PATIENT INFORMATION BOOKLET

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1 PATIENT INFORMATION BOOKLET

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3 GETTING STARTED WITH YOUR MEDICINES TIVICAY (dolutegravir) + lamivudine Tivicay is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. This leaflet is only intended for patients who have been prescribed Tivicay + lamivudine. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed on this website or in the product package leaflet. You can also report side effects directly to the HPRA Pharmacovigilance, Earlsfort Terrace, Dublin 2; Tel: ; Fax: Website: medsafety@hpra.ie. By reporting side effects you can help provide more information on the safety of this medicine.

4 UNDERSTANDING YOUR MEDICINES You have received this booklet because you have been prescribed Tivicay and lamivudine. This booklet simply explains how your medicines work and how to take them. It also provides other important information to help you take your medicines correctly. Please read this booklet carefully and keep it in a safe place so you can refer to it again if you need to. Both of the medicines you have been prescribed should come with their own Patient Information Leaflet (included in the packaging). Please make sure you read these carefully, too, as they contain more detailed information. Your tablets look like this: Tivicay lamivudine 50 mg 300 mg 300 mg Not actual size There are a number of different companies that make lamivudine and each tablet may look different.

5 WHAT ARE TIVICAY AND LAMIVUDINE FOR? Together, Tivicay and lamivudine treat HIV. HIV is a virus that weakens your immune system by destroying a type of white blood cell called a CD4 cell. CD4 cells help your body fight infections and disease. HIV uses CD4 cells to multiply, destroying them in the process. If HIV is left untreated, the number of CD4 cells in the blood (CD4 count) goes down as the amount of virus in the blood (viral load) goes up. Taking Tivicay and lamivudine every day can help reduce your viral load, allowing your CD4 count to go up and your immune system to recover. CD4 CD4 CD4 CD4 CD4 CD4 Patients with high CD4 counts have stronger immune systems and are less likely to get infections and diseases. CD4 CD4 HIV HIV HIV CD4 HIV HIV HIV CD4 Patients with high viral loads are more likely to have weak immune systems. They are also at greater risk of getting HIV-related infections and diseases, and passing the virus to others.

6 HOW DO TIVICAY AND LAMIVUDINE WORK? Tivicay belongs to a group of HIV drugs called integrase inhibitors (INIs). Lamivudine is part of a group called nucleoside analogue reverse transcriptase inhibitors (NRTIs). Tivicay and lamivudine stop the HIV from multiplying in two different ways. 1 2 Lamivudine stops HIV from copying its genetic material after it has entered the CD4 cell Tivicay works by stopping the HIV genetic material from combining with that of the cell HIV 1 CD4 cell 2

7 WHAT DO I NEED TO KNOW BEFORE I START TAKING MY NEW MEDICINES?! You should not take Tivicay or lamivudine if you are allergic to any of the ingredients or are taking dofetilide for a heart condition. It is important to tell your doctor if you have a liver or kidney problem. It is important to tell your doctor if you are pregnant, if you become pregnant, or if you are planning to have a baby. Women of childbearing age should have a pregnancy test before initiation of Tivicay (dolutegravir) and lamivudine, and should use effective contraception while taking Tivicay and lamivudine. Women who are HIV-positive should not breastfeed as HIV can be passed on to the baby through breast milk.

8 CAN I TAKE TIVICAY AND LAMIVUDINE WITH OTHER MEDICINES? The following should not be taken for 6 hours before or until 2 hours after Tivicay and lamivudine: Antacids (for indigestion or heartburn) Calcium, iron supplements and multivitamins Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including herbal medicines and medicines bought without a prescription. Remember to tell your doctor or pharmacist if you begin taking a new medicine while you are on treatment.! Tell your doctor about all other medicines you are taking now, have recently taken or might take in the future.

9 YOUR MEDICINES, ALCOHOL AND RECREATIONAL DRUGS It is very important that you tell your doctor if you drink alcohol or use recreational drugs, even if just occasionally, because interactions between your medication and recreational drugs can increase the risk of side effects. HOW DO I TAKE MY MEDICINES? 1 Tivicay and lamivudine should be taken together once daily, ideally at the same time of day each day. Swallow your tablets together with water/liquid. Tivicay and lamivudine can be taken with or without food.

10 HOW CAN I REMEMBER TO TAKE MY MEDICINES? Make taking your medicines part of an everyday activity, like getting dressed in the morning. It is important that you try to take your medicines at the same time of day, every day, for them to work properly. Here are a few more tips that may help you remember to take your medicines: M T W T F S S Use a pill organiser: with a pill organiser, you only need to sort your pills once a week and you can easily check if you have already taken your medicines. Create a reminder: this could be an alarm, an app or a calendar alert on your phone. If you live with someone who knows you are HIV-positive, you could also ask them if they can help.

11 Keep a diary: to record when you have taken your medicine. You could also put a tick in a calendar. Try storing your medicines in a visible - but safe - spot, for example on a shelf in your bathroom. Make it routine: taking Tivicay and lamivudine as part of your morning or bedtime routine can help you get into the habit of taking your medicines at the same time every day. You may also want to carry an extra dose or two in your purse or wallet so that you don t miss a dose if your plans suddenly change.

12 WHAT IF I MISS A DOSE?? If you forget to take Tivicay: If you miss a dose, take it as soon as you remember. But if your next dose is due within 4 hours, skip the dose you missed and take the next one at the usual time. Then continue your treatment as before. Don t take a double dose to make up for a missed dose. If you forget to take Epivir: If you forget to take a dose, take it as soon as you remember. Then continue your treatment as before. Do not take a double dose to make up for a forgotten dose. If you are not sure what to do, speak to your doctor.! Do not take two doses at the same time to make up for a missed dose.

13 WHAT S THE BEST WAY TO STORE MY MEDICINES? Store your tablets in a cool, dry place away from children and pets.! Don t take your Tivicay or lamivudine after the expiry date shown on the packaging.

14 WHAT ARE THE POSSIBLE SIDE EFFECTS OF TIVICAY AND LAMIVUDINE? Like all medicines, Tivicay and lamivudine may cause side effects. It is hard to know if you will have side effects or how long they will last if you do. It is different for everybody. A list of possible side effects is included in the Patient Information Leaflets that came with your medicines, but the very common ones (affecting more than 1 in 10 people) reported for Tivicay are headache, diarrhoea and nausea. Other common side effects (affecting up to 1 in 10 people) reported for Tivicay and/or lamivudine are rash, itching, stomach pain (abdominal pain) and/or discomfort, muscle pain and discomfort, joint pain, feeling sick (nausea), being sick, headache, dizziness, depression, anxiety, tiredness, lack of energy, insomnia, abnormal dreams, wind, diarrhoea, increase in the level of liver enzymes and/or enzymes produced in the muscle, fever, general feeling of being unwell, cough, irritated or runny nose and hair loss.

15 ! If you experience signs of an allergic reaction, such as swelling of the face and mouth causing breathing difficulties, a skin rash or a high temperature, see a doctor straight away. If your joints become stiff, and/or you experience aches and pains in your joints that make it difficult for you to move, see your doctor straight away.! If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the Patient Information Leaflets. You can also report side effects directly to the HPRA Pharmacovigilance, Earlsfort Terrace, Dublin 2; Tel: ; Fax: Website: medsafety@hpra.ie. By reporting side effects you can help provide more information on the safety of these medicines. Always read the Patient Information Leaflet or instruction supplied with your medicine. It lists the known side effects or problems and advises you on what to do.

16 MAKING THE MOST OF YOUR HEALTHCARE APPOINTMENTS It is important that you talk openly with your HIV care team because: this will help you better understand HIV and your treatment this will help your care team come up with a treatment plan suited to your personal needs. Being active in your care can go a long way, so: Be prepared: Take some time to think about your health before each appointment. Write down any questions or concerns you may have so you don t forget to talk about them with your doctor. Ask! Speak up if you don t understand something your doctor tells you. You may want to bring a family member or friend with you to appointments they can help you ask questions and/or remember useful information.

17 Stay informed: Your care team is a great source of information, but it helps to do your own research, too. The more you know about HIV and your treatment, the more motivated you will be to stay healthy. Helpful Information: My nearest clinic is: My doctor s name is: My emergency contact is: My next appointment is:

18 NOTES

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20 NOTES

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22 TIVICAY is owned by or licensed to the ViiV Healthcare group of companies ViiV Healthcare group of companies or its licensor. IE/DTG3TC/0022/18 December 2018.

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