Zidovudine Accord 50 mg/5 ml oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Zidovudine Accord 50 mg/5 ml Oral solution EFG

Zidovudine

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Zidovudine Accord is and what it is used for.
2. What you need to know before taking Zidovudine Accord.
3. How to take Zidovudine Accord.
4. Possible side effects.
5. How to store Zidovudine Accord.
6. Contents of the pack and other information.

1. What Zidovudine Accord is and what it is used for

Zidovudine Accord 50 mg/5 ml Oral Solution is used to treat HIV (Human Immunodeficiency Virus) infection.

The active substance in Zidovudine Accord is zidovudine. Zidovudine belongs to a group of medicines called antiretrovirals. It belongs to a class of medicines known as nucleoside reverse transcriptase inhibitors (NRTIs).

Zidovudine does not eliminate 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 important for fighting infections.

Zidovudine is used in combination with other medicines (combination therapy) to treat HIV in adults and children. To control HIV infection and prevent the disease from worsening, you must take all your medicines as prescribed.

If you are pregnant, your doctor may prescribe Zidovudine to help prevent HIV from passing to the unborn baby. After birth, the baby may also need to take Zidovudine to prevent HIV infection.

HIV infection is transmitted through sexual contact with an infected person or through contact with infected blood (for example, by sharing injecting needles).

2. What you need to know before taking Zidovudina Accord

Do not take Zidovudina Accord:

• If you are allergic (hypersensitive) to zidovudine or to any of the other ingredients of this medicine (listed in section 6).
• If you have very low white blood cells (neutropenia) or very low red blood cells (anemia).

Zidovudine in newborns

Zidovudine must not be given to newborns with liver problems, including:

• Certain cases of hyperbilirubinemia (high levels in the blood of a substance called bilirubin that may cause yellowing of the skin).
• Other conditions causing high levels of liver enzymes in the blood.

Warnings and precautions

Some patients treated with zidovudine or combination treatments for HIV are at increased risk of serious adverse reactions.

You should be aware of these potential risks:

• Blood abnormalities (anemia, neutropenia, and leukopenia) may occur during treatment.
• Lactic acidosis associated with liver abnormalities may also occur.
• If you have ever had liver disease (including hepatitis B or C).
• If you are significantly overweight (especially if you are a woman)

Talk to your doctor if any of the above apply to you. You may need more frequent visits to your doctor, including additional blood tests while taking this medicine. See section 4 for more information.

Important symptoms to watch for

In some patients with HIV infection (AIDS), signs and symptoms, sometimes severe, may occur during treatment with Zidovudina Accord.

Please read the information in section 4 of this leaflet carefully. If you have any questions about this information, ask your doctor.

→ Consult your doctor.

Use of Zidovudina Accord with other medicines

Tell your doctor or pharmacist if you are using, or have recently used, any other medicines, including herbal medicines or those purchased without a prescription. Remember to inform your doctor or pharmacist if you start taking any new medicine during treatment with Zidovudina Accord.

Do not take the following medicines with Zidovudina Accord:

• Stavudine, used to treat HIV infection.
• Rifampicin, an antibiotic.
• Ribavirin or ganciclovir injections, used to treat infections.

Some medicines may increase your risk of adverse effects or make them worse, for example:

• Sodium valproate, used to treat epilepsy
• Aciclovir, ganciclovir or interferon, used to treat viral infections
• Pyrimethamine, used to treat malaria and other parasitic infections
• Dapsone, used to prevent pneumonia and treat skin infections
• Fluconazole or Flucytosine, used to treat fungal infections such as Candida
• Pentamidine or atovaquone, for parasitic infections such as Pneumocystis pneumonia (PCP)
• Amphotericin or cotrimoxazole, used to treat fungal or bacterial infections
• Probenecid, used to treat gout and similar conditions, and given with certain antibiotics to increase their effectiveness
• Methadone, used as a heroin substitute
• Vincristine, vinblastine or doxorubicin, used to treat cancer

Tell your doctor if you are taking any of these medicines.

Some of the medicines that interact with Zidovudina Accord include:

• Clarithromycin, an antibiotic
• Phenytoin, used to treat epilepsy

Tell your doctor if you are taking clarithromycin or phenytoin. Your doctor may need to monitor you while you are taking Zidovudina Accord.

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you might be pregnant, or plan to become pregnant, consult your doctor to discuss the benefits and risks of taking Zidovudina Accord.

HIV-positive pregnant women who take zidovudine are less likely to transmit HIV infection to their baby.

Zidovudine and similar medicines may cause adverse effects in the fetus. However, the benefit of reducing the risk of HIV infection outweighs the risk of adverse effects.

If you have taken Zidovudina Accord during pregnancy, your doctor may request more frequent visits to monitor your baby's development. These visits may include blood tests and other diagnostic procedures.

Breastfeeding

HIV-positive women must not breastfeed, because HIV infection can be passed to the baby through breast milk.

If you are breastfeeding, or planning to breastfeed, speak to your doctor immediately.

A small amount of the components of zidovudine may also pass into breast milk.

If you are breastfeeding, or planning to breastfeed,

Driving and use of machines:

Zidovudina Accord may affect your ability to drive and use machines, as it may cause dizziness and other adverse effects that could reduce your alertness.

Do not drive or operate tools or machinery unless you feel well.

You will need blood tests

During treatment with Zidovudina Accord, your doctor will request regular blood tests to check for adverse effects. For more information on adverse effects, see section 4 of this leaflet.

Keep regular contact with your doctor

Zidovudina Accord helps you control your condition but does not cure HIV infection. You will need to take it every day to prevent the disease from worsening. You may still develop other infections associated with HIV.

Stay in contact with your doctor and do not stop taking Zidovudina Accord without medical advice.

Protect others

HIV infection is transmitted through sexual contact with an infected person or through transfer of infected blood (e.g., by sharing needles). While taking this medicine, you may still transmit HIV to others, although effective antiretroviral treatment reduces the risk.

Ask your doctor what precautions are necessary to avoid infecting others.

Important information about some of the ingredients of Zidovudina Accord 50 mg/5 ml Oral Solution

This medicine contains hydrogenated glucose syrup (E-965). If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains glycerol. This medicine may cause headache, stomach discomfort, and diarrhea because it contains glycerol.

3. How to take zidovudine Accord

Follow exactly the dosing instructions for Zidovudine Accord provided by your doctor. If you have any doubts, consult your doctor or pharmacist again.

Zidovudine Accord 50 mg/5 ml Oral Solution is administered orally.

The package includes a 10 ml dosing syringe to facilitate administration.

To use Zidovudine Accord 50 mg/5 ml Oral Solution, follow these instructions:

1. Remove the cap from the bottle.
2. Insert the syringe into the adapter.
3. Invert the bottle.
4. Pull the plunger of the syringe outward until the correct volume is withdrawn.
5. Return the bottle to its upright position and remove the syringe from the adapter.
6. Close the bottle tightly with the cap.
7. Administer the dose.
8. Rinse the syringe with clean water.

Adults and adolescents weighing at least 30 kg:

The usual dose of Zidovudine is 25 ml (250 mg) or 30 ml (300 mg) twice daily. Take the doses 12 hours apart.

Children weighing between 9 and 30 kg:

Your doctor will determine the correct dose of Zidovudine for your child based on their weight. Your child may also take 100 mg zidovudine capsules.

The usual dose is 9 mg per kg of body weight twice daily. The maximum dose should not exceed 30 ml (300 mg) twice daily.

Children weighing between 4 and 9 kg:

Your doctor will determine the most appropriate dose for your child based on their weight. The usual dose is 12 mg per kg of body weight twice daily. If your baby cannot take medication orally, your doctor may prescribe injectable zidovudine.

Dosage during pregnancy and delivery:

Administration of Zidovudine Accord is not recommended in pregnant women with less than 14 weeks of gestation. After the fourteenth week, your doctor may prescribe 50 ml (500 mg) given as 10 ml (100 mg) five times daily until the onset of labor. During labor, your doctor may decide to use injectable Zidovudine Accord for infusion until the umbilical cord is clamped. Zidovudine Accord may also be administered to the newborn to prevent HIV infection.

Dosage in patients with hematological adverse reactions:

A dose reduction or interruption of treatment with Zidovudine Accord may be required in patients with reduced hemoglobin or neutrophil levels.

Dosage in elderly patients:

The dose will be adjusted in this patient group according to their general condition.

Dosage in patients with renal or hepatic impairment:

If you have severe kidney or liver problems, your doctor may decide to use a lower dose, depending on organ function. Follow your doctor's advice.

If you take more Zidovudine Accord than you should:

If you have taken more Zidovudine Accord 50 mg/5 ml Oral Solution than prescribed, contact your doctor, pharmacist, or the Toxicology Information Service immediately at telephone number 91 562 04 20.

Taking more Zidovudine Accord than prescribed is unlikely to cause harm, but if this occurs, you should inform your doctor as soon as possible. Symptoms of overdose may include fatigue, headache, and vomiting.

If you forget to take Zidovudine Accord 50 mg/5 ml Oral Solution:

Do not take a double dose to make up for a missed dose. Simply take the dose as soon as you remember, then continue your treatment as originally scheduled.

Do not stop taking Zidovudine Accord without medical advice:

Take Zidovudine Accord for as long as your doctor has instructed. Do not stop taking it unless your doctor advises you to do so.

4. Possible adverse effects

During HIV treatment, there may be an increase in weight and in blood glucose and lipid levels. This may be partly related to improved health, lifestyle, and, in the case of blood lipids, sometimes to the anti-HIV medications themselves. Your doctor will monitor these changes.

Treatment with zidovudine often causes loss of fat from the legs, arms, and face (lipoatrophy). This loss of body fat has been shown not to be completely reversible after stopping zidovudine. Your doctor should monitor for signs of lipoatrophy. If you notice any fat loss in your legs, arms, or face, inform your doctor. When these symptoms occur, zidovudine should be discontinued and your anti-HIV treatment changed.

Like all medicines, Zidovudina Accord 50 mg/5 ml oral solution can have adverse effects, although not everyone experiences them. Some adverse effects may only be detected in blood tests, and may not appear until 4–6 weeks after starting zidovudine. If you experience any of these adverse effects, and if they are severe, your doctor may advise you to stop taking zidovudine.

In addition to the effects described below, others may occur during combination anti-HIV treatment.

?It is important to read the information in “Other possible adverse effects of combination anti-HIV treatment”.

Very common adverse effects

May affect more than 1 in 10 people treated with zidovudine:

• Headache.
• Nausea.

Common adverse effects

May affect up to 1 in 10 people treated with zidovudine:

• Vomiting.
• Diarrhea.
• Stomach pain.
• Dizziness.
• Muscle pain.
• General feeling of being unwell.

Common adverse effects that may show up in blood tests include:

• Decrease in the number of red blood cells (anaemia) and white blood cells (leucopenia or neutropenia).
• Increased liver enzymes in the blood.
• Increased blood bilirubin (a substance produced in the liver), which may cause yellowing of the skin.

Uncommon adverse effects

May affect up to 1 in 100 people treated with zidovudine:

• Skin rash (redness, swelling, or itching of the skin).
• Difficulty breathing.
• Fever (high temperature).
• Generalised pain and fatigue.
• Flatulence.
• Weakness.

Uncommon adverse effects that may show up in blood tests include:

• Reduction in the number of blood cells involved in blood clotting (thrombocytopenia) or in all types of blood cells (pancytopenia).

Rare adverse effects

May affect up to 1 in 1,000 people treated with zidovudine:

• Lactic acidosis (excess lactic acid in the blood; see the next section, “Other possible adverse effects of combination anti-HIV treatment”).
• Liver problems, such as jaundice, enlarged liver, or fatty liver.
• Inflammation of the pancreas.
• Chest pain, heart disturbances.
• Seizures.
• Anxiety and depression, inability to sleep (insomnia), difficulty concentrating, drowsiness.
• Indigestion, loss of appetite, taste disturbances.
• Changes in nail, skin, or oral mucosa colouration.
• Flu-like syndrome: chills, sweating, and cough.
• Skin tingling sensation (as if being pricked by pins or needles).
• Frequent urination.
• Breast enlargement in men.

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

• Decrease in the number of a specific type of red blood cells (pure red cell aplasia).

Very rare adverse effects

May affect up to 1 in 10,000 people treated with zidovudine:

A very rare adverse effect that may show up in blood tests is:

• Bone marrow failure to produce new blood cells (aplastic anaemia).

If you experience any kind of adverse effect

? Consult your doctor or pharmacist. This includes any possible adverse effect not mentioned in this leaflet.

Other possible adverse effects of combination anti-HIV treatment

Other conditions may develop during anti-HIV treatment.

Opportunistic infections may flare up

Patients with advanced HIV infection (AIDS) have a weakened immune system and are more likely to develop serious infections (opportunistic infections). When these patients start treatment, previously hidden infections may flare up, causing signs and symptoms of inflammation. These symptoms are likely due to the immune system reacting to these infections.

In addition to opportunistic infections, autoimmune disorders (a condition in which the immune system attacks healthy body tissue) may also occur after starting anti-HIV medications. Autoimmune disorders may appear many months after treatment has started. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness starting in the hands and feet and moving upwards towards the trunk, palpitations, tremors, or hyperactivity, inform your doctor immediately to receive necessary treatment.

If you have any symptoms of infection during treatment with zidovudine:

? Inform your doctor immediately. Do not take other medicines without your doctor's advice.

Lactic acidosis is a rare but serious adverse effect

Some people taking zidovudine develop a condition called lactic acidosis, along with an enlarged liver. Lactic acidosis is caused by increased levels of lactic acid in the body. It is rare and, if it occurs, usually develops after a few months of treatment. It can be potentially fatal, causing failure of internal organs.

Lactic acidosis is more likely to occur in patients who have liver disease, or in obese individuals (particularly those with significant overweight), especially women.

Signs of lactic acidosis include:

• Difficulty breathing, rapid and deep breathing.
• Drowsiness.
• Numbness or weakness in the limbs.
• Loss of appetite, weight loss.
• Malaise (nausea) and vomiting.
• Stomach pain.

During treatment, your doctor will monitor for any signs indicating you may be developing lactic acidosis. If you have any of the symptoms listed above, or are concerned about any other symptom:

?Contact your doctor as soon as possible.

You may have bone problems

Some patients receiving combination anti-HIV treatment develop a bone disease called osteonecrosis. In this condition, part of the bone tissue dies due to reduced blood supply to the bone.

People are more likely to develop this condition if they:

• Have been on combination anti-HIV treatment for a long time.
• Also take anti-inflammatory medicines called corticosteroids.
• Drink alcohol.
• Have a severely weakened immune system.
• Are overweight.

Signs of osteonecrosis include:

• Joint stiffness.
• Pain (especially in the hip, knee, or shoulders).
• Difficulty moving.

IF YOU NOTICE ANY OF THESE SYMPTOMS:

? Inform your doctor.

Other effects that may appear in blood tests:

Combination anti-HIV treatment may also cause:

• Increased levels of lactic acid in the blood, which in rare cases may lead to lactic acidosis.

This effect may be detected in blood tests during treatment with Zidovudina.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Zidovudine Accord

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

Expiry

Do not use Zidovudine Accord 50 mg/5 ml Oral Solution after the expiry date stated on the container.

After opening, Zidovudine Accord 50 mg/5 ml Oral Solution remains stable for 28 days.

Do not store above 30 °C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If you have any questions, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Zidovudine Accord 50 mg/5 ml Oral Solution

The active substance is Zidovudine.

Each 5 ml of Zidovudine Accord 50 mg/5 ml Oral Solution contains 50 mg of Zidovudine.

The other components are: hydrogenated glucose syrup (E-965), glycerol (E-422), citric acid, sodium benzoate (E-211), sodium saccharin, strawberry flavour (Triacetin (E-1518), Triethyl citrate (E-1505)) and purified water.

Appearance of the product and contents of the container

Packed in 1 plastic bottle of 200 ml. The pack contains a 10 ml dosing syringe.

Clear, practically colourless or slightly yellow solution with a strawberry odour for oral administration.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Accord Healthcare S.L.U.

World Trade Center

Moll de Barcelona s/n, Edifici Est 6ª planta

08039 Barcelona.

Spain

Manufacturer:

Laboratorio Reig Jofré, S.A.

Gran Capità, 10

Sant Joan Despí – 08970 Barcelona

Spain

Date of the most recent revision of this leaflet: April 2022

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.es/