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DIDANOSINE 250MG GASTRO-RESISTANT CAPSULES HARD

Active substance(s): DIDANOSINE

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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 lifethreatening 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.

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Didanosine

Package leaflet: Information for the user

Didanosine

Pharma code position may change as per customer requirement &additional
small pharma code may appear on the front / back panel

• 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:
Your body Weight

Total Daily Dose

more than 60 kg

400 mg, either once daily, or in two 200 mg
doses (taken approximately 12 hours apart).
250 mg, either once daily, or in two 125 mg
doses (taken approximately 12 hours apart).

less than 60 kg

* 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.

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

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.

Keep this medicine out of the sight and reach of children.

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.

Do not store above 30° C.
Blisters- Store in the original packaging.
Bottles- Store in the original container.

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.

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 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.

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.

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High levels of sugar, triglycerides and resistance to insulin may also occur.

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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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