Abacavir/Lamivudine/Zidovudine 300/150/300 mg Teva, filmomhulde tabletten

ATC-Code
J05AR04
Abacavir/Lamivudine/Zidovudine 300/150/300 mg Teva, filmomhulde tabletten

Teva

Verdovend
Nee
Farmacologische groep Direct werkende antivirale middelen

Advertentie

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Vergunninghouder

Teva

Waarvoor wordt dit middel gebruikt?

Abacavir/Lamivudine/Zidovudine is used to treat HIV (human immunodeficiency virus) infection in adults.

Abacavir/Lamivudine/Zidovudine contains three active ingredients that are used to treat HIV infection: abacavir, lamivudine and zidovudine. All of these belong to a group of anti-retroviral medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs).

Abacavir/Lamivudine/Zidovudine helps to control your condition. Abacavir/Lamivudine/Zidovudine does not cure HIV infection; it reduces the amount of virus in your body, and keeps it at a low level. This helps your body to 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 Abacavir/Lamivudine/Zidovudine in the same way. Your doctor will monitor the effectiveness of your treatment.

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Advertentie

Wanneer mag u dit middel niet gebruiken of moet u er extra voorzichtig mee zijn?

Do not take Abacavir/Lamivudine/Zidovudine

  • if you’re allergic (hypersensitive) to abacavir (or any other medicine containing abacavir), lamivudine or zidovudine, or any of the other ingredients of Abacavir/Lamivudine/Zidovudine (listed in Section 6)
  • Carefully read all the information about hypersensitivity reactions in Section 4
  • if you have liver problems
  • if you have severe kidney problems
  • if you have a very low red blood cell count (anaemia) or a very low white blood cell count

(neutropenia)

Do not take Abacavir/Lamivudine/Zidovudine and check with your doctor if you think any of these apply to you.

Warnings and precautions

Hypersensitivity reactions

About 3 to 4 in every 100 patients treated with abacavir in a clinical trial who did not have a gene called HLA-B*5701 developed a hypersensitivity reaction (a serious allergic reaction).

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

Some people taking Abacavir/Lamivudine/Zidovudine are more at risk of serious side effects. You need to be aware of the extra risks:

  • if you have ever had liver disease, including hepatitis B or C (if you have hepatitis B infection, don’t stop Abacavir/Lamivudine/Zidovudine without your doctor’s advice, as your hepatitis may come back)
  • if you’re seriously overweight (especially if you’re a woman)
  • if you’re diabetic and using insulin.
  • Talk to your doctor if any of these apply to you. You may need extra check-ups, including blood tests, while you’re taking your medicine. See Section 4 for more information.

Risk of heart attack

It cannot be excluded that abacavir may increase the risk of having a heart attack.

  • Tell your doctor if you have heart problems, if you smoke, or have other illnesses that may increase your risk of heart disease such as high blood pressure, or diabetes. Don’t stop taking Abacavir/Lamivudine/Zidovudine unless your doctor advises you to do so.

Look out for important symptoms

Some people taking Abacavir/Lamivudine/Zidovudine develop other conditions, which can be serious. You need to know about important signs and symptoms to look out for while you’re taking

Abacavir/Lamivudine/Zidovudine.

  • Read the information ‘Other possible side effects of Abacavir/Lamivudine/Zidovudine’ inSection 4 of this leaflet.

Protect other people

HIV infection is spread by sexual contact with someone who has the infection, or by transfer of infected blood (for example, by sharing injection needles). Abacavir/Lamivudine/Zidovudine will not stop you passing HIV infection on to other people. To protect other people from becoming infected with HIV:

  • Use a condom when you have oral or penetrative sex.
  • Avoid contact with other peoples’ blood — for example, don’t share needles.

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Other medicines and Abacavir/Lamivudine/Zidovudine

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including herbal medicines and medicines obtained without a prescription.

Remember to tell your doctor or pharmacist if you begin taking a new medicine while you’re taking Abacavir/Lamivudine/Zidovudine.

These medicines should not be used with Abacavir/Lamivudine/Zidovudine:

  • stavudine or emtricitabine, to treat HIV infection
  • other medicinal products containing lamivudine, used to treat HIV infection or hepatitis B infection
  • ribavirin or injections of ganciclovir to treat viral infections
  • high doses of co-trimoxazole, an antibiotic.
  • Tell your doctor if you’re being treated with any of these.

Some medicines can make it more likely that you’ll have side effects, or make side effects worse. These include:

  • sodium valproate, to treat epilepsy
  • interferon, to treat viral infections
  • pyrimethamine, to treat malaria and other parasitic infections
  • dapsone, to prevent pneumonia and treat skin infections
  • fluconazole or flucytosine, to treat fungal infections such as candida
  • pentamidine or atovaquone, to treat parasitic infections such as PCP
  • amphotericin or co-trimoxazole, to treat fungal and bacterial infections
  • probenecid, to treat gout and similar conditions, and given with some antibiotics to make them more effective
  • methadone, used as a heroin substitute
  • vincristine, vinblastine or doxorubicin, to treat cancer.
  • Tell your doctor if you’re taking any of these.

Some medicines interact with Abacavir/Lamivudine/Zidovudine

These include:

  • clarithromycin, an antibiotic. If you’re taking clarithromycin, take your dose at least 2 hours before or after you take your Abacavir/Lamivudine/Zidovudine.
  • phenytoin, for treating epilepsy. Tell your doctor if you’re taking phenytoin. Your doctor may need to monitor you while you’re taking Abacavir/Lamivudine/Zidovudine.

Methadone and Abacavir/Lamivudine/Zidovudine

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.

Pregnancy and breast-feeding

Pregnancy

Abacavir/Lamivudine/Zidovudine is not recommended for use during pregnancy. Abacavir/Lamivudine/Zidovudine and similar medicines may cause side effects in unborn babies. If you become pregnant while you’re taking Abacavir/Lamivudine/Zidovudine, your baby may be given extra check-ups (including blood tests) to make sure it is developing normally.

If you are pregnant, if you become pregnant, or if you’re planning to become pregnant:

  • Talk to your doctor immediately about the risks and benefits of taking Abacavir/Lamivudine/Zidovudine during your pregnancy.

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Talk to your doctor immediately.

Children whose mothers took NRTIs (medicines like Abacavir/Lamivudine/Zidovudine) during pregnancy have a reduced risk of being infected with HIV. This benefit is greater than the risk of having side effects.

Breast-feeding

Women who are HIV-positive must not breast-feed, because HIV infection can be passed on to the baby in breast milk.

If you’re breast-feeding, or thinking about breast-feeding:

Driving and using machines

Abacavir/Lamivudine/Zidovudine can make you dizzy and have other side effects that make you less alert. Don’t drive or operate machines unless you’re feeling well.

Abacavir/Lamivudine/Zidovudine contains lactose.

One of the ingredients of Abacavir/Lamivudine/Zidovudine is lactose monohydrate (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Hoe gebruikt u dit middel?

Always take Abacavir/Lamivudine/Zidovudine exactly as your doctor has told you to. Check with your doctor or pharmacist if you are not sure.

Keep in touch with your doctor, and don’t stop taking Abacavir/Lamivudine/Zidovudine without your doctor’s advice.

How much to take

The usual dose of Abacavir/Lamivudine/Zidovudine for adults is one tablet twice a day. Take the tablets at regular times, leaving approximately 12 hours between each tablet.

Swallow the tablets whole, with some water. Abacavir/Lamivudine/Zidovudine can be taken with or without food.

If you take more Abacavir/Lamivudine/Zidovudine than you should

If you accidentally take too much Abacavir/Lamivudine/Zidovudine, tell your doctor or your pharmacist, or contact your nearest hospital emergency department for further advice.

If you forget to take Abacavir/Lamivudine/Zidovudine

If you forget to take a dose, take it as soon as you remember. Then continue your treatment as before.

Don’t take a double dose to make up for a missed dose.

It is important to take Abacavir/Lamivudine/Zidovudine regularly, because if you take it at irregular intervals it may not continue to work against the HIV infection, and you may be more likely to have a hypersensitivity reaction.

If you stop taking Abacavir/Lamivudine/Zidovudine

If you have stopped taking Abacavir/Lamivudine/Zidovudine 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

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related, you will be told never again to take Abacavir/Lamivudine/Zidovudine, or any other medicine containing abacavir. It is important that you follow this advice.

If your doctor advises that you can start taking Abacavir/Lamivudine/Zidovudine 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 have any further questions on the use of this medicine ask your doctor or pharmacist.

Mogelijke bijwerkingen?

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

When you’re being treated for HIV, it can be hard to tell whether a symptom is a side effect of

Abacavir/Lamivudine/Zidovudine or other medicines you are taking, or an effect of the HIV infection itself. So it is very important to talk to your doctor about any changes in your health.

About 3 to 4 in every 100 patients treated with abacavir in a clinical trial who did not have a gene called HLA-B*5701 developed a hypersensitivity reaction (a serious allergic reaction), described on the other side of this leaflet under ‘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 Abacavir/Lamivudine/Zidovudine, other conditions can develop during treatment.

  • It is important to read the information on the other side of this leaflet under ‘Other possible side effects of Abacavir/Lamivudine/Zidovudine’.

Hypersensitivity reactions

Abacavir/Lamivudine/Zidovudine contains abacavir.

Anyone taking Abacavir/Lamivudine/Zidovudine could develop a hypersensitivity reaction to abacavir, which could be life threatening if they continue to take Abacavir/Lamivudine/Zidovudine.

You are more likely to develop such a reaction if you have a gene called HLA-B*5701 (but you can get a reaction even if you don’t have this gene). You should have been tested for this gene before

Abacavir/Lamivudine/Zidovudine was prescribed for you. If you know you have this gene, tell your doctor before you take Abacavir/Lamivudine/Zidovudine.

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, headache
  • occasionally, inflammation of the eye (conjunctivitis), mouth ulcers, low blood pressure.

If you continue to take Abacavir/Lamivudine/Zidovudine, the symptoms will get worse, and may be life-threatening.

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Hypersensitivity reactions can start at any time during treatment with Abacavir/Lamivudine/Zidovudine, but are more likely during the first 6 weeks of treatment.

Occasionally, reactions have developed in people who start taking abacavir again, and had only one symptom on the Alert Card before they stopped taking it.

Very rarely, reactions have developed in people who start taking abacavir again, but who had no symptoms before they stopped taking it.

Contact your doctor immediately:

    • 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 Abacavir/Lamivudine/Zidovudine.

Always carry your Alert Card while you are taking Abacavir/Lamivudine/Zidovudine.

If you have stopped taking Abacavir/Lamivudine/Zidovudine

If you have stopped taking Abacavir/Lamivudine/Zidovudine because of a hypersensitivity reaction, you must NEVER AGAIN take Abacavir/Lamivudine/Zidovudine, or any other medicine containing abacavir. If you do, within hours, your blood pressure could fall dangerously low, which could result in death.

If you have stopped taking Abacavir/Lamivudine/Zidovudine 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 Abacavir/Lamivudine/Zidovudine, or any other medicine containing abacavir. It is important that you follow this advice.

If your doctor advises that you can start taking Abacavir/Lamivudine/Zidovudine 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 Abacavir/Lamivudine/Zidovudine, return all your unused Abacavir/Lamivudine/Zidovudine tablets for safe disposal. Ask your doctor or pharmacist for advice.

Very common side effects

These may affect more than 1 user in 10:

  • headache
  • feeling sick (nausea).

Common side effects

These may affect 1 to 10 users in 100:

  • hypersensitivity reaction
  • being sick (vomiting)
  • diarrhoea
  • stomach pains
  • loss of appetite
  • feeling dizzy
  • tiredness, lack of energy

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  • fever (high temperature)
  • general feeling of being unwell
  • difficulty in sleeping (insomnia)
  • muscle pain and discomfort
  • joint pain
  • cough
  • irritated or runny nose
  • skin rash
  • hair loss.

Common side effects that may show up in blood tests are:

  • a low red blood cell count (anaemia) or low white blood cell count (neutropenia or leucopenia)
  • an increase in the level of liver enzymes
  • an increased amount in the blood of bilirubin (a substance produced in the liver) which may make your skin appear yellow.

Uncommon side effects

These may affect 1 to 10 users in 1,000 people:

  • feeling breathless
  • wind (flatulence)
  • itching
  • muscle weakness.

An uncommon side effect that may show up in blood tests is:

  • a decrease in the number of cells involved in blood clotting (thrombocytopenia), or in all kinds of blood cells (pancytopenia).

Rare side effects

These may affect 1 to 10 users in 10,000:

  • liver disorders, such as jaundice, enlarged liver or fatty liver, inflammation (hepatitis)
  • lactic acidosis (see the next section, ‘Other possible side effects ofAbacavir/Lamivudine/Zidovudine’)
  • inflammation of the pancreas (pancreatitis)
  • chest pain; disease of the heart muscle (cardiomyopathy)
  • fits (convulsions)
  • feeling depressed or anxious, not being able to concentrate, feeling drowsy
  • indigestion, taste disturbance
  • changes in the colour of your nails, your skin, or the skin inside your mouth
  • a flu-like feeling — chills and sweating
  • tingly feelings in the skin (pins and needles)
  • sensation of weakness in the limbs
  • breakdown of muscle tissue
  • numbness
  • passing urine more often
  • enlarged breasts in men.

Rare side effects that may show up in blood tests are:

  • increase in an enzyme called amylase
  • a failure of the bone marrow to produce new red blood cells (pure red cell aplasia).

Very rare side effects

These affect less than 1 user in 10,000:

  • 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)

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  • 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).

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

A very rare side effect that may show up in blood tests is:

  • a failure of the bone marrow to produce new red or white blood cells (aplastic anaemia).

If you get side effects

  • Tell your doctor or pharmacist if any of the side effects gets severe or troublesome, or if you notice any side effects not listed in this leaflet.

Other possible side effects of Abacavir/Lamivudine/Zidovudine

Abacavir/Lamivudine/Zidovudine may cause other conditions to develop during HIV treatment.

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.

If you get any symptoms of infection while you’re taking Abacavir/Lamivudine/Zidovudine:

  • Tell your doctor immediately. Don’t take other medicines for the infection without your doctor’s advice.

Your body shape may change

People taking combination therapy for HIV may find that their body shape changes, because of changes in fat distribution:

  • Fat may be lost from the legs, arms or face.
  • Extra fat may build up around the tummy (abdomen), or on the breasts or internal organs.
  • Fatty lumps (sometimes called buffalo hump) may appear on the back of the neck.

It is not yet known what causes these changes, or whether they have any long-term effects on your health. If you notice changes in your body shape:

  • Tell your doctor.

Lactic acidosis is a rare but serious side effect.

Some people taking Abacavir/Lamivudine/Zidovudine, or other medicines like it (NRTIs), develop a condition called lactic acidosis, together with an enlarged liver.

Lactic acidosis is caused by a build-up of lactic acid in the body. It is rare; if it happens, it usually develops after a few months of treatment. It can be life-threatening, causing failure of internal organs.

Lactic acidosis is more likely to develop in people who have liver disease, or in obese (very overweight) people, especially women.

Signs of lactic acidosis include:

  • deep, rapid, difficult breathing
  • drowsiness
  • numbness or weakness in the limbs
  • feeling sick (nausea), being sick (vomiting)
  • stomach pain.

During your treatment, your doctor will monitor you for signs of lactic acidosis. If you have any of the symptoms listed above or any other symptoms that worry you:

  • See your doctor as soon as possible.

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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.

Other effects may show up in blood tests.

Abacavir/Lamivudine/Zidovudine can also cause:

  • increased levels of lactic acid in the blood, which on rare occasions can lead to lactic acidosis
  • increased levels of sugar and fats (triglycerides and cholesterol) in the blood
  • resistance to insulin (so if you’re diabetic, you may have to change your insulin dose to control your blood sugar).

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

Hoe bewaart u dit middel?

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

This medicinal product does not require any special storage conditions.Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

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 will help protect the environment.

Anvullende Informatie

What Abacavir/Lamivudine/Zidovudine contains

  • The active substances are abacavir, lamivudine and zidovudine. Each tablet contains 300 mg of abacavir, 150 mg of lamivudine and 300 mg of zidovudine.
  • These film-coated tablets also contain cellulose microcrystalline, maize starch pregelatinized, sodium starch glycolate type A and magnesium stearate. The coating contains hypromellose 15 cP, lactose monohydrate, titanium dioxide (E171), indigo carmine aluminium lake (E132), macrogol 4000 and sodium citrate dihydrate.

What Abacavir/Lamivudine/Zidovudine looks like and contents of the pack

  • Film-coated tablet
  • Blue, oval, biconvex, film-coated tablet debossed TEVA on one side and 5531 on the other
  • Abacavir/Lamivudine/Zidovudine Film-coated Tablets are available in white PVC/ACLAR/PVC-Aluminium blisters containing 30, 40, 60 or 90 film-coated tablets and in

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white HDPE bottles with PP child resistant closures containing 60 film-coated tablets and 60 film-coated tablets hospital pack.

  • Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Teva Nederland B.V.

Swensweg 5

2031 GA Haarlem

Nederland

Manufacturer:

TEVA UK Ltd

Brampton Road, Hampden Park, Eastbourne

East Sussex, BN22 9AG

Engeland

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

Nederland

TEVA SANTE

Rue Bellocier

89100 Sens

Frankrijk

TEVA Pharmaceutical Works Private Limited Company Pallagi út 13

4042 Debrecen Hongarije

Teva Czech Industries s.r.o. Ostravská 29, c.p. 305

747 70 Opava, Komárov Tsjechische Republiek

TEVA PHARMA, S.L.U.

C/ C, n° 4, Poligono Industrial Malpica, Zaragoza 50016 Zaragoza

Spanje

Merckle GmbH

Ludwig-Merckle-Strasse 3

89143 Blaubeuren

Duitsland

Teva Operations Poland Sp. z o.o. 25 Sienkiewicza Str.

99-300 Kutno Polen

Teva Operations Poland Sp. z o.o 80 Mogilska Str.

31-546 Kraków Polen

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In het register ingeschreven onder:

RVG: 110864

This medicinal product is authorised in the Member States of the EEA under the following names:

Deze bijsluiter is voor het laatst goedgekeurd in januari 2013

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