Emtricitabine / Tenofovir Disoproxil

• HIV medicine
• Also used to reduce the risk of infection
• Use daily
• May affect your reaction time

Emtricitabine/Tenofovir disoproxil is an HIV medicine. It contains two active substances, emtricitabine and tenofovir disoproxil succinate. Emtricitabine is a nucleoside reverse transcriptase inhibitor and tenofovir is a nucleotide reverse transcriptase inhibitor. Both are generally known as NRTIs.

This medicine works by interfering with the normal working of an enzyme (reverse transcriptase) that is essential for the virus to reproduce itself.

Emtricitabine/Tenofovir disoproxil is used:

• To treat Human Immunodeficiency Virus 1 (HIV-1) infection in adults. It should always be used combined with other medicines to treat HIV infection.
• To reduce the risk of getting HIV-1 infection when taken daily, together with safer sex practices.
• In place of emtricitabine and tenofovir disoproxil when used separately at the same doses.

Emtricitabine/Tenofovir disoproxil is not a cure for HIV infection. While taking this medicine you may still develop infections or other illnesses associated with HIV infection. People who are HIV positive can still pass on HIV when taking this medicine, although the risk is lowered. Be sure to take all necessary precautions to avoid infecting other people.

Always use this medicine exactly as your doctor or pharmacist has told you. The tablets should be taken with food. If you have difficulty swallowing, you can use the tip of a spoon to crush the tablet. Then mix the powder with about half a glass of water or juice, and drink immediately.

Always take the dose recommended by your doctor.

If you are taking this medicine to reduce the risk of getting HIV:

• Take Emtricitabine/Tenofovir disoproxil every day, not just when you think you have been at risk of HIV infection.
• It is important to get tested for HIV regularly.
• Always practise safer sex. Use condoms and do not share personal items that can have blood or body fluids on them, such as toothbrushes, razor blades, needles or other injection or drug equipment.

• Get tested for other sexually transmitted infections such as syphilis and gonorrhoea. These infections make it easier for HIV to infect you.

Dosage

Dosage varies per person and is determined by a doctor. The general dosage guidelines are as follows:

• Adults: one tablet a day.

See the package leaflet for more information on the use of Emtricitabine/Tenofovir disoproxil.

Alcohol/driving

This medicine can cause dizziness. If you feel dizzy while taking Emtricitabine/Tenofovir disoproxil, do not drive and do not use any tools or machines.

This medicine does not interact with alcohol.

If you use too much/forget to use/stop using Emtricitabine/Tenofovir disoproxil

If you take more Emtricitabine/Tenofovir disoproxil than you were told to, consult your doctor or pharmacist.

It is important not to miss a dose of Emtricitabine/Tenofovir disoproxil. If you miss a dose and notice within 12 hours of the time you usually take Emtricitabine/Tenofovir disoproxil, take the tablet preferably with food as soon as possible. If more than 12 hours have passed, skip the dose you missed and take the next scheduled dose as normal.

If you vomit less than one hour after taking Emtricitabine/Tenofovir disoproxil, take another tablet.

Do not stop using Emtricitabine/Tenofovir disoproxil without consulting a doctor first.

Emtricitabine/Tenofovir disoproxil is not suitable for everyone. Do not use this medicine if you are allergic to any of the ingredients (see section 'What Emtricitabine/Tenofovir disoproxil contains').

• For people who have not contracted HIV yet: you must be HIV negative before you start to take Emtricitabine/Tenofovir disoproxil to reduce the risk of getting HIV. This medicine can only help reduce your risk of getting HIV before you are infected.
• People who do have HIV must take Emtricitabine/Tenofovir disoproxil in combination with other drugs.

When should this medicine be used with caution?

The following additional warnings apply when using this medicine.

• Emtricitabine/Tenofovir disoproxil may affect your kidneys. Before and during treatment, your doctor may order blood tests to measure kidney function.
• Talk to your doctor if you have a history of liver disease, including hepatitis (liver inflammation).
• Know your hepatitis B virus (HBV) infection status before starting Emtricitabine/Tenofovir disoproxil. If you have HBV, it is important not to stop taking Emtricitabine/Tenofovir disoproxil.
• Talk to your doctor if you are over 65. Emtricitabine/Tenofovir disoproxil has not been studied in patients over 65 years of age.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, ask your doctor for advice before using this medicine.

Breastfeeding is not recommended in patients with HIV or during treatment with Emtricitabine/Tenofovir disoproxil.

Other medicines and Emtricitabine/Tenofovir disoproxil

Do not take Emtricitabine/Tenofovir disoproxil if you are already taking other medicines that contain the components of Emtricitabine/Tenofovir disoproxil, or any other antiviral medicines that contain tenofovir alafenamide, lamivudine or adefovir dipivoxil.

Taking Emtricitabine/Tenofovir disoproxil with certain other medicines can damage your kidneys. It is especially important to tell your doctor if you are taking any of the following medicines:

• aminoglycosides (for bacterial infection)
• amphotericin B (for fungal infection)
• foscarnet (for viral infection)
• ganciclovir (for viral infection)
• pentamidine (for infections)
• vancomycin (for bacterial infection)
• interleukin-2 (to treat cancer)
• cidofovir (for viral infection)
• non-steroidal anti-inflammatory drugs (NSAIDs) to relieve bone or muscle pains

If you are taking another antiviral medicine called a protease inhibitor to treat HIV, your doctor may order blood tests to closely monitor your kidney function.

It is also important to tell your doctor if you are taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir to treat hepatitis C infection.

Taking Emtricitabine/Tenofovir disoproxil with other antiviral medicines that contain didanosine can raise the levels of didanosine in your blood and may reduce CD4 cell counts. Rarely, inflammation of the pancreas and lactic acidosis (excess lactic acid in the blood), which sometimes causes death, have been reported when medicines containing tenofovir disoproxil and didanosine were taken together. Your doctor will carefully consider whether to treat you with combinations of tenofovir and didanosine.

For more information, see the package leaflet.

Medicines can cause side effects, although some people may not experience any. Side effects that are known to be associated with Emtricitabine/Tenofovir disoproxil include:

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

• Diarrhoea, vomiting, nausea.
• Dizziness, headache.
• Rash.
• Feeling weak.

Common (may affect up to 1 in 10 people):

• Pain, stomach pain.
• Insomnia, abnormal dreams.
• Problems with digestion resulting in discomfort after meals, feeling bloated, flatulence.
• Rashes which may be allergic reactions, itching, changes in skin colour including darkening of the skin in patches.
• Other allergic reactions, such as wheezing, swelling or feeling light-headed.

For a list of all possible side effects, see the package leaflet. If you think you may have lactic acidosis or a severe allergic reaction, get medical help immediately. Consult a doctor if you experience any other side effects.

The active substances in Emtricitabine/Tenofovir disoproxil Mylan are emtricitabine and tenofovir. Each film-coated tablet contains 200 mg emtricitabine and 245 mg tenofovir disoproxil (equivalent to 300 mg tenofovir disoproxil succinate).

The other ingredients are: microcrystalline cellulose, low substituted hydroxypropyl cellulose, red iron oxide (E172), anhydrous colloidal silica, lactose monohydrate, magnesium stearate, hypromellose, titanium dioxide (E171), triacetin, brilliant blue FCF (E133), yellow iron oxide (E172).

The manufacturers of Emtricitabine/Tenofovir disoproxil are:

Mylan Hungary Kft Mylan utca 1, H-2900 Komárom
Hungary

McDermott Laboratories Limited trading as Gerard Laboratories trading as Mylan Dublin 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13
Ireland

Medis International a.s vyrobani zavod Bolatice,Prumyslova, -961/16, Bolatice
747 23, Czech Republic

Read the package leaflet before use. The official package leaflet of Emtricitabine/Tenofovir disoproxil Mylan is available for download here.