Emtricitabine/Tenofovir (PrEP) 30 Tablets

Please read the patient information leaflet carefully before taking this medicine. Take this medicine exactly as described by your doctor.

The recommended dosage of Emtricitabine/Tenofovir (PrEP) for most people is one tablet, once daily. Ideally you should take the tablet as the same time each day with food.

You may hear of alternative regimes for taking PrEP however the above offers the lowest risk of contracting HIV and so we will only prescribe based on taking one tablet daily.

All medicines have the possibility to cause side effects, but these can vary from person to person. If you experience any serious ill effects from taking PrEP or any other medication, get medical help immediately.

Possible serious side effects:

Lactic acidosis (excess lactic acid in the blood)

This is a rare but potentially life-threatening side effect. Lactic acidosis occurs more often in women, particularly when overweight, and in people with liver disease. Lactic acidosis may present with the following symptoms:

• deep rapid breathing,
• drowsiness,
• feeling sick (nausea), being sick (vomiting),
• stomach pain.

Get medical assistance immediately if you think you may have lactic acidosis.

Possible side effects:

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

• diarrhoea, being sick (vomiting), feeling sick (nausea),
• dizziness, headache,
• rash,
• feeling weak.

Tests may also show:

• decreases in phosphate in the blood,
• increased creatine kinase.

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

• pain, stomach pain,
• difficulty sleeping, abnormal dreams,
• problems with digestion resulting in discomfort after meals, feeling bloated, flatulence,
• rashes (including red spots or blotches sometimes with blistering and swelling of the skin), 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.

Tests may also show:

• low white blood cell count (a reduced white blood cell count can make you more prone to infection),
• increased triglycerides (fatty acids), bile or sugar in the blood,
• liver and pancreas problems.

Uncommon side effects (may affect up to 1 in 100 people):

• pain in the abdomen (tummy) caused by inflammation of the pancreas,
• swelling of the face, lips, tongue or throat,
• anaemia (low red blood cell count),
• breakdown of muscle, muscle pain or weakness which may occur due to damage to the kidney tubule cells.

Tests may also show:

• decreases in potassium in the blood,
• increased creatinine in your blood,
• changes to your urine.

Rare side effects (may affect up to 1 in 1,000 people):

• Lactic acidosis (see Possible serious side effects)
• fatty liver,
• yellow skin or eyes, itching, or pain in the abdomen (tummy) caused by inflammation of the liver,
• inflammation of the kidney, passing a lot of urine and feeling thirsty, kidney failure, damage to kidney tubule cells,
• softening of the bones (with bone pain and sometimes resulting in fractures),
• back pain caused by kidney problems.

Damage to kidney tubule cells may be associated with breakdown of muscle, softening of the bones (with bone pain and sometimes resulting in fractures), muscle pain, muscle weakness and decreases in potassium or phosphate in the blood.

If you notice any of the side effects listed above or they become serious, seek medical advice from your doctor or pharmacist.

The frequency of the below side effects is unknown:

• Bone problems. Some patients taking combination antiretroviral medicines such as Emtricitabine/Tenofovir disoproxil Zentiva may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). Taking this type of medicine for an extended period, taking corticosteroids, drinking alcohol, having a very weak immune system, and being overweight, may be some of the many risk factors for developing this disease. Signs of osteonecrosis are:
  • joint stiffness
  • joint aches and pains (especially of the hip, knee and shoulder)
  • difficulty with movement

If you notice any of these symptoms tell your doctor.

If you notice any of these symptoms tell your doctor.

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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard 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.