Consumer Product Information
What is in this leaflet
Read this leaflet carefully before taking VIDEX EC capsules. This leaflet answers
some common questions about VIDEX EC.
It does not contain all the available information. Some of the information contained
in this leaflet may not apply to you.
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
VIDEX EC against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Always follow the instructions that your doctor or pharmacist give you about VIDEX
Keep this leaflet with the medicine. You may need to read it again.
What VIDEX EC is used for
VIDEX is a trade name (manufacturer's name) for the medicine, didanosine. VIDEX belongs
to a group of medicines called nucleoside (NUKE-lee-O-side) analogues. You may also
know didanosine as "ddI".
VIDEX is used to treat adults and children infected with the Human Immunodeficiency
VIDEX EC capsules are a different presentation of VIDEX. EC stands for 'enteric coated'.
The didanosine in the capsules has a special coating which prevents acid in the stomach
from destroying it. The enteric coat protects the beads of didanosine in the stomach,
and then release the didanosine in the small intestine where there is no acid, and
the didanosine can be absorbed.
What is HIV
HIV is a virus that kills important cells in the immune system over time (eg. CD4
cells). When enough of the immune cells have been killed by HIV, the body can become
prone to certain types of infections. Some infections are the cause of "AIDS-defining"
illnesses. This is when someone is said to have developed the Acquired Immunodeficiency
Syndrome or AIDS. AIDS is a serious condition and can lead to death.
How VIDEX EC works
When HIV infects cells in the immune system it takes over part of the cell's internal
workings and uses building blocks from the cell to produce new viruses.
The didanosine in VIDEX EC is a "pretend" building block called a nucleoside analogue.
When HIV infects a healthy cell it can pick up didanosine instead of the cell's real
building blocks stopping HIV from producing more viruses. Interfering with the production
of new viruses helps to reduce the total amount of HIV in the body and slows down
the damage to the immune system.
VIDEX EC is not a cure for HIV infection. Taking it will not necessarily prevent the
illnesses that commonly occur in people with HIV infection or AIDS. You can still
infect other people with HIV while you are taking this medicine.
It is not known how safe VIDEX EC is when it is used for long periods.
VIDEX EC is not addictive.
Your doctor may have prescribed VIDEX EC for another reason. Ask your doctor if you
have any questions about why VIDEX EC has been prescribed for you.
This medicine is available only with a doctor's prescription.
Before you take VIDEX EC capsules
It is important that you check the Information below before taking VIDEX EC.
When you must not take VIDEX EC
Do not take VIDEX EC capsules if you have an allergy to it or to any ingredients in
the formulation listed at the end of this leaflet.
Do not take VIDEX EC capsules with another nucleoside medicine called Zerit.
Do not take VIDEX EC capsules after the expiry date (EXP) printed on the pack. If
you take this medicine after the expiry date has passed, it may not work as well.
Do not use VIDEX EC capsules if the packaging is torn or shows signs of tampering.
Before you start to take VIDEX EC
Tell your doctor if:
1. you have allergies to:
other medicines from the nucleoside analogue group such as zidovudine (AZT)
any other medicines you have been given or purchased
substances such as foods, preservatives or dyes.
Symptoms of an allergic reaction may include:
swelling of the face, lips, tongue or throat which may cause difficulty in swallowing
or breathing, or
severe and sudden onset of pinkish, itchy swellings on the skin, also called hives.
2. you are pregnant or intend to become pregnant.
Experience is limited with the use of VIDEX EC in pregnant women. Therefore, it should
not be used during pregnancy unless it is clearly needed. If there is an urgent need
to consider VIDEX EC during pregnancy, your doctor will discuss with you the benefits
and risks of taking it.
3. you are breast-feeding or planning to breast-feed.
It is not known whether VIDEX EC passes into breast milk. Therefore to avoid possible
side effects in the nursing infant, mothers should stop breast-feeding if they are
taking VIDEX EC (breast-feeding can also transfer HIV to babies).
4. you currently experience or have experienced any medical conditions, especially:
pancreatitis, inflammation of the pancreas which may cause severe upper stomach pain,
often with nausea and vomiting
peripheral neuropathy, a condition which causes tingling, burning pain, or numbness
of the hands or feet
a history of taking neurotoxic medicines ie. medicines that have harmful effects on
the nervous system
liver problems including hepatitis, yellowing of the skin or eyes (jaundice) or prior
use of medicines toxic to the liver. Liver problems may cause higher levels of VIDEX
EC in the blood, increasing the chance of side effects
history of alcohol consumption and/or alcoholism
infections due to low white cell counts
anaemia, a condition in which there is a decreased number of red blood cells
eye problems such as retinitis
If you have not told your doctor about any of the above, tell them before you take
When VIDEX EC is taken with other medicines
Tell your doctor if you are taking other medicines, including vitamin supplements,
herbal preparations or any medicines you buy without a prescription from your pharmacy,
supermarket or health food shop.
It is very important that you do not take other medicines which might cause or worsen
peripheral nerve disease (peripheral neuropathy), or pancreatitis while taking VIDEX
EC. For example pentamidine may increase the risk of developing pancreatitis.
Other medicines may be affected by VIDEX EC, or may affect how well it works. You
may need to use different amounts of your medicine, take your medicines at different
times or you may need to take different medicines. Your doctor will advise you.
Your doctor or pharmacist may have more information on medicines to be careful with
or to avoid while taking VIDEX EC capsules.
How to take VIDEX EC Capsules
VIDEX EC should only be taken once daily. VIDEX EC has been prescribed for you because
your doctor believes that a once daily dosing schedule of didanosine (the active ingredient
in VIDEX EC) is right for you. The preferred dosing schedule of didanosine is twice
daily with VIDEX tablets or VIDEX Powder for Oral Solution.
VIDEX EC should be taken only when prescribed by your doctor. Follow all directions
given to you by your doctor or pharmacist carefully. They may differ from the information
contained in this leaflet.
How much to take
Your doctor will have prescribed the dose of VIDEX EC for you. The dose is related
to your body weight (and surface area for children).
The recommended starting doses for VIDEX are:
Adults greater than or equal to 60 kg in body weight: 400 mg of VIDEX EC, once a day.
Adults less than 60 kg in body weight: 250 mg of VIDEX EC, once a day.
For People with Peripheral Neuropathy:
If you develop peripheral neuropathy while taking VIDEX EC (eg. tingling, burning
pain or numbness in the hands or feet), your doctor may advise you to stop taking
VIDEX EC until the symptoms improve and may then place you back onto VIDEX EC at a
reduced dose. It is important to tell your doctor if you do develop peripheral neuropathy
and follow your doctor's instructions.
For People with Kidney or Liver Problems:
Your doctor may tell you to adjust your daily dosage of VIDEX EC if you have a kidney
or liver disorder.
How to take VIDEX EC
Videx EC capsules should be swallowed whole with a drink of water.
Take your dose of VIDEX EC on an empty stomach. Food interferes with the absorption
of VIDEX EC and should not be taken at the same time as VIDEX EC.
When to take VIDEX EC
Take VIDEX EC on an empty stomach.
You should take VIDEX EC at approximately the same time each day. It is taken as a
single dose once a day. Taking your capsules at the same time each day will have the
best effect. Creating a routine around the time you take VIDEX EC will help you to
not miss any doses.
For people with kidney failure being treated with haemodialysis, take VIDEX EC after
the haemodialysis session has finished. On days when you do not receive dialysis,
VIDEX EC should be taken at the same time of day as it is on days when you receive
How long to take VIDEX EC
VIDEX EC helps control your condition, but does not cure it. Therefore you must take
VIDEX EC every day as directed by your doctor. Continue taking capsules for as long
as your doctor tells you to. Do not stop taking it unless your doctor tells you to
- even if you feel better.
If you forget to take VIDEX EC
If it is almost time for your next dose, skip the dose you missed and take the next
dose when you are meant to.
Otherwise take it as soon as you remember, and then go back to taking it as you would
Do not take a double dose to make up for the dose you missed. This may increase the
chance of you getting an unwanted side effect. If you are not sure what to do, ask
your doctor or pharmacist.
If you have trouble remembering when to take the HIV medicines, ask your pharmacist
for some hints and inform your doctor if you have missed a dose. It is very important
not to miss your doses of VIDEX EC. If you miss doses the virus may become resistant
to your HIV medicines.
If you take too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre (telephone 131126
in Australia or 03 474 7000 in New Zealand), or go to the Accident and Emergency Centre
at your nearest hospital, if you or anyone else takes too much VIDEX EC. Do this even
if there are no signs of discomfort or poisoning.
While you are using VIDEX EC
Things you must do
If you become pregnant while taking VIDEX EC tell your doctor immediately. Pregnant
women have experienced serious side-effects when taking didanosine (the active ingredient
in VIDEX EC) in combination with ZERIT® (stavudine).
If you are about to start taking any new medicines, tell your doctor and pharmacist
that you are taking VIDEX EC. VIDEX EC may interfere with the new medicine you are
about to start.
If you are about to have any medical tests, tell your doctor that you are taking VIDEX
EC, VIDEX EC may interfere with the results of these tests.
If you plan to have surgery, tell your doctor or dentist that you are taking VIDEX
EC. You may wish to discuss disclosure issues with your doctor about who you think
should know you are taking VIDEX EC.
Make sure that you visit your doctor frequently for regular check-ups and medical
tests throughout your entire course of treatment with VIDEX EC. You should have your
kidney and liver functions and blood tested when your doctor advises on a regular
basis to ensure that the body chemistry is functioning normally and that VIDEX EC
Things you must not do
Do not give VIDEX EC to anyone else, even if they have the same condition as you.
Do not use VIDEX EC to treat any other complaints unless your doctor tells you to.
Do not stop taking VIDEX EC or lower the dosage without checking with your doctor.
Your doctor may gradually want to reduce the amount of VIDEX EC you are taking before
Things to be careful of
Be careful driving or operating machinery until you know how VIDEX EC affects you.
Some patients taking VIDEX EC have experienced dizziness. It is not known if this
was caused by VIDEX EC. Make sure you know how you react to VIDEX EC before you drive
a car, operate machinery or do anything else that could be dangerous if you are dizzy.
If you are taking other medicines that cause pancreatitis, you should avoid drinking
alcohol while taking VIDEX EC.
Things that may help
Things that may help general health are suggested below:
regular visits to your doctor to monitor your health
good oral hygiene.
HIV and/or drug therapy may cause dryness of the mouth which can lead to gum disease.
It is recommended that you see your dentist regularly to ensure good oral health.
Talk with your doctor about all of the above suggestions. You can also access further
information about HIV and services for people with HIV by contacting your local AIDS
Council, Positive Living Centre or People Living with HIV/AIDS (PLWH/A) organisation.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking VIDEX EC capsules. VIDEX EC helps most people with HIV infection, but it
may have unwanted side effects in a few people.
All medicines can have side effects. Sometimes they are serious, most of the time
they are not. You may need medical treatment if you get some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
If any of the following happen, stop taking VIDEX EC capsules and tell your doctor
immediately, or go to the Accident and Emergency Centre at your nearest hospital:
swelling of the face, lips, mouth or throat which may cause difficulty in swallowing
yellowing of the skin or eyes, also called jaundice.
These are very serious side effects. If you have them, you may have had a serious
allergic reaction to VIDEX EC. You may need urgent medical attention or hospitalisation.
Tell your doctor immediately, or go to the Accident and Emergency Centre at your nearest
hospital if you notice any of the following:
inflammation of the pancreas (pancreatitis) which may cause severe upper stomach pain,
often with nausea or vomiting. Pancreatitis is the major serious side effect of VIDEX
EC, which can be fatal in some people and must be treated immediately.
peripheral neuropathy which causes tingling, burning pain or numbness in the hands
gout, which causes painful swelling in the joints
changes in vision
limbs turning a bluish colour due to reduced blood circulation, associated with dizziness
and confusion (lactic acidosis)
enlarged liver which is tender to the touch (hepatomegaly).
These are serious side effects of VIDEX EC. You may need urgent medical attention.
Tell your doctor if you notice any of the following and they worry you:
dry mouth and/or dry eyes
Other side effects not listed above may also occur in some patients. Tell your doctor
if you notice anything else that is making you feel unwell.
Do not be alarmed by this list of possible side effects. You may not experience any
After using VIDEX EC
Keep your capsules in the bottle until it is time to take them. If you take the capsules
out of the bottle they may not keep as well.
Keep VIDEX EC capsules in a cool dry place where the temperature stays well below
Do not store VIDEX EC or any other medicines in the bathroom or near a sink. Do not
leave VIDEX EC in the car. Heat and dampness can destroy some medicines.
Keep VIDEX EC where children cannot reach it. A locked cupboard at least 1 1/2 metres
above the ground is a good place to store medicines.
If your doctor tells you to stop taking the capsules, or if they have passed their
expiry date, ask your pharmacist what to do with any that are left over.
Keep any unused medicine out of reach of children.
What VIDEX EC looks like
VIDEX EC capsules are hard, opaque, and white with printing on both sides.
VIDEX EC 125mg '6671' on one side and 'BMS/125 mg' on the other.
VIDEX EC 200mg '6672' on one side and 'BMS/200 mg' on the other.
VIDEX EC 250mg '6673' on one side and 'BMS/250 mg' on the other.
VIDEX EC 400mg '6674' on one side and 'BMS/400 mg' on the other.
VIDEX EC capsules are supplied as single bottles, each bottle contains 30 capsules.
VIDEX EC capsules contain:
methacrylic acid copolymer
sodium starch glycolate
sodium lauryl sulphate
Bristol-Myers Squibb Australia Pty Ltd,
4 Nexus Court, Mulgrave,
Victoria 3170, Australia
VIDEX EC 125mg AUST R 78351
VIDEX EC 200mg AUST R 78353
VIDEX EC 250mg AUST R 78355
VIDEX EC 400mg AUST R 78357
*VIDEX is a registered trademark of a Bristol-Myers Squibb Company.
Date of Preparation: March 2017
You need to consult your doctor regularly as your doctor has access to information
on any changes which may affect you. This information in no way replaces the advice
of your doctor or pharmacist.
AU_CMI_VidexEC_V6.0 March 2017.docx