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Videx (Didanosine)

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. Treatment with Videx has not been shown to reduce the risk of passing HIV to others through sexual contact or blood contamination. Therefore, you must continue to take appropriate precautions to avoid giving HIV to others.

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 (hypersensitive) to didanosine or any of the other ingredients of Videx.

Take special care with 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.

  1. 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.
  2. If you have or have had a liver disease, especially chronic hepatitis B or C, tell your doctor. 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.
  3. 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.
  4. 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.

Do not stop taking Videx without your doctor’s advice because your HIV infection may get worse after stopping treatment.

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. 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.

Taking Videx with food and drink

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

Pregnancy and breast-feeding

If you become pregnant or are planning to become pregnant, 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.

Driving and using machines

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

Important information about some of the ingredients of Videx

Videx tablets contain phenylalanine (aspartame). This 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.

How to take Videx

Always take Videx exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Adults and children (1 year of age or older) must thoroughtly 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. Videx tablets are not recommended for children under 3 months.

How much to take

Not all patients need to take the same dose of Videx. The usual starting dose for adults is as follows.

Each time you take a dose, you must take at least two Videx tablets.

Your weight Daily starting dose
Less than 60kg 250mg, either as a single daily dose, or two 125mg doses (taken approximately 12 hours apart).
60kg or more 400 mg a day, either as a single dose or 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.

The dose for children will be based on body surface area which the doctor will calculate. The usual starting dose is between 90 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 two tablets for children older than 1 year and as a one tablet dose for children under 1 year. The Videx tablets are not recommended for infants under 3 months.

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 product, ask your doctor.

Possible side effects

Like all medicines, Videx 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 Take special care with Videx).

Very common side effects (These are likely to affect more than 10 in every 100 patients)

Digestive problems: diarrhoea

Common side effects (These are likely to affect between 1 to 10 in every 100 patients)

  • Nervous system: peripheral neurologic symptoms (numbness, weakness, tingling or pain in the arms and the legs), headache
  • Digestive problems: nausea, vomiting, abdominal pain
  • Skin: rash
  • General: tiredness
  • Tests may show: increased levels of uric acid, increased bilirubin, increase in some liver enzymes, lack of white blood cells, low red blood cell count, low blood platelet count Uncommon side effects (These are likely to affect between 1 to 10 in every 1000 patients)
  • Digestive problems: pancreatitis
  • Reproductive system and breast disorders: breast enlargement in males Rare to very rare side effects (These are likely to affect less than 1 in every 1000 patients)
  • General: unusual tiredness or weakness, chills and fever, pain
  • Digestive problems: flatulence (wind), parotid gland enlargement, dry mouth
  • Metabolism and nutrition: lactic acidosis (excess of lactic acid in the blood), anorexia, diabetes (starting or getting worse), low or high blood sugar levels
  • Skin: alopecia (unusual hair loss or thinning)
  • Liver problems: excess of fat in the liver, inflammation of the liver, liver failure
  • Infections: sore saliva glands
  • Immune system: sudden life-threatening allergic reaction
  • Eyes: dry eyes, changes in colour of the retina, disease of the nerves of the eyes, causing blindness
  • Muscles and bones: aching muscles, muscle tenderness or weakness, temporary paralysis or weakness of muscles including kidney disease and hemodialysis, joint pain, disease of muscle
  • Tests may show: increased or abnormal levels of some enzymes in the blood 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.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store Videx

Keep out of the reach and sight of children.

Do not use Videx 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 container tightly closed in order to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information

What Videx contains

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.

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.

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

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