ZIDOVUDINE 100 MG CAPSULES HARD

Active substance: ZIDOVUDINE

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Zidovudine 100 mg capsules, hard
Zidovudine 250 mg capsules, hard
Zidovudine
Read all of this leaflet carefully before you start taking this medicine.
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. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours.
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.
In this leaflet:
1. What Zidovudine is and what it is used for
2. Before you take Zidovudine
3. How to take Zidovudine
4. Possible side effects
5. How to store Zidovudine capsules, hard
6. Further information
1.

WHAT ZIDOVUDINE IS AND WHAT IT IS USED FOR

Zidovudine capsules, hard contains the active ingredient zidovudine, which belongs to a
group of medicines called antiretrovirals. It slows down the progression of human
immunodeficiency virus (HIV) infection, which can lead to Acquired Immune Deficiency
Syndrome (AIDS), in both adults and children.
Zidovudine is used in combination with other antiretrovirals, for the treatment of HIV
infected adults and children.
Zidovudine is used in HIV positive pregnant woman for preventing the transmission of
the virus from mother to child.
2.

BEFORE YOU TAKE ZIDOVUDINE

Do not take Zidovudine Capsules, hard
· allergic (hypersensitive) to zidovudine or any other ingredients of
if you are
Zidovudine capsules, hard.
· anaemic (causing breathlessness on exertion or making you look pale) or
if you are
have a low number of cells that fight infection (making you prone to infection).
· must not be given to some new-born babies with liver problems,
Zidovudine
including:
some cases of hyperbilirubinaemia (increased amounts in the blood of a
substance called bilirubin which may make the skin appear yellow)
other problems which cause high levels of liver enzymes in the blood.
Take special care with Zidovudine
·
If your bone marrow is compromised, which increases the risk of bleeding, bruising
or infections.
· liver or kidney problems.
if you have
· any physical signs of fat redistribution, accumulation or loss of body fat.
if you have
Please speak with your doctor if you have a history of liver disease. Patients with
chronic hepatitis B or C and treated with antiretroviral agents are at increased risk of
severe and potentially fatal liver adverse events and may require blood tests for
monitoring of liver function.

P150

Zidovudine
capsules, hard

P150

Zidovudine
capsules, hard

PACKAGE LEAFLET: INFORMATION FOR THE USER

pregnancy) to reduce the risk of transmitting HIV to their unborn child. If you are
prescribed zidovudine earlier than 14 weeks, your doctor will have weighed up the
expected benefits to you against any possible risks to your unborn baby.
Zidovudine is given to the woman up to and during labour and is stopped after delivery.
Note that while use of Zidovudine during pregnancy can reduce the chance that your
baby will get HIV; some may get it even with this treatment.
Breast-feeding
Ask your doctor or pharmacist for advice before using any medicine.
Zidovudine passes into breast milk, so it is recommended that mothers taking this
medicine do not breastfeed. Breastfeeding may also increase the risk of passing on the
HIV virus to the baby.
Driving and using machines
There is no data to suggest that zidovudine affects ability to drive or operate machinery.
Be careful driving or operating machinery until you know how treatment with zidovudine
affects you.
3.

HOW TO TAKE ZIDOVUDINE

Always take zidovudine exactly as your doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
Dosage in adults:
The usual total daily dose is 500 mg to 600 mg, taken in smaller doses two to three
times during the day.
Dosage in children:
3 months - 12 years:
The recommended dose is 360 to 480 mg/m2 per day in 3 or 4 divided doses. The
maximum dosage should not be more than 200 mg every 6 hours.
Dosage during pregnancy and delivery:
Zidovudine is not recommended to be given if you are less than 14 weeks through your
pregnancy. After the fourteenth week, your doctor may tell you to take 500 mg per day
until the beginning of your delivery.
Dosage adjustments in patients with blood related adverse reactions:
Your doctor will recommend an alternative treatment if you have low haemoglobin
concentrations or low number of white blood cells, and in the absence of alternative
treatment your doctor will reduce the dose or stop the treatment.
Dosage in the elderly:
Special care is advised in this age group and appropriate monitoring of patients before
and during use of zidovudine is advised.
Dosage in patient with kidney problems:
Your doctor may decide to use a lower dose of 300 mg to 400 mg per day in 3 to 4
divided doses, depending on how well your kidneys are working.
Dosage in hepatic impairment:
Your doctor will need to monitor for signs of intolerance and adjust the dose and/or
increase the interval between doses as appropriate.
If you take more zidovudine than you should
Accidentally taking too much zidovudine is unlikely to cause any serious problems.
However, you should tell your doctor or your pharmacist, or contact your nearest
hospital emergency department for further advice.

Remember that treatment with zidovudine does not reduce the risk of passing HIV on to
others by sexual contact or blood transfer. You should continue to use appropriate
precautions to prevent this.

If you forget to take zidovudine
It is important to take the total daily dose prescribed to ensure you get maximum
benefit. If you forget to take a dose of your medicine, take it as soon as you remember,
and then continue as before.

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

Do not take a double dose to make up for a forgotten dose.

An interaction means that medicines used at the same time can influence the effect(s)
and/or side effect(s) of each other. An interaction can occur during the use of zidovudine
with:
Rifampicin (an antibiotic used for several serious infections) and stavudine
(antiretroviral drug) may reduce the efficacy of zidovudine.
Lamivudine (antiretroviral drug) and Probenecid (used to treat gout) increases
absorption of zidovudine.
Phenytoin (used to treat epilepsy) blood concentrations may alter when
administered along with zidovudine.
Atovaquone (used to treat lung infections), valproic acid (used to treat seizure),
fluconazole (used especially to treat fungal infections) and methadone (used for
chronic pain management) increase the blood concentrations of zidovudine.
Systemic pentamidine (used to treat lung infections), dapsone (used to treat
leprosy), pyrimethamine (used in treatment of malaria), co-trimoxazole (an
antibiotic), amphotericin (used to treat serious fungus infections), flucytosine (used
to treat certain fungus infections), ganciclovir (used to treat infections caused by
viruses) may increase the risk of adverse effects of zidovudine.
Anticancer drugs such as interferon, vincristine, vinblastine and doxorubicine may
increase the risk of adverse effects of zidovudine.
Clarithromycin (antibacterial drug) reduce the absorption of zidovudine.
Please note that the above medicines may be known to you by other names, often the
brand names. In this section only the active ingredient or therapeutic group of the
medicine is given, and not the brand name. Always thoroughly check the pack and
information leaflet of the medicines you are already using for the active ingredient or
therapeutic group of that medicine.
Taking zidovudine with food and drink
Zidovudine may be taken with or without food.
Pregnancy and breast-feeding
Please see section 3 “How to take Zidovudine” under “Dosage during pregnancy and
breast-feeding”.
Pregnancy
Ask your doctor or pharmacist for advice before using any medicine.
Tell your doctor if you become pregnant or are trying to become pregnant, or you are
breastfeeding.
Zidovudine can be taken by HIV-positive pregnant women (after the first three months of

Black

If you stop taking zidovudine
Because your medicine controls and does not cure your condition, you will normally
need to take it continuously. You should not stop treatment unless your doctor tells you
to.
4.

POSSIBLE SIDE EFFECTS

Like all medicines, zidovudine can cause side effects, although not everybody gets
them.
The following side effects have been observed:
Very Common (Affecting at least 1 of each 10 patients)
·
headache
· (nausea)
feeling sick
Common (Affecting at least 1 of each 100 patients)
· which may cause weakness and shortness of breath
anaemia,
·number of cells that fight infection, which can make you more prone to
reduced
infection
·
dizziness
· (vomiting)
being sick
·pain and diarrhoea
stomach
·
liver disorders e.g. jaundice
·
muscle pain
· generally feeling unwell
tiredness,
Uncommon (Affecting at least 1 of each 1,000 patients)
· in blood platelets, which increases risk of bleeding or bruising
reduction
·in breathing
difficulty
· in the stomach
trapped air
· itching
rash and
·
pain or weakness in muscle
· fever and generalised pain
weakness,
Rare (Affecting at least 1 of each 10,000 patients)
· develop red blood cells, which may cause tiredness or breathlessness
failure to
·
loss of appetite and build up of lactic acid level in the body, that can cause
dehydration and coma
· depression
anxiety and
·
sleeplessness (insomnia)

·needles sensation, sleepiness, inability to concentrate and fits
pins and
· the heart muscles (cardiomyopathy). Symptoms of this may include
disease of
shortness of breath, swelling of your ankles or fluid in your lungs.
·
cough
·in skin colour inside the mouth
changes
·
taste disturbances
·
indigestion
·
inflammation of pancreas
·
liver disorders such as enlarged liver, fatty liver
·skin colour changes
Nail and
· raised or itchy)
rash (red,
·
sweating
· need to urinate (pass water)
increased
· breasts in male patients
enlarged
·
chest pain
·
“flu-like” feeling
·
chills
Very Rare (Affecting less than 1 out of 10,000 patients”)
·
severe reduction in blood cells which can cause weakness, bruising or make
infections more likely
Other possible side effects of combination therapy for HIV:
Old infections may flare up
People with advanced HIV infection (AIDS) have weak immune systems, and are more
likely to develop serious infections (opportunistic infections). When these people start
treatment, they may find that old, hidden infections flare up, causing signs and
symptoms of inflammation. These symptoms are probably caused by the body's
immune system becoming stronger, so that the body starts to fight these infections.
If you get any symptoms of infection while you're taking Zidovudine:
Tell your doctor immediately. Don't take other medicines for the infection without your
doctor's advice.
Your body shape may change
People taking combination therapy for HIV may find that their body shape changes,
because of changes in fat distribution:
·be lost from the legs, arms or face.
Fat may
·may build up around the tummy (abdomen), or on the breasts or internal
Extra fat
organs.
· (sometimes called buffalo hump) may appear on the back of the neck.
Fatty lumps
It is not yet known what causes these changes, or whether they have any long-term
effects on your health. If you notice changes in your body shape:
Tell your doctor.
Lactic acidosis is a rare but serious side effect
Some people taking Zidovudine, or other medicines like it (NRTIs), develop a condition
called lactic acidosis, together with an enlarged liver. Lactic acidosis is caused by a
build-up of lactic acid in the body. It is rare; if it happens, it usually develops after a few
months of treatment. It can be life-threatening, causing failure of internal organs.
Lactic acidosis is more likely to develop in people who have liver disease, or in obese
(very overweight) people, especially women.
Signs of lactic acidosis include:
·
deep, rapid, difficult breathing
·
drowsiness
· or weakness in the limbs
numbness
· (nausea), being sick (vomiting)
feeling sick
·pain.
stomach
During your treatment, your doctor will monitor you for signs of lactic acidosis. If you
have any of the symptoms listed above, or any other symptoms that worry you:
See your doctor as soon as possible.
You may have problems with your bones
Some people taking combination therapy for HIV develop a condition called
osteonecrosis. With this condition, parts of the bone tissue die because of reduced
blood supply to the bone.
People may be more likely to get this condition:
· been taking combination therapy for a long time
if they have
· also taking anti-inflammatory medicines called corticosteroids
if they are
· alcohol
if they drink
·
if their immune systems are very weak
· overweight.
if they are
Symptoms of osteonecrosis include:
·in the joints
stiffness
· pains (especially in the hip, knee or shoulder)
aches and
·moving.
difficulty
If you notice any of these symptoms:
Tell your doctor.
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.
5.

HOW TO STORE ZIDOVUDINE CAPSULES, HARD

Keep out of the reach and sight of children.
Do not use Zidovudine capsules, hard after the expiry date, which is stated on the
carton/label after EXP. The expiry date refers to the last day of that month.
Blisters- Store in the original packaging
Bottles- Store in the original container
Do not use Zidovudine capsules, hard if you notice visible signs of deterioration.
Medicines should not be disposed off via wastewater or household waste. Ask your
pharmacist how to dispose off medicines no longer required. These measures will help
to protect the environment.

6.

FURTHER INFORMATION

What Zidovudine capsules, hard contains
The active substance is zidovudine. Each capsule contains 100 mg/250 mg of
zidovudine.
The other ingredients are:
Capsule contents: Microcrystalline cellulose, starch pregelatinised (maize), sodium
starch glycolate (Type A) and magnesium stearate.
Capsule shell: Gelatin, titanium dioxide (E 171) and sodium lauryl sulfate.
Printing ink: Shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene
glycol, strong ammonia solution, black iron oxide (E172), potassium hydroxide and
purified water.
What Zidovudine capsules, hard looks like and contents of the pack
Capsule, hard.
Zidovudine 100 mg capsules, hard are white/white size '3' hard gelatin capsules filled
with white to off-white granular powder and imprinted with 'D' on white cap and '01' on
white body with black ink.
Zidovudine 250 mg capsules, hard are white/white size '0' hard gelatin capsules filled
with white to off-white granular powder and imprinted with 'D' on white cap and '73' on
white body with black ink.
Zidovudine 100 mg capsules, hard are available in blister packs of 60 (6 X 10), 100 (10
X 10) capsules and HDPE container containing 100 capsules.
Zidovudine 250 mg capsules, hard are available in blister packs of 40 (4 X 10), 60 (6 X
10) capsules and HDPE container containing 100 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Aurobindo Pharma Limited
Ares, Odyssey Business Park
West End Road
South Ruislip HA4 6QD
United Kingdom
Tel: ++ 44 20 8845 8811
Fax: ++ 44 20 8845 8795
Manufacturer
Milpharm Limited
Ares, Odyssey Business Park
West End Road
South Ruislip HA4 6QD
United Kingdom
or
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
This medicinal product is authorised in the Member States of the EEA under the
following names:
Germany
Zidovudin Aurobindo 100 mg/250 mg Hartkapseln
France
ZIDOVUDINE AUROBINDO 100 mg/250 mg, gélules
Spain
ZIDOVUDINA AUROBINDO 100 mg/250 mg cápsulas duras
United Kingdom Zidovudine 100 mg/250 mg capsules, hard
This leaflet was last approved in 04/2012.

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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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