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VIDEX 25 MG CHEWABLE OR DISPERSIBLE TABLET

Active substance: DIDANOSINE

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Package leaflet: Information for the user

Videx 25 mg chewable/dispersible tablets

4352
1282168A3

Didanosine
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.
§ you have any further questions, ask your doctor or pharmacist.
If
§
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.
§ you get any side effects, talk to your doctor or pharmacist. This includes any
If
possible side effects not listed in this leaflet. See section 4.

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What is in this leaflet:
1. What Videx is and what it is used for
2. What you need to know before you take Videx
3. How to take Videx
4. Possible side effects
5. How to store Videx
6. Contents of the pack and other information

1. What Videx is and what it is used for
Videx is an antiviral (or antiretroviral) medicine, used to treat Human Immunodeficiency Virus
(HIV) infection. Videx belongs to a group of medicines called nucleoside reverse transcriptase
inhibitors (NRTIs). It is normally used in combination with other anti‑HIV medicines.
Videx is not a cure for HIV infection. You may continue to develop infections or other illnesses
linked to HIV infection. 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..

2. What you need to know before you take Videx
Videx will only be prescribed to you by a doctor with experience in medicines to treat HIV infection.

Do not take Videx

§ you are allergic to didanosine or any of the other ingredients of this medicine (listed in section 6).
if

Warnings and precautions

Talk to your doctor or pharmacist before taking Videx.
§ you have or have had pancreatitis (inflammation of the pancreas), tell your doctor immediately.
if
Symptoms such as stomach pain or abdominal pain might indicate the development of an
inflammation of the pancreas. It can become life-threatening if left untreated.
§ you feel numbness, tingling and pain in the arms and the legs, tell your doctor. This may be
if
a sign of toxic peripheral neuropathy.
§
taking Videx can cause retinal (eye) or optic nerve changes, on rare occasions. Your doctor
may decide to carry out a retinal examination yearly or if a change in vision occurs.
§
Videx belongs to a class of medicines (NRTIs) that can cause a sometimes fatal condition
called lactic acidosis (excess of lactic acid in your blood) and enlargement of the liver. Symptoms
such as nausea, vomiting and stomach pain might indicate the development of lactic acidosis.
This rare but serious side effect occurs more often in women, particularly if very overweight or in
patients with liver disease. Your doctor will monitor you regularly while you are receiving Videx.
§ you have or have had problems with your kidneys, tell your doctor. This is important because
if
Videx is eliminated from your body through the kidneys and you may need a reduced dose.
§ you have or have had a liver disease, especially chronic hepatitis B or C, tell your doctor.
if
Some people (including pregnant women) who have taken Videx have had serious liver problems.
These problems include hepatomegaly (liver enlargement), steatosis (fat in the liver), liver failure,
and portal hypertension (high blood pressure in the large vein of the liver). You may be at an
increased risk of severe and potentially fatal liver problems. In rare occasions, patients who have
not previously had liver problems can experience liver failure. Your doctor should check your liver
function while you are taking Videx. You should be especially careful if you have a history of heavy
alcohol use or liver problems.
§
signs and symptoms of inflammation from previous infections may occur soon after
anti-HIV treatment is started in some patients with advanced HIV infection (AIDS) and a history
of opportunistic infections. It is believed that these symptoms are due to an improvement in the
body’s immune response, enabling the body to fight infections that may have been present with
no obvious symptoms. If you notice any symptoms of infection, tell your doctor immediately. 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.
§
redistribution, accumulation or loss of body fat may occur in patients receiving antiretroviral
therapy. Contact your doctor if you notice changes in body fat.
§
some patients taking combination antiretroviral therapy may develop a bone disease
called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). The
length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe
immunosuppression, higher body mass index, among others, may be some of the many risk
factors for developing this disease. Signs of osteonecrosis are joint stiffness, aches and pains
(especially of the hip, knee and shoulder) and difficulty in movement. If you notice any of these
symptoms please inform your doctor.
 infants younger than 3 months: there is limited experience with the use of Videx in this age group.
§
interactions: it is not recommended to take Videx in combination with tenofovir disoproxil
fumarate, hydroxyurea, xanthine oxidase inhibitors (e.g. allopurinol) or ribavirin. This may increase
your risk of side effects.
§ not stop taking Videx without your doctor’s advice because your HIV infection may get
do
worse after stopping treatment.

Other medicines and Videx

60 kg or more

Total Daily Dose
250 mg, either once daily, or in two 125 mg doses (taken
approximately 12 hours apart).
400 mg, either once daily, or in two 200 mg doses (taken
approximately 12 hours apart).

Depending on the side effects you may develop and the diseases you are suffering from at the beginning

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Your body weight
Less than 60 kg

Product Code:
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Format/Dimension: 148 x 496 (148 x 38) mm
Tech. Drawing No.:

How much to take
Not all patients need to take the same dose of Videx. The usual dose for adults is based on your
body weight and is taken once daily or divided into two doses taken approximately 12 hours apart,
as follows. Each time you take a dose, you must take at least two but no more than four Videx tablets.

INS VIDEX TAB 25MG (1BTLX60)

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist
if you are not sure.
Adults must thoroughly chew the tablets or mix with at least 30 ml of water before taking. To mix
the tablets, stir the tablets in water until a uniform mixture forms and drink immediately. If additional
flavouring is desired, 30 ml of clear apple juice may be added to the water and Videx mixture. Videx
must be administered at least 30 minutes before a meal.

Product Name:

3. How to take Videx

Anagni
D’Andrea Laura

Videx tablets contain phenylalanine (from the aspartame) and sorbitol.
§
Videx tablets contain a source of phenylalanine. May be harmful for people with phenylketonuria.
§
Videx tablets contain sorbitol. If you have been told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking this medicine.

No

No effects on the ability to drive and use machines have been observed.

£

Driving and using machines

Yes /

If you are pregnant, think you may be pregnant or are planning to have a baby, tell your doctor to
discuss the benefits and risks of your antiretroviral therapy to you and your child. It is not known if
Videx is safe to use during pregnancy.
The combination of didanosine and stavudine in pregnant women increases the risk of lactic acidosis.
Breast-feeding is not recommended while taking Videx. Tell your doctor if you are breast-feeding.

S

Pregnancy and breast-feeding

GB

Videx is not absorbed well if there is food in the stomach. Therefore, take Videx at least 30 minutes
before a meal.

Live Text:
Country:

Videx with food and drink

Production Site:
CTM:

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines. It is especially important that you inform your doctor if you are already being treated with
ganciclovir or valganciclovir. Taking these medicines with Videx may increase the risk of side effects.
Taking Videx with tenofovir disoproxil fumarate, hydroxyurea, xanthine oxidase inhibitors (e.g.
allopurinol) or ribavirin is not recommended.
Taking Videx in combination with medicines that are known to cause peripheral neuropathy or
pancreatitis may increase the risk of these toxicities. If you take these medicines, your health will
need to be carefully monitored.
Medicines whose absorption is influenced by the stomach acid (e.g. itraconazole, ketoconazole)
must be taken at least 2 hours before taking Videx tablets.
Tetracycline and quinolone antibiotics are not to be taken within 2 hours after taking Videx tablets.
Phone contact: +39 0692708387
e-mail contact: artwork@grafimed.it
www.grafimed.it

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of your treatment (e.g. pancreatitis, renal impairment), your doctor may prescribe a different dose.

Use in children

The dose for children will be based on body surface area which the doctor will calculate. The
usual dose is between 120 and 360 mg a day, taken as a single dose, once daily or divided into two
doses taken approximately 12 hours apart. Each dose must be taken as at least two but no more
than four tablets for children older than 1 year and as only one tablet dose for children under 1 year.
The Videx tablets are not recommended for infants under 3 months.
Children (1 year of age or older) must thoroughly chew the tablets or mix with at least 30 ml of water
before taking. To mix the tablets, stir the tablets in water until a uniform mixture forms and drink
immediately. If additional flavouring is desired, 30 ml of clear apple juice may be added to the water
and Videx mixture. Children under 1 year of age, who take a one tablet dose, may chew or have the
tablet mixed in 15 ml of water. Fifteen ml of clear apple juice may be added to the Videx and water
mixture for flavouring. Videx must be administered at least 30 minutes before a meal.
If you take more Videx than you should
If you have taken more Videx than was prescribed by your doctor, or if someone accidentally takes
Videx, contact your doctor or the nearest hospital immediately.
If you forget to take Videx
It is important that you do not miss any doses. If you miss a dose of Videx, take it as soon as possible,
but at least 30 minutes before a meal, and then take your next scheduled dose at its regular time.
However, if it is almost time for your next dose, do not take the missed dose, but wait and take the
next dose at the regular time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Videx
Do not stop taking Videx before talking with your doctor. This is very important because the amount
of virus may start to increase if the medicine is stopped for even a short time. The virus may then
become harder to treat.
If you have any further questions on the use of this medicine, ask your doctor.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you feel stomach pain or abdominal pain. This may be due
to inflammation of the pancreas which can become life-threatening if left untreated (see Warnings
and precautions).
Tell your doctor if you notice any of the following side effects:
Very common side effects (These are likely to affect more than 1 in every 10 patients)
§
Digestive problems: diarrhoea
Common side effects (These are likely to affect between 1 to 10 in every 100 patients)
§
Liver problems: hepatitis (inflammation of the liver)
§
Nervous system: peripheral neurologic symptoms (numbness, weakness, tingling or pain in the
arms and the legs), headache
§
Digestive problems: nausea, vomiting, abdominal pain, flatulence (wind), dry mouth
§
Skin: rash
§
General: unusual tiredness or weakness, chills and fever, pain
§
Reproductive system and breast disorders: breast enlargement in males
§
Metabolism and nutrition: anorexia
§
Muscles and bones: muscle pain, joint pain
§
Tests may show: increased levels of uric acid, increased bilirubin, increased or abnormal levels
of some enzymes including liver enzymes in the blood
Uncommon side effects (These are likely to affect between 1 to 10 in every 1,000 patients)
§
Digestive problems: pancreatitis
§
Liver problems: excess of fat in the liver, liver failure
§
Metabolism and nutrition: lactic acidosis (excess of lactic acid in the blood), diabetes (starting
or getting worse), low or high blood sugar levels
§
Blood: low red blood cell count, low blood platelet count, lack of white blood cells
§
Muscles and bones: muscle tenderness or weakness, temporary paralysis or weakness of
muscles including kidney disease and haemodialysis
§
Eyes: dry eyes, changes in colour of the retina, disease of the nerves of the eyes causing
blindness
§
Infections: sore saliva glands
§
Immune system: sudden life threatening allergic reaction
§
Skin: alopecia (unusual hair loss or thinning)
Rare side effects (These are likely to affect between 1 to 10 in every 10,000 patients)
§
Liver problems: portal hypertension (high blood pressure in the large vein of the liver)
§
Muscles and bones: disease of the muscles
§
Digestive problems: parotid gland enlargement
Changes in body fat have been seen in some patients taking antiretroviral therapy. These
changes include increased amounts of fat in the upper back and neck (“buffalo hump”), breast, and
around the abdomen (“belly”). Loss of fat from the legs, arms and face may also happen. The cause
and long-term effects of these conditions are not known at this time.
High levels of sugar, triglycerides and resistance to insulin may also occur.
Side effects in paediatric patients are similar to those seen in adults. Higher blood cells count
abnormalities have been reported with the combination with zidovudine. Retinal or optic nerve
changes have been reported in a small number of paediatric patients, usually at doses above those
currently recommended. Your doctor may decide to carry out a retinal (eye) examination.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet.You can also report side effects directly (see details below). By reporting side
effects you can help provide more information on the safety of this medicine.
Ireland
HPRA Pharmacovigilance,
Earlsfort Terrace,
IRL Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
Email: medsafety@hpra.ie
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

5. How to store Videx
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle or carton after EXP. The
expiry date refers to the last day of that month.
Do not store Videx tablets above 30°C. Keep the bottle tightly closed in order to protect from
moisture.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.

S

Aesica Queenborough Limited
North Road, Queenborough,
Kent, ME11 5EL
United Kingdom
This leaflet was last revised in XXXX

1282168A3

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£

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Bristol-Myers Squibb, S.r.l.
Contrada Fontana del Ceraso
03012 anagni – Frosinone
Italy

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Manufacturer

Product Code:
1282168A3
Barcode Type:
(2/5: 4352)
Format/Dimension: 148 x 496 (148 x 38) mm
Tech. Drawing No.:

GB

Ireland
Product Authorisation Holder
Bristol-Myers Squibb Pharmaceuticals Ltd, Swords, County Dublin, Ireland.
Tel: 1 800 749 749

Black

United Kingdom
Product Licence Holder
Bristol-Myers Squibb Pharmaceuticals Ltd.,
Uxbridge Business Park, Sanderson Road,
Uxbridge, Middlesex UB8 1DH, England.
Tel: 0800 7311736

INS VIDEX TAB 25MG (1BTLX60)

Marketing Authorisation Holder and Manufacturer

Product Name:

Videx 25 mg chewable/dispersible tablets are supplied in bottles with child resistant closure
containing 60 chewable or dispersible tablets.

Live Text:
Country:

Production Site:
CTM:

What Videx looks like and contents of the pack
The chewable or dispersible tablets are white, imprinted with “25” on one side and “VIDEX” on the
other side.

Printing Colours:

§
The active substance is didanosine. Each tablet contains 25 mg didanosine.
§
The other ingredients are: calcium carbonate, magnesium hydroxide, aspartame, sorbitol,
microcrystalline cellulose, crospovidone, mandarin orange flavour (tangerine oil, mandarin oil,
gum arabic, alpha tocopherol, colloidal silica) and magnesium stearate.

Anagni
D’Andrea Laura

What Videx contains

Phone contact: +39 0692708387
e-mail contact: artwork@grafimed.it
www.grafimed.it

6. Contents of the pack and other information

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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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