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LAMIVUDINE/ZIDOVUDINE MYLAN 150 MG/300 MG FILM-COATED TABLETS

Active substance(s): LAMIVUDINE / ZIDOVUDINE / LAMIVUDINE / ZIDOVUDINE / LAMIVUDINE / ZIDOVUDINE

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(lamivudine/zidovudine)

TBC

Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Lamivudine/Zidovudine is and what it is
used for
2. What you need to know before you take
Lamivudine/Zidovudine
3. How to take Lamivudine/Zidovudine
4. Possible side effects
5. How to store Lamivudine/Zidovudine
6. Contents of the pack and other 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
substances 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. What you need to know before you
take Lamivudine/Zidovudine
Do not take Lamivudine/Zidovudine:

• if you are allergic to lamivudine or zidovudine
or any of the other ingredients of this medicine
listed in 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.

Warnings and precautions

Talk to your doctor or pharmacist before taking
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,
do not 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)
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). You can still pass on HIV when taking this
medicine, although the risk is lowered by effective
antiretroviral therapy.
Discuss with your doctor the precautions needed to
avoid infecting other people.

Other medicines and Lamivudine/Zidovudine
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
This includes 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
• cladribine, used to treat hairy cell leukaemia
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

Description Lamivudine Zidovudine 150 mg, 300 mg All
Component Type Leaflet
Affiliate Item Code 1162090
Superceded Affiliate Item Code N/A
TrackWise PR No. 1162090
MA No. PL 33302/0022

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 and breast-feeding
Pregnancy

If you are pregnant, think you might be pregnant
or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.
Lamivudine/Zidovudine and similar medicines may
cause side effects in unborn babies. If you have taken
Lamivudine/Zidovudine during your pregnancy,
your doctor may request regular blood tests and
other diagnostic tests to monitor the development
of your child. In children whose mother took NRTIs
during pregnancy, the benefit from the protection
against HIV outweighed the risk of 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.
A small amount of the ingredients in this medicine
can also pass into your breast milk.
If you are breast-feeding or thinking of breastfeeding 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. How to take Lamivudine/Zidovudine
Always take Lamivudine/Zidovudine exactly as
your doctor has told you. 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 do not stop
taking Lamivudine/Zidovudine without your
doctor’s advice.

How much to take
Adults and adolescents who weigh 30 kg or
more

The recommended 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 recommended starting dose of Lamivudine/
Zidovudine 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 recommended starting dose of Lamivudine/
Zidovudine 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/
Zidovudine) should be taken separately.

If you take more Lamivudine/Zidovudine than
you should
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 forgotten dose.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist

4. Possible side effects
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.
Treatment with Lamivudine/Zidovudine often causes
a loss of fat from legs, arms and face (lipoatrophy).
This loss of body fat has been shown to be not fully
reversible after discontinuation of zidovudine. Your
doctor should monitor for signs of lipoatrophy.
Tell your doctor if you notice any loss of fat from
your legs, arms, and face. When these signs occur,
Lamivudine/Zidovudine should be stopped and
your HIV treatment changed. Like all medicines,
this medicine can cause side effects, although not
everybody gets them.

Date: 06 Apr 2017

Pharma Code TBC

No. of colours

SAP No. N/A

Colours

Black

Non-Print
Colours

Codes

Vendor Job No. 307492
Trackwise Proof No. 1
Client Market United Kingdom

Packing Site/Printer N/A

Keyline/Drawing No. N/A

Supplier Code N/A

Barcode Info N/A

TBC

TBC

Lamivudine/Zidovudine
150 mg/300 mg
Film-coated Tablets

• 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.

TBC

Package Leaflet: Information for the patient

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Page Count

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Dimensions 160 x 480 mm

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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’.

If you notice any of the following serious side
effects, contact your doctor immediately:

• serious allergic reaction causing swelling of the
face, tongue or throat which may cause difficulty
in swallowing or breathing
• chest pain; feeling tired and breathless with
swollen ankles, which may be caused by disease
of the heart muscle (cardiomyopathy)
• muscle pain, joint pain, tenderness, weakness,
swelling and seizures which may be caused by a
breakdown of muscle tissue (rhabdomyolysis)
• feeling tired and breathless with pale skin,
headache, dizziness, an increase in the number of
infections that you get such as sore throat, mouth
ulcers with fever and chills, bleeding or bruising
more easily than normal, nosebleeds, which may
be due to a decrease in the number of red or
white blood cells or cells which help in clotting
of the blood, which could be caused by problems
with the bone marrow. This may show up in blood
tests.
• yellowing of the skin, or whites of the eyes with
pain in the top of your stomach, feeling and being
sick, loss of appetite with light coloured stools
and dark coloured urine which may be caused by
liver disorders such as jaundice, enlarged liver or
fatty liver, inflammation (hepatitis),
• pain in the upper part of the stomach which
radiates to the back with feeling and being sick,
which may be caused by inflammation of the
pancreas (pancreatitis)
• fits (convulsions)
• deep, rapid, difficult breathing, drowsiness,
numbness or weakness in arms or legs, feeling
and being sick and stomach pains which may be
caused by lactic acidosis (see the next section,
‘Other possible side effects of combination
therapy for HIV’)

Other possible side effects

Very common (may affect more than 1 in 10 people):
• headache
• feeling sick (nausea)
Common (may affect up to 1 in 10 people):
• being sick (vomiting)
• stomach pains
• diarrhoea
• general feeling of being unwell
• high temperature (fever)
• 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:
• 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 (may affect up to 1 in 100 people):
• wind (flatulence)
• feeling breathless
• itching
• muscle weakness
Rare (may affect up to 1 in 1,000 people):
• tingly feelings in the skin (pins and needles)
• sensation of weakness in the limbs
• 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
• numbness
• loss of appetite
• 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.

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.
In addition to the opportunistic infections,
autoimmune disorders (a condition that occurs when
the immune system attacks healthy body tissue)
may also occur after you start taking medicines for
the treatment of your HIV infection. Autoimmune
disorders may occur many months after the start of
treatment. If you notice any symptoms of infection or
other symptoms such as muscle weakness, weakness
beginning in the hands and feet and moving
up towards the trunk of the body, palpitations,
tremor or hyperactivity, please inform your doctor
immediately to seek necessary treatment.

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 is a rare but serious side effect

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 lifethreatening, 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.

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

Reporting of side effects

If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly via Yellow Card Scheme, Website:
www.mhra.gov.uk/yellowcard. By reporting side
effects you can help provide more information on
the safety of this medicine.

5. How to store Lamivudine/Zidovudine
Keep out of the sight and reach 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.
Do not throw away any medicines via wastewater.
Ask your pharmacist how to throw away medicines
you no longer use. These measures will help to
protect the environment.

6. Contents of the pack and other
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:
Tablet 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, marked 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

Mylan S.A.S., 117 Allée des parcs, 69800 Saint-Priest,
France

Manufacturers

Generics [UK] Limited, Potters Bar, Hertfordshire,
EN6 1TL, United Kingdom
Gerard Laboratories, 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland
Mylan Hungary Kft., Mylan utca 1, Komárom, 2900,
Hungary
This leaflet was last revised in August 2016.

CODE No.: MH/DRUGS/25/NKD/89

Description Lamivudine Zidovudine 150 mg, 300 mg All
Component Type Leaflet
Affiliate Item Code 1162090
Superceded Affiliate Item Code N/A
TrackWise PR No. 1162090
MA No. PL 33302/0022

Date: 06 Apr 2017

Pharma Code TBC

No. of colours

SAP No. N/A

Colours

Black

Non-Print
Colours

Codes

Vendor Job No. 307492
Trackwise Proof No. 1
Client Market United Kingdom

Packing Site/Printer N/A

Keyline/Drawing No. N/A

Supplier Code N/A

Barcode Info N/A

1

1162090

Time: 15:49
Page Count

2/2

Equate CMYK
with
Main Font Myriad Pro
Dimensions 160 x 480 mm

Body Text Size 9 pt
Min Text Size used 9 pt

Sign-offs

v2/Oct 2016

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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