Stocrin
efavirenz
efavirenz
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
What Stocrin is and what it is used for
What you need to know before you take Stocrin
How to take Stocrin
Possible side effects
How to store Stocrin
Contents of the pack and other information
Stocrin, which contains the active substance efavirenz, 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. It is used by adults, adolescents and children 3 years of age and older.
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. This will strengthen your immune system and reduce the risk of developing illnesses linked to HIV infection.
if any member of your family (parents, grandparents, brothers or sisters) has died suddenly due to a heart problem 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
magne-sium in your blood.
if you are currently taking any of the following medicines (see also “Other medicines and
Stocrin”):
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methylergonovine) (used to treat migraine and cluster headaches)
mental conditions)
and anxiety)
certain antimalarial treatments methadone (used to treat opiate addiction) elbasvir/grazoprevir
Talk to you doctor before taking Stocrin
You m-ust remain under the care of your doctor while taking Stocrin.
thoughts or have strange thoughts (see section 4, Possible side effects).
If you are taking any of these medicines, your doctor may need to check the level of anticonvulsant medicine in your blood to ensure that it is not affected while
taking Stocrin. Your doctor may give you a different anticonvulsant.
Your doctor may conduct blood tests in order to check how well your liver is working or may switch you to another medicine. If you have severe liver disease,
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treatment and usually go away after the first 2 to 4 weeks.
therapy. If you notice any symptoms, please inform your doctor.
taking another NNRTI, you may be at a higher risk of getting a rash with Stocrin.
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 tell your doctor immediately.
In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection. Autoimmune disorders may occur many months after the start of treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness
beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to
seek necessary treatment.
Stocrin is not recommended for children under the age of 3 years or weighing less than 13 kg because it has not been adequately studied in these patients.
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.
Stocrin may interact with other medicines, including herbal preparations such as Ginkgo biloba extracts. 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 or pharmacist if you are taking any of the following:
protease inhibitors: darunavir, indinavir, lopinavir/ritonavir, ritonavir, ritonavir boosted atazanavir, saquinavir or fosamprenavir/saquinavir. Your doctor may consider giving you an alternative medicine or changing the dose of the protease inhibitors.
maraviroc
the combination tablet containing efavirenz, emtricitabine and tenofovir should not be taken with Stocrin unless recommended by your doctor since it contains efavirenz, the active ingredient of Stocrin.
simeprevir, sofosbuvir/velpatasvir, glecaprevir/pibrentasvir and sofosbuvir/velpatasvir/voxilaprevir.
voriconazole. Stocrin may reduce the amount of voriconazole in your blood and voriconazole may increase the amount of Stocrin in your blood. If you take these two medicines together, the dose of voriconazole must be increased and the dose of efavirenz must be reduced. You must check with your doctor first.
itraconazole. Stocrin may reduce the amount of itraconazole in your blood.
posaconazole. Stocrin may reduce the amount of posaconazole in your blood.
artemether/lumefantrine: Stocrin may reduce the amount of artemether/lumefantrine in your blood.
atovaquone/proguanil: Stocrin may reduce the amount of atovaquone/proguanil in your blood.
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.
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.
alternative treatment.
sertraline.
need to change your dose of bupropion.
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.
need to adjust your dose of warfarin or acenocoumarol.
Serious birth defects have been seen in unborn animals and in the babies of women treated with efavirenz or a combination medicine containing efavirenz, emtricitabine and tenofovir during pregnancy. If you have taken Stocrin or the combination tablet containing efavirenz, emtricitabine, and tenofovir during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
This medicine contains 1 mg of benzoic acid (E210) per mL.
This medicine contains benzyl alcohol (E1519) up to 0.816 mg per mL. Benzyl alcohol may cause allergic reactions.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will give you instructions for proper dosing.
The dose for adults is 24 mL once daily.
The dose for Stocrin may need to be increased or decreased if you are also taking certain medicines (see Other medicines and Stocrin).
Stocrin oral solution may be taken with or without food.
The dose of Stocrin oral solution in mg is not the same as for Stocrin film-coated tablets.
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.
The dose of Stocrin oral solution must be measured using the oral syringe supplied in the carton.
On first use, the bottle adapter must be fitted into the neck of the bottle. To do this, remove the child-resistant cap and the foil seal. The bottle adapter, which is already fixed to the nozzle of the syringe, can then be fitted into the neck of the bottle and pressed firmly down.
Separate the syringe from the adapter. The adapter should now fit closely to the neck so that the cap can be replaced without removing it.
With the bottle upright, fit the tip of the syringe into the bottle adapter.
Turn the bottle upside down with the syringe still in place. Hold the bottle and the syringe firmly in one hand and with the other hand pull back the plunger slightly beyond the mark for the dose required. If air bubbles appear in the syringe, keep the bottle upside down and slowly push in the plunger and pull it back again. Repeat until there are no bubbles in the syringe.
To measure the dose accurately, keep the bottle upside down and push the plunger in slowly until the top of the black ring (the edge nearest the syringe tip) lines up with the dose. Turn the bottle the right way up and remove the syringe. Wipe the adapter and replace the cap tightly over it.
Before giving the dose of the oral solution make sure that the patient is sitting or standing upright. Put the tip of the syringe just inside the mouth, pointing it towards the cheek. Press the plunger slowly to allow time for the medicine to be swallowed. Rapid squirting into the mouth may cause choking.
After use, soak the syringe in warm soapy water for at least a minute. Draw the warm soapy water into the syringe until full and then empty completely. Repeat at least three times. Remove the plunger rod from the barrel and thoroughly rinse both parts with warm running water. If parts of the syringe are not clean, repeat the cleaning instructions. Allow the parts to dry completely prior to reassembly. Do not put the syringe in a dishwasher.
The dose for children weighing 40 kg or more is 24 mL once daily.
The dose for children weighing less than 40 kg is calculated by body weight and is taken once daily as shown below:
Body Weight kg | Stocrin oral solution (30 mg/mL) Dose (mL) | |
3 - < 5 years | 5 years or more | |
13 to < 15 | 12 | 9 |
15 to < 20 | 13 | 10 |
20 to < 25 | 15 | 12 |
25 to < 32.5 | 17 | 15 |
32.5 to < 40 | - | 17 |
40 | - | 24 |
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.
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 have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine 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.
During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves. Your doctor will test for these changes.
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. 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. In addition, some nervous system symptoms (e.g., confusion, slow thoughts and physical movement, and delusions [false beliefs] or hallucinations [seeing or hearing things that others do not see or hear]) may occur months to years after beginning Stocrin therapy. Always notify your doctor immediately if you have these symptoms or any side effects while taking Stocrin.
Diarrhoea occurred in children who took Stocrin oral solution and nelfinavir in combination with other antiretroviral medicines.
skin rash
abnormal dreams, difficulty concentrating, dizziness, headache, difficulty sleeping, drowsiness, problems with coordination or balance
stomach pain, diarrhoea, feeling sick (nausea), vomiting
itching
tiredness
feeling anxious, feeling depressed
Tests may show:
increased liver enzymes in the blood
increased triglycerides (fatty acids) in the blood
nervousness, forgetfulness, confusion, fitting (seizures), abnormal thoughts
blurred vision
a feeling of spinning or tilting (vertigo)
pain in the abdomen (stomach) caused by inflammation of the pancreas
allergic reaction (hypersensitivity) that may cause severe skin reactions (erythema multiforme, Stevens-Johnson syndrome)
yellow skin or eyes, itching, or pain in the abdomen (stomach) caused by inflammation of the liver
breast enlargement in males
angry behaviour, mood being affected, seeing or hearing things that are not really there (hallucinations), mania (mental condition characterised by episodes of overactivity, elation or irritability), paranoia, suicidal thoughts, catatonia (condition in which the patient is rendered motionless and speechless for a period)
whistling, ringing or other persistent noise in the ears
tremor (shaking)
flushing
Tests may show:
increased cholesterol in the blood
itchy rash caused by a reaction to sunlight
liver failure, in some cases leading to death or liver transplant, has occurred with efavirenz.
Most cases occurred in patients who already had liver disease, but there have been a few reports in patients without any existing liver disease.
unexplained feelings of distress not associated with hallucinations, but it may be difficult to think clearly or sensibly
suicide
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via thenationalreporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine 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.
The bottle of Stocrin oral solution should be used within one month after first opening.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Each mL of Stocrin oral solution contains 30 mg of the active substance efavirenz.
The other ingredients are: medium chain triglycerides, benzoic acid (E210) and strawberry/mint flavour [containing benzyl alcohol (E1519) and propylene glycol (E1520)].
Stocrin 30 mg/mL oral solution is supplied in bottles of 180 mL. An oral syringe with a push-in bottle-neck adapter is included in the carton.
Merck Sharp & Dohme B.V. Merck Sharp & Dohme B.V.
Waarderweg 39 Waarderweg 39
2031 BN Haarlem Postbus 581
The Netherlands 2003 PC Haarlem
The Netherlands
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
MSD Belgium
Tél/Tel: +32(0)27766211
UAB Merck Sharp & Dohme Tel.: +370 5 278 02 47
Мерк Шарп и Доум България ЕООД
Тел.: +359 2 819 3737
MSD Belgium
Tél/Tel: +32(0)27766211
Merck Sharp & Dohme s.r.o. Tel.: +420 233 010 111
dpoc_czechslovak @merck.com
MSD Pharma Hungary Kft. Tel.: +361 888 53 00
MSD Danmark ApS Tlf: +45 44 82 40 00
Merck Sharp & Dohme Cyprus Limited Tel: 8007 4433 (+356 99917558)
Bristol-Myers Squibb GmbH & CO. KGaA Tel: +49 89 121 42-0
Merck Sharp & Dohme B.V.
Tel: 0800 9999000 (+31 23 5153153)
Merck Sharp & Dohme OÜ Tel.: +372 6144 200
MSD (Norge) AS Tlf: +47 32 20 73 00
MSD Α.Φ.Β.Ε.Ε
Τηλ: + 30-210 98 97 300
Merck Sharp & Dohme Ges.m.b.H.
Tel: +43 (0) 1 26 044
Bristol-Myers Squibb, S.A. Tel: +34 91 456 53 00
MSD Polska Sp. z o.o. Tel.: +48 22 549 51 00
Bristol-Myers Squibb Sarl. Tél: +33 (0)1 58 83 84 96
Merck Sharp & Dohme, Lda Tel: +351 21 4465700
Merck Sharp & Dohme d.o.o. Tel: + 385 1 6611 333
Merck Sharp & Dohme Romania S.R.L. Tel: + 4021 529 29 00
Bristol-Myers Squibb Pharmaceuticals uc Tel: +353 (0)1 483 3625
Merck Sharp & Dohme, inovativna zdravila d.o.o.
Tel: + 386 1 5204201
Vistor hf.
Sími: +354 535 7000
Merck Sharp & Dohme, s. r. o. Tel.: +421 2 58282010
dpoc_czechslovak @merck.com
Bristol-Myers Squibb S.r.l. Tel: +39 06 50 39 61
MSD Finland Oy
Puh/Tel: +358 (0) 9 804650
Merck Sharp & Dohme Cyprus Limited
Τηλ: 80000 673 (+357 22866700)
Merck Sharp & Dohme (Sweden) AB Tel: +46 (0)77 5700488
SIA Merck Sharp & Dohme Latvija Tel: +371 67364 224