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 are on a controlled sodium diet, contact your doctor before taking this medicine.

200 mg capsules: Each capsule contains 0.85 mg sodium. Therefore, if you are on a controlled sodium diet, contact your doctor before taking this medicine.

250 mg capsules: Each capsule contains 1.0 mg sodium. Therefore, if you are on a controlled sodium diet, contact your doctor before taking this medicine.

400 mg capsules: Each capsule contains 1.7 mg sodium. Therefore, if you are on a controlled sodium diet, contact your doctor before taking this medicine.

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.

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