ZIDOVUDINE ACCORD 50 mg/5 ml ORAL SOLUTION

2. What you need to know before you take Zidovudina Accord

Do not takeZidovudina Accord:

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

Zidovudina for newborns

Zidovudina 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 yellowing of the skin).
• Other problems that cause high levels of liver enzymes in the blood.

Warnings and precautions

Some patients treated with zidovudine or with combination therapy for HIV have a higher risk of suffering from serious side effects.

You should be aware of these possible risks:

• During treatment, it is possible that blood disorders (anemia, neutropenia, and leukopenia) may appear.
• Acidosis associated with liver disorders may also appear.
• If you have ever had liver disease (including hepatitis B or C).
• If you have significant overweight (especially if you are a woman)

Talk to your doctor if any of the above cases affect you. You may need more frequent visits to the doctor, 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 Zidovudina Accord.

Read the information in section 4 of this leaflet carefully, if you have any questions about this information ask your doctor.

→ Consult your doctor.

Using Zidovudina Accord with other medicines

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

Do not take these medicines with Zidovudina Accord:

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

Some medicines may increase the risk of side effects or make them worse, for example:

• Sodium valproate, used to treat epilepsy
• Aciclovir, ganciclovir, or interferon, used to treat viral infections
• Pyrithiamine, used to treat malariaand other parasitic infections
• Dapsone, used to prevent pneumoniaand treat skin infections
• Fluconazole or flucytosine, used to treat fungal infections such as Candida
• Pentamidine or atovaquonefor parasitic infections such as Pneumocystis pneumonia (PCP)
• Amphotericin or cotrimoxazole, used to treat fungal or bacterial infections
• Probenecid, used to treat goutand similar conditions, and administered with some antibiotics to make them more effective
• Methadone, used as a heroin substitute
• Vincristine, vinblastine, or doxorubicin, used to treat cancer

Tell your doctorif you are taking any of these medicines.

Some of the medicines that interact with Zidovudina Accord are:

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

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

Pregnancy, breastfeeding, and fertility

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

If HIV-positive pregnant women take Zidovudina, they are less likely to transmit HIV to their baby.

Zidovudina and similar medicines can cause side effects in the fetus. However, the benefit of reducing the possibility of HIV infection is greater than the risk of side effects.

If you have taken Zidovudina Accord during 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

HIV-positive women should not breastfeed, because HIV can be transmitted to the baby through breast milk.

If you are breastfeeding or plan to breastfeed talk to your doctor immediately.

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

If you are breastfeeding or plan to breastfeed

Driving and using machines:

Zidovudina Accord may affect your ability to drive and use machines, as it can cause dizzinessand other side 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 Zidovudina Accord, your doctor will regularly ask for blood tests to check for side effects. For more information on side effects, see section 4 of this leaflet.

Stay in regular contact with your doctor

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

Stay in touch with your doctor and do not stop taking Zidovudina Accordwithout medical advice.

Protect others

HIV infection is transmitted through sexual contact with someone who has the infection or through contact with infected blood (for example, by sharing injection needles). While taking this medicine, you can still transmit HIV to others, although effective antiretroviral therapy reduces the risk.

Consult your doctor about 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 told you that you have an intolerance to some sugars, consult with them before taking this medicine.

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

3. How to take Zidovudina Accord

Follow exactly the instructions for taking Zidovudina Accord as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

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

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

To use Zidovudina 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. Place the bottle in an inverted position.
4. Pull the syringe plunger out to withdraw the correct volume.
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. Rinse the syringe with clean water.

Adults and adolescents weighing at least 30 kg:

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

Children weighing between 9 and 30 kg:

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

Dosage during pregnancy and childbirth:

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

Dosage in patients with adverse hematological reactions:

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

Dosage in elderly patients:

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

Dosage in patients with kidney or liver problems:

If you have severe kidney or liver problems, your doctor may decide to use a lower dose, depending on the functioning of these organs. 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 contact the Toxicology Information Service, phone 91 562 04 20.

If you take a higher dose than prescribed by your doctor, it is unlikely to cause you any harm, but if this happens, 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 forget to take Zidovudina Accord 50 mg/5 ml Oral Solution:

Do not take a double dose to make up for forgotten doses. Simply take another dose as soon as you remember and then continue your treatment as before.

Do not stop taking Zidovudina Accord without medical advice

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

4. Possible Adverse Effects

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

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

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

In addition to the effects described below, others may appear during combined HIV treatment.

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

Very Common Adverse Effects

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

• Headache.
• Nausea.

Common Adverse Effects

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

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

Common adverse effects that may appear in blood tests are:

• Decrease in the number of red blood cells (anemia) and white blood cells (leukopenia or neutropenia).
• Increase in liver enzymes in the blood.
• Increase in bilirubin (a substance produced in the liver) in the blood, which can give the skin a yellowish color.

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).
• Generalized pain and fatigue.
• Flatulence.
• Weakness.

Uncommon adverse effects that may appear in blood tests are:

• Reduction in the number of blood cells involved in blood clotting (thrombocytopenia) or 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 combined HIV treatment”).
• Liver disorders, such as jaundice, liver enlargement, and fatty liver.
• Pancreatitis.
• Chest pain, heart disorders.
• Seizures.
• Anxiety and depression, insomnia, lack of concentration, drowsiness.
• Indigestion, loss of appetite, alteration of taste.
• Changes in nail, skin, or mouth mucosa color.
• Flu-like syndrome: chills, sweating, and cough.
• Feeling of tingling in the skin (like having pins and needles).
• Frequent urination.
• Increased breast size in men.

A rare adverse effect that may appear in blood tests is:

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

Very Rare Adverse Effects

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

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

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

If you experience any type of adverse effect

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

Other Possible Adverse Effects of Combined HIV Treatment

Other conditions 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 severe 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 immune system reacting to these infections.

In addition to opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also appear after you start taking medications for HIV treatment. Autoimmune disorders can 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 moving up to the body, palpitations, tremors, or hyperactivity, inform your doctor immediately to receive necessary treatment.

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

?Tell your doctor immediately. Do not take other medications 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 increase in liver size. 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 life-threatening, 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 limbs.
• Lack of appetite, weight loss.
• Nausea and vomiting.
• Stomach pain.

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

?See your doctor as soon as possible.

You may have bone problems

Some patients receiving combined HIV treatment develop a bone disease called osteonecrosis. 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.

Signs of osteonecrosis include:

• Stiffness in the joints.
• Pain (especially in the hip, knee, or shoulders).
• Difficulty moving.

IF YOU NOTICE ANY OF THESE SYMPTOMS:

?Tell your doctor.

Other effects that may appear in tests:

Combined HIV treatment can also cause:

• Increased lactic acid levels in the blood, which can rarely lead to lactic acidosis.

This effect can be seen in blood tests during treatment with Zidovudina.

Reporting Adverse Effects

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

5. Storage of Zidovudina Accord

Keep this medication out of 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 above 30 ºC.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Packaging Contents and Additional Information

Composition of Zidovudina Accord 50 mg/5 ml Oral Solution

The active ingredient is Zidovudine.

Each 5 ml of Zidovudina 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 flavor (Triacetin (E-1518), Triethyl citrate (E-1505)), and purified water.

Appearance of the Product and Packaging Contents

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

Transparent solution, practically colorless or slightly yellowish and with a strawberry flavor for oral administration.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 Last Revision of this Leaflet:April 2022

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/