VIDEX 200MG GASTRO-RESISTANT CAPSULES

Active substance: DIDANOSINE

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Commodity No.: 1000007966
Commodity No.: 000-000-000
Core Spec. Ref.: 560x130 Folded
Core Spec. Ref.: Ref.
Pharma-Code No.: 257
Pharma-Code No.: No.
Cutter Outline/Varnish Free Area

Package leaflet: Information for the user

1000007966

Product:
Product: Videx 3x10 caps GB/IE ‘Variaiton 1B/96’
Product Name
Page No.: of 2 2 of 3 3 of 3
DCMF No.:
82677
No.
Page No.: 1 3
DCMF No.:
Proof No.: Proof SN
Date of Proof:
1st
Date
Proof No.: 6th
Date of Proof: 27.01.2015
Colour: Black
Colour: Pantone 412C Pantone 201C

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 appropriate didanosine formulations are available.
Warnings and precautions
Talk to your doctor or pharmacist before taking Videx.
• if you have or have had pancreatitis (inflammation of the pancreas), tell your doctor
immediately. 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.
• if you feel numbness, tingling and pain in the arms and the legs, tell your doctor.
This may be 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.
• if you have or have had problems with your kidneys, tell your doctor. This is
important because Videx is eliminated from your body through the kidneys and you
may need a reduced dose.
• if you have or have had a liver disease, especially chronic hepatitis B or C, tell
your doctor. 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.
• 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.
• do not stop taking Videx without your doctor's advice because your HIV infection
may get worse after stopping treatment.
Other medicines and Videx
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.
Videx with food and drink
Videx is not absorbed well if there is food in the stomach. Therefore, take Videx on an
empty stomach at least 2 hours before or 2 hours after a meal.
Pregnancy and breast-feeding
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 breastfeeding.
Driving and using machines
No effects on the ability to drive and use machines have been observed.
Videx capsules contain sodium.
125 mg capsules: Each capsule contains 0.53 mg sodium. Therefore, if you
controlled sodium diet, contact your doctor before taking this medicine.
200 mg capsules: Each capsule contains 0.85 mg sodium. Therefore, if you
controlled sodium diet, contact your doctor before taking this medicine.
250 mg capsules: Each capsule contains 1.0 mg sodium. Therefore, if you
controlled sodium diet, contact your doctor before taking this medicine.
400 mg capsules: Each capsule contains 1.7 mg sodium. Therefore, if you
controlled sodium diet, contact your doctor before taking this medicine.

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3. How to take Videx
• Always take this medicine exactly as your doctor has told you. Check with your
doctor or pharmacist if you are not sure. The capsules must be swallowed whole
with a full glass of water.
• Do not open or break Videx capsules.
• Take Videx capsules on an empty stomach at least 2 hours before or 2 hours after
a meal. Videx is not absorbed well if there is food in the stomach.
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, as follows:
Your body weight

Total Daily Dose

Less than 60 kg

250 mg, either once daily, or in two 125 mg doses
(taken approximately 12 hours apart).

60 kg or more

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 of your treatment (e.g. pancreatitis, renal impairment), your doctor may
prescribe a different dose.
Use in children
The dose for children older than 6 years 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. Videx capsules must not be taken by children under 6 years.
Other more appropriate formulations are available for children in this age group.
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.

1000007966_GI_BMS_Videx_GB-IE.indd 1

27.01.15 14:20

Product:
Product: Videx 3x10 caps GB/IE ‘Variaiton 1B/96’
Product Name
Page No.: of 2 2 of 3 3 of 3
DCMF No.:
82677
No.
Page No.: 2 3
DCMF No.:
1
Proof No.: Proof SN
Date of Proof:
1st
Date
Proof No.: 6th
Date of Proof: 27.01.2015
Colour: Black
Colour: Pantone 412C Pantone 201C

Commodity No.: 1000007966
Commodity No.: 000-000-000
Core Spec. Ref.: 560x130 Folded
Core Spec. Ref.: Ref.
Pharma-Code No.: 257
Pharma-Code No.: No.
Cutter Outline/Varnish Free Area

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 on an empty stomach at least 2 hours before or after 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 blister or carton
after EXP. The expiry date refers to the last day of that month.
Do not store Videx capsules above 25°C.
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.
6. Contents of the pack and other information
What Videx contains
125 mg capsules
• The active substance is didanosine. Each capsule contains 125 mg didanosine.
• The other ingredients are:
Capsule content: carmellose sodium, diethyl phthalate, 30% methacrylic acid
copolymer dispersion (EUDRAGIT L30D-55), sodium starch glycolate (Type A), talc
and sodium hydroxide.
Capsule shell: gelatin, sodium laurilsulfate and titanium dioxide (E171).
Capsule shell imprints (edible ink): shellac, propylene glycol, potassium hydroxide,
titanium dioxide (E171), yellow and red iron oxide (E172).
200 mg capsules
• The active substance is didanosine. Each capsule contains 200 mg didanosine.
• The other ingredients are:
Capsule content: carmellose sodium, diethyl phthalate, 30% methacrylic acid
copolymer dispersion (EUDRAGIT L30D-55), sodium starch glycolate (Type A), talc
and sodium hydroxide.
Capsule shell: gelatin, sodium laurilsulfate and titanium dioxide (E171).
Capsule shell imprints (edible ink): shellac, propylene glycol, FD&C Blue #2 Aluminium
Lake (E132), titanium dioxide (E171), yellow iron oxide (E172).
250 mg capsules
• The active substance is didanosine. Each capsule contains 250 mg didanosine.
• The other ingredients are:
Capsule content: carmellose sodium, diethyl phthalate, 30% methacrylic acid
copolymer dispersion (EUDRAGIT L30D-55), sodium starch glycolate (Type A), talc
and sodium hydroxide.
Capsule shell: gelatin, sodium laurilsulfate and titanium dioxide (E171).
Capsule shell imprints (edible ink): shellac, propylene glycol, FD&C Blue #2 Aluminium
Lake (E132).
400 mg capsules
• The active substance is didanosine. Each capsule contains 400 mg didanosine.
• The other ingredients are:
Capsule content: carmellose sodium, diethyl phthalate, 30% methacrylic acid
copolymer dispersion (EUDRAGIT L30D-55), sodium starch glycolate (Type A), talc
and sodium hydroxide.
Capsule shell: gelatin, sodium laurilsulfate and titanium dioxide (E171).
Capsule shell imprints (edible ink): shellac, propylene glycol, ammonium hydroxide,
simethicone, red iron oxide (E172).
What Videx looks like and contents of the pack
125 mg capsules
The gastro-resistant hard capsules are opaque white and embossed in tan with “BMS
125 mg” on one half and “6671” on the other half.
200 mg capsules
The gastro-resistant hard capsules are opaque white and embossed in green with “BMS
200 mg” on one half and “6672” on the other half.
250 mg capsules
The gastro-resistant hard capsules are opaque white and embossed in blue with “BMS
250 mg” on one half and “6673" on the other half.
400 mg capsules
The gastro-resistant hard capsules are opaque white and embossed in red with “BMS
400 mg” on one half and “6674” on the other half.
Videx gastro-resistant hard capsules are supplied in cartons containing 30 or 60 gastroresistant hard capsules (with 10 hard capsules per blister card).
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
United Kingdom
Product Licence Holder
Bristol-Myers Squibb Pharmaceuticals Ltd., Uxbridge Business Park, Sanderson Road,
Uxbridge, Middlesex UB8 1DH, England.
Tel: 0800 7311736
Ireland
Product Authorisation Holder
Bristol-Myers Squibb Pharmaceuticals Ltd, Swords, County Dublin, Ireland.
Tel: 1 800 749 749
Manufacturer
Bristol-Myers Squibb, S.r.l.
Contrada Fontana del Ceraso
03012 anagni – Frosinone
Italy
Aesica Queenborough Limited
North Road, Queenborough,
Kent, ME11 5EL
United Kingdom
This leaflet was last revised in December 2014.

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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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