Label: information for the patient

Vemlidy 25 mg film-coated tablets

tenofovir alafenamide

This medicine is subject to additional monitoring, which will facilitate the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this label carefully before starting to take this medicine, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Vemlidy contains the active ingredienttenofovir alafenamide. It is anantiviral medication, known as anucleoside reverse transcriptase inhibitor (NRTI).

Vemlidy is used for thechronic (long-term) treatment of hepatitis Bin adults and adolescents 12 years of age or older, weighing at least 35 kg. Hepatitis B is an infection that affects the liver, caused by the hepatitis B virus. In patients with hepatitis B, Vemlidy controls the infection by stopping the multiplication of the virus.

• If you are allergicto tenofovir alafenamide or to any of the other components of thismedication (listed in section 6).

??If this is your case,?do not take Vemlidy and inform your doctor immediately.

Warnings and precautions

• Be careful not to transmithepatitis B to others.While takingthis medication, you may still infect others. Vemlidy does not reduce the risk of transmission of hepatitis B to others through sexual contact or blood contamination. You should continue to take precautions to avoid this. Consult your doctor about what precautions are necessary to avoid infecting others.

• Inform your doctor if you have a history of liver disease.Patients withliver disease treated for hepatitis B with antiviral medications have a higher risk of severe and potentially fatal liver complications. Your doctor may need to perform blood tests to monitor your liver function.

• Consult your doctor or pharmacist if you have had kidney disease or if blood tests have shown kidney problems, before or during treatment.Before starting treatment and during treatment with Vemlidy, your doctor may request blood tests to monitor your kidney function.

• Consult your doctor if you also have hepatitis C or D.Vemlidy has not been tested inpatients who have hepatitis C or D in addition to hepatitis B.

• Consult your doctor if you also have HIV.If you are unsure if you have HIV, your doctorshould offer you an HIV test before you start taking Vemlidy for hepatitis B.

• If you meet any of these conditions,consult your doctor before starting to take

Vemlidy.

Children and adolescents

Do not administer this medication to children under 12 years of age or weighing less than 35 kg.Vemlidy has not been tested in children under 12 years of age or weighing less than 35 kg.

Other medications and Vemlidy

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication.Vemlidy may interact with other medications. Asa result, the levels of Vemlidy or other medications in your blood may change. This may prevent your medications from working correctly or worsen any adverse effects.

Medications used in the treatment of hepatitis B infectionDo not take Vemlidy with other medications that contain:

• tenofovir alafenamide

• tenofovir disoproxil

• adefovir dipivoxil

Other types of medications

Consult your doctor if you are taking:

• antibioticsused to treat bacterial infections, including tuberculosis, thatcontain:
• • rifabutin, rifampicin, or rifapentine

• antiviral medications used to treat HIV, such as:

• anticonvulsantsused to treat epilepsy, such as:

• herbal medicationsused to treat depression and anxiety, thatcontain:
• • St. John's Wort (Hypericum perforatum)

• antifungal medicationsused to treat fungal infections, that contain:

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

• Inform your doctor immediately if you become pregnant.

• Do not breastfeed during treatment with Vemlidy.It is recommended that you do not breastfeed toavoid passing tenofovir alafenamide or tenofovir to the baby through breast milk.

Driving and operating machinery

Vemlidy may cause dizziness. If you feel dizzy while taking Vemlidy, do not drive or use tools or machinery.

Vemlidy contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Vemlidy contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor.In case of doubt, consult your doctor or pharmacist again.

The recommended dose isone tablet once a day with food. Treatment should continue for the time your doctor indicates. Generally, it is for at least 6 to 12 months and may be for many years.

If you take more Vemlidy than you should

If you accidentally take a larger amount of Vemlidy than the recommended dose, you may be at greater risk of experiencing adverse effects with this medication (see section 4,Adverse Effects).

Consult your doctor or go to the nearest emergency service so they can advise you. Bring the tablet container with you so you can easily describe what you have taken.

If you forgot to take Vemlidy

It is essential not to forget any dose of Vemlidy. If you forget a dose, determine how long it has been since you should have taken it.

• If less than 18 hours have passedsince the time you usually take Vemlidy,take it as soon as possible, and then take your next dose at your usual time.

• If more than 18 hours have passedsince the time you usually take Vemlidy,do not take the missed dose. Wait and take the next dose at your usual time.Do not takea double doseto compensate for the missed doses.

If you vomit within 1 hour of taking Vemlidy, take another tablet.

You do not need to take another tablet if you vomit more than 1 hour after taking Vemlidy.

If you interrupt treatment with Vemlidy

Do not stop taking Vemlidy without your doctor's indication.Stopping treatment with Vemlidymay make your hepatitis B worse. In some patients with advanced liver disease or cirrhosis, this can be potentially fatal. If you stop taking Vemlidy, you will need regular health checks and blood tests for several months to review your hepatitis B infection.

• Consult your doctorbefore stopping Vemlidy for any reason, especially ifyou experience any adverse effects or have another illness.

• Inform your doctor immediatelyabout new or unusual symptoms after stopping treatment, particularly symptoms associated with hepatitis B infection.

• Consult your doctorbefore resuming tablet intake of Vemlidy.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Very Common Adverse Effects

(may affect more than 1 in 10 people)

• Headache

Common Adverse Effects

(may affect up to 1 in 10 people)

• Diarrhea.

• Vomiting

• Nausea

• Dizziness

• Stomach pain

• Joint pain(arthritis)

• Skin rash

• Itching

• Sensation of swelling

• Gas(flatulence)

• Sensation of fatigue

Uncommon Adverse Effects

(may affect up to 1 in 100 people)

• Swelling of the face, lips, tongue, or throat (angioedema)

• Hives (urticaria)

Laboratory tests may also show:

• Increased levels of a liver enzyme (ALT) in the blood.

During treatment for HVB, there may be an increase in weight, lipid concentrations, and/or fasting blood glucose levels. Your doctor will evaluate these changes.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through thenational notification system included in theAppendix V.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the bottle and on the packaging after {CAD}. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture. Keep the bottle perfectly closed.

Medicines should not be thrown down the drain or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of Vemlidy

The active ingredient istenofovir alafenamide. Each Vemlidy film-coated tablet contains tenofovir alafenamide fumarate, equivalent to 25 mg of tenofovir alafenamide.

The other components are

Tablet core:

Lactose monohydrate, microcrystalline cellulose (E460[i]), sodium croscarmellose (E468), magnesium stearate (E470b).

Film coating:

Polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol (E1521), talc (E553b), yellow iron oxide (E172).

Appearance of the product and contents of the pack

Vemlidy film-coated tablets are yellow, round, with “GSI” printed (or marked) on one face of the tablet and “25” on the other face of the tablet. Vemlidy is available in bottles of 30 tablets (with a silica gel desiccant that should be kept in the bottle to help protect the tablets). The silica gel desiccant is contained in a separate sachet or container and should not be taken.

The following pack sizes are available: packs containing 1 bottle of 30 film-coated tablets and packs containing 90 (3 bottles of 30) film-coated tablets. Only some pack sizes may be marketed.

Marketing Authorization Holder

Gilead Sciences Ireland UC

Carrigtohill

County Cork, T45 DP77

Ireland

Responsible Person

Gilead Sciences Ireland UC

IDA Business & Technology Park

Carrigtohill

County Cork

Ireland

For further information about this medicinal product, please consult the representative of the marketing authorisation holder in your country:

Last update of this leaflet{MM/YYYY}.

Further information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.