600 mg film-coated tablets 
efavirenz

Read all of this leaflet carefully before you start using 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 Teva is and what it is used for 
2. What you need to know before you use Efavirenz Teva 
3. How to take Efavirenz Teva 
4. Possible side effects 
5. How to store Efavirenz Teva 
6. Package contents and other information 

1. What Efavirenz Teva is and what it is used for

Efavirenz Teva, which contains the active substance efavirenz, belongs to a group of medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs). It is an antiretroviral agent against the Human immunodeficiency virus ( HIV ) – an infection that works by reducing the viral load in the blood. It is used by adults, adolescents, and children aged 3 years and older.

Your doctor has prescribed Efavirenz Teva for you because you have HIV – infection. Taking Efavirenz Teva 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.

What you need to know before you use Efavirenz Teva

Do not use Efavirenz Teva

  • 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, such as 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 Teva’):
    • 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. Taking these medicines together with Efavirenz Teva may cause serious and/or life-threatening side effects or reduce or eliminate the effects of Efavirenz Teva.

Warnings and cautions

Talk to your doctor before taking Efavirenz Teva.

  • Efavirenz Teva must be taken with other medicines that are active against HIV – the virus. If you are receiving Efavirenz Teva 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, although the risk of effective antiviral therapy is reduced. 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 Teva.
  • 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 have strange thoughts (see section 4 Possible side effect s).
    • 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 it is not affected when you take Efavirenz Teva. 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 to change your treatment to another medicine. If you have severe liver disease, do not take Efavirenz Teva (see section 2, Do not use Efavirenz Teva ).
    • if you have a heart condition, such as an abnormal electrical signal called an extended QT interval.
  • When you start taking Efavirenz Teva, 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 notice signs of severe rash with blisters or fever, stop taking Efavirenz Teva 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 Teva.
    • signs of inflammation or infection. In some patients with advanced HIV infection ( AIDS ) and who have previously had opportunistic infections, signs and symptoms of inflammation from previous infections may occur shortly after starting treatment for HIV. 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, inform 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 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

Efavirenz Teva film-coated tablets are not recommended for children younger than 3 years or weighing less than 40 kg.

Other medicines and Efavirenz Teva

You must not take Efavirenz Teva with certain medicines. These are listed at the beginning of section 2, under Do not use Efavirenz Teva. 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 Teva may interact with other medicines, including herbal medicines such as Ginkgo biloba extract. This means that the amount of Efavirenz Teva 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, therefore, 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
    • the combination medicine containing efavirenz, emtricitabine, and tenofovir should not be taken with Efavirenz Teva unless recommended by your doctor as it contains efavirenz, the active substance in Efavirenz Teva.
  • Drugs used to treat infection by 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 Teva.
  • Medicines used to treat fungal infections:
    • voriconazole. Efavirenz Teva 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 Teva may reduce the amount of itraconazole in your blood.
    • posaconazole. Efavirenz Teva may reduce the amount of posaconazole in your blood.
  • Drugs used to treat malaria:
    • aretmeter / lumefantrine: Efavirenz Teva may reduce the amount of aretmeter / lumefantrine in your blood.
    • atovaquone / proguanil: Efavirenz Teva may reduce the amount of atovaquone / proguanil in your blood.
  • Medicines for the treatment of seizures/seizures (anticonvulsants): carbamazepine, phenytoin, phenobarbital. Efavirenz Teva may reduce or increase the amount of anticonvulsant in your blood. Carbamazepine may reduce the effect of Efavirenz Teva. Your doctor may choose to give you another anticonvulsant medicine.
  • Drugs used to lower blood fats (so-called statins): atorvastatin, pravastatin, simvastatin. Efavirenz Teva 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 treatment with Efavirenz Teva, your doctor may need to change the dose of one of the calcium channel blockers.
  • Immunosuppressive drugs, such as ciclosporin, sirolimus, or tacrolimus(medicines that prevent organ rejection after transplantation): when you start or end treatment with Efavirenz Teva, your doctor will monitor the plasma levels of the immunosuppressive drug and may need to change the dose of one of them.
  • Hormonal contraceptives, such as pills, p- syringe (e.g. Depo-Provera), or P-Rod (for example, Implanon): you must also use a reliable barrier contraceptive (see pregnancy, lactation, and fertility ). Efavirenz Teva may impair the effectiveness of hormonal contraceptives. Pregnancy has occurred in women treated with Efavirenz Teva while using the contraceptive pill. However, it has not been established that treatment with Efavirenz Teva 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 for the treatment of depression, such as imipramine, amitriptyline, or clomipramine.
    • Antibiotics, including the following types: macrolides, fluoroquinolones, or imidazole.

Efavirenz Teva with food and drink

Taking Efavirenz Teva on an empty stomach may reduce the side effects. Grapefruit juice should be avoided when using Efavirenz Teva.

Pregnancy, breastfeeding, and fertility

Women should not become pregnant during treatment with Efavirenz Teva 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 Teva.

If you are at risk of becoming pregnant while taking Efavirenz Teva, 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 the contraceptive pill, syringe ). Efavirenz may remain in your blood for some time after stopping treatment. Therefore, you should continue to use contraceptives, as described above, for 12 weeks after the last dose of Efavirenz Teva.

Tell your doctor immediately if you are pregnant or planning to become pregnant. If you are pregnant, you should only take Efavirenz Teva 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 infants of women treated with efavirenz or a combination drug containing efavirenz, emtricitabine, and tenofovir during pregnancy. If you have taken Efavirenz Teva or the combination tablet that contains efavirenz, emtricitabine, and tenofovir during your pregnancy, your doctor may need to take regular blood tests and other diagnostic tests to monitor the development of your baby.

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

Driving and using machines

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

Efavirenz Teva contains

Lactose

This medicine contains 9.98 mg of lactose (as a monohydrate) per tablet.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Sodium

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’. is next to “sodium-free”.

How to take Efavirenz Teva

Always use 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 Teva may need to be increased or decreased (see “Other medicines and Efavirenz Teva”).
  • Efavirenz Teva is taken by mouth. Efavirenz Teva is recommended for use on an empty stomach, preferably at bedtime. This can reduce the symptoms of certain side effects (such as dizziness and drowsiness). By fasting, the stomach is usually meant 1 hour before or 2 hours after a meal.
  • The tablet should be swallowed whole with water.
  • Efavirenz Teva must be taken every day.
  • Efavirenz Teva should never be used alone to treat HIV. Efavirenz Teva must always be taken in combination with other HIV medicines.

Use for children and adolescents

  • Efavirenz Teva 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.

If you take more Efavirenz Teva then you should

If you take more Efavirenz Teva then you should contact your doctor or nearest emergency department for advice. Bring the medicine package with you so you can account for what you have taken.

If you forget to take Efavirenz Teva

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 Teva

When your Efavirenz Teva 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, 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 Teva or by other medicines you take at the same time 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 can sometimes be a connection 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 Teva. 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 the symptoms, your doctor may suggest that you take Efavirenz Teva 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 Teva.

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

Very common (affects more than 1 user in 10)

  • rash

Common (affects 1 to 10 users in 100)

  • abnormal dreams, difficulty concentrating, dizziness, headache, difficulty sleeping, drowsiness coordination, 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 (affects 1 to 10 users in 1,000)

  • 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), mania (mental state characterized by hyperactivity, elation or irritability), paranoia, suicidal thoughts, catatonia (a condition in which the patient becomes immobile and loses the ability to speak for a period)
  • whistling, ringing, or another persistent sound in the ears
  • trembling (shaking)
  • hemorrhage

Tests can show:

  • elevated blood cholesterol

Rare (affects 1 to 10 users in 10,000)

  • 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 with a history of 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

5. How to store Efavirenz Teva

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 carton after EXP. dat. and on the blister after EXP. The expiration date is the last day of the specified 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.

6. Contents of the packaging and other information

Content declaration

  • Each Efavirenz Teva film-coated tablet contains 600 mg of the active substance efavirenz.
  • The other ingredients in the tablet core are microcrystalline cellulose, hydroxypropyl cellulose, sodium lauryl sulfate, sodium starch glycolate (type A), poloxamer 407, and magnesium stearate. The film coating contains hypromellose, lactose monohydrate, titanium dioxide, macrogol PEG 3350, triacetin, and yellow iron oxide.

What the medicine looks like and the contents of the pack

  • Film-coated tablet: yellow, capsule-shaped, film-coated tablet marked “Teva” on one side and “7541” on the other side.
  • Efavirenz Teva is available in pack sizes of 30, 90 film-coated tablets or 30 x 1/90 x 1 film-coated tablet (in perforated unit dose blisters) or multi-pack bundles or cartons containing 90 film-coated tablets (3 packs of 30 x 1 film-coated tablet). Not all pack sizes may be marketed.

Marketing Authorisation Holder

Teva BV, Swensweg 5, 2031GA Haarlem, The Netherlands

Manufacturer

PLIVA Hrvatska doo (PLIVA Croatia Ltd.), Prilaz Varuna Filipovića 25, 10000 Zagreb, Croatia

Contact the representative of the marketing authorization holder to find out more about this medicine:
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Belgique / België / BelgienTeva Pharma Belgium NV / SA / AGTel: +32 38207373 LithuaniaUAB Sicor BiotechTel: +370 52660203
BulgariaOctavis FADTel: +359 24899585 Luxembourg / LuxemburgTeva Pharma Belgium NV / SA / AG Belgique / BelgienTel: +32 38207373
Czech RepublicTeva Pharmaceuticals CR, sroTel: +420 251007111 HungaryTeva Gyógyszergyár Zrt.Tel: +36 12886400
DenmarkTeva Denmark A / STel: +45 44985511 MaltaTeva Pharmaceuticals Ireland-IrelandTel: +353 19630330
Germanyratiopharm GmbHTel: +49 73140202 The NetherlandsTeva Nederland BVTel: +31 8000228400
EestiUAB Sicor Biotech Eesti subsidiaryTel: +372 6610801 NorwayTeva Norway ASTel: +47 66775590
GreeceTeva Αλλάς Α.Ε.:Ηλ: +30 2118805000 Austriaratiopharm Arzneimittel Vertriebs-GmbHTel: +43 1970070
SpainTeva Pharma, SLUTel: +34 9138732 80 PolandTeva Pharmaceuticals Polska Sp. z ooTel: +48 223459300
FranceTeva HealthTel: +33 155917800 PortugalTeva Pharma – Pharmaceutical Products Lda.Tel: +351 214767550
CroatiaPliva Hrvatska dooTel: + 385 13720000 RomaniaTeva Pharmaceuticals SRLTel: +40 212306524
IrelandTeva Pharmaceuticals IrelandTel: +353 19630330 SloveniaPliva Ljubljana dooTel: +386 15890390
Icelandratiopharm OyFinlandPhone: +358 201805900 Slovak RepublicTeva Pharmaceuticals Slovakia sroTel: +421 257267911
ItalyTeva Italia SrlTel: +39 028917981 Finland / Finlandratiopharm OyPuh / Tel: +358 201805900
LatviaUAB Sicor Biotech subsidiary LatvijāTel: +371 67323666 United KingdomTeva UK LimitedTel: +44 1977628500

Muhammad Nadeem

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