TYBOST 150mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Tybost 150 mg film-coated tablets

cobicistat

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, 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 pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Tybost and what is it used for
2. What you need to know before you take Tybost
3. How to take Tybost
4. Possible side effects
5. Storage of Tybost
6. Contents of the pack and other information

1. What is Tybost and what is it used for

Tybost contains the active substance cobicistat.

Tybost is used for the treatment of human immunodeficiency virus 1 (HIV-1) infection, the virus that causes acquired immune deficiency syndrome (AIDS). It is used in adults and adolescents aged 12 years or older infected with HIV:

• who weigh at least 35 kg (when given with atazanavir 300 mg) or
• who weigh at least 40 kg (when given with darunavir 800 mg).

Tybost acts as a booster(enhancer) of atazanavir or darunavir(both protease inhibitors) to help improve their effect (see section 3 of this leaflet).

Tybost does not directly treat HIV infection, but rather boosts the levels of atazanavir and darunavirin the blood. It does this by delaying the breakdown of atazanavir and darunavir, which will make them stay in the body for longer.

2. What you need to know before you take Tybost

Do not take Tybost

• If you are allergic to cobicistator any of the other ingredients of this medicine (listed in section 6 of this leaflet).

• If you are taking medicines that contain any of the following active substances:
• • alfuzosin,used to treat enlarged prostate
  • amiodarone, quinidine,used to correct irregular heartbeats
  • dabigatran,used to prevent and treat blood clots
  • carbamazepine, phenobarbital, phenytoin,used to prevent seizures
  • rifampicin,used to prevent and treat tuberculosis and other infections
  • dihydroergotamine, ergometrine, ergotamine,used to treat migraines
  • St. John's Wort,Hypericum perforatum, a herbal remedy used for depression and anxiety

• lovastatin, simvastatin,used to lower cholesterol in the blood
• pimozide, lurasidone,used to treat abnormal thoughts or feelings
• sildenafil,used to treat pulmonary arterial hypertension, a disease of the lung that makes it difficult to breathe
• midazolam,given orally or triazolamused to help sleep and/or relieve anxiety

• If you are in any of these situations, do not take Tybost and consult your doctor immediately.

Warnings and precautions

You must remain under the supervision of your doctor while taking Tybost.

You can still transmit HIVwhile taking this medicine, although effective antiretroviral treatment reduces the risk. Consult your doctor about the precautions needed to avoid infecting others. This medicine is not a cure for HIV infection. You may develop infections or other diseases associated with HIV infection. You must remain in regular contact with your doctor.

Consult your doctor before starting Tybost:

• If you are taking another protease inhibitor.Tybost, taken with atazanavir or darunavir, must not be used with another antiviral that requires boosting.

• Consult your doctor or pharmacist if you have or have had kidney disease or if tests have shown kidney problems.Your doctor will carefully consider whether you should be treated with Tybost.

• Consult your doctor or pharmacist if you have or have had severe liver disease or if tests have shown liver problems.Your doctor will carefully consider whether you should be treated with Tybost.

• If you are in any of these situations, consult your doctor before starting Tybost.

Children and adolescents

Do not give this medicine to childrenunder 12 years of age or weighing less than 35 kg (or 40 kg), as explained in section 3 of this leaflet. The use of Tybost in children under 12 years of age or weighing less than 35 kg has not been studied.

Other medicines and Tybost

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.Tybost may interact with other substances. As a result, the blood levels of Tybost or other medicines may be affected. This may prevent your medicines from working properly or may worsen their possible side effects. In some cases, your doctor may need to adjust the dose or check the blood levels of the medicine.

There are medicines that must never be taken with Tybost.

These medicines are specified in the section “Do not take Tybost - If you are taking medicines that contain any of the following active substances”.

Medicines used for the treatment of HIV infection:

You must not take Tybost with other medicines that contain:

• ritonavir
• cobicistat

Tell your doctor if you are taking:

• another protease inhibitor
• efavirenz
• etravirine
• nevirapine
• maraviroc

• Tell your doctorif you are taking any of these medicines for HIV infection.

Other types of medicines:

• ketoconazole, itraconazole, voriconazole, posaconazoleand fluconazole,medicines used to treat fungal infections

• clarithromycin and rifabutin,medicines used to treat bacterial infections, including tuberculosis
• dasatinib, nilotinib, vinblastineand vincristine,medicines used to treat cancer
• corticosteroids,including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone. These medicines are used to treat allergies, asthma, inflammatory bowel disease, inflammatory eye, joint and muscle conditions, and other inflammatory conditions. If alternatives cannot be used, they should only be used after clinical evaluation and with close monitoring by your doctor to assess the adverse effects of corticosteroids.

• metformin,a medicine used to treat type 2 diabetes
• hormonal contraceptivesused to prevent pregnancy
• amlodipine, digoxin, diltiazem, disopyramide, felodipine, flecainide, lidocaine, metoprolol, mexiletine, nicardipine, nifedipine, propafenone, timololand verapamil,medicines used to treat heart problems

• bosentan,a medicine used to treat pulmonary arterial hypertension
• apixaban, edoxaban, rivaroxabanand warfarin,medicines used to prevent and treat blood clots

• salmeterol,a medicine used to treat asthma
• atorvastatin, fluvastatin, pitavastatin, pravastatinand rosuvastatin,medicines used to lower cholesterol
• sildenafiland vardenafil,medicines used to treat impotence, and tadalafil, a medicine used to treat impotence and pulmonary hypertension
• trazodone,a medicine used to treat depression
• ciclosporin, sirolimusand tacrolimus,medicines used to control the body's immune response after a transplant
• buspirone, chlorazepate, diazepam, estazolam, flurazepam, perphenazine, risperidone, thioridazine, zolpidem,medicines used to treat nervous system disorders

• colchicine,a medicine used to treat gout

• Tell your doctorif you are taking any of these medicines.

• Tell your doctor if you are taking these or any other medicines.Do not stop treatment without consulting your doctor.

Pregnancy and breastfeeding

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 taking this medicine.

• Tell your doctor immediately if you are pregnant, think you may be pregnant or are planning to have a baby.Pregnant women must not take Tybost with atazanavir or darunavir. The amounts of these medicines in the blood may decrease during pregnancy, which may make them less effective.

• Do not breastfeed while taking Tybost.It is not known whether the active substance of this medicine can pass into breast milk. If you are a woman with HIV infection, it is recommended that you do not breastfeed to avoid transmitting the virus to your baby through breast milk.

Driving and using machines

Some patients have reported dizziness when taking Tybost with atazanavir or darunavir. If you experience dizziness while taking Tybost, do not drive or use tools or machines.

Tybost contains orange yellow S aluminium lake (E110).

Tell your doctor if you are allergic to orange yellow S aluminium lake (E110).Tybost contains orange yellow S aluminium lake, which may cause allergic reactions.

3. How to take Tybost

Always take this medicine exactly as your doctor has told you.

If you are not sure, consult your doctor or pharmacist.

Recommended dose for adults:

• One tablet a day by mouth, with food.Do not chew, crush or divide the tablet.
• Tybost must be taken with atazanavir (300 mg) or darunavir (800 mg).

Recommended dose for adolescents aged 12 to less than 18 years:

• One tablet a day by mouth, with food.Do not chew, crush or divide the tablet.
• Adolescents who take Tybost with atazanavir (300 mg) must weigh at least 35 kg.
• Adolescents who take Tybost with darunavir (800 mg) must weigh at least 40 kg.

Always take the dose recommended by your doctor.This is to ensure that your medicine is completely effective. Do not change the dose unless your doctor tells you to.

If you take more Tybost than you should

If you accidentally take more than the recommended dose of Tybost, you may be at greater risk of experiencing side effects with this medicine (see section 4 of this leaflet).

Consult your doctor or go to the nearest emergency department immediately. Take the pack of tablets with you so that you can easily describe what you have taken.

If you forget to take Tybost

It is important that you do not miss a dose of Tybost.

If you forget to take a dose and you notice:

• Within 12 hoursof the time you normally take Tybost, you must take the tablet as soon as possible. Take the tablet always with food. Then, take the next dose as usual, in combination with atazanavir or darunavir.

• 12 hours or moreafter the time you normally take Tybost, do not take the missed dose. Wait and take the next dose, with food, at the usual time.

Do not stop treatment with Tybost

Do not stop treatment with Tybost without talking to your doctor first.Stopping Tybost and atazanavir or darunavir may reduce the success of future treatments prescribed by your doctor.

Always keep enough Tybost on hand so that you do not run out.When you see that you are running low on Tybost, go to your doctor or pharmacist so that they can provide you with more.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. When treating HIV infection, it is not always possible to distinguish whether some of the undesirable effects are due to Tybost or to other medicines that you are taking at the same time or to the disease caused by HIV itself. When taking Tybost with atazanavir, the following side effects may occur.

Very common side effects

(may affect more than 1 in 10 people)

• feeling sick (nausea)
• yellowing of the skin, eyes and/or both (jaundice)

Common side effects

(may affect up to 1 in 10 people)

• high blood sugar levels (hyperglycaemia)
• increased appetite, altered sense of taste, dry mouth
• headache, dizziness
• vomiting, diarrhoea, stomach pain, digestive problems that cause pain after eating (dyspepsia), feeling bloated, gas (flatulence)
• increased bilirubin levels in the blood (hyperbilirubinaemia)
• rash
• difficulty sleeping, abnormal dreams, sleepiness, tiredness (fatigue)

Uncommon side effects

(may affect up to 1 in 100 people)

• blood in the urine (haematuria)
• protein in the urine (proteinuria)
• feeling depressed
• itching
• muscle pain, weakness
• kidney stones
• fever
• sleep disorder

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

For more information on the side effects of atazanavir or darunavir, see the package leaflets for these medicines.

5. Storage of Tybost

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 blister after {CAD}. The expiry date is the last day of the month shown.

No special storage conditions are required.

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 protect the environment.

6. Package Contents and Additional Information

Tybost Composition

The active ingredient iscobicistat. Each film-coated tablet contains 150 mg of cobicistat.

The other ingredients are

Tablet core:

Croscarmellose sodium, magnesium stearate, microcrystalline cellulose, silicon dioxide.

Film coating:

Orange yellow FCF aluminum lake (E110), macrogol 3350 (E1521), partially hydrolyzed polyvinyl alcohol (E1203), talc (E553B), titanium dioxide (E171), iron oxide yellow (E172) (see section 2 of this leaflet).

Appearance and Package Contents of the Product

Tybost film-coated tablets are orange, round, biconvex, marked with "GSI" on one side and smooth on the other side of the tablet.

Tybost is available in bottles of 30 film-coated tablets (with a desiccant packet or bottle that should remain in the bottle to help protect the tablets). The desiccant packet or bottle is in a separate packet or bottle and should not be swallowed.

This medicinal product is available in packs of 1 bottle of 30 film-coated tablets and 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

County Cork

Ireland

Further information about this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu

You can also contact the local representative of the marketing authorisation holder for more information about this medicinal product:

Date of last revision of this leaflet:{MM/AAAA}.

Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu