25 mg film-coated tablets
tenofovir alafenamide
What Vemlidy is and what it is used for
Vemlidy contains the active substance tenofovir alafenamide . This is a drug against viral infection ( antiviral drug) also called nucleotide reverse transcriptase inhibitor (NtRTI).
Vemlidy is used to treat chronic (long-term) hepatitis B in adults and adolescents aged 12 and over who weigh at least 35 kg. Hepatitis B is an infection that affects the liver and is caused by the hepatitis B virus et. In patients with hepatitis B, this medicine controls the infection by preventing the virus from multiplying.
What you need to know before you take Vemlidy
Do not take 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 tell your doctor immediately.
Warnings and precautions
- Be careful not to spread your hepatitis B to others. While you are taking this medicine, you can still infect other people. This medicine does not reduce the risk of transmitting hepatitis B to others through sexual contact or blood infection. You must continue to take precautions to avoid this. Discuss with the doctor what precautions are necessary to avoid infecting others.
- Tell your doctor if you have liver disease. Patients with liver disease who are treated for hepatitis B with anti-viral drugs (antiviral drugs) are at higher risk of severe and potentially life-threatening liver complications. Your doctor may need to carry out blood tests to check liver function.
- Talk to your doctor or pharmacist if you have kidney disease or if tests have shown that you have problems with your kidneys, before or during treatment. Before starting treatment and during treatment with Vemlidy, doctors may order blood or urine samples to check how your kidneys are working.
- Talk to your doctor if you also have hepatitis C or D. This medicine has not been tested in patients who have both hepatitis C or D and hepatitis B.
- Talk to 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 this medicine for hepatitis B.
→ If any of these apply to you, talk to your doctor before taking Vemlidy.
There is a risk of kidney problems when you take Vemlidy for a long time (see Warnings and precautions ).
Children and young people
Do not give this medicine to children under 12 years of age and weighing less than 35 kg. It has not been tested on children younger than 12 years and 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 can affect and is affected by other medicines. This can result in the amount of Vemlidy or other medicines in the blood changing. This can make your medicines not work properly or make possible side effects worse.
Medicines used to treat hepatitis B infection
You should not take this medicine with other medicines that contain:
- tenofovir alafenamide
- tenofovir disoproxil
- adefovir dipivoxil
Other types of medicines
Talk to your doctor if you are taking:
- antibiotics used to treat bacterial infections, including tuberculosis, containing:- rifabutin, rifampicin, or rifapentine
- anti-viral medicines used to treat HIV, such as- ritonavir or cobicistat-boosted darunavir, lopinavir, or atazanavir
- anticonvulsant drugs used to treat epilepsy, such as- carbamazepine, oxcarbazepine, phenobarbital, or phenytoin
- herbal medicines used for mild depression and mild anxiety, containing:
- St. John’s wort Hypericum perforatum )
- antifungal medicines used to treat fungal infections, which contain:- ketoconazole or itraconazole
→ Tell your doctor if you are taking these or any other medicines.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
- Tell your doctor immediately if you become pregnant.
- Do not breastfeed during treatment with Vemlidy. The recommendation is not to breastfeed to avoid transferring tenofovir alafenamide or tenofovir to the child through breast milk.
Driving ability and use of machinery
Vemlidy can cause dizziness. If you feel dizzy while taking Vemlidy, you should not drive or use tools or machines
Vemlidy contains lactose
If you have an intolerance to certain sugars, you should consult your doctor before taking this medicine.
Vemlidy contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is almost ‘sodium-free’.
How to take Vemlidy
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
The recommended dose is one tablet once daily with food. It is best to take Vemlidy with food to get the right level of active substance in your body. The treatment should continue for as long as the doctor tells you. Usually, this is at least 6-12 months and can be several years.
If you have taken too much Vemlidy
If you accidentally take more than the recommended dose of Vemlidy, you may run an increased risk of possible side effects of the medicine (see section 4, Possible side effects ).
Immediately contact a doctor or the nearest emergency department for advice. Take the jar of tablets with you so that you can easily describe what you have taken.
If you forget to take Vemlidy
You mustn’t miss a dose. If you miss a dose, calculate how long it has been since you last took a dose.
- If it has been less than 18 hours since the time you usually take Vemlidy, take one dose as soon as possible and then take the next dose at the usual time.
- If it has been more than 18 hours since the time you usually take Vemlidy, do not take the missed dose. Wait and then take the next dose at the usual time. Do not take a double dose to make up for a missed tablet.
If you vomit within 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 taking Vemlidy without consulting a doctor. If you stop taking Vemlidy, your hepatitis B may get worse. In some patients with advanced liver disease or cirrhosis ( cirrhosis ), this can be life-threatening. If you stop taking this medicine, you will need to have regular health checks and blood tests for several months to check for hepatitis B infection.
- Talk to your doctor before you stop taking this medicine for any reason, especially if you experience side effects or have another illness.
- Tell your doctor immediately if new or unusual symptoms develop after you stop treatment, especially symptoms that you associate with hepatitis B infection.
- Talk to your doctor before you start taking Vemlidy tablets again.
If you have any further questions about 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
(may affect more than 1 in 10 users)
- Headache
Usual
(may affect up to 1 in 10 users)
- Diarrhea
- Vomiting
- Nausea
- Dizziness
- Stomach pain
- Joint pain ( arthralgia )
- Rash
- Itching
- Feeling of bloating
- Gas ( flatulence )
- Feeling of fatigue
Less common
( may affect up to 1 in 100 users)
- Swelling of the face, lips, tongue, or throat ( angioedema )
- Hives ( urticaria )
Blood tests may also show:
- An elevated level of a liver enzyme ( ALT ) in the blood
→ Tell your doctor if any of these side effects become serious.
During HBV treatment, body weight may increase as well as fasting levels of lipids and /or glucose in the blood. The doctor will do tests to check for such possible changes.
How Vemlidy should be stored
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the can and carton after EXP. The expiration date is the last day of the specified month.
Store in the original packaging. Moisture sensitive. Close the jar well.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is tenofovir alafenamide . Each Vemlidy film-coated tablet contains tenofovir alafenamide fumarate equivalent to 25 mg of tenofovir alafenamide.
Other ingredients are
Tablet core:
Lactose monohydrate, microcrystalline cellulose (E460(i)), croscarmellose sodium (E468), magnesium stearate (E470b).
Film coating:
Polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol (E1521), talc (E553b), and yellow iron oxide (E172).
Appearance and package sizes of the medicine
Vemlidy film-coated tablets are yellow, round, printed (or marked) with “GSI” on one side of the tablet and “25” on the other side of the tablet. It is supplied in tins of 30 tablets (with silica gel desiccant which must remain in the tin to protect the tablets). The silica gel desiccant is stored in a separate bag or container and must not be swallowed.
The following pack sizes are available: outer cartons containing 1 bottle of 30 film-coated tablets and outer cartons containing 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
Country Cork
Ireland