Zidovudine Altan 2 mg/ml solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Zidovudine 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, 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 you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

The active substance in Zidovudine Altan 2 mg/ml solution for infusion is zidovudine. Zidovudine Altan 2 mg/ml solution for infusion belongs to a group of medicines called antiretrovirals. It belongs to a class 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 CD4 cell count in the blood. CD4 cells are a type of white blood cells important for fighting infections.

Zidovudine Altan 2 mg/ml solution for infusion is used in combination with other medicines ("combination therapy") to treat Human Immunodeficiency Virus (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 want you to take Zidovudine Altan 2 mg/ml solution for infusion to help prevent transmission of the virus from mother to child. After birth, the baby may also need to take Zidovudine Altan 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 injection needles).

2. What you need to know before using 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 low levels of white blood cells (neutropenia) or very low levels of red blood cells (anemia).

Zidovudina Altan for newborns

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

• Some 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

Talk to your doctor or pharmacist before starting to use Zidovudina.

Some patients treated with Zidovudine or combination treatments for HIV are at higher risk of experiencing serious adverse reactions.

You should be aware of these potential 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 any of the above apply to you. You may need more frequent medical check-ups, including additional blood tests while taking this medication. See section 4 for more information.

Important symptoms to watch for

In some patients with HIV infection, signs and symptoms—sometimes serious—may occur during treatment with Zidovudine.

Other medicines and Zidovudina Altan

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Do not take the following medicines with Zidovudine:

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

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, used to treat parasitic infections such as pneumocystis pneumonia (PCP)
• Amphotericin or co-trimoxazole, 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 substitute for heroin
• Vincristine, vinblastine, or doxorubicin, used to treat cancer.

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

Some of the medicines that interact with zidovudine include:

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

Inform 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 Zidovudine, the risk of transmitting HIV infection to their baby is reduced.

Zidovudine and similar medicines may cause adverse effects in the fetus. If you have taken Zidovudine during pregnancy, your doctor may request periodic 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 adverse effects occurring.

Breastfeeding

Breastfeeding is not recommended for women living with HIV because HIV infection can be transmitted to the baby through breast milk.

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

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

Driving and using machines

Zidovudine may cause dizziness and other adverse effects that could reduce your alertness.

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

This medicine contains sodium

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

You will need regular blood tests

During treatment with Zidovudine, your doctor will request regular blood tests to monitor for adverse effects. For more information about adverse effects, see section 4 of this leaflet.

Keep regular contact with your doctor

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

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

3. How to use Zidovudine Altan

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will determine the duration of your treatment with Zidovudine Altan 2 mg/ml solution for infusion. Do not stop treatment prematurely.

Zidovudine 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 patient to patient and depends on a number of factors, including the stage of infection. Your doctor will decide the most appropriate dose for you.

Adults and adolescents over 12 years of age:

The dose of zidovudine you will receive depends 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 determine 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 oral formulations are not feasible.

Pregnancy, childbirth and newborns

Zidovudine Altan is not recommended for pregnant women who are less than 14 weeks pregnant. After the fourteenth week, your doctor may prescribe 500 mg, administered as 100 mg five times daily orally, up to the onset of labor. During childbirth and delivery, your doctor may decide to use injectable zidovudine until the umbilical cord is clamped. The newborn may also be given Retrovir to prevent HIV infection.

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 how well these organs are functioning. Follow your doctor's advice.

If you think that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

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

Zidovudine Altan 2 mg/ml solution for infusion must not be administered by intramuscular route.

Zidovudine 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 Zidovudine Altan than you should

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

If you have any further questions about 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 everyone will experience them.

During treatment for HIV, there may be an increase in weight and in blood glucose and lipid levels. This may be partly related to improved health and lifestyle, and in the case of blood lipids, sometimes to HIV medicines 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 the HIV treatment changed.

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. Some adverse effects may only be detected in your 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 using Zidovudine.

In addition to the effects described below, others may occur during combination antiretroviral therapy for HIV.

It is important to read the information on “Other possible adverse effects of combination antiretroviral therapy for HIV”.

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 (anemia) and white blood cells (leukopenia or neutropenia)
• increased liver enzymes in 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 tiredness
• flatulence
• weakness

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

• reduced number of blood cells involved in blood clotting (thrombocytopenia) or of 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 antiretroviral therapy for HIV”)
• liver problems, such as jaundice, enlarged liver, or fatty liver
• inflammation of the pancreas
• chest pain, heart abnormalities
• seizures
• anxiety and depression, inability to sleep (insomnia), difficulty concentrating, drowsiness
• indigestion, loss of appetite, taste disturbances
• changes in nail, skin, or oral mucosa pigmentation
• flu-like syndrome: chills, sweating, and cough
• skin tingling sensation (as if pricked by needles)
• frequent urination
• breast enlargement in men

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

• decreased number of a 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:

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

If you experience any adverse effect

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

Other possible adverse effects of combination antiretroviral therapy for HIV

Other conditions may develop during antiretroviral treatment for HIV.

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 reactivate, 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 you start taking medicines for HIV infection. Autoimmune disorders may appear many months after starting treatment. If you notice any signs of infection or other symptoms such as muscle weakness, weakness starting in the hands and feet and moving up toward the trunk, palpitations, tremors, or hyperactivity, inform your doctor immediately to receive necessary treatment.

If you have any signs 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 life-threatening, leading to organ failure.

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

Signs of lactic acidosis include:

• difficulty breathing, 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 for any signs that you may be developing lactic acidosis. If you experience any of the symptoms listed above, or are concerned about any other symptom:

? See your doctor as soon as possible.

You may have bone problems

Some patients receiving combination antiretroviral therapy for HIV 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 therapy 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 shoulder)
• difficulty moving

If you notice any of these symptoms, inform your doctor.

Other effects that may appear in blood tests:

Combination antiretroviral therapy for HIV 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 Zidovudine.

Reporting of adverse effects:

If you experience any 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. Zidovudine Altan Storage Instructions

Keep this medicine out of sight and reach of children.

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their containers. This helps protect the environment.

6. Contents of the pack and other information

Composition of Zidovudine Altan 2 mg/ml solution for infusion

The active substance 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 injections.

Appearance of the product and contents of the pack

Zidovudine Altan is a sterile, clear, almost colourless solution with a pH of approximately 5.5.

Zidovudine Altan is supplied in packs of 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 Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Altan Pharmaceuticals, S.A.

C/ Cólquide, 6 Portal 2, 1st Floor, Office F

Edificio Prisma

28231 Las Rozas (Madrid)

Manufacturer:

Altan Pharmaceuticals, S.A.

Polígono Industrial de Bernedo s/n

01118 Bernedo (Álava), Spain

Date of the most recent revision of this leaflet: July 2025

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