Vemlidy

What Vemlidy is and what it is used for

Vemlidy contains the active substance tenofovir alafenamide. This 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 adolescents 12 years of age and older, who weigh at least 35 kg. Hepatitis B is an infection affecting the liver, caused by the hepatitis B virus. In patients with hepatitis B, Vemlidy controls the infection by stopping the virus from multiplying

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. Usually this 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 more than the recommended dose of Vemlidy you may be at increased risk of experiencing possible side effects with this medicine (see section 4, Possible side effects). Contact your doctor or nearest emergency department immediately for advice. Keep the tablet bottle with you so that you can easily describe what you have taken. If you forget to take Vemlidy It is important not to miss a dose of Vemlidy. If you do miss a dose, work out how long since you should have taken it.
• If it is less than 18 hours after you usually take Vemlidy, take it as soon as you can, and then take your next dose at its regular time.
• If it is more than 18 hours after you usually take Vemlidy, then do not take the missed dose. Wait and take the next dose at the regular time. Do not take a double dose to make up for a forgotten tablet. If you are sick (vomit) less than 1 hour after taking Vemlidy, take another tablet. You do not need to take another tablet if you are sick (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 get worse. In some patients with advanced liver disease or cirrhosis, this could be life-threatening. If you stop taking Vemlidy, you will need regular health checks and blood tests for several months to check your hepatitis B infection.
• Talk to your doctor before you stop taking Vemlidy for any reason, particularly if you are experiencing any side effects or you have another illness. 4
• Tell your doctor immediately about new or unusual symptoms after you stop treatment, particularly symptoms you associate with hepatitis B infection.
• Talk to your doctor before you restart taking Vemlidy tablets. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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
• Being sick (vomiting)
• Feeling sick (nausea)
• Dizziness
• Stomach pain
• Joint pain (arthralgia)
• Rash
• Itchiness
• Feeling bloated
• Wind (flatulence)
• Feeling tired Tests may also show:
• Increased level of a liver enzyme (ALT) in the blood  If any of these side effects get serious tell your doctor.

Reporting of side effects If you get 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: United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store Ireland HPRA Pharmacovigilance Earlsfort Terrace IRL
•Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie e-mail: [email protected] 5 Malta ADR Reporting Website: www.medicinesauthority.gov.mt/adrportal By reporting side effects you can help provide more information on the safety of this medicine

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 carton after {EXP}. The expiry date refers to the last day of that month. Store in the original package in order to protect from moisture. Keep the bottle tightly closed. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.