VEMLIDY 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Vemlidy 25 mg Film-Coated Tablets

tenofovir alafenamide

This medicinal product is subject to additional monitoring, which will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Vemlidy and what is it used for
2. What you need to know before you take Vemlidy
3. How to take Vemlidy
4. Possible side effects
5. Storage of Vemlidy
6. Contents of the pack and other information

1. What is Vemlidy and what is it used for

Vemlidy contains the active substance tenofovir alafenamide. It is an antiviral medicine, known as a nucleotide reverse transcriptase inhibitor (NtRTI).

Vemlidy is used for the chronic (long-term) treatment of hepatitis B in adults and adolescents from 12 years of age or older, who weigh 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 virus from multiplying.

2. What you need to know before you take Vemlidy

• If you are allergicto tenofovir alafenamide or any of the other ingredients of this medicine (listed in section 6).

If this is the case for you, do not take Vemlidy and tell your doctor immediately.

Warnings and precautions

• Be careful not to transmit hepatitis B to other people.While you are taking this medicine, you can still infect others. Vemlidy does not reduce the risk of passing on hepatitis B to other people through sexual contact or blood contamination. You must continue to take precautions to avoid this. Ask your doctor about the precautions you should take to prevent infecting other people.

• Tell your doctor if you have a history of liver disease.Patients with liver disease being treated for hepatitis B with antiviral medicines have a higher risk of serious and potentially life-threatening liver problems. Your doctor may need to perform blood tests to check your liver function.

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

• Consult your doctor if you also have hepatitis C or D.Vemlidy has not been tested in patients who have hepatitis C or D as well as hepatitis B.

• Consult your doctor if you also have HIV.If you are not sure whether you have HIV, your doctor should offer you an HIV test before you start taking Vemlidy for hepatitis B.

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

Vemlidy.

Children and adolescents

Do not give this medicine 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 medicines and Vemlidy

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.Vemlidy may interact with other medicines. As a result, the amounts of Vemlidy or other medicines in your blood may change. This may stop your medicines from working properly or may increase any side effects.

Medicines used to treat hepatitis B infectionDo not take Vemlidy with other medicines that contain:

• tenofovir alafenamide

• tenofovir disoproxil

• adefovir dipivoxil

Other types of medicines

Consult your doctor if you are taking:

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

• antiviral medicines used to treat HIV, such as:

• darunavir, lopinavir or atazanavir boosted with ritonavir or cobicistat

• anticonvulsantsused to treat epilepsy, such as:

• carbamazepine, oxcarbazepine, phenobarbital or phenytoin

• herbal medicinesused to treat depression and anxiety, that contain:
• • St. John's Wort (Hypericum perforatum)

• antifungal medicinesused to treat fungal infections, that contain:

• ketoconazole or itraconazole

• Tell your doctor if you are taking any of these or other medicines.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

• Tell your doctor immediately if you become pregnant.

• Do not breast-feed during treatment with Vemlidy.It is recommended that you do not breast-feed to prevent tenofovir alafenamide or tenofovir from passing into your baby's breast milk.

Driving and using machines

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

Vemlidy contains lactose

If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

Vemlidy contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, which is essentially 'sodium-free'.

3. How to take Vemlidy

Always take this medicine exactly as your doctor has told you.Check with your doctor or pharmacist if you are not sure.

The recommended dose is one tablet once a day with food. Treatment should continue for as long as your doctor tells you. This is usually 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 higher dose than recommended, you may be at greater risk of experiencing side effects with this medicine (see section 4, Possible side effects). Contact your doctor or go to the nearest emergency department for advice. Take the tablet pack with you so that you can easily describe what you have taken.

If you forget to take Vemlidy

It is important that you do not miss any dose of Vemlidy. If you miss a dose, determine how long ago you were supposed to take it.

• If it is less than 18 hourssince you were supposed to take Vemlidy, you should take it as soon as possible, and then take your next dose at the usual time.

• If it is more than 18 hourssince you were supposed to take Vemlidy, then do not take the missed dose. Wait and take the next dose at the usual time. Do not take a double doseto make up for a forgotten dose.

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 stop taking Vemlidy

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

• Consult your doctorbefore stopping Vemlidy for any reason, especially if you have any side effects or if you have another illness.

• Tell your doctor immediatelyabout any new or unusual symptoms after stopping treatment, especially symptoms that you think may be related to your hepatitis B infection.

• Consult your doctorbefore restarting Vemlidy tablets.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common side effects

(may affect more than 1 in 10 people)

• Headache

Common side effects

(may affect up to 1 in 10 people)

• Diarrhoea

• Vomiting

• Nausea

• Dizziness

• Stomach pain

• Joint pain (arthralgia)

• Skin rash

• Itching

• Feeling of swelling

• Wind (flatulence)

• Feeling tired

Uncommon side effects

(may affect up to 1 in 100 people)

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

• Hives (urticaria)

Blood tests may also show:

• An increase in the level of a liver enzyme (ALT) in the blood.

• If you get any side effects, talk to your doctor or pharmacist.

During treatment for hepatitis B, there may be an increase in weight, lipid levels and/or blood glucose levels. Your doctor will assess these changes.

Reporting of side effects

If you experience 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 national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Vemlidy

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

Do not use this medicine after the expiry date which is stated on the carton and blister after {EXP}. The expiry date refers to the last day of that month.

Store in the original package to protect from moisture. Keep the bottle tightly closed.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

What Vemlidy contains

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

The other ingredients 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 and packaging of Vemlidy

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

The following pack sizes are available: packs with 1 bottle of 30 film-coated tablets and packs with 90 (3 bottles of 30) film-coated tablets. Not all pack sizes may be marketed.

Marketing authorisation holder

Gilead Sciences Ireland UC

Carrigtohill

County Cork, T45 DP77

Ireland

Manufacturer

Gilead Sciences Ireland UC

IDA Business & Technology Park

Carrigtohill

County Cork

Ireland

You can ask for more information about this medicine from the representative of the marketing authorisation holder:

Date of last revision of this leaflet{MM/YYYY}.

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.