Truvada 245 mg/200 mg film-coated tablets (tenofovir/emtricitabine) – treatment and prevention of HIV-1 infection

Truvada is a medicine that contains two antiretroviral active substances in one film-coated tablet: tenofovir disoproxil (245 mg) and emtricitabine (200 mg). Both belong to the group of reverse transcriptase inhibitors (NRTIs) – they interfere with an enzyme that HIV needs to multiply.

Truvada is used to treat HIV-1 infection, always in combination with other medicines, and to reduce the risk of getting HIV-1 infection (pre-exposure prophylaxis, PrEP) in HIV-negative people, together with safer sex practices. The medicine does not cure HIV infection.

What is Truvada (tenofovir/emtricitabine) used for and how should it be taken correctly?

Basic information about the medicine

What is Truvada used for?

• treatment of HIV-1 infection in adults, always in combination with other antiretroviral medicines;
• treatment of HIV-1 infection in adolescents aged 12 to under 18 years weighing at least 35 kg who have already been treated with other medicines that no longer work or caused side effects;
• reducing the risk of getting HIV-1 infection (PrEP) in adults and adolescents aged 12 to under 18 years (at least 35 kg), when taken every day together with safer sex practices.

Truvada can replace emtricitabine and tenofovir disoproxil taken separately at the same doses. People who are HIV-positive can still pass on the virus during treatment, although effective treatment lowers the risk.

How is it used and dosed?

If you have difficulty swallowing, you can crush the tablet with the tip of a spoon, mix it with about 100 ml (half a glass) of water, orange juice or grape juice and drink it immediately. Do not change the dose unless your doctor tells you to – regular intake also lowers the risk of the virus becoming resistant.

If you vomit less than 1 hour after taking a tablet, take another one; if more than an hour has passed, you do not need another tablet.

Special patient groups

• Children under 12: the medicine is not intended for this age group.
• Adolescents with kidney problems: the medicine must not be given; it is not started, and it is stopped if kidney impairment develops during treatment.
• Over 65 years: the medicine has not been studied in this group – talk to your doctor (according to the SmPC no dose adjustment is needed).
• Kidney impairment (adults): for HIV treatment with creatinine clearance of 30–49 ml/min, dosing every 48 hours is recommended; below 30 ml/min and on dialysis use is not recommended. For PrEP the medicine is not recommended with clearance below 60 ml/min (SmPC).
• Liver impairment: no dose adjustment is needed, but special caution and monitoring are required in hepatitis B or C.

Contraindications – when the medicine must not be used

• allergy to emtricitabine, tenofovir, tenofovir disoproxil or any of the excipients;
• use for HIV risk reduction (PrEP) in people with unknown or positive HIV-1 status.

Precautions and warnings

When used for risk reduction (PrEP):

• you must be tested and HIV-negative before starting; many tests do not detect a recent infection;
• tell your doctor about any flu-like illness (tiredness, fever, joint or muscle aches, headache, vomiting, diarrhoea, rash, night sweats, enlarged lymph nodes) in the month before starting or while taking the medicine – it may be a sign of recent HIV infection;
• take the medicine every day and get tested for HIV regularly; missing doses increases the risk of infection;
• the medicine alone may not prevent infection: always use condoms, do not share needles, toothbrushes or razors, and get tested for other sexually transmitted infections (e.g. syphilis, gonorrhoea).

For treatment and PrEP:

• the medicine can affect the kidneys – the doctor checks kidney function before and during treatment; damage to kidney tubules can also lead to bone problems;
• tell your doctor if you have had liver disease or hepatitis B or C; find out your hepatitis B status before starting;
• tell your doctor if you are lactose intolerant.

Interactions with other medicines, food and drink

• Do not take Truvada with other medicines containing emtricitabine or tenofovir disoproxil, or with medicines containing tenofovir alafenamide, lamivudine or adefovir dipivoxil.
• Medicines that can damage the kidneys: aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, interleukin-2, cidofovir and NSAIDs (painkillers for muscle and bone pain) – be sure to tell your doctor.
• With protease inhibitors the doctor may monitor kidney function more closely.
• Tell your doctor if you take ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir (hepatitis C).
• Combination with didanosine can raise didanosine levels and cause pancreatitis and lactic acidosis.

Whenever possible, Truvada should be taken with food.

Pregnancy and breastfeeding

If you are pregnant or planning a pregnancy, talk to your doctor before taking the medicine; if you took it during pregnancy, the doctor may monitor the child's development.

You must not breastfeed during treatment with Truvada, as the active substances pass into breast milk; women with HIV are advised not to breastfeed to avoid passing the virus to the baby.

Driving and using machines

Truvada can cause dizziness. If you feel dizzy, do not drive or use any tools or machines.

Possible side effects

• Very common: diarrhoea, vomiting, nausea, dizziness, headache, rash, feeling weak; tests may show decreased phosphate and increased creatine kinase.
• Common: pain, stomach pain, difficulty sleeping, abnormal dreams, bloating and wind, rashes and itching, skin discolouration (darkening in patches), other allergic reactions; tests may show low white blood cells, increased triglycerides, bilirubin or sugar, liver and pancreas problems.
• Uncommon: inflammation of the pancreas, swelling of the face, lips, tongue or throat, anaemia, muscle breakdown and muscle weakness; tests may show low potassium and increased creatinine.
• Rare: lactic acidosis, fatty liver, liver inflammation with jaundice, kidney inflammation and failure, damage to kidney tubules, softening of the bones with pain and fractures.
• Not known: osteonecrosis (joint stiffness and pain, especially hip, knee and shoulder). During HIV treatment weight and blood fats and sugar may increase.

Overdose, missed dose and stopping treatment

• Overdose: contact a doctor or the nearest emergency department and take the bottle of tablets with you.
• Missed dose: if you remember within 12 hours of the usual time, take the tablet as soon as possible (preferably with food) and the next one at the usual time; if 12 hours or more have passed, skip the missed dose.
• Stopping treatment: do not stop without talking to your doctor – in HIV treatment the effectiveness drops, in PrEP the risk of infection rises, and in hepatitis B stopping may cause a dangerous worsening of liver disease.

Related information

For additional protection against sexually transmitted infections, which the package leaflet recommends alongside PrEP, see also the category Condoms – products in this category do not replace the medicine prescribed for you.

Composition, pack and manufacturer

• active substances: 245 mg tenofovir disoproxil (300 mg tenofovir disoproxil fumarate, 136 mg tenofovir) and 200 mg emtricitabine per film-coated tablet;
• excipients: croscarmellose sodium; glycerol triacetate (E1518); hypromellose (E464); indigo carmine aluminium lake (E132); lactose monohydrate; magnesium stearate (E572); microcrystalline cellulose (E460); pregelatinised starch (gluten-free); titanium dioxide (E171);
• the medicine contains lactose and is essentially sodium-free (less than 1 mmol per tablet);
• pack: HDPE bottle with child-resistant closure, 30 film-coated tablets and silica gel desiccant (do not swallow);
• marketing authorisation holder: Medicopharmacia d.o.o. Belgrade; manufacturer: Gilead Sciences Ireland UC, Carrigtohill, Co. Cork, Ireland;
• authorisation: 515-01-00383-20-001 of 06.01.2021.

Storage

• Keep out of the sight and reach of children.
• Store in the original package to protect from moisture, with the bottle tightly closed.
• Do not use after the expiry date.

Frequently asked questions

Is Truvada for PrEP taken every day?

Yes. According to the leaflet, for HIV risk reduction Truvada is taken every day, not only when you think you have been at risk. Missing doses or stopping increases the risk of infection.

Does Truvada protect against other sexually transmitted diseases?

No. Truvada only reduces the risk of HIV-1 infection. The leaflet advises always using condoms and getting tested for other sexually transmitted infections such as syphilis and gonorrhoea.

What if I forget a tablet?

If you remember within 12 hours of the usual time, take the tablet as soon as possible, preferably with food. If 12 hours or more have passed, skip the missed dose and take the next one at the usual time.

Why does the doctor check my kidneys during treatment?

Tenofovir is excreted by the kidneys and can damage the kidney tubules. Kidney function is therefore checked before starting and regularly during treatment, and if it is impaired the doctor adjusts or stops the medicine.

Sources

• ALIMS – Patient information leaflet Truvada (PIL)
• ALIMS – Summary of product characteristics Truvada (SmPC)

Sources checked on: 25 October 2026.