzir is not recommended for children less than 6 years old.

Adults with liver disease

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

Step by step instructions
Do not mix Telzir with any other medicines in the bottle or the syringe.

1. Shake the bottle vigorously before use.

2. Remove the bottle cap and keep it safely.

3. Push the plastic adapterinto the neck of the bottle, while holding the bottle firmly.

4. Insert the syringe firmly into the adapter.

5. Turn the bottle upside down.

6. Pull out the syringe plunger until the first portion of your full dose is withdrawn.

7. Turn the bottle the right way up and remove the syringe from the adapter.

8. Put the syringe into your mouth, placing the tip of the syringe against the inside of your cheek. Slowly push the plunger in, allowing time to swallow. Don?t push too hard and squirt the liquid into the back of the throat or you may choke.

9. Repeat steps 4 to 8 in the same way until you have taken the whole dose.

10. Do not leave the syringein the bottle. Take the syringe and the adapter off and wash them thoroughly in clean water. Let them dry completely before you use them again.

11. Close the bottle tightly with the cap.

If you take too much Telzir

If you have taken more than the prescribed dose of Telzir:
? Contact your doctor or pharmacist immediately for advice.

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. Don?t take a double dose to make up for a missed dose.

Don?t stop Telzir without advice

Take Telzir for as long as your doctor recommends. Don?t stop unless your doctor advises you to.

Like all medicines, Telzir can cause side effects, but not everyone gets them. When treating HIV, it can be hard to tell whether side effects are caused by Telzir, by other medicines taken at the same time or by the HIV disease itself. For this reason, it is very important to talk to your doctor about any changes in your health.

Very common side effects
These may affect more than 1 in 10 people:

• Diarrhoea ?
• Increase in cholesterol (a type of blood fat). Your doctor will monitor your blood fat levels before and during treatment with Telzir.

Common side effects
These may affect up to 1 in 10people:

• Increases in triglycerides (a type of blood fat). Your doctor will monitor your blood fat levels before and during treatment with Telzir.
• Feeling sick or being sick ( nausea or vomiting), pain in the stomach, loose stools
• Skin rashes (red, raised or itchy) ? if the skin rash is severe, you may have to stop taking this medicine
• Headache, feeling dizzy
• Feeling tired
• Increases in enzymes produced by the liver called transaminases, increases of an enzyme produced by the pancreas called lipase.
• Tingling or numbness around the lips and mouth.

Uncommon side effects
These may affect up to 1 in 100 people:

• Swelling of the face, lips and tongue ( angioedema).

Rare side effects
These may affect up to 1 in 1000 people:

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

You may experience muscle problems

There have been reports of muscle pain, tenderness or weakness, particularly with antiretroviral therapy including protease inhibitors and nucleoside analogues. On rare occasions, these muscle disorders have been serious ( rhabdomyolysis). If you notice any muscle problems:? Tell your doctor.

Haemophiliacs may bleed more

In patients with haemophilia type A and B, there have been reports of increased bleeding while taking protease inhibitors. If this happens to you:
? Talk to your doctor immediately.

If you get side effects

? Tell your doctor or pharmacist if any of the side effects gets severe or troublesome, or if you notice any side effects not listed in this leaflet.

Other side effects of combination therapy for HIV

Old infections may flare up

People with advanced HIV infection (AIDS) have weak immune systems and are more likely to develop serious infections (opportunistic infections). When these people start treatment, they may find that old, hidden infections flare up, causing signs and symptoms of inflammation. These symptoms are probably caused by the body?s immune system becoming stronger, so that the body starts to fight these infections.

If you get any symptoms of infection or signs of inflammation while you?re taking Telzir: ? Tell your doctor immediately. Don?t take other medicines for the infection without your doctor?s advice.

Your body shape may change

People taking combination therapy may find that their body shape changes, because of changes in fat distribution:

• Fat may be lost from the legs, arms or face
• Extra fat may build up around the tummy (abdomen) or the breasts or internal organs
• Fatty lumps (sometimes called a buffalo hump) may appear on the back of the neck.

It is not yet known what causes these changes, or whether they have any long-term effects on your health. If you notice changes in your body shape:
? Tell your doctor.

You may have problems with your bones

Some people taking combination therapy for HIV develop a condition called osteonecrosis. With this condition, parts of the bone tissue die because of reduced blood supply to the bone.

People may be more likely to get this condition:

• if they have been taking combination therapy for a long time
• if they are also taking anti-inflammatory medicines called corticosteroids
• if they drink alcohol
• if their immune systems are very weak
• if they are overweight. Signs to look out for include:
• stiffness in the joints
• aches and pains (especially in the hip, knee or shoulder)
• difficulty moving. If you notice any of these symptoms: Tell your doctor.

Other effects may show up in tests

Combination therapy for HIV can also cause:

• increased levels of lactic acid in the blood
• increased levels of sugar or fats in the blood
• resistance to insulin (so if you?re diabetic, you may have to change your insulin dose to control your blood sugar).

Keep out of the reach and sight of children.

Do not freeze. Telzir does not require any other special storage conditions.

Do not use Telzir after the expiry date shown on the bottle and the carton.

Throw away the bottle 28 days after first opening it, butdon?t dispose of medicine in your waste water or your household waste. Take it back to your pharmacist who will dispose of it in a way that won?t harm the environment.

What Telzir contains

• The active substance is fosamprenavir. Each ml of suspension contains 50 mg of fosamprenavir as fosamprenavir calcium salt (equivalent to approximately 43 mg of amprenavir).
• The other ingredients are: hypromellose, sucralose, polysorbate 80, calcium chloride dihydrate, artificial grape bubblegum flavour, natural peppermint flavour, purified water, propylene glycol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216).

What Telzir looks like and contents of the pack

Telzir is supplied in plastic bottles containing 225 ml oral suspension. A 10 ml graduated dosing syringe and an adapter are also included in the pack. The suspension is white to off-white.

Telzir is also available as 700 mg film-coated tablets.

Marketing Authorisation Holder and Manufacturer

Manufacturer Marketing Authorisation Holder

Glaxo Wellcome GmbH Co. KG. Industriestrasse 32-36 D-23843 Bad Oldesloe Germany ViiV Healthcare UK Limited 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom

For any information about this medicinal product please contact the local representative of the Marketing Authorisation Holder.

BelgiëBelgiqueBelgien ViiV Healthcare sprlbvba TélTel 32 02 656 25 11 LuxembourgLuxemburg ViiV Healthcare sprlbvba BelgiqueBelgien TélTel 32 02 656 25 11

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Lietuva

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Tel: + 370 5 264 90 00
info.lt@gsk.com

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