Label: Information for the User

Ziagen 20mg/ml Oral Solution

abacavir

Read this label carefully before starting to take this medicine, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribedonly for you, and you should notgive it to others even if they have the same symptomsas you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

IMPORTANT — Hypersensitivity Reactions

Ziagen contains abacavir(which is also the active ingredient in medicines such asKivexa, TriumeqandTrizivir). Some people who take abacavir may develop ahypersensitivity reaction(severe allergic reaction), which can be life-threatening if they continue to take medicines that contain abacavir.

You must carefully read the information about “Hypersensitivity Reactions” in section 4 of this label.

The Ziagen packaging includes aWarning Cardto remind you and healthcare professionals of your hypersensitivity to abacavir.You must remove this card and carry it with you at all times..

1.What is Ziagen and what is it used for

2.What you need to knowbefore starting to take Ziagen

3.How to take Ziagen

4.Possible side effects

5.Storage of Ziagen

6.Contents of the package and additional information

Ziagen is used in the treatment of the infection caused by the HIV (human immunodeficiency virus).

Ziagen contains abacavir as its active ingredient. Abacavir belongs to a group of antiretroviral medications calledinhibitors of reverse transcriptase analogs of nucleosides(NRTIs).

Ziagen does not completely cure HIV infection; it reduces the amount of virus in the body and keeps it at a low level. It also increases the number of CD4 cells in the blood. CD4 cells are a type of white blood cell that plays an important role in helping your body fight infection.

Not everyone responds to Ziagen treatment in the same way. Your doctor will monitor the effectiveness of your treatment.

Do not take Ziagen

• if you areallergic(hypersensitive)to abacavir (or to any other medicine that contains abacavir — such asTriumeq, TrizivirorKivexa) or to any of the other components of this medicine (listed in section 6).

Read carefully all the information about hypersensitivity reactions in section 4 of this leaflet.

Consult your doctorif you think you may be affected by any of these circumstances.

Be especially careful with Ziagen

Some people taking Ziagen for HIV have a higher risk of serious side effects. You need to know that there is a higher risk:

• if you havemoderate or severe liver disease
• if you have ever hadliver disease, including hepatitis B or C
• if you havesignificant overweight(especially if you are a woman)
• if you havesevere kidney disease.

Consult your doctor ifyou have any of these circumstances.You may need additional tests, including blood tests, while taking this medicine. For more information see section 4.

Hypersensitivity reactions to abacavir

Even patients who do not have the gene called HLA-B*5701 can developa hypersensitivity reaction(a severe allergic reaction).

Read carefully all the information about hypersensitivity reactions in section 4 of this leaflet.

Risk of cardiovascular events

It cannot be ruled out that abacavir may increase the risk of cardiovascular events.

Inform your doctorif you have cardiovascular problems, if you smoke or if you have diseases that may increase the risk of cardiovascular diseases, such as high blood pressure or diabetes. Do not stop taking Ziagen unless your doctor advises you to.

Be aware of important symptoms

Some people taking HIV medicines develop other diseases, which can be serious. You need to know what signs and symptoms to look out for while taking Ziagen.

Read the information about “Other possible side effects of HIV combination treatment” in section 4 of this leaflet.

Other medicines and Ziagen

Inform your doctor or pharmacist if you aretakingor have recently takenother medicines,including medicines made from plants and those bought without a prescription.

Remember to inform your doctor or pharmacist if you start taking a new medicine while taking Ziagen.

Some medicines interact with Ziagen

These include:

• phenytoin, to treatepilepsy.

Inform your doctorif you are taking phenytoin. Your doctor may need to monitor you while you are taking Ziagen.

• methadone, used as aheroin substitute.Abacavir increases the rate at which methadone is eliminated from the body. If you are taking methadone, you will need to be monitored for signs of withdrawal. You may need your methadone dose to be adjusted.

Informyour doctorif you are taking methadone.

• riociguat, to treathigh blood pressure in the blood vessels(pulmonary arteries) that carry blood from the heart to the lungs. Your doctor may need to reduce your dose of riociguat, as abacavir may increase your blood levels of riociguat.

Pregnancy

Ziagen is not recommended during pregnancy. Ziagen and similar medicines may cause adverse effects in babies during pregnancy.If you have been takingZiagenduring your pregnancy, your doctor may ask you to have regular blood tests and other diagnostic tests to monitor the development of your baby. In babies whose mothers took INTIs during pregnancy, the benefit of HIV protection was greater than the risk of adverse effects.

Breastfeeding

Ziagen is not recommendedfor women with HIV to breastfeed because HIV infection can be transmitted to the baby through breast milk. A small amount of the components of Ziagen may also pass into breast milk.

If you are breastfeeding or plan to breastfeed,you should consult your doctor as soon as possible.

Driving and operating machines

Do not drive or operate machinesunless you are feeling well.

Important information about some of the components of Ziagen oral solution

This medicine contains the sweetener sorbitol (approximately5 gper dose of 15ml) which may have a mild laxative effect. Do not take medicines that contain sorbitol if you have hereditary intolerance to fructose. The caloric value of sorbitol is 2.6 kcal/g.

Ziagen oral solution also contains preservatives (parahydroxybenzoates) that may cause allergic reactions (possibly delayed).

This medicine contains less than 1 mmol of sodium (23 mg) per dose; this is, essentially “sodium-free”.

Ziagen oral solution contains 50mg/ml of propylene glycol. When taken according to the recommended dosage, each dose of 15ml contains approximately 750mg of propylene glycol.

• If your child is under 5 years old, consult your doctor or pharmacist before giving them this medicine, especially if they have been given other medicines that contain propylene glycol or alcohol.

• If you are pregnant or breastfeeding, do not take this medicine unless recommended by your doctor. Your doctor may perform additional checks while you are taking this medicine.

• If you have liver or kidney disease, do not take this medicine unless recommended by your doctor. Your doctor may perform additional checks while you are taking this medicine.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.Ziagen can be taken with or without food.

Maintain regular contact with your doctor

Ziagen helps control your condition. You will need to take it every day to prevent your disease from worsening. You may continue to develop other infections and diseases associated with HIV infection.

Stay in contact with your doctor and do not stop taking Ziagenwithout first speaking with your doctor.

How much to take

Adults, adolescents, and children weighing at least 25 kg:

The usual dose of Ziagen is 600 mg (30 ml) per day.It can be taken as 300 mg (15 ml) twice a day, or as 600 mg (30 ml) once a day.

Children from 3 months of age with a weight less than 25 kg:

The dose depends on the child's body weight. The recommended dose is 8 mg/kg twice a day or 16 mg/kg once a day, up to a maximum daily total dose of 600 mg per day.

How to measure and take the medication dose

Use the oral administration syringe provided with the package to measure your dose exactly. When full, the syringe contains 10 ml of solution.

1. Remove the plastic wrapper from the syringe/adapter.
2. Remove the cap from the bottle. Put it in a safe place.
3. Remove the adapter from the syringe.
4. While holding the bottle firmly,insert the plastic adapter into the neck of the bottle.
5. Insert the syringefirmly into the adapter.
6. Turn the bottle around.
7. Pull the plunger of the syringeuntil you get the first part of the full dose.
8. Return the bottle to its correct position andremove the syringefrom the adapter.
9. Place the syringe in the mouth, placing the end of the syringe towards the inside of your cheek.Push the plunger slowly, giving time to swallow the medication.Do notintroduce the solution too abruptly into the throat, as you could choke.
10. Clean the syringe well each time it is emptied.
11. Repeat steps 5 to 10in the same way until you have taken the full dose.For example, if your dose is 30 ml, you will need to take 3 syringes of medication.
12. After taking your full dose,washthe syringe well with clean water. Let it dry completely before using it again.
13. Close the bottle wellwith the cap, leaving the adapter inside.

If you take more Ziagen than you should

If you accidentally take more Ziagen than you should, inform your doctor or pharmacist, or contact the emergency service of the nearest hospital for more information.

If you forgot to take Ziagen

If you forget to take a dose, take it as soon as you remember and then continue with your usual treatment.

Do not take a double dose to compensate for the missed doses.

It is essential to take Ziagen regularly, as irregular intake of Ziagen may increase the risk of experiencing a hypersensitivity reaction.

If you have interrupted treatment with Ziagen

If for any reason, you have stopped taking Ziagen — especially because you think it has side effects or due to another illness:

Consult your doctor before resuming treatment. Your doctor will check if your symptoms were related to a hypersensitivity reaction. If your doctor considers it could have been related,he will advise you thatyou should never take Ziagen or any other medication that contains abacavir (e.g. Triumeq, Trizivir, or Kivexa) again.It is essential that you follow this warning.

If your doctor advises you to restart treatment with Ziagen, you can ask him to take the first doses in a place where you have easy access to medical assistance if necessary.

During treatment for HIV, you may experience an increase in weight and levels of glucose and lipids in the blood. This may be partly related to recovery of health and lifestyle, and in the case of lipids in the blood, sometimes to the HIV medications themselves. Your doctor will monitor these changes.

Like all medications, this medication can produce side effects, although not everyone will experience them.

When you are being treated for HIV, it can be difficult to distinguish whether a symptom is a side effect of Ziagen or of other medications you are taking, or is due to an effect of the disease caused by HIV.Therefore, it is very important that you inform your doctor of any changes in your health.

Even patients who do not have the HLA-B*5701 gene can developa hypersensitivity reaction(a severe allergic reaction), described in this prospectus in the box called “Hypersensitivity reactions”.

It is very important that you read and understand the information about this serious reaction.Additionally to the side effects listed below for Ziagen, other disorders can develop during combined HIV treatment.

It is important that you read the information under the heading “Other possible side effects of combined HIV treatment”.

If you have stopped taking Ziagen due to a hypersensitivity reaction,NEVER TAKE Ziagen or any other medication containing abacavir (e.g. Trizivir, Triumeq or Kivexa) again.If you do, within hours, you may experience a drop in blood pressure that can put your life at risk or cause death.

If for any reason, you have interrupted treatment with Ziagen — especially because you think you are experiencing side effects or another illness:

Common side effects

May affectup to 1 in 10people:

• hypersensitivity reaction
• discomfort(nausea)
• headache
• vomiting
• diarrhea
• loss of appetite
• fatigue, lack of energy
• fever (high temperature)
• skin rash.

Rare side effects

May affectup to 1 in 1,000people:

• inflammation of the pancreas(pancreatitis).

Very rare side effects

May affectup to 1 in 10,000people:

• skin eruption, which can form blisters that appear as small darts (central dark spot surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme)
• widespread eruption with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form that causes skin peeling on more than 30% of the body surface (toxic epidermal necrolysis)
• lactic acidosis (excess lactic acid in the blood).

If you notice any of these symptoms, contact a doctor urgently.

If you experience side effects

Consult your doctor or pharmacistif you experience side effects,including possible side effects that do not appear in this prospectus.You can also report them directly through the national notification system included in theAppendixV. By reporting side effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box.The expiration date is the last day of the month indicated.

Do not store above 25°C.

Discard the oral solution after two months from the first time it was opened.

Medicines should not be thrown down the drain or in the trash.Ask your pharmacist how to dispose ofthe containers and medications that you no longerneed.This will help protect the environment.

Composition of Ziagen

The active ingredient of Ziagen oral solution is 20 mg of abacavir (as sulfate) in each ml of solution.

The other components are sorbitol 70% (E420), sodium saccharin, sodium citrate, anhydrous citric acid, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), propylene glycol (E1520), maltodextrin, lactic acid, triacetin, artificial strawberry and banana flavoring, purified water, sodium hydroxide and/or hydrochloric acid for pH adjustment.

Appearance of Ziagen and contents of the package

Ziagen oral solution is a clear or yellowish solution that may turn brown over time, with a strawberry/banana flavor. It is presented in packs containing a white polyethylene bottle with a child-resistant closure. The bottle contains 240 ml (20 mg of abacavir/ml) of solution. The pack includes a 10 ml dosing syringe for oral administration and a plastic adapter for the bottle.

Marketing Authorization Holder

ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands

Responsible for manufacturing

ViiV Healthcare Trading Services UK Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

For more information about this medicine, please contact the local representative of the marketing authorization holder.

The detailed information about this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu/.