Package Insert: Information for the Patient

Persantin 100 mg Coated Tablets

Dipiridamol

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

This medication belongs to a group of medications that prevent platelet aggregation. Consequently, the formation of blood clots is prevented.

This medication is used, in combination with oral anticoagulant medications, to prevent the formation of blood clots in patients with mechanical heart valve implants.

Do not take Persantin:

-if you are allergic to dipyradimole or any of the other components of this medication (listed in section 6).

-if you have hereditary diseases that may be incompatible with any of the excipients of this medication (see “Persantin contains saccharose”).

Warnings and precautions

• if you are to undergo a pharmacological stress test with dipyradimole via intravenous or other adenosine agents (e.g., adenosine, regadenoson), you must interrupt treatment with oral medications containing dipyradimole, such as Persantin, 24 hours before the administration of dipyradimole via intravenous or 48 hours before the administration of other adenosine agents, as it may increase the risk of cardiovascular side effects. Taking dipyradimole orally 24 hours before the test with dipyradimole via intravenous may affect the sensitivity of the test.
• if you have coronary artery hardening, as it may worsen existing angina or cause it for the first time
• if you have severe coronary artery disease, including unstable angina, recent myocardial infarction, circulatory instability, or subvalvular aortic stenosis
• if you have myasthenia gravis (a chronic disease characterized by variable degrees of muscle weakness, which may progress to paralysis), as it may be necessary to adjust the dose (see ”Other medications and Persantin”)

• if you have gallstones and have inflammation of the ascending bile duct, as cases of dipyradimole incorporation into these stones have been described, although these patients had taken oral dipyradimole for years.

Consult your doctor even if any of the circumstances mentioned above have occurred at any time.

Consult your doctor or pharmacist before starting to take this medication.

Other medications and Persantin

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

Dipyradimole may potentiate the effects of a medication called adenosine and of medications that lower blood pressure. Dipyradimole also increases the cardiovascular effects of regadenoson. It may increase the risk of cardiovascular side effects when dipyradimole is not administered 48 hours before the pharmacological stress test with intravenous adenosine agents. It may also reduce the effects of cholinesterase inhibitors, potentially worsening myasthenia gravis (a chronic disease characterized by variable degrees of muscle weakness, which may progress to paralysis; see section “Warnings and precautions”).

When dipyradimole is administered with any substance that affects coagulation, such as anticoagulants and antiplatelet agents (medications used to prevent blood clots or bleeding), the safety profile of these medications should be monitored. The concurrent administration with acetylsalicylic acid and warfarin does not increase the incidence of bleeding or hemorrhage.

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication. Your doctor will then decide whether it is advisable to take this medication.

Dipyradimole is excreted in breast milk, so you should consult with your doctor about the advisability of taking this medication while breastfeeding.

Driving and operating machinery

While taking this medication, you may experience unwanted effects such as dizziness. You should be cautious when driving a car or operating machinery. If you experience dizziness, you should avoid potentially hazardous activities such as driving or using machinery.

Persantin contains saccharose.

This medication contains saccharose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again. Your doctor will inform you of the duration of your treatment with this medication.

It should be taken orally. Swallow the coated tablets with a sufficient amount of water.

The recommended dose for adults is 3-4 coated tablets, taken at different times throughout the day (300-400 mg of dipiridamol per day). The maximum daily dose is 6 coated tablets (600 mg of dipiridamol).

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

Use in children

This medication should not be administered to children, as there is not enough information available for this age group.

If you take more Persantin than you should

Symptoms such as a feeling of heat, hot flashes, sweating, restlessness, feeling of weakness, dizziness, and angina-like discomfort, as well as a decrease in blood pressure and an increase in heart rate, may occur.

If you have taken more medication than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken. Bring the packaging and the leaflet to the healthcare professional.

Information for the doctor: Symptomatic treatment is recommended, and consideration should be given to the need for gastric lavage. The administration of xanthine derivatives (e.g. aminophylline) may counteract the hemodynamic effects of a dipiridamol overdose. Due to its wide distribution to tissues and predominant hepatic elimination, elimination-enhancing procedures are not suitable.

If you forgot to take Persantin

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

If you interrupt treatment with Persantin

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 will experience them.

The following adverse reactions have been reported during the use of Persantin in clinical trials and during post-marketing experience.

Adverse effects usually appear at the beginning of treatment and are usually mild and transient.

Adverse effects are detailed below, grouped by frequency of occurrence.

Very frequent adverse effects (affecting more than 1 in 10 patients):

• headache
• dizziness
• nausea
• diarrhea

Frequent adverse effects (affecting between 1 and 10 in 100 patients):

• angina pectoris
• vomiting
• skin rash (exanthema)
• muscle pain (myalgia)

Adverse effects of unknown frequency (cannot be estimated from available data):

• decrease in the number of platelets in the blood (thrombocytopenia)
• allergic reactions (hypersensitivity)
• rapid swelling of the skin and mucous membranes (angioedema)
• increased heart rate (tachycardia)
• low blood pressure (hypotension)
• seizures
• constriction of the bronchial muscle that makes breathing difficult (bronchospasm)
• hives (urticaria)
• bleeding during a medical procedure
• bleeding after an intervention

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear 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.

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

No special storage conditions are required.

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

Do not dispose of medications through the drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Persantin

• The active ingredient is dipiridamol.
• The other components are anhydrous monocalcium phosphate, cornstarch, anhydrous colloidal silica, magnesium stearate, saccharose, talc, arabic gum, titanium dioxide (E 171), macrogol 6000, bleached wax, and carnauba wax.

Appearance of the product and content of the container

Persantin are round, biconvex, white-coated tablets with a yellow core. They are presented in a container containing 50 coated tablets.

Holder of the marketing authorization

Glenwood GmbH Pharmazeutische Erzeugnisse

Arabellastr.17

81925 Munich

Germany

Responsible for manufacturing

Delpharm Reims, S.A.S.

10 Rue Colonel Charbonneaux

51100 Reims (France)

Date of the last review of this leaflet:October 2021

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