Package Leaflet: Information for the User

Zidovudine Altan 2 mg/ml Infusion Solution

Read the entire package leaflet carefully before you start using the medicine.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you 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 leaflet. See section 4.

1. What Zidovudine Altan 2 mg/ml Infusion Solution is and what it is used for

2. What you need to know before you start using Zidovudine Altan 2 mg/ml Infusion Solution

3. How to use Zidovudine Altan 2 mg/ml Infusion Solution

4. Possible side effects

5. Storage of Zidovudine Altan 2 mg/ml Infusion Solution

6. Contents of the pack and additional information

Zidovudina Altan 2 mg/ml infusion solution belongs to a group of medicines called antiretrovirals. It is used to delay the progression of the Human Immunodeficiency Virus (HIV) in adults and children infected with HIV and those who have developed symptoms of Acquired Immunodeficiency Syndrome (AIDS). To understand how Zidovudina Altan 2 mg/ml infusion solution works, it will help to know how HIV multiplies within the body.

HIV reproduces inside CD4 cells (important cells of the immune system) and converts them into "mini-factories" of more virus, which infect more cells. CD4 cells die when new HIV viruses are released. If this process continues without treatment, eventually there will be few CD4 cells left to fight the disease and infection – a situation that usually leads to the development of AIDS.

Zidovudina Altan 2 mg/ml infusion solution does not kill HIV, but it acts by entering infected CD4 cells, helping to interrupt the production of new viruses and their spread to other cells. Therefore, Zidovudina Altan 2 mg/ml infusion solution helps to maintain the body's resistance to the disease, helping to prevent further deterioration of the immune system.

Zidovudina Altan 2 mg/ml infusion solution is used to treat Human Immunodeficiency Virus (HIV) in adults and children. It is usually used in combination with other similar medicines, except in the case of HIV-positive pregnant women. However, in the case of HIV-positive pregnant women, Zidovudina Altan 2 mg/ml infusion solution can be administered alone (after week 14 of gestation). Zidovudina Altan 2 mg/ml infusion solution is administered during pregnancy to help prevent the transmission of the virus from mother to child. Zidovudina Altan 2 mg/ml infusion solution can also be administered to newborn children for 6 weeks after birth.

No use Zidovudine Altan

If you are allergic to zidovudine or any of the other components of this medication (see section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Zidovudine Altan.

If you or your child have any blood disorder such as anemia (low red blood cell count), kidney or liver problems, are being treated with other medication, or the newborn has jaundice, inform your doctor BEFORE starting treatment.

Remember that zidovudine treatment does not reduce the risk of HIV transmission through sexual contact or blood transfusion. You continue to be able to infect others while using this medication.

Consult your doctor if you have a history of liver disease. Patients with chronic hepatitis B or C and treated with antiretroviral drugs have a higher risk of severe and potentially fatal liver reactions and may require blood tests to monitor liver function.

Use with other medications

Inform your doctor or pharmacist if you are using, have used, recently used, or may need to use any other medication.

As part of your treatment, your doctor may prescribe other medication. This will be compatible with the use of this medication as long as your doctor knows your situation and if you are taking other medications.

Zidovudine may interact with certain medications; these may produce worse side effects. It is essential to inform your doctor if you are taking any of the following medications (ask your doctor if you are unsure):

?Fenitoin, ribavirin, and probenecid.

?Estavudine, rifampicin, atovaquone, valproate sodium, fluconazole, and methadone.

?Dapsone.

?Pentamidine, pyrimethamine, cotrimoxazole, amphotericin, flucytosine, ganciclovir, interferon, vincristine, vinblastine, and doxorubicin.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Women with HIV who are pregnant may use zidovudine (after the first three months of pregnancy) to reduce the risk of HIV transmission to the future child. Zidovudine is administered until and during delivery and is discontinued after it. It is also administered to the newborn during the first six weeks of life.

If you have used zidovudine during your pregnancy, your doctor may request that you visit regularly to monitor your child's development. These visits may include blood tests and other diagnostic tests.

In children whose mothers took nucleoside and nucleotide analogs during pregnancy, the benefit of reducing the possibility of being infected with HIV is greater than the risk of experiencing side effects.

It is essential to carefully weigh the benefits of reducing the risk of HIV infection against possible unknown side effects that the child may experience later. If you are using this medication to reduce the risk of infecting your baby, please discuss any concerns you may have with your doctor.

Driving and operating machinery

This medication may affect your ability to drive and operate machinery.

This medication contains sodium

This medication contains 354 mg (15.4 mmol) of sodium per 100 ml, which should be taken into account in the treatment of patients with low-sodium diets.

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

Your doctor will inform you of the duration of your treatment with Zidovudina Altan 2 mg/ml infusion solution. Do not discontinue treatment before.

Zidovudina Altan 2 mg/ml infusion solution 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 on the most suitable dose for you.

?The usual dose in adults is 1 or 2 mg of zidovudine per kilogram of body weight every 4 hours.

?The usual dose in children is 80 to 160 mg per square meter of body surface area every 6 hours.

?This medication is normally only administered for short periods of time (up to 2 weeks) while an oral formulation is not possible.

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

The required dose of zidovudinemust be administered by slow IV infusion of the productover a period of 1 hour.

Zidovudina Altan 2 mg/ml infusion solution MUST NOT be administered by intramuscular route.

Zidovudina Altan 2 mg/ml infusion solution 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

In patients with initial HIV infection, side effects are less common than in patients with AIDS. However, due to the mechanism of action of zidovudine, it may sometimes cause side effects. If you notice any of these side effects, inform your doctor.

?The most common one is a decrease in red blood cell production, which leads to anemia. If this occurs, symptoms are fatigue and difficulty breathing. In this case, your doctor will probably reduce the dose or temporarily interrupt treatment, usually between two and four weeks, to give time for your blood levels to recover. Less commonly, the production of a certain type of white blood cell may be reduced, making you more prone to infections. Your doctor may want to perform blood tests at regular intervals to monitor your blood counts. Generally, these effects are reversible.

?Nausea, vomiting, changes in the color of the mucous membranes inside the mouth, stomach pain, burning, loss of appetite, diarrhea, and gas in the stomach. In most cases, all these side effects disappear on their own after a few weeks, keep this in mind if you experience them. Inform your doctor if they do not disappear or worsen.

?Headache, dizziness, numbness, inability to concentrate, seizures, depression, anxiety, and inability to sleep.

?Difficulty breathing and coughing.

?Change in nail and skin color, skin rash (redness, inflammation, or itching) and sweating.

?Liver disorders, for example, liver enlargement, fatty liver, and jaundice.

?Pancreatitis, which produces digestive juices and insulin.

?Muscle pain may develop.

?Flu-like symptoms, fever, fatigue, chills, chest pain, breast enlargement in men, changes in taste, general pain, and frequent urination.

?Cardiomyopathy (heart muscle disease). Symptoms may include difficulty breathing, inflammation of the ankles, or fluid in the lungs.

?Some people taking zidovudine may develop a rare but serious condition called lactic acidosis, along with liver enlargement. An increase in lactic acid in the body can lead to coma and, in some cases, put life at risk. When the situation develops, you may experience stomach pain, nausea (dizziness), vomiting, respiratory problems, and numbness. In severe cases, pancreatitis, liver or kidney failure, or increased lactate in the body may develop. If you have liver disease or are an obese woman (with significant overweight), there is a greater risk of developing this situation, which usually appears a few months after treatment.

?Redistribution, accumulation, or loss of body fat may occur in patients receiving combination antiretroviral treatment. Combination antiretroviral treatment may cause a change in body shape due to changes in fat distribution. These may include loss of fat in the legs, arms, and face, an increase in abdominal fat (belly), and fat accumulation in other internal organs, breast enlargement, and the appearance of fat deposits at the back of the neck ("buffalo hump"). At present, the cause and long-term health effects of these events are unknown. Treatment with a combination of antiretrovirals may also cause increased lactic acid and blood sugar, hyperlipemia (increased blood fats), and insulin resistance. Contact your doctor if you notice changes in body fat.

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 that does not appear in this prospectus. 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.

Do not store at a temperature above30°C. Store in the original packaging to protect it from light.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacisthow to disposeofthepackaging and ofthemedicines that you no longerneed. This will help protect the environment.

Composition of Zidovudine Altan 2 mg/ml infusion solution

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 injection preparations.

Appearance of the product and contents of the packaging

PVC (vinyl chloride) bags of 5, 50 ml or 100 ml, containing 2 mg of zidovudine per ml of solution.

Holder of the marketing authorization and manufacturer responsible

Holder of the marketing authorization:

Altan Pharmaceuticals, S.A.

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

Edificio Prisma

28230 Las Rozas (Madrid)

Manufacturer responsible:

Altan Pharmaceuticals, S.A.

Polígono Industrial de Bernedo s/n

01118 Bernedo (Álava)Spain

Last review date of this leaflet:july 2007

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