patient information leaflet invirase 500mg film-coated tablets

PACKAGE LEAFLET: INFORMATION FOR THE USER

Invirase 500 mg film-coated tablets

Saquinavir

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 leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Invirase is and what it is used for
2. Before you take Invirase
3. How to take Invirase
4. Possible side effects
5. How to store Invirase
6. Further information

1. WHAT INVIRASE IS AND WHAT IT IS USED FOR

Invirase is an antiviral agent. It is a member of a class of medicines called protease inhibitors. It is for the treatment of infection with the human immunodeficiency virus (HIV).

Invirase is used by HIV-infected individuals over 16 years of age. Invirase is prescribed for use in combination with ritonavir and other antiretroviral medicines.

2. BEFORE YOU TAKE INVIRASE

Do not take Invirase

if you are allergic (hypersensitive) to saquinavir, ritonavir or any of the other ingredients.
if you have decompensated liver disease (e.g. jaundice or hepatitis with ascites, mental confusion and/or bleeding from veins of the oesophagus).
if you are currently taking any of the following medicines:
- terfenadine and astemizole (commonly used to treat allergy symptoms),
- pimozide (for psychiatric problems),
- cisapride (for heart burn or problems with the digestive system),
- ergot alkaloids (used to treat migraine attacks),
- triazolam and oral (taken by mouth) midazolam (used to help you sleep and/or relieve anxiety),
- amiodarone (used to treat abnormal heart beat),
- flecainide and propafenone (heart medicines),
- rifampicin (used to prevent or treat tuberculosis),
- simvastatin and lovastatin (used to lower blood cholesterol).

Take special care with Invirase

You should know that Invirase/ritonavir is not a cure for HIV infection and that you may continue to develop infections or other illnesses associated with HIV disease. You should, therefore, remain under the care of your doctor while taking Invirase/ritonavir.

Treatment with Invirase/ritonavir has not been shown to reduce the risk of transmission of HIV to others through sexual contacts or contamination with blood. Therefore, you must continue to take appropriate precautions to avoid giving the virus to others.

At present, there is only limited information on the use of Invirase/ritonavir in children under the age of 16 years and in adults over 60 years.

Consult your doctor if you have a history of kidney disease.

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.

There are certain conditions, which you may have, or have had, which require special care before or while taking Invirase/ritonavir. Therefore, before using this medicine, you should have told your doctor if you suffer from diabetes mellitus, diarrhoea, or if you have allergies (see section 4).

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 (see section 4).

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 (see section 4).

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 the 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.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Invirase/ritonavir may be taken with a number of other medications that are commonly used in HIV infection.

There are some medications that must not be taken with Invirase/ritonavir (see section “Do not take Invirase”) or that require dosage reduction of that medicine or Invirase or ritonavir. Ask your doctor or pharmacist for more information about taking Invirase/ritonavir with other medicines.

Medicines that can interact with saquinavir and/or ritoavir include:

other HIV antiviral agents (e.g. nelfinavir, indinavir, nevirapine, delavirdine, efavirenz),
some medicines affecting the immune system (e.g. ciclosporin, sirolimus (rapamycin), tacrolimus),
various steroids (e.g. dexamethasone, ethinyl estradiol, fluticasone),
certain heart medicines (e.g. calcium channel blockers, quinidine, digoxin),
medicines used to lower blood cholesterol (e.g. statins),
antifungals (ketoconazole, itraconazole),
morphine-like medicines (e.g. methadone),
anticonvulsants (e.g. Phenobarbital, phenytoin, carbamazepine),
sedative agents (e.g. midazolam administered by injection),
certain antibiotics (e.g. clarithromycin, erythromycin, quinupristin/dalfopristin, dapsone, rifabutin),
medicines used to treat erectile dysfunction (sildenafil, vardenafil, tadalafil),
medicines to treat depression (e.g. nefazodone, tricyclic antidepressants),
medicines for anticoagulation (warfarin),
herbal preparations containing St. John’s wort or garlic capsules
some medicines that treat diseases related to the acid in the stomach (e.g. omeprazole).

Therefore you should not take Invirase/ritonavir with other medicines without your doctor’s consent.

If you are taking sildenafil, vardenafil, or tadalafil with Invirase/ritonavir talk to your doctor about possible interactions between these medicines and the possible side effects. If you take sildenafil, vardenafil, or tadalafil together with Invirase/ritonavir, you may be at a risk of side effects such as low blood pressure, passing out, visual changes and penile erection lasting for more than 4 hours. If an erection lasts longer than 4 hours, you should get medical help immediately to avoid permanent damage to your penis. Your doctor can explain these symptoms to you.

If you are taking an oral contraceptive to prevent pregnancy, you should use an additional or different type of contraception since ritonavir may reduce the effectiveness of oral contraceptives.

Taking Invirase with food and drink

Invirase must be taken together with ritonavir and with or after food.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine. Inform your doctor if you are pregnant or planning to become pregnant. This medicine should be taken during pregnancy only after consultation with your doctor.

You should not breast-feed your baby if you are taking Invirase/ritonavir.

Driving and using machines

Invirase has not been tested for its effect on your ability to drive a car or operate machinery. However, dizziness and fatigue have been reported during treatment with Invirase. Do not drive or operate machines if you experience these symptoms.

Important information about an ingredient of Invirase

Each film-coated tablet contains lactose (monohydrate) 38.5 mg. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. HOW TO TAKE INVIRASE

Always take Invirase/ritonavir exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Invirase is provided as 500 mg film-coated tablet. For patients in whom the 500 mg film-coated tablet is not suitable, Invirase is also available in the form of 200 mg hard capsules. Your doctor will prescribe Invirase in combination with Norvir (ritonavir) and other HIV medicines. The dosage of Invirase is two 500 mg film-coated tablets with one 100 mg capsule of Norvir (ritonavir) two times daily. Invirase should be taken at the same time as Norvir (ritonavir) and with or after food.

The film-coated tablets should be swallowed together with water.

If you take more Invirase than you should

If you have taken more than the prescribed dose of Invirase/ritonavir you must contact your doctor or pharmacist.

If you forget to take Invirase

Do not take a double dose to make up for a forgotten individual dose. If you forget to take one dose, take this dose as soon as you remember together with some food. Then go on with the regular schedule as prescribed. Do not change the prescribed dose yourself.

If you stop taking Invirase

Continue to take this medicine until your doctor tells you otherwise.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Invirase/ritonavir can cause side effects, although not everybody gets them.

When treating HIV infection it is not always possible to differentiate between unwanted effects caused by Invirase or by any other medicines you take at the same time or by the complications of the infection. For these reasons it is very important to inform your doctor of any change in your condition.

The most frequently (in more than ten in a hundred) reported side effects of saquinavir taken with ritonavir concern the gastrointestinal tract, with feeling sick, diarrhoea, tiredness, vomiting, wind and abdominal pain being the most common. Also, changes in laboratory markers have been reported very commonly.

Other, less frequently reported side effects (in more than one in a hundred but less than one in ten persons), which may occur are: rash, itching, eczema and dry skin, hair loss, dry mouth, headache, peripheral neuropathy (a disturbance of the nerves in the feet and hands that may take the form of numbness, pins and needles, shooting or burning pain), co-ordination problems, fainting, confusion, weakness, dizziness, depression, anxiety, moodswings, night sweats and hot flushes, inability to sleep, libido problems, taste alteration, warts, mouth ulcers, dehydration, abdominal discomfort, indigestion, fever, pain, constipation, decreased as well as increased appetite, inflammation of gastrointestinal tract, piles, discoloured faeces, visual disturbance, eye pain, raised blood pressure, infections of the respiratory tract, muscle spasms, joint pain, blood collection in the joint, painful micturition and infections of the urinary tract, fever and shivering, shortness of breath and chest pain.

Furthermore, inflammation of the liver, fits, allergic reactions, sleepiness and abnormal renal function have been reported.

Your doctor will test your blood regularly to detect possible.

Cases of diabetes mellitus or increased blood sugar levels have been reported in patients receiving this treatment or another protease inhibitor.

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

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.

There have been reports of muscle pain, tenderness or weakness, particularly with combination antiretroviral therapy including protease inhibitors and nucleoside analogues. On rare occasions these muscle disorders have been serious (rhabdomyolysis).

If you experience any side effects that are not in this leaflet, please tell your doctor or pharmacist. Also, tell your doctor if you have any severe or unusual symptoms or if any side effect that you think you may have gets worse or persists.

5. HOW TO STORE INVIRASE

Keep out of the reach and sight of children.

Invirase does not require any special storage conditions.

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 Invirase contains

The active substance is saquinavir. One film-coated tablet of Invirase contains 500 mg of saquinavir as saquinavir mesilate.
The other ingredients are microcrystalline cellulose, croscarmellose sodium, povidone, lactose (monohydrate) 38.5 mg, magnesium stearate, hypromellose, titanium dioxide (E171), talc, glycerol triacetate, iron oxide yellow (E172) and iron oxide red (E172).

Medicine: invirase 500mg film-coated tablets