Package Insert: Information for the User

Zidovudine Accord 50 mg/5 ml Oral Solution

Zidovudine

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

The active ingredient of Zidovudina Accord is zidovudine. Zidovudine belongs to a group of medicines called antiretrovirals. It belongs to a group of medicines known asInhibitors of reverse transcriptase (RTIs).

Zidovudine does not eliminate the HIV infection. It reduces the amount of virus in your body and keeps it at a low level. Zidovudine also increases the count of CD4 cells in the blood. CD4 cells are a type of white blood cells important for fighting infections

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

If you are pregnant, your doctor may prescribe Zidovudine to help prevent the HIV virus from passing to the fetus. After birth, it may be possible for the baby to also take Zidovudine to prevent infection with the HIV virus.

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

Do not takezidovudine Accord:

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

Zidovudine for newborns

Zidovudine should not be administered to newborns with liver problems, including:

• Some cases of hyperbilirubinemia (high levels of a substance called bilirubin in the blood that can cause yellow discoloration of the skin).
• Other problems that cause high levels of liver enzymes in the blood.

Warnings and precautions

Some patients treated with zidovudine or combined antiretroviral therapy for HIV have a higher risk of experiencing severe adverse reactions.

You should be aware of these possible risks:

• During treatment, you may experience blood abnormalities (anemia, neutropenia, and leucopenia).
• You may also experience lactic acidosis associated with liver abnormalities.
• If you have ever suffered from liver diseases (including hepatitis B or C).
• If you have significant obesity (especially if you are a woman).

Speak with your doctor if you are affected by any of the above cases. You may need more doctor visits, even more blood tests while taking the medication.See section 4 for more information.

Important symptoms to be aware of

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

Read section 4 of this prospectus carefully, if you have any questions about this informationask your doctor.

→ Consult your doctor.

Use of Zidovudine Accord with other medications

Inform yourdoctor or pharmacist if you are using, or have recently used, any other medication, including herbal medications or those acquired without a prescription. Remember to inform your doctor or pharmacist if you start taking any new medication during treatment with Zidovudine Accord.

Do not take these medications with Zidovudine Accord:

• Stavudine,to treat HIV infection.
• Rifampicinwhich is an antibiotic.
• Ribavirin or ganciclovir injections, to treat infections.

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

• Valproate sodium, used to treatepilepsy
• Aciclovir, ganciclovir, or interferon, used to treatviral infections
• Pirimethamine, used to treatmalariaand other parasitic infections
• Dapsoneused to preventpneumoniaand treat skin infections
• Fluconazole or Flucitosineused to treat fungal infections such asCandida
• Pentamidine oratovaquonefor parasitic infections such asPCP(Pneumocystis) pneumonia
• Anfotericin or cotrimoxazoleused to treat fungal or bacterial infections
• Probenecidused to treatgoutand similar conditions, and administered with some antibiotics to make them more effective
• Methadone, used as aheroin substitute
• Vincristine, vinblastine, or doxorubicinused totreating cancer

Inform your doctorif you are taking any of these medications.

Some of the medications that interact with Zidovudine Accord are:

• Clarithromycin, an antibiotic
• Phenytoin, used to treatepilepsy

Inform your doctorif you are taking clarithromycin or phenytoin. Your doctor may need to monitor you while taking Zidovudine Accord.

Pregnancy, breastfeeding, and fertility

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

Women with HIV who take zidovudine have a lower risk of transmitting the virus to their baby.

Zidovudine and similar medications may cause adverse effects in the fetus. However, the benefit of reducing the risk of HIV transmission is greater than the risk of adverse effects.

If you have taken Zidovudine Accord during your pregnancy, your doctor may request that you visit more frequently to monitor your child's development. These visits may include blood tests and other diagnostic tests.

Breastfeeding

Women with HIV should not breastfeed, as the virus can be transmitted to the baby through breast milk.

If you are breastfeeding, or plan to breastfeedtalk to your doctor immediately.

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

If you are breastfeeding, or plan to breastfeed

Driving and using machines:

Zidovudine Accord may affect your ability to drive and use machines, as it may cause dizziness and other adverse effects that may make you less alert.

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

You will need blood tests

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

Regular contact with your doctor

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

Stay in contact with your doctor and do not stop taking Zidovudine Accordwithout consulting your doctor.

Protect others

HIV infection is transmitted by having sexual contact with someone who has the infection or by blood transfer (for example, by sharing needles). While taking this medication, you may still transmit HIV to others, although effective antiretroviral treatment reduces the risk.

Consult your doctor about the precautions you need to take to avoid infecting others.

Important information about some of the components of Zidovudine Accord 50 mg/5 ml Oral Solution

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

This medication contains glycerol. This medication may cause headaches, stomach discomfort, and diarrhea because it contains glycerol.

Follow exactly the administration instructions for Zidovudina Accord as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

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

To use Zidovudina Accord 50 mg/5 ml Oral Solution, you must follow the following instructions:

1. Remove the cap from the bottle.
2. Insert the syringe into the adapter.
3. Place the bottle in an inverted position.
4. Pull the syringe plunger out until the correct volume is removed.
5. Place the bottle in its original position and remove the syringe from the adapter.
6. Close the bottle tightly with the cap.
7. Administer the dose.
8. Flush the syringe with clean water.

Adults and adolescents weighing at least 30 kg:

The normal dose of Zidovudina is 25 ml (250 mg) or 30 ml (300 mg) twice a day. Take the doses with a 12-hour interval.

Children weighing between 9 and 30 kg:

Your doctor will decide on the correct dose of Zidovudina for your child based on their weight. Your child may also take 100 mg zidovudina capsules.

The normal dose is 9 mg per kg of weight twice a day. The maximum dose should not exceed 30 ml (300 mg) twice a day.

Children weighing between 4 and 9 kg:

Your doctor will decide on the most suitable dose for your child based on their weight. The normal dose is 12 mg per kg of weight twice a day. If your baby cannot take medication orally, your doctor may prescribe injectable zidovudina.

Posology during pregnancy and childbirth:

Zidovudina Accord is not recommended for pregnant women with less than 14 weeks of pregnancy. After the 14th week, your doctor may prescribe 50ml (500 mg) administered as 10 ml (100 mg) five times a day until the onset of labor. During labor, your doctor may decide to use Zidovudina Accord injectable solution for infusion until the umbilical cord is cut. It is possible that Zidovudina Accord will also be administered to the newborn to prevent HIV infection.

Posology in patients with hematological adverse reactions:

A dose reduction or interruption of treatment with Zidovudina Accord may be necessary in patients with decreased hemoglobin or neutrophil levels.

Posology in elderly patients:

The dose will be adjusted in this group of patients based on their general condition.

Posology in patients with renal or hepatic problems:

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

If you take more Zidovudina Accord than you should:

If you have taken more Zidovudina Accord 50 mg/5 ml Oral Solution than you should, consult your doctor or pharmacist immediately or the Toxicology Information Service, telephone 91 562 04 20.

If you take a dose greater than prescribed by your doctor, it is unlikely to cause any harm, but if this occurs, you should inform your doctor as soon as possible. The effects of taking too much Zidovudina Accord may be fatigue, headache, and vomiting.

If you forgot to take Zidovudina Accord 50 mg/5 ml Oral Solution:

Do not take a double dose to compensate for the missed doses. Simply take another dose as soon as you remember and then continue your treatment as originally planned.

Do not stop taking Zidovudina Accord without medical advice

Take Zidovudina Accord for the time your doctor has indicated. Do not stop taking it unless your doctor recommends it.

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

Treatment with zidovudine often causes a 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 signs of lipoatrophy. If you notice any loss of fat in your legs, arms, and face, inform your doctor. When these symptoms occur, zidovudine should be stopped and the HIV treatment changed.

Like all medicines, Zidovudine Accord 50 mg/5 ml Oral Solution may cause side effects, although not everyone will experience them. Some side effects may be reflected in your blood tests, and may not appear until 4-6 weeks after starting zidovudine. If you experience any of these side effects, and if they are severe, your doctor may advise you to stop taking zidovudine.

Aside from the side effects described below, others may occur during combined HIV treatment.

?It is important to read the information on “Other possible side effects of combined HIV treatment”.

Frequent side effects

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

• Headache.
• Nausea.

Common side effects

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

• Vomiting.
• Diarrhea.
• Abdominal pain.
• Dizziness.
• Muscle pain.
• General feeling of discomfort.

Frequent side effects that may be shown in blood tests are:

• Decrease in the number of red blood cells (anemia) and white blood cells (leucopenia or neutropenia).
• Increased levels of liver enzymes in the blood.
• Increased bilirubin (a substance produced in the liver) in the blood that may give a yellowish color to the skin.

Uncommon side effects

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

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

Uncommon side effects that may be shown in blood tests are:

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

Rare side effects

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

• Lactic acidosis (excess lactic acid in the blood; see the section below, “Other possible side effects of combined HIV treatment”).
• Alterations in the liver, for example jaundice, liver enlargement, and fatty liver.
• Pancreatitis.
• Chest pain, cardiac alterations.
• Seizures.
• Anxiety and depression, insomnia, lack of concentration, drowsiness.
• Indigestion, loss of appetite, alteration of taste.
• Changes in the color of the nails, skin, or mucous membranes of the mouth.
• Flu-like syndrome: chills, sweating, and cough.
• Sensation of pins and needles in the skin.
• Frequent urination.
• Enlargement of the breasts in men.

A rare side effect that may be shown in blood tests is:

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

Very rare side effects

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

A rare side effect that may be shown in blood tests is:

• Failure of the bone marrow to produce new blood cells (aplastic anemia).

If you experience any type of side effect

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

Other possible side effects of combined HIV treatment

Other processes may develop during HIV treatment.

Infections may recur

Patients with advanced HIV infection (AIDS) have a weakened immune system and are more likely to develop serious infections (opportunistic infections). When these people start treatment, they may find that old infections that were hidden reappear, causing signs and symptoms of inflammation. These symptoms are probably caused by the immune system reacting to these infections.

Aside from opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also appear after you have started taking medications for your HIV infection. Autoimmune disorders may appear many months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness starting in the hands and feet and ascending to the trunk of the body, palpitations, tremors, or hyperactivity, inform your doctor immediately to receive the necessary treatment.

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

?Inform your doctor immediately. Do not take other medications without consulting your doctor.

Lactic acidosis is a rare but serious side effect

Some people taking zidovudine develop a condition called lactic acidosis, along with liver enlargement. Lactic acidosis is due to an increase in lactic acid levels in the body. It is rare and usually develops after a few months of treatment. It can be potentially fatal, causing failure of internal organs.

Lactic acidosis is more likely to develop in patients with liver disease, or in obese people (with significant overweight), especially women.

The signs of lactic acidosis include:

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

During treatment, your doctor will monitor any sign that may indicate you are developing lactic acidosis. If you have any of the symptoms mentioned above, or if you are concerned about any other symptom:

?Visit your doctor as soon as possible..

You may have bone problems

Some patients receiving combined HIV treatment develop a bone disease calledosteonecrosis. With this disease, part of the bone tissue dies due to a reduction in blood supply to the bone.

People are more likely to suffer from this disease:

• If they have been taking combined treatment for a long time.
• If they also take anti-inflammatory medications called corticosteroids.
• If they drink alcohol.
• If their immune system is severely weakened.
• If they are overweight.

The 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 the tests:

Combined 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 shown in blood tests during treatment with Zidovudine.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not mentioned in this leaflet. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Expiration Date

Do not use Zidovudina Accord 50 mg/5 ml Oral Solution after the expiration date indicated on the packaging.

Once the packaging is opened, Zidovudina Accord 50 mg/5 ml Oral Solution remains stable for 28 days.

Do not store at a temperature above30 °C.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Zidovudina Accord 50 mg/5 ml Oral Solution

The active ingredient is Zidovudina.

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

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

Appearance of the product and contents of the packaging

It is packaged in 1 200 ml plastic bottle. The packaging contains a 10 ml dosing syringe.

Clear, almost colorless or slightly yellowish solution with a strawberry odor for oral administration.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Accord Healthcare S.L.U.

World Trade Center

Moll de Barcelona s/n, Edifici Est 6th floor

08039 Barcelona.

Spain

Responsible for manufacturing:

Laboratorio Reig Jofré, S.A.

Gran Capità, 10

Sant Joan Despí – 08970 Barcelona

Spain

Date of the last review of this leaflet:April 2022

The detailed and updated information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/