Zidovudine 100 Mg Capsules Hard
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PACKAGE LEAFLET: INFORMATION FOR THE USER
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.
!. BEFORE YOU TAKE ZIDOVUDINE
Do not take Zidovudine Capsules, hard
• ifyouare allergic (hypersensitive) to zidovudine or any other ingredients of Zidovudine capsules, hard.
• ifyouare anaemic (causing breathlessness on exertion or making you look pale) or have a low number of cells that fight infection (making you prone to infection).
• Zidovudine must not be given to some new-born babies with liver problems, 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
• Ifyourbone marrow is compromised, which increases the risk of bleeding, bruising or infections.
• ifyouhave liver or kidney problems.
• ifyouhave any physical signs of fat redistribution, accumulation or loss of body fat. 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.
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.
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.
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.
- Phenvtoin (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
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.
i. 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.
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.
Do not take a double dose to make up for a forgotten dose.
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.
. 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
• feelingsick (nausea)
Common (Affecting at least 1 of each 100 patients)
• anaemia, which may cause weakness and shortness of breath
• reducednumber of cells that fight infection, which can make you more prone to infection
• dizziness
• beingsick (vomiting)
• stomachpain and diarrhoea
• liverdisorders e.g. jaundice
• musclepain
• tiredness, generally feeling unwell
Uncommon (Affecting at least 1 of each 1,000 patients)
• reduction in blood platelets, which increases risk of bleeding or bruising
• difficultyin breathing
• trappedair in the stomach
• rashand itching
• painorweakness in muscle
• weakness, fever and generalised pain
Rare (Affecting at least 1 of each 10,000 patients)
• failureto develop red blood cells, which may cause tiredness or breathlessness
• lossofappetite and build up of lactic acid level in the body, that can cause dehydration and coma
• anxietyand depression
• sleeplessness (insomnia)
I Black
• pinsandneedles sensation, sleepiness, inability to concentrate and fits
• diseaseof the heart muscles (cardiomyopathy). Symptoms of this may include shortness of breath, swelling of your ankles or fluid in your lungs.
• cough
• changesin skin colour inside the mouth
• tastedisturbances
• indigestion
• inflammation of pancreas
• liverdisorders such as enlarged liver, fatty liver
• Nailandskin colour changes
• rash(red, raised or itchy)
• sweating
• increased need to urinate (pass water)
• enlarged breasts in male patients
• chestpain
• “flu-like”feeling
• chills
Very Rare (Affecting less than 1 out of 10,000 patients”)
• severereduction 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:
• Fatmaybe lost from the legs, arms or face.
• Extrafatmay build up around the tummy (abdomen), or on the breasts or internal organs.
• Fattylumps (sometimes called buffalo hump) may appear on the back of the neck. 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
• numbness or weakness in the limbs
• feelingsick (nausea), being sick (vomiting)
• stomachpain.
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:
• iftheyhave been taking combination therapy for a long time
• iftheyare also taking anti-inflammatory medicines called corticosteroids
• iftheydrink alcohol
• iftheirimmune systems are very weak
• iftheyare overweight.
Symptoms of osteonecrosis include:
• stiffnessin the joints
• achesand pains (especially in the hip, knee or shoulder)
• difficultymoving.
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.
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 ARROW 100 mg/250 mg, gelules
Spain ZIDOVUDINA AUROBINDO 100 mg/250 mg capsulas duras
United Kingdom Zidovudine 100 mg/250 mg capsules, hard
This leaflet was last revised in 01/2015.
i. 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.