Lamivudine/Zidovudine 150/300 mg, filmomhulde tabletten

Lamivudine/Zidovudine 150/300 mg, filmomhulde tabletten
Toelatingslandnl
VergunninghouderMylan
ATC-codeJ05AR01
Farmacologische groepenDirect werkende antivirale middelen

Patiëntenbijsluiter

Wat is het en waarvoor wordt het gebruikt?

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

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

Lamivudine/Zidovudine Mylan does not completely cure HIV infection; it reduces the amount of HIV 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 Lamivudine/Zidovudine Mylan in the same way. Your doctor will be monitoring the effectiveness of your treatment.

Wat moet u weten voordat u het gebruikt?

Do not take Lamivudine/Zidovudine Mylan

  • If you are allergic (hypersensitive) to lamivudine or zidovudine or any of the other ingredients of Lamivudine/Zidovudine Mylan tablets (see Section 6)
  • If you have a very low red blood cell count (anaemia) or a very low white blood cell count (neutropenia).

Check with your doctor if you think any of these apply to you.

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Take special care with Lamivudine/Zidovudine Mylan

Some people taking Lamivudine/Zidovudine Mylan or other combination treatments for HIV 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 Lamivudine/Zidovudine Mylan without your doctor’s advice, as your hepatitis may come back)
  • if you have kidney disease
  • if you are seriously overweight (especially if you are a woman)
  • if you are diabetic and using insulin.

Talk to your doctor if any of these apply to you. Your doctor will decide if the active substances are suitable for you. You may need extra check-ups, including blood tests, while you are taking your medicine. See section 4 for more information.

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 Lamivudine/Zidovudine Mylan.

Read the information ‘Other possible side effects of combination therapy for HIV’ in section 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). Lamivudine/Zidovudine Mylan 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
  • do not risk blood transfer – for example do not share needles.

Other medicines and Lamivudine/Zidovudine Mylan

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 Lamivudine/Zidovudine Mylan.

The following medicines should not be used with Lamivudine/Zidovudine Mylan:

  • other medicinal products containing lamivudine, to treat HIV infection or hepatitis B infection
  • emtricitabine, to treat HIV infection
  • stavudine or zalcitabine, to treat HIV infection
  • ribavirin, or injections of ganciclovir to treat viral infections
  • high doses of co-trimoxazole, an antibiotic.

Tell your doctor if you are being treated with any of these.

Some medicines can make it more likely that you will 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

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  • 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 are taking any of these.

Some medicines interact with Lamivudine/Zidovudine Mylan

These include:

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

Pregnancy:

If you are pregnant, if you become pregnant, or if you are planning to become pregnant, talk to your doctor about the risks and benefits to you and your baby of taking Lamivudine/Zidovudine Mylan.

Lamivudine/Zidovudine Mylan and similar medicines may cause side effects in unborn babies. If you become pregnant while you are taking Lamivudine/Zidovudine Mylan, your baby may be given extra check-ups (including blood tests) to make sure it is developing normally.

Children whose mothers took NRTIs (medicines like Lamivudine/Zidovudine Mylan) during pregnancy had 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 are breast-feeding or thinking of breast-feeding talk to your doctor immediately.

Driving and using machines

Lamivudine/Zidovudine Mylan can make you dizzy and have other side effects that make you less alert.

Do not drive or operate machines if you are feeling unwell.

Hoe wordt het gebruikt?

Always take Lamivudine/Zidovudine Mylan exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Swallow Lamivudine/Zidovudine Mylan film-coated tablets, with some water. Lamivudine/Zidovudine Mylan can be taken with or without food.

If you cannot swallow the tablets whole, you may crush and combine them with a small amount of food or drink, and take all the dose immediately.

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Stay in regular contact with your doctor

Lamivudine/Zidovudine Mylan 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 don’t stop taking Lamivudine/Zidovudine Mylan without your doctor’s advice.

How much to take

Adults and adolescents who weigh 30 kg or more

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

Children who weigh between 21 kg and 30 kg

The usual starting dose of Lamivudine/Zidovudine Mylan is one-half tablet (½) taken in the morning and one whole tablet taken in the evening.

Children who weigh between 14 kg and 21 kg

The usual starting dose of Lamivudine/Zidovudine Mylan is one-half tablet (½) taken in the morning and one-half tablet (½) taken in the evening.

For children who weigh less than 14 kg, lamivudine and zidovudine (the ingredients of Lamivudine/Zidovudinen Mylan) should be taken separately.

If you take too much Lamivudine/Zidovudine Mylan

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

If you forget to take Lamivudine/Zidovudine Mylan

If you forget to take a dose of Lamivudine/Zidovudine Mylan, take it as soon as you remember and then continue your treatment as before. Do not take a double dose to make up for a missed dose.

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

Wat zijn mogelijke bijwerkingen?

Like all medicines, Lamivudine/Zidovudine Mylan can cause side effects, although not everybody gets them. When you are being treated for HIV, it can be hard to tell whether a symptom is a side effect of Lamivudine/Zidovudine Mylan, or other medicines you are taking or an effect of the HIV disease itself. For this reason it is very important that you inform your doctor about any changes in your health.

As well as the side effects listed below for Lamivudine/Zidovudine Mylan, 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’.

Very common side effects

These may affect more than 1 in 10 people:

  • headache
  • feeling sick (nausea)

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Common side effects

These may affect up to 1 in 10 people:

  • being sick (vomiting)
  • stomach pains
  • diarrhoea
  • loss of appetite
  • general feeling of being unwell
  • fever (high temperature)
  • joint pain
  • muscle pain and discomfort
  • cough
  • irritated or runny nose
  • skin rash
  • feeling dizzy
  • tiredness, lack of energy
  • difficulty in sleeping (insomnia)
  • hair loss (alopecia)

Common side effects that might 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 of bilirubin (a substance produced by the liver) in the blood, which may make your skin appear yellow.

Uncommon side effects

These may affect up to 1 in 100 people:

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

An uncommon side effect that may show up in a blood test 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 up to 1 in 1000 people:

  • serious allergic reaction causing swelling of the face, tongue or throat which may cause difficulty in swallowing or breathing
  • chest pain; disease of the heart muscle (cardiomyopathy),
  • breakdown of muscle tissue,
  • tingly feelings in the skin (pins and needles)
  • sensation of weakness in the limbs
  • liver disorders such as jaundice, enlarged liver or fatty liver, inflammation (hepatitis),
  • inflammation of the pancreas (pancreatitis)
  • changes in the colour of your nails, your skin or the skin inside your mouth,
  • a flu-like feeling, chills and sweating
  • passing urine more often
  • enlarged breasts in men
  • indigestion, taste disturbance
  • fits (convulsions)
  • numbness
  • feeling depressed or anxious, not being able to concentrate, feeling drowsy

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  • lactic acidosis (see the next section, ‘Other possible side effects of combination therapy for HIV’)

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

  • an 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 may affect up to 1 in 10,000 people:

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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Other possible side effects of combination therapy for HIV

Combination therapy such as Lamivudine/Zidovudine Mylan 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 are taking Lamivudine/Zidovudine Mylan:

Tell your doctor immediately. Do not 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 Lamivudine/Zidovudine Mylan, or other medicines like it (NRTI’s), 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)

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  • 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.

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 that may show up in blood tests

Combination therapy for HIV 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 are diabetic, you may have to change your insulin dose to control your blood sugar).

Hoe moet het worden bewaard?

Keep out of the reach and sight of children.

Do not use Lamivudine/Zidovudine Mylan after the expiry date, which is stated on the carton, bottle or blister after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

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 to protect the environment.

Verdere informatie

What Lamivudine/Zidovudine Mylan contains

The active substances are lamivudine and zidovudine. One tablet contains 150 mg of lamivudine and 300 mg of zidovudine.

The other ingredients are: Core:

Cellulose microcrystalline (E460), colloidal anhydrous silica (E551), sodium starch glycolate (type A), magnesium stearate (E572).

Film-coating (Opadry white 03H58736):

Hypromellose (E464), titanium dioxide (E171), propylene glycol (E1520).

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

Lamivudine/Zidovudine Mylan 150 mg/300 mg film-coated tablets are white to off-white, capsule shaped, biconvex film coated tablets, debossed with “M” on the left of the scoreline and “103” on the right, on one side of the tablet, and scored on the other side.

Lamivudine/Zidovudine Mylan is available in blisters of 30, 60, 100, 200 tablets and in bottles of 60 tablets.

Not all pack sizes may be marketed.

Dit middel is ingeschreven in het register onder nummer RVG 107778.

Marketing Authorisation Holder

Mylan B.V.

Dieselweg 25

Bunschoten

Manufacturer

McDermott Laboratories Limited trading as Gerard Laboratories 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13 Ireland

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

Belgium: Lamivudine/Zidovudine Mylan 150 mg/300 mg Filmomhulde Tabletten Czech Republic: Lamivudin/Zidovudin Mylan 150 mg/300 mg, potahované tablety France: Lamivudine/Zidovudine Mylan 150 mg/300 mg , comprimé pelliculé sécable Germany: Lamivudin/Zidovudin Mylan150mg/30mg Filmtabletten

Italy: Lamivudina e Zidovudina Mylan 150 mg/300 mg compresse rivestite con film Luxembourg: Lamivudine/Zidovudine Mylan 150 mg/300 mg Filmomhulde Tabletten Malta: Lamivudine/Zidovudine Mylan 150 mg/300 mg , comprimé pelliculé

Poland: Lamiwudyna/Zidowudyna Mylan 150mg/300mg tabletki powlekane. Portugal: Lamivudina/Zidovudina Mylan comprimidos revestidos por película. Romania: Lamivudină/Zidovudină Mylan 150 mg/300 mg comprimate filmate Slovakia: Lamivudin/Zidovudin Mylan 150mg / 300mg Filmom obalené tablety

Spain: Lamivudina/Zidovudina Mylan 150 mg/300 mg Comprimidos recubiertos con película EFG The Netherlands: Lamivudine/Zidovudine Mylan 150/300 mg filmomhulde tabletten.

United Kingdom: Lamivudine/Zidovudine Mylan 150 mg/300 mg Film-coated tablets

This leaflet was last approved in August 2011

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Laatst bijgewerkt op 24.08.2022


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