Videx EC 200 mg gastro-resistant hard capsules
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
06-03-2018
Summary of Product characteristics
(SPC)
06-03-2018
Active ingredient:
Didanosine
Available from:
Bristol-Myers Squibb Pharmaceuticals uc
ATC code:
J05AF; J05AF02
INN (International Name):
Didanosine
Dosage:
200 milligram(s)
Pharmaceutical form:
Gastro-resistant capsule
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Nucleoside and nucleotide reverse transcriptase inhibitors; didanosine
Authorization status:
Marketed
Authorization date:
2000-09-15
Patient Information leaflet
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
VIDEX 125 MG GASTRO-RESISTANT HARD CAPSULES
VIDEX 200 MG GASTRO-RESISTANT HARD CAPSULES
VIDEX 250 MG GASTRO-RESISTANT HARD CAPSULES
VIDEX 400 MG GASTRO-RESISTANT HARD CAPSULES
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.
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 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
IF YOU ARE ALLERGIC to didanosine or any of the other ingredients of
this medicine (listed in
section 6).
CHILDREN YOUNGER THAN 6 YEARS: Videx gastro-resistant capsules must
not be taken by this age
group. Other more appropr
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Videx EC 200 mg gastro-resistant hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant hard capsule contains 200 mg of didanosine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant capsule, hard
Gastro-resistant capsules are opaque white and embossed in green with
"6672" on one half, and "BMS 200 mg" on the
other half.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Videx is indicated in combination with other antiretroviral drugs for
the treatment of HIV-1 infected patients only when
other antiretrovirals cannot be used.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Because didanosine absorption is reduced in the presence of food,
Videx gastro
-
resistant capsules must be
administered on an empty stomach (at least 2 hours before or 2 hours
after a meal) (see section 5.2).
POSOLOGY
Videx gastro-resistant capsules are administered on a once daily or a
twice daily regimen (see section 5.1).
The recommended total daily dose is based on patient body weight (kg):
for patients weighing at least 60 kg: 400 mg per day
for patients weighing less than 60 kg: 250 mg per day
The following table defines the administration schedule for all
strengths of the gastro-resistant capsules:
Patient Weight
Total Daily Dose
Corresponding Regimen
at least 60 kg
400 mg
1 capsule of 400 mg (once daily)
or
1 capsule of 200 mg (twice
daily)
less than 60 kg
250 mg
1 capsule of 250 mg (once daily)
or
1 capsule of 125 mg (twice
daily)
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