200 mg / 10 mg film-coated tablets 
emtricitabine / tenofoviralafenamide

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Descovy is and what it is used for 
2. What you need to know before taking Descovy 
3. How to take Descovy 
4. Possible side effects 
5. How to store Descovy 
6. Contents of the packaging and other information 

1. What Descovy is and what it is used for

Descovy contains two active substances:

  • emtricitabine, a type antiretroviral drug called a nucleoside reverse transcriptase inhibitor (NRTI)
  • tenofoviralafenamide,  an antiretroviral medicinal product of a type called nucleotide reverse transcriptase inhibitor (NRTI).

Descovy blocks the activity of reverse transcriptase, an enzyme necessary for the virus to multiply. Therefore, Descovy reduces the amount of HIV in the body.

Descovy is intended to be used in combination with other medicines for the treatment of human immunodeficiency virus ( HIV ‑1) – an infection in adults and adolescents aged 12 years and older weighing at least 35 kg.

2. What you need to know before taking Descovy

Do not take Descovy:

  • If you are allergic to emtricitabine, tenofoviralafenamide, or any of the other ingredients of this medicine (listed in section 6 of the Package Leaflet).

Warnings and cautions

Your treatment with Descovy must be constantly monitored by a doctor.

You can still transmit HIV infection when you take this medicine, even though the risk of effective antiviral therapy is reduced. Discuss with your doctor the necessary steps to avoid infecting others. This medicine does not cure HIV – infection. While taking Descovy you may still develop infections you or other illnesses associated with HIV – infection.

Talk to your doctor before taking Descovy:

  • If you have liver problems or have had liver disease, including hepatitis. Patients with liver disease, including chronic hepatitis B or C, treated with antiretroviral agents are at increased risk of severe and potentially fatal liver complications. If you have hepatitis B, your doctor will carefully choose the best treatment for you.

If you have hepatitis B, your liver problems may worsen after you stop taking Descovy. Do not stop taking Descovy without talking to your doctor (see section 3, Do not stop taking Descovy ).

  • Your doctor may not prescribe Descovy for you if the virus has a K65R mutation.

When you take Descovy

Once you have started taking Descovy, be aware of:

  • Signs of inflammation or infection
  • Joint pain, stiffness, or problems with the skeleton

→  Contact your doctor immediately if you get any of these symptoms. See section 4, Possible side effect is, for more information.

Although kidney problems have not been observed with Descovy, you may experience kidney problems during long-term treatment with Descovy.

Children and young people

Do not give this medicine to children aged 11 years or younger, or who weigh less than 35 kg. The use of Descovy in children aged 11 years and younger has not been studied.

Other drugs and Descovy

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Descovy may affect or be affected by other medicines. This can lead to changes in the amount of Descovy or other medicines in the blood. The medicines may then not work properly or any side effects may be exacerbated. In some cases, your doctor may need to change your dose or check the amount of medicine in your blood.

Drugs used to treat hepatitis B infection:

You should not take Descovy with medicines containing:

  • tenofoviralafenamide
  • tenofovir disoproxil
  • lamivudine
  • adefovir dipivoxil

→  Contact your doctor if you are taking any of these medicines.

Other types of medicines:

Talk to your doctor if you are taking:

  • antibiotics, used to treat bacterial infections including tuberculosis, which contain:
    • rifabutin, rifampicin, and rifapentine
  • antiviral drugs used to treat HIV :
    • emtricitabine and tipranavir
  • antiepileptics used to treat epilepsy, eg:
    • carbamazepine, oxcarbazepine, phenobarbital, and phenytoin
  • (Traditional) herbal medicines, used to treat mild depression and anxiety, which contain:
    • St. John’s wort ( Hypericum perforatum )

→  Tell your doctor if you are taking any of these or other medicines. You should not stop treatment without talking to your doctor.

Pregnancy and breastfeeding

  • 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 and ask about the possible benefits or risks of your antiretroviral treatment for you and your baby.

If you have taken Descovy during your pregnancy, your doctor may ask you to have regular blood tests and other tests to check your baby’s development. For children whose mothers took NRTIs during pregnancy, the benefit of HIV protection outweighs the risk of side effects.

Do not breast-feed during treatment with Descovy. This is because one of the active substances in this medicine passes into breast milk. To avoid transmitting HIV to your baby through breast milk, do not breast-feed your baby.

Driving and using machines

Descovy can cause dizziness. Do not drive or use tools or machines if you feel dizzy while taking Descovy.

Descovy contains excipients

Descovy contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.

3. How to take Descovy

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose is:

Adults: one tablet a day with or without food

Adolescents aged 12 years and older, weighing at least 35 kg: one tablet a day with or without food

You must not chew, crush or split the tablet.

Always take the dose prescribed by your doctor to ensure that the medicine is effective and to reduce the risk of developing resistance to treatment. Do not change the dose unless your doctor tells you to.

If you are on dialysis, you should take your daily dose of Descovy after dialysis has been completed.

If you take more Descovy than you should

If you take more than the prescribed dose of Descovy you may be at greater risk of side effect s of this medicine (see section 4, Possible side effects s ).

Contact your doctor or nearest emergency department immediately for advice. Save the jar so you can show what you have taken.

If you forget to take Descovy

You mustn’t miss a dose of Descovy.

If you miss a dose:

  • If you notice it within 18 hours after the time you usually take Descovy, you must take the tablet as soon as possible. Then take the next dose as usual.
  • If you notice it 18 hours or more after the time you usually take Descovy, do not take the missed dose. Wait and take the next dose at its regular time.

If you vomit within less than 1 hour after a dose of Descovy, take a new tablet.

Do not stop taking Descovy

Do not stop taking Descovy without talking to your doctor. If you stop taking Descovy, it can seriously affect how well a future treatment works. If for any reason you stop taking Descovy, talk to your doctor before taking Descovy tablets again.

When you start to run out of Descovy, get more from your doctor or pharmacist. This is very important because the amount of virus can start to increase even if you only stop taking the medicine for a short time. The disease can then become more difficult to treat.

If you have both HIV – infection and hepatitis B, it is very important not to stop Descovy treatment without first talking to your doctor. You may need to submit blood samples for several months after stopping treatment. In some patients with advanced liver disease or cirrhosis, hepatitis A may worsen if treatment is stopped, which can be life-threatening.

→ Tell your doctor immediately about any new and unexpected symptoms that occur after stopping treatment, especially symptoms that you usually associate with your hepatitis B infection.

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

4. Possible side effects

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

Possible serious side effects: Contact a doctor immediately

  • Signs of inflammation or infection. In some patients with advanced HIV – infection ( AIDS ) who have a history of opportunistic infection, you ( infection s that occurs in people with a weakened immune system), signs and symptoms of inflammation from previous infections you behave shortly after antiretroviral treatment has begun. It is believed that these symptoms are because the body’s immune system has been strengthened so that the body can fight infections that may have been present without giving any clear symptoms.
  • Autoimmune disease (the immune system attacks healthy body tissue) may also occur after you start taking medicines for HIV – infection. Autoimmune diseases can occur many months after starting treatment. Be observant of symptoms of infection or other symptoms such as:
    • muscle weakness
    • weakness that begins in the hands and feet and moves towards the torso
    • palpitations, tremors, or hyperactivity.

→ If you notice the side effects described above, tell your doctor immediately.

Very common side effects are

may occur in more than 1 in 10 people )

  • nausea

Common side effects are

may occur in up to 1 in 10 people )

  • abnormal dreams
  • headache
  • dizziness
  • diarrhea
  • vomiting
  • abdominal pain
  • gas production ( flatulence )
  • rash
  • fatigue

Uncommon side effects are

may occur in up to 1 in 100 people )

  • low red blood cell count ( anemia )
  • indigestion which results in discomfort after meals ( dyspepsia )
  • swelling of the face, lips, tongue, or throat ( angioedema )
  • itching ( pruritus )
  • hives ( urticaria )
  • joint pain ( arthralgia )

→  If any side effects get worse, talk to your doctor.

Other effects that can be seen with HIV treatment

The frequency of the following side effects is unknown (frequency cannot be calculated from the available data).

  • Skeletal problem. Some patients taking combination antiretroviral medicines like Descovy may develop a skeletal disease called osteonecrosis (bone tissue dies due to lost blood supply to the skeleton). Some of the many risk factors for developing this disease are long-term use of this type of drug, treatment with corticosteroids, alcohol consumption, a very weak immune system, and obesity. Signs of osteonecrosis are:
    • joint stiffness
    • joint pain and pain (especially in hips, knees, and shoulders)
    • mobility difficulties

→  Tell your doctor if you notice any of these symptoms.

During HIV treatment, weight gain and increased levels of lipids and glucose in the blood may occur. This is partly related to restored health and lifestyle, but when it comes to blood lipids, there can sometimes be a connection with HIV drugs. The doctor will perform tests to find such changes.

5. How to store Descovy

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 jar after “EXP”. The expiration date is the last day of the specified month.

Store in the original package. Moisture sensitive. Close the jar tightly.

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 packaging and other information

Content declaration

The active substances are emtricitabine and tenofoviralafenamide. One Descovy film-coated tablet contains 200 mg emtricitabine and tenofoviralafenamide fumarate equivalent to 10 mg tenofoviralafenamide.

Other ingredients are

Tablet core:

Microcrystalline cellulose, croscarmellose sodium, magnesium stearate.

Film coating:

Polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, black iron oxide (E172).

What the medicine looks like and the contents of the pack

Descovy film-coated tablets are gray, rectangular tablets. Embossed on one side with “GSI” and on the other side with the number “210”.

Descovy is supplied in jars containing 30 tablets (with desiccant in the form of silica gel which must be stored in the jar to protect the tablets from moisture). The desiccant (silica gel) is in a separate sachet or container and should not be swallowed.

The following pack sizes are available: Outer cartons containing 1 can of 30 film-coated tablets and outer cartons containing 60 (2 cans of 30) and 90 (3 cans 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

Muhammad Nadeem

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