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Package leaflet: Information for the user

Didanosine 200 mg gastro-resistant capsules, hard Didanosine 250 mg gastro-resistant capsules, hard Didanosine 400 mg gastro-resistant capsules, hard

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 Didanosine is and what it is used for

2.    What you need to know before you take Didanosine

3.    How to take Didanosine

4.    Possible side effects

5.    How to store Didanosine

6.    Contents of the pack and other information

1. What Didanosine is and what it is used for

Didanosine is a n antiviral (or antiretroviral) medicine, used to treat Human immunodeficiency virus (HIV) infection. Didanosine belongs to a class of drugs called nucleoside reverse transcriptase inhibitors (NRTIs). It is normally used in combination with other anti-HIV medicines.

Didanosine is not a cure for HIV infection.You may continue to 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 Didanosine

Do not take Didanosine

•    If you are allergic to didanosine or any of the other ingredients of this medicine (listed in section6).

•    Children youger than 6 years: Didanosine gastro-resistant capsules must not be taken in this age group. Other more appropriate didanosine formulations are available.

Warnings and precautions

Talk to your doctor pharmacist before taking Didanosine

•    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 Didanosine 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.

•    if you have, or have had problems with your kidneys, tell your doctor. This is important because Didanosine 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 Didanosine 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 Didanosine. You should be especially careful if you have a history of heavy alcohol use or liver problems.

•    The signs and symptoms of inflammation from previous infections may occur soon after the anti-HIV treatment 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 immune response enabling the body to fight infections that may have been present without 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 a 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 Didanosine in combination with tenofovir disoproxil fumarate, hydroxyurea, xanthine oxidase inhibitors (e.g. allopurinol) or ribavirin. This may increase your risk of side effects.

•    Didanosine 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 may indicate the development of lactic acidosis. This rare side effect occurs more often in women, particularly if very overweight patients with liver disease. Your doctor will monitor you regularly while you are receiving Didanosine.

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

Other medicines and Didanosine

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 Didanosine may increase the risk of side effects.

Taking Didanosine with tenofovir disoproxil fumarate, hydroxurea, xanthine oxidase inhibitors (e.g. allopurinol) or ribavirin is not recommended

Taking Didanosine in association with medicines 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.

Didanosine with food and drink

Didanosine is not absorbed well if there is food in the stomach. Therefore,take Didanosine on an empty stomach (at least 2 hours before or 2 hours after a meal).

Pregnancy and Breast-feeding

Ask your doctor or pharmacist for advice before taking this medicine.

If you are pregnant or planning a pregnancy, you should contact your doctor to discuss with him the benefit / risk of your antiretroviral therapy for you and your child. The safety of didanosine during pregnancy is not known.

The combination of didanosine and stavudine in pregnant women increases the risk of lactic acidosis.

Breast-feeding

It is not recommended to breast-feed while taking Didanosine. Tell your doctor if you are breast-feeding.

Driving and using machines

Didanosine has no effects on the ability to drive or use machines have been observed.

3. How to take Didanosine

Always take Didanosine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Didanosine Capsules should always be swallowed whole and washed down with a full glass of water.

Do not open or break Didanosine capsules.

Didanosine must be taken on an empty stomach, at least 2 hours before or 2 hours after a meal. Didanosine is not well absorbed if there is food in the stomach.

How much to take

Not all patients need to take the same dose of Didanosine. The usual dose for adults is based on your body weight, as follows:

The following table defines the administration schedule for all strengths of the gastro-resistant capsules: * 125 mg strength of Didanosine gastro-resistant capsules is not available. An alternative Didanosine formulation should be used.

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 and adolescents

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 125 mg and 360 mg a day, taken as a single dose once daily. Didanosine 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 Didanosine than you should

If you take more Didanosine Capsules than was prescribed by your doctor or if someone accidentally takes Didanosine, contact your doctor or nearest hospital immediately.

If you forget to take Didanosine

It's important not to miss any dose. If you forget to take a dose of Didanosine, take it as soon as possible, but on an empty stomach, at least 2 hours before or 2 hours after a meal, and then take the next dose at its regular time. However, 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 the forgotten dose.

If you stop taking Didanosine

Do not stop taking Didanosine 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 or pharmacist.

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 (may affect more than 1 in 10 people)

•    Digestive problems: Diarrhoea

Common: (may affect up to 1 in 10 people):

•    Liver problems: hepatitis (inflammation of the liver).

•    Nervous system: peripheral neurological symptoms (numbness, weakness, tingling or pain in the arms or and the legs), headache.

•    Digestive problems: nausea, vomiting and 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: increase levels of uric acid, increased bilirubin, increased abnormal levels of some including liver enzymes in the blood.

Uncommon: (may affect up to 1 in 100 people):

•    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: (may affect up to 1 in 1,000 people):

•    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 health 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/ yellowcard.By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Didanosine

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 label,carton and bottle after EXP. The expiry date refers to the last day of that month.

Do not store above 30° C.

Blisters- Store in the original packaging.

Bottles- Store in the original container.

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 Didanosine contains

-    The active substance is didanosine. Each capsule contains 200mg/250mg/400mg didanosine.

-    The other ingredients are sodium starch glycolate (Type A), carboxymethylcellulose sodium, sodium lauryl sulfate, hypromellose, talc, methacrylic acid - Ethyl Acrylate Copolymer (1:1) dispersion 30% (e.g. polysorbate 80), diethyl phthalate and colloidal anhydrous silica.

Capsule shell: Titanium Dioxide (E171), sodium lauryl sulfate, gelatin, colloidal anhydrous silica.

Capsule shell imprints (edible ink): Shellac, propylene glycol, black iron oxide (E172), potassium hydroxide.

What Didanosine looks like and contents of the pack

Didanosine 200 mg gastro-resistant hard capsule

White / White, size '1' hard gelatin capsules imprinted with 'D' on white cap and '69' on white body with black edible ink filled with white to off-white beadlets.

Didanosine 250 mg gastro-resistant hard capsule

White / White, size '0' hard gelatin capsules imprinted with 'D' on white cap and '10' on white body with black edible ink filled with white to off-white beadlets.

Didanosine 400 mg gastro-resistant hard capsule

White / White, size '00' hard gelatin capsules imprinted with 'D' on white

cap and '09' on white body with black edible ink filled with white to off-white

beadlets.

Dianosine gastro-resistant hard capsules are available in Polyamide/ Aluminium/ PVC/ Paper/ Polyester/ Aluminium blister packs or HDPE bottle packs.

Pack size:

Blister pack: 30 and 60 capsules Bottle pack: 30 and 500 capsules

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Milpharm Limited

Ares Block, Odyssey Business Park West End Road Ruislip HA4 6QD United Kingdom

Manufacturer

APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta

or

Milpharm Limited

Ares Block, Odyssey Business Park West End Road Ruislip HA4 6QD United Kingdom

This leaflet was last approved in 04/2016.

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