Lamivudine/Zidovudine Mylan 150 Mg/300 Mg Film-Coated Tablets
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PACKAGE LEAFLET: INFORMATION FOR THE USER
LAMIVUDINE/ZIDOVUDINE 150 mg/300 mg FILM-COATED TABLETS
(lamivudine and zidovudine)
Read all of this leaflet carefully before you start taking
this medicine
• Keep this leaflet. You may need to read it again.
• If you have any further questions, askyour doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• 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.
In this leaflet:
1. What Lamivudine/Zidovudine is and what it is used for.
2. Before you take Lamivudine/Zidovudine.
3. How to take Lamivudine/Zidovudine.
4. Possible side effects.
5. How to store Lamivudine/Zidovudine.
6. Further information.
1. WHAT LAMIVUDINE/ZIDOVUDINE IS AND WHAT IT IS USED FOR
Lamivudine/Zidovudine is used to treat HIV (human immunodeficiency virus) infection in adults and children.
Lamivudine/Zidovudine 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 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 in the same way. Your doctor will be monitoring the effectiveness of your treatment.
2. BEFOREYOUTAKE LAMIVUDINE/ZIDOVUDINE
Do not take Lamivudine/Zidovudine:
• If you are allergic (hypersensitive) to lamivudine or zidovudine or any of the other ingredients of Lamivudine/Zidovudine 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.
Take special care with Lamivudine/Zidovudine
Some people taking Lamivudine/Zidovudine 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 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 .
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 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
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.
The following medicines should not be used with Lamivudine/Zidovudine:
• 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
• pentamidine or atovaquone to treat parasitic infections such as Pneumocystis pneumonia (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
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.
• 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.
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.
Lamivudine/Zidovudine and similar medicines may cause side effects in unborn babies. If you become pregnant while you are taking Lamivudine/Zidovudine, 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) 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 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.
3. HOWTO TAKE LAMIVUDINE/ZIDOVUDINE
Always take Lamivudine/Zidovudine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Swallow Lamivudine/Zidovudine film-coated tablets, with some water. Lamivudine/Zidovudine 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.
Stay in regular contact with your doctor
Lamivudine/Zidovudine 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 without your doctor's advice.
How much to take
Adults and adolescents who weigh 30 kg or more
The usual dose of Lamivudine/Zidovudine 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 is one-half tablet (%) 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 is one-half tablet (%) taken in the morning and one-half tablet (%) taken in the evening.
For children who weigh less than 14 kg, lamivudine and zidovudine (the ingredients of Lamivudine/Zidovudine) should be taken separately.
If you take too much Lamivudine/Zidovudine
If you accidentally take too much Lamivudine/Zidovudine, tell your doctor or your pharmacist, or contact your nearest hospital emergency department for further advice.
If you forget to take Lamivudine/Zidovudine
If you forget to take a dose of Lamivudine/Zidovudine, 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, askyour doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Lamivudine/Zidovudine 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, 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, 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'.
Stop taking Lamivudine/Zidovudine and contact your doctor or go to your hospital emergency department immediately if you experience any of the following serious side effects:
• severe allergic reaction causing swelling of the face, tongue or throat which may cause difficulty in swallowing or breathing (angioedema)
• flu-like symptoms, such as high temperature, chills, runny nose, sore throat (influenza like syndrome) or mouth ulcers which may be a sign of infection or a lack of white blood cells (neutropenia or leucopenia)
• increased bleeding or bruising due to a decrease in the number of cells involved in blood clotting
(th rombocytopenia)
• chest pain with fatigue and palpitations which may be due to a disease of the heart muscle (cardiomyopathy)
• inflammation of the liver with signs such as feeling sick (nausea) or being sick (vomiting), loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin and eyes, light coloured bowel motions and dark coloured urine (hepatitis)
• inflammation of the pancreas which causes severe upper stomach pain often with nausea and vomiting (pancreatitis)
• weakness, bleeding and bruising more easily than normal, frequent infections which may be a sign of a severe reduction in blood cells (aplastic anaemia or pancytopenia) or failure of the bone marrow to produce new red blood cells (red cell aplasia).
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:
Tell your doctor immediately. Do not take other medicines for the infection without your doctor's advice.
Lactic acidosis
Some people taking 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.
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.
You may experience any of the following less serious side effects listed below:
Very common side effects
These may affect more than 1 in 10 people:
• headache
• feeling sick (nausea).
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
• high temperature (fever)
• joint pain
• muscle pain and discomfort
• cough
• irritated or runny nose
• skin rash
Common side effects that might show up in blood tests are:
• a low red blood cell count (anaemia)
• 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.
Rare side effects
These may affect up to 1 in 1000 people:
• breakdown of muscle tissue (rhabdomyolysis)
• tingly feelings in the skin (pins and needles)
• sensation of weakness in the limbs
• liver disorders such as, enlarged liver or fatty liver
• changes in the colour of your nails, your skin or the skin inside your mouth
• 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.
Rare side effects that may show up in blood tests are:
• an increase in an enzyme called amylase.
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 may cause other conditions to develop during HIV treatment.
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.
Other effects that may show up in blood tests
Combination therapy for HIV can also cause:
• 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).
5. HOWTO STORE LAMIVUDINE/ZIDOVUDINE
Keep out of the reach and sight of children. Do not use Lamivudine/Zidovudine 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. Bottle packs ONLY: Use within 60 days of opening. 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.
6. FURTHER INFORMATION
What Lamivudine/Zidovudine 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), silica, colloidal anhydrous (E551), sodium starch glycolate (type A), magnesium stearate (E572).
Film-coating (Opadry white 03H58736):
Hypromellose (E464), titanium dioxide (E171), propylene glycol (E1520).
What Lamivudine/Zidovudine looks like and contents of the pack
Lamivudine/Zidovudine 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 is available in blisters of 30, 60,
60 x 1 (unit dose blister), 100, 200 tablets and in bottles of 60 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder
Mylan S.A.S, 117 Allee des parcs, 69 800 Saint Priest, France.
Manufacturer
Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.
Generics [UK] Limited, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.
Mylan Hungary Kft. H-2900 Komarom, Mylan utca 1, Hungary.
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hair loss (alopecia). This leaflet was last revised in: January 2013 10004734
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Mylan
Job No. product category market packing site
37006976v1
LAMIVUDINE_ZIDOVUDINE UK 2013
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created 18-JAN-2013 modified DD-MMM-20YY
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product Lamivudine Zidovudine 150.300mg FCTab x60 artwork code component type Leaflet superseded code
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10004734
10004676
MA no. 33302/0022 barcode N/A
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dimensions 175 mm x 500 mm
font & point size Myriad Pro Regular 9pt Myriad Pro Bold 17pt
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