Consumer medicine information

Tenofovir Disoproxil/Emtricitabine/Efavirenz Viatris 300/200/600

Tenofovir disoproxil maleate + Emtricitabine + Efavirenz

BRAND INFORMATION

Brand name

Tenofovir Disoproxil/Emtricitabine/Efavirenz Viatris 300/200/600

Active ingredient

Tenofovir disoproxil maleate + Emtricitabine + Efavirenz

Schedule

TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600

 Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

 1. Why am I using TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600?

TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600 contains the active ingredient tenofovir disoproxil maleate, emtricitabine and efavirenz. This medicine is used to treat Human Immunodeficiency Virus (HIV-1) infection in adults.

See Section 1. Why am I using TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600? in the full CMI.

 2. What should I know before I use TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600?

Do not use if you have ever had an allergic reaction to tenofovir disoproxil maleate, emtricitabine and efavirenz or any of the ingredients listed at the end of the CMI. Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I use TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600? in the full CMI.

 3. What if I am taking other medicines?

Some medicines may interfere with this medicine and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

 4. How do I use TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600?

The usual dose of TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600 is one tablet once a day.

Details are in Section 4. How do I use TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600? in the fullCMI.

 5. What should I know while using TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600?

Things you should do	Remind any doctor or pharmacist you visit that you are using this medicine. When your medicine supply starts to run low, get more from your doctor or pharmacy.
Things you should not do	Do not stop using this medicine suddenly. Avoid doing things that can spread HIV infection.
Driving or using machines	Be careful driving or operating machinery until you know how this medicine affects you. If you are dizzy, have trouble concentrating, or are drowsy, avoid activities that may be dangerous.
Drinking alcohol	Taking this medicine with alcohol or other medicines causing similar side effects such as drowsiness, may increase those side effects.
Looking after your medicine	Keep this medicine and all other medications out of reach of children. Store this medicine in a cool, dry place where it stays below 25°C.

For more information, see Section 5. What should I know while using TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600? in the full CMI.

 6. Are there any side effects?

The common side effects are dizziness, headache, trouble sleeping, drowsiness, trouble concentrating, unusual dreams, rash, tiredness, upset stomach, vomiting, gas and diarrhoea. Tell your doctor right away if any of these side effects bother you.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600

Active ingredients: tenofovir disoproxil maleate, emtricitabine, efavirenz

 Consumer Medicine Information (CMI)

This leaflet provides important information about using TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600.

Where to find information in this leaflet:

1. Why am I using TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600?
2. What should I know before I use TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600?
3. What if I am taking other medicines?
4. How do I use TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600?
5. What should I know while using TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600?
6. Are there any side effects?
7. Product details

 1. Why am I using TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600?

TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600 contains the active ingredients tenofovir disoproxil maleate, emtricitabine and efavirenz. These are combined in one tablet to help control Human Immunodeficiency Virus (HIV-1) infection.

Tenofovir disoproxil and emtricitabine belong to a group of antiviral medicines known as nucleoside and nucleotide reverse transcriptase inhibitors (NRTI). Efavirenz belongs to a group of antiviral medicines known as non-nucleoside reverse transcriptase inhibitors (NNRTI).

TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600 is used to treat HIV-1 infection in adults. This medicine can be taken alone or in combination with other anti-HIV medicines.

Do not take TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600 if you are under the age of 18 years.

Do not take TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600 if you are over the age of 65 before discussing with your doctor.

How TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600 works

HIV-1 infection destroys CD4 T cells, which are important to the immune system. The immune system helps fight infection. After a large number of T cells are destroyed, acquired immune deficiency syndrome (AIDS) may develop.

TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600 helps block HIV-1 reverse transcriptase, a viral chemical in your body (enzyme) that is needed for HIV-1 to multiply. TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600 lowers the amount of HIV-1 in the blood (viral load). TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600 may also help to increase the number of T cells (CD4+ cells), allowing your immune system to improve. Lowering the amount of HIV-1 in the blood lowers the chance of death or infections that happen when your immune system is weak (opportunistic infections).

TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600 does not cure HIV-1 infection or AIDS.

The long-term effects of TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600 are not known at this time. People taking TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600 may still get opportunistic infections or other conditions that happen with HIV-1 infection.

Opportunistic infections are infections that develop because the immune system is weak.

Some of these conditions are:

pneumonia,
herpes virus infections, and
Mycobacterium avium complex (MAC) infections.

This medicine is only available from a pharmacist after it has been prescribed by a doctor who specialises in the treatment of HIV-1 infection.

If you wish to continue receiving treatment with TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600, it is important you remain under the care of a hospital or doctor who specialises in the treatment of HIV-1 infection.

TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600 has not been shown to lower your chance of passing HIV to others through sexual contact, sharing needles, or being exposed to your blood.

Do not share needles or other injection equipment.

Do not share personal items that can have blood or body fluids on them, like toothbrushes or razor blades.

Do not have any kind of sex without protection.

 2. What should I know before I use TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600?

Warnings

Do not use TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600 if:

you are allergic to tenofovir disoproxil maleate, tenofovir disoproxil fumarate, emtricitabine, efavirenz or any of the ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing, rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body.
Always check the ingredients to make sure you can use this medicine.
Do not use TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600 for a condition for which it was not prescribed.
Do not share TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600 with other people even if they have the same symptoms that you have. It may harm them.

Check with your doctor if you have:

kidney problems or are undergoing kidney dialysis treatment
bone problems
liver problems, including Hepatitis B Virus (HBV) infection
HIV infection. Your doctor may want to do tests to check your liver while you take TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600
ever had mental illness or are using recreational drugs or alcohol
ever had seizures or are taking medicine for seizures
ever had a serious allergic drug reaction involving the skin (e.g. Stevens Johnson syndrome)
any medical conditions.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Women taking TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600 should not become pregnant. Serious birth defects have been seen in the babies of animals and women treated with efavirenz (a component of TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600) during pregnancy. It is not known whether efavirenz caused these defects.

Women of child-bearing age receiving treatment with TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600 should not rely only on hormone-based birth control, such as pills, injections or implants.

TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600 may make these contraceptives ineffective. Women must use a reliable form or barrier contraception (such as a condom or diaphragm), even if they also use other methods of birth control.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Do not breast-feed if you are taking TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600.

It is recommended that nursing mothers do not breast-feed during treatment with TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600. In general, women infected with HIV should not breast-feed their infants in order to avoid transmission of HIV to their newborn infant.

The active substances in this medicine (tenofovir and emtricitabine and efavirenz) have been found in breast milk at low concentrations.

Do not breast-feed if you have HIV or HBV.

If you are a woman who has or will have a baby, talk with your doctor or pharmacist about the best way to feed your baby. If your baby does not already have HIV or HBV, there is a chance that the baby can get HIV or HBV through breast-feeding. In general, women infected with HIV should not breast-feed their infants in order to avoid transmission of HIV to their newborn infant.

 3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600 may change the effect of other medicines, including the ones for HIV-1 and may cause serious side effects.

Your doctor may change your other medicines or change their doses. Other medicines, including herbal products may affect TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600.

For this reason, it is very important to let your doctor or pharmacist know what medications, herbal supplements, or vitamins you are taking.

Do not take any other medicines, including prescription or non-prescription medicines and herbal products, without checking with your doctor.

The following medicines may cause serious or life-threatening side effects when taken with TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600.

Do not take elbasvir/grazoprevir with TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600.

It may lose its effect and reduce your response to elbasvir/grazoprevir.

Do not take St. Johns wort (Hypericum perforatum) or products containing St. Johns wort with TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600.

St. John's wort is a herbal product sold as a dietary supplement. Talk to your doctor or pharmacist if you are taking or are planning to take St. John's wort. Taking St. John's wort may decrease TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600 levels and lead to increased viral load and possible resistance to TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600 or cross-resistance to other anti-HIV drugs.

Voriconazole should not be taken with TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600.

It may lose its effect or may increase the chance of having side effects from TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600.

Do not take TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600 if you are already taking any other medicines that contain the same active ingredients.

Do not take TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600 if you are taking other medicines that contain:

Efavirenz
Lamivudine

Do not take TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600 to treat your HIV infection if you are also taking adefovir dipivoxil.

It is also important to tell your doctor if you are taking any of the following:

Bepridil, cisapride (e.g. Prepulsid), midazolam (e.g. Hypnovel), pimozide (e.g. Orap), triazolam (e.g. Halcion), ergot medications (e.g. Cafergot).
Saquinavir (e.g. Invirase), clarithromycin (e.g. Klacid); these medicines may need to be replaced with another medicine when taken with TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600.
Calcium channel blockers such as diltiazem (e.g. Vasocardol) and others; indinavir (e.g. Crixivan); methadone, rifabutin (e.g. Mycobutin), rifampin (e.g. Rifadin).
Lipid-lowering medicines such as atorvastatin (e.g. Lipitor), pravastatin (e.g. Pravachol) or simvastatin (e.g. Zocor).
Antidepressant medicines such as sertraline (e.g. Zoloft) or bupropion (e.g. Zyban); immunosuppressant medicines cyclosporine (e.g. Neoral), tacrolimus (e.g. Prograf) or sirolimus (e.g. Rapamune); these medicines may need to have their dose changed when taken with TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600.
Didanosine (also known as ddI or Videx); tenofovir disoproxil (a component of TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600) may increase the amount of didanosine in your blood, which could result in more side effects. You may need to be monitored more carefully if you are taking didanosine and TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600 together. Also, the dose of didanosine may need to be changed.
Atazanavir sulphate (e.g. Reyataz) or lopinavir/ritonavir (e.g. Kaletra); these medicines may increase the amount of tenofovir disoproxil (a component of TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600) in your blood which could result in more side effects. Atazanavir sulphate is not recommended with TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600. You may need to be monitored more carefully if you are taking TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600 and lopinavir/ritonavir together. Also, the dose of lopinavir/ritonavir may need to be changed.
Other HIV medications including amprenavir (e.g. Agenerase), ritonavir (e.g. Norvir), fosamprenavir calcium (e.g. Telzir), raltegravir (e.g. Isentress), ritonavir or maraviroc (e.g. Celsentri), Also, the dose of maraviroc may need to be changed.
Medicine for seizures such as phenytoin (e.g. Dilantin), carbamazepine (e.g. Tegretol) or phenobarbital (phenobarbitone); your doctor may want to switch you to another medicine or check drug levels in your blood from time to time.
Antifungal medications such as itraconazole (e.g. Sporanox) and posaconazole (e.g. Noxafil); these medicines may need to be replaced with another medicine when taken with TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600.
Hepatitis C antiviral agents such as ledipasvir/sofosbuvir (e.g. HARVONI), or sofosbuvir/velpatasvir (e.g. EPCLUSA), sofosbuvir/velpatasvir/voxilapreir (e.g. VOSEVI), simeprevir (e.g Olysio), bocepravir (e.g. Victrelis) and telaprevir (e.g. Incivek).
Antimalarial Agents such as artemether/lumefantrine (Coartem/Riamet).

These are not all the medicines that may cause problems if you take TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600. Be sure to tell your healthcare provider about all medicines that you take.

It is a good idea to keep a complete list of all the medicines that you take.

Make a new list when medicines are added or stopped. Give copies of this list to your doctor or pharmacist every time you visit your doctor or fill a prescription.

 4. How do I use TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600?

How much to take

The usual dose of TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600 is one tablet once a day.
Take the exact amount of TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600 your doctor has prescribed for you.
Never change the dose on your own.
Do not stop this medicine unless your healthcare provider tells you to stop.
Stay under a doctor's care when taking TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600.
Do not change your treatment or stop treatment without first talking with your doctor.

When to take TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600

Taking TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600 at bedtime may make some side effects less bothersome.

How to take TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600

Always take TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600 on an empty stomach.
Swallow TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600 with water.

If you forget to use TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600

It is important that you do not miss any doses of TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600.

If you miss a dose of TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600, take the missed dose as soon as possible and then take your next scheduled dose at its regular time.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose you missed.

If you think that you have used too much TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600, you may need urgent medical attention.

You should immediately:

phone the Poisons Information Centre (Australia telephone 13 11 26); New Zealand telephone 0800 POISON or 0800 764 766 for advice, or
contact your doctor, or
go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

 5. What should I know while using TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600?

Things you should do

Tell your doctor or pharmacist that you are taking TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600 if you are about to be started on any other medicines.

Your doses may need adjustment.

When your TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600 supply starts to run low, get more from your doctor or pharmacy.

This is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short time. The virus may develop resistance to TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600 and become harder to treat.

Things you should not do

Avoid doing things that can spread HIV infection since TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600 does not stop you from passing the HIV infection to others.

Do not take TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600 if the packaging is torn or shows signs of tampering.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600 affects you.

If you are dizzy, have trouble concentrating, or are drowsy, avoid activities that may be dangerous, such as driving or operating machinery.

Drinking alcohol

Tell your doctor if you drink alcohol.

Taking TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600 with alcohol or other medicines causing similar side effects as TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600, such as drowsiness, may increase those side effects.

Looking after your medicine

Keep your TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600 tablets in the bottle with the cap tightly closed until you take them.

Follow the instructions on the bottle on how to take care of your medicine properly.

Store it in a cool dry place below 25°C away from moisture, heat or sunlight; for example, do not store it:

in the bathroom or near a sink, or
in the car or on window sills.

Keep it where young children cannot reach it.

A locked cupboard at least one-and-a half metres above the ground is a good place to store them.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

 6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Common side effects

Common side effects

What to do

These side effects may be reduced if you take TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600 at bedtime on an empty stomach. They also tend to go away after you have taken the medicine for a few weeks. If you have these common side effects, such as dizziness, it does not mean that you will also have serious psychiatric problems, such as severe depression, strange thoughts or angry behaviour.

It is possible that these symptoms may be more severe if TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600 is used with alcohol or mood altering (recreational) drugs.

dizziness
headache
trouble sleeping
drowsiness
trouble concentrating
unusual dreams

Other common side effects:

Rash. Rashes usually go away without any change in treatment. In a small number of patients, rash may be serious. If you develop a rash, call your doctor immediately.
Tiredness
Upset stomach
Vomiting
Gas and diarrhoea

Speak to your doctor if you have any of these common side effects and they worry you.

Other possible side effects:

Changes in body fat develop in some people receiving anti HIV-1 therapy. These changes may include an increased amount of fat in the upper back and neck ('buffalo hump'), in the breasts and around the trunk. Loss of fat from the legs, arms and face may also happen. The cause and long-term health effects of these fat changes are not known.

Sleeping problems (including difficulty to fall asleep or sleepiness).

Skin discolouration (small spots or freckles) may also occur with TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600.

Serious side effects

Serious side effects

What to do

Lactic Acidosis (build-up of an acid in the blood):

You feel very weak or tired
You have unusual (not normal) muscle pain
You have trouble breathing
You have stomach pain with nausea and vomiting
You feel cold, especially in your arms and legs
You feel dizzy or light headed
You have a fast or irregular heartbeat

Serious Liver Problems
(hepatotoxicity):

Your skin or the white part of your eyes turns yellow (jaundice)
Your urine turns dark
Your bowel movements (stools) turn light in colour
You don't feel like eating food for several days or longer
You feel sick to your stomach (nausea)
You have lower stomach area (abdominal) pain

These side effects may be due to a condition called hepatotoxicity with liver enlargement (hepatomegaly) and fat deposits in the liver (steatosis) which sometimes occurs in patients taking anti HIV-1 medicines.

You may be more likely to get lactic acidosis or liver problems if you are female, very overweight (obese), or have been taking similar nucleoside analog-containing medicines, like TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600, for a long time.
Pancreatitis:

Severe stomach pain or cramps
Nausea
Vomiting

Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Hepatic Flares

If you have HIV-1 infection and hepatitis B virus (HBV) infection you should not stop your TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600 treatment without first discussing this with your doctor, as some patients have had blood tests or symptoms indicating a worsening of their hepatitis ("hepatic flare") after stopping individual components (tenofovir disoproxil, and emtricitabine) of TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600.

You may require medical exams and blood tests for several months after stopping treatment. TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600 is not approved for the treatment of HBV, so you must discuss your HBV therapy with your doctor.

Serious Psychiatric Problems

A small number of patients may experience severe depression, strange thoughts, or angry behaviour while taking TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600.

Some patients have thoughts of suicide and a few have actually committed suicide.

These problems may occur more often in patients who have had mental illness.

Contact your doctor right away if you think you are having these psychiatric problems, so your doctor can decide if you should continue to take TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600.

Kidney Problems

If you have had kidney problems in the past or take other medicines that can cause kidney problems, your doctor should do regular blood tests to check your kidneys.

Changes in Bone Mineral Density (thinning bones)

It is not known whether long-term use of TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600 will cause damage to your bones. If you have had bone problems in the past, your doctor may need to do tests to check your bone mineral density or may prescribe medicines to help your bone mineral density.

Allergy

Some people are allergic to medicines.

If you have any of the following symptoms soon after taking your medicine, DO NOT TAKE ANY MORE Tenofovir TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600 and tell your doctor IMMEDIATELY or go to the accident and emergency department at your nearest hospital.

Skin troubles such as lumpy skin rash or "hives"
Swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing
Wheezing, chest pain or tightness
Fainting

These are very serious side effects. If you have them, you may have a serious allergic reaction.

You may need urgent medical attention or hospitalisation. Hypersensitivity reactions are very rare.

Contact your doctor before stopping TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600 because of side effects or for any other reason.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems or New Zealand at nzphvc.otago.ac.nz/reporting. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

 7. Product details

This medicine is only available with a doctor's prescription.

What TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600 contains

Active ingredient (main ingredient)	tenofovir disoproxil maleate emtricitabine efavirenz
Other ingredients (inactive ingredients)	colloidal anhydrous silica croscarmellose sodium ferric oxide hyprolose lactose monohydrate magnesium stearate microcrystalline cellulose OPADRY II complete film coating system 85F540043 PINK sodium metabisulfite
Potential allergens	sugars as lactose traces of sulfites

Do not take this medicine if you are allergic to any of these ingredients.

What TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600 looks like

TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600 is capsule shaped and pink in colour. Each tablet is debossed with "M" on one side of the tablet and "TEE" on the other side. (AUST R 280721).

Who distributes TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600

Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.viatris.com.au
Phone: 1800 274 276

This leaflet was prepared in April 2022.

TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ VIATRIS 300/200/600_cmi\Apr22/00

Published by MIMS June 2022

BRAND INFORMATION

Brand name

Tenofovir Disoproxil/Emtricitabine/Efavirenz Viatris 300/200/600

Active ingredient

Tenofovir disoproxil maleate + Emtricitabine + Efavirenz

Schedule

1 Name of Medicine

Tenofovir disoproxil maleate, emtricitabine and efavirenz.

2 Qualitative and Quantitative Composition

Each Tenofovir Disoproxil/Emtricitabine/Efavirenz Viatris 300/200/600 tablet contains 300 mg of tenofovir disoproxil maleate (equivalent to 245 mg of tenofovir disoproxil), 200 mg of emtricitabine and 600 mg of efavirenz.
Excipients with known effect. Sugars as lactose and traces of sulfites.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Tenofovir Disoproxil/Emtricitabine/Efavirenz Viatris 300/200/600 tablets are capsule shaped, pink film-coated, biconvex, beveled edge tablets debossed with "M" on one side of the tablet and "TEE" on the other side.

4 Clinical Particulars

4.9 Overdose

Treatment of overdose with Tenofovir/Emtricitabine/Efavirenz should consist of general supportive measures, including monitoring of vital signs and observation of the patient's clinical status. Administration of activated charcoal may be used to aid removal of unabsorbed efavirenz. There is no specific antidote for overdose with efavirenz. Haemodialysis can remove both tenofovir disoproxil and emtricitabine (refer to detailed information below). However, since efavirenz is highly protein bound, dialysis is unlikely to remove significant quantities of it from blood.
Tenofovir. Clinical experience of doses higher than the therapeutic dose of Viread 300 mg is available from two studies. In one study, intravenous tenofovir, equivalent to 16.7 mg/kg/day of tenofovir disoproxil, was administered daily for 7 days. In the second study, 600 mg of tenofovir disoproxil was administered to patients orally for 28 days. No unexpected or severe adverse reactions were reported in either study. The effects of higher doses are not known.
Tenofovir is efficiently removed by haemodialysis with an extraction coefficient of approximately 54%. Following a single 300 mg dose of Viread, a four-hour haemodialysis session removed approximately 10% of the administered tenofovir dose.
Emtricitabine. Limited clinical experience is available at doses higher than the therapeutic dose of Emtriva. In one clinical pharmacology study single doses of emtricitabine 1200 mg were administered to 11 patients. No severe adverse reactions were reported. The effects of higher doses are not known.
Haemodialysis treatment removes approximately 30% of the emtricitabine dose over a 3-hour dialysis period starting within 1.5 hours of emtricitabine dosing (blood flow rate of 400 mL/min and a dialysate flow rate of 600 mL/min). It is not known whether emtricitabine can be removed by peritoneal dialysis.
Efavirenz. Some patients accidentally taking 600 mg twice daily have reported increased nervous system symptoms. One patient experienced involuntary muscle contractions.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

Each Tenofovir Disoproxil/Emtricitabine/Efavirenz Viatris 300/200/600 tablet contains 600 mg of efavirenz, 200 mg of emtricitabine and 300 mg of tenofovir disoproxil maleate. The innovator product contains 600 mg of efavirenz, 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate. All clinical data in this product information (including Pharmacokinetic, Pharmacodynamic, and Clinical trial data) relevant to tenofovir are based on tenofovir disoproxil fumarate. Bioequivalence has been established between the two salt forms of tenofovir disoproxil.

5.3 Preclinical Safety Data

Genotoxicity. Tenofovir. Tenofovir disoproxil was mutagenic in an in vitro mouse L5178Y lymphoma cell assay (tk locus) and in an ex vivo assay for unscheduled DNA synthesis in rat hepatocytes, but it was negative in in vitro bacterial assays for gene mutation and an in vivo mouse micronucleus test for chromosomal damage.
Emtricitabine. Emtricitabine was not mutagenic in bacteria or mouse lymphoma cell assays in vitro nor clastogenic in the mouse micronucleus test in vivo.
Efavirenz. Efavirenz was not genotoxic in assays for gene mutations (S. typhimurium, E. coli and Chinese hamster ovary cells) and chromosomal damage (human peripheral blood lymphocytes, Chinese hamster ovary cells, and a mouse micronucleus assay).
Carcinogenicity. No carcinogenicity studies have been conducted with tenofovir disoproxil, emtricitabine and efavirenz in combination.
Tenofovir. In a long-term carcinogenicity study conducted in mice with tenofovir disoproxil there was a low incidence of duodenal tumours with the highest dose of 600 mg/kg/day. These were associated with a high incidence of duodenal mucosal hyperplasia, which was also observed with a dose of 300 mg/kg/day. These findings may be related to high local drug concentrations in the gastro-intestinal tract, likely to result in much higher exposure margins than that based on the AUC. At therapeutic doses the risk of these duodenal effects occurring in humans is likely to be low. The systemic drug exposure (AUC) with the 600 mg/kg/day dose was approximately 15 times the human exposure at the therapeutic dose of 300 mg/day. No tumourigenic response was observed in rats treated with doses of up to 300 mg/kg/day (5 times the human systemic exposure at the therapeutic dose based on AUC).
Emtricitabine. In long-term oral carcinogenicity studies conducted with emtricitabine, no drug-related increases in tumour incidence were found in mice at doses up to 750 mg/kg/day (32 times the human systemic exposure (AUC) at the therapeutic dose of 200 mg/day) or in rats at doses up to 600 mg/kg/day (38 times the human systemic exposure at the therapeutic dose).
Efavirenz. Long-term carcinogenicity studies in mice and rats were carried out with efavirenz. Mice were dosed with 0, 25, 75,150 or 300 mg/kg/day for 2 years. Incidences of hepatocellular adenomas and carcinomas and pulmonary alveolar/bronchiolar adenomas were increased above background in females. No increases in tumour incidence above background were seen in males. There was no NOAEL in females established for this study because tumour findings occurred at all doses. AUC at the NOAEL (150 mg/kg) in the males was approximately 0.9 times that in humans at the recommended clinical dose. In the rat study no increases in tumour incidence were observed at doses up to 100 mg/kg/day, for which AUCs were 0.1 (males) or 0.2 (females) times those in humans at the recommended clinical dose.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. Active ingredient: tenofovir disoproxil maleate.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSTEDIMA.gif The chemical name for tenofovir disoproxil maleate is: bis(hydroxymethyl) [[(R)-2-(6-amino-9H-purin-9-yl)-1-methylethoxy]methyl] phosphonate, bis(isopropyl carbonate) (ester), (2Z)-but-2-enedioate (1:1). The molecular formula is C₁₉H₃₀N₅O₁₀P.C₄H₄O₄ and molecular weight is 635.51.
Active ingredient: emtricitabine.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSEMTRIC.gif The chemical name for emtricitabine is: 5-fluoro-1-(2R,5S)-[2-(hydroxymethyl)- 1,3-oxathiolan-5- yl]cytosine. The molecular formula is C₈H₁₀FN₃O₃S and molecular weight is 247.24.
Active ingredient: efavirenz.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSEFAVIR.gif The chemical name for efavirenz is: (4S)-6-Chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3 ,1- benzoxazin-2-one. The molecular formula is C₁₄H₉ClF₃NO₂ and molecular weight is 315.68.
CAS number. Tenofovir disoproxil maleate registry no.: 1276030-80-8.
Emtricitabine registry no.: 143491-57-0.
Efavirenz registry no.: 154598-52-4.
Tenofovir disoproxil maleate is a white to off-white crystalline powder with a solubility of 128 mg/mL in water at 25°C. The partition coefficient (log p) for tenofovir is 0.67 and the pKa is 3.5.
Emtricitabine is a white to off-white crystalline powder with a solubility of approximately 170 mg/mL in water at 25°C. The partition coefficient (log p) for emtricitabine is -0.43 and the pKa is 4.90.
Efavirenz is a white to slightly pink crystalline powder. It is practically insoluble in water (< 10 microgram/mL). The partition coefficient (log p) for efavirenz is 5.4 and the pKa is 10.2.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

Summary Table of Changes

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Tenofovir Disoproxil/Emtricitabine/Efavirenz Viatris 300/200/600

Tenofovir disoproxil maleate + Emtricitabine + Efavirenz

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BRAND INFORMATION

Tenofovir Disoproxil/Emtricitabine/Efavirenz Viatris 300 mg/200 mg/600 mg Tablets