Persantin 100 mg coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Persantin 100 mg coated tablets
Dipyridamole
Read the entire leaflet carefully before you start taking 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, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if these are effects not listed in this leaflet. See section 4.
Leaflet contents
- What Persantin is and what it is used for
- What you need to know before taking Persantin
- How to take Persantin
- Possible side effects
- How to store Persantin
- Contents of the pack and other information
1. What Persantin is and what it is used for
This medicine belongs to a group of medicines that prevent platelet aggregation. As a result, the formation of blood clots is prevented.
This medicine is used in combination with oral anticoagulant medicines to prevent blood clots in patients with mechanical heart valve implants.
2. What you need to know before starting Persantin
Do not take Persantin:
- if you are allergic to dipyridamole or any of the other ingredients of this medicine (listed in section 6).
- if you have inherited disorders that may be incompatible with any of the excipients in this medicine (see “Persantin contains sacarose”).
Warnings and precautions
-
if you are scheduled to undergo a pharmacological stress test with intravenous dipyridamole or other adenosine agents (e.g., adenosine, regadenoson), you must stop treatment with oral dipyridamole-containing medicines such as Persantin at least 24 hours before intravenous dipyridamole administration or 48 hours before administration of other adenosine agents, as this may increase the risk of cardiovascular side effects. Taking oral dipyridamole within 24 hours before an intravenous dipyridamole stress test may affect the test's sensitivity.
-
if you have hardening of the coronary arteries, as it may worsen existing angina or trigger it for the first time
-
if you have a severe heart artery disease, including unstable angina, recent myocardial infarction, hemodynamic instability, or subvalvular aortic stenosis
-
if you have myasthenia gravis (a chronic disease characterized by variable degrees of muscle weakness that may progress to paralysis), as dose adjustment may be required (see “Other medicines and Persantin”)
-
if you have gallstones and suffer from ascending cholangitis, as there have been reports of dipyridamole incorporation into gallstones, although these patients had taken oral dipyridamole for years.
Consult your doctor even if any of the above conditions ever applied to you.
Talk to your doctor or pharmacist before starting this medicine.
Other medicines and Persantin
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Dipyridamole may enhance the effects of a drug called adenosine and of antihypertensive medicines. Dipyridamole also increases the cardiovascular effects of regadenoson. It may increase the risk of cardiovascular side effects if dipyridamole is not withheld at least 48 hours before an intravenous adenosine stress test. It may also reduce the effects of cholinesterase inhibitors, potentially worsening myasthenia gravis (a chronic disease characterized by variable degrees of muscle weakness that may progress to paralysis; see section “Warnings and precautions”).
When dipyridamole is administered together with any substance affecting blood coagulation, such as anticoagulants and antiplatelet agents (medicines used to prevent blood clots), the safety profile of these medicines should be closely monitored. Concomitant administration with acetylsalicylic acid and warfarin does not increase the incidence of bleeding or hemorrhage.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will decide whether it is appropriate for you to take this medicine.
Dipyridamole is excreted in breast milk, so you should consult your doctor about whether it is advisable to take this medicine while nursing.
Driving and using machines
While taking this medicine, you may experience undesirable effects such as dizziness. Exercise caution when driving a car or operating machinery. If you experience dizziness, avoid potentially dangerous activities such as driving or using machines.
Persantin contains sacarose.
This medicine contains sacarose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.
3. How to take Persantin
Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again. Your doctor will determine the duration of your treatment with this medicine.
It should be administered orally. Swallow the coated tablets with a sufficient amount of water.
The recommended dose for adults is 3–4 coated tablets, divided into several doses throughout the day (300–400 mg of dipyridamole per day). The maximum daily dose is 6 coated tablets (600 mg of dipyridamole).
If you feel that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.
Use in children
This medicine must not be given to children, as there is insufficient information available for this age group.
If you take more Persantin than you should
Symptoms such as a sensation of warmth, flushing, sweating, restlessness, feeling of weakness, dizziness, anginal discomfort, as well as a drop in blood pressure and increased heart rate may occur.
If you have taken more medicine than you should, consult your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91 562 04 20, stating the medicine and the amount taken. Take the container and the package leaflet to the healthcare professional.
Information for the physician: Symptomatic treatment is recommended and gastric lavage should be considered. Administration of xanthine derivatives (e.g., aminophylline) may counteract the haemodynamic effects of an overdose of dipyridamole. Due to its extensive tissue distribution and predominantly hepatic elimination, procedures aimed at enhancing elimination are not suitable.
If you forget to take Persantin
Do not take a double dose to make up for forgotten doses.
If you stop treatment with Persantin
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.
The following adverse reactions have been reported during clinical trials and post-marketing experience with Persantin.
Adverse effects usually occur at the beginning of treatment and are usually mild and transient.
The adverse effects are listed below, grouped by their frequency of occurrence.
Very common adverse effects (affect more than 1 in 10 patients):
- headache
- dizziness
- nausea
- diarrhoea
Common adverse effects (affect between 1 and 10 in 100 patients):
- chest pain (angina)
- vomiting
- skin rash (exanthema)
- muscle pain (myalgia)
Adverse effects with 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)
- hot flushes
- contraction of bronchial muscles causing breathing difficulty (bronchospasm)
- hives (urticaria)
- bleeding during a medical procedure
- bleeding after surgery
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 via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Persantin
Keep this medicine out of the sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date stated on the packaging. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Persantin
- The active substance is dipyridamole.
- The other components are anhydrous monocalcium phosphate, corn starch, anhydrous colloidal silica, magnesium stearate, sucrose, talc, arabic gum, titanium dioxide (E 171), macrogol 6000, bleached wax, and carnauba wax.
Appearance of the medicine and contents of the pack
Persantin are round, biconvex, coated tablets, white in colour with a yellow core. It is supplied in a container containing 50 coated tablets.
Marketing Authorization Holder
Glenwood GmbH Pharmazeutische Erzeugnisse
Arabellastr.17
81925 Munich
Germany
Manufacturer
Delpharm Reims, S.A.S.
10 Rue Colonel Charbonneaux
51100 Reims (France)
Date of the most recent revision of this leaflet: October 2021
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es