ALPROSTADIL PFIZER 0.5 mg/ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Alprostadil Pfizer 0.5 mg/ml solution for injection

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.
• 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 symptoms are the same as yours.
• If you experience 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 Alprostadil Pfizer is and what it is used for
2. What you need to know before you use Alprostadil Pfizer
3. How to use Alprostadil Pfizer
4. Possible side effects
5. Storage of Alprostadil Pfizer
6. Contents of the pack and further information

1. What Alprostadil Pfizer is and what it is used for

The active substance of Alprostadil Pfizer is alprostadil. It is a medicine that belongs to the group of medicines called prostaglandins.

Alprostadil Pfizer is used to maintain the ductus arteriosus in children born with congenital heart defects, who need to keep this duct open until they can be operated on.

2. What you need to know before you use Alprostadil Pfizer

Do not useAlprostadil Pfizer:

• if you are allergic to alprostadil or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before you start using Alprostadil Pfizer.

Be particularly careful with Alprostadil Pfizer:

• When Alprostadil Pfizer is administered, an interruption of breathing (apnea) may occur, which may be more frequent in babies who weigh less than 2 kg at birth and especially at the beginning of treatment.
• If the baby has a lung disorder with breathing difficulties (respiratory distress syndrome).
• If it is used in prolonged treatments, as weakening of the walls of the ductus arteriosus and pulmonary arteries, as well as abnormal bone growth and in certain cases abnormal growth of gastric cells, which can make stomach emptying difficult, have been observed.
• If the baby has a tendency to bleed.
• When Alprostadil Pfizer is administered, blood pressure, pH, and blood oxygen should be monitored.

Alprostadil Pfizer should only be used for the shortest possible time and at the lowest effective dose, in experienced medical centers equipped with pediatric intensive care units and assisted ventilation systems.

Using Alprostadil Pfizer with other medicines

None have been described.

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

Pregnancy, breastfeeding, and fertility

Not applicable. Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Not applicable.

Alprostadil Pfizercontains ethanol

This medicine contains 99.9% ethanol (alcohol), which corresponds to an amount of 790 mg/ampoule, equivalent to 20 ml of beer or 8 ml of wine.

This medicine is harmful to people who suffer from alcoholism.

The alcohol content should be taken into account in the case of pregnant or breastfeeding women, children, and high-risk groups, such as patients with liver disease or epilepsy.

3. How to use Alprostadil Pfizer

This medicine should only be administered by trained medical personnel and in centers with pediatric intensive care units. Follow exactly the administration instructions of Alprostadil Pfizer indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

It is recommended to start treatment with a dose of 0.05 to 0.1 micrograms of alprostadil/kg body weight/minute. When the desired response is achieved, the dose should be gradually reduced to the lowest dose that allows maintaining the therapeutic response.

If you use more Alprostadil Pfizer than you should

If more alprostadil is administered than necessary, interruption of breathing, slow heartbeats, fever, low blood pressure, and flushing may occur. In this case, the administration rate should be reduced until these symptoms disappear and treated accordingly.

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

If you forget to use Alprostadil Pfizer

Do not administer a double dose to make up for forgotten doses.

If you stop using Alprostadil Pfizer

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common side effects (may affect more than 1 in 10 people):

• Interruption of breathing (apnea)
• Transient fever

Common side effects (may affect up to 1 in 10 people):

• Low potassium levels in the blood (hypokalemia)
• Seizures
• Slow heartbeats
• Low blood pressure
• Fast heartbeats
• Diarrhea
• Flushing
• Redness of the skin

Uncommon side effects (may affect up to 1 in 100 people):

• Obstruction of the stomach outlet
• Thickening of the stomach walls
• Abnormal growth of the bone surface
• Weakening of blood vessels

Reporting of side effects

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

5. Storage of Alprostadil Pfizer

Store in a refrigerator (between 2°C and 8°C).

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

After dilution, the mixture can be stored for a maximum of 24 hours at room temperature.

Do not use this medicine if you notice visible signs of deterioration.

6. Contents of the pack and further information

Composition of Alprostadil Pfizer

• The active substance is alprostadil, 0.5 mg.
• The other ingredients are anhydrous ethanol.

Appearance and pack contents

1 ml glass ampoules. Each pack of Alprostadil Pfizer contains 5 ampoules.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Pfizer, S.L.

Avda. de Europa 20-B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Spain

Manufacturer

Pfizer Manufacturing Belgium NV

Rijksweg 12

2870 Puurs-Sint-Amands

Belgium

Date of last revision of this leaflet: May 2021

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