Vemlidy 25 mg film-coated tablets

Patient Information Leaflet

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 quicker identification of new safety information. You can help by reporting any side effects you may experience. Information on how to report side effects is provided at the end of section 4.

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only; do not pass it on to others, even if they have the same symptoms as you, since it may be harmful to them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Vemlidy is and what it is used for

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

Vemlidy is used for the long-term treatment of chronic hepatitis B in adults and adolescents 12 years of age and older who weigh at least 35 kg. Hepatitis B is a liver infection 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 taking Vemlidy

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

??If this applies to you,?do not take Vemlidy and inform your doctor immediately.

Warnings and precautions

• Take care 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 transmission of hepatitis B to other people through sexual contact or blood contamination. You must continue to take precautions to prevent this. Consult your doctor about which precautions are necessary to avoid infecting others.

• Inform your doctor if you have a history of liver disease. Patients with liver disease treated for hepatitis B with antiviral medicines have an increased risk of serious and potentially life-threatening liver complications. Your doctor may need to carry out 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, either 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 studied in patients who have hepatitis C or D in addition to hepatitis B.

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

• If any of these 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 who weigh less than 35 kg. Vemlidy has not been studied in children under 12 years of age or who weigh less than 35 kg.

Other medicines and Vemlidy

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

Medicines used in the treatment of hepatitis B infection Do not take Vemlidy with other medicines containing:

• tenofovir alafenamide

• tenofovir disoproxil

• adefovir dipivoxil

Other types of medicines

Consult your doctor if you are taking:

• antibiotics used to treat bacterial infections including tuberculosis, containing:

  • rifabutin, rifampicin, or rifapentine

• antiviral medicines used to treat HIV, such as:

• darunavir, lopinavir, or atazanavir boosted with ritonavir or cobicistat

• anticonvulsants used to treat epilepsy, such as:

• carbamazepine, oxcarbazepine, phenobarbital, or phenytoin

• herbal medicines used to treat depression and anxiety, containing:

  • St. John's wort (Hypericum perforatum)

• antifungal medicines used to treat fungal infections, containing:

• ketoconazole or itraconazole

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

• Inform your doctor immediately if you become pregnant.

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

Driving and using machines

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

Vemlidy contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Vemlidy contains sodium

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

3. How to take Vemlidy

Follow exactly the instructions for administering this medication as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet once daily with food. Treatment should continue for as long as your doctor indicates. Generally, treatment lasts at least 6 to 12 months and may continue for many years.

If you take more Vemlidy than you should

If you accidentally take more Vemlidy than the recommended dose, you may be at increased risk of experiencing adverse effects with this medicine (see section 4, Possible side effects).

Contact your doctor or go to the nearest emergency department for advice. Take the medicine bottle with you so you can clearly describe what you have taken.

If you forget to take Vemlidy

It is important not to miss any doses of Vemlidy. If you miss a dose, determine how long it has been since you were supposed to take it.

• If less than 18 hours have passed since your usual Vemlidy dose time, take the missed dose as soon as possible, then take your next dose at the regular time.

• If more than 18 hours have passed since your usual Vemlidy dose time, do not take the missed dose. Wait and take your next dose at the regular time. Do not take a double dose to make up for a missed dose.

If you vomit within 1 hour after 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 cause your hepatitis B to worsen. In some patients with advanced liver disease or cirrhosis, this may be potentially fatal. If you stop taking Vemlidy, you will need periodic health checks and blood tests for several months to monitor your hepatitis B infection.

• Consult your doctor before stopping Vemlidy for any reason, especially if you experience any adverse effects or have another illness.

• Inform your doctor immediately about any new or unusual symptoms after stopping treatment, particularly symptoms you associate with hepatitis B infection.

• Consult your doctor before restarting Vemlidy tablets.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody gets 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)

• Diarrhoea

• Vomiting

• Nausea

• Dizziness

• Stomach pain

• Joint pain (arthralgia)

• Skin rash

• Itching

• Feeling of bloating

• Gas (flatulence)

• Feeling of tiredness

Uncommon adverse 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:

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

• If you consider any of these adverse effects to be severe, inform your doctor.

During treatment for HBV, there may be weight gain and increased levels of lipids and/or fasting blood glucose. Your doctor will evaluate these changes.

Reporting of 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 leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse 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 bottle and on the packaging after {CAD}. The expiry date is the last day of the month indicated.

Store in the original packaging 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 containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vemlidy

The active substance is tenofovir alafenamide. Each film-coated tablet of Vemlidy 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 side of the tablet and “25” on the other side. Vemlidy is available in 30-tablet bottles (with a silica gel desiccant which should be kept in the bottle to help protect your tablets). The silica gel desiccant is contained in a separate sachet or container and must not be swallowed.

The following pack sizes are available: packs containing 1 bottle of 30 film-coated tablets and packs containing 90 tablets (3 bottles of 30) film-coated tablets. Some pack sizes may not 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

For more information about this medicine, contact the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet: {MM/YYYY}.

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