ZIDOVUDINE ALTAN 2 mg/ml SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Zidovudina Altan 2 mg/ml Solution for Infusion

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.Keep this leaflet. You may need to read it again.

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Zidovudina Altan is and what it is used for
2. What you need to know before you use Zidovudina Altan
3. How to use Zidovudina Altan
4. Possible side effects
5. Storage of Zidovudina Altan
6. Contents of the pack and other information

1. What Zidovudina Altan is and what it is used for

The active substance of Zidovudina Altan 2 mg/ml solution for infusion is zidovudine. Zidovudina Altan 2 mg/ml solution for infusion belongs to a group of medicines called antiretrovirals. It belongs to a group of medicines known as Nucleoside Reverse Transcriptase Inhibitors (NRTIs).

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

Zidovudina Altan 2 mg/ml solution for infusion is used in combination with other medicines (“combination therapy”) to treat the Human Immunodeficiency Virus (HIV) in adults and children. To control HIV infection and prevent it from getting worse, you must take all your medicines.

If you are pregnant, your doctor may want you to take Zidovudina Altan 2 mg/ml solution for infusion to help prevent the transmission of the virus from mother to child. After birth, it is possible that the baby will also have to take Zidovudina Altan to prevent HIV infection.

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

2. What you need to know before you use Zidovudina Altan

Do not use Zidovudina Altan

If you are allergic to the active substance zidovudine or to 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 Altan 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 yellowing of the skin)
• Other problems that cause high levels of liver enzymes in the blood.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Zidovudina.

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

You should be aware of these possible risks if:

- You have ever had liver disease (including hepatitis B or C)

- You are significantly overweight (especially if you are a woman).

• Talk to your doctor if you are affected by any of the above circumstances. 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, signs and symptoms, sometimes severe, may appear during treatment with Zidovudina.

Other medicines and Zidovudina Altan

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Do not take these medicines with Zidovudina

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

Some medicines may increase the risk of side effects or make them worse, such as:

• sodium valproate, used to treat epilepsy
• acyclovir, 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, to treat 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 administered with some antibiotics to make them more effective.
• methadone, used as a substitute for heroin.
• 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 zidovudine:

• phenytoin, used to treat epilepsy
• clarithromycin, an antibiotic

Tell your doctor if you are taking phenytoin. Your doctor may need to monitor you while you are taking zidovudine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

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

Zidovudine and similar medicines may cause side effects in the fetus. If you have been taking Zidovudina during your pregnancy, your doctor may request that you have regular blood tests and other diagnostic tests to monitor your child's development. In children whose mothers took NRTIs during pregnancy, the benefit of protection against HIV was greater than the risk of side effects.

Breastfeeding

It is not recommended that HIV-positive women breastfeed because HIV infection can be transmitted to the baby through breast milk.

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

If you are breastfeeding or planning to breastfeed, consult your doctor as soon as possible.

Driving and using machines

Zidovudine may cause dizziness and other side effects that may make you less alert.

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

This medicine contains sodium

This medicine contains 354 mg (15.4 mmol) of sodium (the main component of table salt/cooking salt) per 100 ml. This is equivalent to 17.7% of the maximum recommended daily intake of sodium for an adult.

You will need regular blood tests

During treatment with Zidovudina, your doctor will ask you to have regular 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 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 infection.

Stay in touch with your doctor and do not stop taking Zidovudina without their advice.

3. How to use Zidovudina Altan

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Your doctor will indicate the duration of your treatment with Zidovudina Altan 2 mg/ml solution for infusion. Do not interrupt treatment before.

Zidovudina Altan 2 mg/ml solution for infusion is administered by slow intravenous infusion over a period of one hour. The prescribed dose may vary from one patient to another and will depend on a number of factors, including the stage of the infection. Your doctor will decide the most suitable dose for you.

Adults and adolescents over 12 years:

The dose of Zidovudine to be taken will depend on your body weight. The usual dose is 1 or 2 mg of zidovudine per kilogram of body weight every 4 hours.

Children

Your doctor will decide the correct dose of zidovudine for your child, depending on the child's size.

This medicine is normally only administered for short periods (up to 2 weeks) while it is not possible to administer an oral formulation.

Pregnancy, childbirth, and newborns

Zidovudina Altan is not recommended for administration to pregnant women with less than 14 weeks of pregnancy. After the fourteenth week, your doctor may prescribe 500 mg, administered as 100 mg five times a day orally, until the start of labor. During labor and delivery, your doctor may decide to use injectable zidovudine until the umbilical cord is cut. It is possible that Retrovir will also be administered to the newborn to prevent HIV infection.

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 their function. Follow your doctor's advice.

If you think the action of this medicine is too strong or too weak, tell your doctor or pharmacist.

The required dose of zidovudine must be administered by slow IV infusion of the product over a period of 1 hour.

Zidovudina Altan 2 mg/ml solution for infusion should not be administered intramuscularly.

Zidovudina Altan 2 mg/ml solution for infusion contains 2 mg/ml of zidovudine and is ready for use without further manipulation.

If you use more Zidovudina Altan than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

During treatment for HIV, 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 a loss of fat from the legs, arms, and face (lipoatrophy). This loss of body fat 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 medicines, this medicine can cause adverse effects, although not all people suffer from them. Some adverse effects may be reflected in your blood tests, and may not appear until 4-6 weeks after starting to use Zidovudine.

If you experience any of these adverse effects, and if they are severe, your doctor may advise you to stop using 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 (leukopeniaor

neutropenia)

• increase in blood liver enzymes
• increase in bilirubin(a substance produced in the liver) in blood, which can give a yellowish color to the skin.

Uncommon Adverse Effects

May affect up to 1 in 100people 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 1,000people treated with Zidovudine:

• lactic acidosis (excess of lactic acid in the blood; see the following section, “Other possible adverse effects of combined HIV treatment”)
• liver disorders, such as jaundice, liver enlargement, and fatty liver
• pancreatitis
• chest pain, cardiac 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
• tingling sensation in the skin (like having pins and needles)
• frequent urination
• breast enlargement 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 10,000people treated with Zidovudine:

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

• bone marrow failure 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 prospectus.

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 likely 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 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 moving up to the body, 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 medications without your doctor's advice.

Lactic acidosis is a rare but serious adverse effect

Some people using 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, if it occurs, 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.

Signs of lactic acidosis include:

• difficult, rapid, and deep breathing
• drowsiness
• numbness or weakness in the limbs
• loss of appetite, weight loss
• discomfort (nausea) and vomiting
• stomach pain.

During treatment, your doctor will monitor any signs that may indicate you are developing lactic acidosis. If you have 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 shoulder)
• Difficulty moving

If you notice any of these symptoms, inform 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 Zidovudine.

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 prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Zidovudina Altan

Keep this medicine out of sight and reach of children.

Do not store above 30°C. Store in the original packaging to protect from light.

Do not use this medicine after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of packaging and medicines that are no longer needed. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Zidovudina Altan 2 mg/ml solution for infusion

The active ingredient is zidovudine. Each ml contains 2 mg of zidovudine.

The other components are: sodium chloride, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), and water for injectable preparations.

Product Appearance and Package Contents

Zidovudina Altan is a sterile, clear, and almost colorless solution, with a pH of approximately 5.5.

Zidovudina Altan is supplied in 5 poly (vinyl chloride) (PVC) bags of 50 ml or 5 poly (vinyl chloride) (PVC) bags of 100 ml, each containing 2 mg of zidovudine per ml of solution.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Altan Pharmaceuticals, S.A.

C/ Cólquide, 6 Portal 2, 1ª Planta, Oficina F

Edificio Prisma

28230 Las Rozas (Madrid)

Manufacturer:

Altan Pharmaceuticals, S.A.

Polígono Industrial de Bernedo s/n

01118 Bernedo (Álava) Spain

Date of the last revision of this prospectus:July 2025

“Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/”