50 mg film-coated tablets
efavirenz
What Stocrin is and what it is used for
Stocrin, which contains the active substance efavirenz, belongs to a group of medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs). It is an antiretroviral drug against human immunodeficiency virus ( HIV) infection that works by reducing the amount of virus in the blood. The medicine is used by adults, adolescents, and children aged 3 years and older.
Your doctor has prescribed Stocrin for you because you have an HIV infection. Taking Stocrin in combination with other antiretroviral drugs reduces the amount of virus in the blood. This strengthens your immune system and reduces the risk of developing disease linked to HIV infection.
What you need to know before you take Stocrin
Do not take Stocrin
- if you are allergic to efavirenz or any of the other ingredients of this medicine (listed in section 6). Contact your doctor or pharmacist for advice.
- if you have severe liver disease.
- if you have heart problems, such as changes in the rhythm or frequency of the heartbeat, slow heartbeats, or severe heart disease.
- if someone in your family (parents, grandparents, brothers, or sisters) has died suddenly due to heart problems or was born with heart problems.
- if your doctor has told you that you have high or low levels of electrolytes, such as potassium or magnesium, in your blood.
- if you are using any of the following medicines at the same time (see also “Other medicines and Stocrin”):
- astemizole or terfenadine (to treat allergic symptoms)
- bepridil (for treating heart disease)
- cisapride (to treat heartburn)
- ergot alkaloids (for example, ergotamine, dihydroergotamine, ergonovine, and methylergonovine) (for the treatment of migraine and cluster headaches)
- midazolam or triazolam (for trouble sleeping)
- pimozide, imipramine, amitriptyline, or clomipramine (for the treatment of certain mental disorders)
- St. John’s wort (Hypericum perforatum) (a natural remedy for depression and anxiety)
- flecainide, metoprolol (for treating irregular heart rhythm)
- certain antibiotics ( macrolides , fluoroquinolones , imidazole)
- certain antifungal drugs (triazoles)
- certain medicines against malaria
- methadone (for treating opioid addiction)
- elbasvir/grazoprevir
If you are taking any of these medicines, tell your doctor as soon as possible. If these medicines are taken together with Stocrin, they can cause serious and/or life-threatening side effects or reduce or remove the effect of Stocrin.
Warnings and precautions
Talk to your doctor before taking Stocrin
- Stocrin must be taken together with other medicines that are active against the HIV. If you are given Stocrin because your current treatment has not prevented the virus from multiplying, you must be given another medicine at the same time that you have not taken before.
- You can still transmit HIV when taking this medicine, although the risk is reduced with effective antiviral treatment. It is therefore important that you are careful to avoid infecting other people via sexual contact or blood transfusion. Discuss with your doctor the necessary measures to avoid infecting others. This medicine is not a cure for HIV infection and you may continue to develop an infection or other diseases associated with HIV.
- You should continue to be under medical observation while taking Stocrin.
- Tell your doctor:
- if you previously had a mental illness, such as depression, or alcohol or drug abuse. Tell your doctor immediately if you feel depressed, or have suicidal thoughts, or have strange thoughts (see section 4 Possible side effects ).
- if you have previously had convulsions (seizures or attacks) or if you are being treated with anticonvulsant treatment such as carbamazepine, phenobarbital, and phenytoin. If you are taking any of these medicines, your doctor may need to check the level of the medicine in your blood to make sure it is not affected while you are taking Stocrin. Your doctor may choose to give you another anticonvulsant medicine.
- if you previously had any liver disease, this also applies to chronic hepatitis in an active stage. Patients with chronic hepatitis B or C who are treated with a combination of antiretroviral agents are at increased risk of serious and potentially life-threatening liver side effects. Your doctor may take blood tests to check liver function or to change your treatment to a different medicine. If you have severe liver disease, you should not take Stocrin (see section 2, Do not take Stocrin ).
- if you have a heart condition, such as an abnormal electrical signal called a prolonged QT interval.
- When you start taking Stocrin, pay attention to the following:
- signs of dizziness, difficulty sleeping, drowsiness, difficulty concentrating, or abnormal dreams. These side effects can appear during the first or second day of treatment and usually disappear after the first 2-4 weeks.
- signs of confusion, slow thought and physical movement, delusions (false beliefs), or hallucinations (seeing or hearing things that others do not see or hear). These side effects can appear months to years after starting treatment with Stocrin. Inform your doctor if you notice any symptoms.
- signs of skin rash. If you see signs of a severe skin rash with blisters or fever, stop taking Stocrin and inform your doctor immediately. If you got a rash with another drug in the NNRTI group, you may be more likely to get a rash with Stocrin.
- signs of inflammation or infection. In some patients with advanced HIV infection ( AIDS ) who previously had an opportunistic infection, signs, and symptoms of inflammation from a previous infection may occur shortly after starting anti- HIV treatment. These symptoms are probably due to an improvement in the body’s immune response, which enables the body to fight infections that may have existed without any obvious symptoms. Tell your doctor immediately if you notice any symptoms of infection. In addition to opportunistic infections, autoimmune disorders (conditions where the immune system attacks healthy body tissue) can also occur after you start taking medicines to treat your HIV infection. Autoimmune disorders may occur several months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, a weakness that starts in the hands or feet and moves to the trunk, palpitations, tremors, or hyperactivity, inform your doctor immediately to get the necessary treatment.
- bone tissue problems. Some patients receiving combination antiretroviral therapy may develop a bone disease called osteonecrosis (bone tissue dies due to loss of blood supply to the bone). Some of the many risk factors for developing the disease are long-term combination antiretroviral therapy, use of corticosteroids, alcohol consumption, severe impairment of the immune system, and higher body mass index. Signs of osteonecrosis are joint stiffness and pain (especially in the hip, knee, and shoulders) and difficulty moving. Tell your doctor if you experience any of these symptoms.
Children and young people
Stocrin is not recommended for children younger than 3 years or weighing less than 13 kg as the medicine has not been adequately studied in these patients.
Other medicines and Stocrin
You must not take Stocrin together with certain medicines. These are listed at the beginning of section 2, under Do not take Stocrin . This applies to some common medicines and herbal remedies ( St. John’s wort ) which can cause serious interaction (interaction).
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Stocrin may interact with other medications, including herbal remedies such as extracts of Ginkgo biloba . This means that the amount of Stocrin or other medicine in the blood can be affected. This can mean that the medication’s effect is reduced or absent or that side effects can become worse. In some cases, the doctor therefore needs to change the dosage or measure the drug level in the blood. It is important to tell your doctor or pharmacist if you are taking any of the following:
- Other medicines against HIV infection:
- protease inhibitors: darunavir, indinavir, lopinavir/ritonavir, ritonavir, ritonavir-boosted atazanavir, saquinavir or fosamprenavir/saquinavir. Your doctor may consider giving you another medicine or changing the dose of the protease inhibitor.
- maraviroc
- the combination medicine containing efavirenz, emtricitabine and tenofovir should not be taken with Stocrin unless recommended by your doctor because it contains efavirenz, the active substance in Stocrin.
- Medicines used to treat hepatitis C virus infection : boceprevir, telaprevir, simeprevir, sofosbuvir/velpatasvir, glecaprevir/pibrentasvir and sofosbuvir/velpatasvir/voxilaprevir.
- Medicines used to treat bacterial infections, including tuberculosis and AIDS -related MAC ( mycobacterium avium complex) infection: clarithromycin, rifabutin, rifampicin. Your doctor may consider changing the dose or giving you a different antibiotic . Your doctor may also increase the dose of Stocrin.
- Medicines used to treat fungal infections:
- voriconazole. Stocrin can decrease the amount of voriconazole in your blood and voriconazole can increase the amount of Stocrin in your blood. If you take these two drugs at the same time, the dose of voriconazole must be increased and the dose of efavirenz must be decreased. You must consult your doctor first.
- itraconazole. Stocrin can reduce the amount of itraconazole in your blood.
- posaconazole. Stocrin may decrease the amount of posaconazole in your blood.
- Medicines used to treat malaria:
- aretmeter/lumefantrine: Stocrin can decrease the amount of aretmeter/lumefantrine in your blood.
- atovaquone/proguanil: Stocrin can decrease the amount of atovaquone/proguanil in your blood.
- Medicines for the treatment of convulsions/seizures (anticonvulsants): carbamazepine, phenytoin , phenobarbital. Stocrin can decrease or increase the amount of anticonvulsant medicine in your blood. Carbamazepine may reduce the effect of Stocrin. Your doctor may choose to give you another anticonvulsant medicine.
- Medicines used to lower blood fats (so-called statins): atorvastatin, pravastatin, simvastatin . Stocrin can reduce the amount of statins in your blood. Your doctor will check your cholesterol levels and may consider changing the dose of a statin if necessary.
- Methadone (a drug used to treat opiate addiction): the doctor may recommend an alternative treatment.
- Sertraline (a drug for the treatment of depression): the doctor may need to change the dosage of sertraline .
- Bupropion (a medicine used to treat depression or to help stop smoking): the doctor may need to change the dose of bupropion.
- Diltiazem or similar medicines (so-called calcium blockers which are medicines usually used for high blood pressure or heart problems): when you start Stocrin treatment, your doctor may need to change the dose of one of the calcium blockers.
- Medicines that suppress the immune system, such as cyclosporine, sirolimus or tacrolimus (medicines that prevent rejection of organs after transplantation): when you start or stop treatment with Stocrin, your doctor will monitor the plasma levels of the immunosuppressive medicine and may need to change the dose of one of it.
- Hormonal contraceptives, such as the pill , contraceptive injection (eg Depo-Provera) or contraceptive stick (eg Nexplanon): you must also use a reliable barrier contraceptive (see Pregnancy and breast-feeding). Stocrin can impair the effect of hormonal contraceptives. Pregnancies have occurred in women treated with Stocrin while using the IUD. However, it has not been possible to establish that the treatment with Stocrin caused the lack of protection of the contraceptive.
- Warfarin or acenocoumarol (medicines used to reduce blood clotting): the doctor may need to change the dosage of either warfarin or acenocoumarol.
- Extract of Ginkgo biloba (natural medicine).
- Medicines that affect heart rhythm:
- Medicines to treat heart rhythm problems: eg flecainide or metoprolol .
- Medicines for the treatment of depression , eg imipramine, amitriptyline or clomipramine.
- Antibiotics , including the following types: macrolides , fluoroquinolones or imidazole.
- Metamizole (a medicine used to treat pain and fever).
Stocrin with food and drink
Taking Stocrin on an empty stomach can reduce side effects . Grapefruit juice should be avoided when using Stocrin.
Pregnancy and breastfeeding
Women should not become pregnant during ongoing treatment with Stocrin and for 12 weeks afterwards. Your doctor may ask you to take a pregnancy test to make sure you are not pregnant before starting treatment with Stocrin.
If you are at risk of becoming pregnant while you are receiving Stocrin, you need to use a reliable barrier method of contraception (for example, a condom) together with other methods of contraception such as tablets ( the pill ) or other hormonal methods of contraception (for example, the contraceptive rod, the contraceptive syringe ). Efavirenz may remain in your blood for some time after you stop treatment. Therefore, you should continue to use contraception, as described above, for 12 weeks after the last dose of Stocrin.
Tell your doctor immediately if you are pregnant or plan to become pregnant. If you are pregnant, you should only take Stocrin if you and the doctor decide that there is a clear need. Consult your doctor or pharmacist before taking any medicine.
Serious birth defects have been seen in unborn animals and in infants of women treated with efavirenz or a combination medicine containing efavirenz, emtricitabine and tenofovir during pregnancy. If you have been taking Stocrin or the combination tablet containing efavirenz, emtricitabine and tenofovir during your pregnancy, your doctor may need regular blood tests and other diagnostic tests to monitor your baby’s progress.
You should not breast-feed your baby if you are taking Stocrin.
Driving ability and use of machinery
Stocrin contains efavirenz and may cause dizziness, impaired concentration and drowsiness. If you are affected, you should avoid driving and using machines.
Stocrin contains lactose in each daily dose of 600 mg
If your doctor has told you that you have an intolerance to certain sugars, contact your doctor before taking this medicine. Individuals with these conditions can take Stocrin oral solution, which does not contain lactose .
Stocrin contains sodium in each dose of 600 mg
This medicine contains less than 1 mmol (23 mg) of sodium per 600 mg dose , i.e. it is almost ‘sodium-free’.
How to take Stocrin
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure. Your doctor will tell you what dose to take.
- Dose one for adults is 600 mg once daily.
- If you take certain other medicines at the same time, the dose of Stocrin may need to be increased or decreased (see Other medicines and Stocrin).
- Stocrin is taken by mouth. Stocrin is recommended to be taken on an empty stomach, preferably at bedtime. This can reduce the discomfort of certain side effects (such as dizziness and drowsiness). Fasting usually means 1 hour before or 2 hours after a meal.
- The tablet should be swallowed whole with water.
- Stocrin must be taken every day.
- Stocrin should never be used alone to treat HIV . Stocrin must always be taken in combination with other anti- HIV medicines .
Use for children and adolescents
- Dose one for children weighing 40 kg or more is 600 mg once daily.
- Dose one for children weighing less than 40 kg is calculated according to body weight and is taken once daily according to the table below:
| Body weight kg | Stocrin Dose ( mg) * |
| 13 – < 15 | 200 |
| 15 – < 20 | 250 |
| 20 – < 25 | 300 |
| 25 – < 32.5 | 350 |
| 32.5 – < 40 | 400 |
* Stocrin 50 mg, 200 mg and 600 mg film-coated tablets are available.
If you have taken too much Stocrin
If you have taken too much Stocrin, contact your doctor or nearest emergency department for advice. Take the medicine packaging with you so you can explain what you have taken.
If you forget to take Stocrin
Try not to forget any dose . If you forget to take a dose , take the next dose as soon as possible, but do not take a double dose to make up for the missed dose . If you need help planning the best time to take your medicine, ask your doctor or pharmacist.
If you stop taking Stocrin
When your Stocrin tablets run out, make sure you get more from your doctor or pharmacist. This is very important because the viral load can start to increase as soon as you stop taking the medicine, even if only for a short time. Viruses can then become more difficult to treat.
If you have further questions about this medicine, contact your doctor, pharmacist or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects , although not everybody gets them. When treating HIV infection , it is not always possible to say whether some of the unwanted effects are caused by Stocrin, by other medicines you are taking at the same time or by the HIV disease itself.
During HIV treatment, weight gain and increased levels of lipids and glucose in the blood may occur. This is partly related to restored health and lifestyle, but in the case of blood lipids, there can sometimes be a connection with the HIV drugs. The doctor will do tests to find such changes.
The most notable side effects reported for Stocrin in combination with other anti- HIV drugs are skin rash and central nervous system symptoms .
Always contact your doctor if you develop a rash, as some rashes can be severe. In most cases, the skin rash disappears without the need to change the treatment with Stocrin. Rashes are more common in children than in adults treated with Stocrin.
Symptoms from the central nervous system usually appear at the beginning of treatment, but usually decrease during the first weeks. In one study, central nervous system symptoms often occurred in the first 1 – 3 hours after a dose. If you are affected by the symptoms, your doctor may suggest that you take Stocrin at bedtime and on an empty stomach. Some patients may experience more severe symptoms that affect mood or ability to think clearly. Some patients have committed suicide. The problems have a tendency to occur more often in those who previously had mental illnesses. In addition, some central nervous system symptoms may appear months to years after starting treatment with Stocrin (eg, confusion, slow thought and physical movement, delusions [false beliefs] or hallucinations [seeing or hearing things that others do not see or hear]). Always tell your doctor immediately if you get these symptoms or other side effects while taking Stocrin.
Tell your doctor if you experience any of the following side effects:
Very common (may affect more than 1 in 10 users)
- rash
Common (may affect up to 1 in 10 users)
- abnormal dreams, difficulty concentrating, dizziness, headache, difficulty sleeping, drowsiness, coordination or balance problems
- stomach pain, diarrhoea, nausea, vomiting
- itching
- fatigue
- anxiety, feeling down
Tests may show:
- elevated liver enzymes in the blood
- elevated triglycerides (fatty acids) in the blood
Uncommon (may affect up to 1 in 100 users)
- nervousness, forgetfulness, confusion, seizures, strange thoughts
- blurred vision
- feeling dizzy or unsteady (vertigo)
- abdominal pain caused by inflammation of the pancreas
- allergic reaction (hypersensitivity) which can cause serious skin reactions (erythema multiforme, Stevens-Johnson syndrome)
- yellow skin or eyes, itching or abdominal pain caused by inflammation of the liver
- breast augmentation in men
- angry behavior, mood swings, seeing and hearing imagined things (hallucinations), mania (mental state characterized by hyperactivity, elation or irritability), paranoia , suicidal thoughts, catatonia (condition in which the patient becomes immobile and loses the ability to speak for a period)
- whistling, ringing or other persistent noise in the ears
- tremors (shaking)
- bleeding
Tests may show:
- elevated cholesterol in the blood
Rare (may affect up to 1 in 1,000 users)
- itchy rash caused by a reaction to sunlight
- liver failure, in some cases leading to death or liver transplantation, has occurred with efavirenz. Most cases occurred in patients with a history of liver disease, but a few reports have included patients without any liver disease
- unexplained feeling of anxiety not associated with hallucinations but with possible difficulty thinking clearly or sensibly
- suicide.
How to store Stocrin
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the can and on the carton after Ex. dat. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- Each Stocrin film-coated tablet contains 50 mg of the active substance efavirenz.
- Other ingredients in the tablet core are: croscarmellose sodium, microcrystalline cellulose, sodium lauryl sulfate, hydroxypropyl cellulose, lactose monohydrate and magnesium stearate.
- The film coating contains: hypromellose (E464), titanium dioxide (E171), macrogol 400, yellow iron oxide (E172) and carnauba wax.
Appearance and package sizes of the medicine
Stocrin 50 mg film-coated tablets are supplied in cans of 30 tablets.Stocrin, which contains the active substance efavirenz, belongs to a group of medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs). It is an antiretroviral drug against human immunodeficiency virus ( HIV) infection that works by reducing the amount of virus in the blood. The medicine is used by adults, adolescents and children aged 3 years and olde
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