Prospecto: information for the user

Alprostadil Pfizer 0.5 mg/ml injectable solution

Read this prospect carefully before starting to use this medication,because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribedonlyto you, and you must not give it to other people even iftheyhave the same symptomsas you,as it may harm them.
• If you experienceadverse effects,consult yourdoctor or pharmacist,evenifthey are not listed in this prospect. See section 4.

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

2.What you need to knowbeforestarting touse Alprostadil Pfizer

3.How to use Alprostadil Pfizer

4.Possible adverse effects

5.Storage of Alprostadil Pfizer

6.Contents of the package and additional information

The active ingredient of Alprostadil Pfizer is alprostadil. It is a medication that belongs to the group of medications known as prostaglandins.

Alprostadil Pfizer is used for maintaining the ductus arteriosus in children born with congenital heart defects, who require this duct to remain open until they can be operated on.

Do not useAlprostadil Pfizer:

• if you are allergic to alprostadil or any of the other components ofthis medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Alprostadil Pfizer.

Be especially careful with Alprostadil Pfizer:

• When Alprostadil Pfizer is administered, an interruption of breathing (apnea) may occur, which may be more frequent in newborns weighing less than2 Kgat birth and especially at the beginning of treatment
• if the baby has a respiratory alteration with difficulty breathing (respiratory distress syndrome)
• if used in prolonged treatments, as weakening of the walls of the aortic duct and pulmonary arteries, as well as abnormal growth of bones and in certain cases abnormal growth of gastric cells that may hinder stomach emptying
• if the baby has a tendency to bleed
• When Alprostadil Pfizer is administered, blood pressure, pH, and oxygen levels should be monitored

Alprostadil Pfizershould only be used for the shortest possible time and at the lowest effective dose, in experienced medical centers equipped with pediatric ICU and assisted ventilation systems.

Use of Alprostadil Pfizer with other medications

Not described.

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

Pregnancy, breastfeeding, and fertility

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

Driving and operating machinery

Not applicable.

Alprostadil Pfizercontains ethanol

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

This medication is harmful to individuals with alcoholism.

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

This medication should only be administered by trained medical personnel in pediatric intensive care units. Follow exactly the administration instructions for 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 of0.05to0.1 micrograms of alprostadil/ kg of 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 than necessary is administered, respiratory arrest, slow heart rate, fever, low blood pressure, and shortness of breath may appear. In this case, reduce the administration speed until these symptoms disappear and treat them appropriately.

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 forgot to use Alprostadil Pfizer

Do not administer a double dose to compensate for the missed doses.

If you interrupt treatment with Alprostadil Pfizer

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Adverse effects observed very frequently (may affect more than 1 in 10 people):

• Respiratory arrest (apnea)
• Transient fever

Adverse effects observed frequently (may affect up to 1 in 10 people):

• Low levels of potassium in the blood (potassium deficiency)
• Seizures
• Slow heart rate
• Low blood pressure
• Fast heart rate
• Diarrhea
• Hot flashes
• Redness of the skin

Adverse effects observed infrequently (may affect up to 1 in 100 people):

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

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

Store in the refrigerator (between2°Cand8°C).

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the packagingafter CAD. The expiration date is the last day of the month indicated.

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

Do not use this medication if you observe visible signs of deterioration.

Composition of Alprostadil Pfizer

• The active ingredient is alprostadil, 0.5 mg.
• The other components are anhydrous ethanol.

Appearance of the product and content of the packaging

1ml glass ampoules. Each Alprostadil Pfizer package contains5 ampoules.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Pfizer, S.L.

Avda. de Europa 20-B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Spain

Responsible for manufacturing

Pfizer Manufacturing Belgium NV

Rijksweg 12

2870 Puurs-Sint-Amands

Belgium

Last review date of this leaflet: May 2021

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