Vemlidy

Patient Information Leaflet

Vemlidy 25 mg film-coated tablets

tenofovir alafenamide
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful to them.
• If you experience any adverse reactions, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

If Vemlidy has been prescribed for your child, please note that all the information in this leaflet applies to your child (in this case, read “your child” instead of “you”).

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 (NtRTI).
Vemlidy is used to treat chronic (long-term) hepatitis B in adults and children aged 6 years and older who weigh at least 25 kg. Hepatitis B is a liver infection caused by the hepatitis B virus. In patients with hepatitis B, this medicine controls the infection by preventing the virus from multiplying.

2. What you need to know before taking Vemlidy

Do not take Vemlidy

• if you are allergic to tenofovir alafenamide or to 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

• Be careful not to transmit hepatitis B to other people. While taking this medicine, you may still infect others. This medicine does not reduce the risk of transmitting hepatitis B to other people through sexual contact or blood contamination. To prevent this, you must continue to take precautions. Discuss with your doctor the necessary precautions to avoid infecting others.
• Inform your doctor if you have a history of liver disease. Patients with liver diseases treated for hepatitis B with antiviral medicines have an increased risk of severe and potentially fatal liver complications. Your doctor may need to perform blood tests to monitor your liver function.
• Contact your doctor or pharmacist if you have had kidney problems or if tests have shown kidney problems, either before or during treatment. Before starting treatment and during treatment with Vemlidy, your doctor may prescribe blood or urine tests to monitor how well your kidneys are working.
• Contact your doctor if you also have hepatitis C or D. This medicine has not been tested in patients who have hepatitis C or D in addition to hepatitis B.
• Contact your doctor if you also have HIV. If you are unsure whether you have HIV, your doctor must offer you an HIV test before you start taking this medicine for hepatitis B.

If this applies to you, contact your doctor before taking Vemlidy.
Kidney problems may occur during long-term use of Vemlidy (see Warnings and precautions).
Children and adolescents
Do not give this medicine to children under 6 years of age or weighing less than 25 kg. It has not been studied in children under 6 years of age or weighing less than 25 kg.
Bone problems. Bone mineral loss has been reported in some children receiving Vemlidy. The long-term effects on bone health and the future risk of fractures in children are uncertain. Your doctor will monitor this potential risk. Contact your doctor if bone pain or fractures occur.
Other medicines and Vemlidy
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Vemlidy can interact with other medicines. As a result, the levels of Vemlidy or other medicines in the blood may change, preventing the medicines from working properly or worsening their side effects.
Medicines used to treat hepatitis B
You must not take this medicine together with other medicines containing:

• tenofovir alafenamide
• tenofovir disoproxil
• adefovir dipivoxil

Other types of medicines
Contact 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, including:
  • darunavir, lopinavir, or atazanavir boosted with ritonavir or cobicistat
• anticonvulsants used to treat epilepsy, including:
  • carbamazepine, oxcarbazepine, phenobarbital, or phenytoin
• herbal remedies 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 these or other medicines.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

• Inform your doctor immediately if you become pregnant.
• Do not breastfeed during treatment with Vemlidy. Breastfeeding is not recommended to avoid passing tenofovir alafenamide or tenofovir to the infant through breast milk.

Driving and using machines
Vemlidy may cause dizziness. If you feel dizzy while taking Vemlidy, do not drive and do not operate tools or machinery.
Vemlidy contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Vemlidy contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially ‘sodium-free’.

3. How to take Vemlidy

Take this medicine exactly as prescribed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
The recommended dose is one tablet once daily with food. It is best to take
Vemlidy with food to ensure adequate levels of the active substance are achieved. Treatment should continue
for as long as directed by your doctor. Typically, treatment lasts at least 6–12 months and may continue for many years.
If you take more Vemlidy than you should
If you accidentally take more Vemlidy than recommended, you may be at increased risk
of experiencing possible side effects associated with this medicine (see section 4, Possible side effects).
Contact your doctor or the nearest emergency department immediately for advice. Bring the bottle containing the tablets
with you so you can clearly explain what has been taken.
If you forget to take Vemlidy
It is important not to miss any doses. If you forget a dose, consider how much time has passed since it was due.

• If less than 18 hours have passed since you were supposed to take Vemlidy, take it as soon as possible, then take the next dose at your usual time.
• If more than 18 hours have passed since you were supposed to take Vemlidy, do not take the missed dose. Wait and take the next dose at your usual time. Do not take a double dose to make up for the forgotten tablet.

If you vomit less than 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 treatment with Vemlidy without first consulting your doctor. Stopping
treatment with Vemlidy may cause worsening of hepatitis B. In some patients with advanced liver disease or cirrhosis,
this worsening may potentially be fatal. If you stop treatment with this medicine, you will need regular check-ups and blood tests
to monitor your hepatitis B.

• Talk to your doctor before stopping treatment with this medicine for any reason, especially if you experience side effects or have another illness.
• Contact your doctor immediately if new or unusual symptoms appear after stopping treatment, particularly symptoms you associate with hepatitis B infection.
• Talk to your doctor before restarting Vemlidy tablets.

If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

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

• Headache

Common
(may affect up to 1 in 10 people)

• Diarrhoea
• Feeling unwell (vomiting)
• Feeling of discomfort (nausea)
• Dizziness
• Stomach pain
• Joint pain (arthralgia)
• Skin rash
• Itching
• Feeling of bloating
• Intestinal gas (flatulence)
• Feeling of tiredness

Uncommon
(may affect up to 1 in 100 people)

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

Tests may also show:

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

If any of these side effects worsen, inform your doctor.
During treatment for HBV, an increase in body weight and in levels of lipids (fats) in the blood and/or blood glucose (blood sugar) while fasting may occur. Your doctor will arrange tests to monitor for such changes.
Reporting of side effects
If you get any side effect, including ones not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 outer carton after
“Exp.”. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture. Keep the bottle tightly closed.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Vemlidy contains
The active substance is tenofovir alafenamide. Each Vemlidy film-coated tablet contains tenofovir alafenamide fumarate, equivalent to 25 mg of tenofovir alafenamide.
The other components are
Tablet core:
Monohydrate lactose, microcrystalline cellulose (E460(i)), croscarmellose sodium (E468), magnesium stearate (E470b).
Film coating:
Polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol (E1521), talc (E553b), yellow iron oxide (E172).

Description of the appearance of Vemlidy and contents of the pack
Vemlidy film-coated tablets are yellow, round tablets, printed (or marked) with “GSI” on one side and “25” on the other side. It is marketed in bottles of 30 tablets (with a silica gel desiccant which should be kept in the bottle to help protect the tablets). The silica gel desiccant is contained in a separate sachet or container and must not be ingested.
The following pack sizes are available: outer cartons containing 1 bottle of 30 film-coated tablets and outer cartons containing 90 tablets (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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Gilead Sciences Belgium SRL-BV
Tél/Tel: + 32 (0) 24 01 35 50

България
Gilead Sciences Ireland UC
Тел.: + 353 (0) 1 686 1888

Česká republika
Gilead Sciences s.r.o.
Tel: + 420 910 871 986

Danmark
Gilead Sciences Sweden AB
Tlf: + 46 (0) 8 5057 1849

Deutschland
Gilead Sciences GmbH
Tel: + 49 (0) 89 899890-0

Eesti
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

Ελλάδα
Gilead Sciences Ελλάς Μ.ΕΠΕ.
Τηλ: + 30 210 8930 100

España
Gilead Sciences, S.L.
Tel: + 34 91 378 98 30

France
Gilead Sciences
Tél: + 33 (0) 1 46 09 41 00

Hrvatska
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

Irlanda
Gilead Sciences Ireland UC
Tel: +353 (0) 214 825 999

Ísland
Gilead Sciences Sweden AB
Sími: + 46 (0) 8 5057 1849

Italia
Gilead Sciences S.r.l.
Tel: + 39 02 439201

Κύπρος
Gilead Sciences Ελλάς Μ.ΕΠΕ.
Τηλ: + 30 210 8930 100

Latvija
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

Lietuva
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

Luxembourg/Luxemburg
Gilead Sciences Belgium SRL-BV
Tél/Tel: + 32 (0) 24 01 35 50

Magyarország
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

Malta
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

Nederland
Gilead Sciences Netherlands B.V.
Tel: + 31 (0) 20 718 36 98

Norge
Gilead Sciences Sweden AB
Tlf: + 46 (0) 8 5057 1849

Österreich
Gilead Sciences GesmbH
Tel: + 43 1 260 830

Polska
Gilead Sciences Poland Sp. z o.o.
Tel: + 48 (0) 22 262 8702

Portugal
Gilead Sciences, Lda.
Tel: + 351 21 7928790

România
Gilead Sciences (GSR) S.R.L.
Tel: + 40 31 631 18 00

Slovenija
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

Slovenská republika
Gilead Sciences Slovakia s.r.o.
Tel: + 421 232 121 210

Suomi/Finland
Gilead Sciences Sweden AB
Puh/Tel: + 46 (0) 8 5057 1849

Sverige
Gilead Sciences Sweden AB
Tel: + 46 (0) 8 5057 1849

United Kingdom (Northern Ireland)
Gilead Sciences Ireland UC
Tel: + 44 (0) 8000 113 700

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