EFAVIRENZ MILPHARM 600 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

Patient leaflet - EFAVIRENZ MILPHARM 600 MG FILM-COATED TABLETS

What is in this leaflet

1. What Efavirenz is and what it is used for
2. What you need to know before you take Efavirenz
3. How to take Efavirenz
4. Possible side effects
5. How to store Efavirenz
6. Contents of the pack and other information

1. what efavirenz is and what it is used for

Efavirenz, which contains the active substance efavirenz, belongs to a class of antiretroviral medicines called nonnucleoside reverse transcriptase inhibitors (NNRTIs). It is an antiretroviral medicine that fights human immunodeficiency virus (HIV-1) infection by reducing the amount of the virus in blood. It is used by adults, adolescents and children 3 months of age and older and weighing at least 3.5 kg.

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

Efavirenz 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.

2. what you need to know before you take efavirenz 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 a heart condition, such as changes in the rhythm or rate of the heart beat, a slow heart beat, or severe heart disease.
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 magnesium in your blood.

if you are currently taking any of the following medicines:
- astemizole or terfenadine (used to treat allergy symptoms)
- bepridil (used to treat heart disease)
- cisapride (used to treat heartburn)
- ergot alkaloids (for example, ergotamine, dihydroergotamine, ergonovine, and methylergonovine) (used to treat migraine and cluster headaches)
- midazolam or triazolam (used to help you sleep)
- pimozide,imipramine, amitriptyline or clomipramine (used to treat certain mental conditions)
- elbasvir or grazoprevir (used to treat hepatitis C)
- St. John’s wort (Hypericum perforatum ) (a herbal remedy used for depression and anxiety)
- flecainide, metoprolol (used to treat irregular heart beat)
- certain antibiotics (macrolides, fluoroquinolones, imidazole)
- triazole antifungal agents
- certain antimalarial treatments
- methadone (used to treat opiate addiction)

If you are taking any of these medicines, tell your doctor immediately. Taking these medicines with Efavirenz could create the potential for serious and/or life-threatening side-effects or stop Efavirenz from working properly.

Warnings and precautions

Talk to your doctor or pharmacist before taking Efavirenz.

Efavirenz must be taken with other medicines that act against the HIV virus. If Efavirenz is started because your current treatment has not prevented the virus from multiplying, another medicine you have not taken before must be started at the same time.
You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy. Discuss with your doctor the precautions needed to avoid infecting other people. This medicine is not a cure for HIV infection and you may continue to develop infections or other illnesses associated with HIV disease.
You must remain under the care of your doctor while taking Efavirenz.

Children and adolescents

Efavirenz is not recommended for children under the age of 3 months or weighing less than 3.5 kg because it has not been adequately studied in these patients.

Other medicines and Efavirenz

These are listed under Do not take Efavirenz, at the start of Section 2. They include some common medicines and a herbal remedy (St. John’s wort) which can cause serious interactions.

Tell your doctor , pharmacist or nurse if you are taking, have recently taken or might take any other medicines. Efavirenz may interact with other medicines, including herbal preparation such as Ginkgo biloba extracts. As a result, the amounts of Efavirenz 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:

Pregnancy, breast-feeding and fertility

Women should not get pregnant during treatment with Efavirenz 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 Efavirenz.

If you could get pregnant while receiving Efavirenz, 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 Efavirenz.

Tell your doctor immediately if you are pregnant or intend to become pregnant. If you are pregnant you should take Efavirenz 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 or a combination medicine containing efavirenz, emtricitabine and tenofovir during pregnancy. If you have taken Efavirenz 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.

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

Driving and using machines

Efavirenz contains efavirenz and may cause dizziness, impaired concentration, and drowsiness. If you are affected, do not drive and do not use any tools or machines.

Efavirenz contains lactose

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

Efavirenz contains sodium

This medicine contains less than 1 mmol sodium(23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. how to take efavirenz

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 600 mg once daily.
The dose for Efavirenz may need to be increased or decreased if you are also taking certain medicines (see Other medicines and Efavirenz).
Efavirenz is for oral use. Efavirenz is recommended to be taken on an empty stomach preferably at bedtime. This may make some side effects (for example, dizziness, drowsiness) less troublesome. An empty stomach is commonly defined as 1 hour before or 2 hours after a meal.
It is recommended that the tablet be swallowed whole with water.
Efavirenz must be taken every day.
Efavirenz should never be used alone to treat HIV. Efavirenz must always be taken in combination with other anti-HIV medicines.

Use in children and adolescents

Efavirenz 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 daily.

If you take more Efavirenz than you should

If you take too much Efavirenz, 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 Efavirenz

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 Efavirenz

When your Efavirenz 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 medicine, ask your doctor, pharmacist or nurse.

4. 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 tell whether some of the unwanted effects are caused by Efavirenz 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 efavirenz 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 Efavirenz. Rash was more common in children than in adults treated with efavirenz.

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 Efavirenz 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 Efavirenz.

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

Very common (may affect more than 1 in 10 people) skin rash

Common (may affect up to 1 in 10 people)

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 trigycerides (fatty acids) in the blood
Uncommon (may affect up to 1 in 100 people) 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
Rare (may affect up to 1 in 1,000 people) 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

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via website: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store efavirenz

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 label, carton after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions

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.

6. contents of the pack and other information- the active substance is efavirenz. each film-coated tablet contains 600 mg of efavirenz.

– The other ingredients are:

What Efavirenz looks like and contents of the pack

Yellow coloured, oval shaped, beveled edge, biconvex, film-coated tablets, debossed with ‘L’ on one side and ‘11’ on the other side. The size is 20.1 mm X 9.6 mm.

Efavirenz 600 mg film-coated tablets are available in clear PVC/ PVdC- Aluminium foil blister pack and white opaque HDPE bottle pack with white opaque polypropylene closure.

Blister pack: 30 and 90 tablets

HDPE bottle pack: 30, 90 and 500 tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Milpharm Limited

Ares Block, Odyssey Business Park

West End Road

Ruislip HA4 6QD

United Kingdom

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta or