What is it and how is it used?
STOCRIN belongs to a class of antiretroviral medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs). It is an antiretroviral medicine that fights human immunodeficiency virus (HIV) infection by reducing the amount of the virus in blood.
Your doctor has prescribed STOCRIN for you because you have HIV infection. STOCRIN taken in combination with other antiretroviral medicines reduces the amount of the virus in the blood.
What do you have to consider before using it?
Do not take STOCRIN
If you are taking any of these medicines, tell your doctor immediately. Taking these medicines with STOCRIN could create the potential for serious and/or life-threatening side-effects or stop STOCRIN from working properly.
Take special care with STOCRIN
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.
Use in children
STOCRIN 50 mg hard capsules can be taken by children 3 years of age and older who are able to swallow the capsules (see How to take STOCRIN).
Taking other medicines
You must not take STOCRIN with certain medicines. These are listed under Do not take STOCRIN, at the start of Section 2. They include some common medicines and a herbal remedy (St. John’s wort) which can cause serious interactions.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal remedies.
STOCRIN may interact with other medicines. As a result, the amounts of STOCRIN or other medicines in your blood may be affected. This may stop the medicines from working properly, or may make any side effects worse. In some cases, your doctor may need to adjust your dose or check your blood levels. It is important to tell your doctor if you are taking any of the following:
Other medicines used for HIV infection:
Medicines used to treat bacterial infections, including tuberculosis and AIDS-related mycobacterium avium complex: clarithromycin, rifabutin, rifampicin. Your doctor may consider changing your dose or giving you an alternative antibiotic. In addition, your doctor may prescribe a higher dose of STOCRIN.
Medicines used to treat fungal infections (antifungals):
Medicines used to treat convulsions/seizures (anticonvulsants): carbamazepine, phenytoin, phenobarbital. STOCRIN can reduce or increase the amount of anticonvulsant in your blood. Carbamazepine may make STOCRIN less likely to work. Your doctor may need to consider giving you a different anticonvulsant.
Medicines used to lower blood fats (also called statins): atorvastatin, pravastatin, simvastatin. STOCRIN can reduce the amount of statins in your blood. Your doctor will check your cholesterol levels and will consider changing the dose of your statin, if needed.
Methadone (a medicine used to treat opiate addiction): your doctor may need to change your dose of methadone.
Sertraline (a medicine used to treat depression): your doctor may need to change your dose of sertraline.
Diltiazem or similar medicines (called calcium channel blockers): when you start taking STOCRIN, your doctor may need to adjust your dose of the calcium channel blocker.
Immunosuppressants such as cyclosporine, sirolimus, or tacrolimus (medicines used to prevent organ transplant rejection): when you start or stop taking STOCRIN, your doctor will closely monitor your plasma levels of the immunosuppressant and may need to adjust its dose.
Hormonal contraceptive, such as birth control pills, an injected contraceptive (for example, Depo-Provera), or a contraceptive implant (for example, Implanon): you must also use a reliable barrier method of contraception (see Pregnancy and breast-feeding). STOCRIN may make hormonal contraceptives less likely to work. Pregnancies have occurred in women taking STOCRIN while using a contraceptive implant, although it has not been established that the STOCRIN therapy caused the contraceptive to fail.
Warfarin (amedicine used to reduce clotting of the blood): your doctor may need to adjust your dose of warfarin.
Taking STOCRIN with food and drink
Taking STOCRIN on an empty stomach may reduce the undesirable effects.
Pregnancy and breast-feeding
Women should not get pregnant during treatment with STOCRIN and for 12 weeks thereafter. Your doctor may require you to take a pregnancy test to ensure you are not pregnant before starting treatment with STOCRIN.
If you could get pregnant while receiving STOCRIN, you need to use a reliable form of barrier contraception (for example, a condom) with other methods of contraception including oral (pill) or other hormonal contraceptives (for example, implants, injection). Efavirenz may remain in your blood for a time after therapy is stopped. Therefore, you should continue to use contraceptive measures, as above, for 12 weeks after you stop taking STOCRIN.
Tell your doctor immediately if you are pregnant or intend to become pregnant. If you are pregnant, you should take STOCRIN only if you and your doctor decide it is clearly needed. Ask your doctor or pharmacist for advice before taking any medicine.
Serious birth defects have been seen in unborn animals and in the babies of women treated with efavirenz during pregnancy. If you have taken STOCRIN during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
You should not breast feed your baby if you are taking STOCRIN.
Driving and using machines
STOCRIN may cause dizziness, impaired concentration, and drowsiness.
If you are affected, do not drive and do not use any tools or machines.
Important information about some of the ingredients of STOCRIN
This medicinal product contains 342 mg of lactose in each 600-mg daily dose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Individuals with these conditions may take STOCRIN oral solution, which is free from lactose.
How is it used?
Always take STOCRIN exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Your doctor will give you instructions for proper dose.
Use in children
If you take more STOCRIN than you should
If you take too much STOCRIN contact your doctor or nearest emergency department for advice. Keep the medicine container with you so that you can easily describe what you have taken.
If you forget to take STOCRIN
Try not to miss a dose. If you do miss a dose, take the next dose as soon as possible, but do not take a double dose to make up for a forgotten dose. If you need help in planning the best times to take your medicine, ask your doctor or pharmacist.
If you stop taking STOCRIN
When your STOCRIN supply starts to run low, get more from your doctor or pharmacist. This is very important because the amount of virus may start to increase if the medicine is stopped for even a short time. The virus may then become harder to treat.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
What are possible side effects?
Like all medicines, STOCRIN can cause side effects, although not everybody gets them. When treating HIV infection, it is not always possible to tell whether some of the unwanted effects are caused by STOCRIN or by other medicines that you are taking at the same time, or by the HIV disease itself.
The most notable unwanted effects reported with STOCRIN in combination with other anti-HIV medicines are skin rash and nervous system symptoms.
You should consult your doctor if you have a rash, since some rashes may be serious; however, most cases of rash disappear without any change to your treatment with STOCRIN. Rash was more common in children than in adults treated with STOCRIN.
The nervous system symptoms tend to occur when treatment is first started, but generally decrease in the first few weeks. In one study, nervous system symptoms often occurred during the first 1-3 hours after taking a dose. If you are affected your doctor may suggest that you take STOCRIN at bedtime and on an empty stomach. Some patients have more serious symptoms that may affect mood or the ability to think clearly. Some patients have actually committed suicide. These problems tend to occur more often in those who have a history of mental illness. Always notify your doctor immediately if you have these symptoms or any side effects while taking STOCRIN.
The frequency of the side effects listed below is defined using the following conventions:
Tell your doctor if you notice any of the following side effects:
Very common side effects
Common side effects
Uncommon side effects
Rare
Combination antiretroviral therapy may change your body shape by changing the way body fat is distributed. You may lose fat from your legs, arms and face, gain fat in the abdomen (tummy) and other internal organs, get larger breasts or fatty lumps on the back of the neck (‘buffalo hump’). The cause and long-term health effects of these conditions are not yet known.
Combination antiretroviral therapy may also cause raised lactic acid and sugar in the blood, increased fat levels in the blood (hyperlipaemia) and resistance to insulin. Your doctor will test for these changes.
If any of the side effects get serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How should it be stored?
Keep out of the reach and sight of children.
Do not use STOCRIN after the expiry date which is stated on the bottle and on the carton after EXP. The expiry date refers to the last day of that month.
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.
