Tivicay brochure E

Cutterguide: No Printing Process: Offset, GD: ZS 39603

Size: 195 X 125 mm Pages: 16 Colors: C M Y K (4 Colors), Native File: Indesign CC Windows Generated in: Acrobat Distiller XI

Doctors and HIV consultants/nurses can request additional brochures from GSK/ViiV Healthcare.

TIVICAY® (dolutegravir) This medicinal product is subject to additional monitoring.

Tivicay is used in combination with other antiretroviral medicines to treat adults and adolescents from 12 years of age who are infected with human immunodeficiency virus (HIV).

Tivicay must not be given if you are allergic to dolutegravir or any of the excipients in Tivicay or if you are taking dofetilide, a medicine for disturbances of heart rhythm, as it may cause serious side effects. If you believe this is applicable to you - contact your doctor.

Starting with Tivicay (dolutegravir)

Do not drive or operate machinery if you feel dizzy or experience other types of adverse events that can have impact on your ability to drive or operate machinery.

Read the package leaflet thoroughly before you use Tivicay.

If you want to report an adverse event to any of our medicines or vaccines please contact us by one of the following ways: Web form: se.gsk.com/biverkning Phone: + 46 8 638 93 00 (ask to be connected to Pharmacovigilance) DATE OF PREPARATION: DECEMBER 2015

SE/DLG/0003/15

GSK, BOX 516, 169 29 SOLNA. TFN. 08-638 93 00 SE.GSK.COM, INFO.PRODUKT@GSK.COM TIVICAY is a registered trademark of the ViiV Healthcare Group of Companies. ©2015 ViiV Healthcare group of companies All rights reserved.

SEDLG000315_Tivicay_Brochure_GSKDC-PT-SCD-2015-0385_D2.indd 1-2

PAT I EN T I N F O R M AT I O N

1/19/2016 1:33:54 PM

Introduction You have been given this brochure because you will be using Tivicay and other medicines to inhibit the replication of HIV. This brochure contains the most important information you need when starting your therapy.

The decision to use HIV replication inhibitors is an important one. HIV replication inhibitors can keep the virus under control for a long time, but do demand something from you: it is very important that you take your medication on time every day, even if you do not feel ill all. This is called adherence. If you skip your pills, or take them too late, your HIV at a inhibitors may stop working eventually. If you are very adherent, you maximise replication inh chance together with other antiretrovirals will work for the th e ch chan ance ce that tha hatt Tivicay Tiv ivic icay ay taken t brochure designed a long long g ttime. ime. TThis ime hiss br hi broc ochu oc hure hu re iiss de desi sign si gne e to help you with this.

2

SEDLG000315_Tivicay_Brochure_GSKDC-PT-SCD-2015-0385_D2.indd 3-4

Your doctor and your HIV consultant/nurse can help you with all of the topics covered in this brochure. If there is something you do not understand, if you have doubts about what to do or if you are having difficulties with the treatment, you can ask them for information, advice or support.

IT IS VERY IMPORTANT THAT YOU TAKE YOUR MEDICATION ON TIME EVERY DAY

3

1/19/2016 1:33:55 PM

What is Tivicay?

One Tivicay pill contains 50 mg dolutegravir. Dolutegravir inhibits the replication of HIV. There are currently 6 classes of HIV drugs. Each group suppresses the virus in a different way.

Tivicay belongs to the group of integrase inhibitors. Combined with other HIV replication inhibitors, Tivicay ensures that the amount of virus in your blood (viral load) is reduced.

What does Tivicay look like?

Wha Purpose of antiretroviral therapy The purpose of antiretroviral therapy is to reduce the HIV viral load as much as possible – preferably to undetectable levels – as long as possible. If the amount of virus in your blood is so low that it is almost impossible to measure, the treatment is successful. This will allow your immune system to recover, making you less prone to diseases.

4

SEDLG000315_Tivicay_Brochure_GSKDC-PT-SCD-2015-0385_D2.indd 5-6

Tivicay is available in round, yellow 50 mg tablets.

Tivica 9 mm

5

1/19/2016 1:33:56 PM

How often per day?

What time?

Always use this medication as prescribed. Are you in doubt about the correct use?

Please contact your doctor or pharmacist. The usual dose is one tablet, once daily.

TAKE THE TABLET WITH SOME WATER

ONCE DAILY 9 mm

For patients with resistance to the integrase class (documented or clinically suspected), the recommended dose is one 50 mg tablet twice daily.

You decide at what time you want to take Tivicay, but your HIV consultant/nurse can advise you about the ideal situation for you. It is practical to take Tivicay together with your other HIV medicines. Choose a schedule that makes it as easy as possible to take your pills at the same time every day.

Many people living with HIV use a weekly pill organiser. This means you only need to sort out your pills once a week, and you can easily check if you have already taken your medication. Some people use an alarm (eg, on a mobile phone) to help them remember to take their medication on time. Your HIV consultant/nurse can advise you on pill organisers and the use of an alarm. Also, discuss what you need to do when travelling to a country in a different time zone.

Do I have to take Tivicay with food?

Tivicay can be taken with or without food. When Tivicay is taken twice a day, your doctor may advise you to take it with food.

6

SEDLG000315_Tivicay_Brochure_GSKDC-PT-SCD-2015-0385_D2.indd 7-8

7

1/19/2016 1:33:57 PM

Have you forgotten to take Tivicay?

Have you taken too much Tivicay?

If you have taken too many Tivicay pills, please contact your doctor or pharmacist for advice. Show them the Tivicay packaging if possible.

If you forget to take your medication, take it as soon as possible and return to your usual schedule again. However, if your next dose is scheduled to be taken within 4 hours, skip the missed dose and continue your usual schedule.

Do not take a double dose to compensate for the one you missed. If in doubt, contact your doctor or HIV consultant/nurse.

8

SEDLG000315_Tivicay_Brochure_GSKDC-PT-SCD-2015-0385_D2.indd 9-10

9

1/19/2016 1:33:58 PM

What are the possible side effects of Tivicay?

All medicines may cause side effects, including Tivicay. It is impossible to predict whether you will experience side effects and how long they will last if you do. This is different for everybody.

A complete overview of the possible side effects is listed in the package leaflet. Always inform your doctor, HIV consultant/nurse or pharmacist about all side effects that you experience.

VERY COMMON SIDE EFFECTS ARE: HEADACHE, DIARRHOEA, NAUSEA.

10

SEDLG000315_Tivicay_Brochure_GSKDC-PT-SCD-2015-0385_D2.indd 11-12

Never stop without consulting a doctor Taking your HIV medication on time every day increases the chance of successful longterm treatment against HIV. If you stop without discussing it with a doctor or without supervision, you run the risk of reducing your chances of successful treatment in the future because certain medicines will no longer work (well).

DO NOT STOP USING TIVICAY WITHOUT CONSULTING YOUR DOCTOR OR HIV CONSULTANT/NURSE

11

1/19/2016 1:33:58 PM

Can I use other medicines together with Tivicay?

You are using other HIV replication inhibitors together with Tivicay, but you may also be using other medication. Some medicines can affect how well Tivicay (dolutegravir) works or increase the chances of side effects.

12

SEDLG000315_Tivicay_Brochure_GSKDC-PT-SCD-2015-0385_D2.indd 13-14

Tivicay can also affect how other medicines work. Tivicay must not be given together with dofetilide, as it may cause serious side effects. The package leaflet contains a list of medicines that you must tell your doctor or HIV consultant/nurse about if you are using them.

The dose can be adjusted if necessary however some combinations are not allowed.

Inform your doctor about all other medications that you are using. This is also true for medicines available without a prescription from the pharmacy. For example, simultaneous use with St John’s wort is strongly discouraged. Magnesium/aluminiumcontaining antacid, calcium supplements, iron supplements or multivitamins should be taken well separated in time from the administration of Tivicay (Tivicay should be taken a minimum of 2 hours before or 6 hours after these medicines).

13

1/19/2016 1:33:59 PM

The pharmacy In addition to Tivicay, your doctor also prescribed other HIV medicines. Only start when you have a supply of all different HIV medicines you have been prescribed. This is to avoid running out of one of the prescribed HIV medicines and not being able to take the full prescribed combination of HIV medicines.

How do I store Tivicay?

Keep Tivicay out of the sight and reach of children. There are no specific storage conditions for Tivicay.

Do not use Tivicay after the expiry date stated on the box and the bottle after the letters EXP. Do not throw away any medicines via wastewater or household waste. Take medicines you are no longer using back to the pharmacy.

ASK YOUR DOCTOR FOR: A new prescription on time A prescription that extends longer than the exact day of your next appointment

Hand in your prescription to the pharmacy on time.

14

SEDLG000315_Tivicay_Brochure_GSKDC-PT-SCD-2015-0385_D2.indd 15-16

15

1/19/2016 1:34:00 PM