Triumeq english

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

TRIUMEQ® (dolutegravir/abacavir/lamivudine) This medicinal product is subject to additional monitoring.

Triumeq is indicated for the treatment of adults and adolescents above 12 years of age weighing at least 40 kg who are infected with human Immunodeficiency virus (HIV).

Before initiating treatment with Triumeq screening for carriage of the HLA-B*5701 allele should be performed.

(doluteg gra avirr/a abacavir/lamivudine)

Triumeq must not be given if you are allergic to dolutegravir, abacavir, lamivudine or any of the excipients in Triumeq 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 for you - contact your doctor.

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 Triumeq.

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/TRIM/0015/15

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

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PATI ENT IN FORMATION

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Introduction You have been given this brochure because you will be using Triumeq. 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 at all. This is called adherence.

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.

IF YOU SKIP YOUR PILLS, OR TAKE THEM TOO LATE, YOUR HIV REPLICATION INHIBITORS MAY STOP WORKING EVENTUALLY. If you are very adherent, you maximise the chance that Triumeq will work for a long time. This brochure is designed to help you with this.

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What is Triumeq?

Triumeq is a combination of 3 medicines that inhibit the replication of HIV. One Triumeq pill contains: dolutegravir (50 mg), abacavir (600 mg) and lamivudine (300 mg). There are currently 6 classes of HIV drugs. Each class suppresses the replication of the virus in a different way. Dolutegravir belongs to the class of integrase inhibitors; abacavir and lamivudine are nucleoside reverse transcriptase inhibitors. In Triumeq, this combination of HIV replication inhibitors ensures that the amount of virus in your body (viral load) is reduced.

What do does Triumeq look like?

Triumeq is a biconvex, film-coated oval pill.

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.

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22 mm

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How often per day?

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

Please contact your doctor or pharmacist.

THE USUAL DOSE IS ONE PILL, ONCE DAILY. TAKE THE PILL WITH SOME WATER.

What time?

You decide at what time you want to take Triumeq, but your HIV consultant/nurse can advise you about the ideal situation for you. Choose a schedule in your daily life that makes it as easy as possible to take your pill at the same time every day.

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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 Triumeq with food?

Triumeq has no food restrictions. It can be taken with or without food.

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Have you forgotten to take Triumeq?

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.

What are the possible side effects of Triumeq?

All medication may cause side effects, including Triumeq. 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.

Have you taken too much Triumeq?

If you have taken too many Triumeq pills, please contact your doctor, HIV consultant/nurse, or pharmacist for advice. Show them the Triumeq packaging if possible.

ALWAYS INFORM YOUR DOCTOR, HIV CONSULTANT/NURSE OR PHARMACIST ABOUT ALL SIDE EFFECTS THAT YOU EXPERIENCE.

VERY COMMON SIDE EFFECTS, OCCURRING IN MORE THAN 1 IN 10 USERS, ARE: NAUSEA, INSOMNIA, DIZZINESS AND HEADACHE.

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Testing for a hypersensitivity reaction in advance Some people are hypersensitive to abacavir, one of the components of Triumeq.

This hypersensitivity can be very serious. Your doctor should perform a hypersensitivity test. Based on the result, your doctor can make a reasonably accurate prediction about whether you will develop a hypersensitivity reaction to abacavir.

What to do if you experience hypersensitivity Contact your doctor or HIV consultant/nurse immediately if you develop a skin rash or if you experience symptoms as described in 2 or more of the following groups: GROUP 1

Possible hypersensitivity reaction About 3% to 4% of the users are actually hypersensitive to abacavir. This hypersensitivity usually appears during the first 6 weeks of treatment. Symptoms start out mild but can become more serious with continued use of abacavir. These symptoms should go away once abacavir treatment is stopped.

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• Fever

GROUP 2

GROUP 3

GROUP 4

• Shortness of breath

• Nausea

• Severe tiredness

• Sore throat

• Vomiting

• Coughing

• Diarrhoea

• Aches and pains in the body

• Abdominal Pain

• Feeling generally ill

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Never stop without consulting a doctor If you develop a skin rash or complaints from 2 or more of the groups listed and you continue taking Triumeq, this may be life-threatening. Once you have stopped taking Triumeq because you are hypersensitive to it, you may NEVER take Triumeq or any other drugs that contain abacavir (such as Kivexa®, Trizivir ® or Ziagen®) again.

If you do, you may develop a life-threatening drop in blood pressure within a few hours.

You may not be able to use medicines that contain dolutegravir (Tivicay®) again. If you stopped using Triumeq due to hypersensitivity, return the remaining Triumeq pills to your pharmacy to avoid ever taking one by accident.

Taking your HIV medication on time every day increases the chance of successful long-term 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 TRIUMEQ WITHOUT CONSULTING YOUR DOCTOR OR HIV CONSULTANT/NURSE

Never restart without consulting a doctor If you stopped taking Triumeq – especially if it was due to hypersensitivity – never restart Triumeq or another medicine containing abacavir (such as Kivexa®, Trizivir® or Ziagen®) without consulting your doctor or HIV consultant/nurse.

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Can I use other medicines together with Triumeq?

You may be using other medicines together with Triumeq. Some medicines can affect how well Triumeq works or increase the chances of side effects. Triumeq can also affect how other medicines work. The package leaflet contains a list of medicines that you must tell your doctor or HIV consultant/nurse about if you are using them.

If the dose of one of the active substances in Triumeq needs to be adjusted, you can no longer take Triumeq as a combination pill; the active substances will then have to be given in separate pills with a different dose. 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/aluminium-containing antacid, calcium supplements, iron supplements or multivitamins should be taken well separated in time from the administration of Triumeq (Triumeq should be taken a minimum of 2 hours before or 6 hours after these medicines).

The pharmacy Tips to avoid running out of HIV medication: 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.

How to store Triumeq Keep Triumeq out of the sight and reach of children. Also, keep Triumeq out of the reach of pets. Triumeq should be stored in the original package in order to protect from moisture. The bottle must be kept tightly closed and the desiccant should not be removed. The Triumeq bottle does not require any special temperature storage conditions.

Do not use Triumeq 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.

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