Viracept 250 mg. 270 tablets
Viracept 250 mg. 270 tablets
WHAT VIRACEPT AND WHAT IT IS USED?
What is Viracept?
Viracept contains a medicine called nelfinavir, which is a "protease inhibitor." He belongs to a group of medicines called 'anti-retroviral'.
What is it used Viracept?
Viracept is used in conjunction with other "antiretroviral" drugs for:
• Fight against human immunodeficiency virus (HIV). It helps to reduce the number of HIV particles in the blood.
• Increase the number of certain cells in the blood that help fight infection. They are called CD4 white blood cells. Their number is reduced especially when you have HIV infection. This can lead to increased risk of many types of infections.
Viracept is not a cure for HIV infection. You can still get infections or other illnesses due to HIV. Treatment with Viracept does not stop the transmission of HIV to others through blood or sexual contact. Therefore, when taking Viracept, you must continue to take appropriate precautions to avoid giving the virus to others.
2 BEFORE YOU TAKE VIRACEPT
Do not take Viracept if:
• you are allergic to nelfinavir or any of the other ingredients (listed in section 6 "Further information").
• you are taking any of the medicines listed in the first part of section 2, "Using other medicines", "Do not take Viracept":
Do not take Viracept, if any of these apply to you.
Take special care with Viracept:
Ask your doctor or pharmacist before taking Viracept, if:
• You have kidney problems.
• If you have high blood sugar (diabetes).
• If you have a rare hereditary diseases associated with clotting, called "hemophilia".
• If you have liver disease caused by hepatitis B or C. Your doctor may want you to have regular blood tests.
If any of the above applies to you, or if you are not sure, talk to your doctor or pharmacist before taking Viracept.
Patients with liver disease:
Patients with chronic hepatitis B or C, 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. Consult your doctor if you have a history of liver disease.
Combination antiretroviral therapy may cause changes in body shape due to fat distribution. These may include loss of fat from legs, arms and face, increased fat deposition in the abdomen and other internal organs, breast enlargement and fatty lumps formation of the neck ('buffalo hump'). Reason and late effects of these conditions on health are not known yet. Contact your doctor if you notice changes in body fat.
Signs of previous infections
In some patients with advanced HIV infection and a history of opportunistic infection, can be signs and symptoms of inflammation from previous infections shortly after beginning treatment against HIV. It is believed that these symptoms are due to an improvement in the immune response, allowing it to fight infections that may be present with no obvious symptoms. If you notice any symptoms of infection, please inform your doctor immediately.
Disease of bone (osteonecrosis)
Some patients treated with 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 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, tell your doctor immediately.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you bought without a prescription and herbal medicines. This is because Viracept can affect the way some other medicines. Some other medicines can affect the way Viracept.
Do not take Viracept and tell your doctor or pharmacist if you are taking any of the following medicines:
• Medicines containing ergot alkaloids, eg. cabergoline, ergotamine or lisuride (for Parkinson's disease and migraine)
• Herbal preparations containing St. John's Wort (for depression or improving your mood)
• Rifampicin (for tuberculosis (TB))
Terfenadine or astemizole (allergy) Pimozide (used for mental health problems) Amiodarone or quinidine (for irregular heartbeat) Phenobarbital or carbamazepine (for seizures or epilepsy)
Triazolam or midazolam administered orally (for anxiety or to help you sleep)
Cisapride (HEARTBURN or problems with your digestive system) Omeprazole (for ulcers of the stomach or intestine)
Alfuzosin (for benign prostatic hyperplasia (BPH)) Sildenafil (for pulmonary arterial hypertension (PAH)) Do not take Viracept and tell your doctor or pharmacist if any of these apply to you. If you are not sure, talk to your doctor or pharmacist before taking Viracept.
Tell your doctor or pharmacist if you are taking any of the following medicines: Any other medicines for HIV infection, for example. ritonavir, indinavir, saquinavir and delavirdine, amprenavir, efavirenz or nevirapine
Oral contraceptives ("the pill"). Viracept can prevent the effects of "the pill", so you have to use other methods of birth control (eg. Condoms) while taking Viracept Calcium antagonists, eg. bepridil (for heart problems) Drugs that suppress the immune system, for example. tacrolimus or cyclosporine drugs that reduce gastric acidity, eg. Fluticasone lansoprazole (for hay fever) Phenytoin (for seizures or epilepsy) Methadone (for drug dependence) Sildenafil (to achieve or maintain an erection)
Tadalafil (for pulmonary arterial hypertension (PAH) or to achieve or maintain an erection)
Vardenafil (for pulmonary arterial hypertension (PAH) or to achieve or maintain an erection)
Ketoconazole, itraconazole or fluconazole (for fungal infections) Rifabutin, erythromycin or clarithromycin (for bacterial infections) midazolam administered by injection or diazepam (for anxiety or to help you sleep)
Fluoxetine, paroxetine, imipramine, amitriptyline or trazodone (for depression) of simvastatin, lovastatin, atorvastatin or rosuvastatin (to lower cholesterol in the blood)
Salmeterol (for asthma and chronic obstructive pulmonary disease (COPD)) Warfarin (to decrease the probability of formation of blood clots in your body)
Colchicine (for gout attacks or Mediterranean fever) Bosentan (for pulmonary arterial hypertension (PAH)) If any of the above applies to you, or if you are not sure, talk to your doctor or pharmacist before taking,, Viracept.
Taking Viracept with food and drink:
Take Viracept with food. This will help your body to get the full benefit from your medicine.
Pregnancy, contraception and lactation
• Talk to your doctor before taking Viracept, if you are pregnant or planning a pregnancy.
• Do not breast-feed while taking Viracept, because HIV can be passed to the baby.
• Viracept may interfere with the action of oral contraceptives ("the pill"), so you have to use other methods of contraception (eg condoms) while taking Viracept.
• Ask your doctor or pharmacist before taking any medicine.
Driving and using machines
Viracept is not likely to affect your ability to drive or operate any tools or machines.
3 HOW TO TAKE VIRACEPT?
Always take Viracept exactly as prescribed by your doctor. If you are not sure, ask your doctor or pharmacist. Customary dosages are described below. Follow these instructions carefully to get the most benefit from treatment with Viracept.
Viracept tablets should be taken orally. They should be swallowed whole and taken at mealtimes.
Adults or children who can not swallow tablets, Viracept tablets can be put in water and taken as follows:
• The tablets are placed in a half cup of water and mix with a spoon.
• Once the tablet is dissolved, the dim blue liquid thoroughly and taken immediately.
• the beaker was washed with half a glass of water and drunk, to be sure that the full dose has been taken.
Not recommended acidic food or juice (eg. Orange juice, apple juice or applesauce) be taken with VIRACEPT, because together they can have a bitter taste.
As an alternative, instead, can be taken Viracept 50 mg / g of powder for oral administration. If you want to take a powder instead of tablets, please see leaflet Viracept 50 mg / g oral powder.
Taking this medicine
• Take Viracept with food. This will help your body to get the full benefit of your medicine.
• Take the entire dose at the right time every day. This will help your medicine to work as well.
• Do not stop taking this medication without talking to your doctor first.
How much to take
Adults and children over 13 years
Viracept tablets can be taken two or three times daily with meals. Table 1 below shows the usual doses.
Dose that should be taken by adults and children over 13 years
number of tablets
How much to take each time (in milligrams)
5 1250 mg
Three times daily 3750 mg
Children aged 3 to 13 years
For children aged 3 to 13 years, the recommended dose of Viracept tablets based on their body weight. Careful monitoring weight gain your child to make sure that appropriate total daily dose.
• When your child weighs 18 kg or more, you can give the tablets two or three times daily.
• When your child weighs 18 kg or less should give tablets three times daily.
Different ways are shown in separate tables below.
Table 2: if you give the drug twice daily (for children weighing 18 kg or more) will give 50-55 mg nelfinavir each time for each kg of body weight. Table 3: if you give the medicine three times a day, will give 25-35 mg nelfinavir each time for each kg of body weight, except in children who weigh from 10.5 to 12 kg, 12 to 14 kg and from 18 to 22 kg . These children will be given a different number of tablets with each meal. The table also shows the recommended total Viracept tablets that will give their children every day based on their weight.
Dose should be given twice daily for children from 3 to 13 years who weigh more than 18 kg
Body weight of your child
number of tablets
18 to 22 kg
over 22 kg 5
Dose to be administered three times daily for children aged 3 to 13 years, weighing more than 7,5 kg
the patient in kg
Recommended number of tablets with each meal
Total number of tablets per day
number of tablets
number of tablets
number of tablets
7.5 to 8.5 kg 1 1 1 3
8.5 to 10.5 kg
1 1 1 3
10.5 to 12 kg * 2 1 1 4
12 to 14 kg * 2 1 2 5
14 to 16 kg 2 2 2 6
16 to 18 kg 2 2 2 6
18 to 22 kg * 3 2 2 7
over 22 kg
3 3 3 9
• Children with this weight throughout the day will be given a different number of tablets. Your doctor will monitor the number of HIV particles and CD4 white blood cells your child to make sure that they are unaffected by treatment.
It is important to take the correct number of tablets for each dose. You need to track your child when taking the tablets to be sure that it accepts the recommended number of tablets with food for the body mass.
If you take more than the amount of Viracept:
If you take more Viracept than necessary, talk to a doctor, pharmacist or go straight to the hospital,. Take the medicine pack with you. Among other things, very large doses of Viracept can cause heart rhythm problems.
If you forget to take Viracept:
If you forget to take a dose, take it as soon as you remember.
• If it's time for your next dose, skip the missed dose.
• Do not take a double dose to make up for a missed dose.
If you stop taking Viracept:
Do not stop taking this medication without talking to your doctor first. Take all doses at the right time every day. This will help your medicine to work as well.
4 POSSIBLE SIDE EFFECTS
Like all medicines, Viracept can have side effects, although not everybody gets them. In this drug may experience the following side effects.
Contact your doctor immediately if you notice any of the following side effects:
• Allergic reactions. Signs may include difficulty breathing, fever, itching, swelling of the face and skin rashes that can sometimes form blisters.
• Increased bleeding if you have hemophilia. If you have hemophilia type A or B, in rare cases bleeding may increase.
• Disease of the bone (osteonecrosis). The signs may include joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement. 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).
• Infection. In some patients with advanced HIV infection and a history of opportunistic infection, can be signs and symptoms of inflammation from previous infections shortly after beginning treatment against HIV. It is believed that these symptoms are due to an improvement in the immune response, allowing it to fight infections that may be present with no obvious symptoms.
If you notice any of the above, please contact your doctor immediately.
Other possible side effects that you should talk to your doctor
If any adverse reaction from this list or if you notice any side effects not listed in this leaflet, please tell your doctor.
Very common (affects more than 1 in 10 people):
Common (affects less than 1 in 10 people):
• Low number of certain white blood cells that fight infection (neutrophils).
• Abnormal results of blood tests that show how well they work liver or muscles.
Uncommon (affects less than 1 in 100 people):
• Pancreatitis. Signs include severe stomach pain that spreads to the back.
• 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 deposition in the abdomen (belly) and other internal organs, breast enlargement and fatty lumps on the neck ('buffalo hump'). Reason this condition and late health effects are not known.
Rare (affects less than 1 in 1,000 people):
• Yellowing of the skin or eyes. This may be a sign of liver problems such as hepatitis or jaundice.
• Severe rash (erythema multiforme).
• Swelling of the abdomen.
• High blood sugar (diabetes) or worsening of diabetes.
• There have been rare 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, causing muscle degeneration (rhabdomyolysis).
Other side effects have also been reported:
• Combination antiretroviral therapy may also cause raised lactic acid and sugar in the blood, hyperglycemia (increased fats in the blood) and resistance to insulin.
• Low red blood cells (anemia).
• Lung disease (pneumonia).
• Cases of diabetes or elevated blood sugar levels in patients receiving this treatment or another protease inhibitor
Adverse reactions in children
Nearly 400 children (aged 0 to 13 years) receiving Viracept in clinical trials. Side effects seen in children are similar to those seen in adults. The most commonly reported side effect in children is diarrhea. Side effects rarely led to discontinuation of Viracept.
HOW TO STORE VIRACEPT
Keep out of reach of children.
Do not use after the expiry date stated on the label and carton.
Do not store above 30 ° C.
Store in original container.
6 FURTHER INFORMATION
What does Viracept?
• The active ingredient of Viracept is nelfinavir. Each tablet contains nelfinavir
• The other ingredients are calcium silicate, crospovidone, magnesium stearate, indigo carmine (E 132) as a powder, hypromellose and glycerol triacetate.