Patient leaflet - Zidovudine 100 mg capsules, hard

What Zidovudine is and what it is used for

The active ingredient in zidovudine capsules is zidovudine. Zidovudine is a type of medicine known as an anti-retroviral. It belongs to a group of medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs).

Zidovudine does not get rid of HIV infection; it reduces the amount of virus in your body, and keeps it at a low level. Zidovudine also increases the CD4 cell count in your blood. CD4 cells are a type of white blood cells that are important in helping your body to fight infection.

Zidovudine is used, in combination with other medicines (‘combination therapy’), to treat HIV in adults and children. To control your HIV infection, and to stop your illness getting worse, you must keep taking all your medicines.

If you are pregnant, your doctor may want you to take zidovudine, to help prevent you passing HIV on to your unborn baby. After the birth, your baby may be given zidovudine to help prevent it from getting infected with HIV.

HIV infection is spread by sexual contact with someone who has the infection, or by transfer of infected blood (for example, by sharing injection needles).

What you need to know before you take Zidovudine

Do not take Zidovudine Capsules, hard

•

if you are allergic to zidovudine or any other ingredients of this medicine (listed in Section 6)if you have a very low white blood cell count (neutropenia) or a very low red blood cell count (anaemia).

Zidovudine for new-born babies

Zidovudine must not be given to some new-born babies with liver problems, including:

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some cases of hyperbilirubinaemia (increased amounts in the blood of a substance called bilirubin which may make the skin appear yellow)

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other problems which cause high levels of liver enzymes in the blood.

Warnings and precautions

Talk to your doctor or pharmacist before taking zidovudine

Some people taking zidovudine or combination therapy for HIV are more at risk of serious side effects. You need to be aware of the extra risks:

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if you have ever had liver disease (including hepatitis B or C)

•

if you are seriously overweight (especially if you’re a woman)

Talk to your doctor if any of these applies to you. You may need extra check-ups, including blood tests, while you’re taking your medication. See Section 4 for more information.

Look out for important symptoms

Some people taking medicines for HIV infection develop other conditions, which can be serious. You need to know about important signs and symptoms to look out for while you’re taking zidovudine.

Please read the information in Section 4 of this leaflet. If you have any questions about this information or the advice given: Talk to your doctor.

Other medicines and Zidovudine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including herbal medicines or other medicines you bought without a prescription.

Remember to tell your doctor or pharmacist if you begin taking a new medicine while you’re taking zidovudine capsules.

Don’t take these medicines with Zidovudine

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stavudine, used to treat HIV infection

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ribavirin or injections of ganciclovir to treat viral infections

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rifampicin, which is an antibiotic.

Some medicines can make it more likely that you’ll have side effects, or make side effects worse

These include:

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sodium valproate, used to treat epilepsy

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aciclovir, ganciclovir or interferon, used to treat viral infections

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pyrimethamine, used to treat malaria and other parasitic infections

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dapsone, used to prevent pneumonia and treat skin infections

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fluconazole or flucytosine, used to treat fungal infections such as candida

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pentamidine or atovaquone, used to treat parasitic infections such as PCP

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amphotericin or co-trimoxazole, used to treat fungal and bacterial infections

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probenecid, used to treat gout and similar conditions, and given with some antibiotics to make them more effective

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methadone, used as a heroin substitute

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vincristine, vinblastine or doxorubicin, used to treat cancer.

Tell your doctor if you’re taking any of these.

Some medicines interact with Zidovudine

These include:

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clarithromycin, which is an antibiotic

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phenytoin, used for treating epilepsy.

Tell your doctor if you’re taking clarithromycin or phenytoin. Your doctor may need to monitor you while you’re taking zidovudine.

Pregnancy, breast-feeding and fertility

Pregnancy

If you are pregnant, if you become pregnant, or if you’re planning to become pregnant:

Talk to your doctor about the risks and benefits of taking Zidovudine.

If pregnant women who are HIV-positive take zidovudine, they are less likely to pass the HIV infection on to their unborn babies.

Zidovudine and similar medicines may cause side effects in unborn babies. If you have taken zidovudine during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child. In children whose mothers took NRTIs during pregnancy, the benefit from the protection against HIV outweighed the risk of side effects.

Breast-feeding

Breast-feeding is not recommended in women living with HIV, because HIV infection can be passed on to the baby in breast milk.

A small amount of the ingredients in zidovudine can also pass into your breast milk.

If you are breast-feeding, or thinking about breast-feeding, you should discuss it with your doctor as soon as possible.

Driving and using machines

Zidovudine can make you dizzy and have other side effects that make you less alert.

Don’t drive or operate machinery unless you’re feeling well.

You will need regular blood tests

For as long as you’re taking zidovudine your doctor will arrange regular blood tests to check for side effects. There’s more information about these side effects in Section 4 of this leaflet.

Stay in regular contact with your doctor

Zidovudine helps to control your condition, but it is not a cure for HIV infection. You need to keep taking it every day to stop your illness getting worse. You may still develop other infections and illnesses linked to HIV infection.

Keep in touch with your doctor, and don’t stop taking zidovudine without your doctor’s advice.

Protect other people

HIV infection is spread by sexual contact with someone who has the infection, or by transfer of infected blood (for example, by sharing injection needles). 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.

Zidovudine contains Sodium

This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.

How to take Zidovudine

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

Swallow the capsules whole, with some water.

Zidovudine is also available in other pharmaceutical formulations.

How much zidovudine will you need to take?

100 mg

Adults and adolescents weighing at least 30 kg:

The recommended dose zidovudine is 300 mg twice a day. Take each dose 12 hours apart.

250 mg

Adults and adolescents weighing at least 30 kg:

The recommended dose zidovudine is 250 mg twice a day. Take each dose 12 hours apart.

Use in children and adolescents

Your child can take zidovudine 100 mg capsules.

Children weighing more than 21 kg and less than 30 kg:

The recommended dose of zidovudine is two 100 mg capsules twice daily.

Children weighing at least 14 kg and less than or equal to 21 kg:

The recommended dose of zidovudine is one 100 mg capsule taken in the morning and two 100 mg capsules taken in the evening.

Children weighing at least 8 kg and less than 14 kg:

The recommended dose of zidovudine is one 100 mg capsule twice daily.

Capsules are not suitable for children weighing less than 8 kg.

Pregnancy, childbirth and newborn babies:

You should not normally take zidovudine during the first 14 weeks of your pregnancy. After week 14, the usual dose is 500 mg each day given as one 100 mg capsule five times per day until you start to go into labour. During the labour and birth, your doctor may give you injections of zidovudine, until your baby’s umbilical cord has been clamped. Your new-born baby may also be given zidovudine to help prevent it from getting infected with HIV.

People with kidney or liver problems: If you have severe kidney or liver problems, you may be given a lower dose of zidovudine, depending on how well your kidneys or liver are working. Follow your doctor’s advice.

If you take more zidovudine than you should

If you accidentally taking too much zidovudine is unlikely to cause any serious problems. The most common effects of taking too much zidovudine are tiredness, headaches and being sick (vomiting). If you feel unwell: Ask your doctor or pharmacist for advice.

If you forget to take zidovudine

If you forget to take a dose, don’t worry. You can take your next dose as soon as you remember but not within two hours of your next dose. If you remember within two hours of your next dose, just skip the dose you missed and take your next dose at the usual time. Then continue your treatment as before.

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

If you stop taking zidovudine

Take zidovudine for as long as your doctor recommends. Don’t stop unless your doctor advises you to.

If you have any further questions on the use of this medicine, ask your doctor, or pharmacist

Possible side effects

During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves. Your doctor will test for these changes.

Treatment with zidovudine often causes a loss of fat from legs, arms and face (lipoatrophy). This loss of body fat has been shown to be not fully reversible after discontinuation of zidovudine. Your doctor should monitor for signs of lipoatrophy. Tell your doctor if you notice any loss of fat from your legs, arms, and face. When these signs occur, zidovudine should be stopped and your HIV treatment changed.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects may show up in your blood tests, and may not appear until 4 to 6 weeks after you start taking zidovudine. If you get any of these effects, and if they are severe, your doctor may advise you to stop taking zidovudine.

As well as the effects listed below, other conditions can develop during combination therapy for HIV.

It is important to read the information in ‘Other possible side effects of combination therapy for HIV’.

Very common side effects

These may affect more than 1 in 10 people taking Zidovudine:

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headache

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feeling sick (nausea)

Common side effects

These may affect up to 1 in 10 people taking Zidovudine:

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being sick (vomiting)

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diarrhoea

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stomach pains

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feeling dizzy

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aching muscles

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generally feeling unwell

Common side effects that may show up in your blood tests are:

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a low red blood cell count (anaemia) or low white blood cell count (neutropenia or leucopenia)

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an increase in the level of liver enzymes

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an increased amount in the blood of bilirubin (a substance produced in the liver) which may make your skin appear yellow.

Uncommon side effects

These may affect up to 1 in 100 people taking Zidovudine:

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skin rash (red, raised or itchy skin)

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feeling breathless

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fever (high temperature)

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general aches and pains

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wind (flatulence)

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weakness

Uncommon side effects that may show up in your blood tests are:

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a decrease in the number of cells involved in blood clotting (thrombocytopenia), or in all kinds of blood cells (pancytopenia).

Rare side effects

These may affect up to 1 in 1000 people taking Zidovudine:

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lactic acidosis (excess lactic acid in the blood; see the next section, ‘Other possible side effects of combination therapy for HIV’)

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liver disorders, such as jaundice, enlarged liver or fatty liver

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inflammation of the pancreas

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chest pain; disease of the heart muscle

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fits (convulsions)

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feeling depressed or anxious; not being able to sleep (insomnia); not being able to concentrate; feeling drowsy

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indigestion; loss of appetite; taste disturbance

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changes in the colour of your nails, your skin, or the skin inside your mouth

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a flu-like feeling — chills, sweating and cough

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tingly feelings in the skin (pins and needles)

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passing urine more often

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enlarged breasts in men.

A rare side effect that may show up in your blood tests is:

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a decrease in the number of a type of red blood cell (pure red cell aplasia).

Very rare side effects

These may affect up to 1 in 10,000 people taking Zidovudine that may show up in your blood tests is:

•

a failure of the bone marrow to produce new blood cells (aplastic anaemia).

If you get any side effects

Talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Other possible side effects of combination therapy for HIV:

Some other conditions may develop during HIV treatment.

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.

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.

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.

Lactic acidosis is a rare but serious side effect

Some people taking zidovudine, 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:

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deep, rapid, difficult breathing

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drowsiness

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numbness or weakness in the limbs

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loss of appetite, weight loss

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feeling sick (nausea), being sick (vomiting)

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stomach pain.

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:

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if they have been taking combination therapy for a long time

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if they are also taking anti-inflammatory medicines called corticosteroids

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if they drink alcohol

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if their immune systems are very weak

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if they are overweight.

Signs of osteonecrosis include:

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stiffness in the joints

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aches and pains (especially in the hip, knee or shoulder)

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difficulty moving.

If you notice any of these symptoms:

Tell your doctor.

Other effects may show up in tests

Combination therapy for HIV can also cause:

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increased levels of lactic acid in the blood, which on rare occasions can lead to lactic acidosis

These effects may show up in the blood tests you’ll have while you’re taking zidovudine

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, Website: www.mhra.gov.uk/ yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

How to store Zidovudine

Keep out of the sight and reach 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.

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.

Contents of the pack and other 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 Authourisation Holder

Milpharm Limited,

Ares, Odyssey Business Park,

West End Road,

South Ruislip HA4 6QD,

United Kingdom.

Manufacturer