Ziagen 300 mg film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Ziagen 300 mg film-coated tablets
abacavir
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed only for you and must not be given to other people,
even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
IMPORTANT — Hypersensitivity reactions
Ziagen contains abacavir (which is also the active substance in medicines such as Kivexa, Triumeq and Trizivir). Some people taking abacavir may develop a hypersensitivity reaction (a serious allergic reaction), which may be life-threatening if they continue taking medicines containing abacavir.
You must read carefully the information on “Hypersensitivity reactions” in section 4 of this leaflet.
The Ziagen package includes an Information Card to remind you and medical personnel about abacavir hypersensitivity. You must remove this card and always carry it with you.
Contents of the leaflet
- What Ziagen is and what it is used for
- What you need to know before taking Ziagen
- How to take Ziagen
- Possible side effects
- How to store Ziagen
- Contents of the pack and other information
1. What Ziagen is and what it is used for
Ziagen is used to treat infection caused by HIV (human immunodeficiency virus).
Ziagen contains abacavir as its active substance. Abacavir belongs to a group of antiretroviral medicines known as nucleoside reverse transcriptase inhibitors (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 play an important role in helping your body fight infection.
Not everyone responds to treatment with Ziagen in the same way. Your doctor will monitor the effectiveness of your treatment.
2. What you need to know before taking Ziagen
Do not take Ziagen
- if you are allergic (hypersensitive) to abacavir (or to any other medicine containing abacavir — such as Triumeq, Trizivir, or Kivexa) or to any of the other ingredients of this medicine (listed in section 6).
Please read carefully all the information about hypersensitivity reactions in section 4 of this leaflet.
Consult your doctor if you think any of these circumstances apply to you.
Take special care with Ziagen
Some people taking Ziagen for HIV have a higher risk of experiencing serious side effects. You should be aware that the risk is greater:
- if you have moderate or severe liver disease
- if you have ever had liver disease, including hepatitis B or C
- if you are significantly overweight (especially if you are female)
- if you have severe kidney disease.
Consult your doctor if any of these circumstances apply to you. 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 carry the HLA-B*5701 gene can develop a hypersensitivity reaction (a severe allergic reaction).
Please 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 doctor if you have cardiovascular problems, if you smoke, or if you have conditions that may increase the risk of cardiovascular disease, such as high blood pressure or diabetes. Do not stop taking Ziagen unless your doctor advises you to do so.
Be alert to important symptoms
Some people taking medicines for HIV infection develop other illnesses, which may be serious. You need to know which important signs and symptoms to watch for while taking Ziagen.
Read the information on “Other possible side effects of combination HIV treatment” in section 4 of this leaflet.
Other medicines and Ziagen
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines, including herbal medicines and those obtained without a prescription. Remember to inform your doctor or pharmacist if you start taking a new medicine while on Ziagen.
Some medicines interact with Ziagen
These include:
- Phenytoin, used to treat epilepsy.
Inform 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 eliminated from the body. If you are taking methadone, you should be monitored for symptoms of withdrawal. You may need an adjustment in your methadone dose.
Inform your doctor if you are taking methadone.
- Riociguat, used to treat high blood pressure in the blood vessels (pulmonary arteries) carrying blood from the heart to the lungs. Your doctor may need to reduce your dose of riociguat, as abacavir can increase blood levels of riociguat.
Pregnancy
Use of Ziagen during pregnancy is not recommended. Ziagen and similar medicines may cause adverse effects in babies during pregnancy. If you have taken Ziagen during pregnancy, your doctor may recommend periodic blood tests and other diagnostic tests to monitor your child's development. In children whose mothers took NRTIs during pregnancy, the benefit of protection against HIV was greater than the risk of adverse effects occurring.
Breast-feeding
Breast-feeding is not recommended for women living with HIV, 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 breast-feeding or considering breast-feeding, you must consult your doctor as soon as possible.
Driving and using machines
Do not drive or operate machinery unless you feel well.
Important information about some of the ingredients of Ziagen tablets
This medicine contains less than 1 mmol of sodium (23 mg) per dose unit; essentially, it is “sodium-free”.
3. How to take Ziagen
Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.
Swallow the tablets with some water. Ziagen can be taken with or without food.
If you cannot swallow the tablets whole, you may break them and mix them with a small amount of food or drink; take the entire dose immediately.
Keep regular contact with your doctor
Ziagen helps control your condition. You will need to take it every day to prevent your illness from worsening. You may still develop other infections and illnesses associated with HIV infection.
Stay in contact with your doctor and do not stop taking Ziagen without first talking to your doctor.
How much to take
Adults, adolescents, and children weighing at least 25 kg:
The usual dose of Ziagen is 600 mg daily. This may be taken as one 300 mg tablet twice a day, or two 300 mg tablets once a day.
Children aged one year and older weighing less than 25 kg
The dose depends on your child's body weight. The recommended dose is:
-
Children weighing at least 20 kg but less than 25 kg: The usual dose of Ziagen is 450 mg daily. This may be given as 150 mg (half a tablet) in the morning and 300 mg (one whole tablet) in the evening, or 450 mg (one and a half tablets) once daily, as directed by your doctor.
-
Children weighing at least 14 kg but less than 20 kg: The usual dose of Ziagen is 300 mg daily. This may be given as 150 mg (half a tablet) twice daily, or 300 mg (one whole tablet) once daily, as directed by your doctor.
The tablet may be divided into equal doses.
An oral solution (20 mg abacavir/ml) is available for the treatment of children over three months of age weighing less than 14 kg, as well as for patients who require a reduction in the usual dose or who are unable to take tablets.
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 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 with your regular dosing schedule.
Do not take a double dose to make up for a missed dose.
It is important to take Ziagen regularly, as irregular intake of Ziagen may increase the risk of experiencing a hypersensitivity reaction.
If you have stopped taking Ziagen
If for any reason you have stopped taking Ziagen — especially because you think you are experiencing side effects or due to another illness:
Consult your doctor before restarting treatment. Your doctor will assess whether your symptoms were related to a hypersensitivity reaction. If your doctor considers this possible, you will be advised never to take Ziagen or any other medicine containing abacavir again (e.g. Triumeq, Trizivir or Kivexa). It is important that you follow this warning.
If your doctor advises restarting treatment with Ziagen, they may ask you to take the first doses in a place where you have easy access to medical assistance, if needed.
4. Possible adverse effects
During HIV treatment, there may be an increase in weight and in blood glucose and lipid levels. This may be partly related to the recovery of health and lifestyle, and in the case of blood lipids, sometimes to the HIV medications themselves. Your doctor will monitor these changes.
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
When undergoing HIV treatment, it may be difficult to distinguish whether a symptom is an adverse effect of Ziagen or of other medicines you are taking, or is due to the HIV-related disease itself. Therefore, it is very important that you inform your doctor of any changes in your health.
Even patients who do not carry the HLA-B*5701 gene may develop a hypersensitivity reaction (a serious allergic reaction), described in this leaflet in the section called "Hypersensitivity reactions".
It is very important that you read and understand the information about this serious reaction.
In addition to the adverse effects listed below for Ziagen, other disorders may develop during combination HIV treatment.
It is important that you read the information under the heading "Other possible adverse effects of combination HIV treatment".
Hypersensitivity reactions
Ziagen contains abacavir (active substance also present in Trizivir, Triumeq, and Kivexa).
Abacavir may cause a serious allergic reaction known as a hypersensitivity reaction. These hypersensitivity reactions have been observed more frequently in people taking medicines containing abacavir.
Who experiences these reactions?
Any person taking Ziagen could develop a hypersensitivity reaction to abacavir, which could be life-threatening if you continue taking Ziagen.
Your likelihood of developing this reaction is higher if you have a gene called HLA-B*5701 (but you may still experience this reaction even if you do not have this gene). Before starting treatment with Ziagen, you should have been tested for this gene. If you know you have this gene, tell your doctor before taking Ziagen.
Approximately 3 to 4 out of every 100 patients treated with abacavir in a clinical trial who did not have the HLA-B*5701 gene developed a hypersensitivity reaction.
What are the symptoms?
The most common symptoms are:
•fever (high temperature) and rash.
Other commonly observed signs include:
•nausea (feeling unwell), vomiting, diarrhoea, abdominal pain (stomach), and excessive tiredness.
Other symptoms may include:
Joint or muscle pain, swelling of the neck, difficulty breathing, sore throat, cough, occasional headache, eye inflammation (conjunctivitis), mouth ulcers, low blood pressure, and tingling or numbness in the hands or feet.
When do these reactions occur?
Allergic reactions can occur at any time during treatment with Ziagen, but are most likely to occur within the first 6 weeks of treatment.
If you are caring for a child being treated with Ziagen, it is important that you understand the information about this hypersensitivity reaction. If the child develops the symptoms described below, it is essential that you follow the instructions provided.
Contact your doctor immediately:
1if you develop a rash OR
2if you have symptoms included in at least 2 of the following groups:
- fever
- difficulty breathing, sore throat, or cough
- nausea or vomiting, diarrhoea, or abdominal pain
- excessive tiredness or general aches or malaise.
Your doctor may advise you to stop taking Ziagen.
While you are taking Ziagen, always carry your Patient Information Card with you.
If you have stopped taking Ziagen
If you have stopped taking Ziagen due to a hypersensitivity reaction, NEVER restart Ziagen or any other medicine containing abacavir (e.g. Trizivir, Triumeq, or Kivexa). If you do, within hours you may experience a drop in blood pressure that could be life-threatening or fatal.
If for any reason you have interrupted treatment with Ziagen—especially because you think you are experiencing adverse effects or due to another illness:
Consult your doctor before restarting treatment.
Your doctor will assess whether your symptoms were related to a hypersensitivity reaction. If your doctor considers that there may have been a link, you will be instructed never to take Ziagen or any other medicine containing abacavir (e.g. Trizivir, Triumeq, or Kivexa) again. It is important that you follow this warning.
Occasionally, hypersensitivity reactions have occurred in people who restart abacavir after having experienced only one symptom listed on the Patient Information Card before stopping.
Very rarely, patients who previously took abacavir-containing medicines without hypersensitivity symptoms have developed a hypersensitivity reaction upon re-exposure.
If your doctor advises restarting Ziagen treatment, they may ask you to take the first doses in a place where you have immediate access to medical care, if needed.
If you are hypersensitive to Ziagen, you must return all unused Ziagen tablets so they can be safely disposed of. Consult your doctor or pharmacist.
The Ziagen packaging includes a Patient Information Card to remind you and healthcare professionals about hypersensitivity reactions. Separate the card from the packaging and always carry it with you.
Frequent adverse effects
May affect up to 1 in 10 people:
- hypersensitivity reaction
- nausea
- headache
- vomiting
- diarrhoea
- loss of appetite
- tiredness, lack of energy
- fever (high temperature)
- rash.
Rare adverse effects
May affect up to 1 in 1,000 people:
- inflammation of the pancreas (pancreatitis).
Very rare adverse effects
May affect up to 1 in 10,000 people:
- skin rash, which may blister and look like small targets (a dark centre surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)
- widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens–Johnson syndrome), and a more severe form causing skin peeling over 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 adverse effects
Consult your doctor or pharmacist if you experience any adverse effects, even if they are not listed in this leaflet.
Other possible adverse effects of combination HIV treatment
Combination treatments, including Ziagen, may cause other conditions to develop during HIV treatment.
Symptoms of infection and inflammation
Exacerbation of previous infections
People with advanced HIV infection (AIDS) have a weakened immune system and are more likely to develop serious infections (opportunistic infections). When these people start treatment, they may find that previous, hidden infections flare up, causing signs and symptoms of inflammation. These symptoms are likely due to an improvement in the body's immune response, enabling it to fight these infections. Symptoms usually include fever, along with one or more of the following:
- headache
- stomach pain
- difficulty breathing.
In rare cases, as the immune system becomes stronger, it may also attack healthy tissue (autoimmune disorders). Symptoms of autoimmune disorders may appear many months after starting HIV treatment. Symptoms may include:
- palpitations (rapid or irregular heartbeat) or tremor
- hyperactivity (excessive movement or agitation)
- weakness starting in the hands and feet and moving toward the body trunk.
If you notice any symptoms of infection while taking Ziagen:
Inform your doctor immediately. Do not take any other medicine for the infection unless advised by your doctor.
You may have problems with your bones
Some patients receiving combination HIV treatment develop a bone disease called osteonecrosis. In this condition, part of the bone tissue dies due to reduced blood supply to the bone. People are more likely to develop this condition:
- if they have been on combination treatment for a long time
- if they also take anti-inflammatory medicines called corticosteroids
- if they drink alcohol
- if their immune system is severely weakened
- if they are overweight.
Signs of osteonecrosis include:
- stiffness in the joints
- pain and discomfort (especially in the hip, knee, or shoulder)
- difficulty moving.
If you notice any of these symptoms:
Inform your doctor.
Reporting of adverse effects
If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Ziagen
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date is the last day of the month indicated.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Ziagen
The active substance in each Ziagen film-coated, scored tablet is 300 mg of abacavir (as sulfate).
The other components are microcrystalline cellulose, sodium carboxymethyl starch, magnesium stearate and colloidal anhydrous silica in the tablet core. The coating contains triacetin, hypromellose (E464), titanium dioxide (E171), polysorbate 80 (E433) and yellow iron oxide.
What Ziagen looks like and contents of the pack
Ziagen film-coated tablets are marked on both sides with "GX 623". They are yellow, capsule-shaped, scored tablets, supplied in blister packs containing 60 tablets.
Marketing Authorization Holder
ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, The Netherlands
Manufacturer(s)
Delpharm Poznan Spólka Akcyjna, ul. Grunwaldzka 189, 60-322 Poznan, Poland.
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder.
Belgium/Belgium/Belgium ViiV Healthcare srl/bv Tel/Tel: + 32 (0) 10 85 65 00 | Lithuania ViiV Healthcare BV Tel: + 370 80000334 |
| Luxembourg/Luxembourg ViiV Healthcare srl/bv Belgium/Belgium Tel/Tel: + 32 (0) 10 85 65 00 |
Czech Republic GlaxoSmithKline s.r.o. Tel: + 420 222 001 111 | Hungary ViiV Healthcare BV Tel.: + 36 80088309 |
Denmark GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00 | Malta ViiV Healthcare BV Tel: + 356 80065004 |
Germany ViiV Healthcare GmbH Tel.: + 49 (0)89 203 0038-10 | Netherlands ViiV Healthcare BV Tel: + 31 (0) 33 2081199 |
Estonia ViiV Healthcare BV Tel: + 372 8002640 | Norway GlaxoSmithKline AS Tlf: + 47 22 70 20 00 |
Greece GlaxoSmithKline Monoypresia S.A. Tel: + 30 210 68 82 100 | Austria GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0 |
Spain Laboratorios ViiV Healthcare, S.L. Tel: +34 900 923 501 | Poland GSK Services Sp. z o.o. Tel.: + 48 (0)22 576 9000 |
France ViiV Healthcare SAS Tél.: + 33 (0)1 39 17 6969 Croatia ViiV Healthcare BV Tel: + 385 800787089 | Portugal VIIV HIV HEALTHCARE, UNIPESSOAL, LDA Tel: + 351 21 094 08 01 Romania ViiV Healthcare BV Tel: + 40 800672524 |
Ireland GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955000 | Slovenia ViiV Healthcare BV Tel: + 386 80688869 |
Iceland Vistor hf. Tel: +354 535 7000 | Slovakia ViiV Healthcare BV Tel: + 421 800500589 |
Italy ViiV Healthcare S.r.l Tel: + 39 (0)45 7741600 | Finland GlaxoSmithKline Oy Tel: + 358 (0)10 30 30 30 |
Cyprus ViiV Healthcare BV Tel: + 357 80070017 | Sweden GlaxoSmithKline AB Tel: + 46 (0)8 638 93 00 |
Latvia ViiV Healthcare BV Tel: + 371 80205045 | |
Date of the most recent revision of this leaflet: |
Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.