600 mg film-coated tablets 
efavirenz

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

This leaflet contains information about: 
1. What Efavirenz Sandoz is and what it is used for 
2. What you need to know before taking Efavirenz Sandoz 
3. How to take Efavirenz Sandoz 
4. Possible side effects 
5. How to store Efavirenz Sandoz 
6. Contents of the packaging and other information 

What Efafirenz Sandoz is and what it is used for

Efavirenz Sandoz, which contains the active substance efavirenz, belongs to a group of medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs). It is an antiretroviral drug for human immunodeficiency virus ( HIV- 1) infection that works by reducing the amount of virus in the blood. The drug is used by adults, adolescents, and children who are 3 months or older and weigh at least 3.5 kg.

Your doctor has prescribed Efavirenz Sandoz to you because you have HIV – infection. Taking Efavirenz Sandoz in combination with other antiretroviral medicines reduces the amount of virus in the blood. This strengthens your immune system and reduces the risk of developing the disease that is associated with HIV – infection.

Efavirenz contained in Efavirenz Sandoz may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you take Efavirenz Sandoz

Do not take Efavirenz Sandoz

  • 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 heartbeat, 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, e.g. potassium or magnesium, in your blood.
  • if you are taking any of the following medicines at the same time (see also ‘Other medicines and Efavirenz Sandoz’):
  • astemizole or terfenadine (for the treatment of allergic symptoms)
  • bepridil (for the treatment of heart disease)
  • cisapride (for the treatment of heartburn)
  • ergot alkaloids (eg ergotamine, dihydroergotamine, ergonovine, and methylergonovine) (for the treatment of migraine and cluster headaches)
    • midazolam or triazolam (for insomnia)
    • pimozide, imipramine, amitriptyline, or clomipramine  (for the treatment of certain mental disorders)
    • elbasvir or grazoprevir (for the treatment of hepatitis C)
    • St. John’s wort ( Hypericum perforatum ) (a natural remedy for depression and anxiety)
    • flecainide, metoprolol (for the treatment of irregular heartbeat)
    • certain antibiotics ( macrolides , fluoroquinolones , imidazole)
    • certain antifungal drugs (triazoles)
    • certain anti-malarial drugs
    • methadone (for the treatment of opioid dependence)

If you are taking any of these medicines, tell your doctor as soon as possible. If these medicines are taken with Efavirenz Sandoz, they may cause serious and/or life-threatening side effects or remove the effect of Efavirenz Sandoz.

Warnings and cautions

Talk to your doctor or pharmacist before taking Efavirenz Sandoz.

  • Efavirenz Tablets should be taken with other medicines that are active against HIV – the virus. If you are receiving Efavirenz Sandoz because your current treatment has not prevented the virus from multiplying, you must also be given another medicine that you have not taken before.
  • You can still be infected with HIV while taking this medicine, even if the risk is reduced with effective antiretroviral therapy. Discuss the necessary measures with your doctor to avoid infecting other people. This drug is not a cure for HIV – infection and you may continue to develop infections you or other illnesses associated with HIV.
  • You should continue to be under medical observation while taking Efavirenz Sandoz.
  • Tell your doctor:
    • if you have previously had a mental illness, such as depression, or alcohol or drug abuse. Tell your doctor immediately if you feel depressed, have suicidal thoughts, or strange thoughts (see section 4, Possible side effects ).
    • if you have a history of seizures (seizures or attacks) or if you are being treated with anticonvulsants 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 that it is not affected when you take Efavirenz Sandoz. Your doctor may choose to give you another anticonvulsant.
    • if you have previously had any liver disease, chronic hepatitis also applies in the active stage. Patients with chronic hepatitis B or C and 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 samples to check your liver function or change your treatment to another medicine. If you have severe liver disease, do not take Efavirenz Sandoz(see section 2, Do not take Efavirenz Sandoz).
    • if you have a heart condition, such as an abnormal electrical signal called an extended QT interval.
  • When you start taking Efavirenz Sandoz, pay attention to the following:
    • signs of dizziness, difficulty sleeping, drowsiness, difficulty concentrating, or abnormal dreams. These side effects may occur during the first or second day of treatment and usually disappear after the first 2 – 4 weeks.
    • signs of the rash. If you see signs of severe rash with blisters or fever, stop taking Efavirenz Sandoz and tell your doctor as soon as possible. If you have had a skin rash with another medicine in the NNRTI group, you may be at greater risk of getting a skin rash with Efavirenz Sandoz.
    • signs of inflammation or infection. In some patients with advanced HIV – infection ( AIDS ) and a history of opportunistic infection, you may be signs and symptoms of inflammation from previous infections that happen shortly after anti- HIV started. These symptoms are probably due to an improvement in the body’s immune response, which enables the body to fight infections that may have been present without any obvious symptoms. Tell your doctor immediately if you notice any symptoms of infection. In addition to opportunistic infection, you can autoimmune disorders (a condition in which the immune system attacks healthy body tissue) may also occur after you start taking medicines to treat your HIV – infection. Autoimmune disorders can 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 torso, palpitations, tremors, or hyperactivity, informs your doctor immediately for the necessary treatment.
    • bone tissue problems. Some patients receiving combination antiretroviral therapy may develop a bone disease called osteonecrosis (bone tissue dies due to lost blood supply to the bone). Some of the many risk factors for developing the disease are long-term antiretroviral combination therapy, use of corticosteroids, alcohol consumption, a severe weakening of the immune system, and higher body mass index. Signs of osteonecrosis are stiffness in the joints, ache,s and pains (especially in the hip, knee, and shoulders), and difficulty moving. Tell your doctor if you experience any of these symptoms.

Children and young people

Efavirenz Sandoz is not recommended for use in children less than 3 months of age or weighing less than 3.5 kg, as it has not been adequately studied in these patients.

Other medicines and Efavirenz Sandoz

You must not take Efavirenz Sandoz with certain medicines. These are listed at the beginning of section 2, under “Do not take Efavirenz Sandoz”This applies to certain common medicines and herbal medicines ( St. John’s wort ) that can cause serious interactions (interactions).

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. Efavirenz Sandoz may interact with other medicines, including herbal medicines such as Ginkgo biloba extract . This means that the amount of Efavirenz Sandoz or another medicine in the blood may be affected. This may mean that the effect of the drugs is reduced or absent or that the side effects may be worse. In some cases, the doctor,r therefor,e needs to change the dosage one 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 for HIV infection:
    • protease inhibitors: darunavir, indinavir, lopinavir / ritonavir, ritonavir, ritonavir-enhanced atazanavir, saquinavir or fosamprenavir / saquinavir. Your doctor may consider giving you another medicine or changing the dose of the protease inhibitor. maraviroc
    • Combination medicines containing efavirenz, emtricitabine,e, and tenofovir should not be taken with Efavirenz Sandoz unless recommended by your doctor as it contains efavirenz, the active substance in Efavirenz Sandoz.
  • Medicines used for the treatment of infection with the hepatitis C virus:boceprevir, telaprevir, elbasvir / grazoprevir, simeprevir, sofosbuvir / velpatasvir, sofosbuvir / velpatasvir / voxilaprevir, glekaprevir / pibrentasvir. 
  • Drugs used to treat bacterial infections , which include tuberculosis and AIDS-related MAC ( mycobacterium avium complex) infection: clarithromycin, rifabutin, rifampicin. Your doctor may consider changing your dose or giving you another antibiotic. Your doctor may also increase the dose of Efavirenz Sandoz.
  • Medicines used to treat fungal infections:
    • voriconazole. Efavirenz Sandoz may reduce the amount of voriconazole in your blood and voriconazole may increase the amount of efavirenz in your blood. If you are taking these two medicines at the same time, the dose of voriconazole must be increased and the dose of efavirenz reduced. You must consult your doctor first.
    • itraconazole. Efavirenz Sandoz may reduce the amount of itraconazole in your blood.
    • posaconazole. Efavirenz Sandoz may reduce the amount of posaconazole in your blood.
  • Drugs used to treat malaria:
    • artemeter / lumefantrine: Efavirenz Sandoz may reduce the amount of artemeter / lumefantrine in your blood.
    • atovaquone / proguanil: Efavirenz Sandoz may reduce the amount of atovaquone / proguanil in your blood.
  • Medicines for the treatment of seizures / seizures (anticonvulsants): carbamazepine, phenytoin , phenobarbital. Efavirenz Sandoz may reduce or increase the amount of anticonvulsant in your blood. Carbamazepine may reduce the effect of Efavirenz Sandoz. Your doctor may choose to give you another anticonvulsant medicine.
  • Drugs used to lower blood fats (so-called statins): atorvastatin, pravastatin, simvastatin. Efavirenz Sandoz may reduce the number 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 medicine used to treat opiate addiction): Your doctor may recommend an alternative treatment.
  • Sertraline (a medicine used to treat depression): Your doctor may need to change the dose of sertraline .
  • Bupropion (a medicine used to treat depression or to help you quit smoking): Your doctor may need to change the dose of bupropion.
  • Diltiazem or similar medicines (so-called calcium channel blockers which are commonly used for high blood pressure or heart problems): when you start Efafirenz Sandoz treatment, your doctor may need to change the dose of one of the calcium channel blockers.
  • Immunosuppressive drugs, such as ciclosporin, sirolimus,s, or tacrolimus(medicines that prevent organ rejection after transplantation): when starting or stopping treatment with Efavirenz Sandoz, your doctor will closely monitor the plasma levels of the immunosuppressive drug and may need to change the dose of it.
  • Hormonal contraceptives, such as pills , p- syringe (such as Depo-Provera,) or-Rodd (eg, Implanon):  you must also use a reliable barrier contraceptive (See Pregnancy). Efavirenz Sandoz may impair the effectiveness of hormonal contraceptives. Pregnancy has occurred in women treated with Efavirenz Sandoz while using the contraceptive pill. However, it has not been possible to establish that treatment with Efavirenz Sandoz caused any failure to protect the contraceptive.
  • Warfarin or acenocoumarol (medicines used to reduce blood clotting capacity): your doctor may need to change the dose of warfarin or acenocoumarol.
  • Extract of Ginkgo biloba (herbal medicine).
  • Drugs that affect the heart rhythm:
    • Medicines to treat heart rhythm problems: eg flecainide or metoprolol .
    • Drugs used to treat depression: eg imipramine, amitriptyline,e, or clomipramine.
    • Antibiotics, including the following types: macrolides, fluoroquinolone,s or imidazole.

Efavirenz Sandoz with food and drink

Taking Efavirenz Sandoz on an empty stomach may reduce the side effects .

Grapefruit juice should be avoided when using Efavirenz Sandoz.

Pregnancy and breastfeeding

Women should not become pregnant during treatment with Efavirenz Sandoz and for 12 weeks thereafter. Your doctor may ask you to take a pregnancy test to make sure you are not pregnant before starting treatment with Efavirenz Sandoz.

If you are at risk of becoming pregnant while receiving Efavirenz Sandoz, you will need to use a reliable barrier contraceptive (such as a condom) along with other contraceptive methods such as tablets ( birth control pills ) or other hormonal contraceptives (such as birth control pills , syringes ). Efavirenz may remain in your blood for some time after stopping treatment. Therefore, you should continue to use contraception, as described above, for 12 weeks after the last dose of Efavirenz Sandoz.

Tell your doctor immediately if you are pregnant or planning to become pregnant. If you are pregnant, you should only take Efavirenz Sandoz if you and your doctor decide that there is a clear need. Consult your doctor or pharmacist before taking any medicine.

Serious birth defects have been observed in unborn animals and in infants of women treated with efavirenz or a combination drug containing efavirenz, emtricitabine,e, and tenofovir during pregnancy. If you have taken Efavirenz Sandoz or the combination tablet containing efavirenz, emtricitabine,e, and tenofovir during your pregnancy, your doctor may need to take regular blood tests and other diagnostic tests to monitor your baby’s progress.

You should not breast-feed your baby if you are taking Efavirenz Sandoz.

Driving and using machines

Efavirenz Sandoz contains efavirenz and may cause dizziness, impaired concentration,n, and drowsiness. If you are affected, avoid driving and using tools or machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and / or side effects . Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Efavirenz Sandoz contains lactose

Efavirenz Sandoz contains 100.3 mg of lactose monohydrate 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 medicine.

Other formulations of efavirenz are available in the market for these patients.

How to take Efavirenz Sandoz

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure. Your doctor will tell you which dose to take.

  • Dose one for adults is 600 mg once daily.
  • If you are taking certain other medicines at the same time, the dose of Efavirenz Sandoz may need to be increased or decreased (see section Other medicines and Efavirenz Sandoz).
  • Efavirenz Sandoz is taken by mouth. Efavirenz Sandoz is recommended to be taken on an empty stomach, preferably at bedtime. This can reduce the symptoms of certain side effects (such as dizziness and drowsiness). By fasting,g stomach is usually meant 1 hour before or 2 hours after a meal.
  • The tablet should be swallowed whole with water.
  • Efavirenz Sandoz must be taken every day.
  • Efavirenz Sandoz should never be used alone to treat HIV . Efavirenz Sandoz must always be taken in combination with other HIV medicines.

Use for children and adolescents

  • Efavirenz Sandoz film-coated tablets are not suitable for children weighing less than 40 kg.
  • The dose for children weighing 40 kg or more is 600 mg once a day. Other formulations of efavirenz are available on the market for patients in need of dose adjustment. You should refer to the enclosed package leaflet for suitable formulations for dosing in children (3 to 17 years).

The tablet can be divided into two equal doses.

The tablet can be divided if you have difficulty swallowing it whole.

If you take more Efavirenz Sandothenan you should

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital,l or the Poison Information Center for risk assessment and advice. Bring the medicine package with you so you can account for what you have taken.

If you forget to take Efavirenz Sandoz

Try not to miss a 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 a forgotten dose . If you need help planning when it is best to take your medicine, ask your doctor or pharmacist.

If you stop taking Efavirenz Sandoz

When your Efavirenz Sandoz tablets start to run out, make sure you get more from your doctor or pharmacist. This is very important because the amount of virus can start to increase as soon as you stop taking the medicine, even if it is only for a short time. The virus can then become more difficult to treat.

If you have any further questions on the use of this product, ask your doctor, pharmacist,t, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects , although not everybody gets them.

In the treatment of HIV – infection , it is not always possible to tell whether some of the unwanted effects are caused by Efavirenz Sandoz, by other medicines taken at the same time,e or by the HIV -sjukdomen.

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 when it comes to blood lipids, there may sometimes be a link with HIV drugs. The doctor will perform tests to find such changes.

The most notable side effects reported with efavirenz in combination with other anti- HIV medicines are skin rash and central nervous system symptoms 

Always consult your doctor if you get a rash, as some rashes can be severe. In most cases, the rash disappears without the need to change treatment with Efavirenz Sandoz. The rash is more common in children than in adults treated with efavirenz.

The symptoms of the central nervous system usually appear at the beginning of the treatment, but usually decrease during the first weeks. In one study, central nervous system symptoms often appeared during the first 1-3 hours after a dose. If you are affected by symptoms, your doctor may suggest that you take Efavirenz Sandoz at bedtime and on an empty stomach. Some patients may have more severe symptoms that affect their mood or ability to think clearly. Some patients have committed suicide. The problems tend to occur more often in those who have previously had a mental illness. Always tell your doctor immediately if you get these symptoms or other side effects while taking Efavirenz Sandoz.

Tell your doctor if you experience any of the following side effects:

Very common (may affect more than 1 user in 10)

  • rash

Common (may affect up to 1 in 10 people)

  • abnormal dreams, difficulty concentrating, dizziness, headache, difficulty sleeping, drowsiness, coordination,n, or balance difficulties
  • abdominal pain, diarrhea, nausea, vomiting
  • itching
  • fatigue
  • anxiety, feeling of depression

Tests can show:

  • elevated liver enzymes in the blood
  • elevated triglycerides (fatty acids) in the blood

Uncommon (may affect up to 1 in 100 people)

  • nervousness, forgetfulness, confusion, seizures, strange thoughts
  • dimsyn
  • feeling dizzy or lethargic (dizziness)
  • abdominal pain caused by inflammation of the pancreas
  • allergic reaction (hypersensitivity) that can cause severe skin reactions (erythema multiforme, Stevens-Johnson syndrome )
  • yellow skin or eyes, itching or abdominal pain caused by the hepatitis
  • breast augmentation in men
  • angry behavior, mood swings, seeing and hearing imaginary things (hallucinations, psychosis ), mania (mental state characterized by hyperactivity, elation,n, or irritability), paranoia , suicidal thoughts, catatonia a (condition in which the patient becomes immobile and loses the ability to speak for a period), suicide attempts
  • whistling, bringing,g or another persistent sound in the ears
  • trembling (shaking)
  • hemorrhage

Tests can show:

  • elevated blood cholesterol

Rare (may affect up to 1 in 1,000 people)the

  • the itchy rash caused by a reaction to sunlight
  • Liver failure, which in some cases has led to death or liver transplantation, has occurred with efavirenz. Most cases occurred in patients who already had liver disease, but a few reports have included patients without any liver disease.
  • unexplained anxiety not associated with hallucinations but with possible difficulty thinking clearly or sensibly
  • suicide
  • delusions

5. How to store Efavirenz Sandoz

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 can label, blister or carton after EXP. or EXP. The expiration date is the last day of the specified month.

No special storage instructions.

Jar: Used within 2 months after opening.

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. Contents of the packaging and other information

Content declaration

  • Each film-coated tablet contains 600 mg of the active substance efavirenz.
  • The other ingredients in the tablet core are croscarmellose sodium, microcrystalline cellulose, sodium lauryl sulfate, hydroxypropyl cellulose, lactose monohydrate,e, and magnesium stearate.
  • The film coating contains hypromellose (E464), quinoline yellow aluminum lacquer (E104), titanium dioxide (E171), macrogol,l, and red iron oxide (E172).

What the medicine looks like and the contents of the pack

Efavirenz Sandoz is a yellow, capsule-shaped (9.6 x 19.2 mm), film-coated tablet with a scoreline on both sides. The tablet can be divided into equal doses .

Efavirenz Sandoz film-coated tablets are supplied in:

  • HDPE jar witha a child-resistant polypropylene lid and a sealed container containing silica gel: 30, 90 (3×30) or 120 (4×30) film-coated tablets
  • White, opaque PVC / Aclar / Al blister: 10, 28, 30, 50, 60, 84, 90, 100 or 120 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark

Manufacturer

Lek Pharmaceuticals dd, Verovškova 57, 1526 Ljubljana, Slovenia

or

LEK SA, ul. Domaniewska 50 C, 02-672, Warsaw, Poland

or

SC Sandoz, SRL, Str. Livezeni no. 7A, RO-540472 Targu-Mures, Romania

or

Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany

or

Lek Pharmaceuticals dd, Trimlinei 2D, 9220 Lendava, Slovenia

Muhammad Nadeem

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