Lamivudine + Zidovudine Alphapharm (lamivudine and zidovudine) Drug / Medicine Information

Lamivudine + Zidovudine Alphapharm (lamivudine and zidovudine) Drug / Medicine Information

lamivudine and zidovudine

CONSUMER MEDICINE INFORMATION

What is in this leaflet

Please read this leaflet carefully before you start LAMIVUDINE 150mg + ZIDOVUDINE
300mg Alphapharm. This leaflet answers some common questions about LAMIVUDINE 150mg
+ ZIDOVUDINE 300mg Alphapharm.

It does not contain all the available information. It does not take the place of talking
to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking
LAMIVUDINE 150mg + ZIDOVUDINE 300mg Alphapharm against the benefits they expect it
will have on you.

If you have any concerns about taking this medicine, talk to your doctor or pharmacist.

Keep this leaflet with your medicine.

You may need to read it again.

What LAMIVUDINE 150mg + ZIDOVUDINE 300mg Alphapharm is used for

LAMIVUDINE 150mg + ZIDOVUDINE 300mg Alphapharm contains lamivudine and zidovudine
which belongs to a group of medicines called antiretrovirals.

Please note that lamivudine is available as a stand alone tablet (as LAMIVUDINE Alphapharm
lamivudine 150mg & 300mg tablets).

Lamivudine with zidovudine is used alone or with other antiretrovirals, to slow down
the progressing of human immunodeficiency virus (HIV) infection, which can lead to
Acquired Immune Deficiency Syndrome (AIDS) and other related illnesses (eg, AIDS-related
Complex or ARC).

Lamivudine with zidovudine does not cure AIDS or HIV infection, but slows production
of human immunodeficiency virus. In this way it stops ongoing damage to the body’s
immune system, which fights infection.

Lamivudine with zidovudine does not reduce the risk of passing HIV infection to others.
You will still be able to pass on the HIV virus by sexual activity or by passing on
blood or bodily secretions which carry the HIV virus. You should still use proper
precautions.

While taking LAMIVUDINE 150mg + ZIDOVUDINE 300mg Alphapharm and/or any other therapy
for HIV disease, you may continue to develop other infections and other complications
of HIV infection. You should keep in regular contact with the doctor.The long-term
risks and benefits of taking lamivudine / zidovudine combination tablets are not known.

Your doctor may have prescribed LAMIVUDINE 150mg + ZIDOVUDINE 300mg Alphapharm for
another reason. Ask your doctor if you have any questions about why it has been prescribed
for you.

LAMIVUDINE 150mg + ZIDOVUDINE 300mg Alphapharm is not addictive.

Before you take LAMIVUDINE 150mg + ZIDOVUDINE 300mg Alphapharm

When you must not take them

Do not take LAMIVUDINE 150mg + ZIDOVUDINE 300mg Alphapharm if you have an allergy
to:

any medicine containing lamivudine

any medicine containing zidovudine or

any of the ingredients listed at the end of this leaflet.

Symptoms of an allergic reaction may be mild or severe. They usually include some
or all of the following: wheezing, swelling of the lips/mouth, difficulty in breathing,
hay fever, lumpy rash (“hives”) or fainting.

Do not take LAMIVUDINE 150mg + ZIDOVUDINE 300mg Alphapharm if you are pregnant or
breastfeeding, unless your doctor says you should.

Your doctor should discuss with you the risks and benefits of using LAMIVUDINE 150mg
+ ZIDOVUDINE 300mg Alphapharm if you are pregnant or breast feeding.

Do not take LAMIVUDINE 150mg + ZIDOVUDINE 300mg Alphapharm if you have.

Kidney disease

Liver disease

Reduced red blood cell count (anaemia),

Reduced white blood cell count (neutropenia).

If you have certain conditions, you doctor may advise that you take a lower dose of
lamivudine and/or zidovudine, the active ingredients in LAMIVUDINE 150mg + ZIDOVUDINE
300mg Alphapharm.

Lamivudine and zidovudine are available as separate dosage forms. Ask your doctor
if you are not sure whether you should take LAMIVUDINE 150mg + ZIDOVUDINE 300mg Alphapharm.

Do not take LAMIVUDINE 150mg + ZIDOVUDINE 300mg Alphapharm after the expiry date (EXP)
printed on the pack.

If you take them after the expiry date has passed, it may not work as well.

Do not take LAMIVUDINE 150mg + ZIDOVUDINE 300mg Alphapharm if the packaging is torn
or shows signs of tampering.

If you’re not sure whether you should be taking LAMIVUDINE 150mg + ZIDOVUDINE 300mg
Alphapharm talk to your doctor.

Before you start to take them

You must tell your doctor if:

you are allergic to any other medicines, foods, preservatives or dyes.

You are taking or have taken any other medicines.

You have, or have ever had, hepatitis B infection.

You have, or ever had, liver problems.

When you stop taking LAMIVUDINE 150mg + ZIDOVUDINE 300mg Alphapharm

If you have a long-standing viral infection of your liver (hepatitis B) it may flare
up. This can cause serious illness particularly if your liver is already not working
very well. If you have both HIV and hepatitis B, when you stop taking your LAMIVUDINE
150mg + ZIDOVUDINE 300mg Alphapharm, your doctor is likely to arrange tests from time
to time to check how well your liver is working and to measure virus levels.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any
that you get without a prescription from a pharmacy, supermarket or health food shop.

If you take ribavirin and LAMIVUDINE 150mg + ZIDOVUDINE 300mg Alphapharm together
it may cause or worsen anaemia. Please contact your doctor if you notice symptoms
of anaemia (such as tiredness and shortness of breath). Your doctor will advise you
whether you should stop taking LAMIVUDINE 150mg + ZIDOVUDINE 300mg Alphapharm.

There is little information about the way other medicines might affect the way LAMIVUDINE
150mg + ZIDOVUDINE 300mg Alphapharm works, or how LAMIVUDINE 150mg + ZIDOVUDINE 300mg
Alphapharm affects other medicines. Particular care is needed when taking the painkiller,
paracetamol.

Your doctor or pharmacist will be able to tell you what to do when taking LAMIVUDINE
150mg + ZIDOVUDINE 300mg Alphapharm with other medicines.

Tell your doctor if you are taking any of the medicines below:

Ribavirin, paracetamol

Phenytoin, oxazepam, lorazepam.

Aspirin, codeine, morphine, methadone, rifampicin, indometacin, ketoprofen, naproxen,
cimetidine, clofibrate, probenecid.

Pentamidine, pyrimethamine, dapsone, atovaquone, amphotericin B (amphotericin), flucytosine,
ganciclovir, interferon, trimethoprim, sulfamethoxazole, clarithromycin.

Vincristine, vinblastine and doxorubicin.

Aciclovir, inosine pranobex, adriamycin, ciprofloxacin

Stavudine, zalcitabine or emtricibine

Sorbitol-containing medicines (usually liquids) used regularly.

LAMIVUDINE 150mg + ZIDOVUDINE 300mg Alphapharm should not be taken with stavudine
or zalcitabine

Use in children

LAMIVUDINE 150mg + ZIDOVUDINE 300mg Alphapharm is not recommended for use in children
under 12 years of age. Because it is a fixed dose combination tablet it cannot be
adjusted according to the size and weight of the patient.

How to take LAMIVUDINE 150mg + ZIDOVUDINE 300mg Alphapharm

Your doctor will tell you have many LAMIVUDINE 150mg + ZIDOVUDINE 300mg Alphapharm
to take and how often to take them. You will also find this information on the label
or your medicine.

Follow all directions given to you by your doctor or pharmacist carefully.

They may differ from the information contained in this leaflet.

If you do not understand the instructions on the box, ask your doctor or pharmacist
for help.

How much to take

The usual dosage of LAMIVUDINE 150mg + ZIDOVUDINE 300mg Alphapharm is one tablet twice
a day.

How to take them

Swallow the LAMIVUDINE 150mg + ZIDOVUDINE 300mg Alphapharm whole with a full glass
of water. Do not divide.

When to take them

Your doctor or pharmacist will be able to tell you when you should take your LAMIVUDINE
150mg + ZIDOVUDINE 300mg Alphapharm tablets.

How long to take them

Because your medicine helps to control your condition, but does not cure it, you will
need to take the tablets every day. Do not stop taking your medicine without first
talking to your doctor.

If you forget to take them

If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to. Otherwise, take it as soon as you remember, then go back
to taking it as you would normally.

Do not take a double dose to make up for the dose you missed.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13
11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you
think that you or anyone else may have taken too much LAMIVUDINE 150mg + ZIDOVUDINE
300mg Alphapharm. Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

Keep telephone numbers for these places handy.

If you are not sure what to do contact your doctor or pharmacist

While you are using LAMIVUDINE 150mg + ZIDOVUDINE 300mg Alphapharm

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking LAMIVUDINE 150mg + ZIDOVUDINE 300mg Alphapharm.

There is little information about the way other medicines might affect the way that
LAMIVUDINE 150mg + ZIDOVUDINE 300mg Alphapharm works. You must tell your doctor or
pharmacist that you are taking LAMIVUDINE 150mg + ZIDOVUDINE 300mg Alphapharm before
you start taking medicines you buy from a pharmacy, health food shop or supermarket.
This is especially important regarding medicines which might have an effect on the
kidneys, liver, red or white blood cells or other body cells.

Tell your doctor if you become pregnant or are trying to become pregnant.

Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed.

Otherwise, your doctor may think that it was not effective and change your treatment
unnecessarily.

Things you must not do

Do not stop taking LAMIVUDINE 150mg + ZIDOVUDINE 300mg Alphapharm or change the dosage
without checking with your doctor.

Do not give LAMIVUDINE 150mg + ZIDOVUDINE 300mg Alphapharm to anyone else, even if
they have the same condition as you.

Do not take LAMIVUDINE 150mg + ZIDOVUDINE 300mg Alphapharm to treat any other complaints
unless your doctor tells you to.

Do not give this medicine to children under 12 years of age. Because it is a fixed
dose combination tablet it cannot be adjusted according to the size and weight of
the patient.

Things to be careful of

Be careful driving or operating machinery until you know how LAMIVUDINE 150mg + ZIDOVUDINE
300mg Alphapharm affects you.

LAMIVUDINE 150mg + ZIDOVUDINE 300mg Alphapharm taken alone generally do not cause
any problems with your ability to drive a car or operate machinery. However, as with
many other medicines, LAMIVUDINE 150mg + ZIDOVUDINE 300mg Alphapharm may cause headache
and tiredness in some people.

Side effects

Check with your doctor or pharmacist as soon as possible if you do not feel well while
you are taking LAMIVUDINE 150mg + ZIDOVUDINE 300mg Alphapharm , even if you think
that the problems are not connected with the medicine or are not listed in this leaflet.

Like all medicines, LAMIVUDINE 150mg + ZIDOVUDINE 300mg Alphapharm can cause some
side effects. If they occur, they are most likely to be minor and temporary. However,
some may be serious and need medical attention.

The most serious side effects include:

Reduced red blood cell count (anaemia).

Reduced white blood cell count (neutropenia).

The frequency and severity of anaemia and neutropenia are greater in patients with
advanced HIV disease, or in patients who start taking LAMIVUDINE 150mg + ZIDOVUDINE
300mg Alphapharm in the later stages of HIV disease.

While you are taking LAMIVUDINE 150mg + ZIDOVUDINE 300mg Alphapharm , it is very important
that your doctor keeps a close check on your health and takes blood samples to monitor
levels of red and white blood cells. If you develop anaemia or neutropenia, your doctor
may reduce or stop the dose of LAMIVUDINE 150mg + ZIDOVUDINE 300mg Alphapharm , or
recommend standard treatment for these conditions. As your doctor any questions which
you may have.

It is not known whether many of these side effects are due to taking LAMIVUDINE 150mg
+ ZIDOVUDINE 300mg Alphapharm or taking LAMIVUDINE 150mg + ZIDOVUDINE 300mg Alphapharm
while taking other medicines. Some of these symptoms may occur as part of HIV infection,
AIDS and AIDS-related Complex.

The side effects listed below have been reported:

Body odour, sweating, chills, swelling of lips and/or tongue, flu-like symptoms, fever,
increased sensitivity to pain, back pain, enlarged glands, chest pain, weakness, weight
loss, generally feeling unwell, breast enlargement in male patients.

Widening of blood vessels, possibly leading to low blood pressure or feeling faint.

Constipation, difficulty in swallowing, gas from stomach or bowel, diarrhoea, bleeding
gums or nose, blood in stools, mouth ulcers, heartburn, vomiting, loss or reduction
in appetite, nausea.

Abdominal discomfort or pain.

Muscle aches or pains, muscle shaking or spasm or twitching, muscle disease.

Enlarged fatty liver, abnormal results of blood tests of liver function, inflammation
of the pancreas.

Confusion, depression, nervousness, fainting, loss of mental clarity, dizziness, seizures,
severe headache, sleeplessness, fatigue/tiredness.

Cough, sore throat, hay fever, sinus problems, hoarseness, change to perception of
taste.

Acne, itchiness, skin rash, changes in nail, skin or mouth colour.

Vision problems, hearing loss, sensitivity to light.

Passing too much urine, pain, difficulty or increased frequency of passing urine.

Reduction in all blood cells.

Increased bruising or bleeding.

Blood chemistry changes, with excess acidity of the blood.

Unusual feelings in any part of the body, such as numbness, burning, tingling or pins
and needles.

Hair loss.

Changes in fat distribution have been reported in association with combination antiretroviral
therapy. These may include:

Loss of body fat from areas such as legs, arms and face.

Increased fat appearing in areas such as abdomen (belly) and other internal organs,
breasts and the back of the neck.

Within the first few weeks of treatment with anti-HIV medicines, some people, particularly
those that have been HIV positive for some time, may development inflammatory reactions
(eg, pain, redness, swelling, high temperature) which may resemble an infection and
may be severe. It is thought that these reactions are caused by a recovery in the
body’s ability to fight infections, previously suppressed by HIV. If you become concerned
about any of the new symptoms, or any changes in your health after starting HIV treatment,
please discuss with your doctor immediately.

Ask your doctor or pharmacist to answer any questions you may have. If you experience
any of these side effects, and they concern you, see your doctor or pharmacist.

If you think you are having an allergic reaction to LAMIVUDINE 150mg + ZIDOVUDINE
300mg Alphapharm , TELL YOUR DOCTOR IMMEDIATELY or go to the nearest Accident and
Emergency department at your nearest hospital. Symptoms usually include some or all
of the following:

Wheezing

Swelling of the lips/mouth

Difficulty in breathing

Hay fever

Lumpy rash (“hives”)

Fainting

If you have any of the following symptoms soon after starting to take your medicine,
DO NOT TAKE ANY MORE LAMIVUDINE 150MG + ZIDOVUDINE 300MG ALPHAPHARM and tell your
doctor IMMEDIATELY or go to the nearest accident and emergency department at your
nearest hospital:

Severe stomach pain or cramps.

Nausea.

Vomiting.

These side effects may be due to a condition called pancreatitis.

If you are on medication for HIV and become very sick, with fast breathing, stop taking
LAMIVUDINE 150mg + ZIDOVUDINE 300mg Alphapharm and consult your doctor immediately.
You may have a condition known as “lactic acidosis”. The fast breathing is due to
high acid levels in the blood. Your liver may not be working properly and gets big
and fatty. This can be life threatening. This illness occurs more often in women than
men.

See your doctor if you feel generally unwell with a loss of appetite, nausea, vomiting,
itching, yellowness of the skin or eyes or dark coloured urine, or if the blood tests
of your liver function are abnormal. It is likely you will have to stop taking LAMIVUDINE
150mg + ZIDOVUDINE 300mg Alphapharm.

This is not a complete list of all possible side effects. Others may occur in some
people and there may be some side effects not yet known.

Side effects may depend on whether you take LAMIVUDINE 150mg + ZIDOVUDINE 300mg Alphapharm
alone, or also have taken other antiretroviral medication(s). Less is known about
possible side effects of taking LAMIVUDINE 150mg + ZIDOVUDINE 300mg Alphapharm with
other antiretrovirals.

Tell your doctor if you notice any else that is making you feel unwell, even if it
is on this list.

Ask your doctor or pharmacist if you don’t understand anything in this list.

Do not be alarmed by this list of possible side effects. You may not experience any
of them.

After using LAMIVUDINE 150mg + ZIDOVUDINE 300mg Alphapharm

Storage

Keep this medicine where children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.

Keep your tablets in a cool dry place where the temperature stays below 30°C.

Do not store LAMIVUDINE 150mg + ZIDOVUDINE 300mg Alphapharm or any other medicine
in the bathroom or near a sink. Do not leave it on a window sill or in the car.

Heat and dampness can destroy some medicines.

Keep your tablets in the bottle until it is time to take them.

If you take the tablets out of the bottle they may not keep well.

Disposal

If your doctor tells you to stop taking LAMIVUDINE 150mg + ZIDOVUDINE 300mg Alphapharm
or the expiry date has passed, ask your pharmacist what to do with any tablets left
over.

Product description

What it looks like

LAMIVUDINE 150mg + ZIDOVUDINE 300mg Alphapharm is a white to off-white, capsule shaped,
biconvex film coated tablet, debossed with “M” on left of the scoreline and “103”
on right, on one side and scored on the other side.

LAMIVUDINE 150mg + ZIDOVUDINE 300mg Alphapharm is supplied in 60 tablet bottles.

Ingredients

LAMIVUDINE 150 mg + ZIDOVUDINE 300 mg Alphapharm contains 150 mg of lamivudine and
300 mg of zidovudine as the active ingredient.

It also contains the following inactive ingredients:

Microcrystalline cellulose.

Sodium starch glycollate type A.

Magnesium stearate.

Colloidal anhydrous silica.

Propylene glycol (film coating).

Opadry Complete Film Coating System 03H58736 White (Proprietary Ingredient Number
106640).

This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo
dyes.

Supplier

LAMIVUDINE 150 mg + ZIDOVUDINE 300 mg Alphapharm is supplied in Australia by:

Alphapharm Pty Limited

Level 1, 30 The Bond

30-34 Hickson Road

Millers Point NSW 2000

www.mylan.com.au

 

Australian registration numbers:

LAMIVUDINE 150mg + ZIDOVUDINE 300mg Alphapharm bottle:

AUST R 167477

 

This leaflet was prepared in August 2019.

 

LAMIVUDINE 150mg + ZIDOVUDINE 300mg Alphapharm_cmiAug19/00

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