Patient leaflet - Agenerase

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7. KOTHER SPECIAL WARNING(S), IF NECESSARY
8. EXPIRY DATE

EXP {MM/YYYY}

I 9. SPECIAL STORAGE CONDITIONS

Do not store above 25°C.

Discard the oral solution 15 days after first opening the bottle.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

Any unused product or waste material should be disposed of in accordance with local require

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HO

PACKAGE LEAFLET : INFORMATION FOR THE USER Agenerase 50 mg soft capsules

Amprenavir

Read all of this leaflet carefully before you start taking this medicine.

Keep this leaflet. 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. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side effects not listed in this leafl please tell your doctor or pharmacist.

In this leaflet:

What Agenerase is and what it is used for

Before you take Agenerase

How to take Agenerase

Possible side effects

How to store Agenerase

Further information

WHAT AGENERASE IS AND WHAT IT IS USED FOR

inhibitors. These medicines are

Agenerase belongs to a group of antiviral medicines called p used for treating human immunodeficiency virus (HIV) infec

Agenerase is used in protease inhibitor experienced HIV-1 infected adults and children above the age of 4 years. Agenerase is prescribed for use in combination with other antiretroviral medicinal products. Your doctor will normally direct that Agenerase capsules should be taken with low doses of ritonavir to boost its efficacy. The choice of Agenerase will be based on any resistance testing your doctor may have carried out and your treatment history.

The benefit of amprenavir boosted with ritonavir has not been demonstrated in PI naïve patients.

2. BEFORE YOU TAKE AGENERASE

Do not take Agenerase

if you are allergic (hypersensitive) to amprenavir or to any of the other ingredients in Agenerase.

– if you have severe liver disease (see ‘Take special care with Agenerase’).
– you are currently taking any of the following medicines:

^^^*- astemizole or terfenadine (commonly used to treat allergy symptoms – these medicines may be available without prescription)

– pimozide (used to treat schizophrenia)
– cisapride (used to relieve certain stomach problems)
– ergot derivatives (used to treat headaches)
– rifampicin (used to treat tuberculosis)
– amiodarone, quinidine (used to treat abnormal heart beat)
– flecainide and propafenone (heart medicines)
– triazolam and oral (taken by mouth) midazolam (used to help you sleep and / or relieve anxiety)
– bepridil (used to treat hypertension).

– if you are currently taking any products containing St John’s wort (Hypericum perforatum ) as this may stop Agenerase from working properly (see Taking/using other medicines).

Tell your doctor if you have any of these listed conditions, or are taking any of the medicines listed above.

Take special care with Agenerase

You will need to take Agenerase every day. This medicine helps to control your condition, but it is not a cure for HIV infection. You can still continue to develop other infections and other illnesses associated with HIV disease. You should keep in regular contact with your doctor. Do not stop taking your medicine without first talking to your doctor.

If your doctor has recommended that you take Agenerase capsules together with low doses of ritonavir, used to boost its activity, then please make sure that you carefully read the ritonavir Package Leaflet before starting therapy.

At present, there is insufficient information to recommend the use of Agenerase in children less than four years of age. There is also insufficient information to recommend the use of Agenerase capsules boosted with ritonavir in children of 4 to 12 years of age or any patients weighing less than fifty kilograms.

Agenerase may interact with other medicines that you are taking, so it is important that you read the next section “Taking/using other medicines” before taking this medicine.

You should tell your doctor about any medical conditions that you have or have had.

– Please speak with your doctor if you have a history of liver disease. Patients with chronic hepatitis B or C and treated with antiretroviral agents are at increased risk for severe and potentially fatal liver adverse events and may require blood tests for control of liver function.
– The use of Agenerase together with ritonavir has not been studied in patients with liver disease. If your liver disease is severe you must not use this combination.
– Agenerase capsules (without the boosting effect of ritonavir) have been studied in patients with liver impairment. If you suffer from liver disease and your doctor decides to use unboosted Agenerase capsules (that is without ritonavir), the dose of Agenerase may need to be adjusted.
– There have been reports of increased bleeding in patients with haemophilia taking protease inhibitors. The reason for this is not known. You may need additional factor VIII to control bleeding.
– Redistribution, accumulation or loss of body fat may occur in patients receiving combination antiretroviral therapy. Contact your doctor if you notice changes in body fat.
– In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is believed that these symptoms are due to an improvement in the body’s immune response, enabling the body to fight infections that may have been present with no obvious symptoms. If you notice any symptoms of infection, please inform your doctor immediately.
– If you have any other health concerns, discuss these with your doctor.

Bone problems

Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease. Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement. If you notice any of these symptoms please inform your doctor.

Treatment with Agenerase has not been shown to reduce the risk of passing HIV infection on to others by sexual contact or by blood transfer. You should continue to use appropriate precautions to prevent this.

Taking/using other medicines

Before starting treatment with Agenerase, please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is very important , as taking some types of medicines at the same time as Agenerase can strengthen or weaken the effect of the medicines. This can sometimes lead to serious medical conditions.

There are some medicines that you must not take with Agenerase (please see ‘Do not take Agenerase’ for further information).

Agenerase may interact with certain other medicines. The use of the following medicines, together with Agenerase, should only take place on the basis of medical advice: anaesthetics (e.g. lidocaine), antibiotics (e.g. rifabutin, clarithromycin, dapsone and erythromycin), antifungals (e.g. ketoconazole, itraconazole), antimalarials (e.g. halofantrine), anticonvulsant medicines (e.g. carbamazepine, phenytoin and phenobarbital), calcium channel blockers (e.g. amlodipine, diltiazem, felodipine, isradipine, nicardipine, nifedipine, nimodipine, nisoldipine and verapamil), cholesterol lowering medicines (e.g. atorvastatin, lovastatin and simvastatin), erectile dysfunction medicines (e.g. sildenafil and vardenafil), non-nucleoside reverse transcriptase inhibitors (e.g. delavirdine, efavirenz and nevirapine), opioids (e.g. methadone), hormones like oestrogens and progestogens (e.g. hormonal contraceptives such as the ‘pill’), some glucocorticoids (e.g. fluticasone propionate and budesonide), tricyclic antidepressants (e.g. desipramine and nortriptyline), sedative agents (e.g. midazolam administered by injection), paroxetine, and others (e.g. clozapine and loratadine).

If you are taking certain medicines that can cause serious side effects, such as carbamazepine, phenobarbital, phenytoin, lidocaine, cyclosporine, tacrolimus, rapamycin, tricyclic antidepressants and warfarin, at the same time as you are taking Agenerase, your doctor may carry out additional blood tests to minimise any potential safety problems.

If you are taking the contraceptive pill, it is recommended that you use an alternative method (e.g. a condom) to prevent pregnancy while you are taking Agenerase. The concomitant use of Agenerase and contraceptive pill may result in a decrease of the therapeutic effect of Agenerase.

Taking Agenerase with food and drink

Agenerase capsules should be swallowed whole with water or another drink. They can be taken with or without food.

Pregnancy and breast-feeding

Inform your doctor if you are pregnant or planning to become pregnant soon. The safe use of Agenerase in pregnancy has not been established. Ask your doctor or pharmacist before taking any medicine.

Breast feeding your baby is not recommended while you are taking Agenerase. It is recommended that

HIV positive women do not breast feed their infants in order to avoid transmission of HIV.

Driving and using machines

No studies on the effects of Agenerase on the ability to drive and use machines have been done. If Agenerase makes you dizzy, do not operate any tools or machines.

Important information about ingredients of Agenerase capsules

These capsules contain glycerol, which can cause adverse effects in high doses. Glycerol can cause headache, stomach upset and diarrhoea.

These capsules also contain sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product

Because Agenerase capsules contain vitamin E, you should not take additional vitamin E supplements.

3. HOW TO TAKE AGENERASE

Always take Agenerase exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

If you need to take an antacid for indigestion, or if you are taking a drug containing an antacid (e.g.

didanosine), you are advised to take it more than an hour before or after Agenerase, otherwise the effects of Agenerase may be reduced.

Swallow Agenerase capsules whole with water or another drink. They can be taken w without food.

Adults and adolescents (of 12 years of age and older) (greater than 50 kg bod usual dose of Agenerase capsules is 600 mg twice daily with ritonavir 100 combination with other antiretroviral medicinal products. If your doctor deci

inappropriate for you to take ritonavir, you will need to take increase mg twice a day).

t) : the ice daily, in s it is

of Agenerase (1200

Children (4 to 12 years) and patients less than 50 kg body w

according to your weight by your doctor. The usual dose each kg of body weight, twice a day. You should not t In some cases, your doctor may adapt the dose of concomitantly with Agenerase.

: the dose will be calculated nerase capsules is 20 mg for than 2400 mg per day.

ase when other drugs are administered

To derive the full benefit of Agenerase, it is very by your doctor.

;ant that you take the full daily dose prescribed

An oral solution of Agenerase is available for children or adults unable to swallow capsules.

If you take more Agenerase than you should

If you have taken more than the prescribed dose of Agenerase, you should contact your doctor or pharmacist immediately for advice.

If you forget to take A

If you forget to take a dose of Agenerase, take it as soon as you remember and then continue as before.

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

If you stop taking Agenerase

You must not stop taking Agenerase without consulting your doctor.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Agenerase can cause side effects, although not everybody gets them. When treating HIV infection, it is not always possible to tell whether some of the undesirable effects that occur are caused by Agenerase, by other medicines taken at the same time or by the HIV disease. For this reason, it is very important that you inform your doctor about any changes in your health.

Very common side effects (these can affect more than 10 in 100 patients treated)

Headache, feeling tired
Diarrhoea, feeling sick, vomiting, flatulence
Skin Rashes (red, raised or itchy) – Occasionally, the skin rash may be severe and you may have to stop taking this medicine.

Common side effects (these can affect 1 to 10 in 100 patients treated)

Increases in triglycerides (a type of blood fat), changes in body shape because of fat redistribution,

Moodiness, depression, difficulty sleeping, loss of appetite

Tingling or numbness around the lips and mouth, uncontrolled movements

Pain, discomfort or excess acid in the stomach, loose stools,

Increases in enzymes produced by the liver called transaminases, increases of an enzyme produced by the pancreas called amylase

Uncommon side effects (these can affect less than 1 in 100 patients treated)

Increases in blood sugar or cholesterol (a type of blood fat) Increases in the blood of a substance called bilirubin Swelling of the face, lips and tongue (angioedema)

Rare side effects (these can affect 1 in 1,000 patients treated)

A severe or life-threatening skin reaction (Stevens Johnson

Other possible effects

In patients with haemophilia Type A and B, there have been reports of increased bleeding while taking protease inhibitors. Should this happen to you, seek immediate advice from your doctor.

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).

Combination antiretroviral therapy may cause changes in body shape due to changes in fat distribution. These may include loss of fat from legs, arms and face, increased fat in the abdomen (belly) and other internal organs, breast enlargement and fatty lumps on the back of the neck (‘buffalo hump’). The cause and long-term health effects of these conditions are not known at this time. Combination antiretroviral therapy may also cause raised lactic acid and sugar in the blood, hyperlipaemia (increased fats in the blood) and resistance to insulin.

If any of the side effects gets serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

OW TO STORE AGENERASE

Keep out of the reach and sight of children.

Do not store above 30o C. Keep the container tightly closed, in order to protect from moisture.

Do not use Agenerase after the expiry date which is stated on the 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.

FURTHER INFORMATION

What Agenerase contains

The active substance is amprenavir

Each Agenerase capsule contains 50 mg of amprenavir.

The other ingredients within the capsule are d-alpha tocopheryl polyethylene glycol 1000 succinate (TPGS), macrogol 400 (polyethylene glycol 400) and propylene glycol. The capsule shell contains gelatin, glycerol, d-sorbitol and sorbitans solution, titanium dioxide and red printing ink.

What Agenerase looks like and contents of the pack

Agenerase 50 mg soft capsules are supplied in plastic bottles containing 480 soft capsules. These soft capsules are oblong, opaque, off white to cream in colour and marked with the code GX CC1.

Marketing Authorisation Holder and Manufacturer

Manufacturer

Marketing Authorisation

Glaxo Wellcome Operations

Priory Street

Ware

Hertfordshire SG12 ODJ

United Kingdom

Glaxo Group Ltd

Glaxo Wellcome House Berkeley Aven Greenford

Middlesex UB6 ONN United Kingdom

For any information about this medicinal product please contact the local representative of the

Marketing Authorisation Holder

Etnrapua <

rnakcoCMumKnaÖH EOOfl

Ten.: + 359 2 953 10 34

Česká republika

GlaxoSmithKline s.r.o.

Tel: + 420 222 001 111

België/Belgique/Belgien

GlaxoSmithKline s.a./n.v.

Tél/Tel: + 32 (0)2 656 21 11

Luxembourg/Luxemburg

GlaxoSmithKline s.a./n.v.

Belgique/Belgien

Tel/Tel: + 32 (0)2 656 21 11

Magyarorszag

GlaxoSmithKline Kft.

Tel.: + 36 1 225 5300

Malta

GlaxoSmithKline Malta

Tel: + 356 21 238131

Danmark

Nederland

GlaxoSmithKline Pharma A/S

Tlf: + 45 36 35 91 00

GlaxoSmithKline BV Tel: + 31 (0)30 6938100

Deutschland

GlaxoSmithKline GmbH & Co. KG

Tel.: + 49 (0)89 36044 8701

Norge

GlaxoSmithKline AS

Tlf: + 47 22 70 20 00

Eesti

GlaxoSmithKline Eesti OÜ

Österreich

GlaxoSmithKline Pharma GmbH

Tel: + 372 6676 900

EXXáSa

GlaxoSmithKline A.E.B.E.

Tql: + 30 210 68 82 100

España

GlaxoSmithKline, S.A.

Tel: + 34 902 202 700

France

Laboratoire GlaxoSmithKline

Tél.: + 33 (0)1 39 17 84 44

Ireland

GlaxoSmithKline (Ireland) Limited

Tel: + 353 (0)1 4955000

Ísland

GlaxoSmithKline ehf.

Sími: + 354 530 3700

Italia

GlaxoSmithKline S.p.A.

Tel: + 39 (0)45 9218 111

Kúnpog

GlaxoSmithKline Cyprus Ltd

Tql: + 357 22 89 95 01

Latvija

GlaxoSmithKline Latvia SIA

Tel: + 371 67312687

Lietuva

GlaxoSmithKline Lietuva UAB

Tel: + 370 5 264 90 00

Tel: + 43 (0)1 97075 0

Polska

GSK Commercial Sp. z o.o.

Tel.: + 48 (0)22 576 9000

Portugal

GlaxoSmithKline – Produtos Farmacéuticos, Lda.

Tel: + 351 21 412 95 00

România

GlaxoSmithKline (GSK) S.R.L.

Tel: + 4021 3028 208

Slovenija

GlaxoSmithKline d.o.o.

Tel: + 386 (0)1 280 25 00

Slovenská republika

GlaxoSmithKline Slovakia s. r. o.

Tel: + 421 (0)2 49 10 33 11

Suomi/Finland

GlaxoSmithKline Oy

Puh/Tel: + 358 (0)10 30 30 30

Sverige

GlaxoSmithKline AB

Tel: + 46 (0)8 638 93 00

United Kingdom

GlaxoSmithKline UK

Tel: + 44 (0)800 221441

This leaflet was last approved on

PACKAGE LEAFLET : INFORMATION FOR THE USER Agenerase 150 mg soft capsules

Amprenavir

Read all of this leaflet carefully before you start taking this medicine.

Keep this leaflet. 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. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side effects not listed in this leafl please tell your doctor or pharmacist.

In this leaflet:

What Agenerase is and what it is used for.

Before you take Agenerase

How to take Agenerase

Possible side effects

How to store Agenerase

Further information

WHAT AGENERASE IS AND WHAT IT IS USED FOR

Agenerase belongs to a group of antiviral medicines called p used for treating human immunodeficiency virus (HIV) infection.

hibitors. These medicines are

The benefit of amprenavir boosted with ritonavir has not been demonstrated in PI naïve patients.

2. BEFORE YOU TAKE AGENERASE

Do not take Agenerase

if you are allergic (hypersensitive) to amprenavir or to any of the other ingredients in Agenerase.

– if you have severe liver disease (see ‘Take special care with Agenerase’).
– you are currently taking any of the following medicines:

^^^*- astemizole or terfenadine (commonly used to treat allergy symptoms – these medicines may be available without prescription)

– pimozide (used to treat schizophrenia)
– cisapride (used to relieve certain stomach problems)
– ergot derivatives (used to treat headaches)
– rifampicin (used to treat tuberculosis)
– amiodarone, quinidine (used to treat abnormal heart beat)
– flecainide and propafenone (heart medicines)
– triazolam and oral (taken by mouth) midazolam (used to help you sleep and / or relieve anxiety)
– bepridil (used to treat hypertension).

– if you are currently taking any products containing St John’s wort (Hypericum perforatum ) as this may stop Agenerase from working properly (see Taking/using other medicines).

Tell your doctor if you have any of these listed conditions, or are taking any of the medicines listed above.

Take special care with Agenerase

ren less than nerase capsules less than fifty

At present, there is insufficient information to recommend the use of Ageneras four years of age. There is also insufficient information to recommend the use boosted with ritonavir in children of 4 to 12 years of age or any patients weighi kilograms.

Agenerase may interact with other medicines that you are taking, so it is important that you read the next section “Taking/using other medicines” before taking this medicine.

You should tell your doctor about any medical conditions that you have or have had.

– Please speak with your doctor if you have a history of liver disease. Patients with chronic hepatitis B or C and treated with antiretroviral agents are at increased risk for severe and potentially fatal liver adverse events and may require blood tests for control of liver function.
– The use of Agenerase together with ritonavir has not been studied in patients with liver disease. If your liver disease is severe you must not use this combination.
– Agenerase capsules (without the boosting effect of ritonavir) have been studied in patients with liver impairment. If you suffer from liver disease and your doctor decides to use unboosted Agenerase capsules (that is without ritonavir), the dose of Agenerase may need to be adjusted.
– There have been reports of increased bleeding in patients with haemophilia taking protease inhibitors. The reason for this is not known. You may need additional factor VIII to control bleeding.
– Redistribution, accumulation or loss of body fat may occur in patients receiving combination antiretroviral therapy. Contact your doctor if you notice changes in body fat.
– In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is believed that these symptoms are due to an improvement in the body’s immune response, enabling the body to fight infections that may have been present with no obvious symptoms. If you notice any symptoms of infection, please inform your doctor immediately.
– If you have any other health concerns, discuss these with your doctor.

Bone problems

Taking/using other medicines

There are some medicines that you must not take with Agenerase (please see ‘Do not take Agenerase’ for further information).

Agenerase may interact with certain other medicines. The use of the following medicines, together with Agenerase, should only take place on the basis of medical advice: anaesthetics (e.g. lidocaine), antibiotics (e.g. rifabutin, clarithromycin, dapsone and erythromycin), antifungals (e.g. ketoconazole, itraconazole), antimalarials (e.g. halofantrine), anticonvulsant medicines (e.g. carbamazepine, phenytoin and phenobarbital), calcium channel blockers (e.g. amlodipine, diltiazem, felodipine, isradipine, nicardipine, nifedipine, nimodipine, nisoldipine and verapamil), cholesterol lowering medicines (e.g. atorvastatin, lovastatin and simvastatin), erectile dysfunction medicines (e.g. sildenafil and vardenafil), non-nucleoside reverse transcriptase inhibitors (e.g. delavirdine, efavirenz and nevirapine), opioids (e.g. methadone), hormones like oestrogens and progestogens (e.g. hormonal contraceptives such as the ‘pill’), some glucocorticoids (e.g. fluticasone propionate and budesonide), tricyclic antidepressants (i.e. desipramine and nortriptyline), sedative agents (e.g. midazolam administered by injection), paroxetine, and others (e.g. clozapine and loratadine).

Taking Agenerase with food and drink

Agenerase capsules should be swallowed whole with water or another drink. They can be taken with or without food.

Pregnancy and breast-feeding

Inform your doctor if you are pregnant or planning to become pregnant soon. The safe use of Agenerase in pregnancy has not been established. Ask your doctor or pharmacist before taking any medicine.

Breast feeding your baby is not recommended while you are taking Agenerase. It is recommended that HIV positive women do not breast feed their infants in order to avoid transmission of HIV.

Driving and using machines

No studies on the effects of Agenerase on the ability to drive and use machines have been done. If Agenerase makes you dizzy, do not operate any tools or machines.

Important information about ingredients of Agenerase capsules

These capsules contain glycerol, which can cause adverse effects in high doses. Glycerol can cause headache, stomach upset and diarrhoea.

These capsules also contain sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product

Because Agenerase capsules contain vitamin E, you should not take additional vitamin E supplements.

3. HOW TO TAKE AGENERASE

Always take Agenerase exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

If you need to take an antacid for indigestion, or if you are taking a drug containing an antacid (e.g. didanosine), you are advised to take it more than an hour before or after Agenerase, otherwise the effects of Agenerase may be reduced.

– Swallow Agenerase capsules whole with water or another drink. They can be taken with or without food.
- Adults and adolescents (of 12 years of age and older) (greater than 50 kg body weight) : the usual dose of Agenerase capsules is 600 mg twice daily with ritonavir 100 mg twice daily, in combination with other antiretroviral medicinal products. If your doctor decides it is inappropriate for you to take ritonavir, you will need to take increased doses of Agenerase (1200 mg twice a day).

mg twice a day).

Children (4 to 12 years) and patients less than 50 kg body weight : the dose will be calculated according to your weight by your doctor. The usual dose for Agenerase capsules is 20 mg for

each kg of body weight, twice a day. You should not take more than 2400 mg per day.

In some cases, your doctor may adapt the dose of Agenerase when other drugs are administered concomitantly with Agenerase.

To derive the full benefit of Agenerase, it is very important that you take the full daily dose prescribed by your doctor.

An oral solution of Agenerase is available for children or adults unable to swallow capsules.

If you take more Agenerase than you should

If you have taken more than the prescribed dose of Agenerase, you should contact your doctor or pharmacist immediately for advice.

If you forget to take Agenerase

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

If you stop taking Agenerase

You must not stop taking Agenerase without consulting your doctor.

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

4. POSSIBLE SIDE EFFECTS

Very common side effects (these can affect more than 10 in 100 patients treated)

Headache, feeling tired
Diarrhoea, feeling sick, vomiting, flatulence
Skin Rashes (red, raised or itchy) – Occasionally, the skin rash may be severe and you may have to stop taking this medicine.

Common side effects (these can affect 1 to 10 in 100 patients treated)

Increases in triglycerides (a type of blood fat), changes in body shape because of fat redistribution,

Moodiness, depression, difficulty sleeping, loss of appetite

Tingling or numbness around the lips and mouth, uncontrolled movements

Pain, discomfort or excess acid in the stomach, loose stools,

Increases in enzymes produced by the liver called transaminases, increases of an enzyme produced by the pancreas called amylase

Uncommon side effects (these can affect less than 1 in 100 patients treated)

Increases in blood sugar or cholesterol (a type of blood fat)
Increases in the blood of a substance called bilirubin
Swelling of the face, lips and tongue (angioedema)

Rare side effects (these can affect 1 in 1,000 patients treated

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

Other possible effects

In patients with haemophilia Type A and B, there have been reports of increased bleeding while taking protease inhibitors. Should this happen to you, seek immediate advice from your doctor.

If any of the side ffects gets serious, or you notice any effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE AGENERASE

Keep out of the reach and sight of children.

Do not store above 30o C. Keep the container tightly closed, in order to protect from moisture.

Do not use Agenerase after the expiry date which is stated on the 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. FURTHER INFORMATION

What Agenerase contains

The active substance is amprenavir

Each Agenerase capsule contains 150 mg of amprenavir.

The other ingredients within the capsule are d-alpha tocopheryl polyethylene glycol 1000 succinat (TPGS), macrogol 400 (polyethylene glycol 400) and propylene glycol. The capsule shell contains gelatin, glycerol, d-sorbitol and sorbitans solution, titanium dioxide and red printing ink.

What Agenerase looks like and the contents of the pack

Agenerase 150 mg soft capsules are supplied in plastic bottles containing 240 soft capsules. These soft capsules are oblong, opaque, off white to cream in colour and marked with the code GX CC2.

Marketing Authorisation Holder and Manufacturer

Manufacturer

Marketing Aut

ion Holder

Glaxo Wellcome Operations

Priory Street

Ware

Hertfordshire SG12 ODJ

United Kingdom

Glaxo Group Ltd

Glaxo Wellcome House

Berkeley Avenue

Greenford

Middlesex UB6 ONN

United Kingdom

For any information about this medic Marketing Authorisation Holder.

België/Belgique/Belgien

GlaxoSmithKline s.a./n.v.

Tél/Tel: + 32 (0)2 656 21 11

oduct please contact the local representative of the

Efc^rapufl rnaKcoCMumKnaňH EOOfl Ten.: + 359 2 953 10 34

Luxembourg/Luxemburg

GlaxoSmithKline s.a./n.v.

Belgique/Belgien

Tél/Tel: + 32 (0)2 656 21 11

Magyarország

GlaxoSmithKline Kft.

Tel.: + 36 1 225 5300

Česká republika

GlaxoSmithKline s.r.o.

Tel: + 420 222 001 111

Malta

GlaxoSmithKline Malta

Tel: + 356 21 238131

Danmark

GlaxoSmithKline Pharma A/S

Tlf: + 45 36 35 91 00

Nederland

GlaxoSmithKline BV Tel: + 31 (0)30 6938100

Deutschland

GlaxoSmithKline GmbH & Co. KG

Norge

GlaxoSmithKline AS

Tel.: + 49 (0)89 36044 8701

Eesti

GlaxoSmithKline Eesti OÜ

Tel: + 372 6676 900

EXXáSa

GlaxoSmithKline A.E.B.E.

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PACKAGE LEAFLET : INFORMATION FOR THE USER Agenerase 150 mg soft capsules

Amprenavir

Read all of this leaflet carefully before you start taking this medicine.

Keep this leaflet. 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. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side effects not listed in this leafl please tell your doctor or pharmacist.

In this leaflet:

What Agenerase is and what it is used for

Before you take Agenerase

How to take Agenerase

Possible side effects

How to store Agenerase

Further information

WHAT AGENERASE IS AND WHAT IT IS USED FOR

Agenerase belongs to a group of antiviral medicines called p used for treating human immunodeficiency virus (HIV) infection.

hibitors. These medicines are

The benefit of amprenavir boosted with ritonavir has not been demonstrated in PI naïve patients.

2. BEFORE YOU TAKE AGENERASE

Do not take Agenerase

– if you are allergic (hypersensitive) to amprenavir or to any of the other ingredients in Agenerase.
– if you have severe liver disease (see ‘Take special care with Agenerase’).
– you are currently taking any of the following medicines:

^^^*- astemizole or terfenadine (commonly used to treat allergy symptoms – these medicines may be available without prescription)

– pimozide (used to treat schizophrenia)
– cisapride (used to relieve certain stomach problems)
– ergot derivatives (used to treat headaches)
– rifampicin (used to treat tuberculosis)
– amiodarone, quinidine (used to treat abnormal heart beat)
– flecainide and propafenone (heart medicines)
– triazolam, oral (taken by mouth) midazolam (used to help you sleep and / or relieve anxiety)
– bepridil (used to treat hypertension).

– if you are currently taking any products containing St John’s wort (Hypericum perforatum ) as this may stop Agenerase from working properly (see Taking/using other medicines).

Tell your doctor if you have any of these listed conditions, or are taking any of the medicines listed above.

Take special care with Agenerase

ren less than nerase capsules less than fifty

Agenerase may interact with other medicines that you are taking, so it is important that you read the next section “Taking/using other medicines” before taking this medicine.

You should tell your doctor about any medical conditions that you have or have had.

– Please speak with your doctor if you have a history of liver disease. Patients with chronic hepatitis B or C and treated with antiretroviral agents are at increased risk for severe and potentially fatal liver adverse events and may require blood tests for control of liver function.
– The use of Agenerase together with ritonavir has not been studied in patients with liver disease. If your liver disease is severe you must not use this combination.
– Agenerase capsules (without the boosting effect of ritonavir) have been studied in patients with liver impairment. If you suffer from liver disease and your doctor decides to use unboosted Agenerase capsules (that is without ritonavir), the dose of Agenerase may need to be adjusted.
– There have been reports of increased bleeding in patients with haemophilia taking protease inhibitors. The reason for this is not known. You may need additional factor VIII to control bleeding.
– Redistribution, accumulation or loss of body fat may occur in patients receiving combination antiretroviral therapy. Contact your doctor if you notice changes in body fat.
– In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is believed that these symptoms are due to an improvement in the body’s immune response, enabling the body to fight infections that may have been present with no obvious symptoms. If you notice any symptoms of infection, please inform your doctor immediately.
– If you have any other health concerns, discuss these with your doctor.

Bone problems

Taking/using other medicines

There are some medicines that you must not take with Agenerase (please see ‘Do not take Agenerase’ for further information).

Agenerase may interact with certain other medicines. The use of the following medicines, together with Agenerase, should only take place on the basis of medical advice: anaesthetics (e.g. lidocaine), antibiotics (e.g. rifabutin, clarithromycin, dapsone and erythromycin), antifungals (e.g. ketoconazole, itraconazole), antimalarials (e.g. halofantrine), anticonvulsant medicines (e.g. carbamazepine, phenytoin and phenobarbital), calcium channel blockers (e.g. amlodipine, diltiazem, felodipine, isradipine, nicardipine, nifedipine, nimodipine, nisoldipine and verapamil), cholesterol lowering medicines (e.g. atorvastatin, lovastatin and simvastatin), erectile dysfunction medicines (e.g. sildenafil and vardenafil), non-nucleoside reverse transcriptase inhibitors (e.g. delavirdine, efavirenz and nevirapine), opioids (e.g. methadone), hormones like oestrogens and progestogens (e.g. hormonal contraceptives such as the ‘pill’), some glucocorticoids (e.g. fluticasone propionate and budesonide), tricyclic antidepressants (i.e. desipramine and nortriptyline), sedative agents (e.g. midazolam administered by injection), paroxetine, and others (e.g. clozapine and loratadine).

Taking Agenerase with food and drink

Agenerase capsules should be swallowed whole with water or another drink. They can be taken with or without food.

Pregnancy and breast-feeding

Inform your doctor if you are pregnant or planning to become pregnant soon. The safe use of Agenerase in pregnancy has not been established. Ask your doctor or pharmacist before taking any medicine.

Breast feeding your baby is not recommended while you are taking Agenerase. It is recommended that HIV positive women do not breast feed their infants in order to avoid transmission of HIV.

Driving and using machines

No studies on the effects of Agenerase on the ability to drive and use machines have been done. If Agenerase makes you dizzy, do not operate any tools or machines.

Important information about ingredients of Agenerase capsules

These capsules contain glycerol, which can cause adverse effects in high doses. Glycerol can cause headache, stomach upset and diarrhoea.

These capsules also contain sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product

Because Agenerase capsules contain vitamin E, you should not take additional vitamin E supplements.

3. HOW TO TAKE AGENERASE

Always take Agenerase exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

– Swallow Agenerase capsules whole with water or another drink. They can be taken with or without food.
- Adults and adolescents (of 12 years of age and older), (greater than 50 kg body weight) : the usual dose of Agenerase capsules is 600 mg twice daily with ritonavir 100 mg twice daily, in combination with other antiretroviral medicinal products. If your doctor decides it is inappropriate for you to take ritonavir, you will need to take increased doses of Agenerase (1200 mg twice a day).
- Children (4 to 12 years) and patients less than 50 kg body weight : the dose will be calculated according to your weight by your doctor. The usual dose for Agenerase capsules is 20 mg for each kg of body weight, twice a day.. You should not take more than 2400 mg per day.

In some cases, your doctor may adapt the dose of Agenerase when other drugs are administered concomitantly with Agenerase.

To derive the full benefit of Agenerase, it is very important that you take the full daily dose prescribed by your doctor.

An oral solution of Agenerase is available for children or adults unable to swallow capsules.

If you take more Agenerase than you should

If you have taken more than the prescribed dose of Agenerase, you should contact your doctor or pharmacist immediately for advice.

If you forget to take Agenerase

If you forget to take a dose of Agenerase, take it as soon as you remember and then continue as before.

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

If you stop taking Agenerase

You must not stop taking Agenerase without consulting your doctor.

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

4. POSSIBLE SIDE EFFECTS

Very common side effects (these can affect more than 10 in 100 patients treated)

Headache, feeling tired
Diarrhoea, feeling sick, vomiting, flatulence
Skin Rashes (red, raised or itchy) – Occasionally, the skin rash may be severe and you may have to stop taking this medicine.