Alprostadil Pfizer 0.5 mg/ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Alprostadil Pfizer 0.5 mg/ml solution for injection

Read the entire 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, since it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Alprostadil Pfizer is and what it is used for
2. What you need to know before using Alprostadil Pfizer
3. How to use Alprostadil Pfizer
4. Possible side effects
5. How to store Alprostadil Pfizer
6. Contents of the pack and other 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 a group of medicines called prostaglandins.

Alprostadil Pfizer is used to maintain the patency of the ductus arteriosus in newborns born with congenital heart defects, who require this duct to remain open until they can undergo surgery.

2. What you need to know before using Alprostadil Pfizer

Do not use Alprostadil Pfizer:

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

Warnings and precautions

Talk to your doctor or pharmacist before starting treatment with Alprostadil Pfizer.

Take special care with Alprostadil Pfizer:

• When Alprostadil Pfizer is administered, breathing interruption (apnea) may occur, which may be more frequent in babies born weighing less than 2 kg, especially at the beginning of treatment.
• If the baby has a lung disorder with breathing difficulty (respiratory distress syndrome).
• If used for prolonged treatment, as weakening of the walls of the ductus arteriosus and pulmonary arteries has been observed, as well as abnormal bone growth and, in certain cases, abnormal gastric cell growth that may impair stomach emptying.
• If the baby has a tendency to bleed.
• When Alprostadil Pfizer is administered, blood pressure, blood pH, and blood oxygen levels must be monitored.

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

Use of Alprostadil Pfizer with other medicines

No interactions have been reported.

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take 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 Pfizer contains ethanol

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

This medicine is harmful for individuals suffering from alcoholism.

The alcohol content should be taken into account in 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. Always follow exactly the administration instructions for Alprostadil Pfizer provided by your doctor. If in 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 stepwise to the lowest dose that maintains the therapeutic effect.

If you use more Alprostadil Pfizer than you should

If more alprostadil is administered than required, breathing may stop, slow heartbeats, fever, low blood pressure, and flushing may occur. In such a case, the infusion rate should be reduced until these symptoms disappear, and appropriate treatment should be given.

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

If you forget to use Alprostadil Pfizer

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

If you stop treatment with Alprostadil Pfizer

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 experiences them.

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

• Cessation of breathing (apnea)
• Transient fever

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

• Low blood potassium levels (potassium deficiency)
• Seizures
• Slow heartbeats
• Low blood pressure
• Rapid heartbeats
• Diarrhea
• Hot flushes
• Skin redness

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

• Blockage of the stomach outlet
• Thickening of the stomach walls
• Abnormal growth of a bone surface
• Weakness of blood vessels

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through 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. 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 stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

After dilution, the solution may be stored for up to 24 hours at room temperature.

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

6. Package contents and other information

Composition of Alprostadil Pfizer

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

Nature of the product and package contents

1 ml glass vials. Each Alprostadil Pfizer pack contains 5 vials.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 the most recent review of this leaflet: May 2021

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