Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - ziagen

Document Subject

Generated Narrative: MedicinalProductDefinition mpe03871853d4da5dc011fec7c683b275d

identifier: http://ema.europa.eu/identifier/EU/1/99/112/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Ziagen 300 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-e03871853d4da5dc011fec7c683b275d

identifier: http://ema.europa.eu/identifier/EU/1/99/112/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - ziagen

Attesters

What is in this leaflet

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

Ziagen is used to treat HIV (human immunodeficiency virus) infection.

Ziagen contains the active ingredient abacavir. Abacavir belongs to a group of anti-retroviral medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs).

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

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

Do not take Ziagen:
if you are allergic (hypersensitive) to abacavir (or any other medicine containing abacavir such as Trizivir, Triumeq or Kivexa) or any of the other ingredients of this medicine (listed in Section 6) Carefully read all the information about hypersensitivity reactions in Section 4. Check with your doctor if you think this applies to you.

Take special care with Ziagen
Some people taking Ziagen for HIV are more at risk of serious side effects. You need to be aware of the extra risks:

• if you have moderate or severe liver disease
• if you have ever had liver disease, including hepatitis B or C
• if you are seriously overweight (especially if you are a woman)
• if you have severe kidney disease Talk to your doctor if any of these apply to you. You may need extra check-ups, including blood tests, while you are taking your medicine. See Section 4 for more information.

Abacavir hypersensitivity reactions
Even patients who don t have the HLA-B*5701 gene may still develop a hypersensitivity reaction (a serious allergic reaction).

Carefully read all the information about hypersensitivity reactions in Section 4 of this leaflet.

Risk of cardiovascular events
It cannot be excluded that abacavir may increase the risk of having cardiovascular events. Tell your doctor if you have cardiovascular problems, if you smoke, or have other illnesses that may increase your risk of cardiovascular diseases such as high blood pressure, or diabetes. Do not stop taking Ziagen unless your doctor advises you to do so.

Look out for important symptoms
Some people taking medicines for HIV infection develop other conditions, which can be serious. You need to know about important signs and symptoms to look out for while you are taking Ziagen. Read the information Other possible side effects of combination therapy for HIV in Section 4 of this leaflet.

Other medicines and Ziagen
Tell your doctor or pharmacist if you are taking any other medicines, or if you have taken any recently, including herbal medicines or other medicines you bought without a prescription. Remember to tell your doctor or pharmacist if you begin taking a new medicine while you are taking Ziagen.

Some medicines interact with Ziagen
These include:

• phenytoin, for treating epilepsy Tell your doctor if you are taking phenytoin. Your doctor may need to monitor you while you are taking Ziagen.

• methadone used as a heroin substitute. Abacavir increases the rate at which methadone is removed from the body. If you are taking methadone, you will be checked for any withdrawal symptoms. Your methadone dose may need to be changed. Tell your doctor if you are taking methadone.

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

Pregnancy
Ziagen is not recommended for use during pregnancy. Ziagen and similar medicines may cause side effects in unborn babies. If you have taken Ziagen during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child. In children whose mothers took NRTIs during pregnancy, the benefit from the protection against HIV outweighed the risk of side effects.

Breast-feeding
Breast-feeding is not recommended in women living with HIV because HIV infection can be passed on to the baby in breast milk. A small amount of the ingredients in Ziagen can also pass into your breast milk. If you are breast-feeding, or thinking about breast-feeding, you should discuss it with your doctor as soon as possible.

Driving and using machines
Do not drive or operate machines unless you are feeling well.

Important information about some of the other ingredients of Ziagen tablets. This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially sodium-free .

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Swallow the tablets with some water. Ziagen can be taken with or without food. If you cannot swallow the tablet(s), you may crush and combine them with a small amount of food or drink, and take all the dose immediately.
Stay in regular contact with your doctor
Ziagen helps to control your condition. You need to keep taking it every day to stop your illness getting worse. You may still develop other infections and illnesses linked to HIV infection. Keep in touch with your doctor, and do not stop taking Ziagen without your doctor s advice.

How much to take
Adults, adolescents and children weighing at least 25 kg
The usual dose of Ziagen is 600 mg a day. This can be taken either as one 300 mg tablet twice a day or two 300 mg tablets once a day.
Children from one year of age weighing less than 25 kg
The dose given depends on the body weight of your child. The recommended dose is:

• Children weighing at least 20 kg and less than 25 kg: The usual dose of Ziagen is 450 mg a day. This can be given as 150 mg (half of a tablet) taken in the morning and 300 mg (one whole tablet) taken in the evening, or 450 mg (one and a half tablets) once a day as advised by your doctor.
• Children weighing at least 14 kg and less than 20 kg: The usual dose of Ziagen is 300 mg a day. This can be given as 150 mg (half of a tablet) twice daily, or 300 mg (one whole tablet) once a day as advised by your doctor.
  The tablet can be divided into equal doses. An oral solution (20 mg abacavir/ml) is also available for the treatment of children over three months of age and weighing less than 14 kg, or for people who need a lower than usual dose, or who cannot take tablets.
  If you take more Ziagen than you should
  If you accidentally take too much Ziagen, tell your doctor or your pharmacist, or contact your nearest hospital emergency department for further advice.

If you forget to take Ziagen
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.

It is important to take Ziagen regularly, because if you take it at irregular intervals, you may be more likely to have a hypersensitivity reaction.

If you have stopped taking Ziagen
If you have stopped taking Ziagen for any reason - especially because you think you are having side effects, or because you have other illness: Talk to your doctor before you start taking it again. Your doctor will check whether your symptoms were related to a hypersensitivity reaction. If the doctor thinks they may have been related, you will be told never again to take Ziagen, or any other medicine containing abacavir (e.g. Triumeq,Trizivir or Kivexa). It is important that you follow this advice.

If your doctor advises that you can start taking Ziagen again, you may be asked to take your first doses in a place where you will have ready access to medical care if you need it.

During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves. Your doctor will test for these changes.

Like all medicines, this medicine can cause side effects, although not everyone gets them.

When you are being treated for HIV, it can be hard to tell whether a symptom is a side effect of Ziagen or other medicines you are taking, or an effect of the HIV disease itself. So it is very important to talk to your doctor about any changes in your health. Even patients who don t have the HLA-B*5701 gene may still develop a hypersensitivity reaction (a serious allergic reaction), described in this leaflet in the panel headed Hypersensitivity reactions .

It is very important that you read and understand the information about this serious reaction.

As well as the side effects listed below for Ziagen, other conditions can develop during combination therapy for HIV.
It is important to read the information later in this section under Other possible side effects of combination therapy for HIV . Hypersensitivity reactions
Ziagen contains abacavir (which is also an active substance in Trizivir , Triumeq and Kivexa). Abacavir can cause a serious allergic reaction known as a hypersensitivity reaction. These hypersensitivity reactions have been seen more frequently in people taking medicines that contain abacavir.

Who gets these reactions?
Anyone taking Ziagen could develop a hypersensitivity reaction to abacavir, which could be life threatening if they continue to take Ziagen. You are more likely to develop such a reaction if you have the HLA-B5701 gene (but you can get a reaction even if you do not have this gene). You should have been tested for this gene before Ziagen was prescribed for you. If you know you have this gene, tell your doctor before you take Ziagen. About 3 to 4 in every 100 patients treated with abacavir in a clinical trial who did not have the HLA- B5701 gene developed a hypersensitivity reaction.

What are the symptoms?
The most common symptoms are:

• fever (high temperature) and skin rash Other common symptoms are:
• nausea (feeling sick), vomiting (being sick), diarrhoea, abdominal (stomach) pain, severe tiredness Other symptoms include:

Pains in the joints or muscles, swelling of the neck, shortness of breath, sore throat, cough, occasional headaches, inflammation of the eye (conjunctivitis), mouth ulcers, low blood pressure, tingling or numbness of the hands or feet.

When do these reactions happen?
Hypersensitivity reactions can start at any time during treatment with Ziagen, but are more likely during the first 6 weeks of treatment.

If you are caring for a child who is being treated with Ziagen, it is important that you understand the information about this hypersensitivity reaction. If your child gets the symptoms described below it is essential that you follow the instructions given.

Contact your doctor immediately:
1 if you get a skin rash, OR 2 if you get symptoms from at least 2 of the following groups:

• fever

• shortness of breath, sore throat or cough

• nausea or vomiting, diarrhoea or abdominal pain

• severe tiredness or achiness, or generally feeling ill Your doctor may advise you to stop taking Ziagen.

If you have stopped taking Ziagen
If you have stopped taking Ziagen because of a hypersensitivity reaction, you must NEVER AGAIN take Ziagen, or any other medicine containing abacavir (e.g. Trizivir, Triumeq or Kivexa). If you do, within hours, your blood pressure could fall dangerously low, which could result in death. If you have stopped taking Ziagen for any reason - especially because you think you are having side effects, or because you have other illness: Talk to your doctor before you start again. Your doctor will check whether your symptoms were related to a hypersensitivity reaction. If the doctor thinks they may have been, you will then be told never again to take Ziagen, or any other medicine containing abacavir (e.g. Trizivir, Triumeq or Kivexa). It is important that you follow this advice. Occasionally, hypersensitivity reactions have developed in people who start taking abacavir containing products again, but who had only one symptom on the Alert Card before they stopped taking it.

Very rarely, patients who have taken medicines containing abacavir in the past without any symptoms of hypersensitivity have developed a hypersensitivity reaction when they start taking these medicines again.

If your doctor advises that you can start taking Ziagen again, you may be asked to take your first doses in a place where you will have ready access to medical care if you need it.

If you are hypersensitive to Ziagen, return all your unused Ziagen tablets for safe disposal. Ask your doctor or pharmacist for advice. The Ziagen pack includes an Alert Card, to remind you and medical staff about hypersensitivity reactions. Detach this card and keep it with you at all times.

Common side effects
These may affect up to 1 in 10 people:

• hypersensitivity reaction
• feeling sick (nausea)
• headache
• being sick (vomiting)
• diarrhoea
• loss of appetite
• tiredness, lack of energy
• fever (high temperature)
• skin rash

Rare side effects
These may affect up to 1 in 1,000 people:

• inflammation of the pancreas (pancreatitis)

Very rare side effects
These may affect up to 1 in 10,000 people:

• skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)
• a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens Johnson syndrome), and a more severe form causing skin peeling in 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 get side effects
Tell your doctor or pharmacist if any of the side effects get severe or troublesome, or if you notice any side effects not listed in this leaflet.

Other possible side effects of combination therapy for HIV
Combination therapy including Ziagen may cause other conditions to develop during HIV treatment.

Symptoms of infection and inflammation
Old infections may flare up
People with advanced HIV infection (AIDS) have weak immune systems, and are more likely to develop serious infections (opportunistic infections). When these people start treatment, they may find that old, hidden infections flare up, causing signs and symptoms of inflammation. These symptoms are probably caused by the body s immune system becoming stronger, so that the body starts to fight these infections. Symptoms usually include fever, plus some of the following: headache stomach ache difficulty breathing

In rare cases, as the immune system becomes stronger, it can also attack healthy body tissue (autoimmune disorders). The symptoms of autoimmune disorders may develop many months after you start taking medicine to treat your HIV infection. Symptoms may include: palpitations (rapid or irregular heartbeat) or tremor hyperactivity (excessive restlessness and movement)
weakness beginning in the hands and feet and moving up towards the trunk of the body

If you get any symptoms of infection while you are taking Ziagen: Tell your doctor immediately. Do not take other medicines for the infection without your doctor s advice.

You may have problems with your bones
Some people taking combination therapy for HIV develop a condition called osteonecrosis. With this condition, parts of the bone tissue die because of reduced blood supply to the bone. People may be more likely to get this condition:

• if they have been taking combination therapy for a long time
• if they are also taking anti-inflammatory medicines called corticosteroids
• if they drink alcohol
• if their immune systems are very weak
• if they are overweight Signs of osteonecrosis include:
• stiffness in the joints
• aches and pains (especially in the hip, knee or shoulder)
• difficulty moving If you notice any of these symptoms: Tell your doctor.

Reporting of side effects
If you get 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.

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

Do not take this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Do not store above 30 C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures help protect the environment.

What Ziagen contains
The active substance in each Ziagen film-coated, scored tablet is 300 mg of abacavir (as sulfate).

The other ingredients are microcrystalline cellulose, sodium starch glycollate, magnesium stearate and colloidal anhydrous silica in the core of the tablet. The tablet coating contains triacetin, methylhydroxypropylcellulose, titanium dioxide, polysorbate 80 and iron oxide yellow.

What Ziagen looks like and contents of the pack
Ziagen film-coated tablets are engraved with GX 623 on both sides. The scored tablets are yellow and capsule-shaped and are provided in blister packs containing 60 tablets.

Marketing Authorisation Holder:
ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands

Manufacturer:
Delpharm Pozna Sp ka Akcyjna, ul., Grunwaldzka 189, 60-322 Poznan, Poland.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

Belgi /Belgique/Belgien ViiV Healthcare srl/bv T l/Tel: + 32 (0) 10 85 65 Lietuva ViiV Healthcare BV Tel: + 370 80000
ViiV Healthcare BV Te .: + 359 80018Luxembourg/Luxemburg ViiV Healthcare srl/bv Belgique/Belgien T l/Tel: + 32 (0) 10 85 65 esk republika GlaxoSmithKline s.r.o. Tel: + 420 222 001 cz.info@gsk.com

Magyarorsz g ViiV Healthcare BV Tel.: + 36 80088Danmark GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 dk-info@gsk.com

Malta ViiV Healthcare BV Tel: + 356 80065Deutschland ViiV Healthcare GmbH
Tel.: + 49 (0)89 203 0038-viiv.med.info@viivhealthcare.com

Nederland ViiV Healthcare BV
Tel: + 31 (0) 33 2081Eesti ViiV Healthcare BV Tel: + 372 8002Norge GlaxoSmithKline AS Tlf: + 47 22 70 20 firmapost@gsk.no

GlaxoSmithKline A.E.B.E. : + 30 210 68 82 sterreich GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0 at.info@gsk.com

Espa a Laboratorios ViiV Healthcare, S.L. Tel: +34 900 923 es-ci@viivhealthcare.com

Polska GSK Services Sp. z o.o. Tel.: + 48 (0)22 576 9France ViiV Healthcare SAS
T l.: + 33 (0)1 39 17 6Infomed@viivhealthcare.com

Hrvatska ViiV Healthcare BV Tel: + 385 800787Portugal VIIVHIV HEALTHCARE, UNIPESSOAL, LDA
Tel: + 351 21 094 08 viiv.fi.pt@viivhealthcare.com

Rom nia ViiV Healthcare BV Tel: + 40 800672Ireland GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955Slovenija ViiV Healthcare BV Tel: + 386 80688 sland Vistor hf.
S mi: +354 535 7Slovensk republika ViiV Healthcare BV Tel: + 421 800500Italia ViiV Healthcare S.r.l
Tel: + 39 (0)45 7741Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 (0)10 30 30
ViiV Healthcare BV : + 357 80070Sverige GlaxoSmithKline AB Tel: + 46 (0)8 638 93 info.produkt@gsk.com

Latvija ViiV Healthcare BV Tel: + 371 80205United Kingdom (Northern Ireland) ViiV Healthcare BV
Tel: + 44 (0)800 221customercontactuk@gsk.com

This leaflet was last revised in {MM/YYYY}

Detailed information on this medicine is available on the European Medicines Agency web site: